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J Altern Complement Med. 2018 Jul;24(7):684-693. doi: 10.1089/acm.2017.0388. Epub 2018 Mar 22.

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

Author information

1
1 Department of Health and Nutrition, Louis Bolk Institute , Bunnik, The Netherlands .
2
2 Department of Nursing, Mid-Sweden University , Sundsvall, Sweden .
3
3 Naturopathy and Integrative Medicine, Department of Gynecological Endocrinology and Reproductive Medicine, University Women's Hospital , Universitätsfrauenklinik Heidelberg, Heidelberg, Germany .

Abstract

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:

PMS/PMDD; homeopathy; pragmatic trials; premenstrual; randomized clinical trials

PMID:
29565636
DOI:
10.1089/acm.2017.0388
[Indexed for MEDLINE]

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