Cocculine is a homeopathic medicinal product used for nausea and motion sickness in France. Cocculine consists of four homeopathic components: Cocculus indicus 4 CH, Tabacum 4 CH, Nux vomica 4 CH, and Petroleum 4 CH. It has been evaluated for the management of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer.
Research Evidence Summaries
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.doi: 10.1186/1471-2407-12-603
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
Intervention Characteristics/Basic Study Process:
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 consisted of 431 patients.
- The median age was 52.8 years with a range of 20–74 years.
- All of the patients were female.
- Patients were chemotherapy-naïve with non-metastatic breast cancer and scheduled to receive six adjuvant cycles of chemotherapy including at least three initial cycles of 500 mg/m 95-fluoruracil, 50 mg/m adriamycin, and 500 mg/m cyclophosphamide (FAC 50); 500 mg/m 5-fluoruracil, 100 mg/m epirubicin, and 500 mg/m cyclophosphamide (FEC 100), or 75 mg/m docetaxel, 50 mg/m adriamycine, and 500 mg/m cyclophosphamide (TAC).
- To be included patients must have had no previous malignancies (except those in complete remission for more than five years), no contraindications to corticoids or 5-HT3 receptor antagonists, and no prior treatment with cocculine or other antiemetics within the previous 15 days. Patients had to be able to be followed up with by phone.
- Patients were excluded from the study if they were pregnant or lactating.
The study was conducted at multiple outpatient sites in France.
Phase of Care and Clinical Applications:
All patients were in active antitumor treatment.
This was a randomized, multi-centered, double-blind, longitudinal, placebo-controlled, phase III trial.
- Patients measured nausea and vomiting by using the Functional Living Index for Emesis (FLIE) with five days recall (on day six for the first three cycles).
- A patient self-evaluation (EVA) daily diary was used to record nausea occurrence and intensity and the number of vomiting episodes on days 1–5.
- Investigators recorded adverse events using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTC AE V3.0). They also measured treatment compliance by intake of study drugs and counting returned drug boxes.
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.
- A risk of bias exists because of the sample characteristics.
- The investigators did not measure or control for history of alcohol consumption, nausea and vomiting during pregnancy, or anxiety level about nausea and vomiting before randomization.
- Because the study began on the first cycle of chemotherapy, the investigators had no chance to determine prior CINV experience or anticipatory nausea and vomiting.
Nurses should advise patients who use any complementary interventions that some can be ineffective and costly.