Condition category
Urological and Genital Diseases
Date applied
02/02/2009
Date assigned
03/04/2009
Last edited
01/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Canning

ORCID ID

Contact details

Institute of Psychological Sciences
University of Leeds
Leeds
LS2 9JT
United Kingdom
s.e.canning@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UI04-6748

Study information

Scientific title

A randomised, double-blind, placebo-controlled trial to test the efficacy of Hypericum perforatum (St John’s Wort) as a treatment for premenstrual syndrome (PMS)

Acronym

Study hypothesis

The primary objective of the proposed study is to determine whether hypericum perforatum (900 mg/day) is more beneficial than placebo supplements in relieving premenstrual symptoms in women diagnosed as having at least mild pre-menstrual syndrome (PMS).

Ethics approval

Leeds (West) Research Ethics Committee approval obtained 23 June 2005 (ref: 04/Q1205/173)

Study design

Interventional single centre randomised double-blind placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-menstrual syndrome (PMS)

Intervention

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 they were randomised to receive either Hypericum perforatum or placebo for two menstrual cycles. After a placebo-treated washout cycle, women were crossed over to placebo or Hypericum perforatum for a further two menstrual cycles.

Intervention type

Drug

Phase

Phase IV

Drug names

Hypericum perforatum (St John's Wort)

Primary outcome measures

Improvement in premenstrual symptoms measured using the Daily Symptom Report, completed daily by the participants throughout the trial.

Secondary outcome measures

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)

Overall trial start date

01/06/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

41

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychological Sciences
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Room 10.110
Level 10
Worsley Building
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

The Rosalind Bolton Bequest (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20155996

Publication citations

  1. Results

    Canning S, Waterman M, Orsi N, Ayres J, Simpson N, Dye L, The efficacy of Hypericum perforatum (St John's wort) for the treatment of premenstrual syndrome: a randomized, double-blind, placebo-controlled trial., CNS Drugs, 2010, 24, 3, 207-225, doi: 10.2165/11530120-000000000-00000.

Additional files

Editorial Notes