MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: June 2014

There are many terms for this type of treatment: energy healing, Therapeutic Touch, Reiki, spiritual healing and para-normal healing are just some of the better-known ones. These interventions are based of the belief that some sort of ‘energy’ can be channelled by the healer into the body of the patient to assist its capacity for self-healing. Needless to say that their biological plausibility is suspiciously close to zero.

This new study was aimed at testing the effectiveness of energy healing on the well-being of patients and at assessing the influence on the results of participating in a randomized controlled trial. A total of 247 colorectal cancer patients were included in the trial. One half of them were randomized to either:

  • healing (RH) or
  • control (RC)

The other half of the patients was not randomized and had either:

  • self-selected healing (SH) or
  • self-selected control condition (SC)

All patients completed questionnaires assessing well-being Quality of Life (QoL), depressive symptoms, mood, and sleep quality), attitude toward complementary and alternative medicine (CAM), and faith/spirituality at baseline, 1 week, and 2 months post-intervention. Patients were also asked to indicate, at baseline, whether they considered QoL, depressive symptoms, mood, and sleep quality as important outcomes.

Compared with controls, no overall effect of healing were noted on QoL, depressive symptoms, mood, or sleep quality in the intervention groups (RH, SH). Effects of healing on mood were only found for patients who initially had a positive attitude toward CAM and considered the outcome in question as important.

The authors of this study arrived at the following conclusions: Whereas it is generally assumed that CAMs such as healing have beneficial effects on well-being, our results indicated no overall effectiveness of energy healing on QoL, depressive symptoms, mood, and sleep quality in colorectal cancer patients. Effectiveness of healing on well-being was, however, related to factors such as self-selection and a positive attitude toward the treatment.

Survey after survey shows that ‘energy healing’ is popular amongst cancer patients. But medicine is no popularity contest, and the existing clinical trials have mostly failed to show that these treatments work beyond a sometimes remarkably strong placebo-effect. Consequently, several systematic reviews have arrived at conclusions that were far from positive:

There is no robust evidence that Therapeutic Touch promotes healing of acute wounds

We found inconclusive evidence that interventions with spiritual or religious components for adults in the terminal phase of a disease may or may not enhance well-being

The serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness

…the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer

 …the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven

Since the publication of our previous systematic review in 2000, several rigorous new studies have emerged. Collectively they shift the weight of the evidence against the notion that distant healing is more than a placebo

This new and fairly rigorous trial clearly points in the same direction. Thus we a faced with the fact that these treatments are:

  1. utterly implausible
  2. not supported by good clinical evidence

What follows seems as simple as it is indisputable: energy healing is nonsense and does not merit further research.

Traditional Chinese medicine (TCM) is often promoted as an effective therapy for cancer, and are numerous controlled clinical studies published in Chinese literature, yet no systematic analysis has been done of this body of evidence. This systematic review summarizes the evidence from controlled clinical studies published in Chinese on this subject.

The researchers looked for controlled clinical studies of TCM therapies for all kinds of cancers published in Chinese in four main Chinese electronic databases and found 2964 reports including 2385 randomized clinical trials and 579 non-randomized controlled studies.

The top seven cancer types treated were lung cancer, liver cancer, stomach cancer, breast cancer, esophagus cancer, colorectal cancer and nasopharyngeal cancer. The majority of studies (72%) applied TCM therapy combined with conventional treatments, whilst fewer (28%) applied only TCM therapy in the experimental groups. Herbal medicine was the most frequently tested TCM therapy (2677 studies, 90.32%).

The most frequently reported outcome was clinical symptom improvement (1667 studies, 56.24%) followed by biomarker indices (1270 studies, 42.85%), quality of life (1129 studies, 38.09%), chemo/radiotherapy induced side effects (1094 studies, 36.91%), tumor size (869 studies, 29.32%) and safety (547 studies, 18.45%). Completeness and adequacy of reporting appeared to improve with time.

The authors of this paper drew the following conclusion: data from controlled clinical studies of TCM therapies in cancer treatment is substantial, and different therapies are applied either as monotherapy or in combination with conventional medicine. Reporting of controlled clinical studies should be improved based on the CONSORT and TREND Statements in future. Further studies should address the most frequently used TCM therapy for common cancers and outcome measures should address survival, relapse/metastasis and quality of life.

Almost 3000 controlled clinical trials! This number is likely to impress many people – unless, of course, one knows that the quality of these studies is dismal. Interestingly, no formal assessment of study quality was included in this analysis. But it was mentioned that only 63 of these trials reported patient-blinding, and only 5 were deemed to be “relatively well designed” by the authors of this paper (who, incidentally, are strong proponents of TCM).

What I find the most interesting aspect of this article is the fact that the authors fail to mention how many of the studies reported a positive result – in a way, they don’t need to: there is plenty of evidence to show that virtually all of the Chinese studies of TCM are positive. In my view, this invalidates this body of evidence completely.

Analysis like the present one tend to lead us up the garden path. They suggest that there is a realistic hope for effective new treatments hidden in this difficult to access, large amount of data. This might lead other researchers to try to replicate some of the original studies. I fear that they would be wasting their time. From all I know, they are irreproducible.

In all walks of life, we have complete nutters who claim utter nonsense – in homeopathy probably more than in other areas. I knew that for quite some time, of course, but what I discovered on ‘the world’s leading homeopathy portal’ was still somewhat of a revelation to me: the overt promotion of homeopathy as an alternative cancer cure!

Hard to believe? See for yourself!

What follows (in italics) are excerpts from a long and detailed interview with a homeopathic physician published on this website.

Q: What does a typical treatment day look like for the patient?

A: Treatment starts with a comprehensive anamnesis that lasts several hours and includes the entire history of the patient till the occurrence of the tumor. This is followed by the analysis and evaluation of symptoms to find the basic homeopathic remedy [2] and the presently indicated remedy of the patient. We search for remedies for possible miasmatic blockages and also tumor specific remedies. We keep an eye on all iatrogenic damages caused by chemotherapy or radiation and try to have remedies at hand. When these complex considerations are finished an individual treatment concept is worked out. We prepare a list of parameters together with the patient that includes all currently present and disturbing symptoms such as pain, sleep disturbances, appearance and extent of the tumor, psychic problems like anxiety and grief etc. We also include laboratory values such as tumor markers, the erythrocyte sedimentation rate and blood pressure as important control parameters.

After applying the homeopathic remedy, usually in Q-potency, we analyze the patient’s symptoms daily to check their reaction to the remedy. It is very important to assess the patient’s reaction to the Q-potency as the development of symptoms shows us how to proceed with their treatment. The big advantage in the hospital is that we can observe our patients daily and investigate their reaction to the Q potency…

Q: I wish more homeopathic hospitals would be built here in Europe and worldwide! Where do you see the main problems for the establishment of homeopathic hospitals and which difficulties did you have to overcome?

A: A broader acceptance of homeopathy is necessary. Many health insurances still refuse to pay the costs, even though homeopathy is much cheaper than conventional cancer treatment with its chemotherapy or radiation.

I think outpatient clinics should be built first, where cancer patients can be treated without the necessary investment in hospitals. Orthodox medicine and the pharma industry should be open for cooperation with homeopathic physicians…

When homeopathic treatment is successful in rebuilding the immune system and reestablishing the basic regulation of the organism then tumors can disappear again. I’ve treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases.

Q: Do you include chemotherapy and radiation in your treatment?

A: Orthodox medicine considers the tumor to be a mass of abnormal cells which has to be combated. But it is important to know that the immune system has been disturbed long before the tumor appeared. We try to activate the immune system and to initiate an immune modulation by means of homeopathy. If this is successful tumors can disappear again. I have a very critical view of chemotherapy and radiation as the benefit is often very small and they diminish the chance of a real cure. Radiation can be useful in cases where metastases have invaded the spinal column and there is danger of fracture or there are already some broken vertebral bodies.

Chemotherapy may be useful in children suffering from leukemia, in Hodgkins-Lymphoma, testicular cancer and some forms of ovarian tumors. But these types of cancer only constitute 6% of all tumors. In all other types of cancer the benefit is more doubtful. We apply chemotherapy to gain some time in patients acutely affected by very rapidly growing tumors. But how can chemotherapy or radiation cure a patient ? It is only the immune system that can recognize the damaged DNA of the tumor cell and combat the tumor. However, the more chemotherapy the patient gets the more their immune system is weakened.

A: Yes, even in incurable cases homeopathy can help palliate without detrimental side effects.Even if our primary goal is to cure and prevent cancer, many patients are far beyond this stage. You describe some successfully treated patients with long time follow up in your book. Do any particular cases stand out in your memory?

JW: There are many cases I recall. These are the moments when you are sitting together with the patient to do the case anamnesis, hearing their history and feeling their despair when they were given up “officially” by orthodox medicine.

Now, tell me again that homeopathy is not dangerous – its remedies might be relatively harmless, but its practitioners certainly aren’t.

Tai Chi has been suggested to have many health benefits. Might it even prolong life? There are many enthusiasts who claim just that, but is there any evidence?

This study is a retrospective cross-sectional investigation to compare the rejuvenating and anti-ageing effects among a Tai Chi group (TCC) and a brisk walking group (BW) and a no exercise habit group (NEH) of volunteers. Thirty-two participants were separated into three groups: the TCC group (practicing TC for more than 1 year), the BW group (practicing BW for more than 1 year), and the NEH group. The CD34+ cell counts in peripheral blood of the participants was determined, and the Kruskal‐Wallis test was used to evaluate and compare the antiaging effects of the three groups. The results show that the participants in the TCC group (N = 10) outperformed the NEH group (N = 12) with respect to the number of CD34+ progenitor cells. No significant difference was found between the TCC group and the BW group. The authors of this study conclude that TCC practice sustained for more than 1 year may be an intervention against aging as effective as BW in terms of its benefits on the improvement of CD34+ number.

I was alerted to this new paper by several rather sensational headlines in the daily press which stated that Tai chi (TC) had anti-aging effects. So I searched for the press release about the article where I found the following quotes:

“It is possible that Tai Chi may prompt vasodilation and increase blood flow,” said Lin. “Considering that BW may require a larger space or more equipment, Tai Chi seems to be an easier and more convenient choice of anti-aging exercise.” “This study provides the first step into providing scientific evidence for the possible health benefits of Tai Chi.” said Dr. Paul R. Sanberg, distinguished professor at the Center of Excellence for Aging and Brain Repair, Morsani College of Medicine, University of South Florida, Tampa, FL. “Further study of how Tai Chi can elicit benefit in different populations and on different parameters of aging are necessary to determine its full impact.”

Personally, I find both the press release and the original conclusions of the authors quite amazing. If anyone wanted to write a textbook on how not to do such things, he/she could use them as excellent examples.

Seen with just a tinge of critical thinking the paper reports a flimsy case-control study comparing three obviously self-selected groups of people who had chosen to follow different exercise regimen for several months. In all likelihood they also differed in terms of life-style, nutrition, sleeping pattern, alcohol intake, smoking habits and a million other things. These rather tiny groups were then compared according to a surrogate measure for ageing and some differences were identified.

BIG DEAL!

To conclude from this, or even to imply, that TC has anti-ageing effects is as far-fetched as claiming the tooth fairy has money problems.

This story could be just funny or trivial or boring – however, I think, it is also a bit worrying. It shows, I fear, how uncritical researchers in conjunction with some naïve press officer are able to induce silly journalists and headline-writers to mislead the public.

I find it always nice to see that people appreciate my work. Yet sometimes I am a little surprised to realise what some commercially interested firms make of it. Recently I came across a website that proudly used my research for advertising the use of magnetic bracelets against pain. Here is the text in question:

The extra strong magnets make this magnetic bracelet the fastest acting pain reliever. While wearing this magnetic bracelet customers with wrist and hand pain report significant pain relief….

What is a magnetic bracelet and what are the benefits? Magnetic bracelets are a piece of jewelry, worn for the therapeutic benefits of the magnetic field. Magnetic bracelets has been used successfully by many people for pain relief of inflammatory conditions such as arthritis, tendinitis and bursitis.

A randomized, placebo controlled trial with three parallel groups, came to the conclusion : Pain from osteoarthritis of the hip and knee decreases when wearing magnetic bracelets. It is uncertain whether this response is due to specific or non-specific (placebo) effects. Tim Harlow, general practitioner, Colin Greaves, research fellow, Adrian White, senior research fellow, Liz Brown, research assistant, Anna Hart, statistician, Edzard Ernst, professor of complementary medicine.

The entrepreneurs seem to have forgotten a few things which we tried to make clear in our paper:

  • this article was published in the Christmas issue of the BMJ which specialises in publishing unusual and odd findings with a high entertainment value,
  • in our paper, we point out that “the contamination of group B with stronger magnets prevented a more objective estimation of any-placebo effect”,
  • and stressed that “there were problems with the weak magnets”,
  • and that “a per-specification analysis suggested (but could not confirm) a specific effect of magnetic bracelets over and above placebo”.

Most importantly, this was just one trial, and surely one swallow does not make a summer! We should always consider the totality of the reliable evidence. Being conscientious researchers, at the time, we did exactly that and conducted a systematic review. Here is the abstract in its full beauty:

BACKGROUND:

Static magnets are marketed with claims of effectiveness for reducing pain, although evidence of scientific principles or biological mechanisms to support such claims is limited. We performed a systematic review and meta-analysis to assess the clinical evidence from randomized trials of static magnets for treating pain.

METHODS:

Systematic literature searches were conducted from inception to March 2007 for the following data sources: MEDLINE, EMBASE, AMED (Allied and Complementary Medicine Database), CINAHL, Scopus, the Cochrane Library and the UK National Research Register. All randomized clinical trials of static magnets for treating pain from any cause were considered. Trials were included only if they involved a placebo control or a weak magnet as the control, with pain as an outcome measure. The mean change in pain, as measured on a 100-mm visual analogue scale, was defined as the primary outcome and was used to assess the difference between static magnets and placebo.

RESULTS:

Twenty-nine potentially relevant trials were identified. Nine randomized placebo-controlled trials assessing pain with a visual analogue scale were included in the main meta-analysis; analysis of these trials suggested no significant difference in pain reduction (weighted mean difference [on a 100-mm visual analogue scale] 2.1 mm, 95% confidence interval -1.8 to 5.9 mm, p = 0.29). This result was corroborated by sensitivity analyses excluding trials of acute effects and conditions other than musculoskeletal conditions. Analysis of trials that assessed pain with different scales suggested significant heterogeneity among the trials, which means that pooling these data is unreliable.

INTERPRETATION:

The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment. For osteoarthritis, the evidence is insufficient to exclude a clinically important benefit, which creates an opportunity for further investigation.

So, would I, on the basis of the current best evidence, recommend magnetic bracelets to people who suffer from pain? No! In my view, only charlatans would do such a thing.

In the early 1920s, a French physician thought he had discovered the virus that caused the Spanish flu. It oscillated under his microscope, and he thus called it oscillococcus. Not only did it cause the flu, in the opinion of his discoverer, but it was also responsible for a whole host of other diseases, including cancer. In fact, the virus does not exist, or at least nobody ever confirmed it existed, but that fact did not stop our good doctor to make a homeopathic remedy from it which he thought would cure all these diseases. His remedy, Oscillococcinum, is made from the liver and heart of a duck because the imaginative inventor believed that the fictitious virus was present in these organs of this animal.

To understand all this fully, one needs to know that the duck organs are so highly diluted that no molecule of the duck is present in the remedy. It is sold in the C200 potency. This means that one part of organ extract is diluted 1: 10 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 (a note to Boiron’s legal team: I had a hell of a time getting all these zeros right; in case, I got it wrong after all, it is an honest error – please do not sue me for it!). The dilution is so extreme that it amounts to a single molecule per a multitude of universes.

Given these facts it seems unlikely that the remedy has any effects on human health which go beyond those of a placebo. Let’s see what the current Cochrane review says about its effectiveness: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).

Considering that the first author of this review works for the British Homeopathic Association and the senior author is the homeopath of the Queen, this seems a pretty clear statement, don’t you think?

Regardless of the scientific evidence, Oscillococcinum made of ‘Anas Barbariae Hepatis et Cordis Extractum‘, as it is officially called, became a homeopathic best-seller. In the US alone Boiron, the manufacturer, is said to sell US$ 15 m per year of this product. Not only that, in France, where the remedy is a popular medicine sold in virtually all pharmacies and often recommended as soon as you walk into a pharmacy, it is hard to find anyone who does not swear by the ‘potentized‘ duck or is willing to discuss its merits critically.

The amazing duck, it seems, has turned into a ‘holy cow’.

If we search on ‘Medline’ for ‘complementary alternative medicine’ (CAM), we currently get about 13000 hits. A little graph on the side of the page demonstrates that, during the last 4 years, the number of articles on this subject has grown exponentially.

Surely, this must be very good news: such intense research activity will soon tell us exactly which alternative treatments work for which conditions and which don’t.

I beg to differ. Let me explain why.

The same ‘Medline’ search informs us that the majority of the recent articles were published in an open access journal called ‘Evidence-Based Complementary and Alternative Medicine’ (eCAM). For example, of the 80 most recent articles listed in Medline (on 26/5/2014), 53 came from that journal. The publication frequency of eCAM and its increase in recent years beggars belief: in 2011, they published just over 500 articles which is already a high number, but, in 2012, the figure had risen to >800, and in 2013 it was >1300 (the equivalent 2013 figure for the BMJ/BMJ Open by comparison is 4, and that for another alt med journal, e.g. Forsch Komplement, is 10)

How do they do it? How can eCAM be so dominant in publishing alt med research? The trick seems to be fairly simple.

Let’s assume you are an alt med researcher and you have an article that you would like to see published. Once you submit it to eCAM, your paper is sent to one of the ~150 members of the editorial board. These people are almost all strong proponents of alternative medicine; critics are a true rarity in this group. At this stage, you are able to suggest the peer reviewers for your submission (all who ever accepted this task are listed on the website; they amount to several thousand!), and it seems that, with the vast majority of submissions, the authors’ suggestions are being followed.

It goes without saying that most researchers suggest colleagues for peer reviewing who are not going to reject their work (the motto seems to be “if you pass my paper, I will pass yours). Therefore even faily flimsy bits of research pass this peer review process and get quickly published online in eCAM.

This process explains a lot, I think: 1) the extraordinarily high number of articles published 2) why currently more than 50% of all alt med research originate from eCAM 3) why so much of it is utter rubbish.

Even the mere titles of some of the articles might demonstrate my point. A few examples have to suffice:

  • Color distribution differences in the tongue in sleep disorder
  • Wen-dan decoction improves negative emotions in sleep-deprived rats by regulating orexin-a and leptin expression.
  • Yiqi Huoxue Recipe Improves Heart Function through Inhibiting Apoptosis Related to Endoplasmic Reticulum Stress in Myocardial Infarction Model of Rats.
  • Protective Effects of Bu-Shen-Huo-Xue Formula against 5/6 Nephrectomy-Induced Chronic Renal Failure in Rats
  • Effects and Mechanisms of Complementary and Alternative Medicine during the Reproductive Process
  • Evidence-based medicinal plants for modern chronic diseases
  • Transforming Pain into Beauty: On Art, Healing, and Care for the Spirit

This system of uncritical peer review and fast online publication seems to suit many of the people involved in this process: the journal’s owners are laughing all the way to the bank; there is a publication charge of US$ 2000 per article, and, in 2013, the income of eCAM must therefore have been well over US$2 000 000. The researchers are equally delighted; they get even their flimsiest papers published (remember: ‘publish or perish’!). And the evangelic believers in alternative medicine are pleased because they can now claim that their field is highly research-active and that there is plenty of evidence to support the use of this or that therapy.

But there are others who are not served well by eCAM habit of publishing irrelevant, low quality articles:

  • professionals who would like to advance health care and want to see reliable evidence as to which treatments work and which don’t,
  • the public who, in one way or another, pay for all this and might assume that published research tends to be relevant and reliable,
  • the patients who have given their time to researchers in the hope that their gift will improve health care,
  • ill individuals who hope that alternative treatments might relieve their suffering,
  • politicians who rely on research to be reliable in order to arrive at the right decisions.

Come to think of it, the vast majority of people should be less than enchanted with eCAM and similar journals.

It has often occurred to me that some people use alternative medicine not as medicine but as something entirely different. A new investigation sheds an interesting light on this question.

The aim of this study was to explore how and why Australian men with cancer use complementary therapies (CTs) and how their significant others (SOs) contribute to the regular uptake of CTs. Semi-structured interviews were conducted with 26 male cancer patients and 24 SOs. Participants were purposefully sampled from a preceding Australian survey investigating the use of CTs in men with cancer.

Three core themes were identified: men used CTs as (a) problem-focused coping (e.g., diet modification), (b) emotion-focused coping (e.g., meditation), and (c) meaning-based coping (e.g., prayer). Practicing CTs helped men to cope with physical, emotional, and spiritual concerns, although some men spoke of difficulties with practicing meditation to regulate their emotions. SOs were supportive of men’s coping strategies but were only rarely involved in men’s emotion-focused coping.

The authors conclude that CTs have the potential to facilitate coping with cancer, independent of any measurable physiological benefit. Our findings suggest that when clinicians engage in conversations about CTs use, they should consider the type of coping strategy employed by their patient. Such information may enhance the efficacy of some interventions (e.g., meditation) and also provide for an opportunity to discuss patients’ expectations concerning CTs.

If these findings are generalizable – I always have problems when researchers draw sweeping conclusions on the basis of two dozen patients – then it would seem to follow that alternative medicine is being used as some sort of ‘Ersatz’ religion. Religious coping strategies are effective in Spiritual growth that results in positive or negative situations. It is the perception of an individual’s relationship with God that brings meaning, purpose and emotional comfort when dealing with circumstances. Prayer, meditation, worship are all examples of religious coping strategies. Positive coping strategies associate with better mental health and negative coping strategies relate to poorer mental and physical health.

Leading researchers have split religious coping into two categories: positive religious coping and negative religious coping. Individuals who use positive religious coping are likely to seek spiritual support and look for meaning in a traumatic situation. Negative religious coping (or Spiritual Struggles) expresses conflict, question, and doubt regarding issues of God and faith. The effects of religious coping are measured in many different circumstances, each with different outcomes. Some common experiences where people use religious coping are fear-inflicting events such as 9/11 or the holocaust, death and sickness, and near death experiences.

I do not want to labour my point (that alternative medicine might be an ‘Ersatz’ religion) beyond reason. Nonetheless, I would be very interested to hear what my readers feel about it.

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