Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2002; 7: 112
This study is part of a research process that began in 1996 with an observational study that identified a population of women with breast cancer seeking complementary and alternative medicine for difficult menopausal symptoms. The results of a pilot study in this population suggested a homoeopathic intervention was effective in the management of these symptoms and a randomised placebo-controlled trial was designed to explore the components contributing to the positive effects observed. This study was designed as a pilot study acknowledging the possibility that the consultation itself would provide a beneficial effect, making any comparison of small groups more challenging.
Patients were recruited locally using predefined inclusion criteria. Women were seen at 4-weekly intervals for 16 weeks. Double-blinding was maintained throughout the study. The primary outcome measure was the Measure Yourself Medical Outcome Profile (MYMOP). Other outcome measures included the Hospital Anxiety and Depression score, the European Organisation for Research and Treatment in Cancer Quality of Life Score, the Menopausal Symptom Scale and Likert scales assessing daily frequency and intensity of flushes.
Fifty-three women were randomised to the study and 45 (85%) completed it; 74.5% of women experienced a major improvement or complete resolution of symptoms. All four items on MYMOP improved over the study period by an average of 0.8, which is regarded as a significant change. Verum and placebo groups were well matched and there was no statistically significant difference between groups for the primary endpoint. However, helpfulness and satisfaction scores approached significance for the treatment group.
Final data analysis continues and will be presented at the conference.
