Towards an evidence-based homeopathic treatment for PMS

Objective: Homeopathy could offer safe and effective treatment for women with premenstrual syndrome/symptoms (PMS/S). A research program on effectiveness and efficacy was initiated to evaluate a semi-standarised individualised homeopathic treatment of women with PMS/S.

Methods/Results: The first step of our research program was to standardise individualised homeopathic treatment, to facilitate clinical research. Therefore, a semi-standardised computerised algorithm was developed and validated for homeopathic treatment of women with PMS/S with 11 medicines. A questionnaire was used to collect the women's keynote symptoms and characteristics for the 11 medicines. The first homeopathic prescription had to be according to the algorithm outcome. At follow-up, the prescription could be changed according to the analysis of the doctor. This semi-standarisation of the treatment minimised variability in prescription between the participating doctors, enabled optimum reproducibility of the treatment, yet respected the individualised approach.

Secondly, the use of this algorithm was evaluated in Dutch homeopathic practice in 38 women with 3 months follow-up. In an extension of this feasibility study, with 9 months follow-up and in a sample of 77 women suffering from PMS/S, we further evaluated the utility of the semi-standardised algorithm, measured changes in premenstrual symptom scores and detected possible predictive characteristics. This research was conducted in practices of 20 homeopathic doctors in the Netherlands between 2007-2011. Recruitment in this study proved difficult and the dropout rate was considerable. The algorithm proved useful and effective in daily homeopathic practice. We detected a significant decline in mean PMS-symptom scores over time, especially in women with moderate to severe PMS.

Next, in October 2012 we started an international pragmatic trial to evaluate the feasibility of a larger trial to establish the added value of this homeopathic treatment compared with usual care only. This project is a collaboration between research groups at the Louis Bolk Institute, Driebergen, the Netherlands, the Mid-Sweden University, Sundsvall, Sweden and the Women's Hospital, University of Heidelberg, Germany.

Previously, a double blind randomised placebo controlled pilot study was conducted in Israel on individualised homeopathic treatment for PMS with 5 homeopathic medicines. The homeopathic treatment proved superior to placebo, with significant results. For the homeopathic medicine selection, the ‘symptom-cluster’ approach was used: women first completed a questionnaire with symptoms representing keynotes of the homeopathic medicines. Women, whose symptom cluster matched the remedy picture of one of the homeopathic medicines were included in the trial. Other women were assigned to a parallel trial.

Conclusions: So far, positive clinical data have been obtained for the effectiveness and efficacy of homeopathic treatment in PMS. This line of research can act as an example on how to build up evidence for individualised homeopathic treatment in specific clinical conditions.