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

Monthly Archives: January 2019

I am indebted to my good friend and long-term admirer Dana Ullman for alerting me to this new (2019) paper. It reports a study aimed to test whether homeopathic medication administration to COPD patients during the influenza-exposure period may help to reduce the frequency of common URTIs.

This prospective, observational, multicenter study was carried out in Cantabria, Spain. Patients with COPD were divided into two groups: group 1 received conventional treatment + homeopathic medication (diluted and dynamized extract of duck liver and heart; Boiron) (OG); group 2 received conventional treatment only (CG). The primary endpoint was the number of URTIs between the 4-5 months follow up (mean 4.72 ± 0.96) from basal to last visit. Secondary endpoints included the duration of URTIs, number and duration of COPD exacerbations, use of COPD drugs, changes in quality of life (QoL), compliance, and adverse events (AEs).

219 patients were analyzed (OG = 109, CG = 110). There was a significant reduction in mean number of URTIs during the follow-up period in OG compared to CG (0.514 ± 0.722 vs. 1.037 ± 1.519, respectively; p = 0.014). Logistic regression analysis showed a 3.3-times higher probability of suffering ≥2 URTI episodes in CG (p = 0.003, n = 72). OG patients having ≥1 URTI also had a significant reduction in mean URTI duration per episode (3.57 ± 2.44 days OG vs. 5.22 ± 4.17 days CG; p = 0.012). There was no significant difference in mean number of exacerbations, mean duration of exacerbations, or QoL between OG and CG. There was a greater decrease in proportion of patients using corticosteroids for exacerbations between baseline and visit 2 in OG compared to CG (22.1% vs. 7.5% fewer respectively, p = 0.005). Exacerbator phenotype patients had a significant decrease in number of URTIs (0.54 ± 0.72 vs. 1.31 ± 1.81; p = 0.011), and fewer COPD exacerbations (0.9 ± 1.3 vs. 1.5 ± 1.7; p = 0.037) in OG vs. CG, respectively.

The authors concluded that homeopathic medication use during the influenza-exposure period may have a beneficial impact at reducing URTIs’ number and duration in COPD patients and at reducing the number of COPD exacerbations in patients with the exacerbator phenotype. Further studies are needed to confirm the effects observed in this study.

Evidently, Dana thinks highly of this new evidence for Boiron’s duck diluted out of existence, markeded as Oscillococcinum. Do we now have to eat out words? Does homeopathy work after all? Has Dana been right all along?

‘fraid not!

Here are just a few of the most obvious flaws of this trial:

  1. It was not an observational study as I understand it.
  2. It followed the infamous A+B versus B design (which never generates a negative result).
  3. As such it did not control for placebo effects.
  4. It cannot achieve its stated aim.
  5. Its statistical analysis seems faulty.
  6. It lacks randomisation which means the 2 groups differed in many undetected ways.
  7. The primary endpoints were assessed by an undisclosed method.

But there is more, much more.

Conflicts of interest:

J.L. Garcia-Rivero has received speaker’s fees from Boiron Laboratories. G. Diaz Saez (the senior author of the trial) was the Medical Director of Boiron Laboratories when the study was carried out and continued to collaborate in the study after leaving this post. A. Viejo Casas has received speaker’s fees from Boiron Laboratories. All authors of this study, except for G. Diaz, received fees for including patients.

Funding:

This work was supported by Boiron Laboratories.

I REST MY CASE

About a year ago, I published a blog-post about LIVE BLOOD ANALYSIS (LBA). My conclusion at the time was that LBA is an ineffective, potentially dangerous diagnostic method for exploiting gullible consumers. My advice is to avoid practitioners who employ this technique. But perhaps it was too harsh?

Recently, this post started to attract a lively discussion. Surely, a good reason to re-visit the subject and see whether anything has changed.

First, we need to remind ourselves what LBA is. This website by a LBA practitioner explains:

Live Blood Analysis uses a drop of live blood from the patient’s finger that has not been killed by staining, and viewed under a special microscope using a darkfield condenser.

This enables the blood sample to be illuminated from the sides, making the various components phosphoresce behind a dark background. This makes it possible to see very small particles, smaller than a cell that would not normally be visible under a normal light microscope. All the living components of the blood are seen clearly, and can be viewed by the patient and therapist using a video camera and a dedicated monitor.

The examination of live blood is valuable for the early detection of serious health conditions. It is possible to see at what stage of pathological development the body is in, simply from using one drop of blood. Because the precursors to serious health imbalances may be observed in the state of ever-present floras found in the blood, health imbalances may be averted by reading these early warning signs and making the necessary changes that will allow one to rebalance the physiology. These markers are also applicable in the course of tracking the progression and reversal of degenerative conditions that may already be in motion…

Depending on the irregularities found in the blood, there are a wide variety of different conditions that can be determined.

The following are just a few examples:

  • Indication of low immune status
  • Liver and spleen stress
  • Vitamin and mineral deficiencies
  • Hormonal imbalances
  • Fungal infections
  • Parasite infestation
  • Digestive problems
  • Atherosclerotic predisposition
  • Heavy metal toxicity
  • Predisposition to cancer or other degenerative diseases

END OF QUOTE

Next, we need to see whether there is any new evidence that might support these astonishingly far-reaching claims. To find out, I conducted a couple of Medline-searches. The result is easily reported: none of the claims seems to be supported by any evidence. Neither did I find any evidence to show that LBA is a valid diagnostic tool – nothing on sensitivity, reliability, etc.

And what does that mean for LBA-practitioners and their patients?

Evidently, I am not an expert on legal matters, but I guess it means that the former are fraudulent and the latter should ask their money back. In any case, as an expert in SCAM, I can confidently tell you that, in my view, LBA is bogus.

Oscillococcinum is by now well-known to readers of this blog, I am sure (see for instance here, here and here). It seems an important topic, not least because the infamous duck-placebo is the world’s best-selling homeopathic remedy. Just how popular it is was recently shown in a survey by the formidable ‘Office for Science and Society’ of the McGill University in Canada.

The researchers surveyed the five biggest pharmacy chains in Quebec: Jean-Coutu, Familiprix, Uniprix, Proxim, and Pharmaprix. For each chain, a sample of 30 pharmacies was chosen by a random number generator.

The calls started with the following script: “I would like to know if you carry a certain homeopathic remedy. It’s called Oscillococcinum, it’s a homeopathic remedy against the flu made by Boiron.” If they did not have it, the investigator asked if this was something they normally carried. He spoke to either a floor clerk or a member of the pharmacy staff behind the counter, depending on who knew the answer.

Out of the 150 pharmacies on the island of Montreal that were called for this investigation, 66% of them reported carrying Oscillococcinum (30% did not, while 4% could not be reached, often because the listed pharmacy had closed). Some chains were more likely to sell the product, with Jean-Coutu and Pharmaprix being the most likely (80% of their stores had it) and Proxim being the least likely (50% of their stores carried it).

The McGill researcher stated that the fact that two-thirds of Montreal-based pharmacies will sell us a pseudo-treatment for the flu that targets adults, children and infants alike is hard to square with the Quebec Order of Pharmacists’ mission statement. They describe said mission as “ensuring the protection of the public”, but how is the public protected when pharmacies are selling them placebo pills? The harm is partly financial: 30 doses of these worthless globules retail for CAD 36. It is also in the false sense of security parents will gain and the delay in proper treatment if needed. And, ultimately, it is in the legitimization of a pseudoscience the founding principle of which is that the more you add water to something (like alcohol), the more powerful it becomes.

I can only full-heartedly agree. One might even add a few more things, for instance that there are other dangers as well:

  1. If pharmacists put commercial gain before medical ethics, we might find it hard to trust this profession.
  2. If people take Oscillococcinum and their condition subsequently disappears (because of the self-limiting nature of the disease), they might believe that homeopathy is effective and consequently use it for much more serious conditions – with grave consequences, I hasten to add.
  3. If consumers thus start trusting homeopaths, they might also fall for some of their abominable health advice, e. g. that about not vaccinating their children.
  4. If a sufficiently large percentage of people believe in the magic of shaken water, our rationality will be undermined and we will encounter phenomena like Brexit or fascists as presidents (sorry, I has to get that off my chest).

Chronic back pain is often a difficult condition to treat. Which option is best suited?

A review by the US ‘Agency for Healthcare Research and Quality’ (AHRQ) focused on non-invasive nonpharmacological treatments for chronic pain. The following therapies were considered:

  • exercise,
  • mind-body practices,
  • psychological therapies,
  • multidisciplinary rehabilitation,
  • mindfulness practices,
  • manual therapies,
  • physical modalities,
  • acupuncture.

Here, I want to share with you the essence of the assessment of spinal manipulation:

  • Spinal manipulation was associated with slightly greater effects than sham manipulation, usual care, an attention control, or a placebo intervention in short-term function (3 trials, pooled SMD -0.34, 95% CI -0.63 to -0.05, I2=61%) and intermediate-term function (3 trials, pooled SMD -0.40, 95% CI -0.69 to -0.11, I2=76%) (strength of evidence was low)
  • There was no evidence of differences between spinal manipulation versus sham manipulation, usual care, an attention control or a placebo intervention in short-term pain (3 trials, pooled difference -0.20 on a 0 to 10 scale, 95% CI -0.66 to 0.26, I2=58%), but manipulation was associated with slightly greater effects than controls on intermediate-term pain (3 trials, pooled difference -0.64, 95% CI -0.92 to -0.36, I2=0%) (strength of evidence was low for short term, moderate for intermediate term).

This seems to confirm what I have been saying for a long time: the benefit of spinal manipulation for chronic back pain is close to zero. This means that the hallmark therapy of chiropractors for the one condition they treat more often than any other is next to useless.

But which other treatments should patients suffering from this frequent and often agonising problem employ? Perhaps the most interesting point of the AHRQ review is that none of the assessed nonpharmacological treatments are supported by much better evidence for efficacy than spinal manipulation. The only two therapies that seem to be even worse are traction and ultrasound (both are often used by chiropractors). It follows, I think, that for chronic low back pain, we simply do not have a truly effective nonpharmacological therapy and consulting a chiropractor for it does make little sense.

What else can we conclude from these depressing data? I believe, the most rational, ethical and progressive conclusion is to go for those treatments that are associated with the least risks and the lowest costs. This would make exercise the prime contender. But it would definitely exclude spinal manipulation, I am afraid.

And this beautifully concurs with the advice I recently derived from the recent Lancet papers: walk (slowly and cautiously) to the office of your preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

 

Really? Acupuncture for chronic back Pain?

If you doubt it, the following announcement might amaze you:

In response to the U.S. opioid crisis, HHS is focused on preventing opioid use disorder and providing more evidence-based non-pharmacologic treatment options for chronic pain. The Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare & Medicaid Services (CMS) and that National Institutes of Health (NIH) are collaborating in this effort. The Agency for Healthcare Research and Quality published a systematic review of noninvasive, nonpharmacological treatment for chronic pain in June 2018 (https://effectivehealthcare.ahrq.gov/sites/default/files/cer-209-evidence-summary-non-pharma-chronic-pain.pdf). This review included assessment of several nonpharmacological interventions, including exercise, acupuncture, spinal manipulation, and multidisciplinary rehabilitation for CLBP. The NIH recently issued a Funding Opportunity Announcement for interested parties to apply to conduct an efficient, large-scale pragmatic trial to evaluate the impact of, and strategies to best implement, acupuncture treatment of older adults (65 years and older) with chronic low back pain. The announcement can be found here: https://grants.nih.gov/grants/guide/rfa-files/RFA-AT-19-005.html.

CMS is opening this national coverage analysis (NCA) to complete a thorough review of the evidence to determine if acupuncture for CLBP is reasonable and necessary under the Medicare program. CMS is soliciting public comment on this topic. We are particularly interested in comments that include scientific evidence and discuss appropriate clinicians and training requirements to provide acupuncture that improves health outcomes. In addition, for commenters recommending Coverage with Evidence Development, we are interested in comments related to appropriate outcomes and study designs. While CMS has conducted previous national coverage analyses on acupuncture, the scope of this current review is limited to acupuncture for chronic low back pain.

END OF QUOTE

The evidence whether acupuncture is effective for chronic back pain is far from clear. NICE recently stated that it no longer recommends acupuncture because the evidence is not strong. Others have shown that acupuncture is superior to sham as well as no acupuncture control for back pain, with differences between groups close to .5 SDs compared with no acupuncture control, and close to .2 SDs compared with sham. A further systematic review stated that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention.Yet another systematic review found that acupuncture for chronic nonspecific low back pain was associated with significantly lower pain intensity than placebo but only immediately post-treatment (VAS: -0.59, 95 percent CI: -0.93, -0.25). However, acupuncture was not different from placebo in post-treatment disability, pain medication intake, or global improvement in chronic nonspecific low back pain. Acupuncture did not differ from sham-acupuncture in reducing chronic non-specific neck pain immediately after treatment (VAS: 0.24, 95 percent CI: -1.20, 0.73). Acupuncture was superior to no treatment in improving pain intensity (VAS: -1.19, 95 percent CI: 95 percent CI: -2.17, -0.21), disability (PDI), functioning (HFAQ), well-being (SF-36), and range of mobility (extension, flexion), immediately after the treatment. In general, trials that applied sham-acupuncture tended to produce negative results (i.e., statistically non-significant) compared to trials that applied other types of placebo (e.g., TENS, medication, laser). Results regarding comparisons with other active treatments (pain medication, mobilization, laser therapy) were less consistent Acupuncture was more cost-effective compared to usual care or no treatment for patients with chronic back pain.

Confused?

Me too!

My reading of these and other papers is that acupuncture might have a small and probably not clinically relevant effects which is hard to differentiate from bias and confounding.

Is this enough for reimbursement from the public purse?

In my view, the answer is no.

I am sure that others will have different interpretations of the published evidence. If so, you have until 14 February to write to the CMS.

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.

 

The claim that homeopathy can cure cancer is so absurd that many people seem to think no homeopaths in their right mind would make it. Sadly, this turns out to be not true. A rather dramatic example is this extraordinary book. Here is what the advertisement says:

The global medical fraternity has been exploring various alternative approaches to cancer treatment. However, this exceptional book, “Healing Cancer: A Homoeopathic Approach” by Dr Farokh J Master, does not endorse a focused methodology, but it paves the way to a holistic homoeopath’s approach. For the last 40 years, the author has been utilising this approach which is in line with the Master Hahnemann’s teachings, where he gives importance to constitution, miasms, susceptibility, and most important palliation. It is a complete handbook, a ready reference providing authentic information on every aspect of malignant diseases. It covers the cancer related topics beginning from cancer archetype, clinical information on diagnosis, prevention, conventional treatment, homoeopathic aspects, therapeutics, polycrest remedies, rare remedies, Indian remedies, wisdom from the repertory, naturopathic and dietary suggestions, Iscador therapy, and social aspects of cancer to the latest researches in the field of cancer. Given the efforts put in by the author in writing this vast book, encompassing decades of clinical experience, this is indeed a valuable addition to the homoeopathic literature. In addition to homoeopaths, this book will indeed be useful for medical doctors of other modalities of therapeutics who also wish to explore a holistic approach to cancer patients since this book is the outcome of author’s successful efforts in introducing and integrating homoeopathy to the mainstream cancer treatment.

END OF QUOTE

I do wonder what goes on in the head of a clinician who spent much of his life convincing himself and others that his placebos cure cancer and then takes it upon him to write a book about this encouraging other clinician to follow his dangerous ideas.

Is he vicious?

Is he in it for the money?

Is he stupid?

Is he really convinced?

Whatever the answer, he certainly is dangerous!

For those who do not know already: homeopathy is totally ineffective as a treatment for cancer; to think otherwise can be seriously harmful.

Belgian homeopaths, together with the ‘European Committee for Homeopathy’, have published a statement which I find too remarkable to withhold it from you:

START OF QUOTE

Users of homeopathic medicines can no longer remain silent about the untruths circulating in the media. These lies raise doubts which naïve and gullible people take on board all too easily and then see homeopathy as quackery. None of this is accurate!

Because they fear seeing some of their ‘certainties’ questioned, the SKEPP movement is firing off at anything that current science cannot yet explain with both barrels.

The contents of homeopathic medicines
SKEPP states that a homeopathic medicine is nothing more than a drop of water in a swimming pool and therefore has nothing in it. This is  wrong. Tests performed on a high homeopathic potency (30CH) of Gelsemium sempervirens (Yellow Jasmine, a very common homeopathic medicine) have detected 36 micrograms of a specific substance per gram of solution [1]. Opponents denounce homeopathic medicines as being nothing but water. This is  wrong. This water, the solvent itself, contains a specific signature of the active ingredient. Basic research has demonstrated this [2].

Clinical efficacy.
By asserting at every opportunity that there is no evidence of the clinical effectiveness of homeopathy, opponents sow doubt. Correction:  such proof [3] does exist.  The fact that critics refuse to look at or accept these data speaks volumes about their attitude to science.
What is true, however, is that there is  not enough  scientific evidence of effectiveness. Science demands a lot of such evidence – and rightly so. There would be more if the universities applied the rules correctly!  For example: The Professional Union of Homeopathic Physicians had accepted a double-blind research protocol for fibromyalgia which took account of homeopathy’s individualized approach. This research was to be carried out at the Rheumatology Department of a hospital in Brussels with the agreement of the Rector of the Faculty of Medicine. But the hospital’s ethics committee decided that it would be unethical to test a ‘placebo’ (the homeopathic medicine) versus another placebo! Making an a priori assumption that homeopathic medicine is just a placebo, even before beginning the study, flies in the face of scientific objectivity.

Patients are not stupid!
In the meantime, Pro Homeopathia, the Belgian association of homeopathy patients, is no longer able to contain its members’ exasperation. It has published an article [4]  which denounces in direct terms the accusations of credulity, or even stupidity levelled at patients, in blatant disregard of their therapeutic freedom of choice and their capacity for critical thought.

Dare to ask questions! 
Why all this misinformation in the press? Why do these ‘experts’, whose opinions on homeopathy above all betray their profound misunderstanding of this discipline, flood the media with fake news? What is the hidden agenda behind this campaign of systematic denigration? Homeopathy and many other complementary medicines only want to collaborate, both in medical practice and in scientific research … fair play! It’s called integrative medicine!

References
[1]Nanoparticle Characterization of Traditional Homeopathically-Manufactured Cuprum metallicum and Gelsemium Sempervirens Medicines and Controls. Novembre 2018: https://www.thieme-connect.de/DOI/DOI?10.1055/s-0038-1666864)
[2]Nuclear Magnetic Resonance characterization of traditional homeopathically-manufactured copper (Cuprum metallicum) and a plant (Gelsemium sempervirens) medicines and controls. Août 2017: https://doi.org/10.1016/j.homp.2017.08.001
[3]Model validity and risk of bias in randomized placebo-controlled trials of individualised homeopathic treatment. 2016: http://dx.doi.org/10.1016/j.ctim.2016.01.005 //Clinical verification in homeopathy and allergic conditions. 2012 http://dx.doi.org/10.1016/j.homp.2012.06.002 //Scientific framework of homeopathy 2017. www.lmhi.org/Article/Detail/42)
[4]http://www.homeopathie-unio.be/uploads/files/unprotected/Presse/Attaques%20Hom%C3%A9o-FR2.pdf

END OF QUOTE

For regular readers of this blog, any comment on this little article might well be superfluous. For newcomers, I nevertheless provide a few thoughts. In doing so, I simply follow the three headings used above.

The contents of homeopathic medicines

A homeopathic C30 potency (the one that is used most frequently) is a dilution of 1 part homeopathic stock to 1000000000000000000000000000000000000000000000000000000000000 parts of diluent. This amounts to little more than one molecule of stock per universe. This is an undeniable fact, and the reference provided (incidentally, the link to it is dead) does not change it in any way. The theory of ‘the memory of water’ is an implausible hypothesis that has no basis in reality. It is believed only by homeopaths, and ‘studies’ that seemingly support it are flimsy, false or biased, and usually only get published in journals such as ‘Homeopathy’ (where also the reference provided appeared).

Clinical efficacy

This is a subject that we have already discussed ad nauseam. Highly diluted homeopathic remedies are pure placebos. If someone does not believe this nor all the evidence provided on this blog, they perhaps trust the many independent international bodies that have looked at the totality of the reliable evidence for or against homeopathy. Their verdicts are unanimously negative. (The above-cited decision of the ethics committee is therefore the only one that is ethically possible.)

Patients are not stupid!

That is absolutely correct; patients are certainly not stupid. And their experiences are certainly real. What is often wrong, however, is the interpretation of their experiences. When a patient’s symptoms improve after taking a highly diluted remedy, the perceived improvement is due to a long list of factors that are unrelated to the remedy: placebo, natural history, regression towards the mean, etc.

Patients are not stupid, but the misinformation homeopaths incessantly publish might render them stupid – one more reason why such irresponsible nonsense ought to stop.

 

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.

 

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories