The efficacy of treatment with St Johns Wort for premenstrual syndrome (PMS)

ISRCTN	ISRCTN31487459
DOI	https://doi.org/10.1186/ISRCTN31487459
Secondary identifying numbers	UI04-6748

Submission date: 02/02/2009
Registration date: 03/04/2009
Last edited: 01/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Sarah Canning
Scientific

Institute of Psychological Sciences
University of Leeds
Leeds
LS2 9JT
United Kingdom

Email	s.e.canning@leeds.ac.uk

Study information

Study design	Interventional single centre randomised double-blind placebo-controlled cross-over study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised, double-blind, placebo-controlled trial to test the efficacy of Hypericum perforatum (St Johns Wort) as a treatment for premenstrual syndrome (PMS)
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(s)	Leeds (West) Research Ethics Committee approval obtained 23 June 2005 (ref: 04/Q1205/173)
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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Hypericum perforatum (St John's Wort)
Primary outcome measure	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 study start date	01/06/2005
Overall study end date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	41
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 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

England
United Kingdom

Study participating centre

Institute of Psychological Sciences

Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

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

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Hospital/treatment centre

The Rosalind Bolton Bequest (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2010		Yes	No

The efficacy of treatment with St Johns Wort for premenstrual syndrome (PMS)