Study Note
Brief summary
40 patients with head and neck tumors received either 2000mg ginger powder (non-standardized preparation in capsules) or a placebo during radiotherapy for two weeks. The symptoms of dry mouth were not changed by ginger, the amount of spit was significantly greater, which may also provide relief. No side effects were reported. The study is not well reported, suggesting that the study was not methodologically well conducted and the results must be interpreted with caution.
40 Patienten mit Kopf-Hals-Tumoren erhielten entweder 2000mg Ingwerpulver (nicht standardisierte Herstellung in Kapseln) oder ein Plazebo während der Radiotherapie über zwei Wochen. Die Symptome der Mundtrockenheit wurden durch Ingwer nicht verändert, bedeutsam größer war die Menge an Spucke, was evtl. auch Linderung verschafft. Nebenwirkungen sind nicht berichtet. Die Studie ist nicht gut berichtet, so dass die Vermutung naheliegt, dass die Studie methodisch nicht gut durchgeführt worden ist und die Ergebnisse mit Vorsicht interpretiert werden müssen.
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
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Prospective
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| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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Monocentric
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| 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
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Double
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| Is randomized
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Yes
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| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
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No
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| Number of arms
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2
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Study characteristics
| Inclusion criteria
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Age over 18 years, a dose of radiation received over 4,500 cGy, the radiation received during the period 6 to 7 weeks, minor and major salivary glands involvement, one or two sides of the face in the field of radiation, and over the last three months of receiving radiation.
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| Exclusion criteria
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Being pregnant, diabetes, asthma, Sjogren's syndrome, lack of ability to feed by mouth, using anti-depressant medications, a history of allergy to ginger or corn starch and people who have had recurrence of cancer and residence outside the city of Ahvaz and the lack of consent of the participation in the study.
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| N randomized
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40
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| 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.
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PP Analysis
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| Specifications on analyses
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Wilcoxon signed rank test and Binomial test and Mann-Whitney
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| Countries of data collection
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Iran
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| LoE Level of evidence
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Level 2 Oxford 2011
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| Outcome timeline Data collection times
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T0: Baseline
T1: End of study
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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.
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Curative
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| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
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NI
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| 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
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NI
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| Specifications on cancer stages
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NI
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| Comorbidities
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NI
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| Current cancer therapies
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Radiation therapy
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| Specifications on cancer therapies
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Head and neck radiotherapy
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| Previous cancer therapies
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NI
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| Gender
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Mixed
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| Gender specifications
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30 % female
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| Age groups
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Adults (18+)
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| Age groups specification
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Mean: 45 years
Range: 20-70 years
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Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention
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| Number of participants (arm) N randomized
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20
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N=0
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| Drop-out reasons
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NA
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| Intervention
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Ginger capsules
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| Dosage and regime
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Daily dose, 4x500mg ginger capsules, every 6 hours, for 2 weeks
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| One-time application
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No
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| 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.
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14
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| Side effects / Interactions
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NI
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| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Placebo
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| Number of participants (arm) N randomized
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20
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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N=0
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| Drop-out reasons
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NA
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| Intervention
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Placebo-capsules
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| Dosage and regime
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Daily dose, 4x500mg capsules, every 6 hours, for 2 weeks
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| One-time application
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No
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| 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.
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14
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| Side effects / Interactions
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NI
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Outcomes
Xerostomia
| Outcome type As specificed by the authors
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NI
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| Outcome specification
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Dry mouth, difficulty chewing / swallowing / speaking, burning sensation in the mouth, bad taste, waking up at night, prosthetic mesh, meeting people, talking to people, leaving the house
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| Type of measurement
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Diary questionnaire
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| 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".
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NA
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| 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".
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Xerostomia symptoms:
Intervention-arm:
Significant improvement in: dry mouth, difficulty chewing / swallowing / speaking, burning sensation in mouth (general, daily, nightly), waking up at night, bad taste, saliva weight (p<0.05)
Placebo-arm:
Significant improvement in terms of:
dry mouth, difficulty chewing / swallowing, burning sensation in mouth (general, nightly), meeting people, saliva weight (p<0.05)
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
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?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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?
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| Bias in measurement of the outcome
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?
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| Bias in selection of the reported result
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?
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| Other sources of bias
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?
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| Overall RoB judgment
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?
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Salivary gland function
| Outcome type As specificed by the authors
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NI
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| Outcome specification
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Amount/weight of saliva, unstimulated
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| Type of measurement
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Scale
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| 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".
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NA
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| 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".
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Significantly higher increase in intervention-arm than in placebo-arm:
Mean (SD) intervention arm vs. placebo arm: 2.051 (0.659) vs. 0.997 (0.947); p<0.01
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
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?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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?
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| Bias in measurement of the outcome
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?
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| Bias in selection of the reported result
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?
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| Other sources of bias
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?
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| Overall RoB judgment
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?
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Funding and Conflicts of Interest
| Funding
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NI
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| Conflicts of Interest
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NI
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Further points for assessing the study
Sample
| Power analysis performed
|
?
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| - Sample size corresponds to power analysis
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?
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| - Reasons for insufficient sample size based on power analysis
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?
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| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
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?
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| Ethnicity mentioned
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?
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Alternative Explanation
| Other explanations for an effect besides the investigated intervention
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?
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| - Possibility of attention effects
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?
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| - Possibility of placebo effects
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?
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| - Other reasons
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?
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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
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?
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| Correction for multiple testing
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?
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| Measurement of compliance
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?
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| Consistent reporting in numbers (figures, flowchart, abstract, results)
|
?
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| Comprehensive and coherent reporting
|
?
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| Cross-over
|
?
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| - Sufficient washout period
|
?
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| - Tested for carry-over effects
|
?
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| - Tested for sequence effects
|
?
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Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
|
?
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| Side effects systematically recorded
|
?
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| Side effects considered in result interpretation
|
?
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| Ethics votum
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?
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Additional Notes
