MD, PhD, FMedSci, FSB, FRCP, FRCPEd

supplements

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.

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.

NATURAL NEWS announced the death of Nicholas Gonzalez with the following words:

It is with great sadness that we report the death of health freedom advocate and individualized nutrition specialist Dr. Nick Gonzalez, who on the eve of July 21 died from an alleged heart attack. Dr. Gonzalez’ contributions to anticancer nutrition protocols and an array of other nutritional therapies have been invaluable, and we would like to honor this pioneering natural healer by recognizing his benevolent legacy…

In contrast to the conventional cancer treatment model, Dr. Gonzalez’s approach was always about helping individuals heal through individualized care. Along with fellow colleague Dr. Linda Isaacs, Dr. Gonzalez helped build a repository of dietary protocols to help patients overcome their specific conditions through advanced nutritional therapies. His methodology centered around detoxification, supplementation with healing foods and nutrients, and specialized enzyme therapy…

Dr. Gonzalez was always a strong adherent to sound science, and he was never in it for the money. His humble, cogent approach to helping people heal naturally without drugs or surgery is a legacy worth remembering and passing on, and we’re thankful to have gotten to know this honorable man during his time on this earth…

This sounds as though Gonzalez was some kind of medical genius and scientific pioneer. Most cancer experts would disagree very sharply with this. Here is what Louise Lubetkin wrote on this blog about him, and I very much encourage you to read her whole post.

Those who recognize and appreciate a fine example of pseudoscientific baloney when they see one know that there is no richer seam, no more inexhaustible source, than the bustling, huckster-infested street carnival that is alternative medicine. There one can find intellectual swindlers in abundance, all offering outrageously implausible claims with the utmost earnestness and sincerity. But the supreme prize, the Fabergé egg found buried among the bric-a-brac, surely belongs to that most convincing of illusionists, the physician reborn as an ardent advocate of alternative medicine…

So what are we to make of Gonzalez? Is he a cynical fraud or does he genuinely believe that coffee enemas, skin brushing and massive doses of supplements are capable of holding back the tsunami of cancer?

At the end of the day it hardly matters: either way, he’s a dangerous man.

Personally, I believe much more in the text of Louise Lubetkin. How about you?

Soy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control. In fact, genistein, one of the isoflavones in soy, is a powerful anti-inflammatory agent and as such it might help control asthma symptoms. But speculation and wishful thinking does not lead anywhere. What we need is a good study to test the efficacy of soy in asthma patients.

Yes, you guessed it: such an investigation has just been published, The objective of this trial was to determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease.

The study was designed as a multi-centre, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 pulmonary and allergy centres in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six patients aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24.

Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks.

The primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation.

Mean changes in pre-bronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, −0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, −0.07 to 0.07 L) in the soy isoflavone group. The difference was not significantly different. Mean changes in symptom scores on the Asthma Control Test, number of episodes of poor asthma control, and changes in exhaled nitric oxide did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL (P < .001) in participants receiving the supplement.

The authors concluded that among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication, use of a soy isoflavone supplement, compared with placebo, did not result in improved lung function or clinical outcomes. These findings suggest that this supplement should not be used for patients with poorly controlled asthma.

This is a good study and a squarely negative finding. As far as I can see, there is no dietary supplement that is of proven effectiveness for asthma. Yet, the hype and bogus claims in this realm continue unabated. This trial provides solid evidence, but will it change much? I doubt it. Supplement manufacturers will simply say: THEY USED THE WRONG PRODUCT/DOSE/TREATMENT SCHEDULE !!! And the exploitation of asthma patients will continue just as before.

Few alternative remedies are more popular than colloidal silver, i.e. tiny particles of silver suspended in a liquid, and few represent more irresponsible quackery. It is widely promoted as a veritable panacea. Take this website (one of thousands), for instance; it advertises colloidal silver in the most glowing terms:

Here are some of the diseases against which Colloidal Silver has been used successfully Acne, Allergies, Appendicitis, Arthritis, Blood parasites, Bubonic plague, Burns (colloidal silver is one of the few treatments that can keep severe burn patients alive), Cancer, Cholera, Conjunctivitis, Diabetes, Gonorrhoea, Hay Fever, Herpes, Leprosy, Leukaemia, Malaria, Meningitis, Parasitic Infections both viral and fungal, Pneumonia, Rheumatism, Ringworm, Scarlet Fever, Septic conditions of eyes, ears, mouth, throat, Shingles, Skin Cancer, Syphilis, all viruses, warts and stomach ulcer.In addition it also has veterinary uses, such as for canine Parvo virus. You’ll also find Colloidal Silver very handy in the garden since it can be used against bacterial, fungal / viral attacks on plants.It would also appear highly unlikely that any germ warfare agents could survive an encounter with CS, as viruses such as E Bola and Hanta are in the end merely viruses and bacteria.Colloidal Silver is non-toxic, making it safe for both children, adults and pets. Colloidal Silver is in fact a pre 1938 healing modality, making it exempt from FDA jurisdiction.

So why haven’t you heard of it? It’s suspected that the user friendly economics of Colloidal Silver may have something to do with its low profile in the media. Colloidal Silver shines a spotlight on the over expensive and deadly nature of the pharmaceutical industry, who are larger than the Pentagon economically.

That’s right, plenty of bogus claims (it goes without saying that there is no good evidence to support any of them) and, for good measure, some conspiracy theory as well – the perfect mix for making a fast buck!

But sometimes things do not work out as planned. The following text was recently published on the website of Essex County Council:

A man claiming to sell a cure for cancer has been fined £750 following an investigation by Essex Trading Standards. Steven Cook, 54, of East Road, West Mersea, was charged with an offence under the Cancer Act after suggesting Colloidal Silver was a treatment for cancer.

Mr Cook pleaded guilty at Colchester Magistrates’ Court on Friday 12 September. Magistrates imposed a fine of £750 and ordered him to pay £1,500 costs. Cllr Roger Hirst, Essex County Council’s cabinet member for Trading Standards, said: “Trading Standards’ advice to people who are considering whether to take any substance not prescribed for a medical purpose, either preventative or as a treatment, is to consult their doctor first.

“I hope the public feel safer knowing that Essex Trading Standards will take action where traders are trying to sell products which are neither medically proven nor safe.”

Mr Cook runs a website, www.colloidalsilveruk.com, selling various products containing silver. One of the products on sale was “Ultimate Colloidal Silver”, a liquid containing silver that Mr Cook made in his own home. Trading Standards said the website implied that the product can cure cancer – and this is an offence under the Cancer Act. Mr Cook has now updated the website and removed any claims that colloidal silver can cure some cancers.

So, there is some hope! Occasionally, fraudsters are being found out and punished. But the bad news, of course, is that this sort of thing occurs far too rarely and when it does happen, the punishment is far too lenient. Consequently, the public’s protection from fraudsters exploiting the most vulnerable patients is woefully insufficient.

Poor sleep quality during pregnancy is a frequent problem. Drug treatment can be problematic due to possible adverse effects for mother and embryo/foetus. Many pregnant women prefer natural treatments and assume that ‘natural’ equals harmless.

In the present study, the sedative effects of Bryophyllum pinnatum were investigated. This remedy is a phytotherapeutic medication predominantly used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a promising risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnosis.

In this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician’s consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse effects perceived by the patients during the treatment were recorded.

The results show that the number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a reduction in tiredness during the day. There was, however, no evidence for a prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.

From these data, the authors concluded that B. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.

Clinical trials of anthroposophic remedies, i.e. remedies which are based on the school of medicine founded by Rudolf Steiner, are very rare. Therefore this trial could be important.

B. pinnatum is a plant used in traditional Tai medicine against hypertension, and to some extend this makes sense: it contains cardiac glycosides which might help lowering elevated blood pressure. The reason for its use as a hypnotic, however, is not clear.

So, is B pinnatum really a ‘suitable treatment of sleep problems in pregnancy’? I doubt it for the following reasons:

  • the effects documented in this study are far from convincing,
  • we would need much more solid data to issue such a general recommendation,
  • cardiac glycosides can cause very serious adverse effects,
  • the sample size of the study is at least one dimension too small for assuming that it is safe,
  • we know nothing about its potential to cause harm to the foetus.

Personally, I find it irresponsible to draw conclusions such as the ones above on the basis of data which are flimsy to the extreme. I ask myself, to what extend wishful thinking might be a regrettable characteristic for the entire field of anthroposophic medicine.

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