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
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
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.