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

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2012
INTERVENTION: 1. Individualised homeopathic treatment using a semi‐standardised algortihm additional to usual care; 2. Usual care only. CONDITION: ; Premenstrual syndrome (PMS), Premenstrual dysphoric disorder (PMDD) ; ; PRIMARY OUTCOME: Phase I:; ; 1. Time needed to recruit 38 women in each country (114 women in 3 countries);; ; 2. Preferences of the women for several treatment options;; ; 3. Adherence of women to the therapy they are randomised to;; ; 4. Numbers of complete patient records returned;; ; 5. Numbers of complete reports returned by homeopaths/doctors;; ; 6. Agreement between algorithm outcome and first homeopathic prescription;; ; 7. Opinion about the semi standardised treatment protocol of the homeopaths/homeopathic physicians in Germany and Sweden;; ; 8. Mean percentage of change in PMS symptom scores after 4 months, measured through daily recording of patient rated symptoms scores by the Daily Record of Severity of Problems (DRSP) before treatment and in the 2nd and 4th cycle after the start of the intervention.; ; ; ; Phase II (if phase I has positive outcomes):; ; 1. Percentage of responders defined as = 50% reduction of PMS symptom score after 4 menstrual cycles (4 months), through daily recording of patient rated symptoms scores by the Daily Record of Severity of Problems (DRSP). SECONDARY OUTCOME: Phase I and II: ; ; 1. Changes of functional impairment score relating to work‐productivity, social activities and relationships by the DRSP‐FI (after 2 and 4 months/cycles); ; ; 2. Changes in the Pre Menstrual Tension Syndrome Self‐Rating Visual Analogue Scale (PMTS‐VAS) after 4 months/cycles. (measured in 1st week of menses during all menstrual cycles); ; ; 3. self‐reported changes in main concern and well being by the Measure Yourself Concerns and Well‐being (MYCaW), measured at intake and after 4 months/cycles; ; ; 4. Changes in use of (pain) medication for premenstrual symptoms in a diary alongside the DRSP after 2 and 4 months/cycles, also assessed during an interview by phone, 1 and 3 months/cycles after the start of the intervention; ; ; 5. Satisfaction with treatment and health care provider using the Participants’ Satisfaction questionnaire (PS), a VAS‐based scale, presented after the last visit; ; ; 6. Disease related costs: Direct and indirect cost with a direct relation to PMS will be calculated in both groups. The calculation will be based on diaries and interviews; ; ; 7. The participants’ expectations about the treatment they (will) receive will be documented by short questionnaires (PE), one before randomisation and one 2 months/cycles after the start of the intervention. INCLUSION CRITERIA: 1. Women aged 18‐50; 2. Written informed consent; 3. Diagnosis PMS or PMDD after keeping symptom diaries during two menstrual cycles; 4. Able to read and express themselves in language of country where the trial is done; 5. Access to phone and internet.
Epistemonikos ID: 310bc1a7519484a5e04f9a0023379553562037f9
First added on: Aug 22, 2024