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Klein-Laansma, C.T., M. Jong, C. von Hagens, J.P. Jansen, H. van Wietmarschen, M.C. Jong. 2018. Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study. The journal of alternative and complementary medicine. 24(7):1-10.

Aantal pagina's: 10

DOI: 10.1089/acm.2017.0388

Soort document: Journal Article

Meer over auteurs/freelancers verbonden aan het LBI :
Dr. Miek C. Jong ;
Dr. Herman van Wietmarschen


Taal van het document: Engels

Title in English: Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study

Abstract / summary in English:

Objectives: Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated.

Design: A multicenter, randomized, controlled pragmatic trial with parallel groups.

Settings/Location: The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany.

Subjects: Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized.

Interventions: Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences.

Outcome measures: Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed.

Results: In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03).

Conclusions: With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.


Keywords in English: premenstrual, PMS/PMDD, homeopathy, randomized clinical trials, pragmatic trials
Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study