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Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.
Louis Bolk Institute, Bunnik, The Netherlands.
Mid Sweden University, Faculty of Human Sciences, Department of Nursing Sciences.ORCID iD: 0000-0002-3907-2197
University Women's Hospital, Universitätsfrauenklinik Heidelberg, Heidelberg, Germany.
Louis Bolk Institute, Bunnik, The Netherlands.
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2018 (English)In: Journal of Alternative and Complementary Medicine, ISSN 1075-5535, E-ISSN 1557-7708Article in journal (Refereed) Epub ahead of print
Abstract [en]

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.

Place, publisher, year, edition, pages
2018.
Keyword [en]
PMS/PMDD, homeopathy, pragmatic trials, premenstrual, randomized clinical trials
National Category
Other Health Sciences
Identifiers
URN: urn:nbn:se:miun:diva-33471DOI: 10.1089/acm.2017.0388PubMedID: 29565636OAI: oai:DiVA.org:miun-33471DiVA, id: diva2:1196725
Available from: 2018-04-11 Created: 2018-04-11 Last updated: 2018-04-11Bibliographically approved

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Jong, MatsJong, Miek C.

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