Homeopathic add-on treatment versus usual care for premenstrual disorders (PMD).

Background:

Worldwide, a meaningful proportion (8-32%) of women suffers from moderate to severe premenstrual disorders. Moderate to severe PMS and Premenstrual Dysphoric Disorder (PMDD) seem to be associated with impaired work productivity and increased absenteeism, and thus pose a potential economic burden. At present, evidence-based pharmacological treatments of women with PMDD and severe PMS are the use of antidepressants of the Selective Serotonine Re-uptake Inhibitors (SSRI)-type and the Combined Oral Contraceptive (COC) drospirenone/ethinylestradiol. These treatments are often unsatisfactory and women have reported to prefer more ‘natural and safe’ treatment approaches.

A previous pilot study has shown that homeopathy may be a promising treatment strategy to improve symptoms and quality of life of women who suffer from premenstrual disorders. Therefore, we want to pilot the feasibility, effect size (phase I) and investigate the added value (phase II) of a well-defined previously tested homeopathic intervention compared to usual care.



Objectives:

The aim of phase I of this proposed pilot study is to investigate the feasibility of an international pragmatic study on the added value of an individualised homeopathic treatment of women with premenstrual disorders compared to usual care only. In case the recruitment for to the pilot study goes according to plan, the results are promising and implementation of the homeopathic treatment is evaluated as feasible in the three countries, we will enter phase II of the study. For phase II, additional women will be recruited and randomised. A new sample size will be calculated based on the effect size of the pilot study, to be able to detect possible significant differences between the homeopathy-add-on and usual care group. The study will be extended by two years.



Interventions:

For the homeopathic treatment we will use a previously developed semi-standardised algorithm with 11 homeopathic medicines.

For usual care women will visit their general practitioner or specialist (depending on country) who will give care as usual.



Study population:

Women with premenstrual disorders will be recruited at primary care settings and outpatient clinics in the Netherlands, Sweden and Germany.



Duration:

Women will be randomly assigned to 4 months/cycles of homeopathic add-on treatment or usual care only.



Design:

Multi-centre, international, randomised, controlled pragmatic study with two parallel groups.



Countries of recruitment:

The Netherlands, Sweden and Germany.

Phase I:

To investigate whether it is feasible to organise an international multi-centre pragmatic trial to study the value of individualised homeopathic add-on treatment using a semi-standardised algorithm in women with premenstrual disorders, compared to usual care only.



Phase II:

If the feasibility evaluation has positive results and preliminary results tend to be in favour of homeopathy, we will additionally evaluate the added value of individualised homeopathic add-on treatment in women with PMD compared to usual care only in a larger sample of women.

Main measurements:

1. Before the start of the intervention;

2. 2 months after the start of the intervention;

3. 4 months after the start of the intervention.

1. Individualised homeopathic treatment using a semi-standardised algortihm additional to usual care;

2. Usual care only.