Changing With Herbs

Randomised, controlled pilot study of the

effectiveness of treatment of menopausal
problems by medical herbalists
Background

 More research on herbs than any

other form of CAM
 mostly on single plants and extracts
 little on synergy
 almost none on practitioner based
herbal therapy
 examine the whole package of care
What is Herbal Medicine ?

 Use of PLANTS as medicine

 30-35% of drugs based on plant compounds
(aspirin, contraceptive pill, digoxin, gaviscon, ephedrine, morphine…)
 oldest form of medicine: herbal from China
2500BC
 Probably most common form of medicine
world-wide (WHO)
 more modern research into herbal medicine
than any other CAM therapy
 herbalists use whole plant extracts rather
than isolated plant chemicals
Why Herbal Treatment of the
menopause?
 Common reason for consulting
herbalist (Beatty and Denham survey)
 evidence from RCTs of effectiveness
of single plant extracts (soy, black
cohosh, red clover, sage,) at
alleviating symptoms
 it fits well into herbalists
multifaceted, holistic approach
Who could benefit from herbal
treatment of the menopause?
 Women not wishing to take HRT
 women who cannot tolerate HRT side
effects
 women for whom HRT is
contraindicated e.g with personal or
family history of breast cancer or
thrombosis
CONSULTATION WITH A
HERBAL PRACTITIONER
 Series of consultations throughout the
treatment process comprising:
 full medical and drug history
 appropriate physical examinations
 diagnosis
 nutritional and lifestyle advice
 individualised care plan
 prescription of individually formulated
herbal remedies adapted at each
consultation.
How do we view the
menopause?
Pennell Report

 A natural life  Caused by failure of

event endocrine organs
experienced which leads eventually
by nearly all to accelerated
women frequency of illness,
around 50. It disease and disability.
is part of the It is amenable to
normal ageing treatment through HRT
process and other therapies
Menopause
 May be problem free - natural event
 some women have symptoms
 for some these cause problems
 permanent cessation of periods
 average age UK 51
 large range of ages
 may also follow hysterectomy
Menopausal symptoms
 Vasomotor : hot flushes, night sweats,
palpitations
 somatic: headaches, joint aches, vaginal
dryness, tingling and numbness, breast
tenderness, breathing difficulties,
 mental: tiredness, difficulty sleeping, poor
memory and concentration, mood swings,
panic attacks, anxiety, depression, loss of
libido
Method 1
 randomised, controlled trial, using
outcomes measures.
 This method was chosen after
consultation with patients,
practitioners, academics, GPs and
statisticians.
 Suitable for examining a holistic
package of care, which is part of a
complex system of treatment
 Method 2
subjects: 45 women volunteers aged 45-59
from one Bristol GP practice, with self
defined menopausal problems

 block randomised with

twice as many control as
intervention patients
 Treatment group (n=15)
 Control group (n=30)
 6 appointments in 5 months
 wait 4 months for treatment
with NIMH herbalist  outcomes measures by
 outcomes measures by post post at designated time
at designated time points points
 then offered treatment
Outcome measures
 Greene Climacteric scale.
validated scale, easy to use.

Mymop2
patient centred scale which
includes a quality of life element

Hot flush visual analogue scale
(VAS).
Inclusion / exclusion criteria

 Aged 45-59
 not had a period for 3 months
 suffering menopausal problems for 3
months or more
 not in the last 3 months had HRT or other
hormone treatment, taken tamoxifen or
had general anaesthetic
 no other CAM treatment for menopause
 no current psychiatric treatment
 not advised by Dr to take HRT because of
Funding

 National Institute of Medical

Herbalists
 National Institute of Medical
Herbalists Education Fund
 Research Sponsor University of
Central Lancashire
Recruitment
Herbal treatment of the
menopause
GP practice of 5000
 252 letters to women 45-59 not on HRT
 161 replies (64%)
 of these 161, 45 recruited
 116 excluded
 1 met criteria and wanted to enter but
was number 46, so too late!
 Herbal treatment of the menopause recruitment

GP practice of 5000

Data search for women age 45-59 not on HRT

252

send letters inviting these women to participate

161 replies

telephone these women and discuss inclusion/ exclusion criteria

45 entered into trial 116 excluded

complete baseline outcome measures
block randomised to

15 treatment 30 control
Reasons for exclusion of 116
 82 still menstruating
 18 with no symptoms
 9 on hormone therapy (HRT, mirena coil, minipill )
 2 natural progesterone cream
 1 tamoxifen trial
 2 osteoporosis
 4 psychiatric treatment or medication
 6 couldn’t cope with project (MRSA, ME, MS, allergies,
chemotherapy, pituitary adenoma)
 12 CAM therapy (9 herbal, 2 homeopathic, 1 acupuncture)
 3 move away
 3 lose touch
 1 wanted to enter but was number 46!
 Details of 45 recruits
 12 on medication  Of those declining HRT
(thyroxine, reasons given
analgesics, diuretics,  4 could cope with
inhalers, antacids) symptoms
 8 on supplements  4 not want to interfere with
 21 had been offered a natural process
HRT  5 not want long term
 10 had taken HRT medication
but stopped because  6 had side effects
of side effects or  2 concerned with safety
been on 9 yrs and
told to stop
 1 FH breast Ca
 1 concerned about pregnant
mares used to produce
Recruits experience of herbal
medicine

 31/45 had taken herbal medicines in

some form before
 (69%)
 13/45 had consulted a herbalist before
 (29%)
Recruits expectations on entry n=45

 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
Current status of trial
 Controls (n=30)
 Treatment  28 complete all questionnaires
(n=15)  27 request treatment
 20 take up treatment
 12 completed
 8 completed treatment
 2 ongoing  9 ongoing
 1dropped out  8 drop out (dislike taste, difficult
(6 operations to fit in appointments and
on leg, lifestyle advice, not want to do
MRSA) questionnaires, taking Chinese
herbs, hormone treatment, ?)
 Symptom1 Symptom2 Total Percentage *
Hot flushes 17 6 23 51
Night sweats 2 5 7 16
Vasomotor total 19 11 30 67 %
Insomnia 5 3 8 18
tiredness 3 7 10 22
Total insomnia 8 10 18 40%
and tired
Anxiety and 3 1 4 9
panic
Depression 0 5 5 11
Mood swings 1 4 5 11
Poor memory 2 6 8 18
and
concentration
Total 6 16 22 47%
psychological
/ cognitive
Joint and muscle 6 5 11 24 %
aches and pains
Headache 3 3 6 13
Bloating 1 0 1 2
Loss of interest 1 2 3 4
in sex

*As the women chose 2 symptoms this will add up to more than
100
 Mymop 2 activities chosen by 45 recruits

Activities affected by menopause Number of women %

selecting this n=45
Exercise (walking, jogging, 14 31%
cycling, gym, yoga, jiving, skiing,
exercise class, general)
Work both paid, gardening and 12 27%
housework
Going out, socialising, making 8 18%
contact
Concentrating on writing, 4 9%
performing or creating art
Confidence loss 3 7%
Sex 3 7%
No activity affected 1 3%
Life gets in the way !

 Various issues have complicated the lives of the

women taking part and therefore the project e.g.:

 hospital admissions (meningitis, MRSA, fractures, car

crash)

 family issues (partner’s cancer returns, death of

parent, mother with Alzheimer's, divorce, moving
house, holidays)
 Christmas, hottest summer for 500 years
 Feedbac
k

“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”
Thanks to the team!
 Julia Green
 Sue Hawkey
 Alison Denham
 Herbalists: Ann Freeman, Sue
Redfern, Margaret Macmillan
 Jennifer Ingram
 Rosemary Greenwood
 The Spence Group Practice