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).
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.
Yes, I know, lately I have been neglecting my ‘ALT MED HALL OF FAME’. This is entirely my fault; there are so many candidates waiting to be admitted that, I have been hesitant as to who should be next. Today, I came across an article about Deepak Chopra and his latest book, Super Genes. It tells “how lifestyle shifts can help you reboot your health at a genetic level.” If it were just for this single sentence, he would deserve to be admitted – no, not into what you just thought, into the ‘ALT MED HALL OF FAME’, of course’.
I will save you the expense of buying his book (don’t worry, Deepak is already a multi-millionaire) by repeating what the article said about his ‘6 pillars of wellbeing’ (another cracker!!!):
• A typical modern diet is very likely to cause inflammation, which research has linked to many chronic diseases and obesity.
• To reduce inflammation, add prebiotics – substances that buffer the body from inflammation – such as oatmeal, pulpy orange juice, bran cereal and bananas to your breakfast.
• Consume probiotics – foods that contain active bacteria – once a day for gut health. These foods include active yoghurt, pickles and sauerkraut.
• Eat mindfully – eat only when you’re genuinely hungry and stop when you are full.
• Reduce snacking by eating only one measured portion in a bowl; never eat straight from a bag or packet.
• Three factors generally lie behind the problem of chronic stress: repetition, unpredictability and a lack of control. Think of a dog barking outside your window; you don’t know when it will end and you have no way of stopping it.
• Decrease background noise and distractions at work. Also, avoid multitasking by dealing with one thing at a time.
• Leave work on time at least three times a week and don’t bring work home. Leave the office at the office.
• Avoid people who are sources of pressure and conflict. Even normal office behaviour, such as forming cliques and gossiping, is a source of stress that has the potential to be emotionally devastating.
• If you struggle to deal with negative emotions, ask your doctor about cognitive behaviour therapy.
• The secret to exercise is this: keep going and don’t stop. It’s better to be active all your life at a lower level, rather than to be at a near professional-level in high school, say, and then stop completely.
• At work get up and move around once an hour and devote half your lunch break to movement, even if it’s walking around the block.
• Be in nature more: go outside for five to 10 minutes three times a day.
• Acquire more active friends and join them in their activities. Plan a shared exercise activity with your spouse or friends twice a week.
• Make leisure time more creative – think beyond TV or internet.
• Volunteer to help the needy with housecleaning, painting and repairs.
This will serve as both exercise and a morale boost.
• Meditate every day for 10 minutes.
Sit with your eyes closed in a quiet place, put your attention on the tip of your nose and focus on the sensation of your breath coming in and out of your nostrils.
• Don’t look at meditation as an aid for the bad days you experience (“I’m feeling good today, so I don’t need to meditate”). It should be a lifelong practice.
• Take 10 minutes out of your lunch break to sit alone with eyes closed, preferably outside in nature.
• Notice what a relief it is to take big deep breaths when you are upset or nervous, and how ragged your breath becomes when you are anxious or stressed.
• Join an organised meditation course in your area. Search for meetup.com to find local groups that meet all around the country.
• Make your bedroom as dark as possible. If total darkness is impossible, wear a sleep mask.
• Drink a glass of warm almond milk, which is rich in calcium and promotes melatonin, a hormone that helps to regulate the sleep-wake cycle.
• Experiment with herbal teas associated with good sleep such as chamomile, valerian, passionflower, lavender and kava kava.
• Explore abhyanga, a self-massage technique that uses warmed sesame oil, lightly massaged into arms, legs, neck and torso (go to YouTube to see tutorials).
• Don’t ignore insomnia. In some studies sleep disorders have been associated with triggering Alzheimer’s disease and are also associated with high blood pressure.
• Take responsibility for your feelings. Wellbeing depends upon happiness, yet most people don’t really make that connection.
• Write down five specific things that make you happy and, on a daily basis, do at least one of them.
• Set a “good news policy” at meal times, whether it’s the radio station you choose to listen to or the topic of conversation around the table.
• Explore a time in your past when you were happy and learn from it, whether that means re-embracing an old hobby or getting in touch with an old friend.
• Become comfortable with delayed gratification – consider how your choices will make you feel in the future as well as today.
END OF QUOTE
My favourite website about Deepak Chopra is the one by Tom Williamson. It states that “it has been said by some that the thoughts and tweets of Deepak Chopra are indistinguishable from a set of profound sounding words put together in a random order, particularly the tweets tagged with “#cosmisconciousness”. This site aims to test that claim! Each “quote” is generated from a list of words that can be found in Deepak Chopra’s Twitter stream randomly stuck together in a sentence.” It seems to me that Deepak himself might have made ample use of this site for writing his latest book, and if you should ever run out of platitudes or empty phrases, this site will serve you well.
Deepak has published plenty of best-sellers, but he has as good as nothing to show for himself in the peer-reviewed medical literature. (When you are that famous, you obviously don’t need to bother anymore with trivia such as evidence, science and all that jazz.) This means that I had to deviate from my usual admission criteria for the “prophet of alternative medicine”, as Deepak likes to be called. But he is well worth making an exception, I am sure you agree, he is the absolute super-star!
Super-star of what?
I let you decide!
One of the things about alternative medicine that I find most regrettable is the fact that researchers in this area abuse science for their very own promotional aims. This phenomenon is so very common, in my view, that many of the individuals involved in it are no longer aware of it. Science, they seem to think, is a tool for marketing products or for popularising the idea that alternative medicine is the best thing since sliced bread.
To support this bold statement, I could show you virtually hundreds of articles. But this might bore your socks off, and instead I will focus on just one paper which has just been published and makes my point in an exemplary fashion.
The new clinical investigation was performed to confirm the benefit of complementary medicine in patients with breast cancer undergoing adjuvant hormone therapy (HT). A total of 1561 patients were treated according to international guidelines. They suffered from arthralgia and mucosal dryness induced by the adjuvant HT. In order to reduce the side-effects, the patients were complementarily treated with a combination of sodium selenite, proteolytic plant enzymes (bromelaine and papain) and Lens culinaris lectin. Outcomes were documented before and four weeks after complementary treatment. Validation was carried-out by scoring from 1 (no side-effects/optimal tolerability) to 6 (extreme side-effects/extremely poor tolerability). A total of 1,165 patients suffering from severe side-effects (symptom scores >3) were enrolled in this investigation.
Overall, 62.6% of patients (729 out of 1,165) suffering from severe arthralgia and 71.7% of patients (520 out of 725) with severe mucosal dryness significantly benefited from the oral combination product. Mean scores of symptoms declined from 4.83 before treatment to 3.23 after four weeks of treatment for arthralgia and from 4.72 before treatment to 2.99 after four weeks of treatment for mucosal dryness, the primary aims of the present investigation. The reduction of side-effects of HT was statistically significant after four weeks.
The authors concluded that this investigation confirms studies suggesting a benefit of complementary treatment with the combination of sodium selenite, proteolytic enzymes and L. culinaris lectin in patients with breast cancer.
Where should I start?
- This ‘investigation’ was nothing other than a survey.
- There was no control group, and we therefore cannot tell whether the patients would not have done just a well or even better without taking this supplement.
- No objective outcome measure was included.
- What happened to the ~400 patients who were not included in the analyses?
- Even the authors admit that their aim was “to confirm the benefit of complementary medicine…”, and it goes without saying that, with such an aim in mind, any scientific rigor is not welcome.
On this blog, I have repeatedly tried to alert consumers and patients to the risks of herbal medicine. The risks include:
- toxicity of one or more ingredients of the plant,
- interactions with other medicines,
- contamination with toxic non-herbal substances such as heavy metals,
- adulteration with synthetic drugs such as steroids,
- ineffectiveness in treating the target disease
- reduction of adherence to prescribed medicines.
A new paper throws more light on the latter issue which has been not well-studies so far.
The objective of this study was to investigate the relationship between the use of medicinal plants and medication adherence in elderly people. The authors conducted an observational, cross-sectional study of elderly residents in Cuité-PB, Northeastern Brazil, through a household survey. A stratified proportional and systematic random sample of 240 elders was interviewed in their homes and the use of pharmaceutical medicines and of medicinal plants was assessed by direct examination. The association of medication adherence with socio-demographic, clinical, medication and use of medicinal plants was analysed with multiple logistic regression.
The results showed that medication non-adherence increases with use of herbal medicines (adjusted odds ratio 2.022, 95% CI 1.059–3.862, p = 0.03), as well as with the number of different medicinal plants used (adjusted odds ratio 1.937, 95% CI 1.265–2.965, p = 0.002).
The authors concluded that this study provides first-hand evidence that the use of herbal medicines is associated with poor medication adherence. Given the high frequency of the use of herbal medicines, further research into the mechanisms of this association is justified.
This conclusion is well-put, I think. If these findings are confirmed in other populations, we are confronted with a somewhat paradoxical situation: combining herbal and synthetic medicines can reduce adherence to the synthetic drugs and, in cases where adherence is not affected, it could increase the risk of herb/drug interactions.
Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients, and it is a symptom that is often difficult to treat. As always in such a situation, there are lots of alternative therapies on offer. Yet the evidence for most is flimsy, to put it mildly.
But perhaps there is hope? The very first RCT with a 2016 date to be reviewed on this blog investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.
Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.
Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.
The authors concluded that ‘IP may control moderate-severe CRF in breast cancer patients.’
The website of the manufacturer provides the following information on IP:
Inner Power is a functional food that provides various nutrients, such as zinc and copper. Zinc is a nutrient that your body needs to maintain your sense of taste. Zinc is also vital in keeping the skin and mucous membranes healthy and in regulating metabolism of proteins and nucleic acids. Copper helps the body form red blood cells and bones and regulates many enzymes that are found in the body. One pouch of Inner Power each day is the recommended daily serving.
- Consuming a large amount of the product will not cure any underlying disease or improve your health condition.
- Do not consume too much of the product because excessive zinc intake may inhibit the absorption of copper.
- Observe the recommended daily serving of the product. This product should not be given to infants or children.
The recommended daily serving of the product (1 pouch/day) contains 43% of the reference daily intake of zinc and 50% of the reference daily intake of copper. Inner Power is neither categorized as a food for special dietary use nor approved individually by the Ministry of Health, Labour, and Welfare. You should eat well-balanced meals consisting of staple foods, including a main dish and side dishes.
I cannot say that this inspires me with confidence.
What about the trial itself?
To be honest, I am not impressed. The most obvious flaw is, I think, that there was not the slightest attempt to control for placebo effects. As I pointed out so many times before: with the ‘A+B versus B’ design, one can make any old placebo appear to be effective.
The search for an effective treatment of obesity is understandably intense. Many scientists are looking in the plant kingdom for a solution, but so far none has been forthcoming – as we have already discussed on this blog before (e. g. here, and here). One herbal slimming aid is currently becoming popular: Yerba Mate also called Ilex paraguariensis, a plant many of us know from teas and other beverages. Our review concluded that the evidence for it was unconvincing but that it merited further study. This was 10 years ago, and meanwhile the evidence has moved on.
The aim of a recent study was to investigate the efficacy of Yerba Mate supplementation in subjects with obesity. For this purpose, a randomized, double-blind, placebo-controlled trial was conducted. Korean subjects with obesity (body mass index (BMI) ≥ 25 but < 35 kg/m(2) and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women) were given oral supplements of Yerba Mate capsules (n = 15) or placebos (n = 15) for 12 weeks. They took three capsules per each meal, total three times in a day (3 g/day). Outcome measures were efficacy (abdominal fat distribution, anthropometric parameters and blood lipid profiles) and safety (adverse events, laboratory test results and vital signs).
During 12 weeks of Yerba Mate supplementation, statistically significant decreases in body fat mass and percent body fat compared to the placebo group were noted significant. The WHR was significantly also decreased in the Yerba Mate group compared to the placebo group. No clinically significant changes in any safety parameters were observed.
The authors concluded that Yerba Mate supplementation decreased body fat mass, percent body fat and WHR. Yerba Mate was a potent anti-obesity reagent that did not produce significant adverse effects. These results suggested that Yerba Mate supplementation may be effective for treating obese individuals.
These are encouraging results, but the conclusions go way too far, for my taste. The study was tiny and does therefore not lend itself to far-reaching generalisations. What would be helpful, is a review of other evidence. As it happens, such a paper has just become available. Its authors evaluated the impact of yerba maté on obesity and obesity-related inflammation and demonstrate that yerba maté suppresses adipocyte differentiation as well as triglyceride accumulation and reduces inflammation. Animal studies show that yerba maté modulates signaling pathways that regulate adipogenesis, antioxidant, anti-inflammatory and insulin signaling responses.
The review authors concluded that the use of yerba maté might be useful against obesity, improving the lipid parameters in humans and animal models. In addition, yerba maté modulates the expression of genes that are changed in the obese state and restores them to more normal levels of expression. In doing so, it addresses several of the abnormal and disease-causing factors associated with obesity. Protective and ameliorative effects on insulin resistance were also observed… it seems that yerba maté beverages and supplements might be helpful in the battle against obesity.
I am still not fully convinced that this dietary supplement is the solution to the current obesity epidemic. But the evidence is encouraging – more so than for most of the many other ‘natural’ slimming aids that are presently being promoted for this condition by gurus like Dr Oz.
What we needed now is not the ill-informed, self-interested voice of charlatans; what we need is well-designed research to define efficacy, effect size and risks.
While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.
This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.
In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.
Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.
The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.
This sounds like good news for naturopathy! However, there are several important caveats:
- the authors seem to have only looked at US studies (naturopathy is a European tradition!),
- the searches were done three years ago, and more recent data were thus omitted,
- the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
- rigorous trials were very scarce; and for each condition, they were even more so,
- the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.
My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.
Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.
I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.
The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.
Discussions about the dietary supplements are often far too general to be truly useful, in my view. For a meaningful debate, we need to define what supplement we are talking about and make clear what condition it is used for. A recent paper meets these criteria well and is therefore worth a mention.
The review was aimed at addressing the controversy regarding the optimal intake, and the role of calcium supplements in the treatment and prevention of osteoporosis. The authors demonstrate that most studies on the subject show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg per day .
The authors argue that supplements are therefore not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses.
These facts, the authors argue, must be balanced against the possible harm. The risks of regularly taking calcium supplements include an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention.
The authors draw the following detailed conclusions: “Concern regarding the safety of calcium supplements has led to recommendations that dietary calcium should be the primary source, and supplements reserved only for those who are unable to achieve an adequate dietary intake. The current recommendations for intakes of 1000–1200 mg day−1 are not firmly based on evidence. The longitudinal bone densitometry studies reviewed here, together with the new data included in this review relating to total body calcium, suggest that intakes in women consuming only half these quantities are satisfactory and thus, they do not require additional supplementation. The continuing preoccupation with calcium nutrition has its origin in a period when calcium balance was the only technique available to assess dietary or other therapeutic effects on bone health. We now have persuasive evidence from direct measurements of changes in bone density that calcium balance does not reflect bone balance. Bone balance is determined by the relative activities of bone formation and bone resorption, both of which are cellular processes. The mineralization of newly formed bone utilizes calcium as a substrate, but there is no suggestion that provision of excess substrate has any positive effect on either bone formation or subsequent mineralization.
Based on the evidence reviewed here, it seems sensible to maintain calcium intakes in the region of 500–1000 mg day−1 in older individuals at risk of osteoporosis, but there seems to be little need for calcium supplements except in individuals with major malabsorption problems or substantial abnormalities of calcium metabolism. Because of their formulation, costs and probable safety issues, calcium supplements should be regarded as pharmaceutical agents rather than as part of a standard diet. As such, they do not meet the standard cost–benefit criteria for pharmaceutical use and are not cost-effective. If an individual’s fracture risk is sufficient to require pharmaceutical intervention, then safer and more effective measures are available which have been subjected to rigorous clinical trials and careful cost–benefit analyses. Calcium supplements have very little role to play in the prevention or treatment of osteoporosis.”
Clear and useful words indeed! I wish there were more articles like this in the never-ending discussion about the complex subject of dietary supplements.