MD, PhD, FMedSci, FSB, FRCP, FRCPEd

supplements

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A recent article in the Guardian revealed that about one third of Australian pharmacists are recommending alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.

For this survey of 240 Australian pharmacies, mystery shoppers were sent in to speak to a pharmacist at the prescription dispensing counter and ask for advice about feeling stressed. The results show that three per cent of the pharmacists recommended homeopathic products, despite a comprehensive review of all existing studies on homeopathy finding that there is no evidence they work in treating any condition and that ‘people who choose homeopathy may put their health at risk if they reject or delay treatments’. Twenty-six percent of all pharmacists recommended Bach flower remedies to relieve stress. A comprehensive review of all existing studies on Bach flower remedies found no difference between the remedies and placebos. Fifty-nine per cent of people were just told the complementary and alternative product recommended to them worked, and 24% were told the product was scientifically proven, without any evidence being provided to them.

Asked about these findings, Dr Ken Harvey, a prominent Australian expert, said they demonstrated that some pharmacists were failing in their professional duty to consumers. “Pharmacists are giving crazy advice, and it is dangerous in some cases,” he said. “My view is that pharmacists, if they are going to sell these products, need to have a big shining sign over the shelves of the complementary and alternative medicine section that says ‘these products have not been assessed by the government regulators to see if they work, please talk to pharmacist’.Pharamacists are giving poor advice and they clearly have a conflict of interest,” Harvey said.

If you had hoped that in other countries pharmacists behave more responsibly, I must disappoint you. The information available shows that, when it comes to alternative medicine, pharmacists across the globe act much more like shop-keepers than like health care professionals. They are in the habit of putting profit before their duty to abide by the rules of evidence-based practice. And, in doing do, they violate their own ethical codes so regularly that I ask myself why they bothered to even implement one.

On this blog I have written so often about this issue that one could come to the conclusion that I have a bee under my bonnet:

The truth, however, is not that I am the victim of a bee.

The truth is that this is a very important public health issue.

The truth is that pharmacists show little signs of even trying to get to grips with it.

The truth is that pharmacists who sell bogus medicines put profit before professional ethics.

The truth is that such behaviour is not that of health care professionals but that of shop-keepers.

The truth is that I intend to carry on reminding these pharmacists that they are behaving like charlatans.

A new joint position statement of the Italian Society of Diabetology (SID) and of the Italian Society for the Study of Arteriosclerosis (SISA) has recently been published. In the context of this blog, it seems relevant enough for its summary to be reproduced here:

Evidence showed that LDL-cholesterol lowering is associated with a significant cardiovascular risk reduction. The initial therapeutic approach to hypercholesterolaemia includes dietary modifications but the compliance to recommendations is often inadequate. Some dietary components with potential cholesterol-lowering activity are present in small amounts in food. Therefore, in recent years the use of “nutraceuticals” (i.e., nutrients and/or bioactive compounds with potential beneficial effects on human health) has become widespread. Such substances may be added to foods and beverages, or taken as dietary supplements (liquid preparations, tablets, capsules). In the present manuscript, the cholesterol-lowering activity of some nutraceuticals (i.e. fiber, phytosterols, soy, policosanol, red yeast rice and berberine) will be discussed along with: 1) the level of evidence on the cholesterol-lowering efficacy emerging from clinical trial; 2) the possible side effects associated with their use; 3) the categories of patients who could benefit from their use.

DATA SYNTHESIS:

Based on the current literature, the cholesterol-lowering effect of fiber, phytosterols and red yeast rice is consistent and supported by a good level of evidence. Over berberine, there is sufficient evidence showing significant cholesterol-lowering effects, although the results come from studies carried out almost exclusively in Asian populations. Data on the effects of soy are conflicting and, therefore, the strength of recommendation is quite low. The evidence on policosanol is inconclusive.

CONCLUSION:

Although health benefits may arise from the use of nutraceuticals with cholesterol-lowering activity, their use might be also associated with possible risks and pitfalls, some of which are common to all nutraceuticals whereas others are related to specific nutraceuticals.

END OF QUOTE

Many advocates of alternative medicine are highly sceptical of the value of statins. Yet, it seems clear that statins exert considerably larger effects on our lipid profile than nutraceuticals. So, why not use the treatment that is best documented and most efficacious? One answer could lie in the well-known adverse effects of statins. However, can we be sure that nutraceuticals are devoid of serious side-effects? I am not sure that we can: statins have been fully investigated, and we therefore are well-informed about their risks. Nutraceuticals, by contrast, have not been monitored in such detail, and their safety profile is therefore not as well-understood.

Other advocates of alternative medicine argue that cholesterol (I use the term simplistically without differentiating between the ‘good and bad’ cholesterol) has been hyped by the pharmaceutical industry and is, in truth, not nearly as important a risk factor as we have been led to believe. This line of thought would consequently deny the need to lower elevated cholesterol levels and therefore negate the need for cholesterol-lowering treatments. This stance may be popular, particularly in the realm of alternative medicine, but, to the best of my knowledge, it is erroneous.

Obviously, the first line treatment for people with pathological lipid profiles is the adoption of different life-styles, particularly in terms of nutrition. This may well incorporate some of the nutraceuticals mentioned above. If that strategy is unsuccessful in normalizing our blood lipids – and it often is – we should consider the more effective conventional medications; and that unquestionably includes statins.

I do not expect that everyone reading these lines will agree with me, yet, after studying the evidence, this is my honest conclusion – and NO, I am not paid or otherwise rewarded by the pharmaceutical industry or anyone else!

 

The Committees of Advertising Practice (CAP) write and maintain the UK Advertising Codes, which are administered by the Advertising Standards Authority. On their website, the CAP recently published an updated advertising code for naturopathy. As we have regularly discussed the fact that the public is being frequently misled in this area, I consider the code important in the context of this blog. I therefore take the liberty of repeating it here – not least in the hope that this helps preventing misinformation in the future [the numbers in square brackets refer to me footnotes below].

START OF QUOTE

What is Naturopathy?

Naturopathy is a holistic [1] approach to healthcare that uses a combination of one or more different disciplines (for example herbal medicine or hydrotherapy) and a healthy lifestyle [2] in order to gain and maintain a healthy body [3].

What claims are likely to be acceptable?

The promotion of a healthy [4] lifestyle is likely to acceptable as are claims that go no further than those commonly accepted for healthy [4] eating, sleeping well, taking exercise and the like.

What claims are likely to be problematic?

The ASA and CAP have not yet been provided with evidence which demonstrates that Naturopathy can be used to treat medical conditions (Rule 12.1).  Therefore, any claims that go beyond accepted claims for a healthy [4] lifestyle are likely to be problematic [5] unless they are supported by a robust body of evidence.  In 2013, the ASA ruled against claims on a marketer’s website which said that Naturopathy could be used to treat acute and chronic illness and disease because the marketer had not provided any evidence in support of their claims (CNM The College of Naturopathic Medicine Ltd, 13 March 2013).

What about serious medical conditions?

Claims to offer treatment on conditions for which medical supervision should be sought [6] are likely to be considered to discourage essential treatment unless that treatment is carried out under the supervision of a suitably qualified health professional (Rule 12.2).

END OF QUOTE

Naturopathy has been the subject of my posts before – see for instance here, here, here, here and here. Naturopathy can be dangerous to the point where it can kill the patient – see for instance here and here. Therefore it is important that advertising gets regulated. To make it very clear: the above statement by the CAP is, in my view, a step in the right direction, and I encourage alternative practitioners to look up the equivalent CAP documents for their specific therapy.

Having said that, I still feel the need to make a few comments:

  1. It is misleading to call naturopathy ‘holistic’. This is often factually incorrect and also gives the impression that conventional medicine is not holistic – see also here.
  2. Are we sure that all lifestyles promoted by naturopaths are, in fact, healthy?
  3. Maintaining a healthy body is naturopathy speak for DISEASE PREVENTION. Who decides what is effective prevention? On what evidence? How come many naturopaths are against the most effective means of prevention of all times – vaccination?
  4. Who decides what is ‘healthy’? On what evidence?
  5. Why ‘problematic’? Are they not wrong or bogus or false or fraudulent or criminal?
  6. Are there conditions for which medical supervision should not be sought? Which are they?

Perhaps I have a weak spot for fish oil; more likely, however, I just like positive news – and, in alternative medicine, there is not much of it. That’s why I have written about the potential benefits of fish-oil again and again and again and again.

Reduced intake of fish oil, i.e. n−3 long-chain polyunsaturated fatty acids (LCPUFAs), may be a contributing factor to the increasing prevalence of asthma and other wheezing disorders. Yet the evidence is neither clear nor strong. This study was aimed at shedding more light on the issue; specifically, it tested the effect of supplementation with n−3 LCPUFAs in pregnant women on the risk of persistent wheeze and asthma in their offspring.

The investigators randomly assigned 736 pregnant women at 24 weeks of gestation to receive 2.4 g of n−3 LCPUFA (fish oil) or placebo (olive oil) per day. Their children were followed prospectively with extensive clinical phenotyping. Neither the investigators nor the participants were aware of group assignments during follow-up for the first 3 years of the children’s lives, after which there was a 2-year follow-up period during which only the investigators were unaware of group assignments. The primary end point was persistent wheeze or asthma, and the secondary end points included lower respiratory tract infections, asthma exacerbations, eczema, and allergic sensitization.

A total of 695 children were included in the trial, and 95.5% completed the 3-year, double-blind follow-up period. The risk of persistent wheeze or asthma in the treatment group was 16.9%, versus 23.7% in the control group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.97; P=0.035), corresponding to a relative reduction of 30.7%. Prespecified subgroup analyses suggested that the effect was strongest in the children of women whose blood levels of eicosapentaenoic acid and docosahexaenoic acid were in the lowest third of the trial population at randomization: 17.5% versus 34.1% (hazard ratio, 0.46; 95% CI, 0.25 to 0.83; P=0.011). Analyses of secondary end points showed that supplementation with n−3 LCPUFA was associated with a reduced risk of infections of the lower respiratory tract (31.7% vs. 39.1%; hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.033), but there were no statistically significant associations between supplementation and asthma exacerbations, eczema, or allergic sensitization.

The authors concluded that supplementation with n−3 LCPUFA in the third trimester of pregnancy reduced the absolute risk of persistent wheeze or asthma and infections of the lower respiratory tract in offspring by approximately 7 percentage points, or one third.

The authors must be congratulated. This trial is stunning in many ways: it was carefully designed and executed; its results are clear and important; its write-up is excellent. The research was supported by private and public research funds, all of which are listed at www.copsac.com. The Lundbeck Foundation, the Danish Ministry of Health, the Danish Council for Strategic Research, the Danish Council for Independent Research, and the Capital Region Research Foundation provided core support.

It is debatable whether the intake of fish oil falls under the umbrella of alternative medicine. In a way, it reminds me of the famous saying: what do we call alternative medicine that works? We call it medicine. It also holds an important reminder for all who make claims about the benefit of alternative therapies: extraordinary claims require extraordinary evidence.

Can these findings be translated into practical advice to consumers? The NEJM discussed this question in an accompanying article in which the case of a fictional pregnant woman (Ms. Franklin) was considered. Here is what they concluded: …there is benefit and little risk associated with n−3 LCPUFA supplementation. Even though we do not know Ms. Franklin’s EPA and DHA levels, there is likely to be a benefit for her child, at little risk, cost, or inconvenience. She should start taking n−3 LCPUFA supplements.

Despite my soft spot for fish oil, I might add that, while we give advice of this nature, we nevertheless need to insist on independent replications to have certainty.

Yes, the festive season is upon us and therefore it is high time to discuss detox (yet again). As many of us are filling their fridges to the brim, most of us prepare for some serious over-indulgence. Following alt med logic, this must prompt some counter-measures, called detox.

The range of treatments advocated by detox-fans is weird and wide (see also below):

  • various alternative diets,
  • herbal, vitamins, minerals and other ‘natural’ supplements,
  • various forms of chelation therapy,
  • electromagnetic devices,
  • colonic irrigation and enemas,
  • various forms of skin bruising,
  • cupping,
  • sauna and other means of inducing extensive sweating,
  • homeopathy,
  • ear candles,
  • foot-baths,
  • etc., etc.

I suppose it was to be expected that detox often goes with other crazy beliefs. This website, for instance, shows that it is even associated with anti-vaxx:

START OF QUOTE

Whether you believe vaccines to be harmful or not, one has to admit that all the ingredients added to vaccines cannot be good for anyone, especially children.

As David Wolfe has discussed, vaccines contain the following: sucrose, fructose, dextrose, potassium phosphate, aluminum potassium sulfate, peptone, bovine extract, formaldehyde, FD&C Yellow #6, aluminum lake dye, fetal bovine serum, sodium bicarbonate, monosodium glutamate, aluminum hydroxide, benzethonium chloride, lactose thimerosal, ammonium sulfate, formaldehyde, glutaraldehyde, bovine extract), calf serum, aluminum phosphate, aluminum hydroxyphosphate sulfate, and ethanol.

That is a long scary list and many of these things will not leave the body naturally. Thus, a gentle detox is necessary.

Detoxification Bath

Living Traditionally suggests a detoxification bath with both Zendocrine and epsom salt. Zendocrine is an essential oil mixture made up of tangerine, rosemary, geranium, juniper berry, and cilantro. Rosemary, juniper berry, and cilantro are good choices for detoxification and tangerine and geranium are purifiers.

Garlic

Garlic has been scientifically proven to treat heavy metal poisoning. Organic Lifestyle Magazine suggests consuming three cloves a day to help remove toxins.

Silica

Silica is also good for a heavy metal detox. Natural News states, “Aluminum (Al) is passed out through the urine when one supplements silica. It seems there’s little danger of taking too much, as long as adequate water is consumed and vitamin B1 and potassium levels are maintained.”

One of the best ways to get silica in your system is with the horsetail herb, rye, barley, oats, wheat, and alfalfa sprouts nuts.

Chlorella

Chlorella is one of the best detoxifying substances available. According to Dr. Mercola, “Chlorella is uniquely designed to not bind to the minerals your body naturally needs to function optimally. It does not bind to beneficial minerals like calcium, magnesium, or zinc. It’s almost as if chlorella knows which metals belong in your body and which chemicals need to be removed. Supplementing with chlorella is like unleashing a tiny army inside your body to fight the battle of removing toxins from your tissues and ushering them back outside your body where they belong.”
You can take it in supplement form or add a powdered version to your smoothie.

Probiotics

Probiotics are what is needed to put good bacteria system to rights when it has been thrown off by toxins. “They can provide assistance by decreasing the number of bad bacteria while helping to restore balance between good and bad bacteria in the gut and to keep your body functioning properly.” (LiveStrong)

Some probiotic foods include: organic yogurt, kefir, sauerkraut, kombucha, and fermented vegetables.

Omega-3

Omega 3 oils are especially good for cell repair and keeping your brain healthy. This is because of their high fat content is similar to the fats that are naturally part of cell and brain systems. (Daily Mail)

A teaspoon daily should be enough or you could take a supplement.

Cilantro

According to Natural Society, cilantro is a very gentle detoxification tool. It is also effective for removing heavy metals from the brain.
For 2-3 weeks, add a teaspoon of cilantro to your food, smoothie, or just eat it up. You can also substitute with 6-7 drops of cilantro essential oil by adding it to your bath.

END OF QUOTE

Don’t you just adore the sources quoted by the author as evidence for his/her statements?

As I said, the therapies recommended for detox are diverse. Yet, they have one important feature in co<span style=”color: #668a1d;”>mmon: they are not based on anything remotely resembling good evidence. As I stressed in my article of 2012:

The common characteristics of all of these approaches are that they are unproved. Even experts who are sympathetic to alternative medicine and AD admit: ‘while there are hundreds of randomized controlled trials on drug and alcohol detox, there are no such trials of detox programs focusing on environmental toxins … at present, “detox” is certainly more of a sales pitch than a science’. The ‘studies’ of AD that have been published are of such poor methodological quality that no conclusions can be drawn from them.

While there is a total absence of sound evidence for benefit, some of these treatments have been associated with risks which depend on the nature of the treatment and can be particularly serious with diets (malnutrition), supplements (hepatoxicity), chelation (electrolyte depletion) and colonic irrigation (perforation of the colon).

Yet detox is big business’. A recent survey, for instance, suggested that 92% of US naturopaths use some form of detox. To lay people, its principles seem to make sense and, in many of us, the desire to ‘purify’ ourselves is deep rooted. Thus detox-entrepreneurs (including Prince Charles who, several years ago, launched a ‘Detox-Tincture’ via his firm Duchy Originals) are able to exploit a gullible public.

Proponents of detox are keen to point out that ‘a modern science of ‘detoxicology’ seems to be emerging’. If there is such a thing, it should address the following, fundamental questions:

  • What are the toxins and toxicants?
  • What evidence exists that they damage our health?
  • How do we quantify them?
  • How do we diagnose that a patient requires detox?
  • Which treatments are effective in eliminating which toxins?

Currently, there is insufficient evidence to answer any of these questions. Until this situation changes, I do not think a ‘science of detox’ exists at all.

A press-release from a company based in Germany recently caught my attention. I here present only the most relevant sections from this document:

Natural remedies like medicinal mushrooms also called vitality mushrooms haven proven helpful in prevention and as a support in the therapy, of diabetes type 2. This could be shown by long-time observational studies in naturopathy, for example by MykoTroph – Institute for Medicinal Mushrooms. Medicinal mushroom Coprinus has regenerating effects on the pancreas; it also helps the sensitization of the receptors responsible for the absorption of insulin and claims to have a blood sugar lowering effect.

Medicinal mushroom Maitake has positive effects on the fat metabolism and the sensitivity of insulin receptors. Diabetes type 2 is often linked to circulation problems, vascular diseases and hypertension. Therefore, regular monitoring of the blood pressure, blood lipids, triglycerides and body weight is highly important. The intake of Maitake can help ‒ even in a preliminary stage ‒ to get a grip on these determining factors.

Within the scope of a holistic therapy of diabetes type 2 with metabolic syndrome, the combined intake of medicinal mushrooms and Nopal juice (prickly pear) can be very reasonable. Nopal juice has a lowering effect on the glycemic index of ingested food. The consequence is a slower release of carbohydrates in the intestines and is therefore favorable for a healthy level of blood sugar…

Medicinal mushrooms are available as mushroom powder capsules. According to observational studies of MykoTroph – Institute for Medicinal Mushrooms, especially mushroom powder derived from the whole mushroom has proven effective. Only if the mushroom powder is derived from the whole mushroom, the powder will contain all of the effective ingredients of medicinal mushrooms. It should also be taken care that the mushrooms are from certified organic production. For further information, please visit us on http://www.mykotroph.com
a Japanese study participants comprised 726 Japanese T2DM outpatients free of history of CVD. Life styles were analyzed using self-reported questionnaires. The relationship between dietary patterns, identified by factor analysis, and potential risk factors for CVD was investigated by linear and logistic regression analyses….The “Seaweeds, Vegetables, Soy products and Mushrooms” pattern, characterized by high consumption of seaweeds, soy products and mushrooms, was associated with lower use of diabetes medication and healthier lifestyles.

END OF QUOTE

These are claims that could be relevant to millions of diabetic patients worldwide – but are they true?

The study cited above did indeed show an association; but an association is not necessarily a causal relationship! So what evidence is there fore a causal relationship between mushroom-consumption and diabetes? The answer is: frustratingly little.

A Cochrane review concluded that “evidence from a small number of randomised controlled trials does not support the use of G lucidum [Ganoderma lucidum (also known as lingzhi or reishi)] for treatment of cardiovascular risk factors in people with type 2 diabetes mellitus. Future research into the efficacy of G lucidum should be placebo-controlled and adhere to clinical trial reporting standards.”

The authors of another Cochrane review concluded that “our review did not find sufficient evidence to justify the use of G. lucidum as a first-line treatment for cancer. It remains uncertain whether G. lucidum helps prolong long-term cancer survival. However, G. lucidum could be administered as an alternative adjunct to conventional treatment in consideration of its potential of enhancing tumour response and stimulating host immunity. G. lucidum was generally well tolerated by most participants with only a scattered number of minor adverse events. No major toxicity was observed across the studies. Although there were few reports of harmful effect of G. lucidum, the use of its extract should be judicious, especially after thorough consideration of cost-benefit and patient preference. Future studies should put emphasis on the improvement in methodological quality and further clinical research on the effect of G. lucidum on cancer long-term survival are needed. An update to this review will be performed every two years.”

A further study determined whether a supplement of Agaricus blazei Murill extract improves insulin resistance in type 2 diabetes. It was designed as a clinical randomized, double-blind, placebo-controlled trial. Diabetic patients were randomly assigned to either receiving supplement of Agaricus blazei Murill (ABM) extract or placebo (cellulose) 1500 mg daily for 12 weeks. At the end of the study, the subjects who received supplement of ABM extract (n = 29) showed significantly lower HOMA-IR index than the control group (n = 31). The plasma adiponectin concentration increased by 20% in the ABM group after 12 weeks of treatment, but decreased 20% among those taking the placebo. The authors concluded that “ABM extract improves insulin resistance among subjects with type 2 diabetes. The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect. Studies with longer periods of follow-up should be conducted in the future.”

On the basis of all this evidence, it seems fair to conclude that mushrooms have little or no effect on diabetes.

And what about the above press-release?

Diabetes is a serious condition that can be well-controlled with diet, exercise and drugs. Many diabetics are nevertheless fed up with taking drugs throughout their entire life and would only be too happy to exchange them for ‘something natural’. Therefore patients might try mushrooms or other natural ‘cures’, if they are promoted in this way. However, this decision could prove fatal (examples of such tragedies abound).

In view of these considerations, I find such promotion irresponsible, unethical and outright dangerous.

Athletes tend to adopt a healthy life-style, and today this seems to include the regular intake of a range of dietary supplements. Supplements specifically marketed for sports-people promote good health and performance, we are constantly told – but is this true?

A 2010 review found that “there is good evidence that caffeine can improve single-sprint performance, while caffeine, creatine and sodium bicarbonate ingestion have all been demonstrated to improve multiple-sprint performance. The evidence is not so strong for the performance-enhancing benefits of β-alanine or colostrum. Current evidence does not support the ingestion of ribose, branched-chain amino acids or β-hydroxy-β-methylbutyrate, especially in well trained athletes.”

However, a 2011 paper was considerably more cautious: “For most supplements, the evidence is weak, or even completely absent. A few supplements, including caffeine, creatine, and bicarbonate, are supported by a strong research base. Difficulties arise when new evidence appears to support novel supplements: in recent years, β-alanine has become popular, and the use of nitrate and arginine is growing. Athletes seldom wait until there is convincing evidence of efficacy or of safety, but caution is necessary to minimize risk.”

The purpose of this new article was to collect the most recent data regarding the safety of well-known or emerging dietary supplements used by athletes.

The review suggests that about 90% of sports supplements contain estrogenic endocrine disruptors, and about 25% of them having a higher estrogenic activity than acceptable. About 50% of the supplements are contaminated by melamine, a source of non-protein nitrogen. Additional data accumulate toward the safety of nitrate ingestion. In the last 2 years, the safety of emerging supplements such as higenamine, potentially interesting to lose weight, creatine nitrate and guanidinoacetic acid has been evaluated but still needs further investigation.

The authors of this article claim that “the consumption of over-the-counter supplements is very popular in athletes. Although most supplements may be considered as safe when taking at the recommended doses, athletes should be aware of the potential risks linked to the consumption of supplements. In addition to the risks linked to overdosage and cross-effects when combining different supplements at the same time, inadvertent or deliberate contamination with stimulants, estrogenic compounds, diuretics or anabolic agents may occur.”

Despite these cautions, the market for supplements is growing and the myth that supplements are good for health continues. The truth is, however, more complex and far less encouraging:

  • It is impossible to generalise across the entire range of highly diverse supplements.
  • Some have positive effects.
  • The vast majority do nothing at all.
  • Most are quite harmless.
  • Some can have serious adverse effects.
  • All of them cause harm to your bank account.

Antrodia cinnamomea (AC) is a fungus which is used in Taiwan as a remedy for cancer, hypertension, hangover and other conditions. There are several commercial AC products and the annual market is worth over $100 million in Taiwan alone.

Several studies have suggested anti-cancer properties in vitro but few clinical trials have been reported. Now Taiwanese researchers published a double-blind, randomized clinical study to investigate whether AC had acceptable safety and efficacy in advanced cancer patients receiving chemotherapy.

Patients with advanced and/or metastatic adenocarcinoma, performance status (PS) 0-2, and adequate organ function who had previously been treated with standard chemotherapy were randomly assigned to receive routine chemotherapy regimens with AC (20 ml twice daily) orally for 30 days or placebo. The primary endpoint was 6-month overall survival (OS); the secondary endpoints were disease control rate (DCR), quality of life (QoL), adverse event (AE), and biochemical features within 30 days of treatment.

A total of 37 subjects with gastric, lung, liver, breast, and colorectal cancer (17 in the AC group, 20 in the placebo group) were enrolled in the study. Disease progression was the primary cause of death in 4 (33.3 %) AC and 8 (66.7 %) placebo recipients. Mean OSs were 5.4 months for the AC group and 5.0 months for the placebo group (p = 0.340), and the DCRs were 41.2 and 55 %, respectively (p = 0.33). Most hematologic, liver, or kidney functions did not differ significantly between the two groups, but platelet counts were lower in the AC group than in the placebo group (p = 0.02). QoL assessments were similar in the two groups, except that the AC group showed significant improvements in quality of sleep (p = 0.04).

12906_2016_1312_fig2_html

The above figure shows the survival curves for both groups.

The authors concluded as follows: Although we found a lower mortality rate and longer mean OS in the AC group than in the control group, AC combined with chemotherapy was not shown to improve the outcome of advanced cancer patients, possibly due to the small sample size. In fact, the combination may present a potential risk of lowered platelet counts. Adequately powered clinical trials will be necessary to address this question.

I agree, the survival curve looks promising. But we must not get carried away: this was a tiny sample size and a relatively short treatment period. Thus the difference could be a coincidence or an artefact.

The investigators are sufficiently cautious in the interpretation of their findings, and most of us would probably agree that it is necessary to submit such traditional remedies to proper scientific tests. Yet, I feel a sense of unease when I read such articles.

On the one hand, it is possible that such investigations meaningfully contribute to progress. On the other hand, I wonder whether they merely end up providing a significant boost to the trade of bogus remedies sold at high prices to desperate patients. Do the benefits really out-weigh the risks? We will probably never know.

But to minimize the risk, the authors should now swiftly conduct a more definitive trial and create some clarity about the value or otherwise of this traditional cancer remedy.

In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.

According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”

The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”

This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.

Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.

On this blog, I have discussed the lamentable quality of TCM products before (e. g. here, here and here). In a nutshell, far too high percentages of them are contaminated with toxic substances or adulterated with prescription drugs. It is no question: these deficits put many consumers at risk. Equally, there is no question that the problem has been known for decades.

For the Chinese exporters, such issues are a great embarrassment, not least because TCM-products are amongst the most profitable of all the Chinese exports. In the past, Chinese officials have tried to ignore or suppress the subject as much as possible. I presume they fear that their profits might be endangered by being open about the dubious quality of their TCM-exports.

Recently, however, I came across a website where unusually frank and honest statements of Chinese officials appeared about TCM-products. Here is the quote:

China is to unroll the fourth national survey of traditional Chinese medicine (TCM) resources to ensure a better development of the industry, said a senior health official…

With the public need for TCM therapies growing, the number of medicine resources has decreased and people have turned to the cultivated ones. However, due to a lack of standards, the cultivated TCM resources are sometimes less effective or even unsafe for human use, said Wang Guoqiang, director of the State Administration of TCM, at a TCM seminar held in Kunming, Yunnan Province in southwest China.

There is a pressing need to protect TCM resources, Wang said. “I’ve heard people saying that medicine quality will spell doom for the TCM industry, which I must admit, is no exaggeration,” he said.

The survey has been piloted in 922 counties in 31 provinces in China since 2011. According to its official website, it will draw a clear picture of the variety, distribution, storage and growth trends of TCM resources, including herbs, animals, minerals and synthetic materials.

TCM includes a range of traditional medical practices originating in China. It includes such treatments as herbal medicine, acupuncture, massage (tuina), exercise (qigong) and dietary therapy.

Although well accepted in the mainstream of medical care throughout East Asia, TCM is considered an alternative medical system in much of the western world and has been a source of controversy. A milestone in the recognition of TCM came when Chinese pharmaceutical chemist Tu Youyou won a Nobel Prize in 2015 for her discovery of Artemisinin, a medicinal herb, to help treat malaria.

END OF QUOTE

Surely, these are remarkable, perhaps even unprecedented statements by Chinese officials:

…cultivated TCM resources are sometimes less effective or even unsafe for human use…

…medicine quality will spell doom for the TCM industry…

Let’s hope that, after such words, there will be appropriate actions… finally.

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