Clinical Pharmacology - Complimentary Medicine Flashcards
what is CAM?
The World Health Organisation defines complementary and alternative medicine (CAM) as:
a ‘broad set of health care practices that are not part of that country’s own tradition and are not integrated into the dominant health care system’
The National Center for Complementary and Alternative Medicines Defines CAM as:
“a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine,”
why is the interperation of what constitudes CAM unclear?
This means that national, cultural, and ethnic differences, together with the extensive and expanding list of complementary and alternative medicines, make interpretation of what constitutes CAM difficult
CAM approaches are ______ and include modalities such as herbal and homeopathic therapies, acupuncture, aromatherapy, Reiki, Shiatsu and yoga.
Few CAM approaches are supported by robust _______, effectiveness or _____ data
Use is wide-spread, with ______ reportedly the major users both in health and disease
diverse
efficacy
safety
women
Key Underlying Dogma (of CAM):
what are the main principles of CAM?
The treatments have a long history and have thus stood the ‘test of time’
The treatments enjoy a lot of support
The treatments are natural and therefore safe
The treatments are holistic
The treatments tackle the root causes of the problem
The treatments are being suppressed by the establishment
The treatments are inexpensive and so value for money
are CAMs safe and is there evidence for this?
Some CAM modalities have been used for centuries and exponents of CAM cite this as evidence of safety
However there is a real lack of scientifically valid safety and efficacy data
(lack of) Reporting AEs/ADRs
No evidence of harm is not the same as evidence of safety
These issues surrounding CAM are of particular concern in high risk patient groups, who are they?
Children
Pregnancy – teratogenesis and fetogenesis
Patients using prescribed medications - Polypharmacy
Multimorbidity
what are some examples of CAM?
(These are just a fraction of CAMs that are available to the public)
Herbal medicine = real active ingredient
Homeopathy
Acupuncture
Anthroposophic medicine = Steiner, self healing, homeopathy, etc
Aromatherapy
Ayuveda = traditional Indian medicine
Chiropractic
Hypnosis
Meditation
Naturopathy
Osteopathy
Reflexology
Reiki = healing energy by palm
Shiatsu
Yoga
Chinese Medicine = real active ingredient
Vitamins & Minerals
Massage
Nutraceutical
Acupressure
Spiritual Healing/Prayer
Alexander Technique
Applied Kinesiology
Autogenic Training
What are the main CAMs used in the UK?
Why Are We Talking About?
- Approximately 80% of the population worldwide use CAM
- Homeopathy is available on NHS: 60% of Scottish GP practices use homeopathic and or herbal preparations
there are a number of concerns around CAM, what are they?
Implausibility of most therapies
Lack of evidence for benefit
Lack of evidence for safety
Evidence of harm
Adverse Effects / Herb-Drug Interactions
Unqualified practitioners / Missed diagnoses
Stopping conventional medicine
Cost-effectiveness?
which pateints use CAM in the UK?
80% of the UK population
60% of all cancer patients use or have used CAM
60% of all pregnant women in the UK use CAM
1% of children under 1 year of age are prescribed homeopathy
Users tend to be:
- Affluent
- Educated
- Family and friends also use
Why Do People Use CAM?
Desire to have personal ________ over their own health
___________ with conventional treatment
Perception that conventional medicine lacks/disregards an _______ approach
Concerns about the ____ ________ of prescribed medications
control
Dissatisfied
holistic
side effects
The majority of CAM users do not appear to be _________ with conventional medicine
But do find these health care alternatives more congruent with their own ______, ______ and philosophical orientations toward health and life
dissatisfied
values
beliefs
Why Do People Use CAM?
Don’t see any distinctions between US and Them
Think it’s natural, safe and harmless
Philosophical dissatisfaction with conventional medicine
Side effects from conventional medicines
Lack of effective mainstream treatments (for their condition)
Chronic symptoms
Hype
“Holistic”
Promote health
Family and relatives use CAM
Don’t regard CAM as CAM, they think it is part of medicine
60% of Scottish GP practices prescribe homeopathic or herbal medicines and other CAM practices
30% of maternity staff recommend CAM to pregnant women
The Question is:
Why Do Healthcare Professionals Recommend CAM?
Patient demand
Placebo effect
“Feel good” factor in terminal illness, distressing hospital experiences
Genuine belief in a therapy
Experience - Seeing is Believing (GP they have seen it work)
Use CAM themselves (the health professional uses them)
what are herbals/natural products?
Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations.
There are differences between countries in the regulatory classification of ‘herbals’.
In the UK some herbal products are classified as food supplements or cosmetics and others as medicines
In the USA all herbal medicines and products are described as ‘Dietary Supplements’
Most ocmmonlu used CAM in the UK
what do herbals contain?
All herbals contain active ingredients
Often multiple active compounds
Many contain adulterants :
- Heavy metals 61%
- Bacteria
- Prescription Medicines 24%
what is the usage of CAM in breats cancer patients?
70% have used or are using CAM
Two thirds were on adjuvant endocrine therapy and half reported concurrent use of herbal therapies
One third reported the use of a supplement with estrogenic activity (this is something we don’t want)
119 possible herb-drug interactions - 55 with tamoxifen, 66 with anastrazole, 6 with letrozole and 2 with exemestane
The herbal supplements most commonly implicated were - soya, cranberry, echinacea, glucosamine, grapefruit and garlic
Herbals and Early Pregnancy - how are they used?
Two thirds of women use CAM during first trimester of pregnancy.
28 different CAM modalities.
Herbal products are the most common (37% of women),
25 different herbal products used.
Strongest predictor for CAM use - Use by family and friends p < 0.001
Late pregnancy - how are CAMs used?
Two thirds of women use CAM during the last trimester
A total of 30 different CAM modalities
Oral herbal products the most common (38% of respondents)
40 different products
Strongest predictors for use:
- Complementary and alternative medicine use before pregnancy P<.001);
- A university education p<.001),
- Complementary and alternative medicine use by family or friends P<.001.
why does it matter if pregnant women are using CAMs?
No safety or efficacy data
Teratogenesis (if used during first trimester of pregnancy)
Fetogenesis (if used during final trimester of pregnancy)
Drug-Herb Interactions:
- Half of pregnant women use prescribed medication (range1-12) and Half of these use 36 different oral herbal products (range 1-6)
- 20-25% of all pregnant women concurrently use prescribed and herbal medicines
- 13% of these suffer from a moderate/severe herb-drug interaction
what is the efficacy of herbalism?
Very little evidence on effectiveness as practised
Some trials on specific products
Little current NHS use
is herbalism safe?
Contamination, adulteration and misidentification of herbal remedies
Variation between the labelled content of products and their actual content
Serious toxic effects from some
Biggest problem is lack of data
Drug-herb interactions are a major concern, esp St John’s Wort and multiple herbs with warfarin
what is homeopathy?
Homeopathy is a “treatment” based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself
A 2010 House of Commons Science and Technology Committee report on homeopathy said that homeopathic remedies perform no better than placebos (dummy treatments)
Hahnemann believed that “like cures like” and that minute concentrations of a particular toxin could cure the very same symptoms it would cause in larger doses. i.e. Find a toxin which produced similar symptoms to a disease and then use that toxin in minute concentrations to cure the disease
Remedies are produced by the repeated dilution and succession (shaking) of the substance
Potency increases with the number of dilutions and succussions
how is the dilation process of homeotherapy done?
The dilution level is printed on the bottle of medicine
A typical homeopathic dilution is 30X, where the X represents 10. One part toxin is mixed with 10 parts water or alcohol
The mix is shaken; one part of this mix is added to 10 parts of water or alcohol again; The whole process is repeated 30 times.
Dilution is 1030 or 1 in a million trillion trillion
If the dilution is 30C the dilution is 1:10030
Whole process known as Potentisation
how doe shomeotherapy work?
Homeopathy’s healing powers are attributed to “water memory” — the concept that water has the ability to remember the shape of the toxin it once contained
what is the efficacy of homeopathy?
Scientifically implausible
Major issues with quality of studies
No convincing evidence
“Now doctors need to be bold and honest with their patients about homeopathy’s lack of benefit, and with themselves about the failings of modern medicine to address patients’ needs for personalised care.”
is homepathy safe?
Homeopathy is generally regarded as safe and harmless
Rarely reports of adverse effects, including aggravation of symptoms, have been made
what are the issues with homeopathy and safety?
- Missed Diagnosis
- Inappropriate treatment
- Adulteration
what is acupuncture?
Based on traditional Chinese medicine
Vital force called “Qi” which circulates along channels called meridians
There are 12 main meridians, and these correspond to 12 major functions or “organs” of the body
Balance of “yin” and “yang”
Trigger points targeted for needling to deal with pain
Acupuncture is a treatment derived from ancient Chinese medicine. Fine needles are inserted at certain sites in the body for therapeutic or preventative purposes
what is the process of getting acupuncture done?
4 -10 points are needled during a session
Needles are left in place for 10-30 minutes, although can be shorter
Needles may be stimulated by twirling or an electrical current
A typical course of treatment for a chronic condition would be 6 – 12 sessions over 3 months. This might be followed by “top up” treatments
what is the efficacy of acupuncture?
Partially explicable within conventional physiology of pain.
Stimulates pain fibres entering the dorsal horn of the spinal cord. These cause inhibition of pain impulses
Stimulate release of endogenous opioids and other neurotransmitters such as serotonin
Some research evidence that acupuncture has effects greater than sham treatment or placebo in pain, but little evidence for use in other conditions
how is acupuncture used in back pain?
Acupuncture is not more effective than other conventional and “alternative” treatments
The data suggest that acupuncture and dry-needling may be useful adjuncts to other therapies for chronic low-back pain
Because most of the studies were of lower methodological quality, there certainly is a further need for higher quality trials in this area
is acupuncture beneficial in storke?
Acupuncture appeared to be safe but without clear evidence of benefit
is acupuncutre beneficial in asthma and epilepsy?
The current evidence does not support acupuncture as a treatment for epilepsy
is acupuncture safe?
The incidence of adverse effects has been reported at around 10%
However in a reasonable well conducted trial from China the incidence of any adverse events was 42.4% with traditional acupuncture,
40.7% with minimal acupuncture and 16.7% with non-invasive sham acupuncture.
Serious adverse events similar to any harm with needle use have been reported - Pneumothorax, Infection, Pneumopericardium, Organ puncture/Cardiac tamponade
what is aromatherapy?
Aromatherapy is the use of concentrated essential oils extracted from herbs, flowers, and other plants to treat diseases
It is commonly administered by massaging into the skin
how are aromatherapy treatments done?
Inhalation: dropping several drops of essential oil into a bowl of steaming water and the vapours inhaled for a few moments. The effect is enhanced by placing a towel over both the head and the bowl
Massage: aromatic essential oils combined with a base oil can be applied to a specific problem area or the entire body
Diffusion: oil-containing compounds sprayed into the air or placing a few drops of essential oil in a diffuser and heating
Hot or cold compresses containing essential oils can be used for muscle aches and pains, bruises or headaches
Soaking baths containing essential oils and lasting for 10-20 minutes for skin problems and for calming or soothing nerves
how may aromatherapy be dangerous?
Skin irritation with frequent use
Photosensitivity - Avoid prolonged exposure to the sun,
Excessive inhalation can cause headaches and fatigue;
Insomnia - peppermint,
Origanum, sage, savory, thyme, and wintergreen, are not safe for home use.
Skin irritation -basil, lemon grass, fennel, rosemary, and verbena
Bronchial spasms, and people with asthma should not use
Abortifacient (precipitate abortion) - Avoid aromatherapy during pregnancy sage, rosemary, juniper
what is the efficacy of aromatherapy?
“Aromatherapy is pleasant and relatively safe compared with many other ways of spending an hour or so and £20 to £45”
“The data do not undermine a hypothesis that aromatherapy massage is pleasant, slightly anxiolytic, and often enjoyable for patients in stressful situations.
“However, the data do not support a hypothesis that there may be legitimate clinical indications for the prescription of aromatherapy massage in a health care setting; it seems to have no lasting effects, good or bad.”
how may aromatherapy be used for cancer symptoms?
Massage and aromatherapy massage confer short term benefits on psychological wellbeing
Effect on anxiety supported by limited evidence
Effects on physical symptoms may also occur
Evidence is mixed as to whether aromatherapy enhances the effects of massage. Replication, longer follow up, and larger trials are need to accrue the necessary evidence
UK Regulation of CAM:
how is pharmacovigilance odne?
yellow card
what do doctors need to know?
Be aware of what is available via complementary practitioners, on-line and over the counter
Ask patients about CAM use, as may not disclose
Be aware of the potential for significant harm to patients
Be aware of the changing fashion in CAM use
How to evaluate evidence of safety and efficacy
Appropriate use in the NHS
whata re the different mindsets that people may have in regards to CAMs?
People who believe that alternative medicine works in way that science cannot possibly comprehend – ‘magic’ believers;
People who believe that alternative medicine can be explained by untested or untestable theories – ‘pseudoscience believers’;
People who believe in alternative medicine because they have seen or experienced it’s positive effects – ‘anecdotal believers’-”seeing is believing”
what is the key underlying dogma?
The treatments have a long history and have thus stood the ‘test of time’
The treatments enjoy a lot of support
The treatments are natural and therefore safe. (this is a false claim)
The treatments are holistic
The treatments tackle the root causes of the problem. (untrue)
The treatments are being suppressed by the establishment. (untrue)
The treatments are inexpensive and so value for money
Summary:
A wide range of CAM _________
Concerns over:
- _______ and ____-effectiveness
- Safety
Awareness (of their use) important
Critical evaluation needed
therapies
Efficacy
cost
