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

bias

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Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.

But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.

The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).

After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.

There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.

The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.

The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study  fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.

PS

I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?

It is time to stop this nonsense!

It gives a bad name to science, misleads the public and inhibits progress.

The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:

… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.

Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”

Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”

For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.

If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…

In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…

David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…

Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”

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On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:

  1. Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
  2. Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).

The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).

So-called alternative medicine (SCAM) is a seriously dangerous option for cancer patients who aim at curing their cancer with it. One cannot warn patients often and strongly enough, I believe. But when it comes to supportive cancer treatment (care that does not aim at changing the natural history of the disease), SCAM might have a place. I said ‘might’ because its exact role is far from clear.

The aim of this study was to investigate the effects of a complex, nurse-led, supportive care intervention using SCAM on patients’ quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynaecologic cancers undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of SCAM applications and counseling for symptom management, as well as SCAM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after SCAM.

In total, 126 patients were randomly assigned into the IG and 125 patients into the CG. The patients’ medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT, but there was a significant group difference in favour of the IG, 6 months later. IG patients did also experience significant better emotional functioning and less fatigue.

The authors concluded that the tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self-management competencies.

A prospective, pragmatic, bicentric, randomized controlled trial! Doesn’t this sound rigorous? In fact, this term merely hides a trial that was destined to generate a positive result. As it followed the infamous A+B versus B design, it hardly had a chance to not come out positive.

The only thing I find amazing is that the short-term results failed to be statistically significant. Far too many SCAM researchers, it seems to me, view science as a tool for promoting their dubious ideas.

The use of SCAM with the aim of improving QoL might be helpful. But this assumption cannot be accepted on the basis of opinion; we need good science to find out which forms of SCAM are worth employing. Sadly, studies like the above are not in this category.

If you ask me, it is high time that this misleading nonsensical and unethical pseudo-research stops!

Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

“Eating elderberries can help minimise influenza symptoms.” This statement comes from a press release by the University of Sydney. As it turned out, the announcement was not just erroneous but it also had concealed that the in-vitro study that formed the basis for the press-release was part-funded by the very company, Pharmacare, which sells elderberry-based flu remedies.

“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” A University of Sydney spokeswoman confirmed Pharmacare was shown a copy of the press release before it was published.

This is an embarrassing turn of events, no doubt. But what about elderberry (Sambucus nigra) and the flu? Is there any evidence?

A systematic review quantified the effects of elderberry supplementation. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. The authors concluded that these findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.

WHAT?!?!

The alternative to antibiotic misuse can only be the correct use of antibiotics. And, in the case of viral infections such as the flu, this can only be the non-use of antibiotics. My trust in this review, published in a SCAM journal of dubious repute, has instantly dropped to zero.

Perhaps a recent overview recently published in THE MEDICAL LETTER provides a more trustworthy picture:

No large randomized, controlled trials evaluating the effectiveness of elderberry for prevention or treatment of influenza have been conducted to date. Elderberry appears to have some activity against influenza virus strains in vitro. In two small studies (conducted outside the US), adults with influenza A or B virus infection taking elderberry extract reported a shorter duration of symptoms compared to those taking placebo. Consuming uncooked blue or black elderberries can cause nausea and vomiting. The rest of the plant (bark, stems, leaves, and root) contains sambunigrin, which can release cyanide. No data are available on the safety of elderberry use during pregnancy or while breastfeeding. CONCLUSION — Prompt treatment with an antiviral drug such as oseltamivir (Tamiflu, and generics) has been shown to be effective in large randomized, controlled trials in reducing the duration of influenza symptoms, and it may reduce the risk of influenza-related complications. There is no acceptable evidence to date that elderberry is effective for prevention or treatment of influenza and its safety is unclear.

Any take-home messages?

Yes:

  1. Elderberry supplements are not of proven effectiveness against the flu.
  2. The press officers at universities should be more cautious when writing press-releases.
  3. They should involve the scientists and avoid the sponsors of the research.
  4. In-vitro studies can never tell us anything about clinical effectiveness.
  5. SCAM-journals’ articles must be taken with a pinch of salt.
  6. Consumers are being misled left, right and centre.

My former institution, the medical school of Vienna, had invited me to give the key-note for a conference entitled ‘Esoterik in der Medizin‘ (22/5/2019). The event was to celebrate the success of a new course for medical students which was initiated after Prof Frass’ lectures on homeopathy had been discontinued. Remarkably, this move had been prompted by complaints from students arguing that Frass was promoting non-evidence-based, bogus concepts.

Whenever I go back to Vienna, I have mixed feelings; pleasant and not so pleasant memories (see below) come to the fore. This time, however, all turned out well, and I was more than delighted.

The new course signifies the realisation that so-called alternative medicine (SCAM) must be covered in any sound medical curriculum. Once graduated, students will be asked by patients about SCAM and have an ethical duty to inform them responsibly. Thus they need to know the essential facts and not the biased perspective that Frass and other enthusiasts tend to convey.

I have always considered this to be important but, as far as I can see, very few medical school manage to deal with this issue adequately. More often than not, the task of running such courses is given to proponents of SCAM who then try to brain-wash the unsuspecting students. The result can be seriously harmful to generations of patients. I am delighted to report that my former medical school has successfully avoided this pitfall. Quackademia has come to an end in Vienna!

In my view, the highlight of the recent event was the students’ presentation of their course-work. They had been supervised in small groups to research selected topics related to SCAM and were given 5 minute slots to present their findings. I truly felt this was impressive. The dedication, the quality of the research and the clarity of the presentations were extraordinary. In my 40 odd years of teaching medical students, I have never seen anything remotely similar (here I should mention perhaps that, 25 years ago when I was teaching in Vienna, medical students seemed to be as unmotivated as they get).

The students’ presentation were followed by 90 minutes of moderated discussion of the audience (the event was open to the public) and 4 experts. Here too, I was positively surprised by the quality of the contributions and the general openness of the debate.

So, overall the both the meeting and, more importantly, the new course for students can be considered a great success, and the organisers must be congratulated on it. For me personally, the most significant aspect was a matter entirely unrelated to SCAM. It was the introductory speech of the dean of the medical school. He announced me as the key-note speaker by praising my research on the Nazi history of the faculty. It was this research that, to some considerable degree, made me leave Vienna in 1993. To see it now appreciated by my former colleagues is deeply moving.

 

Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.

But is it effective?

The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.

Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).

The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.

I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:

  • Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
  • The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
  • There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
  • There seemed to be a sizable publication bias hidden in the data.
  • All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
  • Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.

I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.

A series of article in The Times yesterday (to which I had made several minor contributions) focussed on the dangers of homeoprophylaxis/homeopathic vaccinations. Sadly, the paper is behind a paywall. I therefore will try to summarise some of the relevant points.

A courageous Times-reporter went under cover to extract some of the anti-vaccination views from a lay homeopath. This particular homeopath happened to charge £330 from customers who want to protect themselves or their family from infectious diseases (£130 for a homeopathic remedy kit, plus £200 for the compulsory instructions via skype that automatically come with the kit). Here are some of the most obvious porkies uttered by that homeopath:

  • Only 30% of healthcare professionals get vaccinated.
  • Rubella is a very mild disease.
  • Cancer patients don’t get fever.
  • Measles mainly kills children with severe disease.
  • Anything which messes with natural immunity could contribute to autism.
  • Health officials devised a seven-step recipe to scare consumers into vaccinating their kids.
  • Fevers should be celebrated.

This new undercover research by the Times is reminiscent of our own investigation of 2002. At the time, we contacted 168 homoeopaths, of whom 104 (72%) responded, 27 (26%) withdrawing their answers after debriefing. We also contacted 63 chiropractors, of whom 22 (44%) responded, six (27%) withdrawing their responses after debriefing.  Only 3% of professional homoeopaths and 25% of the chiropractors advised in favour of the MMR vaccination. Almost half of the homoeopaths and nearly a fifth of the chiropractors advised against it. (This tiny and seemingly insignificant study almost cost me my job: some homeopaths complained to my peers at Exeter University who then, in their infinite wisdom, conducted a most unpleasant investigation into my allegedly ‘unethical’ research; full details of this amazing story are provided in my memoir.)

But perhaps you think that homeoprophylaxis might be effective after all? In this case, you would be mistaken! As discussed a couple of weeks ago, a recent study demonstrated that such treatments are ineffective. Its authors concluded that homeopathic vaccines do not evoke antibody responses and produce a response that is similar to placebo. In contrast, conventional vaccines provide a robust antibody response in the majority of those vaccinated.

The Times article stated that about half of all new parents have been exposed to anti-vaxx propaganda. Consequently, global measles cases have risen by 300% in the first three months of this year compared to last year. Faced with measles outbreaks across the world, it is hard to deny that homeopaths who promote homeopathic vaccinations are a significant risk to public health.

The Times considered the issue sufficiently important to add an editorial. Its opening sentence sums up the issue well, I think: The evidence supporting claims that homeopathic remedies offer an effective alternative to the measles vaccine can be summarised in one word: zero. And its concluding sentences are even clearer: Tobacco companies are obliged to carry prominent public health warnings on their products. Homeopaths should too.

If one agrees with this sentiment, I suggest, we also consider the same for some:

  1. chiropractors;
  2. doctors of anthroposophical medicine;
  3. naturopaths;
  4. doctors practising integrative medicine.

And furthermore I suggest we disregard the many pro-vaccination statements by the professional organisations of these clinicians – they are nothing but semi-transparent fig-leaves and a politically-correct lip services which they neither enforce nor even truly mean.

 

The Canadian Chiropractic Association (CCA)… published a report to support clearer understanding of the chiropractic profession… Here are a few crucial quotes (in bold print) from this document (my are comments in normal print).

Put simply, chiropractors are spine, muscle and nervous system experts specifically trained to diagnose the underlying cause and recommend treatment options to relieve pain, restore mobility and prevent re occurrence without surgery or pharmaceuticals…

By this definition, I am a chiropractor! – and so are osteopaths, physiotherapists, several other SCAM practitioners, and most doctors.

… there is a concept in the pharmaceutical industry known as a risk-benefit analysis which is used to assess how much benefit a medication has compared to the potential risk. The riskier the medication, the less likely it will become mainstream.(2)

The concept of risk/benefit analysis applies to all medicine. It needs, of course, good knowledge of both the risks and the benefits. The second sentence of this paragraph is nonsense and suggests that the CCA fails to understand the concept.

Spinal manipulations should be recommended for patients when a similar risk-benefit assessment has been conducted. This assessment on the safety of chiropractic treatments is performed via the patient intake form and physical examination.

As there is no reporting system of adverse effects of spinal manipulations, a risk/benefit analysis is impossible. The second sentence of this paragraph is nonsense; there are no examinations that tell us about the risks of spinal manipulation.

Adverse reactions lasting less than 24 hours include headaches, stiffness, fatigue, local pain, prickling sensation, nausea, hot skin/flushing, and fainting. In up to 50% of patients, one or more of these have been reported over the span of a lifetime.(3, 4)

Perhaps adverse reactions last ON AVERAGE 24 hours; they can last up to 3 days.  About half of all patients experience such reactions.

Exact numbers on adverse events from chiropractic manipulation are difficult to extract due to variables such as research design, inclusion criteria and study selection. There is still a lot of research to be conducted on the role of spinal manipulation in individuals with serious adverse events.

The frequency of adverse events is unknown because there is no adequate reporting scheme.

Chiropractic treatment is a safe option for the prevention, assessment, diagnosis and management of musculoskeletal conditions and associated neurological system. Canadian chiropractors have over 4,200 hours of core competency training in the musculoskeletal system. It is up to each individual patient and their healthcare provider to assess the safety of chiropractic treatments and potential risks associated, and decide if spinal manipulation is right for them.

There is no good evidence that chiropractic treatment is safe.

There is no good evidence that chiropractic treatment is effective for disease prevention.

Chiropractic treatment is an option for assessment and diagnosis??? This is another nonsensical claim.

Chiropractic treatment is an option for associated neurological system??? Another nonsense!

Each individual patient and their healthcare provider assessing the safety is not an option.

References used in the quotes:

2 Risk: benefit analysis of drugs in practice Drug and Therapeutics Bulletin 1995;33:33-35.

3 Non-drug management of chronic low back pain Drug and Therapeutics Bulletin 2009;47:102-107.

4 Gibbons P, Tehan P. HVLA thrust techniques: what are the risks? International Journal of Osteopathic Medicine. 2006 Mar 1;9(1):4-12.

The references cited are pitiful!

In conclusion, I suggest the CCA re-read their statement and revise it according to the evidence, common sense and the rules of the English language. As it stands, it’s just too embarrassing – even for chiropractic standards!

Chiropractic spinal manipulative therapy (CSMT) for migraine?

Why?

There is no good evidence that it works!

On the contrary, there is good evidence that it does NOT work!

A recent and rigorous study (conducted by chiropractors!) tested the efficacy of chiropractic 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 results show that migraine days were significantly reduced within all three groups from baseline to post-treatment. 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 sustained throughout the RCT. The authors concluded that the effect of CSMT observed in our study is probably due to a placebo response.

One can understand that, for chiropractors, this finding is upsetting. After all, they earn a good part of their living by treating migraineurs. They don’t want to lose patients and, at the same time, they need to claim to practise evidence-based medicine.

What is the way out of this dilemma?

Simple!

They only need to publish a review in which they dilute the irritatingly negative result of the above trial by including all previous low-quality trials with false-positive results and thus generate a new overall finding that alleges CSMT to be evidence-based.

This new systematic review of randomized clinical trials (RCTs) evaluated the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability.

The searches identified 6 RCTs eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. The results showed that spinal manipulation reduced migraine days with an overall small effect size as well as migraine pain/intensity.

The authors concluded that spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Bob’s your uncle!

Perhaps not perfect, but at least the chiropractic profession can now continue to claim they practice something akin to evidence-based medicine, while happily cashing in on selling their unproven treatments to migraineurs!

But that’s not very fair; research is not for promotion, research is for finding the truth; this white-wash is not in the best interest of patients! I hear you say.

Who cares about fairness, truth or conflicts of interest?

Christine Goertz, one of the review-authors, has received funding from the NCMIC Foundation and served as the Director of the Inter‐Institutional Network for Chiropractic Research (IINCR). Peter M. Wayne, another author, has received funding from the NCMIC Foundation and served as the co‐Director of the Inter‐Institutional Network for Chiropractic Research (IINCR)

And who the Dickens are the  NCMIC and the IINCR?

At NCMIC, they believe that supporting the chiropractic profession, including chiropractic research programs and projects, is an important part of our heritage. They also offer business training and malpractice risk management seminars and resources to D.C.s as a complement to the education provided by the chiropractic colleges.

The IINCR is a collaborative effort between PCCR, Yale Center for Medical Informatics and the Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School. They aim at creating a chiropractic research portfolio that’s truly translational. Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic Christine Goertz, DC, PhD (PCCR) is the network director. Peter Wayne, PhD (Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School) will join Anthony J. Lisi, DC (Yale Center for Medical Informatics and VA Connecticut Healthcare System) as a co-director. These investigators will form a robust foundation to advance chiropractic science, practice and policy. “Our collective efforts provide an unprecedented opportunity to conduct clinical and basic research that advances chiropractic research and evidence-based clinical practice, ultimately benefiting the patients we serve,” said Christine Goertz.

Really: benefiting the patients? 

You could have fooled me!

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