Pilot Study – treatment of menopausal symptoms
Evidence for integration: randomised, controlled pilot study of the effectiveness of treatment of menopausal symptoms by medical herbalists. Julia Green , Sue Hawkey , Alison Denham , Jenny Ingram
Background Women have been shown to be frequent users of CAM for symptoms associated with the menopause. Three groups of women may find it useful: women who do not wish to use hormone replacement therapy (HRT), where HRT it is contra-indicated (Nelson, 2002) or where side effects have been sufficiently unpleasant for the woman to stop its use (Waldman, 1998). It has been shown that CAM practitioners treat women for a wide range of menopausal symptoms and that women appreciate the holistic nature of CAM consultations. We know from asking herbal practitioners that help with menopausal symptoms is a frequent request from patients (Beatty, Denham, 1998) and a clinical audit showed that herbal practitioners consider that herbal medicine can be prompt and effective in treating symptoms including hot flushes and night sweats.
Clinical trials have shown that that some single plant extracts can be useful in treating symptoms associated with the menopause (Hunter, 1998). However the range of products and claims made for over-the-counter products are confusing (Gingrich, Fogel, 2003).
Aims
The purpose of this pilot study is to evaluate the effectiveness of care given by herbal practitioners. It will also address some of the methodological problems of trial design for complex interventions within complementary medicine and primary care (Mason, et al, 2002). This methodological issue is also encountered in primary care whenever the intervention is more complex than a medication (Campbell, et al, 2000).
There are very few studies of the clinical practice of herbal practitioners and this pilot study will provide useful information on practical trial design for future researchers.
Design of the pilot study has been a step-by-step process over 5 years in consultation with various stake holders: patients, herbal practitioners, university departments, local health care trusts, local research forums and general practitioners.
Approval for the pilot study has been gained from the local healthcare trust research ethics committee.
Setting
The pilot study is set in primary care both to reflect the normal care of women with menopausal problems and to provide experience relevant to the design of future clinical trials within primary care.
Recruitment Women between the age of 45-59 from one Bristol GP list were identified from the GP database. The search excluded women already receiving a prescription for HRT. Women were sent a letter describing the pilot study, inviting them to participate and to contact the trial co-ordinator if they were suffering from problems associated with the menopause.
Treatment and control group
Women are invited to an initial interview to explain the arrangements for the study, to ensure that the inclusion and exclusion criteria are met and to discuss any concerns which the patient wishes to discuss before giving consent to enter the study.
The 45 patients entered into the pilot study will be randomised into control and treatment groups. The treatment group will receive normal treatment from one of three designated local herbal practitioners and have six appointments in five months. This is a waiting list study and the control group will be offered the same treatment after four months.
Consultation with herbal practitioner The menopause involves many experiential changes and is thus suited to the many faceted approach of herbal practitioners. The consultation offers the opportunity for an in-depth discussion (Eldin, Dunford, 1999) which includes the role of emotional factors. Prescriptions for relatively similar conditions may vary substantially which means that it is possible to suit the prescription to the particular symptoms and constitution of the individual woman.
The three practitioners taking part in the pilot study discussed appropriate dietary advice and overall approach to lifestyle advice but will be free to care for each patient as they would in normal practice.
Consultations include:
• full medical and drug history
• appropriate physical examinations
• diagnosis
• nutritional and lifestyle advice including advice on exercise
• individualised care plan
• prescription of individually formulated herbal medicines adapted at each consultation
Outcome measures
Both groups will complete outcomes measures, administered by post at designated time intervals.
Primary outcome measure:
Greene Climacteric scale (Greene, 1998).
This validated measure has 21 questions scored 0-3 and was chosen because it includes a good range of symptoms yet is straightforward for the patient to complete.
Secondary measures:
Mymop2 (Paterson, Britten, 2000).
This is a patient generated measure of outcomes which was developed for use in complementary medicine and provides a better picture of the significance of symptoms to the wellbeing of patients.
Hot flush visual analogue scale.
This is the most important symptom to many women.
Results
This ongoing pilot study will determine baseline scores and changes in scores on the Greene scale and monitor recruitment and drop-out rates to facilitate more accurate sample size calculations for a full-scale trial.
Conclusions
The results of the pilot study will be of interest to different audiences and it is intended that the results and different aspects of the trial design be submitted for publication in journals which reach herbal practitioners, CAM researchers and health professionals with a particular interest in the menopause.
It is intended that the results of the pilot study will add to the relevant evidence both for integration of CAM into primary care and for purchase of services from independent practitioners. An adequate evidence base for purchasing depends on evaluation of a range of sources so that services can be offered which would both widen patient choice and increase the availability of effective care.
Funding
This project is supported by the National Institute of Medical Herbalists (www.nimh.org.uk) using a legacy dedicated to funding of research given in 1996, and the National Institute of Medical Herbalists Education Fund, 56 Longbrook Street, Exeter, EX4 6AH.
Members of the National Institute of Medical Herbalists have all undertaken a minimum of 3 years training in medical sciences, clinical skills and herbal therapeutics. They are fully insured and subject to a code of ethics, and mandatory continuing professional development. NIMH is represented on the Herbal Medicine Regulatory Working Group which will publish its report on recommendations on the statutory regulation of herbal practitioners in Autumn 2003.
Campbell, M, et al. (2000) Framework for design and evaluation of complex interventions to improve health. British Medical Journal 321, pp 694-6
Beatty, C, Denham, A. (1998) Review of Practice:preliminary data collection for clinical audit. European Journal of Herbal Medicine 4 (2), pp 32-3
Eldin, S, Dunford, A. (1999) Herbal medicine in primary care. Oxford: Butterworth-Heinemann.
Gingrich, P, Fogel, C. (2003) Herbal therapy use by perimenopausal women. Journal of Obstetric, Gynecological and Neonatal Nursing 32(2), 181-9
Greene, J. (1998) Constructing a standard climacteric scale. Maturitas 29, pp 25-31
Hunter, A. (1998) Cimicifuga racemosa: pharmacology, clinical trials and clinical use. European Journal of Herbal Medicine 5 (1), pp 19-25
Mason, S, Tovey, P, Long, A. (2002) Evaluating complementary medicine: methodological challenges of randomised controlled trials. British Medical Journal 325, pp 832-4
Nelson, H. (2002) Assessing benefits and harms of hormone replacement therapy: clinical applications. Journal of the American Medical Association 288 (7), 882-4
Paterson C, Britten N. (2000) In pursuit of patient-centred outcomes: a qualitative evaluation of MYMOP, Measure Yourself Medical Outcome Profile. Journal of Health Service Research and Policy 5, pp 27-36
Waldman T. (1998) Menopause: where HRT is not an option. Part 1. Journal of Women’s Health 7 (5), pp 559-65
Background Women have been shown to be frequent users of CAM for symptoms associated with the menopause. Three groups of women may find it useful: women who do not wish to use hormone replacement therapy (HRT), where HRT it is contra-indicated (Nelson, 2002) or where side effects have been sufficiently unpleasant for the woman to stop its use (Waldman, 1998). It has been shown that CAM practitioners treat women for a wide range of menopausal symptoms and that women appreciate the holistic nature of CAM consultations. We know from asking herbal practitioners that help with menopausal symptoms is a frequent request from patients (Beatty, Denham, 1998) and a clinical audit showed that herbal practitioners consider that herbal medicine can be prompt and effective in treating symptoms including hot flushes and night sweats.
Clinical trials have shown that that some single plant extracts can be useful in treating symptoms associated with the menopause (Hunter, 1998). However the range of products and claims made for over-the-counter products are confusing (Gingrich, Fogel, 2003).
Aims
The purpose of this pilot study is to evaluate the effectiveness of care given by herbal practitioners. It will also address some of the methodological problems of trial design for complex interventions within complementary medicine and primary care (Mason, et al, 2002). This methodological issue is also encountered in primary care whenever the intervention is more complex than a medication (Campbell, et al, 2000).
There are very few studies of the clinical practice of herbal practitioners and this pilot study will provide useful information on practical trial design for future researchers.
Design of the pilot study has been a step-by-step process over 5 years in consultation with various stake holders: patients, herbal practitioners, university departments, local health care trusts, local research forums and general practitioners.
Approval for the pilot study has been gained from the local healthcare trust research ethics committee.
Setting
The pilot study is set in primary care both to reflect the normal care of women with menopausal problems and to provide experience relevant to the design of future clinical trials within primary care.
Recruitment Women between the age of 45-59 from one Bristol GP list were identified from the GP database. The search excluded women already receiving a prescription for HRT. Women were sent a letter describing the pilot study, inviting them to participate and to contact the trial co-ordinator if they were suffering from problems associated with the menopause.
Treatment and control group
Women are invited to an initial interview to explain the arrangements for the study, to ensure that the inclusion and exclusion criteria are met and to discuss any concerns which the patient wishes to discuss before giving consent to enter the study.
The 45 patients entered into the pilot study will be randomised into control and treatment groups. The treatment group will receive normal treatment from one of three designated local herbal practitioners and have six appointments in five months. This is a waiting list study and the control group will be offered the same treatment after four months.
Consultation with herbal practitioner The menopause involves many experiential changes and is thus suited to the many faceted approach of herbal practitioners. The consultation offers the opportunity for an in-depth discussion (Eldin, Dunford, 1999) which includes the role of emotional factors. Prescriptions for relatively similar conditions may vary substantially which means that it is possible to suit the prescription to the particular symptoms and constitution of the individual woman.
The three practitioners taking part in the pilot study discussed appropriate dietary advice and overall approach to lifestyle advice but will be free to care for each patient as they would in normal practice.
Consultations include:
• full medical and drug history
• appropriate physical examinations
• diagnosis
• nutritional and lifestyle advice including advice on exercise
• individualised care plan
• prescription of individually formulated herbal medicines adapted at each consultation
Outcome measures
Both groups will complete outcomes measures, administered by post at designated time intervals.
Primary outcome measure:
Greene Climacteric scale (Greene, 1998).
This validated measure has 21 questions scored 0-3 and was chosen because it includes a good range of symptoms yet is straightforward for the patient to complete.
Secondary measures:
Mymop2 (Paterson, Britten, 2000).
This is a patient generated measure of outcomes which was developed for use in complementary medicine and provides a better picture of the significance of symptoms to the wellbeing of patients.
Hot flush visual analogue scale.
This is the most important symptom to many women.
Results
This ongoing pilot study will determine baseline scores and changes in scores on the Greene scale and monitor recruitment and drop-out rates to facilitate more accurate sample size calculations for a full-scale trial.
Conclusions
The results of the pilot study will be of interest to different audiences and it is intended that the results and different aspects of the trial design be submitted for publication in journals which reach herbal practitioners, CAM researchers and health professionals with a particular interest in the menopause.
It is intended that the results of the pilot study will add to the relevant evidence both for integration of CAM into primary care and for purchase of services from independent practitioners. An adequate evidence base for purchasing depends on evaluation of a range of sources so that services can be offered which would both widen patient choice and increase the availability of effective care.
Funding
This project is supported by the National Institute of Medical Herbalists (www.nimh.org.uk) using a legacy dedicated to funding of research given in 1996, and the National Institute of Medical Herbalists Education Fund, 56 Longbrook Street, Exeter, EX4 6AH.
Members of the National Institute of Medical Herbalists have all undertaken a minimum of 3 years training in medical sciences, clinical skills and herbal therapeutics. They are fully insured and subject to a code of ethics, and mandatory continuing professional development. NIMH is represented on the Herbal Medicine Regulatory Working Group which will publish its report on recommendations on the statutory regulation of herbal practitioners in Autumn 2003.
Campbell, M, et al. (2000) Framework for design and evaluation of complex interventions to improve health. British Medical Journal 321, pp 694-6
Beatty, C, Denham, A. (1998) Review of Practice:preliminary data collection for clinical audit. European Journal of Herbal Medicine 4 (2), pp 32-3
Eldin, S, Dunford, A. (1999) Herbal medicine in primary care. Oxford: Butterworth-Heinemann.
Gingrich, P, Fogel, C. (2003) Herbal therapy use by perimenopausal women. Journal of Obstetric, Gynecological and Neonatal Nursing 32(2), 181-9
Greene, J. (1998) Constructing a standard climacteric scale. Maturitas 29, pp 25-31
Hunter, A. (1998) Cimicifuga racemosa: pharmacology, clinical trials and clinical use. European Journal of Herbal Medicine 5 (1), pp 19-25
Mason, S, Tovey, P, Long, A. (2002) Evaluating complementary medicine: methodological challenges of randomised controlled trials. British Medical Journal 325, pp 832-4
Nelson, H. (2002) Assessing benefits and harms of hormone replacement therapy: clinical applications. Journal of the American Medical Association 288 (7), 882-4
Paterson C, Britten N. (2000) In pursuit of patient-centred outcomes: a qualitative evaluation of MYMOP, Measure Yourself Medical Outcome Profile. Journal of Health Service Research and Policy 5, pp 27-36
Waldman T. (1998) Menopause: where HRT is not an option. Part 1. Journal of Women’s Health 7 (5), pp 559-65
