premenstrual disorders
Conditions
Interventions
Usual care (UC): Depends on the treatment for PMS or PMDD that is usually
provided by the GP or specialist doctor. This can differ in each country and
between physicians in the same country, because
Sponsors
Louis Bolk Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age 18-50 diagnosis PMS or PMDD written informed consent accessible by telephone and internet able to read and speak the native language of the participating country
Exclusion criteria
Exclusion criteria: Major psychiatric co-morbidity or physical co-morbidity with large impact on general health Absence of menses (after hysterectomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I· -Time needed to recruit 114 women in three countries -Preferences of the women for several treatment options -Adherence of women to the therapy they are randomised to -Numbers of complete patient records returned -Numbers of complete reports returned by homeopaths/doctors -Agreement between algorithm outcome and first homeopathic prescription -Opinion about the semi standardised treatment protocol of the homeopaths/homeopathic physicians in Germany and Sweden -Mean percentage of change in PMS symptom scores after 4 menstrual cycles measured through daily recording of patient rated symptoms scores by the Daily Record of Severity of Problems (DRSP). Phase II (if phase I has positive outcomes) -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
| Measure | Time frame |
|---|---|
| Phase I+II -Changes of functional impairment score relating to work-productivity, social activities and relationships by the DRSP-FI. -Changes in the Pre Menstrual Tension Syndrome Self-Rating Visual Analogue Scale (PMTS-VAS) -Self-reported changes in main concern and well being by the Measure Yourself Concerns and Well-being (MYCaW) -Changes in use of (pain) medication for premenstrual symptoms in a diary alongside the DRSP. -Satisfaction with treatment and health care provider using the Patient Satisfaction Questionnaire (PSQ), a VAS-based scale. -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. -Participants* preferences for several treatment options will be documented by a short questionnaire (PPref) -The participants* expectations about the treatment they will receive will be documented by short questionnaires (PE) | — |
Countries
Netherlands
Outcome results
None listed