Dataset Information

Searching for Evidence to Support the Use of Ginger in the Prevention of Chemotherapy-Induced Nausea and Vomiting.

ABSTRACT: Patients with cancer frequently use dietary supplementation and herbal therapies to control symptoms of disease and adverse effects of cancer therapy. Despite the widespread use of dietary supplementation and herbal therapies in oncology, robust scientific evidence in this area is lacking. Not only do these products need to be tested in large and well-designed observational or randomized studies, but their manufacturing process must be improved to achieve higher levels of standardization in product quality. Ginger is frequently used to counteract chemotherapy-induced nausea and vomiting (CINV), and some suggestions that it might be effective against CINV come from randomized and/or crossover clinical trials. However, several limitations in the methods of these studies limit their power and generalizability. The authors are conducting a randomized, double-blind study with a large sample size and homogeneous inclusion criteria in order to evaluate the efficacy of a well-standardized ginger extract in reducing nausea in patients with cancer. The widespread use of standardized herbal therapies and natural components among patients requires that scientific and rigorous research strategies are applied in this field to guide the physicians and the patients in safer use.

SUBMITTER: Bossi P

PROVIDER: S-EPMC4921900 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Searching for Evidence to Support the Use of Ginger in the Prevention of Chemotherapy-Induced Nausea and Vomiting.

Bossi Paolo P Cortinovis Diego D Cossu Rocca Maria M Roila Fausto F Seminara Patrizia P Fabi Alessandra A Canova Stefania S Verri Elena E Fatigoni Sonia S Iannace Alessandro A Macchi Fabio F Ripamonti Carla C

Journal of alternative and complementary medicine (New York, N.Y.) 20160426 6

Patients with cancer frequently use dietary supplementation and herbal therapies to control symptoms of disease and adverse effects of cancer therapy. Despite the widespread use of dietary supplementation and herbal therapies in oncology, robust scientific evidence in this area is lacking. Not only do these products need to be tested in large and well-designed observational or randomized studies, but their manufacturing process must be improved to achieve higher levels of standardization in prod ...[more]

PMID: 27115042

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Project description:Nausea and vomiting are the most common side effects of chemotherapy. They must be managed because they can increase the risk of malnutrition in patients, which can adversely affect treatment. The objective of this study was to evaluate the effect of ginger supplementation as an adjuvant treatment for alleviating chemo We checked. therapy-induced nausea and vomiting (CINV). This study searched for randomized controlled trials (RCTs) related to ginger supplement intake for CINV in three electronic databases (i.e., Medline (PubMed), Embase, and Web of Science). The search period ranged from each database's first date of service to 5 November 2021. Two investigators independently performed abstract screenings, full-text screenings, data extraction, and risk of bias analyses (ROB). The Cochrane ROB tool was used for the assessment of ROB. This study systematically reviewed 23 RCTs. The effects of ginger supplementation were compared to those of placebo or antiemetic agents. This study conducted a meta-analysis after classifying the effects of ginger supplementation on acute and delayed CINV into subgroups due to the clinical heterogeneity between these RCTs. The results showed that the incidence of acute nausea (p = 0.53), the incidence of delayed nausea (p = 0.31), the incidence of acute vomiting (p = 0.09), and the incidence of delayed vomiting (p = 0.89) were not significantly different between the ginger supplement intake group and the control group. However, it was found that the ginger supplement intake group, which took not more than 1 g of ginger supplementation per day for above four days, had significantly less acute vomiting than the control group (OR 0.30; 95% CI 0.12 to 0.79; p = 0.02; I2 = 36%). Ginger supplementation may reduce the incidence of acute chemotherapy-induced vomiting. However, this study could not confirm the effects of ginger supplementation on the incidence of chemotherapy-induced nausea and delayed vomiting. Therefore, it will be necessary to conduct additional studies with sufficient sample sizes using high-quality RCTs to evaluate the effects of ginger supplementations based on the results of this study.

Project description:ImportanceThe prevention of chemotherapy-induced nausea and vomiting has an important role in the overall management of cancer treatment.ObjectiveTo evaluate whether adding aprepitant to palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI (fluorouracil, leucovorin, and irinotecan) or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) chemotherapy regimens among women with gastrointestinal cancer at higher risk.Design, setting, and participantsThis phase 3, double-blind, placebo-controlled randomized clinical trial recruited young women (age ≤50 years) who drank little or no alcohol and had gastrointestinal cancer for which they received FOLFOX or FOLFIRI chemotherapy. A total of 248 women were enrolled and assigned in the ratio 1:1 to intervention and control groups from August 4, 2015, to March 31, 2020. Intention-to-treat analysis was used to evaluate patient baseline characteristics and efficacy. The analysis was conducted on October 30, 2020.InterventionsPatients were randomly assigned to the aprepitant group (aprepitant, 125 mg, orally 60 minutes before initiation of chemotherapy on day 1 and 80 mg orally each morning of days 2 and 3; palonosetron, 0.25 mg, intravenously; and dexamethasone, 6 mg, orally 30 minutes before chemotherapy initiation on day 1) or the placebo group (placebo, 125 mg, orally 60 minutes before initiation of chemotherapy on day 1 and 80 mg orally on each morning of days 2 and 3; palonosetron, 0.25 mg, intravenously; and dexamethasone, 12 mg, orally 30 minutes before chemotherapy initiation on day 1).Main outcomes and measuresThe primary end point was the complete response (CR) rate, defined as the proportion of patients without emesis episodes or rescue medication use during the overall phase of the first cycle. Other efficacy indicators, such as no vomiting and no nausea, were measured as the secondary and exploratory end points.ResultsA total of 248 women from 4 clinical centers in China entered this study, and 243 patients (aprepitant regimen, 125 patients [51.4%]; placebo regimen, 118 patients [48.5%]) were evaluable for efficacy and safety; mean (SD) age of the total population was 40.1 (7.3) years. The CR rate was significantly higher in the aprepitant group vs the control group overall (107 [87.0%] vs 80 [66.7%]; P < .001) and in the acute (114 [92.7%] vs 91 [75.8%]; P = .001) and delayed (109 [88.6%] vs 84 [70.0%]; P = .001) phases of the trial. The incidence of adverse events was similar between the 2 groups (100 [80.0%] vs 96 [81.3%]; P = .79), and no grade 3 or 4 aprepitant treatment-related adverse events were observed. Multivariable analysis revealed that aprepitant use was the only independent factor associated with CR during the overall phase.Conclusions and relevanceThe combination of aprepitant with palonosetron and dexamethasone provided increased antiemetic efficacy in the FOLFOX or FOLFIRI chemotherapy regimen and was well tolerated by younger women with gastrointestinal cancer who have a history of little or no alcohol consumption.Trial registrationClinicalTrials.gov Identifier: NCT03674294.

Dataset Information

Searching for Evidence to Support the Use of Ginger in the Prevention of Chemotherapy-Induced Nausea and Vomiting.

Publications

Searching for Evidence to Support the Use of Ginger in the Prevention of Chemotherapy-Induced Nausea and Vomiting.

Similar Datasets

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