Framework of the project
Informed consent, voluntariness, anonymity
After the intake women will have at least 24 hours time for reflection before they sign the informed consent form. Participation to the study is voluntarily. At any moment, all women can resign from participation without further explanation. When a woman decides to end participation to the study this will have no effect at all on the continuation of the treatment. All data will be processed in the strictest confidence and anonymity, we will be using codes.
Before the first consultation women who want to participate keep online pre-printed PMS symptom diaries during two menstrual cycles. After completion of these diaries it is possible to diagnose PMS or PMDD. If and when the diagnosis PMS or PMDD has been confirmed based on these diaries, a woman can participate in the study.
Drawing lots and second chance
Lots will be drawn to decide if a woman will have homeopathic add-on treatment or usual care only. We expect improvement of symptoms in both groups. Women who would prefer homeopathic treatment but are assigned to the usual care group, will be given the opportunity to have homeopathic treatment after 4 months. This will not be part of the investigation.
Before the start of the treatment women will complete the special homeopathic questionnaire. This will help the homeopath/homeopathic physician to decide about the first homeopathic medicine to prescribe during the homeopathic treatment. Homeopathic treatment can be given as an only treatment or as an addition to other therapies.
The family physician or specialist will provide a treatment for PMS/PMDD as is usual in conventional health care. This can be advice about food, lifestyle and exercise, because this could help a lot in the first place. When there are more severe complaints medication could be offered. Side-effects could occur, but this will be different for each woman. There is no pressure or obligation to accept any form of therapy. Together, the doctor and yourself will decide about a treatment that most suits your personal situation and preferences.
How often, how long?
After application, women will keep PMS-diaries during two months/menstrual cycles to be able to confirm the diagnosis PMS or PMDD. After that, they will have an intake interview with the research nurse or physician.
The duration of the treatment is four months/cycles. So, in total, the study will take about seven months/cycles. There will be consultations with the treating homeopath or physician at the start and after two and four months/cycles of treatment, so three times in total. In between, after one and three months of treatment, the women will be interviewed by telephone by a member of the research team. Regularly, women will have to complete questionnaires. In the second and fourth month/cycle of the treatment, they will again keep the PMS symptom diaries.