CAMIH - User contributions [en]

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T13:20:25Z

VMathies:

{{Reference
|Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

In dieser Studie werden vier verschiedenen Gruppen mit Schilddrüsenkrebs untersucht, die zu verschiedenen Zeitpunkten beginnen, zusätzlich zur Radiojodtherapie gelöstes Vitamin C zu saugen, um den Speichelfluss zu stimulieren (1, 5, 13 oder 25 Stunden nach der Radiojodtherapie). Das Ziel der Vitamin C-Gabe war, über die Stimulation des Speichelflusses die Ausscheidung des Radiojods aus den Speicheldrüsen zu beschleunigen und damit die Speicheldrüsen zu schützen. Die Autoren fanden keine bedeutsamen Unterschiede zwischen den vier Gruppen hinsichtlich der radioaktiven Exposition der Speicheldrüsen. Ein Nachteil dieser Studie ist, dass keine Kontrollgruppe vorhanden ist, die überhaupt kein Vitamin C bekommen hat. Somit sagt diese Studie nur aus, dass es keine Unterschiede gibt, zu welchem Zeitpunkt Vitamin C gegeben wird.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number n (Male/Female):
Arm A: 2/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 1 hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 25 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary activity
|Type of measurement=Scintigraphy
|Results during intervention=No data available
|Results after intervention=No data available
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary Absorbed Dose

Frage: Wurde mit Formel berechnet; das einzige was hierfür gemessen werden musste, war die Masse der Speicheldrüsen mittels CT
Was gebe ich dann als Type of measurement an? Others?
|Type of measurement=Others
|Results during intervention=Single parotid gland: no differences between arms (P=0.37)
Single submandibular gland: no differences between arms (P=0.28)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=2
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary cumulated activities in first 24h after 131I ingestion divided by total cumulated activities
|Type of measurement=Scintigraphy
|Results during intervention=Parotid gland: no differences between arms (P=0.21)
Submandibular gland: no differences between arms (P=0.16)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=3
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary absorbed dose during the first 24 h after 131I ingestion
|Type of measurement=Others
|Results during intervention=Parotid gland: no differences between arms (P=0.32)
Submandibular gland: no differences between arms (P=0.24)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=4
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO: Low dropout, evenly distributed per arm

CONTRA: Very small sample size per arm; No comparison sample without vitamin C; Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T13:18:40Z

VMathies:

{{Reference
|Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

In dieser Studie werden vier verschiedenen Gruppen mit Schilddrüsenkrebs untersucht, die zu verschiedenen Zeitpunkten beginnen, zusätzlich zur Radiojodtherapie gelöstes Vitamin C zu saugen, um den Speichelfluss zu stimulieren (1, 5, 13 oder 25 Stunden nach der Radiojodtherapie). Das Ziel der Vitamin C-Gabe war, über die Stimulation des Speichelflusses die Ausscheidung des Radiojods aus den Speicheldrüsen zu beschleunigen und damit die Speicheldrüsen zu schützen. Die Autoren fanden keine bedeutsamen Unterschiede zwischen den vier Gruppen hinsichtlich der radioaktiven Exposition der Speicheldrüsen. Ein Nachteil dieser Studie ist, dass keine Kontrollgruppe vorhanden ist, die überhaupt kein Vitamin C bekommen hat. Somit sagt diese Studie nur aus, dass es keine Unterschiede gibt, zu welchem Zeitpunkt Vitamin C gegeben wird.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number n (Male/Female):
Arm A: 2/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 1 hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 25 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary activity
|Type of measurement=Scintigraphy
|Results during intervention=No data available
|Results after intervention=No data available
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary Absorbed Dose

Frage: Wurde mit Formel berechnet; das einzige was hierfür gemessen werden musste, war die Masse der Speicheldrüsen mittels CT
Was gebe ich dann als Type of measurement an? Others?
|Type of measurement=Others
|Results during intervention=Single parotid gland: no differences between arms (P=0.37)
Single submandibular gland: no differences between arms (P=0.28)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=2
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary cumulated activities in first 24h after 131I ingestion divided by total cumulated activities
|Type of measurement=Scintigraphy
|Results during intervention=Parotid gland: no differences between arms (P=0.21)
Submandibular gland: no differences between arms (P=0.16)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=3
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=salivary absorbed dose during the first 24 h after 131I ingestion
|Type of measurement=?
|Results during intervention=Parotid gland: no differences between arms (P=0.32)
Submandibular gland: no differences between arms (P=0.24)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=4
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO: Low dropout, evenly distributed per arm

CONTRA: Very small sample size per arm; No comparison sample without vitamin C; Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T13:15:37Z

VMathies:

{{Reference
|Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

In dieser Studie werden vier verschiedenen Gruppen mit Schilddrüsenkrebs untersucht, die zu verschiedenen Zeitpunkten beginnen, zusätzlich zur Radiojodtherapie gelöstes Vitamin C zu saugen, um den Speichelfluss zu stimulieren (1, 5, 13 oder 25 Stunden nach der Radiojodtherapie). Das Ziel der Vitamin C-Gabe war, über die Stimulation des Speichelflusses die Ausscheidung des Radiojods aus den Speicheldrüsen zu beschleunigen und damit die Speicheldrüsen zu schützen. Die Autoren fanden keine bedeutsamen Unterschiede zwischen den vier Gruppen hinsichtlich der radioaktiven Exposition der Speicheldrüsen. Ein Nachteil dieser Studie ist, dass keine Kontrollgruppe vorhanden ist, die überhaupt kein Vitamin C bekommen hat. Somit sagt diese Studie nur aus, dass es keine Unterschiede gibt, zu welchem Zeitpunkt Vitamin C gegeben wird.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number n (Male/Female):
Arm A: 2/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 1 hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary activity
|Type of measurement=Scintigraphy
|Results during intervention=No data available
|Results after intervention=No data available
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary Absorbed Dose

Frage: Wurde mit Formel berechnet; das einzige was hierfür gemessen werden musste, war die Masse der Speicheldrüsen mittels CT
Was gebe ich dann als Type of measurement an? Others?
|Type of measurement=Others
|Results during intervention=Single parotid gland: no differences between arms (P=0.37)
Single submandibular gland: no differences between arms (P=0.28)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=2
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary cumulated activities in first 24h after 131I ingestion divided by total cumulated activities
|Type of measurement=Scintigraphy
|Results during intervention=Parotid gland: no differences between arms (P=0.21)
Submandibular gland: no differences between arms (P=0.16)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=3
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=salivary absorbed dose during the first 24 h after 131I ingestion
|Type of measurement=?
|Results during intervention=Parotid gland: no differences between arms (P=0.32)
Submandibular gland: no differences between arms (P=0.24)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=4
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO: Low dropout, evenly distributed per arm

CONTRA: Very small sample size per arm; No comparison sample without vitamin C; Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T13:14:30Z

VMathies:

{{Reference
|Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

In dieser Studie werden vier verschiedenen Gruppen mit Schilddrüsenkrebs untersucht, die zu verschiedenen Zeitpunkten beginnen, zusätzlich zur Radiojodtherapie gelöstes Vitamin C zu saugen, um den Speichelfluss zu stimulieren (1, 5, 13 oder 25 Stunden nach der Radiojodtherapie). Das Ziel der Vitamin C-Gabe war, über die Stimulation des Speichelflusses die Ausscheidung des Radiojods aus den Speicheldrüsen zu beschleunigen und damit die Speicheldrüsen zu schützen. Die Autoren fanden keine bedeutsamen Unterschiede zwischen den vier Gruppen hinsichtlich der radioaktiven Exposition der Speicheldrüsen. Ein Nachteil dieser Studie ist, dass keine Kontrollgruppe vorhanden ist, die überhaupt kein Vitamin C bekommen hat. Somit sagt diese Studie nur aus, dass es keine Unterschiede gibt, zu welchem Zeitpunkt Vitamin C gegeben wird.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number n (Male/Female):
Arm A: 2/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary activity
|Type of measurement=Scintigraphy
|Results during intervention=No data available
|Results after intervention=No data available
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary Absorbed Dose

Frage: Wurde mit Formel berechnet; das einzige was hierfür gemessen werden musste, war die Masse der Speicheldrüsen mittels CT
Was gebe ich dann als Type of measurement an? Others?
|Type of measurement=Others
|Results during intervention=Single parotid gland: no differences between arms (P=0.37)
Single submandibular gland: no differences between arms (P=0.28)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=2
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=Salivary cumulated activities in first 24h after 131I ingestion divided by total cumulated activities
|Type of measurement=Scintigraphy
|Results during intervention=Parotid gland: no differences between arms (P=0.21)
Submandibular gland: no differences between arms (P=0.16)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=3
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary gland function
|Outcome specification=salivary absorbed dose during the first 24 h after 131I ingestion
|Type of measurement=?
|Results during intervention=Parotid gland: no differences between arms (P=0.32)
Submandibular gland: no differences between arms (P=0.24)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=4
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO: Low dropout, evenly distributed per arm

CONTRA: Very small sample size per arm; No comparison sample without vitamin C; Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T11:56:32Z

VMathies:

{{Reference
|Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

In dieser Studie werden vier verschiedenen Gruppen mit Schilddrüsenkrebs untersucht, die zu verschiedenen Zeitpunkten beginnen, zusätzlich zur Radiojodtherapie gelöstes Vitamin C zu saugen, um den Speichelfluss zu stimulieren (1, 5, 13 oder 25 Stunden nach der Radiojodtherapie). Das Ziel der Vitamin C-Gabe war, über die Stimulation des Speichelflusses die Ausscheidung des Radiojods aus den Speicheldrüsen zu beschleunigen und damit die Speicheldrüsen zu schützen. Die Autoren fanden keine bedeutsamen Unterschiede zwischen den vier Gruppen hinsichtlich der radioaktiven Exposition der Speicheldrüsen. Ein Nachteil dieser Studie ist, dass keine Kontrollgruppe vorhanden ist, die überhaupt kein Vitamin C bekommen hat. Somit sagt diese Studie nur aus, dass es keine Unterschiede gibt, zu welchem Zeitpunkt Vitamin C gegeben wird.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number n (Male/Female):
Arm A: 2/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Salivary activity
|Outcome specification=NA
|Type of measurement=Scintigraphy
|Results during intervention=No data available
|Results after intervention=No data available
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary Absorbed Dose
|Outcome specification=Frage: Wurde mit Formel berechnet; das einzige was hierfür gemessen werden musste, war die Masse der Speicheldrüsen mittels CT
Was gebe ich dann als Type of measurement an? Others?
|Type of measurement=Others
|Results during intervention=Single parotid gland: no differences between arms (P=0.37)
Single submandibular gland: no differences between arms (P=0.28)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=2
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary cumulated activities
|Outcome specification=Salivary cumulated activities in first 24h after 131I ingestion divided by total cumulated activities
|Type of measurement=Scintigraphy
|Results during intervention=Parotid gland: no differences between arms (P=0.21)
Submandibular gland: no differences between arms (P=0.16)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=3
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary Absorbed Dose
|Outcome specification=salivary absorbed dose during the first 24 h after 131I ingestion
|Type of measurement=?
|Results during intervention=Parotid gland: no differences between arms (P=0.32)
Submandibular gland: no differences between arms (P=0.24)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=4
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO: Low dropout, evenly distributed per arm

CONTRA: Very small sample size per arm; No comparison sample without vitamin C; Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T11:45:12Z

VMathies:

{{Reference
|Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

In dieser Studie werden vier verschiedenen Gruppen mit Schilddrüsenkrebs untersucht, die zu verschiedenen Zeitpunkten beginnen, zusätzlich zur Radiojodtherapie gelöstes Vitamin C zu saugen, um den Speichelfluss zu stimulieren (1, 5, 13 oder 25 Stunden nach der Radiojodtherapie). Das Ziel der Vitamin C-Gabe war, über die Stimulation des Speichelflusses die Ausscheidung des Radiojods aus den Speicheldrüsen zu beschleunigen und damit die Speicheldrüsen zu schützen. Die Autoren fanden keine bedeutsamen Unterschiede zwischen den vier Gruppen hinsichtlich der radioaktiven Exposition der Speicheldrüsen. Ein Nachteil dieser Studie ist, dass keine Kontrollgruppe vorhanden ist, die überhaupt kein Vitamin C bekommen hat. Somit sagt diese Studie nur aus, dass es keine Unterschiede gibt, zu welchem Zeitpunkt Vitamin C gegeben wird.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number n (Male/Female):
Arm A: 2/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=20
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Salivary activity
|Outcome specification=NA
|Type of measurement=Scintigraphy
|Results during intervention=No data available
|Results after intervention=No data available
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=Salivary Absorbed Dose
|Outcome specification=Frage: Wurde mit Formel berechnet; das einzige was hierfür gemessen werden musste, war die Masse der Speicheldrüsen mittels CT
Was gebe ich dann als Type of measurement an? Others?
|Type of measurement=Others
|Results during intervention=Single parotid gland: no differences between arms (P=0.37)
Single submandibular gland: no differences between arms (P=0.28)
|Results after intervention=NA
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=2
}}
{{Outcome
|Outcome type=?
|Outcome name=?
|Outcome specification=?
|Type of measurement=?
|Results during intervention=?
|Results after intervention=?
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO: Low dropout, evenly distributed per arm

CONTRA: Very small sample size per arm; No comparison sample without vitamin C; Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T11:03:14Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T11:00:56Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-18T10:58:49Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:25:51Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:24:15Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:23:30Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:22:56Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:21:22Z

VMathies:

{{Reference
|Reference=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note
|Study Note=?
}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number (n, M/F):
Arm A: 1/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=18
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=18
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=19
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=17
|Drop-out=3
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=4
}}
{{Arm Overview}}
=Outcomes=

{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO
Low dropout, evenly distributed per arm

CONTRA
Very small sample size per arm
No comparison sample without vitamin C

Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:18:24Z

VMathies:

{{Reference
|Reference=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note
|Study Note=?
}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number (n, M/F):
Arm A: 1/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=18
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h for 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=18
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=-999
|Drop-out=1
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at 13 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h in the daytime over 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=3
}}
{{Arm Overview}}
=Outcomes=

{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO
Low dropout, evenly distributed per arm

CONTRA
Very small sample size per arm
No comparison sample without vitamin C

Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:15:28Z

VMathies:

{{Reference
|Reference=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note
|Study Note=?
}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=?, NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number (n, M/F):
Arm A: 1/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=18
|Drop-out=2
|Drop-out reasons=Did not complete salivary dosimetry measurements
|Intervention=Sucking vitamin C at 5 hours after ingestion of 131I
|Dosage and regime=100 mg every 4 h for 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=18
|Drop-out=2
|Drop-out reasons=Showed distant metastases on posttherapy scans
|Intervention=Sucking vitamin C at hour after ingestion of 131I
|Dosage and regime=100 mg every 4 h for 6 d
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=?
|Number of participants (arm)=-999
|Drop-out=?
|Drop-out reasons=?
|Intervention=?
|Dosage and regime=?
|One-time application=No
|Duration in days=?
|Side Effects / Interactions=?
|Order number=1
}}
{{Arm Overview}}
=Outcomes=

{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO
Low dropout, evenly distributed per arm

CONTRA
Very small sample size per arm
No comparison sample without vitamin C

Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T10:08:44Z

VMathies:

{{Reference
|Reference=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note
|Study Note=?
}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=?, NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number (n, M/F):
Arm A: 1/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm Overview}}
=Outcomes=

{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=PRO
Low dropout, evenly distributed per arm

CONTRA
Very small sample size per arm
No comparison sample without vitamin C

Only a few baseline characteristics investigated (no information to cancer stage); arm differences possible.
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:59:18Z

VMathies:

{{Reference
|Reference=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note
|Study Note=?
}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=Presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=?, NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=Radioiodine therapy (131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=Number (n, M/F):
Arm A: 1/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=Mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm Overview}}
=Outcomes=

{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=?
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:57:32Z

VMathies:

{{Reference
|Reference=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
}}
{{Study Note
|Study Note=?
}}
=Brief summary=
In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy). The aim of the vitamin C administration was to accelerate the excretion of radioiodine from the salivary glands by stimulating saliva flow, thereby protecting the salivary glands. The authors found no significant differences between the four arms regarding the radioactive exposure of the salivary glands. A drawback of this study is the absence of a control group that received no vitamin C at all. Therefore, this study only indicates that there are no differences regarding the timing of vitamin C administration.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Single
|Is randomized=Yes
|Cross-over=No
|Number of arms=4
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=18 y old, case of recently diagnosed differentiated papillary or follicular thyroid cancer, undergone total thyroidectomy, referred to the Department of Nuclear Medicine, West China Hospital, for ablation of remnant thyroid tissue, stage pT1–T3, N0–N1, M0. For women of childbearing potential: a negative result on serum human chorionic gonadotropin pregnancy testing required
|Exclusion criteria=presence of distant metastases; a previous history of salivary gland disorders, collagen tissue disease, diabetes, previous 131I therapy, or external radiation to the head or neck; or difficulty drinking a large amount of water.
|N randomized=80
|Analysis=PP Analysis
|Specifications on analyses=NI
|Countries of data collection=China
|LoE=2b Oxford 2009
|Outcome timeline=A: 1 hour after ingestion of 131I
B: 5 hours after ingestion of 131I
C: 13 hours after ingestion of 131I
D: 25 hours after ingestion of 131I
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=?, NI
|Types of cancer=Head and Neck Cancers - Thyroid Cancer
|Stage cancer=Early Stage
|Cancer stage specification=pT1–T3, N0–N1, M0
|Comorbidity=NI
|Current cancer therapy=Radioiodine treatment
|Specifications on cancer therapies=radioiodine therapy(131I)
|Previous cancer therapies=Surgery
|Gender=Mixed
|Gender specifications=number (n, M/F):
Arm A: 1/16
Arm B: 3/15
Arm C: 7/12
Arm D: 2/15
|Age groups=Adults (18+)
|Age groups specification=mean (SD)
Arm A: 44 (14)
Arm B: 42 (14)
Arm C: 43 (13)
Arm D: 39 (12)
}}
=Arms=

{{Arm Overview}}
=Outcomes=

{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This work was supported by the National Natural Science Fund of China (grants 30670585 and 30870724).
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=?
}}

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:49:57Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:49:21Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:33:14Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:29:02Z

VMathies:

Liu et al. (2010): Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:28:37Z

VMathies: Created page with "{{Reference |Reference=Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial }} {{Study Note |Study Note=? }} =Brief summary= In this study, four different arms of thyroid cancer patients were examined, each beginning at different times to suck dissolved vitamin C in addition to radioiodine therapy to stimulate saliva flow (1, 5, 13, or 25 hours after radioiodine therapy..."

Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial

2024-07-17T09:21:05Z

VMathies: Created page with "{{Publication |Title=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial |Topic=Vitamin C |Author=Liu, B; Kuang, A; Huang, R; Zhao, Z; Zeng, Y; Wang, J; Tian, R |Year=2010 |Journal=Journal of nuclear medicine |DOI=http://dx.doi.org/10.2967/jnumed.109.071449 |Authors Abstract=In this study, vitamin C was administered at various times as a sour stimulant to thyroid cancer patients, a..."

{{Publication
|Title=Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial
|Topic=Vitamin C
|Author=Liu, B; Kuang, A; Huang, R; Zhao, Z; Zeng, Y; Wang, J; Tian, R
|Year=2010
|Journal=Journal of nuclear medicine
|DOI=http://dx.doi.org/10.2967/jnumed.109.071449
|Authors Abstract=In this study, vitamin C was administered at various times as a sour stimulant to thyroid cancer patients, and the effect on salivary absorbed dose of therapeutic radioiodine (131I) was investigated.

Methods: Patients with differentiated thyroid cancer who had been prepared for thyroid remnant ablation after total thyroidectomy were prospectively recruited and, using a random-number table, were divided into 4 groups. In the hypothyroid condition, the patients in groups A, B, C, and D began sucking vitamin C (100 mg every 4 h in the daytime over 6 d) at 1, 5, 13, and 25 h, respectively, after receiving 3.7 GBq of (131)I. Scintigraphic images of the head and neck were serially acquired after (131)I administration to assess biokinetics in the salivary glands. Calculation of salivary absorbed dose was based on the MIRD schema of the Society of Nuclear Medicine.

Results: Seventy-two patients (18, 18, 19, and 17 patients from groups A, B, C, and D, respectively) were eligible for the analysis of salivary dosimetry. Differences in absorbed doses to the parotid salivary gland (0.18 +/- 0.11, 0.16 +/- 0.07, 0.16 +/- 0.09, and 0.16 +/- 0.12 mGy/MBq in groups A, B, C, and D, respectively; P = 0.37) and submandibular salivary gland (0.19 +/- 0.05, 0.17 +/- 0.05, 0.18 +/- 0.07, and 0.17 +/- 0.06 mGy/MBq, respectively; P = 0.28) were not statistically significant among groups. Salivary cumulated activities arising from the first 24 h after (131)I administration accounted for 86.08% +/- 7.89% (range, 75%-98%) of total cumulated activities. Differences in salivary absorbed dose during the first 24 h were not statistically significant among the 4 groups either (P = 0.32 and 0.24, respectively, for the parotid and submandibular salivary glands).

Conclusion: Salivary stimulation with vitamin C at any time after (131)I administration has only a limited effect on salivary absorbed dose in thyroid cancer patients.
}}

Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial

2024-07-17T09:09:30Z

VMathies:

{{Reference
|Reference=Publication: Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, colorectal cancer patients were examined in the first 24 hours after surgical removal of the colon. One group received an additional intravenous injection of vitamin C during the operation and the other group only a placebo. The vitamin C group reported less pain at rest after the operation (both groups reported similar pain ratings during coughing) and two hours after the operation the vitamin C group needed less morphine. This difference disappeared 6 and 24 hours after surgery. Apart from this, the vitamin C group needed fewer additional opiates postoperatively. The two groups did not differ in terms of perceived fatigue, reported nausea and vomiting and length of hospital stay after surgery. A major criticism of this study is that in most cases the authors did not indicate whether the patients differed in terms of the characteristics examined at the beginning of the study. For example, when recording pain, it is important to know whether the patients had a generally high or low sensitivity to pain.

In dieser Studie wurden Darmkrebspatienten in den ersten 24 Stunden nach der operativen Entfernung des Dickdarms untersucht. Eine Gruppe bekam während der Operation zusätzlich intravenös Vitamin C gespritzt und die andere Gruppe nur ein Placebo. Die Vitamin C Gruppe berichtete nach der Operation im Ruhezustand weniger Schmerzen (Während Husten gaben beide Gruppe ähnliche Schmerzeinstufungen an) und zwei Stunden nach der Operation brauchte die Vitamin C Gruppe weniger Morphium. Dieser Unterschied verschwand 6, bzw. 24 Stunden nach der Operation. Abgesehen davon brauchte die Vitamin C Gruppe weniger zusätzliche Opiate postoperativ. Die beiden Gruppen unterschieden sich nicht hinsichtlich der eingeschätzten Erschöpfung, der berichteten Übelkeit und Erbrechen und der Aufenthaltsdauer im Krankenhaus nach der Operation. Ein großer Kritikpunkt an dieser Studie ist, dass die Autoren in den meisten Fällen nicht angegeben haben, ob sich die Patienten hinsichtlich untersuchter Merkmale schon zu Beginn der Studie unterschieden haben. So ist es z.B. bei der Erfassung der Schmerzen wichtig zu wissen, ob es Patienten mit einer generell hohen oder niedrigen Schmerzempfindlichkeit sind.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Double
|Is randomized=Yes
|Cross-over=No
|Number of arms=2
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=Colon cancer patients aged 20 to 75 years, scheduled for elective laparoscopic colectomy
under general anesthesia
|Exclusion criteria=Patients with history of allergy to systemic opioids, substance use disorder, coagulopathy, chronic opioid use, sleep apnea, and analgesic use within 24 h
|N randomized=100
|Analysis=PP Analysis, ITT Analysis
|Countries of data collection=Korea South
|LoE=1b Oxford 2009
|Outcome timeline=T0: Baseline (pre-/peri-op)
T1: 2h post-op
T2: 6h post-op
T3: 24h post-op
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Colorectal Cancer
|Stage cancer=NI
|Cancer stage specification=NI
|Comorbidity=NI
|Current cancer therapy=Surgery
|Specifications on cancer therapies=Elective laparoscopic colectomy
|Previous cancer therapies=NI
|Gender=Mixed
|Gender specifications=Per group
- placebo: 29 male, 21 female
- intervention: 28 male, 22 female
|Age groups=Adults (18+)
|Age groups specification=Mean (SD) per group:
- placebo: 64.5 (10.6) years
- intervention: 65.4 (9.6) years
}}
=Arms=

{{Arm
|Arm type=Placebo
|Number of participants (arm)=48
|Drop-out=2
|Drop-out reasons=Not arm specified: complications (anastomotic leak and additional ileostomy)
|Intervention=Saline 50 mL
|Dosage and regime=Intravenous, 30 minutes
|One-time application=Yes
|Duration in days=1
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=49
|Drop-out=1
|Drop-out reasons=Not arm specified: complications (anastomotic leak and additional ileostomy)
|Intervention=Ascorbic acid
|Dosage and regime=50mg/kg (ascorbic acid 10 g/20 mL) mixed with normal saline for a total injection volume of 50 mL; intravenous, 30 minutes
|One-time application=Yes
|Duration in days=1
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Pain
|Outcome specification=At rest and while coughing
Pain at 2h, 6h and 24h
|Type of measurement=NRS (Numeric Rating Scale)
|Results during intervention=NA
|Results after intervention=Estimated mean (SD) from graphic:
2, 6 and 24h post-op: at rest significantly lower in intervention compared to placebo; p's<0.05 (no values reported, only graphs)

While coughing: no significant difference at any time point; p's>0.05
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=postoperative opiate consumption
|Outcome specification=Consumption in mg at 2h, 6h and 24h
|Type of measurement=Others
|Results during intervention=NA
|Results after intervention=Morphine use (in mg) at 2h was significantly lower in intervention arm (p<0.05), no significant difference between the two arms at 6h and 24h (p's>0.05).
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Secondary
|Outcome name=Fatigue
|Outcome specification=Fatigue at baseline and at 2h, 6h and 24h
|Type of measurement=NRS (Numeric Rating Scale)
|Results during intervention=NA
|Results after intervention=No difference between groups in postoperative fatigue scores (p's>0.05)
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Secondary
|Outcome name=Frequency of rescue analgesics
|Outcome specification=frequency of postoperative rescue analgesics
|Type of measurement=Others
|Results during intervention=?
|Results after intervention=Rescue analgesics were required more frequently in the placebo arm; significant difference compared to intervention arm (p = 0.00).

Frequency as Mean(SD):
Intervention: 0.8(0.8)
Placebo: 1.4(1.0)
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=NI
|Conflicts of Interest=According to authors no conflict of interest
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=Large sample according to power analysis, double-blinded, exact results could only be taken from the graph, no information on whether the arms differed in terms of pain perception at the beginning of the study, only the difference between A and B was considered at all time points, no development over time
}}
=Additional Notes=

Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial

2024-07-17T08:58:17Z

VMathies:

{{Reference
|Reference=Publication: Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, colorectal cancer patients were examined in the first 24 hours after surgical removal of the colon. One group received an additional intravenous injection of vitamin C during the operation and the other group only a placebo. The vitamin C group reported less pain at rest after the operation (both groups reported similar pain ratings during coughing) and two hours after the operation the vitamin C group needed less morphine. This difference disappeared 6 and 24 hours after surgery. Apart from this, the vitamin C group needed fewer additional opiates postoperatively. The two groups did not differ in terms of perceived fatigue, reported nausea and vomiting and length of hospital stay after surgery. A major criticism of this study is that in most cases the authors did not indicate whether the patients differed in terms of the characteristics examined at the beginning of the study. For example, when recording pain, it is important to know whether the patients had a generally high or low sensitivity to pain.

In dieser Studie wurden Darmkrebspatienten in den ersten 24 Stunden nach der operativen Entfernung des Dickdarms untersucht. Eine Gruppe bekam während der Operation zusätzlich intravenös Vitamin C gespritzt und die andere Gruppe nur ein Placebo. Die Vitamin C Gruppe berichtete nach der Operation im Ruhezustand weniger Schmerzen (Während Husten gaben beide Gruppe ähnliche Schmerzeinstufungen an) und zwei Stunden nach der Operation brauchte die Vitamin C Gruppe weniger Morphium. Dieser Unterschied verschwand 6, bzw. 24 Stunden nach der Operation. Abgesehen davon brauchte die Vitamin C Gruppe weniger zusätzliche Opiate postoperativ. Die beiden Gruppen unterschieden sich nicht hinsichtlich der eingeschätzten Erschöpfung, der berichteten Übelkeit und Erbrechen und der Aufenthaltsdauer im Krankenhaus nach der Operation. Ein großer Kritikpunkt an dieser Studie ist, dass die Autoren in den meisten Fällen nicht angegeben haben, ob sich die Patienten hinsichtlich untersuchter Merkmale schon zu Beginn der Studie unterschieden haben. So ist es z.B. bei der Erfassung der Schmerzen wichtig zu wissen, ob es Patienten mit einer generell hohen oder niedrigen Schmerzempfindlichkeit sind.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Double
|Is randomized=Yes
|Cross-over=No
|Number of arms=2
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=Colon cancer patients aged 20 to 75 years, scheduled for elective laparoscopic colectomy
under general anesthesia
|Exclusion criteria=Patients with history of allergy to systemic opioids, substance use disorder, coagulopathy, chronic opioid use, sleep apnea, and analgesic use within 24 h
|N randomized=100
|Analysis=PP Analysis, ITT Analysis
|Countries of data collection=Korea South
|LoE=1b Oxford 2009
|Outcome timeline=T0: Baseline (pre-/peri-op)
T1: 2h post-op
T2: 6h post-op
T3: 24h post-op
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Colorectal Cancer
|Stage cancer=NI
|Cancer stage specification=NI
|Comorbidity=NI
|Current cancer therapy=Surgery
|Specifications on cancer therapies=Elective laparoscopic colectomy
|Previous cancer therapies=NI
|Gender=Mixed
|Gender specifications=Per group
- placebo: 29 male, 21 female
- intervention: 28 male, 22 female
|Age groups=Adults (18+)
|Age groups specification=Mean (SD) per group:
- placebo: 64.5 (10.6) years
- intervention: 65.4 (9.6) years
}}
=Arms=

{{Arm
|Arm type=Placebo
|Number of participants (arm)=48
|Drop-out=2
|Drop-out reasons=Not arm specified: complications (anastomotic leak and additional ileostomy)
|Intervention=Saline 50 mL
|Dosage and regime=Intravenous, 30 minutes
|One-time application=Yes
|Duration in days=1
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=49
|Drop-out=1
|Drop-out reasons=Not arm specified: complications (anastomotic leak and additional ileostomy)
|Intervention=Ascorbic acid
|Dosage and regime=50mg/kg (ascorbic acid 10 g/20 mL) mixed with normal saline for a total injection volume of 50 mL; intravenous, 30 minutes
|One-time application=Yes
|Duration in days=1
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Pain
|Outcome specification=At rest and while coughing
Pain at 2h, 6h and 24h
|Type of measurement=NRS (Numeric Rating Scale)
|Results during intervention=NA
|Results after intervention=Estimated mean (SD) from graphic:
2, 6 and 24h post-op: at rest significantly lower in intervention compared to placebo; p's<0.05 (no values reported, only graphs)

While coughing, no significant difference at any time point; p's>0.05
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=postoperative opiate consumption
|Outcome specification=Consumption in mg at 2h, 6h and 24h
|Type of measurement=Others
|Results during intervention=NA
|Results after intervention=Morphine use (in mg) at 2h was significantly lower in intervention arm (p<0.05), no significant difference between the two arms at 6h and 24h (p's>0.05).
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Secondary
|Outcome name=Fatigue
|Outcome specification=Fatigue at baseline and at 2h, 6h and 24h
|Type of measurement=NRS (Numeric Rating Scale)
|Results during intervention=NA
|Results after intervention=No difference between groups in postoperative fatigue scores (p's>0.05)
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Secondary
|Outcome name=Frequency of rescue analgesics
|Outcome specification=frequency of postoperative rescue analgesics
|Type of measurement=Others
|Results during intervention=?
|Results after intervention=Rescue analgesics were required more frequently in the placebo arm; significant difference compared to intervention arm (p = 0.00).

Frequency as Mean(SD):
Intervention: 0.8(0.8)
Placebo: 1.4(1.0)
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=NI
|Conflicts of Interest=According to authors no conflict of interest
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes
|Additional Notes=Large sample according to power analysis, double-blinded, exact results could only be taken from the graph, no information on whether the arms differed in terms of pain perception at the beginning of the study, only the difference between A and B was considered at all time points, no development over time
}}
=Additional Notes=

Jeon et al. (2016): Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial

2024-07-10T09:13:12Z

VMathies:

{{Reference
|Reference=Publication: Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial
}}
{{Study Note}}
=Brief summary=
In this study, colorectal cancer patients were examined in the first 24 hours after surgical removal of the colon. One group received an additional intravenous injection of vitamin C during the operation and the other group only a placebo. The vitamin C group reported less pain at rest after the operation (both groups reported similar pain ratings during coughing) and two hours after the operation the vitamin C group needed less morphine. This difference disappeared 6 and 24 hours after surgery. Apart from this, the vitamin C group needed fewer additional opiates postoperatively. The two groups did not differ in terms of perceived fatigue, reported nausea and vomiting and length of hospital stay after surgery. A major criticism of this study is that in most cases the authors did not indicate whether the patients differed in terms of the characteristics examined at the beginning of the study. For example, when recording pain, it is important to know whether the patients had a generally high or low sensitivity to pain.

In dieser Studie wurden Darmkrebspatienten in den ersten 24 Stunden nach der operativen Entfernung des Dickdarms untersucht. Eine Gruppe bekam während der Operation zusätzlich intravenös Vitamin C gespritzt und die andere Gruppe nur ein Placebo. Die Vitamin C Gruppe berichtete nach der Operation im Ruhezustand weniger Schmerzen (Während Husten gaben beide Gruppe ähnliche Schmerzeinstufungen an) und zwei Stunden nach der Operation brauchte die Vitamin C Gruppe weniger Morphium. Dieser Unterschied verschwand 6, bzw. 24 Stunden nach der Operation. Abgesehen davon brauchte die Vitamin C Gruppe weniger zusätzliche Opiate postoperativ. Die beiden Gruppen unterschieden sich nicht hinsichtlich der eingeschätzten Erschöpfung, der berichteten Übelkeit und Erbrechen und der Aufenthaltsdauer im Krankenhaus nach der Operation. Ein großer Kritikpunkt an dieser Studie ist, dass die Autoren in den meisten Fällen nicht angegeben haben, ob sich die Patienten hinsichtlich untersuchter Merkmale schon zu Beginn der Studie unterschieden haben. So ist es z.B. bei der Erfassung der Schmerzen wichtig zu wissen, ob es Patienten mit einer generell hohen oder niedrigen Schmerzempfindlichkeit sind.

=Study Design=

{{Study Design (RCT)
|Perspective=Prospective
|Centralized=Monocentric
|Blinding=Double
|Is randomized=Yes
|Cross-over=No
|Number of arms=2
}}
=Study characteristics=

{{RCT study general properties
|Inclusion criteria=Colon cancer patients aged 20 to 75 years, scheduled for elective laparoscopic colectomy
under general anesthesia
|Exclusion criteria=Patients with history of allergy to systemic opioids, substance use disorder, coagulopathy, chronic opioid use, sleep apnea, and analgesic use within 24 h
|N randomized=100
|Analysis=PP Analysis, ITT Analysis
|Countries of data collection=Korea South
|LoE=1b Oxford 2009
|Outcome timeline=T0: Baseline (pre-/peri-op)
T1: 2h post-op
T2: 6h post-op
T3: 24h post-op
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=NI
|Types of cancer=Colorectal Cancer
|Stage cancer=NI
|Cancer stage specification=NI
|Comorbidity=NI
|Current cancer therapy=Surgery
|Specifications on cancer therapies=Elective laparoscopic colectomy
|Previous cancer therapies=NI
|Gender=Mixed
|Gender specifications=Per group
- placebo: 29 male, 21 female
- intervention: 28 male, 22 female
|Age groups=Adults (18+)
|Age groups specification=Mean (SD) per group:
- placebo: 64.5 (10.6) years
- intervention: 65.4 (9.6) years
}}
=Arms=

{{Arm
|Arm type=Placebo
|Number of participants (arm)=48
|Drop-out=2
|Drop-out reasons=Not arm specified: complications (anastomotic leak and additional ileostomy)
|Intervention=Saline 50 mL
|Dosage and regime=Intravenous, 30 minutes
|One-time application=Yes
|Duration in days=1
|Side Effects / Interactions=NI
|Order number=2
}}
{{Arm
|Arm type=Intervention
|Number of participants (arm)=49
|Drop-out=1
|Drop-out reasons=Not arm specified: complications (anastomotic leak and additional ileostomy)
|Intervention=Ascorbic acid
|Dosage and regime=50mg/kg (ascorbic acid 10 g/20 mL) mixed with normal saline for a total injection volume of 50 mL; intravenous, 30 minutes
|One-time application=Yes
|Duration in days=1
|Side Effects / Interactions=NI
|Order number=1
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Pain
|Outcome specification=At rest and while coughing
Pain at 2h, 6h and 24h
|Type of measurement=NRS (Numeric Rating Scale)
|Results during intervention=NA
|Results after intervention=Estimated mean (SD) from graphic:
2, 6 and 24h post-op: at rest significantly lower in intervention compared to placebo; p's<0.05 (no values reported, only graphs)

While coughing, no significant difference at any time point; p's>0.05
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Primary
|Outcome name=postoperative opiate consumption
|Outcome specification=Consumption in mg at 2h, 6h and 24h
|Type of measurement=Others
|Results during intervention=NA
|Results after intervention=Morphine use (in mg) at 2h was significantly lower in intervention arm (p<0.05), no significant difference between the two arms at 6h and 24h (p's>0.05).
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Secondary
|Outcome name=Fatigue
|Outcome specification=Fatigue at baseline and at 2h, 6h and 24h
|Type of measurement=NRS (Numeric Rating Scale)
|Results during intervention=NA
|Results after intervention=No difference between groups in postoperative fatigue scores (p's>0.05)
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome
|Outcome type=Secondary
|Outcome name=Frequency of rescue analgesics
|Outcome specification=frequency of postoperative rescue analgesics
|Type of measurement=Others
|Results during intervention=?
|Results after intervention=Rescue analgesics were required more frequently in the placebo arm; significant difference compared to intervention arm (p = 0.00).

Frequency as Mean(SD):
Intervention: 0.8(0.8)
Placebo: 1.4(1.0)
|Bias arising from the randomization process=?
|Bias due to deviation from intended intervention (assignment to intervention)=?
|Bias due to deviation from intended intervention (adhering to intervention)=NA
|Bias due to missing outcome data=?
|Bias in measurement of the outcome=?
|Bias in selection of the reported result=?
|Other sources of bias=?
|Overall RoB judgment=?
|Order number=1
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=NI
|Conflicts of Interest=According to authors no conflict of interest
}}
=Further points for assessing the study=

{{Further points for assessing the study
|Samples sufficiently large=?
|power analysis performed=?
|reasons given for samples being too small according to power analysis=?
|Ethnicity mentioned=?
|Possibility of attention effects=?
|Possibility of placebo effects=?
|Other reasons=?
|Testing for normal distribution=?
|Correct application of statistical tests=?
|Correction for multiple testing=?
|Measurement of compliance=?
|Blinding reliable=?
|Check whether blinding was successful=?
|Consistent reporting in numbers=?
|sufficient washout period=?
|Tested for carry-over effects=?
|Were sequence effects tested=?
|Comprehensive and coherent reporting=?
|Were side effects systematically recorded=?
|Effect sizes reported=?
|Side effects taken into account in the interpretation of the results=?
|mono- or multicentric=?
|Ethics / CoI / Funding=?
}}
{{Additional Notes}}
=Additional Notes=