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

pseudo-science

Osteopathic visceral manipulation (OVM) have been our subject several times before. The method has been developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, OVM is a miracle cure for just about every disease imaginable. Most of us hearing such claims hear alarm bells ringing – rightly so, I think. The evidence for OVM is thin, to put it mildly. But now, there is a new study to consider.

Brazilian researchers designed a placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of OVM of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle.

Visceral manipulation techniques for stomach (a), liver (b), and placebo technique (c).

Visceral manipulation techniques for stomach (a), liver (b), and placebo technique (c).

Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores and pain area. Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG. No differences were identified between the OVMG and the PVMG for cervical range of motion.

The authors concluded that the results of this pilot study indicate that a single session of osteopathic visceral manipulation for the stomach and liver reduces cervical pain and increases the amplitude of the upper trapezius muscle EMG signal immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. Patients treated with placebo visceral mobilisation reported a significant decrease in pain immediately after treatment. The effect of this intervention on the cervical range of motion was inconclusive. The results of this study suggest that further investigation is necessary.

There are numerous problems with this study:

  • The authors call it a pilot study. Such a trial is for exploring the feasibility of a proper study. With the introduction of a placebo-OVM, this would make sense. The relevant question would then be: is the placebo valid and indistinguishable from the real thing? Sadly, this issue is not even addressed in the trial.
  • A pilot study certainly is not for evaluating the effectiveness of an intervention. Sadly, this is precisely what the authors used it for. The label ‘pilot’, it seems, was merely given to excuse the many methodological flaws of their trial.
  • For an evaluation of treatment effects, the study was far too small. This means the reported results can be discarded as meaningless.
  • If we nevertheless took them seriously, we would want to explain how the findings were generated. The authors believe that they were caused by OVM. I find this most unlikely.
  • The more plausible explanation would be that patient-blinding was unsuccessful. In other words, the placebo is not indistinguishable from the real OVM. Looking at the pictures above, one can easily see that the patients were able to tell to which group they had been allocated.
  • The failure to blind patients (and, of course, the therapists), in turn, would mean that the verum group were better motivated to out-perform the placebo group in the outcome measures.
  • Finally, I disagree with the authors’ view that the results of this study suggest that further investigation is necessary. On the contrary, I think that any further investment into OVM is ill-advised.

My conclusion: OVM is an implausible, non-evidence-based SCAM, and dodgy science is not going to make it look any more convincing.

Excellent journals always publish excellent science!

If this is what you believe, you might want to read a study of chiropractic just published in the highly respected SCIENTIFIC REPORTS.

The objective of this study was to investigate whether a single session of chiropractic care could increase strength in weak plantar flexor muscles in chronic stroke patients. Maximum voluntary contractions (strength) of the plantar flexors, soleus evoked V-waves (cortical drive), and H-reflexes were recorded in 12 chronic stroke patients, with plantar flexor muscle weakness, using a randomized controlled crossover design. Outcomes were assessed pre and post a chiropractic care intervention and a passive movement control. Repeated measures ANOVA was used to asses within and between group differences. Significance was set at p < 0.05. Following the chiropractic care intervention there was a significant increase in strength (F (1,11) = 14.49, p = 0.002; avg 64.2 ± 77.7%) and V-wave/Mmax ratio (F(1,11) = 9.67, p = 0.009; avg 54.0 ± 65.2%) compared to the control intervention. There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention. There were no other significant differences. Plantar flexor muscle strength increased in chronic stroke patients after a single session of chiropractic care. An increase in V-wave amplitude combined with no significant changes in H-reflex parameters suggests this increased strength is likely modulated at a supraspinal level. Further research is required to investigate the longer term and potential functional effects of chiropractic care in stroke recovery.

In the article we find the following further statements (quotes in bold, followed by my comments in normal print):

  • Data were collected by a team of researchers from the Centre for Chiropractic Research at the New Zealand College of Chiropractic. These researchers can be assumed to be highly motivated in generating a positive finding.
  • The entire spine and both sacroiliac joints were assessed for vertebral subluxations, and chiropractic adjustments were given where deemed necessary, by a New Zealand registered chiropractor. As there is now near-general agreement that such subluxations are a myth, the researchers treated a non-existing entity.
  • The chiropractor did not contact on a segment deemed to be subluxated during the control set-up and no adjustive thrusts were applied during any control intervention. The patients therefore were clearly able to tell the difference between real and control treatmentsParticipants were not checked for blinding success.
  • Maximum isometric plantarflexion force was measured using an isometric strain gauge. Such measurements crucially depend on the motivation of the patient.
  • The grant proposal for this study was reviewed by the Australian Spinal Research Foundation to support facilitation of funding from the United Chiropractic Association. Does this not mean the researchers had a conflict of interest?
  • The authors declare no competing interests. Really? They were ardent subluxationists supported by the United Chiropractic Association, an organisation stating that chiropractic is concerned with the preservation and restoration of health, and focuses particular attention on the subluxation, and subscribes to to the obsolete concept of vitalism: we ascribe to the idea that all living organisms are sustained by an innate intelligence, which is both different from and greater than physical and chemical forces. Further, we believe innate intelligence is an expression of universal intelligence.

So, in essence, what we have here is an under-powered study sponsored by vitalists and conducted by subluxationists treating a mythical entity with dubious interventions without controlling for patients’ expectation pretending their false-positive findings are meaningful.

I cannot help wondering what possessed the SCIENTIFIC REPORTS to publish such poor science.

Acupuncture is all over the news today. The reason is a study just out in BMJ-Open.

The aim of this new RCT was to investigate the efficacy of a standardised brief acupuncture approach for women with moderate-tosevere menopausal symptoms. Nine Danish primary care practices recruited 70 women with moderate-to-severe menopausal symptoms. Nine general practitioners with accredited education in acupuncture administered the treatments.

The acupuncture style was western medical with a standardised approach in the pre-defined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group received no acupuncture but was offered treatment after 6 weeks. Outcomes were the differences between the two groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.

Thirty-six patients received the intervention, and 34 were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes, day-and-night sweats, general sweating, menopausal-specific sleeping problems, emotional symptoms, physical symptoms and skin and hair symptoms compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent three weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.

The authors concluded that the standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention.

The only thing that I find amazing here is the fact the a reputable journal published such a flawed trial arriving at such misleading conclusions.

  • The authors call it a ‘pragmatic’ trial. Yet it excluded far too many patients to realistically qualify for this characterisation.
  • The trial had no adequate control group, i.e. one that can account for placebo effects. Thus the observed outcomes are entirely in keeping with the powerful placebo effect that acupuncture undeniably has.
  • The authors nevertheless conclude that ‘acupuncture treatment produced a fast and clinically relevant reduction’ of symptoms.
  • They also state that they used this design because no validated sham acupuncture method exists. This is demonstrably wrong.
  • In my view, such misleading statements might even amount to scientific misconduct.

So, what would be the result of a trial that is rigorous and does adequately control for placebo-effects? Luckily, we do not need to rely on speculation here; we have a study to demonstrate the result:

Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.

Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.

Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)

Setting: Community in Australia.

Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.

Interventions:10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.

Measurements: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.

Results: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.

Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.

Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

My conclusion from all this is simple: acupuncture trials generate positive findings, provided the researchers fail to test it rigorously.

In 2004, my team published a review analysing the diversity of so-called alternative medicine (SCAM) research published in one single year (2002) across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. In total 652 abstracts of articles were assessed. Germany and the UK were the only two European countries to publish in excess of 100 articles in that year (Germany: 137, UK: 183). The majority of articles were non-systematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various SCAM modalities and investigated the safety of CAM. We concluded that important national differences exist in terms of the nature of SCAM research. This raises important questions regarding the reasons for such differences.

One striking difference was the fact that, compared to the UK, Germany had published far less research on SCAM that failed to report a positive result (4% versus 14%). Ever since, I have wondered why. Perhaps it has something to do with the biggest sponsor of SCAM research in Germany: THE CARSTENS STIFTUNG?

The Carstens Foundation (CF) was created by the former German President, Prof. Dr. Karl Carstens and his wife, Dr. Veronica Carstens. Karl Carstens (1914-1992) was the 5th President of federal Germany, from 1979 to 1984. Veronica Carstens (1923-2012) was a doctor of Internal Medicine with an interest in natural medicine and homeopathy in particular. She is quoted by the CF stating: „Der Arzt und die Ärztin der Zukunft sollen zwei Sprachen sprechen, die der Schulmedizin und die der Naturheilkunde und Homöopathie. Sie sollen im Einzelfall entscheiden können, welche Methode die besten Heilungschancen für den Patienten bietet.“ (Future doctors should speak two languages, that of ‘school medicine’ [Hahnemann’s derogatory term for conventional medicine] and that of naturopathy and homeopathy. They should be able to decide on a case by case basis which method offers the best chances of a cure for the patient.***)

Together, the two Carstens created the CF with the goal of sponsoring SCAM in Germany. More than 35 million € have so far been spent on more than 100 projects, fellowships, dissertations, an own publishing house, and a patient societyNatur und Medizin” (currently ~23 000 members) with the task of promoting SCAM. Projects the CF proudly list as their ‘milestones’ include: 

  • an outpatient clinic of natural medicine for cancer
  • a project ‘Natural medicine and homeopathy for children and adolescents’.

The primary focus of the CF clearly is homeopathy, and it is in this area where their anti-science bias gets most obvious. I do invite everyone who reads German to have a look at their website and be amazed at the plethora of misleading claims.

Their expert for all things homeopathic is Dr Jens Behnke (‘Referent für Homöopathieforschung bei der Karl und Veronica Carstens-Stiftung: Evidenzbasierte Medizin, CAM, klinische Forschung, Grundlagenforschung’). He is not a medical doctor but has a doctorate from the ‘Kulturwissenschaftlichen Fakultät der Europa-Universität Viadrina’ entitled ‘Wissenschaft und Weltanschauung. Eine epistemologische Analyse des Paradigmenstreits in der Homöopathieforschung’ (Science and world view. An epistemological analysis of the paradigm-quarrel in homeopathy research). His supervisor was Prof Harald Walach who has long been close to the CF.

Behnke claims to be an expert in EBM, clinical research and basic research but, intriguingly, he has not a single Medline-listed publication to his name. So, we only have his dissertation to assess his expertise.

The very 1st sentence of his dissertation is noteworthy, in my view: Die Homöopathie ist eine Therapiemethode, die seit mehr als 200 Jahren praktiziert wird und eine beträchtliche Zahl an Heilungserfolgen vorzuweisen hat (Homeopathy is a therapeutic method, that is being used since more than 200 years and which is supported by a remarkable number of therapeutic successes). In essence, the dissertation dismisses the scientific approach for evaluating homeopathy as well as the current best evidence that shows homeopathy to be ineffective.

Behnke dismisses my own research on homeopathy without even considering it. He first claims to have found an error in one of my systematic reviews and then states: Die Fragwürdigkeit der oben angeführten Methoden rechtfertigt das Übergehen sämtlicher Publikationen dieses Autors im Rahmen dieser Arbeit. Wenn einem Wissenschaftler die aufgezeigte absichtliche Falschdarstellung aufgrund von Voreingenommenheit nachgewiesen werden kann, sind seine Ergebnisse, wenn überhaupt, nur nach vorheriger systematischer Überprüfung sämtlicher Originalpublikationen und Daten, auf die sie sich beziehen, verwertbar. Essentially, he claims that, because he has found one error, the rest cannot be trusted and therefore he is entitled to reject the lot.

In the same dissertation, we read the following: Ernst konstatiert in allen … Arbeiten zur Homöopathie ausnahmslos, dass es keinerlei belastbare Hinweise auf eine Wirksamkeit homöopathischer Arzneimittel über Placeboeffekte hinaus gebe (Ernst states in all publications on homeopathy without exception that no solid suggestions exist at all for an effectiveness of homeopathic remedies). However, it is demonstrably wrong that all of my papers arrive at a negative judgement of homeopathy’s effectiveness; here are three that spring into my mind:

So, applying Behnke’s own logic outlined above, one should argue that, because I have found one error in his research, the rest of what Behnke will (perhaps one day be able to) publish cannot be trusted and therefore I am entitled to reject the lot.

That would, of course, be tantamount to adopting the stupidity of one’s own opponents. So, I will certainly not do that; instead, I will wait patiently for the sound science that Dr Behnke (and indeed the CF) might eventually produce.

 

***phraseology that is strikingly similar to that of Rudolf Hess on the same subject.

The Journal of Experimental Therapeutics and Oncology states that it is devoted to the rapid publication of innovative preclinical investigations on therapeutic agents against cancer and pertinent findings of experimental and clinical oncology. In the journal you will find review articles, original articles, and short communications on all areas of cancer research, including but not limited to preclinical experimental therapeutics; anticancer drug development; cancer biochemistry; biotechnology; carcinogenesis; cancer cytogenetics; clinical oncology; cytokine biology; epidemiology; molecular biology; pathology; pharmacology; tumor cell biology; and experimental oncology.

After reading an article entitled ‘How homeopathic medicine works in cancer treatment: deep insight from clinical to experimental studies’ in its latest issue, I doubt that the journal is devoted to anything.

Here is the abstract:

In the current scenario of medical sciences, homeopathy, the most popular system of therapy, is recognized as one of the components of complementary and alternative medicine (CAM) across the world. Despite, a long debate is continuing whether homeopathy is just a placebo or more than it, homeopathy has been considered to be safe and cost-effectiveness therapeutic modality. A number of human ailments ranging from common to serious have been treated with homeopathy. However, selection of appropriate medicines against a disease is cumbersome task as total spectrum of symptoms of a patient guides this process. Available data suggest that homeopathy has potency not only to treat various types of cancers but also to reduce the side effects caused by standard therapeutic modalities like chemotherapy, radiotherapy or surgery. Although homeopathy has been widely used for management of cancers, its efficacy is still under question. In the present review, the anti-cancer effect of various homeopathic drugs against different kinds of cancers has been discussed and future course of action has also been suggested.

I do wonder what possessed the reviewers of this paper and the editors of the journal to allow such dangerous (and badly written) rubbish to get published. Do they not know that:

  1. homeopathy is a placebo therapy,
  2. homeopathy can not cure any cancer,
  3. cancer patients are highly vulnerable to false hope,
  4. such an article endangers the lives of many cancer patients,
  5. they have an ethical, moral and possibly legal duty to prevent such mistakes?

What makes this paper even more upsetting is the fact that one of its authors is affiliated with the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Family welfare my foot!

This certainly is one of the worst violations of healthcare and publication ethic that I have come across for a long time.

 

If so-called alternative medicine (SCAM) ever were to enter the Guinness Book of Records, it would most certainly be because it generates more surveys than any other area of medical inquiry. I have long been rather sceptical about this survey-mania. Therefore, I greet any major new survey with some trepidation.

The aim of this new survey was to obtain up-to-date general population figures for practitioner-led SCAM use in England, and to discover people’s views and experiences regarding access. The researchers commissioned a face-to-face questionnaire survey of a nationally representative adult quota sample (aged ≥15 years). Ten questions were included within Ipsos MORI’s weekly population-based survey. The questions explored 12-month practitioner-led SCAM use, reasons for non-use, views on NHS-provided SCAM, and willingness to pay.

Of 4862 adults surveyed, 766 (16%) had seen a SCAM practitioner. People most commonly visited SCAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access SCAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended SCAM to users. These SCAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded SCAM. Responders were willing to pay varying amounts for SCAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their SCAM use.

The authors concluded that SCAM is commonly used in England, particularly for musculoskeletal and mental health problems, and by affluent groups paying privately. However, less well-off people are also being GP-referred for NHS-funded treatments. For SCAM with evidence of effectiveness (and cost-effectiveness), those of lower SES may be unable to access potentially useful interventions, and access via GPs may be able to address this inequality. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of SCAM, and consider its availability on the NHS.

I feel that a few critical thoughts are in order:

  1. The authors call their survey an ‘up-date’. The survey ran between 25 September and 18 October 2015. That is more than three years ago. I would not exactly call this an up-date!
  2. Authors (several of whom are known SCAM-enthusiasts) also state that practitioner-led SCAM use was about 5% higher than previous national (UK and England) surveys. This may relate to the authors’ wider SCAM definition, which included 11 more therapies than Hunt et al (a survey from my team), or increased SCAM use since 2005. Despite this uncertainty, the authors write this: Figures from 2005 reported that 12% of the English population used practitioner-led CAM. This 2015 survey has found that 16% of the general population had used practitioner-led CAM in the previous 12 months. Thus, they imply that SCAM-use has been increasing.
  3. The main justification for running yet another survey presumably was to determine whether SCAM-use has increased, decreased or remained the same (virtually everything else found in the new survey had been shown many times before). To not answer this main question conclusively by asking the same questions as a previous survey is just daft, in my view. We have used the same survey methods at two points one decade apart and found little evidence for an increase, on the contrary: overall, GPs were less likely to endorse CAMs than previously shown (38% versus 19%).
  4. The main reason why I have long been critical about such surveys is the manner in which their data get interpreted. The present paper is no exception in this respect. Invariably the data show that SCAM is used by those who can afford it. This points to INEQUALITY that needs to be addressed by allowing much more SCAM on the public purse. In other words, such surveys are little more that very expensive and somewhat under-hand promotion of quackery.
  5. Yes, I know, the present authors are more clever than that; they want the funds limited to SCAM with evidence of effectiveness and cost-effectiveness. So, why do they not list those SCAMs together with the evidence for effectiveness and cost-effectiveness? This would enable us to check the validity of the claim that more public money should fund SCAM. I think I know why: such SCAMs do not exist or, at lest, they are extremely rare.

But otherwise the new survey was excellent.

 

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

Patients with rheumatoid arthritis (RA) have a higher risk of coronary heart disease (CHD). Despite good evidence for effectiveness, acupuncture is often advocated for RA, and it has not been reported to prevent CHD in patients with RA.

The authors of this analysis aimed to assess the risk of developing CHD in acupuncture-users and non-users of patients with RA. They identified 29,741 patients with newly diagnosed RA from January 1997 to December 2010 from the Registry of Catastrophic Illness Patients Database from the Taiwanese National Health Insurance Research Database. Among them, 10,199 patients received acupuncture (acupuncture users), and 19,542 patients did not receive acupuncture (no-acupuncture users). After performing 1:1 propensity score matching by sex, age, baseline comorbidity, conventional treatment, initial diagnostic year, and index year, there were 9932 patients in both the acupuncture and no-acupuncture cohorts. The main outcome was the diagnosis of CHD in patients with RA in the acupuncture and no-acupuncture cohorts.

Acupuncture users had a lower incidence of CHD than non-users (adjusted HR = 0.60, 95% CI = 0.55-0.65). The estimated cumulative incidence of CHD was significantly lower in the acupuncture cohort (log-rank test, p < .001). Subgroup analysis showed that patients receiving manual acupuncture of traditional Chinese medicine style, electroacupuncture, or combination of both all had a lower incidence of CHD than patients never receiving acupuncture treatment. The beneficial effect of acupuncture on preventing CHD was independent of age, sex, diabetes mellitus, hypertension, hyperlipidemia, and statins use.

The authors concluded that this is the first large-scale study to reveal that acupuncture might have beneficial effect on reducing the risk of CHD in patients with RA. This study may provide useful information for clinical utilization and future studies.

Pigs might fly, but – call me a sceptic – I somehow doubt it almost as much as I doubt that acupuncture might have beneficial effect on reducing the risk of CHD.

Why?

Because of two reasons mainly:

  1. For the life of me, I cannot see a mechanism by which acupuncture achieves this extraordinary feast (the authors allege an anti-inflammatory effect of acupuncture which I find wholly unconvincing).
  2. There is a much simpler explanation for the observed outcomes.

The propensity score used here did, of course, only match the groups for a hand-full of factors. Yet there are many more that could play a part which the authors could not consider because they did not have the data to do so. The one that foremost comes to my mind is a generally healthier life-style of the patients using acupuncture. I think it stands to reason that people who bother to have and pay for an additional treatment are higher motivated to adhere to a life-style (e. g. smoking-cessation, exercise, nutrition, stress) that reduces the CHD-risk. And the influence of this factor could be very significant indeed. As the devil’s advocate, I could therefore even postulate that acupuncture itself had a slightly detrimental effect which, however, was over-ridden by the massive effect of the healthier life-style.

And the lesson to learn from all this?

Before we conclude about ‘beneficial effects’ of acupuncture or any other therapy, we need RCTs that effectively eliminate these rather obvious confounders.

 

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

Once again, I am indebted to the German homeopathy lobbyist, Jens Behnke (research officer at the Karl and Veronica Carstens-Foundation); this time for alerting me via a tweet to the existence of the ‘Institute for Scientific Homeopathy’ run by Dr K Lenger. Anyone who combines the terms ‘scientific’ and ‘homeopathy’ has my full attention.

The institution seems to be small (too small to have its own website); in fact, it seems to have just one member: Dr Karin Lenger. But size is not everything! Lenger has achieved something extraordinary: she has answered the questions that have puzzled many of us for a long time; she has found the ‘modus operandi’ of homeopathy by discovering that:

  • Homeopathy is a regulation therapy that acts (and reacts) as per the principle of resonance to deal hypo- and hyper-functions of pathological pathways.
  • As per resonance principle, the fundamental principles of homeopathy have the same frequencies so that the resonance principle can work.
  • Pathological pathways are cured by using their highly potentized substrates, inhibitors, and enzymes.
  • The efficacy of homeopathy now has a scientific base and is completely explained by applying biochemical and biophysical laws.

Progress at last!

If that is not noteworthy, what is?

But there is more!

This website, for instance, explains that Lenger Karin Dr.rer.nat., pursued Diploma in Biochem, studied Biochemistry at the Universities of Tubingen and Cologne. Her research topics revolved around enzymatic gene regulation, cancer research, enzymatic mechanisms of steroid hormones at the Medical University of Lubeck. In 1987 she became a Lecturer for Homeopathy at DHU ((Deutsche Homöopathie Union = German Homeopathy Union). Since 1995 she worked as a Homeopathic Practitioner and developed the “biochemical homeopathy” by using highly potentized substrates of pathological enzymes for her patients. She detected magnetic photons in high homeopathic potencies by two magnetic resonance methods and developed a model of physical and biochemical function of homeopathy.

Karin Lenger detected magnetic photons in highly diluted and potentized homeopathic remedies. Since the living body is an electromagnetic wavepackage (Einstein), the homeopathic law of Similars (Hahnemann 1755-1843) can be expressed as: the frequencies of the patient must match the frequencies of the remedies. Homeopathy is a regulation therapy curing hypo and hyperfunction of a pathological pathway by resonance: highly potentized substrates, inhibitors, enzymes, receptors of the distinct pathological pathways cure according to biochemical rules: A homeopathic symptom picture is obtained by poisoning a volunteer with a toxin. Simultaneously he develops psychological symptoms, the toxicological pathway and e.g. frequencies I-V. The highly potentized toxin has the frequencies I-V. The patient has symptoms as if he was poisoned by the toxin: during his illness he developed the toxicological pathway, frequencies I-V and psychological symptoms. The potentized toxin cures simultaneously the patient’s frequencies by resonance, his pathological pathway and the psychological symptoms. A stitch of honey bee, apis mellifica, causes a red oedema; a patient developing a red oedema at the finger-joint by rheumatism is cured by highly potentized Apis mellifica. Paralyses caused by a lack of the neurotransmitter acetylcholine bound to the acetylcholine-receptor at the post-synapsis can be healed by using these potentized remedies: the venom of cobra, Naja tripudians containing the receptor’s irreversible inhibitor cobrotoxin, the reversible inhibitor Atropine and Acetylcholine, daily applied. The availability of acetylcholine is maintained by glycolysis and fatty acid oxidation. This can be supported by giving these remedies: Lecithin, Lipasum, Glycerinum, Glucosum and Coenzyme A.

And in case, you are not yet fully convinced, a recent publication is bound to ball you over. Here is its abstract, if you need more, the link allows you to read the full paper as well:

Homeopathy, a holistic therapy, is believed to cure only acute symptoms of a beginning illness according to the Laws of Similars; but not deep, bleeding, septic wounds. The homeopaths refuse to heal according to special medical indications. Based on Lenger’s detection of magnetic photons in homeopathic remedies a biochemical and biophysical model of homeopathic healing was developed Biochemical, pathological pathways can be treated by their highly potentized substrates and inhibitors. Three groups of patients with moderate, severe and septic wounds had been successfully treated with the suitable remedies depending on the biochemical pathological state.

___________________________________________________________

Do I sense a Nobel Prize in the offing?

Surely!

Lenger’s clinical trial is baffling. But much more impressive are the ‘magnetic photons’ and the reference to Einstein. This is even more significant, if we consider what the genius (Einstein, not Lenger!) is reported to have said about homeopathy:  Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

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