Complementary therapies

Question 1

What is it

Answer 1

Question 2

Why is it important

Answer 2

• Up to 1 in 4 people in England used some form of CAM in past year
• Most people do not tell their doctors that they are using CAM
• Often perceived by the general public as safe as it is natural
• Community pharmacies sell CAM e.g. herbal, nutritional supplements (good profit margins)
• Pharmacists often asked for advice about CAM products
• Need to provide evidence-based advice re-effectiveness and safety
• May affect conventional therapy e.g. drug interactions
• Legislation/regulation much improved in past decade

Question 3

What is good evidence

Answer 3

• Gold standard in conventional medicine is the RCT
• Large RCTs
• Even stronger evidence are lots of RCTs together- a meta-analysis or systematic review
• Published in peer reviewed journals

Question 4

Difficulties faced by CAM researchers

Answer 4

• Treatment often not just one intervention
• Often difficult to have a comparator placebo
• Difficult to blind, so clinician and patient basis
• Lack of funding, so trial often small
• CAM easily purchased, so how to control
• Lack of standardisation of therapies

Question 5

Herbal medicines (rational phytotherapy)

Answer 5

• Often a complex mixture of ingredients
• Not clear what is the active ingredient
• Concentration of plant constituents may vary depending on environment (climate, altitude, growing conditions) or genetic factors
• Harvesting and storage can affect quality
• Part of the plant used => varying strength of active ingredient
• Patients purchase, so less structured system for reporting ADRs

Question 6

Herbal therapy

Answer 6

• Variation in amount of active ingredient between products and even between batches
• Only recommend licensed preparations
• If unlicensed, at least use a well known quality manufacturer

Question 7

Reference sources- medicines complete

Answer 7

• Stockleys drug interaction
• Stockleys herbal medicines interactions
• Herbal medicines
• Dietary supplements

Question 8

An example- St Johns wort

Answer 8

• Extract from the leaves and flowers of the plant hypericum perforatum
• Main active constituents- hypericin and hyperforin
• Indication- mild depression and lots of other claims

Question 9

Is it effective

Answer 9

• Evidence for use in depression
• Cochrane systematic review in 2008 looked at 29 studies in 5489 patients (with mild to moderate symptom) that compared treatment with SJW for 4-12 weeks with placebo or standard anti-depressants
• SJW superior to placebo
• Similarly effective to standard anti-depressants
• Results more favourable in German studies
• Concluded effective but can only apply to the preparations included in the studies

Question 10

Is it effective

Answer 10

• NICE found evidence from RCTs suggesting that compared to placebo, SJW increased the likelihood of achieving a 50% reduction of symptoms of depression
• BUT
• Insufficient evidence to determine if it was effective for achieving remission
• NICE advises that SJW should NOT be prescribed for treating depression because there is an absence of long term data, dose uncertainty, variability, potency and serious interaction with other medication

Question 11

Mechanism of action

Answer 11

• Serotonergic 5HT-3 and 4 receptor antagonist
• Down regulates beta-adrenergic serotonergic 5-HT1 and 2 receptor
• Hyperforin also inhibits GABA and L-glutamate
• Hypericin has an affinity for sigma receptors and acts as a receptor antagonist at adenosine, BDZ, GABA-A and B and IP₃ receptors
  
  • Hypericin inhibits COMT and MAO in vitro

Question 12

Is it safe

Answer 12

• Cochrane review concluded that there were fewer side effects with SJW than with standard antidepressants
• Most common: GI, insomnia, restlessness, dizziness, fatigue, dry mouth
• Evidence that taking 2-4g daily can increase the risk of photosensitivity
• BUT it is a potent inducer of some CYP450 enzymes

Question 13

Drug interactions

Answer 13

• Differences between preparations make interactions difficult to predict
• Interacts with (everything)
• Always ask about patients full drug history
• Do not co-prescribe with a conventional anti-depressant
• If switching from SJW to or from conventional anti-depressants you need to allow for a “wash out” period

Question 14

Conclusion SJW

Answer 14

• Provided patient is not more than mildly depressed and not taking any interacting drugs, not pregnant or breastfeeding SJW can be recommended
• BUT ideally should see medical help for CBT (proven effective for mild depression)
• Advice that patient it will take 2-4 weeks before seeing the beneficial effect
• Stick to the same preparation
• Report any side effects (then can yellow card report)

Question 15

An example- Glucosamine

Answer 15

• Extract from marine exoskeletan or made synthetically
• Commonly available as: Glucosamine sulphate, hydrochloride and in combination with chondroitin sulphate
• Indication- joint pain in OA

Question 16

Osteoarthritis

Answer 16

• Glucosamine is sugar which is an important consituent of articular (joint) cartlidge
• Glucosamine supplements sold for patient with arthritis as in OA
• OA is a wear and tear condition- cartilage end of bones breaks down
• Administration of glucosamine thought to stimulate production of cartilage components and allow rebuilding of damage cartilage

Question 17

Is it effective

Answer 17

• Cochrane systematic review- 2008 looked at 25 studies with 4963 patient with OA
• Analysis restricted to studies with adequate allocation concealment failed to show any benefit for pain
• Overall, some pain improvement, but no conclusion re functional improvement
• Health Technology Assessment- 2009 inconsistent findings with only a modest effect on pain and function
• But concluded there was evidence that glucosamine sulphate shows some clinical effectiveness in the treatment of OA of the knee
• The benefit of the addition of chondroitin remains uncertain

Question 18

Is it effective

Answer 18

• Natural medicines comprehensive database (NMCD)- for hydrochloride salt conflicting evidence in OA. For sulphate salt, there is better evidence in knee OA, with some studies (>3 years) showing significant improvement in pain & functionality compared to placebo in patients
• There is a licensed preparation in UK
• NICE CG177 Oestoarthritis care and management- Glucosamine or chondroitin not recommended for OA
• BNF- Mechanism of action not understood and there is limited evidence to show it is effective. Marked as a less suitable for prescribing

Question 19

Glucosamine- Is it safe

Answer 19

• Most common: Mild GI disturbance
• Also headache, drowsiness, insomnia and skin reactions.
• Generally comparable to placebo
• Concern re use in diabetic patients- monitor BG more closely
• Use cautiously in patient with asthma (Unidentified allergic reaction)
• Use with caution in patients with renal impairment or those taking nephrotoxic medication

Question 20

Drug interactions

Answer 20

• Significant drug interaction with warfarin
• Theoretical interaction with some anti-mitotic chemotherapy agents such as doxorubicin

Question 21

Conclusion- glucosamine

Answer 21

• Limited evidence for knee OA
• The only evidence is for glucosamine sulphate
• Need to give it a trial for several months at a dose of 1500mg dd or 500 tds
• Products vary in content and strength of active ingredients- stick to the same brand
• Report any side effects (yellow card)
• Prescribers in primary care should not initiate glucosamine and chondroitin for any new patient and support prescribers in deprescribing glucosamine and chondroitin in all patients
• Same recommendation for all herbal product and homoeopathy

Question 22

Cranberry and UTI

Answer 22

• Juice, syrup, capsule and tablets
• Cranberries prevent bacteria (particularly E.coli) from adhering to uroepithelial cells that line bladder wall, so they cannot infect the mucosal surface of the urinary tract
• In vitro, this adhesion is mediated by two component fructose, and substances called proanthocyanidins (PAC)
• Cochrane 2012: No evidence juice helpful in preventing UTIs in most population groups; other preps need standardising
• Cochrane 2010: No RCTs have been performed to assess the effectiveness of cranberry juice or cranberry product for the treatment of UTI
  
  • Therefore, at the present time there is no evidence

Question 23

Cranberry juice and UTIs

Answer 23

• NICE CKS
  
  • Cranberry juice or other cranberry products are not recommended as there is no good evidence to support their use for treating urinary tract infection
  • Or prevention of recurrent cystitis
  • Warfarin interaction

Question 24

Other commonly requested sold herbals

Answer 24

• Echinacea
• Ginkgo biloba
• Ginseng
• Garlic
• Saw palmetto
• Evening primrose
• Red clover

Question 25

Summary

Answer 25