International investigation comparing additional homeopathic treatment and usual care only in women with premenstrual disorders (PMS or PMDD).

Many women suffer from symptoms in the days before the onset of menses. In moderate to severe cases PreMenstrual Syndrome (PMS) can be diagnosed. In an investigation in the United States it was estimated that mild premenstrual symptoms occurred in 15,6% of women in the fertile age, moderate symptoms in 67,1% and severe symptoms in 12,7%. In 4,7 % PreMenstrual Dysphoric Disorder (PMDD) was diagnosed, this means that depressive symptoms predominate. PMS and PMDD cause a serious burden for many women, can lead to relational problems and less productivity at work. Several conventional drugs have been tested for PMS and PMDD. There is evidence that a certain type of antidepressant and a combination contraceptive pill could alleviate symptoms in severe PMS or PMDD. These treatments are often unsatisfying and after cessation of treatment relapse of symptoms could occur. Moreover, these treatments are not suitable for women with mild to moderate symptoms and women who prefer a more natural approach. At present, many women with premenstrual symptoms get no or insufficient treatment. Homeopathic treatment could offer a safe and effective alternative.

From 2007-2011 we evaluated a protocol for individualised homeopathic treatment with 11 medicines in homeopathic medical practice in the Netherlands. This proved successful.

In the proposed study we will investigate the feasibility of organising a large international trial with two treatment groups. One group will get additional homeopathic treatment, the other group will get usual care only by the family physician or specialist. Lots will be drawn to decide to which group a person will be assigned. Women who would like to have homeopathic treatment and are assigned to the usual care group will be able to get homeopathic treatment after termination of the study. The investigation will be held in the Netherlands, Germany and Sweden. In this study, we will strive to include 38 participating women in each country.

The treatments during the study will take about 4 months (or the duration of 4 menstrual cycles). Before the treatment starts, women have to keep symptom diaries during two complete menstrual cycles (about two months). That will be necessary to be able to confirm the diagnosis. This means that in total the duration of the study for each women will be about 7 months.

We want to investigate if we will be able to recruit a sufficient number of women who want to participate, we want to know their preferences for treatment for PMS/PMDD and what they expect from the treatment. We will evaluate if women complete the symptom diaries and questionnaire as required and if the doctors and homeopath can handle the study protocol. We will evaluate the nature of usual care in the 3 countries (this could vary) and will compare the treatment results in both groups. We will measure the course of symptoms and use of medication by the diaries and questionnaires. After the treatment we will ask some questions about satisfaction of the participants with the treatment.

Women in the homeopathy group will get homeopathic treatment additional to usual care and therefore visit a homeopath/homeopathic physician. For the homeopathic prescription they will use a computerised algorithm with 11 medicines. The consultation will be as usual in homeopathic practice. The first consultation will take about an hour, the follow-up visits will take about half an hour.
Women in the usual care group will visit their family physician/specialist for usual treatment. This could be advice about lifestyle, nutrition, supplements, physical exercise. Medication options are antidepressants, a combined contraceptive pill, tranquilizers, diuretics (against water retention) or pain killers if appropriate. There will be no force or obligation to follow a certain treatment and the preferences of the women will be respected. Referral to a gynaecologist (in case of PMS) of psychiatrist (in case of PMDD) will be possible.
For both groups, follow-up visits will be scheduled after 2 and 4 months/menstrual cycles. After 1 and 3 months/cycles women will be phoned by a member of the research team for a quick check. If needed an extra visit will be planned.