Changing with Herbs: reflections on research into herbal medicine carried out in primary care

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Changing with Herbs reflections on research into
herbal medicine carried out in primary care
Welcome

• Alison Denham, FNIMH
• Herbal practitioner, Senior Lecturer

Informing healthcare practice through
research11 May 2006
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..Research Team.

• Funding National Institute of Medical
  Herbalists, National Institute of Medical
  Herbalists Education Fund
• Research Sponsor University of Central
  Lancashire
• Trial co-ordinator Dr Julia Green, MNIMH,
  National Institute of Medical Herbalists, 54 Mary
  Arches Street, Exeter, Devon, EX4 3BA
• Alison Denham, FNIMH, Senior Lecturer in Herbal
  Medicine, University of Central Lancashire,
  Preston, PR1 2HE
• Sue Hawkey, MNIMH, National Institute of Medical
  Herbalists, 54 Mary Arches Street, Exeter, Devon,
  EX4 3BA
• Dr Jennifer Ingram, Research and Development
  Support Unit, United Bristol Healthcare Trust,
  Bristol Royal Infirmary, Marlborough Street, BS2
  8HW

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...research is about sharing experience

• We have recently completed a randomised,
  controlled pilot study of treatment of menopausal
  symptoms by medical herbalists
• to develop appropriate methodology to evaluate
  treatment by qualified herbal practitioners
• to support subsequent studies to improve the
  evidence base for the practice of herbal
  practitioners
• Issues raised in the pilot study are relevant in
  evaluation of care given by a healthcare
  practitioner

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Aim of this presentation

• To describe the pilot study
• To discuss the evaluation of a complex
  intervention in primary care
• To discuss the use of a waiting-list control

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methodology to assess change in primary care is
a challenge

• the classic randomised-controlled trial studies
  the connection between a specific intervention in
  a well-defined population and a specific outcome.
• whereas, in pragmatic trials in primary care
  (Campbell, et al, 2000)
• the intervention may be complex
• the population may be diverse
• patients perceive change in a multi-faceted
  manner and patient satisfaction is an important
  outcome

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Outline of studyLocal research ethics committee
approval Sept 2002

• 45 menopausal women, aged 45-59, no menstrual
  period for 3 months
• recruited by letter from one Bristol GP practice
  to all women not prescribed HRT, invited to take
  part if
• experiencing menopausal problems
• entry into trial at interview with trial
  co-ordinator
• block randomised between treatment group (15) and
  waiting-list control group (30)
• waiting list trial controls treated after 4
  months
• both groups completed outcomes measures (Greene
  Scale, MYMOP, VAS hot flush scale) by post
• intervention 5 personal consultations over 18
  weeks,
• with one of three local members of the National
  Institute of Medical Herbalists

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..no placebo, no double-blind..

• too many variables to allow placebo treatment
• to research the contribution of one or other part
  of the treatment would be of interest, but would
  break the package of care
• our goal was to investigate the normal practice
  of herbal practitioners (Macpherson, 2004)

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Consultation a very complex intervention

• full clinical history, physical examination,
  diagnosis
• discuss nutrition, exercise, emotions etc
• personal care plan
• individual prescription, 5-9 herbs in the
  medicine, dispensed by the herbalist
• treatment by a medical herbalist is holistic

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also, where there is engagement, a sense of
being with the patient

• there is emotional resonance and the
• therapeutic nature of the practitioner
• is present in any healing encounter (Richardson,
  2001)
• quality of intent varies between practitioners
• in herbal medicine, the prescription also
  varies substantially between practitioners

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Analysis of prescriptions during the pilot study

• 35 women in the treatment group and the control
  group
• average of 4 consecutive prescriptions per woman
  (max. 6)
• so, total of 145 prescriptions, taken over 2
  14 weeks
• average 6 herbs per prescription (min 4, max
  9)
• total of 77 herbs were used
• the practitioners trained together and were
  relatively consistent in prescribing. This is a
  minimum estimate of herbs which might be used in
  future studies.

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Leonurus
cardiaca
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for example 57 of the women gave aches and
pains as a main indication

• CC hot flushes, poor memory and concentration,
  joint pains, reoccurrence of Acne vulgaris
  (age 53)
• Herb (Tincture) ml/ week Note on
  usage
• Cimicifuga racemosa 20 hot flushes,
• anti-rheumatic
• Salvia officinalis 20 hot
  flushes
• Rumex crispus 20 bowel
  cleanser, detox
• Rad. Taraxacum officinale 20 liver function
• Ginkgo biloba 20
  cerebral circulation
• Dose 5ml tds 100 (300 ml
  prescribed)

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Waiting-list control

• Eligible population of 252
• 161 women replied to the initial letter, but 82
  (50) excluded as still menstruating
• Does waiting equal no treatment?
• Better as participant has no fear of
  randomisation to placebo?
• How significant is improvement over the waiting
  group?

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Women found the waiting-list trial acceptable

• Treatment Group (n15)
• 14 completed (completed all questionnaires)
• 1 dropped out (6 operations on leg, MRSA)
• Control Group (n30)
• 30 complete control phase
• 28 complete all questionnaires
• Our worries about dropout in the control group or
  dissatisfaction with the number of questionnaires
  were unnecessary
• 20 take up treatment after waiting 15 complete
  treatment

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positive patient feedback

• A feedback questionnaire revealed satisfaction
  amongst participants with
• the quality of care by the herbalist, the chance
  to discuss the menopause transition, lifestyle,
  dietary and emotional changes
• and, the opportunity to take part in the clinical
  trial
• Avon Primary Care Research Collaborative have
  approved a nested qualitative study in which
  participants and practitioners are interviewed to
  discover their experiences in taking part in the
  study.

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..but, the randomised controlled double-blind
clinical trial (RCT) is the norm.

• placebo mock tablet or intervention allows
  for non-specific effects, expectation of
  participants
• to reject the placebo is to reject an important
  part of the RCT
• particularly as control arms in RCTs often show a
  high placebo response
• eg symptom score and maximum urinary flow in
  benign prostatic hypertrophy (Nickel, 1998)

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differing points of view

• if the placebo is defined as any effect
  attributable to the symbolic importance of a
  treatment, treatment setting or treatment
  process (Papakostas, Daras, 2001) eg
• demonstrating care and concern,
• enabling an understandable and satisfying
  explanation of the illness,
• promise of better symptom control
• non-specific effects eg self-monitoring (Stone
  et al, 2005) and expectations may be
  particularly significant in complementary
  medicine

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Expectations in NIMH menopause study

• 45 participants
• 27 expected some improvement in symptoms
• 10 had no expectations
• 5 expected at least no harm
• 4 expected a holistic approach and lifestyle
  change
• 1 expected a better sense of wellbeing
• maybe suggestibility of patients is
  overestimated (Kaptchuk, 2001)

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examples of use of waiting-list controls

• Not commonly used but recently published trials
  include
• Cognitive behaviour therapy for adolescents with
  chronic fatigue syndrome (Stulemeijer, et al,
  2005)
• Acupuncture in patients with osteoarthritis of
  the knee (Witt et al, 2005)
• Homeopathic care for prevention of upper
  respiratory tract infections in children
  (Steinsbekk, et al, 2005)
• Didgeridoo playing as alternative treatment for
  obstructive sleep apnoea (Puhan, et al, 2006)

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Conclusions

• A peri-menopausal population would be more
  relevant to clinical practice and give better
  recruitment
• A waiting-list randomised controlled trial with
  several appropriate outcomes measures proved a
  suitable methodology for investigating a complex
  intervention
• Interviews with participants will improve the
  planning of future clinical trials in herbal
  medicine

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References

• Campbell, M, et al. (2000) Framework for design
  and evaluation of complex interventions to
  improve health. British Medical Journal 321, pp
  694-6
• Kaptchuk, T. (2001) the double-blind, randomized,
  placebo-controlled trial Gold standard or golden
  calf? Journal of Clinical Epidemiology 54, pp
  541-549
• MacPherson, H. (2004) Pragmatic clinical trials.
  Complementary Therapies in Medicine 12, 136-140
• Nickel, J (1998) Placebo therapy of benign
  prostatic hyperplasia a 25-month study. British
  Journal of Urology 81, 383-387
• Papakostas, Y, Daras, M. (2001) Placebos, Placebo
  Effect, and the response to the healing
  situation the evolution of a concept. Epilepsia
  42 (12), 1614-1625
• Puhan, M, et al. (2006) Didgeridoo playing as
  alternative treatment for obstructive sleep
  apnoea syndrome randomised controlled trial.
  British Medical Journal 332 (7536), 266-70

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References

• Richardson, J. (2001) Intersubjectivity and the
  therapeutic relationship. In ed. Peters, D,
  Understanding the Placebo Effect in Complementary
  Medicine. London Churchill Livingstone
• Steinsbekk. A et al. (2005) Homeopathic care for
  the prevention of upper respiratory tract
  infections in children a pragmatic, randomised,
  controlled trial comparing individualised
  homeopathic care and waiting-list controls.
  Complementary Therapies in Medicine 13(4), 231-8
• Stone, D, et al (2005) Patient Expectations in
  placebo-controlled randomized clinical trials.
  Journal of Evaluation in Clinical Practice 11
  (1), pp 77-84
• Stulemeijer, M, et al. (2005) Cognitive behaviour
  therapy for adolescents with chroninc fatigue
  syndrome randomised controlled trial. British
  Medical Journal (International Edition) 330,
  7481, 14-17
• Witt, C, et al (2005) Acupuncture in patients
  with osteoarthritis of the knee a randomised
  trial. Lancet 366 (9480), 136-43

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Bibliography

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extract from Greene Climacteric Scale