Dr Roberts Flashcards
Who can be a herbal practitioner?
In theory, anyone, there are no legal requirements or regulatory bodies but some do voluntarily join
Can an acupuncture clinical be shut down?
The local council can shut down acupuncture clinics if the hygiene is not good (similar to a tattoo parlor). It is just like food hygiene standards but it is not a legal requirement.
What are herbal medicines classed as?
More of a product - can’t claim to cure, treat or prevent disease but can have health claims as in ‘for a healthy nervous system’ or ‘for a healthy cardiovascular system’
Can herbal medicines be registered?
Traditional medicines can have a “use based on traditional use” so they have a license through traditional herbal medicine so it tightens regulation through the MHRA. No traditional herbal medicinal product shall be: placed on the market, or distributed by way of wholesale dealing unless a traditional herbal registration has been granted by the licensing authority (which is in force and has been granted in accordance with the community provisions).
What are the new controls for herbal medicines from the MHRA?
Herbal medicines to be marketed in the UK are now required to be registered as a traditional herbal medicines or have marketing authorisation from the MHRA
Are there any exemptions to the MHRA control of herbal medicines?
It only applies to industrially-produced herbal medicines so small, made on-site herbal shops are classed as ingredients so are exempt. There are also ways around this, for example, turmeric is an ingredient but is claimed to reduce inflammation and enhance health.
How can medicines be licensed under the traditional medicines regulation (TMR)?
Produce bibliographic or expert evidence of traditional use
They should have been in medicinal use for at least 30 years (most don’t have this)
At least 15 of the 30 years use must relate to the EU (unsure of BREXIT rule changes)
This replaces the requirement to demonstrate efficacy in the case of medicines to be given Marketing Authority
What are the monitoring/manufacturing requirements for herbal medicines?
Manufacturing under GMP (good manufacturing practice)
Safety monitoring and quality must be carried out (fewer herbal products will be contaminated)
Patient information is required - ie dose, side effects etc
How can herbal medicines receive an MHRA license?
Given Marketing Authorisation by MHRA jsut like any other medicine
Required to demonstrate safety, quality, efficacy, and accompanied by product information sheet
e.g. digitalis leaf, digitalis prepared. POM. Can only be made available via a prescription from a registered doctor or dentist
What are the difficulties with unlicensed herbal medicines?
No specific standards of safety or quality
doesn’t require product information e.g. dose, ADRs etc
No assessed by the MHRA as to their safety, quality or patient information
Manufacturing quality varied greatly
The strength and dose may vary widely e.g. picked, stored, this may change level or active ingredient
An unlicensed product may have fewer side effect warnings but ut is not to be assumed that it is safer (assume none is false)
The internet is difficult to police so MHRA has little control over sale.
Why do people use herbal medicines?
natural and therefore must be safer than conventional medicines
Worry regarding animal testing
Perceptions that there are no side effects because they are natural
40% of people think herbal medicines are safe because they are natural
What are the top selling herbal ingredients?
Ginkgo biloba St.John's wort Ginseng Garlic Echinacea Saw palmetto
How does st.johns work (hypericum) work?
Anti-depressant
Treats mild to moderate depression
Assume anti-depressed action is due to hyperforin as pure hyperforin has anti-depressant actions
Inhibits NA & 5-HT reuptake - similar to other anti-depressants
What are the issues with St. John’s wort?
- Drug interactions: induces CYP450, increase in P-glycoprotein drug transporter. Decrease in drug levels (e.g. digoxin) through reduced efflux.
Serotonin syndrome: report of a women taking SJW for 10 days and then took 20mg paroxetine - complained of nausea, weakness, fatigue and became incoherent
Side effects of SJW?
Hypericin causes photosensitivity - skin irritation
What is ginkgo biloba used for?
- leaf extract used
- used for memory/concentration problems
- dizziness, tinnitys, headaches, storke
- relaxes blood vessels - evidence??
- reduces blood viscoocity - anti-platelet? - soe=me suggest it reduces platelet aggregation
If haemorrhagic stroke - could worsen symptoms
Bilobalide?
Neuroprotective effects in ischaemia reperfusion reported
Ginkgolides A,B,C
Platelet activating factor antagonists?
What did a recent study for dementia and ginkgo show?
- given an extract to patients with mild to moderate dementia over 6 months
- no evidence that it produces a beneficial effect in this 6 month period
- 1 fatal cerebral haemorrhage in GB group
- no sig. difference in blood clotting time between groups
Benefits of garlic?
- anti-hypertensive, antithrombotic, anti-microbial, cancer-preventing, lipid-lowering
- some evidence to support these
- active compound = allicin
- sulfides - garlic (diallyl trisulphide): release H2S, antiinflammatory, vasodilator - high conc needed to show this
Use of saw palmetto - fruit
0 benign prostatic hyperplasia
-evidence that it improves urinary flow in mild to moderate BPH
Use of black cohosh?
- menopausal symptoms
- no evidence that it reduces symptoms
- need for further well conducted trials
- hepatoxicity reported