MD, PhD, FMedSci, FSB, FRCP, FRCPEd

supplements

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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.

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!!!):

DIET

• 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.

STRESS

• 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.

EXERCISE

• 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.

MEDITATION

• 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.

SLEEP

• 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.

EMOTIONS

• 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.
Science, I had always assumed, is a means of generating progress. This sort of pseudoscience can only generate the opposite. The sad thing is that, in alternative medicine, pseudoscience of this nature seems to dominate the scene. The victims here are we all: as the false-positive findings accumulate, the overall evidence is being distorted and wrong therapeutic decisions become inevitable.

On this blog, I have repeatedly tried to alert consumers and patients to the risks of herbal medicine. The risks include:

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.

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