Chiropractors (and other alternative practitioners) tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure.
This sounds perfectly logical to me, but is there any evidence for it? Yes, there is!
The WSJ recently reported that over 80% of the money that Medicare paid to US chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens spent roughly $359 million on unnecessary chiropractic care that year, a review by the Department of Health and Human Services’ Office of Inspector General (OIG) found.
The OIG report was based on a random sample of Medicare spending for 105 chiropractic services in 2013. It included bills submitted to CMS through June 2014. Medicare audit contractors reviewed medical records for patients to determine whether treatment was medically necessary. The OIG called on the Centers for Medicare and Medicaid Services (CMS) to tighten oversight of the payments, noting its analysis was one of several in recent years to find questionable Medicare spending on chiropractic care. “Unless CMS implements strong controls, it is likely to continue to make improper payments to chiropractors,” the OIG said.
Medicare should determine whether there should be a cut-off in visits, the OIG said. Medicare does not pay for “supportive” care, or maintenance therapy. Patients who received more than a dozen treatments are more likely to get medically unnecessary care, the OIG found, and all chiropractic care after the first 30 treatment sessions was unnecessary, the review found. However, a spokesperson for US chiropractors disagreed: “Every patient is different,” he said. “Some patients may require two visits; some may require more.”
I have repeatedly written about the fact that chiropractic is not nearly as cost-effective as chiropractors want us to believe (see for instance here and here). It seems that this evidence is being systematically ignored by them; in fact, the evidence gets in the way of their aim – which often is not to help patients but to maximise their cash-flow.
Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.
Yet acupuncture is precisely the therapy such patients might be tempted to employ.
Because irresponsible or criminally naïve acupuncturists advertise it!
Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….
I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:
Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.
In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:
Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.
However, this does not deter them to conclude on a positive note:
In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.
So, why do I find this irresponsibly and dangerously misleading?
Here a just a few reasons why this meta-analysis should not be trusted:
- There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
- The primary studies all look extremely weak; this means they are likely to be false-positive.
- They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
- All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.
My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.
A new study tested the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3).
The RCT began with a one-month run-in followed by three months intervention. The outcome measures were quantified at the end of the intervention and at 3, 6 and 12 months of follow-up. The primary end-point was the number of migraine days per month. Secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.
The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.
The authors concluded that it is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.
Chiropractors often cite clinical trials which suggest that CSMT might be effective. The effects sizes are rarely impressive, and it is tempting to suspect that the outcomes are mostly due to bias. Chiropractors, of course, deny such an explanation. Yet, to me, it seems fairly obvious: trials of CSMT are not blind, and therefore the expectation of the patient is likely to have major influence on the outcome.
Because of this phenomenon (and several others, of course), sceptics are usually unconvinced of the value of chiropractic. Chiropractors often respond by claiming that blind studies of physical intervention such as CSMT are not possible. This, however, is clearly not true; there have been several trials that employed sham treatments which adequately mimic CSMT. As these frequently fail to show what chiropractors had hoped, the methodology is intensely disliked by chiropractors.
The above study is yet another trial that adequately controls for patients’ expectation, and it shows that the apparent efficacy of CSMT disappears when this source of bias is properly accounted for. To me, such findings make a lot of sense, and I suspect that most, if not all the ‘positive’ studies of CSMT would turn out to be false positive, once such residual bias is eliminated.
I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
END OF QUOTE
Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.
“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”
Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.
According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.
And what should we conclude from all this?
I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.
Over on ‘SPECTATOR HEALTH’, we have an interesting discussion (again) about homeopathy. The comments so far were not short of personal attacks but this one by someone who called himself (courageously) ‘Larry M’ took the biscuit. It is so characteristic of deluded homeopathy apologists that I simply have to share it with you:
Ernst grew up with homeopathy , saw how well it worked , and chose to become a so-called expert in alternative medicine . To his surprise, he met with professional disapproval . Being the weak ego-driven person that he is , he saw an opportunity to still come out on top. He sold his soul in exchange for the notoriety that he now receives for being the crotchety old homeopathy hater that he has become . As with all homeopathy haters, his fundamentalist zeal  is evidence of his secret self-loathing  and fear that his true beliefs will be found out . It’s no different than the evangelical preacher who rails against gays only to be eventually found out to be a closeted gay .
There is not much that makes me speechless these days, but this comment almost did. There is someone who clearly does not even know me and he takes it upon himself to interpret and re-invent my past, my motives and my actions at will. How deluded is that?
After re-reading the comment, I began to see the funny side of it, had a giggle and decided to add a few elements of truth in the form of this blog-post. So I took the liberty to insert some reference numbers into Larry’s text which refer to my brief points below.
- This is at least partly true; our family doctor was a prominent homeopath. Whenever one of us was truly ill, he employed conventional treatments.
- I was impressed as a young physician working in a homeopathic hospital to see that patients improved on homeopathy – even though, at medical school, I had been told that the remedies were pure placebos. This contradiction fascinated me, and I began to do some own research into the subject.
- I did not ‘choose’, I had a genuine interest; and I don’t think that I am a ‘so called’ expert – after 2 decades of research and hundreds of papers, this attribute seems a trifle unfitting.
- The disapproval came from the homeopathy fans who were irritated that someone had the audacity to undertake a truly CRITICAL assessment of their treatments and actions.
- The amateur psychology here speaks for itself, I think.
- Yes, I am no spring chicken! But I am not a ‘hater’ of anything – I try to create progress by convincing people that it is prudent to go for treatments that are evidence-based and avoid those that do not generate more good than harm.
- This attitude is not a ‘fundamental zeal’, it is the only responsible way forward.
- This made me laugh out loud! Nothing could be further from the truth.
- My ‘true belief’ is that patients deserve the best treatments available. I have no fear of being ‘found out’; on the contrary, during my career I stood up to several challenges of influential people who tried to trip me up.
- This is hilarious – does Larry not feel how pompously ridiculous and ridiculously pompous he truly is?
This might be all too trivial, if such personal attacks were not an almost daily event. The best I can do with them, I have concluded, is to expose them for what they are and demonstrate how dangerously deluded the advocates of quackery really are. In this way, I can perhaps minimize the harm these people do to public health and medical progress.
Chiropractic for animals?
Yes, it can!!!
Animal Chiropractic “is a field of animal health care that focuses on the preservation and health of the neuro-musculo-skeletal system. Why? Nerves control everything that happens in your animals. Anything adversely affecting the nervous system will have detrimental effects that will resonate throughout the entire body. The command centers of the nervous system are the brain and spinal cord which are protected by the spine. The spine is a complex framework of bones (vertebra), ligaments, muscles and nerves. If the movement and biomechanics of the vertebra become dysfunctional, they can interfere with the performance of the nerves that are branching off of the spinal cord and going to the all of the muscles and organs. As this occurs, your animal can lose normal mobility; resulting in stiffness, tension, pain and even organ dysfunction. Additionally, when normal movement is affected, and left unattended, it will ultimately impact your animal’s entire wellbeing and quality of life…”
As you see, much the same nonsense as for human chiropractic is now also advertised for animals, particularly horses. Chiropractic for horses and other animals has become a thriving business; today there are even colleges that specialise in ‘educating’ animal chiropractors, and the ‘AMERICAN VETERINARY CHIROPRACTIC ASSOCIATION promotes “animal chiropractic to professionals and the public, and [acts] as the certifying agency for doctors who have undergone post-graduate animal chiropractic training. Members working together within their disciplines to expand and promote the knowledge and acceptance of animal chiropractic to their professions, the public and governments; locally, nationally and internationally.”
Recently I came across a remarkable website which promoted chiropractic specifically for horses. Here are a few paragraphs from the promotional text:
In recent years, the demand among horse owners for alternative equine therapies has spurred many veterinarians to explore therapies like acupuncture and chiropractic. Equine chiropractic techniques provide relief by restoring movement to the spinal column and promoting healthy neurologic functioning. In turn, the entire musculoskeletal system benefits, and the overall health of the animal increases.
Perhaps the greatest clinical application of chiropractic techniques is for animals with a vague sort of lameness that is not localized to any specific area, and for horses that experience a sudden decline in performance for seemingly no reason. These issues often relate back to musculoskeletal disorders that can be diagnosed through chiropractic techniques.
Some horse owners use chiropractic as a preventative measure. Subclinical conditions, meaning those that do not yet show symptoms, can often be detected by an equine chiropractor, as can abnormal biomechanics that could cause lameness down the road. Conditions that originate in the spine often result in a changed gait that can affect how force is applied to joints in the lower limbs. Over time, this shifted force can cause lameness, but chiropractic attention may help identify and deal with problems before they become a real issue…
Several situations can benefit from meeting with an equine chiropractor. The most significant sign that a horse could benefit from chiropractic treatment is pain. If the animal’s behavior suddenly changes or its posture seems abnormal, the horse may be experiencing pain. Similarly, reduced performance, refusing to jump, and tossing the head under saddle can indicate pain.
Owners should familiarize themselves with the many signs that a horse is experiencing pain. Some other indicators include chronic weight loss, sensitivity when being groomed, and difficulty turning. A chiropractor is a great option for identifying the issues leading to these behaviors and correcting them as quickly as possible — before the problems compound.
While pain is a great reason to seek equine chiropractic therapy, individuals may also want to consider the option if the horse is not responding to more conventional therapies. Chiropractors can also aid in recovery after significant trauma or lameness. However, horse owners should recognize that chiropractic therapy does not reverse degenerative changes already present, so working with a practitioner early in a disease’s progression can slow its advancement. Chiropractic may also help manage chronic conditions and prevent them from worsening…
END OF QUOTE
And where is the evidence for all this? I did a quick search and found virtually nothing to write home about. A review which I did locate made it clear why: “…only anecdotal evidence exists in horses…”
And that statement does, of course, prompt me to quickly remind everyone: THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!
Chiropractors may not be good at treating diseases or symptoms, but they are certainly good at promoting their trade. As this trade hardly does more good than harm, one could argue that chiropractors are promoting bogus and potentially harmful treatments to fill their own pockets.
Does that sound too harsh? If you think so, please read what Canadian researchers have just published:
This study aimed to investigate the presence of critiques and debates surrounding efficacy and risk of Spinal Manipulative Therapy (SMT) on the social media platform Twitter. Specifically, it examined whether there is presence of debate and whether critical information is being widely disseminated.
An initial corpus of 31,339 tweets was compiled through Twitter’s Search Application Programming Interface using the query terms “chiropractic,” “chiropractor,” and “spinal manipulation therapy.” Tweets were collected for the month of December 2015. Post removal of tweets made by bots and spam, the corpus totalled 20,695 tweets, of which a sample (n=1267) was analysed for sceptical or critical tweets.
The results showed that there were 34 tweets explicitly containing scepticism or critique of SMT, representing 2.68% of the sample (n=1267). As such, there is a presence of 2.68% of tweets in the total corpus, 95% CI 0-6.58% displaying explicitly sceptical or critical perspectives of SMT. In addition, there are numerous tweets highlighting the health benefits of SMT for health issues such as attention deficit hyperactivity disorder (ADHD), immune system, and blood pressure that receive scant critical attention. The presence of tweets in the corpus highlighting the risks of “stroke” and “vertebral artery dissection” is also minute (0.1%).
The authors drew the following conclusions: In the abundance of tweets substantiating and promoting chiropractic and SMT as sound health practices and valuable business endeavors, the debates surrounding the efficacy and risks of SMT on Twitter are almost completely absent. Although there are some critical voices of SMT proving to be influential, issues persist regarding how widely this information is being disseminated.
I have no doubt that this paper will be sharply criticised by chiropractors, other manipulators and lobbyists of quackery. Yet I think it is an interesting and innovative approach to describe what is and is not being said on public media. The fact that chiropractors hardly ever publicly criticise or challenge each other on Twitter or elsewhere for even the most idiotic claims is, in my view, most telling.
Few people would doubt that such platforms have become hugely important in forming public opinions, and it seems safe to assume that consumers views about SMT are strongly influenced by what they read on Twitter. If we accept this position, we also have to concede that Twitter et al. are a potential danger to public health.
The survey is, however, not flawless, and the authors are the first to point that out: Given the nature of Twitter discussions and the somewhat limited access provided by Twitter’s API, it can be challenging to capture a comprehensive collection of tweets on any topic. In addition, other potential terms such as “chiro” and “spinal adjustment” are present on Twitter, which may produce datasets with somewhat different results. Finally, although December 2015 was chosen at random, there is nothing to suggest that other time frames would be significantly similar or different. Despite these limitations, this study highlights the degree to which discussions of risk and critical views on efficacy are almost completely absent from Twitter. To this I would add that a comparison subject like nursing or physiotherapy might have been informative, and that somehow osteopaths have been forgotten in the discussion.
The big question, of course, is: what can be done about creating more balance on Twitter and elsewhere? I wish I had a practical answer. In the absence of such a solution, all I can offer is a plea to everyone who is able of critical thinking to become as active as they can in busting myths, disclosing nonsense and preventing the excesses of harmful quackery.
Let’s all work tirelessly and effectively for a better and healthier future!
Low back pain (LBP) is a ‘minor complaint’ in the sense that it does not cost patients’ lives. At the same time, LBP is amongst the leading causes of disability and one of the most common reasons for patients to seek primary care. Chiropractors, osteopaths, physical therapists and general practitioners are among those treating LBP patients, but there is only limited evidence regarding the effectiveness offered by these provider groups.
The aim of this systematic review was to estimate the clinical effectiveness and to systematically review economic evaluations of chiropractic care compared to other commonly used approaches among adult patients with non-specific LBP.
A comprehensive search strategy was conducted to identify 1) pragmatic randomized clinical trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. The primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine estimates of effect sizes. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized.
Six RCTs and three full economic evaluations were included. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). The authors found similar effects for chiropractic care and the other types of care. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Highly divergent conclusions (favours chiropractic, favours medical care, equivalent options) were noted for economic evaluations of chiropractic care compared to medical care.
The authors drew the following conclusions: moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.
This is a thorough and timely review. Its results are transparent and clear, however, its conclusions are, in my view, more than a little odd.
Let me try to re-formulate them such that they are better supported by the actual data: There is no good evidence to suggest that chiropractic care is better or worse that conventional therapeutic approaches currently used for LBP. The pooled sample size dimensions too small to allow any statements about the risks of the various approaches. The data are also too weak for any pronouncements on the relative cost-effectiveness of the various options. Given these limitations, the decision which approach to use should be based on a more comprehensive analysis of the therapeutic risks.
The point I am trying to make is quite simple:
- The fact that RCTs fail to show adverse effects could be due to the small collective sample size and/or to the well-known phenomenon that, in well-controlled trials, adverse effects tend to be significantly rarer than in routine care.
- Hundreds of serious adverse events have been reported after chiropractic spinal manipulations; to these we have to add the fact that ~50% of all chiropractic patients suffer from transient, mild to moderate adverse effects after spinal manipulations.
- If we want to generate a realistic picture of the safety of a therapy, we need to include case-reports, case-series and other non-RCT evidence.
- Conventional treatments of LBP may not be free of adverse effects, but some are relatively safe.
- It seems reasonable, necessary and ethical to consider a realistic picture of the relative risks when deciding which therapy amongst equally (in)effective treatments might be best.
To me, all this seems almost painfully obvious, and I ask myself why the authors of this otherwise sound review failed to consider such thoughts. As one normally is obliged to, the authors included a section about the limitations of their review:
Our review has limitations. First, we did not search the grey literature for clinical effectiveness studies. McAuley et al. showed that the inclusion of results from the grey literature tend to decrease effectiveness estimates in meta-analyses because the unpublished studies tend to report smaller treatment effects. Second, critical appraisal requires scientific judgment that may vary among reviewers. This potential bias was minimized by training reviewers to use a standardized critical appraisal tool and using a consensus process among reviewers to reach decisions regarding scientific admissibility. Most of the original between-group differences and pooled estimates in our meta-analysis did not favour a specific provider group, and we believe it is unlikely that the inclusion of unpublished grey literature would change our conclusions. Third, the low number of clinical trials prevents us from conducting a meaningful investigation for publication bias. Fourth, the majority of the included clinical effectiveness studies (three out of five) and all three economic evaluations were conducted in the United States. Caution should therefore be used when generalizing our findings to other settings or jurisdictions. With respect to economic evaluations in particular, local healthcare systems and insurance plans may have a higher impact on cost than the type of healthcare provider.
Remarkably, this section does not mention their useless assessment of the risks with one word. Why? One answer might be found in the small-print of the paper:
The authors … have the following competing interests: MAB: Personal fees from Ordre des chiropraticiens du Québec for one teaching presentation, outside the submitted work. MJS: Position at the Nordic Institute of Chiropractic and Clinical Biomechanics is funded by the Danish Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication. RBDS: Nothing to disclose. JB: Nothing to disclose. PH: Nothing to disclose. AB: Position at the School of Physical and Occupational Therapy at McGill University is funded by the Canadian Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication.
After > 200 years of existence, homeopathy still remains unproven – in fact, most rational thinkers would call it disproven. Today only homeopaths doubt this statement; they work hard to find a water-tight proof that might show the doubters to be wrong.
What is better suited for this purpose than a few rigorous animal experiments?
Engystol® is a popular homeopathic product promoted as an anti-viral agent manufactured by Heel GmbH, Baden-Baden, Germany. In several in vivo and in vitro studies, it apparently affected an immune response. This new study was to “evaluate the innate and adaptive immuno-modulatory effects of oral Engystol® (1 or 10 tablets/L water consumed), prior to and post antigenic challenge in a mouse model with a well-characterized and clinically measureable immune system.”
The investigators first evaluated the murine immune response when oral Engystol® was given alone for 28 days. to mice. The animals were then challenged with an antigen-specific H5N1 HA vaccine while on Engystol® for an additional 33 days. Serum and supernatants from cultured splenic lymphocytes were collected and screened with a 32-cytokine panel. Serum vaccine epitope-specific IgG titers plus T cell and B cell phenotypes from splenic tissue were also evaluated.
The results showed that Engystol® alone did not alter immunity. However, upon vaccine challenge, Engystol® decreased CD4+/CD8+ ratios, altered select cytokines/chemokines, and anti-H5N1 HA IgG titers were increased in the group of mice receiving 10 tablet/L.
The authors concluded that “these data suggest that Engystol® can modulate immunity upon antigenic challenge.”
Engystol is being advertised as “a homeopathic preparation which has been scientifically proven to significantly reduce the duration and severity of symptoms during an acute viral infection and help protect from subsequent infections.” I was unable find good evidence for this claim and therefore have to assume that it is bogus. The only human trial I was able to locate was this one:
To compare the effects of a complex homeopathic preparation (Engystol; Heel GmbH, Baden-Baden, Germany) with those of conventional therapies with antihistamines, antitussives, and nonsteroidal antiinflammatory drugs on upper respiratory symptoms of the common cold in a setting closely related to everyday clinical practice.
Nonrandomized, observational study over a treatment period of maximally two weeks.
Eighty-five general and homeopathic practices in Germany.
Three hundred ninety-seven patients with upper respiratory symptoms of the common cold.
Engystol-based therapy or common over-the-counter treatments for the common cold. Patients receiving this homeopathic treatment were allowed other short-term medications, but long-term use of analgesics, antibiotics, and antiinflammatory agents was not permitted. Patients were allowed nonpharmacological therapies such as vitamins, thermotherapies, and others.
MAIN OUTCOME MEASURES:
The effects of treatment were evaluated on the variables fatigue, sensation of illness, chill/tremor, aching joints, overall severity of illness, sum of all clinical variables, temperature, and time to symptomatic improvement.
Both treatment regimens provided significant symptomatic relief, and this homeopathic treatment was noninferior in a noninferiority analysis. Significantly more patients (P < .05) using Engystol-based therapy reported improvement within 3 days (77.1% vs 61.7% for the control group). No adverse events were reported in any of the treatment groups.
This homeopathic treatment may be a useful component of an integrated symptomatic therapy for the common cold in patients and practitioners choosing an integrative approach to medical care.
Let me comment on the human study first. It is an excellent example of the bias that can be introduced by non-randomization. The patients in the homeopathic group obviously were those who chose to be treated homeopathically. Consequently they had high expectations in this therapy. Consequently they reported better results than the control group. In other words the reported outcomes have nothing to do with the homeopathic remedy.
But what about the animal study? Animals, we hear so often, do not exhibit a placebo response. Does that render this investigation any more reliable?
The answer, I am afraid is no.
The animal study in question had no control group at all. Therefore a myriad of factors could have caused the observed result. This study is very far from a poof of homeopathy!
But even if the findings of the two studies had not been the result of bias and confounding, I would be more than cautious about viewing them as anything near conclusive. The reason lies in the nature of this particular homeopathic remedy.
Engystol® contains Vincetoxicum hirundinaria (D6), Vincetoxicum hirundinaria (D10), Vincetoxicum hirundinaria (D30), sulphur (D4) and sulphur (D10). In other words, it is one of those combination remedies which are not sufficiently dilute to be devoid of active molecules. Sulphur D4, for instance, means that the remedy contains one part of sulphur in 10 000 parts of diluent. It is conceivable, even likely that such a concentration might affect certain immune parameters, I think.
And my conclusion from all this?
The proof of homeopathy – if it ever came – would need to be based on investigations that are more rigorous than these two rather pathetic studies.
I have moaned about the JACM several times on this blog (for instance here). It is a very poor journal, in my view, but it nevertheless is important because it is the one with the highest impact factor in this field. Despite all this I missed something important that recently happened to the JACM: a few months ago, it got a new editor in chief: John Weeks.
Had I been more attentive, I would have known this already in May when Weeks wrote in the HuffPo this: “I was asked a month ago, out of the blue, if I would like to become editor-in-chief of the first peer-reviewed, indexed journal in what is now the “integrative health and medicine” field. The journal was born 20 years ago when — as my father would have put it — “integrative medicine” was hardly a gleam in anyone’s eye. The publication is the Journal of Alternative and Complementary Medicine.”
I have a vague memory of meeting him once at a conference and sitting next to him during a dinner. For those who haven’t heard of him, here is how he once described himself:
I have been involved as an organizer-writer in the emerging fields of complementary, alternative and integrative medicine since 1983. Happily, I have learned some things. I was once called an “expert in alternative medicine” by Medical Economics and later an “alternative care (integration) expert” by Modern Healthcare. The name-calling was proud-making, even if I was so-dubbed by reporters who were on their first forays into the field.
Both anointed me before I went on sabbatical in Costa Rica and later Nicaragua with my family in 2002. Part of the reason for sabbatical was that whatever expertise I may have developed often ran frustratingly short of being able to offer robust, successful business models with readers and clients. More than once I counseled people against the initiatives they planned. Trends taught me to recognize the invisible handwriting of a sure failure event behind the bubbling enthusiasm of an initiate. I needed a break from the work. My family and I took it!
I was away from the United States for three years. I had my hand back in things for the last 2.5 years. I assisted a philanthropist on her integrative medicine investments in community clinics, CAM schools and academic health centers. From early 2004 forward, and out of home offices in Monteverde, Costa Rica, and then Granada, Nicaragua, I helped organize and direct the National Education Dialogue to Advance Integrated Health Care: Creating Common Ground…
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Is Weeks going to be a good editor who throws out all the trash that JACM has been publishing on a far too regular basis? Well, the good news, I suppose, is that he cannot possibly be worse than his predecessor. Perhaps we should see for ourselves what the new man thinks and writes. Here is an excerpt from his recent editorial on the question of medical errors in conventional medicine and the role of integrative medicine in this difficult issue:[A] whole-system solution to medical errors suggests many roles for traditional, alternative, complementary, and integrative approaches and practices. First, better use of these new therapies and provider types expands the tools and strategies for keeping the locus of care out in communities instead of in the problematic hospital environment. One of the commentators at Medscape for instance pointed out that when it comes to “errors” that lead to death, the most significant culprits are the errors individuals make in living the standard U.S. life-style. A starting place in limiting medical deaths is for us to take better care of ourselves. We’ll be less likely to need treatment or to be admitted if we do. The across-the-board engagement by multiple integrative and traditional medicine practitioners with life-style medicine, there are clearly important roles for integrative and traditional practices and practitioners.
More evidence that integrative practice keeps people healthy and out of hospitals would be useful. Our research needs to capture these life-changing outcomes better. The values movement is toward primary care and community medicine. Outpatient care offers a home-field advantage for traditional medical systems and licensed integrative health practitioners, from yoga and massage therapists to acupuncture and Oriental medicine specialists and integrative, chiropractic, and naturopathic doctors. And when people are admitted to hospitals, broader integrative teams need to be available to catch, hold, and treat the whole person and help keep them from being biomedically reduced. Such efforts would be served by research data that measure quadruple-aim outcomes. Think patient experience, enhancing life-style skills, faster healing times, diminished hospital stays, and more pleasure of practitioners in their caregiving. Some have begun gathering these outcomes. We need bushels more. We’ll also have a growing need for reports that delineate processes and obstacles overcome in highly functioning integrative care teams.
The whole-system response to medical deaths is opening minds and doors to integrative practices and to leadership from the integrative community. In one remarkable example, the state of Oregon is seeking to reduce the morbidity and mortality associated with opioids through prioritizing the care of chiropractors, acupuncturists, and massage and yoga therapists. To maximize our effectiveness as agents of change in helping create health in those we serve, more of us need to study up on the emerging language, goals, and methods of the value-based movement, then match up to these aims in our study designs and selections of outcomes. Advancing whole-person care and linking to the emerging values appear to be our best opportunities to help shape the path away from death and toward safety and health.
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Impressed? Me neither!
In my view, this reads like an accumulation of platitudes, wishful thinking and uncritical waffling. The passage that I found positively worrying was this one: More evidence that integrative practice keeps people healthy and out of hospitals would be useful. Our research needs to capture these life-changing outcomes better. The editor of a medical journal should, I think, know that research is not for confirming beliefs but for testing hypotheses. In all this verbose rambling, I really cannot find a good reason why integrative medicine might have a role in reducing medical errors. More worrying still, I cannot find a trace of critical thinking.
As I was writing this, I remembered more about the only personal encounter I had with Weeks years ago. For some reason we talked about THE ‘textbook’ of naturopaths, entitled THE TEXTBOOK OF NATURAL MEDICINE. I remember explaining to Weeks that it contained a lot of factual errors and outright nonsense. He very much disputed my view, seemed to take it personally, and even got quite stroppy. In the end, we agreed to disagree.
Neither this episode nor indeed the editorial are all that important – we will simply have to wait and see how the JACM does under its new editor.