| Reference ↗
|
| Title
|
The effect of Ginkgo biloba extract on genotoxic damage in patients with differentiated thyroid carcinoma receiving thyroid remnant ablation with Iodine-131
|
| Topic
|
Ginkgo
|
| Author
|
Dardano, A, Ballardin, M, Caraccio, N, Boni, G, Traino, C, Mariani, G, Ferdeghini, M, Barale, R, Monzani, F
|
| Year
|
2012
|
| Journal
|
Thyroid
|
| DOI
|
https://doi.org/10.1089/thy.2010.0398
|
Study Note
Brief summary
Differentiated thyroid cancer (DTC) is a type of thyroid cancer that has developed in the cells of the thyroid gland that are responsible for the production of thyroid hormones. DTC is usually treated by removing the thyroid gland followed by radioiodine therapy. There is some evidence that radioiodine can cause damage to genetic material. In this study, the researchers investigated the efficacy of Ginkgo biloba extract (GBE) on the occurrence of gene-damaging substances in blood plasma. Patients were randomized to receive either GBE at a dose of 120 mg per day or a placebo. GBE reduced the transient increase in markers of genetic damage caused by radioiodine therapy. No side effects of GBE were observed in the patients studied.
Differenzierter Schilddrüsenkrebs (DTC) ist eine Art von Schilddrüsenkrebs, der sich in den Zellen der Schilddrüse entwickelt hat, die für die Produktion der Schilddrüsenhormone verantwortlich sind. DTC wird in der Regel durch Entfernung der Schilddrüse und anschließende Radiojodtherapie behandelt. Es gibt einige Hinweise darauf, dass Radiojod Schäden am genetischen Material verursachen kann. In dieser Studie untersuchten die Forscher die Wirksamkeit von Ginkgo biloba-Extrakt (GBE) auf das Auftreten von genschädigenden Substanzen im Blutplasma. Patienten wurden randomisiert und erhielten entweder GBE in einer Dosis von 120 mg pro Tag oder ein Placebo. GBE verringerte den vorübergehenden Anstieg der Marker für genetische Schäden, die durch die Radiojodtherapie verursacht wurden. Es wurden keine Nebenwirkungen von GBE bei den untersuchten Patienten beobachtet.
Study Design
| Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies
|
Prospective
|
| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
|
NI
|
| Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties
|
Double
|
| Is randomized
|
Yes
|
| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
|
No
|
| Number of arms
|
2
|
Study characteristics
| Inclusion criteria
|
Had undergone near-total thyroidectomy for DTC (differentiated thyroid cancer), at enrollment considered to be free of cancer metastases (serum thyroglubin level < 10ng/ml, negative anti-TG antibody titer and negative ultrasound neck examination
|
| Exclusion criteria
|
Not treated with external radiotherapy, no other illness except thyroid carcinoma
|
| N randomized
|
23
|
| Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.
|
ITT Analysis
|
| Specifications on analyses
|
ITT not specified, but no drop-out reported.
|
| Countries of data collection
|
Italy
|
| LoE Level of evidence
|
2b Oxford 2009
|
| Outcome timeline Data collection times
|
Blood samples were drawn just before and at various intervals after 131I therapy (at baseline and at 7, 17, 28, and 90 days).
|
Characteristics of participants
| Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.
|
Adjuvant
|
| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
|
Head and Neck Cancers - Thyroid Cancer
|
| Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis
|
NI
|
| Specifications on cancer stages
|
Free of cancer metastases
|
| Comorbidities
|
NI
|
| Current cancer therapies
|
Radioiodine treatment
|
| Specifications on cancer therapies
|
131I treatment
|
| Previous cancer therapies
|
Surgery
|
| Gender
|
Mixed
|
| Gender specifications
|
65% female
|
| Age groups
|
Adults (18+)
|
| Age groups specification
|
Median (range): 42 (18-73) years
|
Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
|
Intervention
|
| Number of participants (arm) N randomized
|
10
|
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
|
0
|
| Drop-out reasons
|
NA
|
| Intervention
|
Gingko biloba extract (standardized and tiltrated gingko biloba tree leaves extract Egb 761 Tanaken®; Beaufour-Ipsen International, Paris, France)
|
| Dosage and regime
|
120mg/daily
Duration: 3 days prior to radioiodine treatment until 30 days after
+ Radioiodine therapy (Iodine -131 therapy): after 30 days without levothyroxine, all patients received a dose of 3.7 GBq (100mCi)
|
| One-time application
|
No
|
| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
|
-999
|
| Side effects / Interactions
|
No clinically relevant side effects.
|
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
|
Placebo
|
| Number of participants (arm) N randomized
|
13
|
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
|
0
|
| Drop-out reasons
|
NA
|
| Intervention
|
Placebo
|
| Dosage and regime
|
120mg/daily
Duration: 3 days prior to radioiodine treatment until 30 days after
+ Radioiodine therapy (Iodine -131 therapy): after 30 days without levothyroxine, all patients received a dose of 3.7 GBq (100mCi)
|
| One-time application
|
No
|
| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
|
-999
|
| Side effects / Interactions
|
No clinically relevant side effects.
|
Outcomes
Laboratory parameters
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Micronuclei in lymphocytes
|
| Type of measurement
|
Blood Test
|
| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
NA
|
| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
Significantly lower increase in Micronuclei in the Ginkgo arm (day 7: Mean=11.5, SD=2.4; day 90: Mean=2.9, SD=1.4) compared to placebo (day 7: Mean=17.1, SD=2.3; day 90: Mean=9.0, SD=1.3), p<0.01
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| 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
|
?
|
Laboratory parameters
| Outcome type As specificed by the authors
|
Primary
|
| Outcome specification
|
Chromosome-damaging properties, so called "clastogenic" factors (CFs)
|
| Type of measurement
|
Blood Test
|
| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
NA
|
| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
Significantly lower increase in "clastogenic" factors in the Ginkgo arm (day 7: Mean=5.0, SD=2.9; day 90: Mean=1.9, SD=0.9) compared to placebo (day 7: Mean=10.5, SD=2.1; day 90: Mean=5.5, SD=1.2), p<0.05
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| 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
|
?
|
Funding and Conflicts of Interest
| Funding
|
NI
|
| Conflicts of Interest
|
NI
|
Further points for assessing the study
Sample
| Power analysis performed
|
?
|
| - Sample size corresponds to power analysis
|
|
| - Reasons for insufficient sample size based on power analysis
|
|
| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
|
?
|
| Ethnicity mentioned
|
?
|
Alternative Explanation
| Other explanations for an effect besides the investigated intervention
|
|
| - Possibility of attention effects
|
?
|
| - Possibility of placebo effects
|
?
|
| - Other reasons
|
?
|
Statistics
| Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing
|
|
| Correction for multiple testing
|
?
|
| Measurement of compliance
|
?
|
| Consistent reporting in numbers (figures, flowchart, abstract, results)
|
?
|
| Comprehensive and coherent reporting
|
?
|
| Cross-over
|
|
| - Sufficient washout period
|
?
|
| - Tested for carry-over effects
|
?
|
| - Tested for sequence effects
|
?
|
Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
|
?
|
| Side effects systematically recorded
|
?
|
| Side effects considered in result interpretation
|
?
|
| Ethics votum
|
?
|
Additional Notes
CONTRA:
