View source for Yekta et al. (2012): Ginger as a miracle against chemotherapy-induced vomiting

{{Reference
|Reference=Publication: Ginger as a miracle against chemotherapy-induced vomiting
}}
{{Study Note}}
=Brief summary=

=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=Patients with histologic diagnosis of breast cancer, history of receiving at least one chemotherapy injection, receiving single-day cycles of chemotherapy (each cycle separated from next by ≥ 2 weeks); experiencing vomiting in previous sessions, and having normal values of hematologic and biomedical laboratory parameters.
|Exclusion criteria=Patients were excluded if they were receiving multiple-day chemotherapy; receiving concurrent radiotherapy with high risk of causing emesis (ie, total body, hemi body, upper abdomen, and craniospinal radiation); taking therapeutic doses of warfarin, aspirin, or heparin; had a history of bleeding disorder(s) like severe thrombocytopenia; had an allergy to ginger or had taken it in the last week; had gastrointestinal disorders and cancers; and had other emesis-inducing diseases, such as hypertension, liver, and renal failure.
Patients who forgot to take capsules ≥ 3 consecutive times; used other antiemetic drugs or therapeutic methods except the routine antiemetic; had severe gastrointestinal problems during the study; and refusal to continue participating in trial.
|N randomized=98
|Analysis=PP Analysis
|Specifications on analyses=T-test and Fisher´s exact test for comparing the 2 arms 
For examine differences in the profile of the diseases: Kruskal-Wallis and Chi-square test were applied
|Countries of data collection=Iran
|LoE=Level 2 Oxford 2011
|Outcome timeline=NI
}}
=Characteristics of participants=

{{Characteristics of participants
|Setting=Curative, NI
|Types of cancer=Breast Cancer
|Stage cancer=NI
|Cancer stage specification=NI
|Comorbidity=NI
|Current cancer therapy=Chemotherapy
|Specifications on cancer therapies=NI
|Previous cancer therapies=NI
|Gender=Female
|Gender specifications=100 % female
|Age groups=Adults (18+)
|Age groups specification=NI
}}
=Arms=

{{Arm
|Arm type=Intervention
|Number of participants (arm)=49
|Drop-out=9
|Drop-out reasons=Discontinuation of Chemotherapy, lack of compliance or death
|Intervention=red capsules of ginger (Zintoma)
|Dosage and regime=250 mg dry powered ginger root and included 5.38 mg (2.15%) 6-gingerol, 1.8 mg (0.72%) 8-gingerol, 4.19 mg (1.78%) 10-gingerol, and 0.92 mg (0.37%) 6-shagaol
6 days starting 3 days before the chemotherapy session
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=Heartburn, no significant difference between arms:
* anticipatory: p= 0.2
* acute: p= 0.06
* delayed: p= 0.5
|Order number=1
|Arm topic=Ginger
}}
{{Arm
|Arm type=Placebo
|Number of participants (arm)=49
|Drop-out=9
|Drop-out reasons=Discontinuation of Chemotherapy, lack of compliance or death
|Intervention=starch capsules (placebo)
|Dosage and regime=Daily dose 4x250mg, every 6 hours for 6 days from three days before the start of Chemotherapy
|One-time application=No
|Duration in days=6
|Side Effects / Interactions=Heartburn, no significant difference between arms:
* anticipatory: p= 0.2
* acute: p= 0.06
* delayed: p= 0.5
|Order number=2
|Arm topic=Ginger
}}
{{Arm Overview}}
=Outcomes=

{{Outcome
|Outcome type=Primary
|Outcome name=Vomiting
|Outcome specification=NA
|Type of measurement=Observation
|Results during intervention=NA
|Results after intervention=Vomiting (all phases): significantly lower in Intervention;
Anticipatory: Intervention vs. Placebo (Min, Mean±SD, Max): 0, 0.05 ± 0.3, 2 vs. 0, 1.5 ± 5.9, 35 (p= 0.04)
Acute: Intervention vs. Placebo (Min, Mean±SD, Max): 0, 2.7 ± 1.2, 15 vs. 0, 3.7 ± 2.5, 17 (p= 0.04)
Delayed: Intervention vs. Placebo (Min, Mean±SD, Max): 0, 3.3 ± 1.1, 18 vs. 0, 7.9 ± 3.9, 37 (p= 0.003)
Total: Intervention vs. Placebo (Min, Mean±SD, Max): 0, 2.3 ± 5.1, 23 vs. 0, 7.9 ± 14, 54 (p= 0.002)
|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 topic=Ginger
}}
{{Outcome Overview}}
=Funding and Conflicts of Interest=

{{Funding and Conflicts of Interest
|Funding=This study was carried out by the financial support of research deputy of Tehran University of Medical Sciences and with the favor of Cancer Research Centre of Imam Khomeini Hospital.
|Conflicts of Interest=NI
}}
=Further points for assessing the study=

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