Yekta et al. (2012): Ginger as a miracle against chemotherapy-induced vomiting
| Reference ↗ | |
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| Title | Ginger as a miracle against chemotherapy-induced vomiting |
| Topic | Ginger |
| Author | Parsa Yekta, Z, Ebrahimi, SM, Hosseini, M, Nikbakht Nasrabadi, A, Sedighi, S, Salehi Surmaghi, MH, Madani, H |
| Year | 2012 |
| Journal | Iranian Journal of Nursing and Midwifery Research |
| DOI | https://www.researchgate.net/publication/249321809_Ginger_as_a_miracle_against_chemotherapy-induced_vomiting |
Study Note
Brief summary
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 | Monocentric |
| 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 | 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: 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. | 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 of evidence | Level 2 Oxford 2011 |
| Outcome timeline Data collection times | NI |
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. | Curative, NI |
|---|---|
| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included | Breast 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 | NI |
| Comorbidities | NI |
| Current cancer therapies | 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 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 | 49 |
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date | 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 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. | 6 |
| Side effects / Interactions | Heartburn, no significant difference between arms:
|
| 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 | 49 |
| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date | 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 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. | 6 |
| Side effects / Interactions | Heartburn, no significant difference between arms:
|
Outcomes
Vomiting
| Outcome type As specificed by the authors | Primary |
|---|---|
| Outcome specification | NA |
| Type of measurement | Observation |
| 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". | 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) |
| 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 | 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. |
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| 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 | ? |