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

conflict of interest

The General Chiropractic Council (GCC) is the statutory body regulating all chiropractors in the UK. Their foremost aim, they claim, is to ensure the safety of patients undergoing chiropractic treatment. They also allege to be independent and say they want to protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession.

That sounds good and (almost) convincing.

But is the GCC truly fit for purpose?

In a previous post, I found good reason to doubt it.

In a recent article, the GCC claimed that they started thinking about a new five-year strategy and began to shape four key strategic aims. So, let’s have a look. Here is the crucial passage:

 

A clear strategy is vital but, of course, implementation and getting things changed are where the real work lie. With that in mind, we have a specific business plan for 2019 – the first year of the new strategic plan. You can read it here. This means you’ll see some really important changes and benefits including:

  • Promote standards: review and improvements to CPD processes, supporting emerging new degree providers, a campaign to promote the public choosing a registered chiropractor
  • Develop the profession: supporting and enabling work with the professional bodies
  • Investigate and act: a full review of, and changes to, our Fitness to Practice processes to enable a more ‘right touch’ approach within our current legal framework, sharing more learning from the complaints we receive
  • Deliver value: a focus on communication and engagement, further work on our culture, a new website, an upgraded registration database for an improved user experience.

The changes being introduced, backed by the GCC’s Council, will have a positive effect. I know Nick, the new Chief Executive and Registrar and the staff team will make this a success. You as chiropractors also have an important role to play – keep engaging with us and take your own action to develop the profession, share your ideas and views as we transform the organisation, and work with us to ensure we maintain public confidence in the profession of chiropractic.

END OF QUOTE

Am I the only one who finds this more than a little naïve and unprofessional? More importantly, this statement hints at a strategy mainly aimed at promoting chiropractors regardless of whether they are doing more good than harm. This, it seems, is not in line with the GCC’s stated aims.

  • How can they already claim that the changes being introduced will have a positive effect?
  • Where in this strategy is the GCC’s alleged foremost aim, the protection of the public?
  • Where is any attempt to get chiropractic in line with the principles of EBM?
  • Where is an appeal to chiropractors to adopt the standards of medical ethics?
  • Where is an independent and continuous assessment of the effectiveness of chiropractic?
  • Where is a critical evaluation of its safety?
  • Where is an attempt to protect the public from the plethora of bogus claims made by UK chiropractors?

I feel that, given the recent history of UK chiropractic, these (and many other) points should be essential elements in any long-term strategy. I also feel that this new and potentially far-reaching statement provides little hope that the GCC is on the way towards getting fit for purpose.

I would warn every parent who thinks that taking their child to a chiropractor is a good idea. For this, I have three main reasons:

  1. Chiropractic has not been shown to be effective for any paediatric condition.
  2. Chiropractors often advise parents against vaccinating their children.
  3. Chiropractic spinal manipulations can cause harm to kids.

The latter point seems to be confirmed by a recent PhD thesis of which so far only one short report is available. Here are the relevant bits of information from it:

Katie Pohlman has successfully defended her PhD thesis, which focused on the assessment of safety in pediatric manual therapy. As a clinical research scientist at Parker University, Dallas, Texas, she identified a lack of prospective patient safety research within the chiropractic population in general and investigated this deficit in the paediatric population in particular.

Pohlman used a cross-sectional survey to assess the barriers and facilitators for participation in a patient safety reporting system. At the same time, she also conducted a randomized controlled trial comparing the quantity and quality of adverse event reports in children under 14 years receiving chiropractic care.

The RCT recruited 69 chiropractors and found adverse events reported in 8.8% and 0.1% of active and passive surveillance groups respectively. Of the adverse events reported, 56% were considered mild, 26% were moderate and 18% were severe. The frequency of adverse events was more common than previously thought.

This last sentence from the report is somewhat puzzling. Our systematic review of the risks of spinal manipulation showed that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

The 8.8% reported by Pohlman are therefore not even one fifth of the average incidence figure reported previously in all age groups.

What could be the explanation for this discrepancy?

There are, of course, several possibilities, including the fact that infants cannot tell the clinician when their pain has increased. However, the most likely one, in my view, lies in the fact that RCTs are wholly inadequate for investigating risks because they typically include far too few patients to generate reliable incidence figures about adverse events. More importantly, clinicians included in such studies are self-selected (and thus particularly responsible/cautious) and are bound to behave most carefully while being part of a clinical trial. Therefore it seems possible – I would speculate even likely – that the 8.8% reported by Pohlman is unrealistically low.

Having said that, I do feel that the research by Kathie Pohlman is a step in the right direction and I do applaud her initiative.

The 2018 World Federation of Chiropractic ACC Education Conference was held on 24-27 October in London. It resulted in several consensus statements developed by the attendees. I happen to know this from a short report that has just been published; it can be found here.

Of the 10 points made in this consensus, I find only the following noteworthy:

“Chiropractic education programs have an ethical obligation to support an evidence-based teaching and learning environment.”

Perhaps it is me – English is not my first language – but I find the phraseology used in this sentence strangely complicated and confusing. I have been a teacher of medical students for most of my life, but I am not sure what an ‘evidence-based teaching and learning environment’ is. I know what ‘evidence-based’ means, of course. However, what exactly is:

  • a teaching environment?
  • a learning environment?
  • and how does ‘evidence-based’ apply to either of the two?

Is there evidence that some environments are better suited than others for teaching?

Is there evidence that some environments are better suited than others for learning?

I suppose the answer must be YES!

The environment, i. e. the space and conditions in which teaching and learning happen should, for instance, be/include:

  • quiet,
  • not cramped,
  • not too cold,
  • not too hot,
  • equipped with ergometric chairs and desks,
  • well-lit,
  • there should be visual aids,
  • access to computers,
  • a library,
  • good mentoring and support,
  • etc.

So, the consensus of the education conference wanted to optimise the environmental conditions of teaching and learning for chiropractic lecturers and students? Most laudable, I must say!

But still, it seems like a missed opportunity for an ‘Education Conference’ not to have stated something about the content of teaching and learning. Personally, I find it a pity that they did not state: Chiropractic education programs have an ethical obligation to be evidence-based.

Or is that what they really wanted to say?

Naaahh … come to think of it … they cannot possibly make such a demand.

Why?

Because, in this case, they would have to teach students not to become chiropractors.

Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:

  • medical care,
  • group exercise,
  • individualised exercise plus manual therapy.

All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.

Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).

A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.

The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.

In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.

Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).

Manual therapy procedures used in this trial included:

  • lumbar distraction mobilization,
  • hip joint mobilization,
  • side posture lumbar/sacroiliac joint mobilization,
  • and neural mobilization.

Is there any good reason to assume that these interventions work for LSS? I doubt it!

And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.

And why do I find such studies objectionable?

Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials

  • could harm patients,
  • might waste money,
  • and hinder progress.

 

A few weeks ago, I was interviewed by a journalist who wanted to publish the result in a magazine. He now informed me that his editor decided against it, and the interview thus remained unpublished. I have the journalist’s permission to publish it here. The journalist who, in my view, was well-prepared (much better than most), prefers to remain unnamed.

Q: How would you describe yourself?

A: I am a researcher of alternative medicine.

Q: Not a critic of alternative medicine?

A: Primarily, I am a researcher; after all, I have published more Medline-listed research papers on the subject than anyone else on the planet.

Q: You are retired since a few years; why do you carry on working?

A: Mainly because I see a need for a critical voice amongst all the false and often dangerous claims made by proponents of alternative medicine. But also because I enjoy what I am doing. Since I retired, I can focus on the activities I like. There is nobody to tell me what to do and what not to do; the latter happened far too often when I was still head of my research unit.

Q: Fine, but I still do not quite understand what drives you. Who is motivating you to criticise alternative medicine?

A: Nobody. Some people claim I am paid for my current activities. This is not true. My blog actually costs me money. My books never return enough royalties to break even, considering the time they take to write. And for most of my lectures I don’t charge a penny.

Q: There are people who find this hard to believe.

A: I know. This just shows how money-orientated they are. Do they want me to publish my tax returns?

Q: Sorry, but I still don’t understand your motivation.

A: I guess what motivates me is a sense of responsibility, a somewhat naïve determination to do something good as a physician. I am one of the only – perhaps even THE only – scientist who has researched alternative medicine extensively and who is not a promoter of bogus therapies but voices criticism about them. There are several other prominent and excellent critics of alternative medicine, of course, but they all come ‘from the outside’. I come from the inside of the alternative medicine business. This probably gives me a special understanding of this field. In any case, I feel the responsibility to counter-balance all the nonsense that is being published on a daily basis.

Q: What’s your ultimate aim?

A: I want to create progress through educating people to think more critically.

Q: Which alternative medicine do you hate most?

A: I do not hate any of them. In fact, I still have more sympathy for them than might be apparent. For my blog, for instance, I constantly search for new research papers that are rigorous and show a positive result. The trouble is, there are so very few of those articles. But when I find one, I am delighted to report about it. No, I do not hate or despise any alternative medicine; I am in favour of good science, and I get irritated by poor research. And yes, I do dislike false claims that potentially harm consumers. And yes, I do dislike it when chiropractors or other charlatans defraud consumers by taking their money for endless series of useless interventions.

Q: I noticed you go on about the risks of alternative medicine. But surely, they are small compared to the risks of conventional healthcare, aren’t they?

A: That’s a big topic. To make it simple: alternative medicine is usually portrayed as risk-free. The truth, however, is that there are numerous risks of direct and indirect harm; the latter is usually much more important than the former. Crucially, the risk-free image is incongruent with reality. I want to redress this incongruence. And as to conventional medicine: sure, it can be much more harmful. But one always has to see this in relation to the proven benefit. Chemotherapy, for instance, can kill a cancer patient, but more likely it saves her life. Homeopathic remedies cannot kill you, but employed as an alternative to an effective cancer treatment, homeopathy will certainly kill you.

Q: Homeopathy seems to be your particular hobby horse.

A: Perhaps. This is because it exemplifies alternative medicine in several ways, and because I started my alternative ‘career’ in a homeopathic hospital, all those years ago.

Q: In what way is homeopathy exemplary?

A: Its axioms are implausible, like those of many other alternative modalities. The clinical evidence fails to support the claims, like with so many alternative therapies. And it is seemingly safe, yet can do a lot of harm, like so many other treatments.

Q: You have no qualification in homeopathy, is that right?

A: No, I have no such qualifications. And I never said so. When I want to tease homeopaths a little, I state that I am a trained homeopath; and that is entirely correct.

Q: In several countries, homeopathy has taken spectacular hits recently. Is that your doing?

A: No, I don’t think so. But I do hope that my work has inspired the many dedicated activists who are currently protesting against the reimbursement of homeopathy by the public purse in the UK, Germany, France, Spain, etc.

Q: You often refer to medical ethics; why is that?

A: Because, in the final analysis, many of the questions we already discussed are really ethical issues. And in alternative medicine, few people have so far given the ethical dimensions any consideration. I think ethics are central to alternative medicine, so much so that I co-authored an entire book on this topic this year.

Q: Any plans for the future?

A: Plenty.

Q: Can you tell me more?

A: I will publish another book in 2019 with Springer. It will be a critical evaluation of precisely 150 different alternative modalities. I am thinking of writing yet another book, but have not yet found a literary agent who wants to take me on. I have been offered a new professorship at a private University in Vienna, and am hesitant whether to accept or not. I have been invited to give a few lectures in 2019 and hope to receive more invitations. Last not least, I work almost every day on my blog.

Q: More than enough for a retiree, it seems. Thank you for your time.

A: My pleasure.

On their website, the UK ‘ROYAL COLLEGE OF CHIROPRACTORS (RCC) published a short statement regarding the safety of chiropractic. Here it is in full:

Experiencing mild or moderate adverse effects after manual therapy, such as soreness or stiffness, is relatively common, affecting up to 50% of patients. However, such ‘benign effects’ are a normal outcome and are not unique to chiropractic care.

Cases of serious adverse events, including spinal or neurological problems and strokes caused by damage to arteries in the neck, have been associated with spinal manipulation. Such events are rare with estimates ranging from 1 per 2 million manipulations to 13 per 10,000 patients; furthermore, due to the nature of the underlying evidence in relation to such events (case reports, retrospective surveys and case-control studies), it is very difficult to confirm causation (Swait and Finch, 2017).

For example, while an association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractor visits has been reported in a few case-control studies, the risk of stoke has been found to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly present with neck pain, it is possible they seek therapy for this symptom from a range of practitioners, including chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). This highlights the importance of ensuring careful screening for known neck artery stroke risk factors, or signs or symptoms that there is an ongoing problem, is performed prior to manual treatment of patients (Swait and Finch, 2017). Chiropractors are well trained to do this on a routine basis, and to urgently refer patients if necessary.

END OF QUOTE

The statement reads well but it might not be entirely free from conflicts of interest. Yet, in the name of accuracy, completeness and truthfulness, I take the liberty of making a few slight alterations. Here is my revised version:

Experiencing mild or moderate adverse effects after chiropractic spinal manipulations, such as pain or stiffness (usually lasting 1-3 days and strong enough to impair patients’ quality of life), is very common. In fact, it affects around 50% of all patients. 

Cases of serious adverse events, including spinal or neurological problems and strokes often caused by damage to arteries in the neck, have been reported after spinal manipulation. Such events are probably not frequent (several hundred are on record including about 100 fatalities).  But, as we have never established proper surveillance systems, nobody can tell how often they occur. Furthermore, due to our reluctance of introducing such surveillance, some of us are able to question causality.

An association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractic spinal manipulation has been reported in about 20 independent investigations. Yet one much-criticised case-control study found the risk of stoke to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly have neck pain, it is possible they seek therapy for this symptom from chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). Ensuring careful screening for known neck artery stroke risk factors, or signs that there is an ongoing problem would therefore be important (Swait and Finch, 2017). Sadly, no reliable screening tests exist, and neck pain (the symptom that might be indicative of VAD) continues to be one of the conditions most frequently treated by chiropractors.

I do not expect the RCC to adopt my improved version. In case I am wrong, let me state this: I am entirely free of conflicts of interest and will not charge a fee for my revision. In the interest of advancing public health, I herewith offer it for free.

An article alerted me to a new report on alternative medicine in the NHS. The report itself is so monumentally important that I cannot find it anywhere (if someone finds a link, please let us know). Behind it is our homeopathy-loving friend David Tredinnick MP, chair of the All-Party Parliamentary Group. I am sure you remember him; he is ‘perhaps the worst example of scientific illiteracy in government’. And what has David been up to now?

His new report by the All-Party Parliamentary Group for Integrated Healthcare is urging the NHS to embrace more medicine to ease the mounting burden on service provision. It claims that more patients suffer from two or more long-term health conditions than ever before, and that their number will amount to 18 million by 2025.

And the solution?

Isn’t it obvious?

David Tredinnick MP, chair of the All-Party Parliamentary Group, insists that the current approach being taken by the government is unsustainable for the long-term future of the country. “Despite positive signs that ministers are proving open to change, words must translate into reality. For some time our treasured NHS has faced threats to its financial sustainability and to common trust in the system. Multimorbidity is more apparent now in the UK than at any time in our recent history. As a trend it threatens to swamp a struggling NHS, but the good news is that many self-limiting conditions can be treated at home with the most minimal of expert intervention. Other European governments facing similar challenges have considered the benefits of exploring complementary, traditional and natural medicines. If we are to hand on our most invaluable institution to future generations, so should we.”

Hold on, this sounds familiar!

Wasn’t there something like it before?

Yes, of course, the ‘Smallwood Report‘, commissioned over a decade ago by Prince Charles. It also proclaimed that the NHS could save plenty of money, if it employed more bogus therapies. But it was so full of errors and wrong conclusions that its impact on the NHS was close to zero. At the time, I concluded that the ‘Smallwood report’ is one of the strangest examples of an attempt to review CAM that I have ever seen. One gets the impression that its conclusions were written before the authors had searched for evidence that might match them. Both Mr Smallwood and the ‘Freshminds’ team told me that they understand neither health care nor CAM. Mr Smallwood stressed that this is positive as it prevents him from being ‘accused of bias’. My response was that ‘severely flawed research methodology almost inevitably leads to bias’.

And which other European countries might the Tory Brexiter David refer to?

Not Spain?

Not France?

Not Austria?

Not Germany?

Sadly, I have not seen Tredinnick’s  new oeuvre and do not know its precise content. What I do know, however, that the evidence, for alternative medicine’s cost effectiveness has not improved; if anything, it has become more negative. From that, one can safely conclude that Tredinnick’s notions of NHS-savings through more use of alternative medicine are erroneous. Therefore, I suspect the new report will swiftly and deservedly go the same way as its predecessor, the ‘Smallwood Report’: straight into the bins of Westminster.

Many chiropractors tell new mothers that their child needs chiropractic adjustments because the birth is in their view a trauma for the new-born that causes subluxations of the baby’s spine. Without expert chiropractic intervention, they claim, the poor child risks serious developmental disorders.

This article (one of hundreds) explains it well: Birth trauma is often overlooked by doctors as the cause of chronic problems, and over time, as the child grows, it becomes a thought less considered. But the truth is that birth trauma is real, and the impact it can have on a mother or child needs to be addressed. Psychological therapy, physical therapy, chiropractic care, acupuncture, and other healing techniques should all be considered following an extremely difficult birth.

And another article makes it quite clear what intervention is required: Caesarian section or a delivery that required forceps or vacuum extraction procedures, in-utero constraint, an unusual presentation of the baby, and many more can cause an individual segment of the spine or a region to shift from its normal healthy alignment. This ‘shift’ in the spine is called a Subluxation, and it can happen immediately before, during, or after birth.

Thousands of advertisements try to persuade mothers to take their new-born babies to a chiropractor to get the problem sorted which chiropractors often call KISS (kinetic imbalance due to suboccipital strain-syndrome), caused by intrauterine-constraint or the traumas of birth.

This abundance of advertisements and promotional articles is in sharp contrast with the paucity of scientific evidence.

A review of 1993 concluded that birth trauma remains an underpublicized and, therefore, an undertreated problem. There is a need for further documentation and especially more studies directed toward prevention. In the meantime, manual treatment of birth trauma injuries to the neuromusculoskeletal system could be beneficial to many patients not now receiving such treatment, and it is well within the means of current practice in chiropractic and manual medicine.

A more critical assessment of … concluded that, given the absence of evidence of beneficial effects of spinal manipulation in infants and in view of its potential risks, manual therapy, chiropractic and osteopathy should not be used in infants with the kinetic imbalance due to suboccipital strain-syndrome, except within the context of randomised double-blind controlled trials.

So, what follows from all this?

How about this?

Chiropractors’ assumption of an obligatory birth trauma that causes subluxation and requires spinal adjustments is nothing more than a ploy by charlatans for filling their pockets with the cash of gullible parents.

It is time, I think, to express my gratitude to Dr Jens Behnke, a German homeopath employed by the pro-homeopathy lobby group the ‘Carstens Stiftung’, who diligently tweets trials of homeopathy which he obviously believes prove the value of his convictions.

The primary objective of this new study was to evaluate the efficacy of homoeopathy for women suffering from polycystic ovary syndrome. This condition is characterised by:

  • irregular periods which means your ovaries don’t regularly release eggs,
  • abnormally high levels of male hormones in the body, which may cause physical signs such as excess facial or body hair,
  • polycystic ovaries – ovaries become enlarged and contain many fluid-filled sacs (follicles) which surround the eggs.

There’s no cure for PCOS, but the symptoms can usually be treated. As so often in such situations, homeopaths are happy to step into the fray.

This single-blind, randomised, placebo-controlled pilot study was conducted at two research centres in India. The cases fulfilling the eligibility criteria were enrolled (n = 60) and randomised to either the homoeopathic intervention (HI) (n = 30) or placebo (P) (n = 30) with uniform lifestyle modification (LSM) for 6 months.

The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18) in HI + LSM group and none (n = 0) in control group. Statistically significant difference was observed in the reduction of intermenstrual duration in HI + LSM in comparison to placebo + LSM group. Significant improvements were also observed in HI+LSM group in domains of weight, fertility, emotions and menstrual problems. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated homeopathic remedy.

The authors concluded that HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

This trial might convince believers (mostly because they do not even need convincing), but it cannot convince anybody capable of critical thinking. Here is why:

  • According to its authors, this trial was a pilot study; this means it should not report any results and merely focus on the feasibility of a definitive trial.
  • Researchers were not blinded, meaning that they might have influenced the outcome in more than one way.
  • The primary endpoint was subjective and could have been influenced by the non-blinded researchers.
  • 0% success rate in achieving the primary endpoint in the placebo group is not plausible.
  • Compliance to LSM was not checked; as the homeopathy group lost more weight, these patients seemed to have complied better (probably due to being better motivated by the non-blinded researchers).

So?

My conclusion is not very original but all the more true: POORLY DESIGNED STUDIES USUALLY GENERATE UNRELIABLE RESULTS. 

For some researchers, the question whether homeopathy works beyond a placebo effect is not as relevant as the question whether it works as well as an established treatment. To answer it, they must conduct RCTs comparing homeopathy with a therapy that has been shown beyond reasonable doubt to be effective, i.e better than placebo. Such a drug is, for instance, Ibuprofen.

The purpose of this study was to compare the efficacy of Ibuprofen and homeopathic Belladonna for orthodontic pain. 51 females and 21 males, were included in this study. Cases with non-extraction treatment plan having proper contacts’ mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. They were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group took Belladonna 6C (that’s a dilution of 1: 1000000000000). Patients were given two doses of medication of their respective remedies one hour before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) and one dose 6 h after the placement. Pain scores were recorded on a visual analogue scale (VAS) 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning.

The comparisons showed that there were no differences between the two groups at any time point.

(Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group)

The authors concluded that Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.

FINALLY, THE PROOF HOMEOPATHS HAVE BEEN WAITING FOR: HOMEOPATHY DOES WORK AFTER ALL!

Not so fast – before we draw any conclusions, let’s have a closer look at this study. Here are a few of its limitations (apart from the fact that it was published in a journal that does not exactly belong to the ‘crème de la crème’ of medical publications):

  • Patients obviously knew which group they were assigned to; thus their expectations would have influenced the outcome.
  • The same applies to the researchers (the study could have been ‘blind’ using a ‘double dummy’ method, but the researchers did not use it).
  • The study was an equivalence trial (it did not test whether homeopathy is superior to placebo, but whether its effects are equivalent to Ibuprofen); such studies need sample sizes that are about one dimension larger than was the case here.

Therefore, all this trial does demonstrate that the sample was too small for an existing group difference in favour of Ibuprofen to show.

So sorry, my homeopathic friends!

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