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Title: Exploratory study of ginger and peppermint as complementary therapies for the management of chemotherapy-induced nausea and vomiting in women with breast cancer : a double-blind, placebo-controlled, randomised clinical trial
Author: Dabbour, Rasha
ISNI:       0000 0004 2722 2818
Awarding Body: University of Manchester
Current Institution: University of Manchester
Date of Award: 2007
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Background: Chemotherapy-induced nausea and vomiting (CINV) is still one of the most serious and distressing problems that faces chemotherapy patients. Introduction of new antiemetic drugs such as Neurokinin receptor antagonists and 5HT 3 receptor antagonists reduce the patient's experience of such symptoms in the acute phase (first 24 hours after chemotherapy administration). However, these drugs are not satisfactory in controlling the delayed symptoms (symptoms occurring after 24 hours). Using complementary and alternative medicine (CAM) is very common among cancer patients and herbal therapy is the most popular. Ginger and peppermint are herbs that have clinical supportive evidence against different gastrointestinal complaints including nausea and vomiting. In most studies ginger and peppermint have been shown to be safe and efficacious, and thus might be beneficial for cancer patients receiving chemotherapy. Purpose: To evaluate the efficacy of ginger and of peppermint as complementary therapy for the treatment of CINV, and to determine whether it is feasible to conduct a double-blind RCT using these two herbs. Method: Women with breast cancer with previous experience of CINV, who attended the chemotherapy unit to receive their second chemotherapy treatment, were invited to participate in a double-blind placebo-controlled parallel group randomised trial. All the patients received a moderately high emetogenic adjuvant chemotherapy which contained either AC (doxorubicin and cyclophosphamide); FEC (cyclophosphamide, epirubicin, and fluorouracil); EpiCMF regime (Epirubicin) or EC (epirubicin and cyclophosphamide). During an 18-month period, 55 women (41 % of the eligible) were randomly allocated to receive either 2200 mg ginger capsules (n=19), 400 mg peppermint oil capsules (n=18), or identical placebo (glucose) capsules (n=18) daily (divided into two doses) starting one hour before their third chemotherapy cycle and continuing for another 6 days. All the participants recorded their nausea and vomiting experience using the Rhodes index of nausea, vomiting and retching before the chemotherapy administration, and again daily for 7 consecutive days. They also completed the EORTC QLQ-C30 and its breast cancer module (quality of life questionnaires) before starting the treatment and 7 days later. Results: 39/55 participants remained in the study and provided evaluable data; 6 were considered early drop-outs (before the scheduled study intervention); 10 cases had not returned their follow-up questionnaires and one took the study capsules for less than three days. Of the remaining 37 patients, 15 received ginger, 10 received peppermint and 12 received placebo. There were no significant differences in outcomes between the three groups. Similar adverse effects were reported with all the participants. Conclusion: Although ginger and peppermint have been used for the treatment of nausea and vomiting in different situations, the study failed to detect any statistically significant differences between the groups. Nevertheless, this result should not be conclusive as the study was underpowered. Moreover, this study shows how difficult it is to conduct a double-blind, placebo-controlled trial using capsule forms of herbs for the treatment of CINV.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available