Perol, D., Provencal, J., Hardy-Bessard, A.C., Coeffic, D., Jacquin, J.P., Agostini, C., . . . Ray-Coquard, I. (2012). Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial. BMC Cancer, 12, 603.
To evaluate the efficacy of cocculine (a complex homeopathic medicine) in the control of chemotherapy-induced nausea and vomiting (CINV) in patients with nonmetastatic breast cancer who are undergoing standard chemotherapy regimens
Participants were randomized to receive standard antiemetic treatment plus either a complex homeopathic remedy (cocculine) and or the matching placebo in addition to standard antiemetic prophylactic (8 mg ondansetron [or 3 mg granisetron] and 80 mg methylpredinosolone twice daily). Cocculine is a registered remedy in France for the treatment of nausea and travel sickness. It contains four homeopathic components: Cocculus indicus, tabacum, nux vomica, and petroleum.
Patients were stratified by participating center and type of chemotherapy regimen. Study treatments (cocculine and placebo) were given as two tablets on the evening before chemotherapy; two tablets three times on day 1, and two tablets on the morning and evening of day 2.
Nausea and vomiting were monitored for five days by completing the Functional Living Index-Emesis (FLIE) on day 6. The study regimen was repeated in cycles 2 and 3, and symptoms were monitored until cycle 6.
The study was conducted at multiple outpatient sites in France.
All patients were in active antitumor treatment.
This was a randomized, multi-centered, double-blind, longitudinal, placebo-controlled, phase III trial.
No difference was found between the two arms.
Adding a complex homeopathic medicine (cocculine) to standard antiemetic prophylaxis does not improve the control of CINV in patients just diagnosed with breast cancer.
Nurses should advise patients who use any complementary interventions that some can be ineffective and costly.