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International Randomized Controlled Pilot Study on Homeopathy and PMS: Latest Outcomes, Opportunities and Pitfalls
05 February 2018 (online)
Study Design: A multi-centre, international, randomized, controlled pragmatic study with two parallel groups. Study period: October 2012–July 2016.
Objective: To investigate the feasibility of organizing an international multi-centre pragmatic trial on individualized homeopathic add-on treatment (HT) using a semi-standardized algorithm in women with premenstrual disorders (PMS/PMDD), compared with usual care only (UC).
Methods: After a 2 months’ screening phase with symptom diaries (DRSP—Daily Record of Severity of Problems), women diagnosed with PMS/PMDD were randomized to HT or UC. Preferences and expectations were recorded. During treatment (4 months), the women regularly completed diaries and questionnaires.
Results: In the Netherlands, 38 women were included after 2 years. In Sweden, recruitment was delayed by discussions about homeopathy; once resumed, it was slow and stopped after 3 years, 22 women were included. In Germany, even non-randomized case series with individualized homeopathy were classified as drug trials by the authorities, so the study could not proceed. In total, 244 women were interested, 71 completed diaries; in 61, the diagnosis of PMS/PMDD was confirmed; 60 were randomized (HT: 28; UC: 32); and data of 46 women were analyzed. The majority had preference for homeopathy (83.3%) and objected to oral contraceptive pills (81.7%) or antidepressants (75%). In the HT group, Sepia officinalis and Natrum muriaticum were the most prescribed homeopathic medicines.
After 4 months, the relative mean change of DRSP scores in the HT group was significantly better than in the UC group (ANCOVA; p = 0.0028). No confounders were identified.
Conclusion: In this study, the added value of this homeopathic treatment compared with usual care only was demonstrated by significant differences in change of symptom scores. However, with respect to recruitment and different legal status, it does not seem feasible to perform larger pragmatic randomized controlled clinical trials on individualized homeopathic treatment of PMS in Europe.
Keywords: Premenstrual, PMS/PMDD, homeopathy add-on, individualized homeopathy, usual care, pragmatic, DRSP