NHS Herbal Medicine - Myths and Realities - University Of Lincoln ...

NHS Herbal Medicine
- Myths and Realities
Saul Berkovitz MRCP, MCPP, MFHom
Consultant Physician
Royal London Hospital for Integrated Medicine
University College London Hospital NHS Trust

The phytotherapy clinic, RLHIM
• 2007-
• Integrated with orthodox and other forms of
complementary medicine
• ‘Generalist’ secondary care setting
• Severe complex chronic disorders

• Quality
• Safety
Aims of the clinic
• Effectiveness
• Clinical practice
• (Teaching)
• (Research)

Methods
• Development of Herbal Formulary
– Based on safety, not efficacy
Risk rating performed by two RLHIM pharmacists
– Red (High Risk)
– Amber (Moderate Risk)
– Green (Low Risk)
– Unknown
• Tinctures / pills but no loose dried herbs
• Stringent QA vetting of suppliers

• Documentation
Methods
– Access database in doctor’s office and pharmacy
– Labelling function
– Dispensary
– One specialist herbal pharmacist
– Training for other pharmacists
• Checking for interactions
– Current medication card
– Pharmacist double-check against interaction data

SINGLE HERB OR FLEXIBLE COMBINATION
FIXED COMBINATION
GENERALLY SMALLER GENERALLY LARGER DOSES
DOSES
SINGLE CONDITION WIDER VIEW OF HEALTH
USUALLY TABLETS USUALLY TINCTURES
STANDARDISED USUALLY UNSTANDARDISED
SOME “EVIDENCE BASE” LITTLE OR NO “EVIDENCE BASE”

Herbal Evidence base
• ~5000 randomised controlled trials on Medline
• 353 Systematic reviews in NHS Evidence
• No herbal medication yet approved in any
NICE guidelines

Positive
• St John’s Wort for depression
• Horse chestnut for symptoms of varicose veins
• Gingko for intermittent claudication
• Kava for generalised anxiety syndrome*
• Peppermint oil for irritable bowel syndrome
• Devil’s claw and willow bark for acute exacerbations of
chronic low back pain
• Cranberries for prevention of urinary tract infection
• Agnus castus for premenstrual syndrome
• Andrographis for acute upper respiratory tract infection

Major depression –
Cochrane review of St John’s Wort
• Mild to moderate depression
• 29 studies, 5489 patients (30 to 388)
• 18 v placebo
• 17 v standard antidepressants
Linde et al 2008

Depression – St John’s Wort
Major depression
RR = 1.15 (95% CI 1.02-1.29)
Mild to moderate depression
RR = 1.71 (1.40-2.09)
Compared with SSRI’s
RR = 0.98 (0.85-1.12)
Compared with tri- or tetracyclics
RR = 1.03 (0.93-1.14)
Linde et al 2008

NICE guideline on depression 2010
10.9.5 Clinical summary
St John’s wort is more effective than placebo on achieving response
in both moderate and severe depression, and on reducing symptoms
of depression in moderate depression.
There appears to be no difference between St John’s wort and other
antidepressants, other than in moderate depression where it is better
at achieving response and in severe depression where it is less
effective than low-dose antidepressants in achieving response.
However, St John’s wort appears as acceptable as placebo and more
Acceptable than antidepressants, particularly TCAs, with fewer people
leaving treatment early due to side effects and reporting adverse
events.

NICE guideline on depression 2010
Recommendation
• Although there is evidence that St John’s wort may be of
benefit in mild or moderate depression, practitioners
should:
• not prescribe or advise its use by people with
depression because of
– uncertainty about appropriate doses
– persistence of effect
– variation in the nature of preparations
– potential serious interactions with other drugs (including oral
contraceptives, anticoagulants and anticonvulsants)
• advise people with depression of the different potencies
of the preparations available and of the potential serious
interactions of St John’s wort with other drugs.

Rheumatic complaints – Litozin
• Standardised rosehip extract
• Anti-inflammatory
• In OA (v placebo)
– Two crossover RCT’s (n=112, 94; 24w)
– One parallel RCT (n=100, 16w)
• In RA (v placebo)
– One parallel RCT (89, 24w)
• Adverse effects insignificant
• No known interactions
• Available in UK
Christensen Osteo Cart 2008

Butterbur (Petasites hybridus) for migraine
• Systematic review
– 2 placebo-controlled RCT’s
– 293 participants, 12-16 weeks
– 15% less migraine per month
– 15% greater response rate v placebo
• No major adverse effects*
• Available in UK
Agosti et al Phytomedicine 2006

Vitex agnus castus for
premenstrual syndrome
• Pituitary dopaminergic agonist
PMS
• v placebo (n=170, 12w)
– 52% vs 24% responder rate
• V placebo (Chinese) (n=202, 3 cycles)
– 80% vs 50% responder rate
• Versus fluoxetine (41,8w)
– Similar effectiveness
Cyclical mastalgia
• Versus placebo (97,12w)
Schellenberg BMJ 2001; He et al, Maturitas 2009;
Halaska et al Breast 1999; Atmaka et al Psychopharmacol 2003

Diagnosis and treatment of premenstrual
disorders – expert review 2011
O’Brien et al BMJ 2011

Echinacea for URTI –
Cochrane review
• 16 studies, 22 comparisons
• 14 treatment studies (2190 participants)
• 2 prevention studies (411 participants)
• Meta-analysis not possible due to different
products and doses
• Possible benefit for treatment (9 “positive”, one
“trend”, 6 “negative” comparisons v placebo)
• No benefit for cold prevention (3 negative
comparisons v placebo)
Linde et al 2009

Echinacea for URTI treatment
• 719 adult patients with new onset common cold
• Patients were randomly assigned to 1 of 4 parallel groups:
– No pills
– placebo pills (blinded),
– echinacea pills (blinded),
– Echinacea pills (unblinded, open-label).
• Echinacea groups received ~ 10.2 g of dried echinacea root for 24
hours, then 5.1 g/d for 4 days.
• 10% improvement (non-significant) in mean global severity for
Echinacea (blinded) vs placebo
• 7% reduction (0.5/7 days) (non-significant) in mean illness duration
with Echinacea (blinded) v placebo
Barratt et al Ann Int Med 2010

Andrographis paniculata for URTI
• Two systematic reviews
• Seven randomised controlled trials (n = 896)
• All trials moderate to high quality
• Superior to placebo in alleviating symptoms
of URTI (p

Promising
• Turmeric, Aloe vera for ulcerative colitis
• Wormwood for Crohn’s disease
• Cat’s claw, Boswellia, rosehip* and comfrey leaf
cream for osteoarthritis
• Rosehip for rheumatoid arthritis
• Rhodiola for depression
• Globe artichoke, chilli pepper, Iberogast (multiherb
extract), peppermint oil / caraway oil for functional
dyspepsia
• Pelargonium for acute bronchitis* and COPD
exacerbation
• Sinupret® for acute sinusitis*
• Topical products for skin diseases

Topical products for skin conditions –
Atopic eczema
• Atopiclair (liquorice /
grape seed extract)
• St John’s Wort cream
Psoriasis
• Mahonia aquifolium
cream
• Indigo naturalis cream
‘promising’ research
Acne vulgaris
• Tea tree oil
Rosacea
• Chrysanthellum indicum
cream

Negative
• Saw palmetto for LUTS / BPH
• Valerian for insomnia
• Boswellia for Crohn’s disease
• Echinacea for treatment of acute upper
respiratory tract infection
• Milk thistle for chronic liver disease
• Gingko for mild to moderate dementia

Saw palmetto for BPH –
Cochrane review
• 5222 subjects from 30 randomised trials, 4 - 60 wks
• For IPSS, SP not superior to
– placebo (WMD -0.77 points)
• (95% CI -2.88 to 1.34, P > 0.05; 2 trials)
–finasteride(0.40 points)
• (95% CI -0.57 to 1.37, P > 0.05; 1 trial)
– tamsulosin (-0.52 points)
• (95% CI -1.91 to 0.88, P > 0.05; 2 trials)
• For nocturia, SP > placebo (not in highest quality studies)
• No significant difference between SP and placebo for
prostate size or mean urine flow
Tacklind J et al 2009

Uncertain
• Passionflower and Valerian for anxiety
• Feverfew for migraine
• Black cohosh for menopausal symptoms
• Echinacea for prevention of acute upper
respiratory tract infection
• Traditional Chinese Medicine for any indication
• Individualised Western Herbal Medicine for any
indication

Anxiety - systematic reviews
Title of review Last update Number of
studies
Kava for anxiety
Number of
patients
2003 12 700
Passiflora for anxiety C 2007 2 198
Valerian for anxiety C
2007 1 36

Feverfew (Tanacetum parthenium)
for migraine - Cochrane review
• Five studies (343, 4-24w)
• Various preparations
• Mixed results
• ‘Insufficient evidence’
Tanacetum parthenium
Pittler, Ernst, 2004

Feverfew for migraine - RCT
• Feverfew CO 2 extract, MIG-99
• Versus placebo (170, 16w)
– Patients with at least 4 attacks per month
– Extra reduction of 0.6 migraines per month v placebo
– Odds Ratio 3.4 for ‘responder rate’
• Not available in UK
Diener et al, Cephalalgia 2005

Individualised phytotherapy

Evidence base of
‘Western herbal medicine’
• Systematic review of ‘individualised herbal medicine’ for
any indication
• 3 studies
– OA knee (Western tincture) – small pilot (n=40)
– IBS, Chemotherapy-induced toxicity (Chinese capsules)
• None showed definite efficacy over placebo or
standardised herbal therapy
Ernst E. et al. Postgrad Med J 2007

Pilot study of Western herbal
medicine for osteoarthritis
• 20 patients randomized to an individualised formula chosen from
11 most commonly used herbs OR a placebo formula (25%
ethanol, water, caramel, aniseed flavouring)
• Ten weeks; 2 appointments: herbs, lifestyle, standardised dietary
advice and nutritional supplements
• The formula could be ‘modified’ at the second appointment.
• Patients also got standardised
• 14 participants completed study (9 active, 5 placebo)
• Problems with palatability of placebo
Hamblin et al JRSH 2008

Further developments
• Pilot prospective, randomized, waiting list controlled trial in primary care at one
urban UK GP practice.
• Participants were 45 women aged 46–59, experiencing self-defined menopausal
symptoms and no menstrual bleeding for 3 months.
• Randomized into treatment group (n = 15), control group (n = 30) waiting 4m
• Six consultations over 5 months: herbs, lifestyle, nutrition
• Change in menopausal symptoms using the validated Greene Climacteric Scale.
MYMOP for changes in self-defined most troublesome symptoms.
• Treatment group demonstrated a statistically and clinically significant reduction
in menopausal symptoms compared to the control group.
– Total scores
– Hot flushes
– Libido increased
• Evidence to support herbal medicine as a treatment choice during menopause.

Further developments
• Feasibility study for Chinese herbal medicine in endometriosis
• Herbal formulae pre-cooked and dispensed as individual doses in sealed
plastic sachets
• Development and testing of a plausible placebo decoction
• Participants were randomised at a distant pharmacy to receive either an
individualised herbal prescription or a placebo
• Randomisation, double blinding and allocation concealment were successful
and the study model appeared to be feasible and effective
Placebo group
(n=15)
Active group
(n=13)
Correct guess
3 (20%)
8 (62%)
Incorrect guess
8 (53%)
2 (15%)
Did not know
4 (27%)
3 (23%)
• Improvement in design of the placebo decoction needed using food colourings
and flavourings instead of dried food to guarantee therapeutic inertia

Back to reality…..

Results
• 422 patients treated so far
• 1579 prescriptions
• Tinctures (746), tablets (833)
• 80 different primary diagnoses
– 23 represented only once

100
90
80
70
60
50
40
30
20
10
0
CFS/ME
URTI
Anxiety
Conditions seen
Insomnia
Asthma
OA
IBS
Menopause
M790
UC
BP

180
160
140
120
100
80
60
40
20
0
Withania
Glycyrrhiza
Valeriana
Tincture herbs used
Echinacea
Eleuthero
Viburnum
Hypericum
Matricaria
Vitex
Passiflora
Zingiber
Ginkgo

160
140
120
100
80
60
40
20
0
Andrographis
Echinacea
Tablet herbs used
Turmeric
Valerian
Boswellia
Rosehip
Horse chestnut
Artichoke
Rehmannia
Butterbur

Results - Outcome assessment
• ORIDL score in routine care
• 147 / 422 patients with one or more outcomes
• (194 patients only had one prescription)
• Completion ratio = 147 / 214 = 64%

The following questions ask what has been the overall effect
due to this therapy on your main complaint, general feeling of
well-being, up to the present time?
+4 Cured /Back to normal
+3 Major Improvement
+2 Moderate improvement, affecting daily living
+1 Slight improvement, no effect on daily living
0 No change/Unsure
-1 Slight deterioration, no effect on daily living
-2 Moderate deterioration, affecting daily living
-3 Major deterioration
-4 Disastrous deterioration
Please complete the 2 boxes using the scale shown above:
The main complaint for which you came for treatment
Your overall well-being

50
45
40
35
30
25
20
15
10
5
0
Main complaint
0 1 2 3

50
45
40
35
30
25
20
15
10
5
0
General Wellbeing
0 1 2 3 NK

Results - Adverse events
• Systematic, prospective reporting
• 31 adverse events (28 mild, 3 moderate, none severe)
– Poor taste (5)
– GI upset (17)
– Feeling drunk
– Triggering of migraine
– Generally unwell
– Aggravation of joint pains
– Worsening of symptoms
– Worsening of depression with Valerian
– Eczematous rash possibly associated with liquorice tablets
– Worsening eosinophilia in Churg-Strauss syndrome possibly
associated with Echinacea

Further developments
• Chinese herbal formulae
• Inflexibility of herbal formulary
• Tablet issues with regard to THMPD
• Black cohosh

Myths and Realities
MYTHS
Autonomy
Involvement of herbalists
Evidence base regarded
REALITIES
Scrutiny
Health professionals
Evidence base disregarded

Conclusions
• A herbal medicine service is feasible in NHS
• Negotiating obstacles with NHS regulatory
authorities is possible
• Constant vigilance is necessary in a changing
environment
• saul.berkovitz@uclh.nhs.uk

Acknowledgements
RLHH Pharmacy
• Claudia Avellone
• Belinda Croft
• Ananti Shah
Database
•Tom Kirby
Herbal Clinic Launch and Patient Leaflet
• Sato Liu