Pre-menstrual syndrome (PMS) Urological and Genital Diseases Pain and other conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Random allocation to:
1. Hypericum perforatum tablets (900 mg/day)
2. Placebo tablets
After the three screening cycles, all women underwent a placebo run-in phase of two menstrual cycles, after which
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged between 18 and 45 years 2. In good physical and psychological health (assessed by a clinician) 3. Regular menstrual cycles (25 - 35 days) 4. Experiencing at least a 30% increase in the total scale score on the Daily Symptom Report from their follicular (cycle days 5 - 10) to luteal (cycle days -6 to -1) phase in at least two out of three menstrual cycles
Exclusion criteria
Exclusion criteria: 1. Using hormonal contraception or treatment 2. Pregnant or breast-feeding 3. Taking prescribed or over the counter medication for PMS 4. Taking prescribed drugs which could interact with Hypericum perforatum 5. Photosensitive 6. Meeting criteria for anxiety and/or depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in premenstrual symptoms measured using the Daily Symptom Report, completed daily by the participants throughout the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Other mood questionnaires, completed at the end of each week throughout the trial: 1.1. State Trait Anxiety Inventory 1.2. Beck Depression Inventory 1.3. Aggression Questionnaire 1.4. Barratt Impulsiveness Scale 2. Hormone levels, measured during the follicular (days 5 - 10) and luteal (days -6 to -1) phases of study cycles 3 (screening), 5 (placebo run-in), 7 (treatment phase I: Hypericum perforatum or placebo), 8 (washout) and 10 (treatment phase II: placebo or Hypericum perforatum): 2.1. Follicle stimulating hormone (FSH) 2.2. Luteinising hormone (LH) 2.3. Oestradiol 2.4. Progesterone 2.5. Prolactin 2.6. Testosterone 3. Cytokine concentration, measured during the follicular (days 5 - 10) and luteal (days -6 to -1) phases of study cycles 3 (screening), 5 (placebo run-in), 7 (treatment phase I: Hypericum perforatum or placebo), 8 (washout) and 10 (treatment phase II: placebo or Hypericum perforatum): 3.1. Interleukin-1 beta (IL-1beta) 3.2. Interleukin-6 (IL-6) 3.3. Interleukin-8 (IL-8) 3.4. Interferon-gamma (IFN-gamma) 3.5. Tumour-necrotising factor-alpha (TNF-alpha) | — |
Countries
United Kingdom
Outcome results
None listed