<<

Complementary : Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Complementary Medicine: Exploring the Issues Dr Ken Harvey and Grace Jackel and Aaron Kovacs (SPH&PM Summer Research Program students)

Short Course (3 of 3 sessions), Nov 2014, Multicultural Hub

Issues that could be explored

• What is complementary &/or ? • Who uses it, why and what for? • Regulation of products and practitioners; • The current review of the private health insurance rebate for natural ; • How do we know if it works: what is evidence? • Evidence for and against specific products &/ or therapies for certain conditions; • Sources of good information about complementary medicine, and

• Using complementary medicine wisely. 2

Dr Ken Harvey Page 1 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Recap: TGA list of evaluated registered CMs

• Of the 25 products on the list most are unremarkable: Iron, Calcium, D, Psyllium fibre and Ispaghula husk for , Clove oil for toothache. • More innovative products are: – IBEROGAST (Flordis). A specific nine herb mixture, “for the treatment of functional dyspepsia and ”. – KALOBA (Schwabe) containing a specific extract of Pelargonium sidoides (EPs 7630) for “for the treatment of bronchitis and sinusitis” (an alternative to prescribing an antibiotic). – FLEXAGIL (Blackmores). A specific extract of Symphytum officinale (Comfrey) for topical application for the “relief of lower back , painful joints and strains”. http://www.tga.gov.au/industry/cm-basics-regulation- evaluation.htm 3

Specific products &/or therapies: Evidence?

4

Dr Ken Harvey Page 2 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

You wanted to know about:

Product / Condition Glucosamine / Turmeric (curcumin) / Evening primrose oil Omega‐3 fatty acids (fish oil / krill oil / Preventing cardiovascular disease; cod oil / Chia seeds) arthritis; immune boosting Calcium & Vitamin D Osteoporosis Vitamin C / Garlic / Echinacea Colds (prevention and symptom relief); immune boosting Magnesium (Nigari flakes, etc) Health & rejuvenation; muscle cramps; Pain / General well being

5

Sources of good information about CM

• Summarised evidence: – National Center for Complementary and Alternative Medicine • http://nccam.nih.gov/health/decisions – Medline Plus • http://www.nlm.nih.gov/medlineplus/ – The Library • http://www.thecochranelibrary.com – PubMed Health • http://www.ncbi.nlm.nih.gov/pubmedhealth/ – Healthdirect Australia • http://www.healthdirect.gov.au/ • Original clinical trials – PubMed • http://www.ncbi.nlm.nih.gov/pubmed/ 6

Dr Ken Harvey Page 3 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Glucosamine: Who uses it?

• The 45 and Up Study is the largest study of healthy ageing ever undertaken in Australia. • It involved self‐reported data on over 265,000 participants aged 45 and over. • The study found that 58,630 (22%) participants reported using glucosamine in the 4 weeks prior to the survey. • Use was higher for those who were female, non‐smokers, residing in inner/outer regional areas, with higher income and private health insurance. • Use was associated with a reported condition of osteoarthritis.

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0041540 7

Glucosamine for osteoarthritis

’s Way Glucosamine 1500 mg contains the clinically recommended daily dose of glucosamine in just one convenient tablet. • Glucosamine is considered the most important nutrient for the protection, renewal and building of joint tissue and in forming the ‘cushioning’ effect of the joints and surrounding tissues. • Glucosamine promotes the protection, repair and rebuilding of damaged joints and cartilage in the fingers, hands, wrists, knees, back, neck, hips, ankles and feet. • Clinical trials and research show that glucosamine helps: $30.99 (180 tabs) – Provide temporary relief of the pain of osteoarthritis, SAVE $9.00 – Reduce joint inflammation and swelling, RRP $39.99 – Increase joint mobility, Dose: 1 tab per day – Keep all the joints in the body lubricated and supple. (17 cents per day) http://tinyurl.com/lppbv6f 8

Dr Ken Harvey Page 4 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Glucosamine for osteoarthritis

• Cenovis® Glucosamine 750 helps to maintain the structure and function of cartilage in joints, while also helping to repair and rebuild damaged cartilage. – May assist in the management of osteoarthritis. – Temporarily relieves pain and enhances joint mobility. – May help reduce the joint inflammation, swelling and tenderness associated with arthritis. – May assist in the maintenance of proper joint function. – May provide temporary relief of joint pain. – May enhance joint mobility. – Maintains structure and function of joint cartilage. $30.19 (200 tabs) – May help reduce joint inflammation, swelling and tenderness associated with arthritis. Dose: 2 caps daily 30 cents per day http://www.cenovis.com.au/glucosamine-750/ 9

Glucosamine for osteoarthritis

• Blackmores Glucosamine 1500 offers a convenient, one a day dose to help reduce joint inflammation and swelling, and help relieve the pain caused by osteoarthritis. • Supplementary glucosamine sulfate helps reduce cartilage wear, increase joint mobility and decrease joint stiffness in osteoarthritis. – Effective for osteoarthritic pain relief – Helps reduce cartilage wear – Contains the most scientifically validated form of glucosamine; glucosamine sulfate sodium chloride complex – Results expected after 2‐4 weeks • Clinical trials have shown that 1500 mg glucosamine sulfate as $59.49 (180 tabs) sodium chloride complex significantly improves pain and Dose 1 tab per day functionality in osteoarthritis. In addition, glucosamine sulfate 33 cents per day may have a long‐term protective effect, acting to reduce cartilage wear. http://www.blackmores.com.au/products/glucosamine-1500 10

Dr Ken Harvey Page 5 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Glucosamine for osteoarthritis

• DONA® Glucosamine is a patented formulation of glucosamine sulfate clinically proven to reduce the pain and assist in the management of osteoarthritis. • DONA Glucosamine may also help to maintain joint health and rebuild cartilage that has been worn away by progressive age or injury. • It is manufactured using a patented process by one of the leading natural medicine companies in the world, Madaus/Rottapharm. • DONA Glucosamine was developed following many 750 mg (120 tabs) years of research and has been the subject of 25 Dose: 2 daily clinical trials. $1.00 per day http://www.flordis.com.au/product/dona-glucosamine 11

Glucosamine for osteoarthritis

Brand Formulation Daily Daily Dose Price Nature’s Way Glucosamine hydrochloride 1 tab $0.17 1500 mg Cenovis Glucosamine hydrochloride 2 caps $0.30 750 mg Blackmores Glucosamine sulphate sodium 1 tab $0.33 chloride complex 1500 mg Flordis Glucosamine sulphate 2 tabs $1.00 (Rottapharm DONA) 750 mg Glucosamine is sold by itself in the form of glucosamine hydrochloride or sulphate or in combination with other supplements (such as chondroitin). 12

Dr Ken Harvey Page 6 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Glucosamine for osteoarthritis

• Major studies of glucosamine for osteoarthritis of the knee have had conflicting results. – A large National Institutes of Health (NIH) study, compared glucosamine hydrochloride, chondroitin, both supplements together, celecoxib (a prescription drug used to manage osteoarthritis pain), or a (an inactive substance) in patients with knee osteoarthritis. Most participants in the study had mild knee pain. Those who received the prescription drug had better short‐term pain relief (at 6 months) than those who received aplacebo. – Overall, those who received the supplements had no significant improvement in knee pain or function, although the investigators saw evidence of improvement in a small subgroup of patients with moderate‐to‐severe pain who took glucosamine and chondroitin together. – In several European studies, participants reported that their knees felt and functioned better after taking glucosamine. The study participants took a large, once‐a‐day dose of a preparation of glucosamine sulfate (Rottapharm) sold as a prescription drug in Europe. – In general, research on chondroitin has not shown it to be helpful for pain from knee or hip osteoarthritis. http://nccam.nih.gov/health/glucosaminechondroitin 13

Glucosamine for osteoarthritis

• A few studies have looked at whether glucosamine or chondroitin can have beneficial effects on joint structure. Some but not all studies found evidence that chondroitin might help, but the improvements may be too small to make a difference to patients. There is little evidence that glucosamine has beneficial effects on joint structure. • No serious side effects have been reported in large, well‐conducted studies of people taking glucosamine, chondroitin, or both for up to 3years. • However, glucosamine or chondroitin may interact with the (blood‐ thinning) drug warfarin (Coumadin) and also the way your body handles sugar, especially if you have diabetes or other blood sugar problems, such as insulin resistance or impaired glucose tolerance. • If you take warfarin or have blood sugar problems, make sure you talk to your doctor about potential side effects if you are considering or taking glucosamine or chondroitin supplements. • [Many, but not all products, are derived from seafood and thus are not suitable for those with an to shellfish] 14

Dr Ken Harvey Page 7 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Glucosamine for osteoarthritis

• This update includes 25 studies with 4963 patients. • Pain: High quality studies showed that pain improved about the same whether people took glucosamine or fake pills. – However, if all of the studies are examined (including low quality and old studies), then glucosamine improved pain more than fake pills. – Studies testing only the Rotta brand of glucosamine (including low quality and older studies) showed that glucosamine improved pain more than fake pills. • Function: The high quality studies show that glucosamine improved function more than fake pills when measured by one type of scale, but improved the same amount as fake pills when measured by another scale. – Studies testing only the Rotta brand of glucosamine (including low quality and older studies) showed that glucosamine improved function more than fake pills. • Side effects: There was no difference in the number of people taking glucosamine or placebo who reported side effects; these mainly included stomach upset and other joint pain.

Cochrane Database Syst Rev. 2005 Apr 18;(2):CD002946. 15

Glucosamine and chondroitin for knee osteoarthritis

• A double‐blind randomised placebo‐controlled with 2‐year follow‐up. • 605 participants, aged 45–75 years, with chronic knee pain and evidence of knee joint narrowing were randomised to once daily: – glucosamine sulfate, potassium chloride 1500 mg (n=152), – chondroitin sulfate 800 mg (n=151), – both dietary supplements (n=151) or – matching placebo capsules (n=151). • All four groups demonstrated reduced knee pain over the first year, but no significant differences between groups (p=0.93) were detected. • 303 (50% ) of knee X‐rays were available for the 2‐year follow‐up. – The combination (glucosamine–chondroitin) resulted in a statistically significant (p=0.046) reduction of 2‐year joint narrowing compared to placebo: mean difference 0.10 mm (95% CI 0.00 mm to 0.20 mm). Regardless, is this of clinical significance? – no significant structural effect for the single treatment allocations was detected.

http://ard.bmj.com/content/early/2014/01/06/annrheumdis-2013-203954 16

Dr Ken Harvey Page 8 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

The problem with p values:

• The current consensus is that if p is less than .05, a study has reached the holy grail of being statistically significant, and therefore likely to be published. • Over .05 and it’s usually back to the drawing board. • However, it’s been contended that using .05 is a key reason why false claims are published and many published results fail to replicate. Some advocate requiring .005 or even .001 as the criterion for . • But this would require larger and more expensive studies. • A confidence interval gives us the best estimate of the true effect, and also indicates the extent of uncertainty in our results. Confidence intervals also us to integrate results from a number of experiments into a meta‐analysis.

http://theconversation.com/the-problem-with-p-values-how-significant-are-they-really-20029 17

Glucosamine for osteoarthritis

• Conclusion: – The divergent results of randomised controlled trials can be attributable to the use of different glucosamine preparations, different trial methodologies, study populations, durations and possibly the influence of product sponsors. – The evidence for is inconclusive. – The U.K. National Institute for Health and Care Excellence (NICE) 2014 osteoarthritis guidelines state: • The use of glucosamine or chondroitin products is not recommended. • Activity, exercise and weight loss are important non‐drug measures. • Paracetamol is the first choice for pain relief. – If you wish to trial glucosamine use the sulphate form (1500 mg daily) and objectively evaluate your pain using a daily diary for three months before and after.

https://www.nice.org.uk/guidance/cg177/resources/guidance-osteoarthritis-pdf 18

Dr Ken Harvey Page 9 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Turmeric (curcumin) for osteoarthritis

• Our special formulation of curcumin has been shown in clinical trials to: – Improve mobility in osteoarthritis, – Decrease osteoarthritis pain, swelling and inflammation. – Help reduce the impact of osteoarthritis on social and leisure activities. – Be absorbed up to 29 times more effectively than standard curcumin extracts. – Get into your bloodstream twice as fast as standard curcumins to get to work faster! • In fact, in recent clinical trials, people with osteoarthritis who took the special Meriva® curcumin in Curcumin Anti‐Inflammatory Pain Reliever could $49.95 walk over twice as far on a treadmill test as those SAVE30% who did not. $34.95 http://www.ausnaturalcare.com.au/curcumin-anti-inflammatory-pain-reliever-60-tabs 19

Turmeric (curcumin) for osteoarthritis

$49.95 SAVE30% $34.95 20

Dr Ken Harvey Page 10 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Turmeric (curcumin) for osteoarthritis

• Wagner Curcumin 30 Capsules • Each capsule provides Meriva® Curcumin phospholipid complex 550mg Equiv. Curcumin 99mg • Taken daily, Wagner Bio‐Curcumin may help: – Temporarily relieve pain associated with arthritis and osteoarthritis – Reduce joint inflammation and swelling, thereby increasing joint mobility and movement – Relieve symptoms of medically diagnosed irritable bowel syndrome (IBS) – Maintain healthy cholesterol levels (in healthy individuals) $33.99 SAVE $15.00 http://www.chemistwarehouse.com.au/product.asp?id=71537&pname= $18.99 Wagner+Curcumin+30+Capsules 21

Turmeric (curcumin) for osteoarthritis

• With nearly 30 times increased bioavailability than regular curcumin, one capsule is bioequivalent to 810mg of ordinary curcumin powder – May help down‐regulate inflammatory mediators. – Helps reduce joint inflammation associated with arthritis. – Antioxidant support. – Helps reduce the oxidation of LDL cholesterol. – Helps maintain healthy digestive function and emulsify fats in the digestive tract. – Supports normal contraction. – In vitro evidence suggests curcumin may support liver function by up‐regulating phase 2 detoxification enzymes. – In vitro evidence suggests curcumin may support the repair of DNA damaged by oxidative stress.

http://www.bioceuticals.com.au/product/preview/Theracurmin-BioActive-300mg 22

Dr Ken Harvey Page 11 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Turmeric (curcumin) for osteoarthritis

• NCCAM: – There is little reliable evidence to support the use of turmeric for any health condition because few clinical trials have been conducted. – Turmeric is considered safe for most adults however high doses or long‐term use of turmeric may cause , nausea, or diarrhoea. – People with gallbladder disease should avoid using turmeric as a dietary supplement, as it may worsen the condition. – http://nccam.nih.gov/health/turmeric/ataglance.htm • Medline Plus: – Some research shows that taking some turmeric extracts can reduce the pain caused by osteoarthritis of the knee. • Cochrane: 23 – No results.

Turmeric (curcumin) for osteoarthritis

• Efficacy and safety of Meriva®, a curcumin‐ phosphatidylcholine complex, during extended administration in osteoarthritis patients (Altern Med Rev. 2010 Dec;15(4):337‐44). – The long‐term efficacy and safety of Meriva were investigated in an eight month study involving 100 OA patients. – The clinical end points (Western Ontario and McMaster Universities [WOMAC] score, Karnofsky Performance Scale Index, and treadmill walking performance) were complemented by the evaluation of a series of inflammatory markers. – The treatment consisted of two 500‐mg tablets daily, one after breakfast and one after dinner (1,000 mg/day, corresponding to 200 mg curcumin/day). – Significant improvements of both the clinical and biochemical end points were observed for Meriva compared to the control group. This, coupled with an excellent tolerability, suggests that Meriva is worth considering for the long‐term complementary management of osteoarthritis. • Comment: – The same authors had previously conducted a smaller preliminary trial with similar results but these 2010 results are yet to be replicated. 24

Dr Ken Harvey Page 12 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Turmeric (curcumin) for osteoarthritis

• No clinical trials found on the use of Theracurmin® in osteoarthritis. • Only studies on absorption and blood levels.

25

Evening Primrose oil for osteoarthritis

• Famously associated with relief of the symptoms of PMT, premenstrual breast pain and the hot flushes and sweats of menopause. • Evening Primrose Oil also helps relieve the pain of swollen joints, arthritis and rheumatism. • The health benefits of Blooms Evening Primrose Oil 1000 mg extends to improving digestion, relief of constipation and the maintenance of healthy blood RRP: $27.95 pressure, blood circulation and cholesterol levels in $20.96 healthy people. You save: $6.99 ( 26.00 %)

http://www.discountvitaminsexpress.com.au/evening-primrose-oil-1000mg-200-capsules.html 26

Dr Ken Harvey Page 13 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Evening Primrose oil for osteoarthritis

• Medline Plus: – There is not enough evidence to support the use of evening primrose oil for any health condition. – The best‐designed clinical trials of evening primrose oil for premenstrual symptoms (PMS) found no effect. – Evening primrose oil does not appear to affect menopausal symptoms. – Evening primrose oil is well tolerated by most people, when taken for short periods of time. Mild side effects include gastrointestinal upset and headache. However, the safety of long‐term use of evening primrose oil has not been established. – Evening primrose oil may increase bleeding in people who are taking the anticoagulant (blood thinning) medication warfarin. • Medline: – No clinical trials found on the use of Evening Primrose Oil in osteoarthritis. 27

Omega‐3 fatty acids (fish oil): disease

• 5 Things To Know About Omega‐3s for Heart Disease – Experts agree that fish rich in omega‐3 fatty acids should be included in a heart‐healthy diet (a least 2‐3 times a week). – Omega‐3s in supplement form have not been shown to protect against heart disease. – Omega‐3 supplements may interact with drugs that affect blood clotting. – Fish liver oils (which are not the same as fish oils) contain A and D as well as omega‐3 fatty acids; these vitamins can be toxic in high doses. The amounts of vitamins in fish liver oil supplements vary from one product to another. – Talk to your health care provider before using omega‐3 supplements. http://nccam.nih.gov/health/tips/omega3 28

Dr Ken Harvey Page 14 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Omega‐3 fatty acids: arthritis

http://www.arthritisvic.org.au/Complementary-Therapies/Complementary-Therapies/Fish-Oils 29

Omega‐3 fatty acids: Immune boosting

http://nccam.nih.gov/research/results/spotlight/120913 30

Dr Ken Harvey Page 15 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Omega‐3 fatty acids: Krill oil

• What’s the difference between fish oil and krill oil? • In a word, absorbability. While fish oil and krill oil both contain omega‐3 fatty acids, they exist in different forms. • The omega‐3 in krill oil is mainly in the form of phospholipids, while the omega‐3 found in fish oil is mainly in the form of triglycerides. The omega‐3 in phospholipid form is more easily absorbed by the body. • As a result, you may not need to take as much krill oil in order to get the same health benefits.

http://naturesown.com.au/health-centre/krill-oil-vs-fish-oil-the-great-debate/ 31

Omega‐3 fatty acids: Krill oil Lipids Health Dis. 2014; 13(1): 137. Published online Aug 26, 2014. doi: 10.1186/1476-511X-13-137

A re‐examination of krill oil bioavailability studies • It has proven difficult to compare the bioavailability of krill oil vs. fish oil due to several of the characteristics of krill oil. • However, several claims have been made suggesting greater bioavailability of krill oil vs. fish oil. These have largely been based on a statistical argument where a somewhat lower dose of krill oil has been used to result in a similar bloodstream level of EPA and/or DHA or their total. • However, the magnitude of the dosage differential is shown to be too small to be expected to result in differing blood levels of the long chain n‐3 PUFAs. • It is concluded that there is at present no evidence for greater bioavailability of krill oil vs. fish oil and that more carefully controlled human trials must be performed to establish their relative after chronic administration.

32

Dr Ken Harvey Page 16 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Omega‐3 fatty acids: Chia seeds

• Chia is an edible seed that comes from the desert plant Salvia hispanica, grown in Mexico dating back to Mayan and Aztec cultures. • Chia seeds are an unprocessed, whole‐grain food that can be absorbed by the body. Chia seed contains a high concentration of the omega‐3 fatty acid, alpha‐ linolenic acid. They also contains a significant concentration of dietary fibre, protein, calcium, magnesium, iron, and antioxidants • The mild, nutty flavour of chia seeds makes them easy to add to foods and beverages. They are most often sprinkled on cereal, sauces, vegetables, rice dishes, or yogurt or mixed into drinks and baked goods. • There is no evidence of any special health benefits apart

from the nutrients they contain. 33

Calcium & Vitamin D: Preventing osteoporosis

http://www.healthdirect.gov.au/osteoporosis-prevention 34

Dr Ken Harvey Page 17 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Calcium & Vitamin D: Preventing osteoporosis Recommended sun exposure Melbourne (face, hands & arm) Dec‐Jan (10:00 or 14:00) 6‐8 min Jul‐Aug (12:00) 25 min

The groups at greatest risk of vitamin D deficiency in Australia are dark-skinned and veiled women (particularly in pregnancy), their infants, and older persons living in residential care 35

Vitamin C / Garlic / Echinacea for colds

• Helps to reduce the severity and duration of colds. • Helps to protect against free radical damage. • Promotes wound healing via its role in collagen production. • Stress of all kinds, including ill health and emotional stress, increases the excretion of vitamin C from the body and may 130 tabs increase the need for this vitamin. $14.95

http://www.blackmores.com.au/products/bio-c-1000mg 36

Dr Ken Harvey Page 18 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Vitamin C / Garlic / Echinacea for colds

• Vitamin C (ascorbic acid) for preventing and treating the common cold has been a subject of controversy for 70 years. • This review is restricted to placebo‐controlled trials testing 0.2 g/day or more of vitamin C. • Regular ingestion of vitamin C had no effect on preventing common colds in the ordinary population, based on 29 trials involving 11,306 participants. • Thirty‐one trials examined the effect of regular vitamin C on common cold duration (9745 episodes). In adults the duration of colds was modestly reduced by 8% (3% to 12%). • Seven comparisons examined the effect of therapeutic vitamin C (3249 episodes). No consistent effect of vitamin C was seen on the duration or severity of colds in the therapeutic trials.

http://summaries.cochrane.org/CD000980/ARI_vitamin-c-for-preventing-and- 37 treating-the-common-cold

Vitamin C / Garlic / Echinacea for colds

• Cenovis Garlic capsules can help to relieve the symptoms of colds. • May assist in the management of upper respiratory tract infections. • It may also help relieve the symptoms of mucous congestion and coughs, while helping maintain immune health and Odourless Garlic providing antibacterial properties. 90 Capsules $4.69 SAVE $1.26 RRP $5.95 38

Dr Ken Harvey Page 19 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Vitamin C / Garlic / Echinacea for colds

• Garlic is popularly believed to be useful for the common cold. • This belief is based on traditional use and some laboratory evidence that garlic has antibacterial and antiviral properties. • There is widespread usage of garlic supplements. • A single trial suggested that garlic may prevent occurrences of the common cold but more studies are needed to validate this finding. • Claims of effectiveness appear to rely largely on poor‐quality evidence.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006206.pub4/abstract 39

Vitamin C / Garlic / Echinacea for colds

• Echinacea plant preparations are widely used for common colds. • Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and the addition of other components. • Twenty‐four double‐blind trials with 4631 participants including a total of 33 comparisons of Echinacea preparations and placebo met the inclusion criteria. • Echinacea products have not here been shown to provide benefits for treating colds. • It is possible there is a weak benefit from some Echinacea products however the effects are of questionable clinical relevance.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000530.pub3/abstract 40

Dr Ken Harvey Page 20 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Magnesium (Nigari flakes, etc)

• Nagari is food grade magnesium chloride supplied in flakes manufactured in Japan from deep sea . • An excellent source of natural magnesium chloride. This product is mentioned in the October 2008 edition of nexus magazine.

Nigari Flakes • To find out how to use nigari in a medicinal (Magnesium Chloride) way try reading the above Nexus magazine 600g $42.00 article.

http://www.melbournefooddepot.com/buy/nigari-flakes-magnesium-chloride- 41 600g/F00207

Magnesium (Nigari flakes, etc) Magnesium chloride for health and rejuvenation http://www.nexusmagazine.com/ Feb - Mar 2008, pg 21-26

• Magnesium intake with our food has greatly declined due to the use of inorganic fertilisers • Also because the medical profession overemphasises our need for a high calcium intake and excessive calcium supplementation at the expense of magnesium. • If the magnesium levels are low, then the calcium levels rise to restore balance. • What does the body do with the excess calcium in the blood? It dumps it into tissue wherever there is some chronic inflammation.

42

Dr Ken Harvey Page 21 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Magnesium (Nigari flakes, etc) Magnesium chloride for health and rejuvenation http://www.nexusmagazine.com/ Feb - Mar 2008, pg 21-26

• This leads to the calcification of joints, as in arthritis, and to the calcification of ovaries and other glands, resulting in declining hormone production. Calcifying kidneys eventually require dialysis, and calcifications in breast tissue, especially the milk ducts, are often managed with unnecessary mastectomies and other invasive treatments. • A solution to this problem is to lower calcium levels in the blood by keeping up a high intake of magnesium. • Magnesium chloride can be added to food or drink, like juice, mostly to disguise the salty‐bitter taste. I mix it with juice myself, a quarter of a teaspoon at a time, and it is fine. • When dealing with factors such as stress, advancing age, cardiovascular problems and signs of calcification, up to 1,000 mg is the daily dosage recommended by many health practitioners. 43

Miracle Mineral Supplement A Miracle Treatment for Malaria and Other Diseases http://www.nexusmagazine.com/ Feb - Mar 2008, pg 19-24

• About the author: – Jim Humble has written a book, Breakthrough: The Miracle Mineral Supplement of the 21st Century – Parts I and II, available from his website http://www.miraclemineral.org . – Part I can be downloaded for free. • We recommend that readers visit his web site to learn more about chlorine dioxide, the use of his Miracle Mineral Supplement and his treatment protocols.

Dr Ken Harvey Page 22 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Miracle Mineral Solution slammed by AMA & TGA

• Ten Victorians have reported being poisoned by MMS in the past five years – which is believed to be a “vast under‐reporting” of cases – critics say the bleach is potentially deadly. • It is recommended to treat diseases including cancer, HIV/AIDS, and and it’s suggested it is a “promising” treatment for Ebola. • The product contains 28% sodium chlorite solution (bleach) which, mixed with acid which produces chlorine dioxide. • Victorian Poisons Information Centre specialist Dr Dawson MacLeod said people had reported symptoms including vomiting and diarrhoea after using MMS. Of the 10 people who had reported being poisoned by MMS, four had to be hospitalised. • MMS solution available Dr MacLeod said, “There’s no basis in for it being for sale online from an effective.” Australian website. http://tinyurl.com/pfxencd; http://www.tga.gov.au/alert/miracle- 45 mineral-solution-mms

Magnesium

• Swisse Ultiboost Magnesium is a premium quality formula containing a bioavailable form of magnesium (citrate) to help reduce muscle cramps and spasms, support a healthy nervous system and help relieve (PMS) symptoms. • Lifestyle factors such as prolonged stress and lack of sleep may deplete magnesium levels. • Swisse Ultiboost Magnesium has been formulated based on scientific evidence to support a physically active lifestyle 46

Dr Ken Harvey Page 23 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Magnesium

http://ods.od.nih.gov/factsheets/Magnesium-Consumer/ 47

Magnesium

http://ods.od.nih.gov/factsheets/Magnesium-Consumer/ • Magnesium is found naturally in many foods. You can get recommended amounts of magnesium by eating a variety of foods, including the following: – Legumes, nuts, seeds, whole grains, and green leafy vegetables (such as spinach) – Milk, yogurt, and fortified breakfast cereals . • Magnesium is also available in multivitamin‐mineral supplements and other dietary supplements. – Forms of magnesium in dietary supplements that are more easily absorbed by the body are magnesium aspartate, magnesium citrate, magnesium lactate, and magnesium chloride. • Pathological effects of primary nutritional deficiency of magnesium occur only rarely unless low intakes are accompanied by prolonged diarrhoea or excessive urinary loss. • Symptoms of magnesium deficiency include loss of appetite, nausea, vomiting, fatigue, and weakness. Extreme magnesium deficiency can cause numbness, tingling, muscle cramps, seizures and an abnormal heart rhythm.. • In healthy people, the kidneys can get rid of any excess in the urine. But magnesium in dietary supplements and medications should not be consumed in amounts above the upper limit, unless recommended by a health care provider. 48

Dr Ken Harvey Page 24 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Magnesium

http://ods.od.nih.gov/factsheets/Magnesium-Consumer/

• High intakes of magnesium supplements can cause diarrhoea, nausea, and abdominal cramping. • Extremely high intakes of magnesium can lead to irregular heartbeat and cardiac arrest. • Magnesium supplements can interact or interfere with some . For example: – Bisphosphonates, used to treat osteoporosis, are not well absorbed when taken too soon before or after taking dietary supplements or medications with high amounts of magnesium. – Antibiotics might not be absorbed if taken too soon before or after taking a dietary supplement that contains magnesium. – Diuretics can either increase or decrease the loss of magnesium through urine, depending on the type of diuretic. – Prescription drugs used to ease symptoms of acid reflux or treat peptic ulcers can cause low blood levels of magnesium when taken over a long period of time. N.B Nexus suggested – Very high doses of zinc supplements can interfere with the body’s 1000mg / day ability to absorb and regulate magnesium. 49

Magnesium

• http://www.nhmrc.gov.au/ guidelines/publications/n3 5‐n36‐n37

50

Dr Ken Harvey Page 25 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Magnesium: Cramps restless leg syndrome

• Leg cramps: – Two recent systematic reviews evaluated the effect of magnesium versus placebo for the treatment of nocturnal leg cramps; the overall effect of magnesium was found insignificant: • http://www.ncbi.nlm.nih.gov/pubmed/22972143 • http://www.ncbi.nlm.nih.gov/pubmed/24280947 – See also: • http://www.nps.org.au/publications/health‐professional/health‐news‐ evidence/2014/magnesium‐leg‐cramps • Restless legs syndrome (RLS): – A common medical condition that results in uncomfortable urges to move the legs, especially in the evening and at night, and often interferes with sleep. The cause is unknown. – There are prescription drugs (dopamine agonists) that have been shown to help but also cause adverse effects (discuss with your GP).

Acupuncture

http://www.acupuncture.org.au/Health_Services/Acupuncture.aspx 52

Dr Ken Harvey Page 26 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Acupuncture

• Acupuncture is known to treat a wide range of disorders including: – Musculoskeletal disorders such as osteoarthritis, , lumbago, weak back, low , , gout, tenosynovitis, shoulder and neck pain, cervicobrachial syndrome, 'frozen shoulder', and ''. – The disorders above which appear in bold have been recognised by the World Health Organisation (December 1979) as having been successfully treated by acupuncture. The disorders which do not appear in bold above are other common disorders which have been found to respond well to acupuncture. http://www.acupuncture.org.au/Health_Services/Acupuncture.aspx 53

Acupuncture

• How much do we know about acupuncture? – There have been extensive studies conducted on acupuncture, especially for back and neck pain, osteoarthritis/knee pain, and headache. However, researchers are only beginning to understand whether acupuncture can be helpful for various health conditions. • What do we know about the effectiveness of acupuncture? – Research suggests that acupuncture can help manage certain pain conditions, but evidence about its value for other health issues is uncertain. • What do we know about the safety of acupuncture? – Acupuncture is generally considered safe when performed by an experienced, well‐trained practitioner using sterile needles. Improperly performed acupuncture can cause serious side effects.

http://nccam.nih.gov/health/acupuncture/introduction 54

Dr Ken Harvey Page 27 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Acupuncture

• It’s difficult to compare acupuncture research results from study to study and to draw conclusions from the cumulative body of evidence. • This is because studies may use different acupuncture techniques (e.g., electrical vs. manual), controls (“placebo” or “sham” ) and varied outcome measures. • An emerging theme in acupuncture research is the role of the placebo. • For example, a 2009 of research on the pain‐relieving effects of acupuncture compared with placebo (simulated) or no acupuncture was inconclusive. • The reviewers found a small difference between acupuncture and placebo and a moderate difference between placebo and no acupuncture but the effect of placebo acupuncture varied considerably.

http://nccam.nih.gov/health/acupuncture/acupuncture-for-pain.htm 55

Acupuncture Trials

Traditional meridian points

Sham Placebo Acupuncture Device

http://www.the-rheumatologist.org/details/article/873613/Is_Acupuncture_for_Pain_a_Placebo_Treatment.html 56

Dr Ken Harvey Page 28 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Clinical trial information

• Registration: – Prospective. – Enforced & monitored by funding bodies, journals and professional societies. • Summary results: – Published on register within one year of the trial’s completion (currently FDA only). • Journal publication: – But negative results often either not submitted for publication or not accepted. • Full clinical study report to made publically available: – Currently produced only for regulatory and licensing purposes but “commercial‐ in‐confidence”.

Make clinical trials count:

http://www.alltrials.net 58

Dr Ken Harvey Page 29 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Make clinical trials count:

59

Issues that could be explored

• What is complementary &/or alternative medicine? • Who uses it, why and what for? • Regulation of products and practitioners; • The current review of the private health insurance rebate for natural therapies; • How do we know if it works: what is evidence? • Evidence for and against specific products &/ or therapies for certain conditions; • Sources of good information about complementary medicine, and

• Using complementary medicine wisely. 60

Dr Ken Harvey Page 30 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Sources of good information about CM

• Summarised evidence: – National Center for Complementary and Alternative Medicine • http://nccam.nih.gov/health/decisions • http://nccam.nih.gov/health/herbsataglance.htm – Medline Plus • http://www.nlm.nih.gov/medlineplus/ – The Cochrane Library • http://www.thecochranelibrary.com – PubMed Health • http://www.ncbi.nlm.nih.gov/pubmedhealth/ • Original clinical trials – PubMed • http://www.ncbi.nlm.nih.gov/pubmed/ • 61 • http://quackwatch.com/

Using complementary medicine wisely • To use CM wisely: – ALWAYS tell your health practitioners about ALL the medicines you take. – Ask your practitioner for advice, especially: • Evidence of efficacy from well conducted clinical trials concerning the specific product recommended, • Possible side‐effects and potential interactions with your existing therapy. – Search for independent information from trusted sources used in this course: • Also good consumer sites e.g. – https://www.chf.org.au/useful‐links.php – http://www.chronicillness.org.au/ – http://www.arthritisaustralia.com.au/ – Be very skeptical about promotional claims. 62

Dr Ken Harvey Page 31 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Remember: CM are no substitute for a good diet and exercise

http://www.shapeup.gov.au/start-shaping-up 63

Health care interventions: Choosing wisely

2015 Short course (8 sessions) • Medical advances have helped many of us live longer and have a better quality of life. • Yet a number of studies have shown that around one third of what we spend on health care is probably unnecessary, wasteful and sometimes harmful. This is especially true for medical interventions near the end‐of‐life. • Ironically, many doctors die differently from their patients. They don’t want fancy treatment, expensive chemotherapy offering little benefit or cardiopulmonary resuscitation (CPR). They know the downsides and they just say no.

64

Dr Ken Harvey Page 32 Complementary Medicine: Exploring the Issues U3A Short Course (3 of 3 sessions), Nov 2014

Health care interventions: Choosing wisely

• This 2015 short course will encourage people to ask questions of their healthcare professionals about the risks, benefits and costs of certain medical investigations and procedures. • Topics to be covered will include cardiopulmonary resuscitation (CPR), cancer chemotherapy, screening for breast, colorectal cancer and prostate cancer, testosterone therapy in ageing men, polypharmacy (multiple medications), antipsychotics in dementia and the use of antibiotics for upper respiratory tract infection. • We will also discus (with Dr Rodney Syme) dying with dignity, advance healthcare directives, refusal of treatment and

enduring medical power of attorney certificates. 65

Health care interventions: Choosing wisely

http://www.youtube.com/watch?v=FqQ-JuRDkl8; http://www.choosingwisely.org/; 66 http://www.youtube.com/watch?v=ZPWTPXvnC_w

Dr Ken Harvey Page 33