Jacobs, J., Herman, P., Heron, K., Olsen, S., & Vaughters, L. (2005). Homeopathy for menopausal symptoms in breast cancer survivors: A preliminary randomized controlled trial. Journal of Alternative and Complementary Medicine, 11, 21–27.

This was a preliminary trial evaluating effectiveness of two types of homeopathy for treatment of menopausal symptoms in breast cancer survivors.

At the initial visit, a homeopathic practitioner conducted a homeopathic evaluation of each participant and prescribed an individualized homeopathic medication that best matched the symptom profile for that participant. A homeopathic pharmacist randomized the participants tothree treatment groups:

1. A placebo combination medicine and a verum single remedy
2. A verum combination medicine and a placebo single remedy
3. Two placebo medications

All study medications were donated by the Standard Homeopathic Company. The treatments were identical in taste, appearance, and odor and were dispensed in identical containers. The combination medicine was Hyland’s Menopause, which is sold over-the-counter in the United States. It contained three homeopathic medicines: Amyl nitrate, Sanguinaria canadensis, and Lachesis.

Participants were mailed a one-week daily hot flush diary to complete during the week prior to call.

Eighty-three (83) participants completed the initial homeopathic visit and were randomized into the three treatment groups. Of this total, 28 patients (33.7%) withdrew, including 11 who reported no relief from hot flashes, 7 who had a cancer recurrence or withdrew because of other illness, 5 who said the study was inconvenient, and 4 who were lost to follow up. Sixty-six (66) participants completed at least six months of the study (80.5%).

• Inclusion criteria:
  • Women with a history of breast cancer who had completed all surgery, chemotherapy, and radiation treatment.
  • Tamoxifen use was allowed.
  • Participants had a history of hot flashes for at least one month, with an average of at least three hot flashes per day in the week prior to beginning treatment.
• Exclusion criteria:
  • Other medications for the treatment of hot flashes, including specific vitamin regimens, herbs, estrogen or progestational agents, antidepressants, or sleep medications were not permitted.
  • Concurrent chronic health problems such as rheumatoid arthritis, asthma, heart disease, and inflammatory bowel disease and corticosteroid use.
  • Those expected to receive additional chemotherapy or radiation treatment within the next year were not allowed to participate.
  • Women who were pregnant or planned to become pregnant in the next year were also excluded.

Participants stratified by age (younger or older than 50 years), breast cancer staging, and use of tamoxifen.

The study was a randomized, double-blinded, placebo-controlled trial. Participants received controlled an individualized homeopathic single remedy, homeopathic combination medicine, or a placebo.

Homeopathic providers saw or called participants every two months for one year.

No significant difference was reported for the primary outcome measure, the hot flash severity score, or in the total hot flashes among the three groups in the univariate model adjusted for baseline, time, and tamoxifen use over the period of 1 year. The single remedy group had a lower severity score and fewer hot flashes as a whole, which was most marked during the first three months of the study, with a positive trend (p = 0.1) at three months compared to placebo. However, in the combination homeopathy group not receiving tamoxifen, there was a statistically significant increase in the hot flash severity score compared to placebo (p= 0.01) and a highly significant difference when compared to single homeopathic remedy (p= 0.001). Similarly, there was a highly significant increase in the total number of hot flashes in the combination group compared to placebo (p = 0.006) and compared to single remedy (p=0.002) in the group not receiving tamoxifen. There was also a statistically significant increase in headaches in the group receiving the homeopathic combination at 6 months (p = 0.04) and 12 months (p = 0.03). In the multivariate analysis, which included baseline values, time, age, last month in the study, and treatment group, the same statistically significant relationships between treatment group and tamoxifen/no tamoxifen were found for both severity score and total number of hot flashes.

The small sample size precludes definitive answers. Difficulty in retaining participants for one year was a major problem. Use of three arms made treatment decisions difficult, although the average number of remedy changes found over the one-year study period is not unusual in homeopathic practice. Use of the homeopathic combination medicine in an ongoing daily regimen, rather than as it is used in current over-the-counter treatment, was a major flaw in this study.