“Changing with herbs” Treatment of menopausal symptoms by qualified herbal practitioners: a prospective randomised controlled trial Julia Green and Sue Hawkey Herbal practitioners researchers
The study question
• Population: 45 women aged 46-59 from 1 GP practice “experiencing menopausal problems” • Interventions: - normal care from herbal practitioner - waiting list control • Primary outcome Greene climacteric scale
Rationale for the study
• Many women find menopausal symptoms troublesome • Want alternative evidence backed treatment options • Women consult herbalists about the menopause. Herbal medicine research so far has concentrated on the product, not holistic practice
Participants’ experience of menopause...
“a bit embarrassing. I’m a teacher you know and if you suddenly get sweat running down in the middle of your class it’s a bit awkward really”
“It’s so difficult emotionally to cope with: I think I look back and thought it a dreadful time, I found it awfully difficult, I was miserable, hot flushes were awful, I couldn’t sleep…”
… Consultation: a very complex intervention …
• full clinical history, physical examination, diagnosis • discuss nutrition, exercise, emotions etc • personal care plan • individual prescription, 59 herbs in the medicine, dispensed by the herbalist • treatment by a medical herbalist is holistic
Outline of study:
Local research ethics committee approval: Sept 2002
• 45 menopausal women • recruited by letter from one Bristol GP practice • entry into trial at interview • block randomised between treatment group (15) and waiting-list control group (30); • both groups completed outcomes measures by post (Greene Scale, MYMOP,) • intervention: 6 personal consultations over 18 weeks,with one of three local members of the National Institute of Medical Herbalists
Assessed for eligibility Women aged 46-59 on neither HRT nor oral contraceptives identified by database search (n=252) Replies to letters (n=161) Enrollment
Flowchart of participants through trial
Excluded (n=116) Not meeting inclusion criteria (n=116)
Of these still menstruating (n=82, other exclusion criteria (n=34)
Women recruits block randomised (n=45)
Refused to participate (n= 0) Other reasons (n= 0)
Allocated to treatment by 3 herbal practitioners (n=15) Received allocated intervention (n=14) Did not receive allocated intervention (n= 1) Allocation Complications of previous operation
Allocated to waiting list control (n= 30) Received allocated intervention (n= 30) Did not receive allocated intervention (n= 0)
Lost to follow-up (n= 0) Discontinued intervention (n= 0)
Follow-Up
Lost to follow-up (n=1) Moved away without valid forwarding address before completing timepoint 4 outcomes measures. Data up to then included. Discontinued intervention (n=0)
Analyzed (n=14) Excluded from analysis (n= 0)
Analysis
Analyzed (n=30)
Total Greene scores over time for the treated and control groups
conclusions
Treatment package by qualified herbal practitioners: • reduced overall menopausal symptoms • reduced vasomotor symptoms • increased libido • Evidence for treatment choices for women with menopausal symptoms • It was possible to assess a complex intervention with a pragmatic RCT
Feedback…
“I found this study interesting and put many suggestions into practice…I did feel better on the herbal medicine and hot flushes disappeared..my blood pressure also came down” “I have valued the support…I have decided to continue with herbal medicine” “why does it have to taste so horrible?”
“I found the herbalist very supportive..the remedy has been effective”
And now…
• Publication • Nested qualitative study funded by Avon Primary Care Research Collaborative “Not on my own”, to explore the experience of both participants and practitioners • Bigger study?
…..research team….
Thanks to the participants, to the herbal practitioners, to the Spence
Group Practice, Bristol, Caroline Beatty and funders: National Institute of Medical Herbalists, NIMH Education Fund Research sponsor University of Central Lancashire For nested qualitative study, Avon Primary Care Research Collaborative Trial co-ordinator: Dr Julia Green, MNIMH medical herbalist and researcher Alison Denham, FNIMH, Senior Lecturer in Herbal Medicine, University of Central Lancashire Rosemary Greenwood, Research and Development Support Unit, United Bristol Healthcare Trust Sue Hawkey, MNIMH, Lecturer in Herbal Medicine, University of East London Dr Jennifer Ingram, Research and Development Support Unit, United Bristol Healthcare Trust