MD, PhD, FMedSci, FSB, FRCP, FRCPEd

clinical trial

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Being constantly on the look-out for new, good quality articles on alternative therapy which suggest that a treatment might actually work, I was excited to find not just one or two but four recent publications on an old favourite of mine: massage therapy.

The first paper described a study aimed to investigate the effect of whole body massage on the vital signs, Glasgow Coma Scale (GCS) scores and arterial blood gases (ABG) in trauma ICU patients.

In a randomized, double-blind trial, 108 trauma ICU patients received whole body massage or routine care only. The patients vital signs; systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR), Temperature (T), GCS score and ABG parameters were measured in both groups before the intervention and 1 hour and 3 hours after the intervention. The patient in experimental group received full body massage in 45 minute by a family member.

Significant differences were observed between experimental and control groups in SBP 1 hour and 3 hours after intervention, DBP, RR and PR 1 hour after intervention, and GCS 1 hour and 3 hours after intervention. Significant differences were also observed between experimental and control groups in O2 saturation, PH and pO2. No significant differences between experimental and control groups were noted in Temperature, pCO2 and HCO3.

The authors concluded that massage therapy is a safe and effective treatment in intensive care units to reduce patient’s physical and psychological problems. Therefore the use of massage therapy is recommended to clinical practice as a routine method.

The second paper reported a clinical trial on 66 male and female nurses working in intensive care units of Isfahan University of Medical Sciences, Iran.

Patients were randomly divided into experimental and control groups. The Occupational Stress Inventory (OSI) (Osipow and Spokane, 1987) was completed by participants of the two groups before, immediately after, and 2 weeks after the intervention. Swedish massage was performed on participants of the experimental group for 25 min in each session, twice a week for 4 weeks.

Results showed a significant difference in favour of the massage therapy in overall mean occupation stress scores between experimental and control groups two weeks after the intervention.

The authors concluded that it is recommended that massage, as a valuable noninvasive method, be used for nurses in intensive care units to reduce their stress, promote mental health, and prevent the decrease in quality of nursing work life.

The third paper described a randomized controlled trial evaluating the effects of post-operative massage in patients undergoing abdominal colorectal surgery.

One hundred twenty-seven patients were randomized to receive a 20-min massage or social visit and relaxation session on postoperative days 2 and 3. Vital signs and psychological well-being (pain, tension, anxiety, satisfaction with care, relaxation) were assessed before and after each intervention.

Post-operative massage significantly improved the patients’ perception of pain, tension, and anxiety, but overall satisfaction was unchanged.

The authors concluded that massage may be beneficial during postoperative recovery for patients undergoing abdominal colorectal surgery. Further studies are warranted to optimize timing and duration and to determine other benefits in this clinical setting.

The fourth paper reported a systematic review was to evaluate the effectiveness of massage on the short- and long-term outcomes of pre-term infants.

Literature searches were conducted using the PRISMA framework. Validity of included studies was assessed using criteria defined by the Cochrane Collaboration. Assessments were carried out independently by two reviewers with a third reviewer to resolve differences.

Thirty-four studies met the inclusion criteria, 3 were quasi-experimental, 1 was a pilot study, and the remaining 30 were RCTs. The outcomes that could be used in the meta-analysis and found in more than three studies suggested that massage improved daily weight gain by 0.53 g, and resulted in a significant improvement in mental scores by 7.89 points. There were no significant effects on length of hospital stay, caloric intake, or weight at discharge. Other outcomes were not analyzed either because the units of measurement varied between studies, or because means and standard deviations were not provided by the authors. The quality of the studies was variable with methods of randomization and blinding of assessment unclear in 18 of the 34 trials.

The authors concluded that massage therapy could be a comforting measure for infants in the NICU to improve weight gain and enhance mental development. However, the high heterogeneity, the weak quality in some studies, and the lack of a scientific association between massage and developmental outcomes preclude making definite recommendations and highlight the need for further RCTs to contribute to the existing body of knowledge.

I am not saying that these articles are flawless, nor that I agree with all of their conclusion. What I am trying to indicate is that we finally have here an alternative therapy that is promising.

Alternative?

When I worked in Germany and later in Austria, massage was considered to be entirely mainstream. It was only after I had moved to the UK when I realised that, in English-speaking countries, it is mostly considered to be alternative. Perhaps this classification is wrong?

Perhaps we should differentiate according to what type of massage we are talking about. In the realm of alternative medicine – and not just there, I suppose – this seems good advice indeed.

The above papers are about classical massage therapy, but there are some types pf massage which are less than conventional: aura-massage, Marma massage, Indian head massage, shiatsu etc. etc. the list seems endless. These are alternative in more than one sense, and they have one thing in common: there is, as far as I can see, no good evidence to show that they do anything to human health.

My conclusion therefore is that, even with something as common as massage therapy, we need to be careful not to be roped in by the charlatans.

Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.

But is the claim really true?

A recent trial might provide the answer.

The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.

Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.

Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.

The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!

Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.

Convinced?

Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:

  • Respect for autonomy – patients must have the right to refuse or choose their treatments.
  • Beneficence – researchers and clinicians must act in the best interest of the patient.
  • Non-maleficence – the expected benefits of interventions must outweigh their risks.
  • Justice – the distribution of health resources must be fair.
  • Respect for persons – patients must be treated with dignity.
  • Truthfulness and honesty – informed consent is an essential element in research and clinical practice.

While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?

After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.

  1. Nonsensical research projects
  2. Lack of informed consent

NONSENSICAL RESEARCH PROJECTS

At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.

But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.

I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.

INFORMED CONSENT

Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.

In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.

But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:

  • you will receive either a homeopathic remedy or a placebo,
  • the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
  • this means that you will receive either a homeopathic or a conventional placebo,
  • neither of these can possibly help your condition,
  • the study can therefore not advance our knowledge in any way,
  • during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.

If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.

I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.

CONCLUSION

There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.

Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:

The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).

Conclusions

Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

Let us be clear about what has happened here. I think, the events can be summarised as follows:

  • the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
  • they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
  • the question raises, what should the researchers give to the control group?
  • someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
  • the researchers are impressed and ask: but what precisely could we use?
  • let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
  • another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
  • the team is in agreement,
  • Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
  • a protocol is written,
  • ethics approval is obtained,
  • the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.

And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.

BOB’S YOUR UNCLE!

EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.

When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.

A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.

The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.

At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.

This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.

This is not disappointing; in my view, this is scientific misconduct by

  • the authors,
  • the institutions employing the authors,
  • the ethics committee that has passed the ‘research’,
  • the sponsors of the ‘research’,
  • the peer-reviewers of the paper,
  • the journal and its editors responsible for publishing this paper.

The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.

A new RCT of Reiki healing has been published by US authors from the following institutions: Union Institute & University, Psychology Program, Brattleboro, VT, Coyote Institute, Augusta and Bangor, ME, Eastern Maine Medical Center and Acadia Hospital, Bangor, ME, University of New England College of Osteopathic Medicine, Biddeford, ME, Coyote Institute, Orono, ME. The purpose of this study was to determine if 30 minutes of healing touch could reduce burnout in community mental health clinicians.

The authors utilized a crossover design to explore the efficacy of Reiki versus sham Reiki, a pseudo treatment performed by volunteers who had no experience with Reiki and pretended to be healers vis-à-vis the patients. This sham control intervention was designed to mimic true Reiki.

Subjects were randomized to whether they started with Reiki or sham. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Measure Your Medical Outcome Profile Version 2 (MYMOP-2) were used as outcome measures. Multilevel modeling was used to represent the relations among variables.

The results showed that real Reiki was significantly better than sham Reiki in reducing burnout among community mental health clinicians. Reiki was significant in reducing depersonalization, but only among single people. Reiki reduced the primary symptom on the MYMOP also only among single people.

The authors concluded that the effects of Reiki were differentiated from sham Reiki. Reiki could be helpful in community mental health settings for the mental health of the practitioners.

My team has published on Reiki (see here and here, for instance), and on this blog I have repeatedly been expressed my doubts that Reiki is more than an elaborate placebo (see here and here, for instance). Do these new results mean that I need to eat my words and henceforth praise the wonders of Reiki? No, I don’t think so!

Having conducted studies on ‘energy healing’ myself, I know only too well of the many pitfalls and possibilities of generating false-positive findings with such research. This new study has many flaws, but we need not look far to find the reason for the surprising and implausible finding. Here is my explanation why this study suggests one placebo to be superior to another placebo.

The researchers had to recruit 16 Reiki healers and several non-Reiki volunteers to perform the interventions on the small group of patients. It goes without saying that the Reiki healers were highly motivated to demonstrate the value of their therapy. This means they (unintentionally?) used verbal and non-verbal communication to maximise the placebo effect of their treatment. The sham healers, of course, lacked such motivation. In my view, this seemingly trivial difference alone is capable of producing the false-positive result above.

There are, of course, ways of minimising the danger of such confounding. In our own study of ‘energy healing’ with sham healers as controls, for instance, we instructed both the healers and the sham healers to abstain from all communication with their patients, we filmed each session to make sure, and we asked each patient to guess which treatment they had received. None of these safeguards were incorporated in the present study – I wonder why!

In the realm of alternative medicine, we encounter many therapeutic claims that beggar belief. This is true for most modalities but perhaps for none more than chiropractic. Many chiropractors still adhere to Palmer’s gospel of the ‘inate’, ‘subluxation’ etc. and thus they believe that their ‘adjustments’ are a cure all. Readers of this blog will know all that, of course, but even they might be surprised by the notion that a chiropractic adjustment improves the voice of a choir singer.

This, however, is precisely the ‘hypothesis’ that was recently submitted to an RCT. To be precise, the study investigated the effect of spinal manipulative therapy (SMT) on the singing voice of male individuals.

Twenty-nine subjects were selected among male members of a local choir. Participants were randomly assigned to two groups: (A) a single session of chiropractic SMT and (B) a single session of non-therapeutic transcutaneous electrical nerve stimulation (TENS). Recordings of the singing voice of each participant were taken immediately before and after the procedures. After a 14-day wash-out period, procedures were switched between groups: participants who underwent SMT on the first occasion were now subjected to TENS and vice versa. Recordings were assessed via perceptual audio and acoustic evaluations. The same recording segment of each participant was selected. Perceptual audio evaluation was performed by a specialist panel (SP). Recordings of each participant were randomly presented thus making the SP blind to intervention type and recording session (before/after intervention). Recordings compiled in a randomized order were also subjected to acoustic evaluation.

No differences in the quality of the singing on perceptual audio evaluation were observed between TENS and SMT.

The authors concluded that no differences in the quality of the singing voice of asymptomatic male singers were observed on perceptual audio evaluation or acoustic evaluation after a single spinal manipulative intervention of the thoracic and cervical spine.

Laughable? Yes!

There is nevertheless an important point to be made here, I feel: some claims are just too silly to waste resources on. Or, to put it in more scientific terms, hypotheses require much more than a vague notion or hunch.

To set up, conduct and eventually publish an RCT as above requires expertise, commitment, time and money. All of this is entirely wasted, if the prior probability of a relevant result approaches zero. In the realm of alternative medicine, this is depressingly often the case. In the final analysis, this suggests that all too often research in this area achieves nothing other than giving science a bad name.

This post is dedicated to all homeopathic character assassins.

Some ardent homeopathy fans have reminded me that, some 25  years ago, I published (OH, WHAT A SCANDAL!!!) a positive trial of homeopathy; I even found a website that proudly announces this fact. Homeopaths seem jubilant about this discovery (not because they now need to revise their allegations that I never did any trials; or the other, equally popular claim, that I have always been squarely against their trade but) because the implication is that even I have to concede that homeopathic remedies are better than placebo. In their view, this seems to beg the following important and embarrassing questions:

  • Why did I change my mind?
  • Am I not contradicting myself?
  • Who has bribed me?
  • Am I in the pocket of Big Pharma?
  • Does this ‘skeleton in my closet’ discredit me for all times?

I remember the trial in question quite well. We conducted it during my time in Vienna, and I am proud of several innovative ideas that went into it. Here is the abstract in full:

The aim of this study was to test the effectiveness of a combined homeopathic medication in primary varicosity. A well-defined population of 61 patients was randomized into active medication (Poikiven®) or placebo. Both were given for 24 d. At the start of the trial, after 12 d medication and at the end of the study, objective and subjective parameters were recorded: venous filling time, leg volume, calf circumference, haemorheological measurements and patients’ symptoms such as cramps, itching, leg heaviness, pain during standing and the need to elevate the legs. The results show that venous filling time is changed by 44% towards normal in the actively-treated group. The average leg volume fell significantly more in this group, but calf circumferences did not change significantly and blood rheology was not altered in any relevant way. None of the patients reported side-effects. Subjective complaints were relieved significantly more by Poikiven than by placebo. These results suggest that the oral treatment of primary varicosity using Poikiven is feasible.

So, there we have it: a homeopathic remedy (as tested by me) is clearly better than placebo normalising important objective parameters as well as subjective symptoms of varicose veins. Is that not a contradiction of what I keep saying today, namely that homeopathy is a placebo therapy?

YES AND NO! (But much more NO than YES)

Yes, because that was clearly our result, and I never tried to deny it.

No, because our verum was far from being a homeopathic, highly diluted remedy. It contained Aesculus D1 12,5 ml, Arnica D1 2,5 ml, Carduus marianus D1 5 ml, Hamamelis D1 10 ml, Lachesis D6 5 ml, Lycopodium D4 5 ml, Melilotus officinalis D1 10 ml. Take just the first of these ingredients, Aesculus or horse chestnut. This is a herbal medicine that has been well documented (even via a Cochrane review) to be effective for the symptoms of varicose veins, and it contains Aesculus in the D1 potency. This means that it is diluted merely by a factor of 1:10. So, for all intents and purposes, our verum was herbal by nature, and there is no surprise at all that we found it to be effective.

[Here is a little ‘aside’: Aesculus is a proven treatment for varicose veins. Homeopathy must always rely on the ‘like cures like’ principle. Therefore, if Aesculus had been used in the homeopathic way, would it not, according to homeopathic dogma, had to worsen the symptoms of our patients rather than alleviating them?]

All of this would be trivial to the extreme, if it did not touch upon an important and confusing point which is often used as an ‘escape route’ by homeopaths when they find themselves between a rock and a hard place. Some trials of homeopathy are positive because they use medications which are homeopathic only by name. This regularly creates considerable confusion. In the recent BMJ debate I tried to address this issue head on by stating at the outset: ” Nobody questions, of course, that some substances used in homeopathy, such as arsenic or strychnine, can be pharmacologically active, but homeopathic medicines are typically far too dilute to have any effect.”

And that’s the point: homeopathic remedies beyond a C12 potency contain nothing, less dilute ones contain little to very little, and D1 potencies are hardy diluted at all and thus contain substantial amounts of active ingredients. Such low potencies are rarely used by homeopaths and should be called PSEUDO-HOMEOPATHIC, in my view. Homeopaths tend to use this confusing complexity to wriggle out of difficult arguments, and often they rely on systematic reviews of homeopathic trials which can generate somewhat confusing overall findings because of such PSEUDO-HOMEOPATHIC remedies.

To make it perfectly clear: the typical homeopathic remedy is far too dilute to have any effect. When scientists or the public at large speak of homeopathic remedies, we don’t mean extracts of Aesculus or potent poisons like Arsenic D1 (has anyone heard of someone claiming to have killed rats with homeopathy?); we refer to the vast majority of remedies which are highly dilute and contain no or very few active molecules – even when we do not explain this somewhat complicated and rather tedious circumstance each and every time. I therefore declare once and for all that, unless I indicate otherwise, I do NOT mean potencies below C6 when I speak of a ‘homeopathic remedy’ (sorry homeopathy fans, perhaps I should have done this when I started this blog).

What if our Vienna study all those years ago had tested not the pseudo-homeopathic ‘Poikiven’ but a highly dilute, real homeopathic remedy and had still come up with a positive finding? Would that make me inconsistent, dishonest, untrustworthy or corrupt? Certainly not!

I have always urged people to not go by the results of single trials. There are numerous reasons why a single study can produce a misleading result. We should therefore, wherever possible, rely on systematic reviews that critically evaluate the totality of the evidence (I would always mistrust even my own trial data, if it contradicted the totality of the reliable evidence) – and such analyses clearly fail to show that homeopathy is more than a placebo.

And even, if none of this had happened, and I had just changed my mind about homeopathy because

  • the evidence changed,
  • I had become wiser,
  • I had learnt how to think like a scientist,
  • I had managed to see behind the smokescreen many homeopaths put up to hide the truth?

Would that discredit me? I don’t think so! As someone once said, being able to change one’s mind is a sign of intelligence.

I am sure that the weird world of homeopathic character assassination will soon find something else to discredit me – but for now…

I REST MY CASE.

Chiropractors are back pain specialists, they say. They do not pretend to treat non-spinal conditions, they claim.

If such notions were true, why are so many of them still misleading the public? Why do many chiropractors pretend to be primary care physicians who can take care of most illnesses regardless of any connection with the spine? Why do they continue to happily promote bogus treatments? Why do chiropractors, for instance, claim they can treat gastrointestinal diseases?

This recent narrative review of the literature, for example, was aimed at summarising studies describing the management of disorders of the gastrointestinal (GI) tract using ‘chiropractic therapy’ broadly defined here as spinal manipulation therapy, mobilizations, soft tissue therapy, modalities and stretches.

Twenty-one articles were found through searching the published literature to meet the authors’ inclusion criteria. The retrieved articles included case reports to clinical trials to review articles. The majority of articles chronicling patient experiences under chiropractic care reported that they experienced mild to moderate improvements in GI symptoms. No adverse effects were reported.

From this, the authors concluded that chiropractic care can be considered as an adjunctive therapy for patients with various GI conditions providing there are no co-morbidities.

I think, we would need to look for a long time to find an article with conclusions that are more ridiculous, false and unethical than these.

The old adage applies: rubbish in, rubbish out. If we include unreliable reports such as anecdotes, our finding will be unreliable as well. If we do not make this mistake and conduct a proper systematic review, we will arrive at very different conclusions. My own systematic review, for instance, of controlled clinical trials drew the following conclusion: There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

That probably says it all. I only want to add a short question: SHOULD THIS LATEST CHIROPRACTIC ATTEMPT TO MISLEAD THE PUBLIC BE CONSIDERED ‘SCIENTIFIC MISCONDUCT’ OR ‘FRAUD’?

Osteopathy is a difficult subject. In the US, osteopaths are (almost) identical with doctors who have studied conventional medicine and hardly practice any manipulative techniques at all. Elsewhere, osteopaths are alternative healthcare providers specialising in what they like to call ‘osteopathic manipulative therapy’ (OMT). As though this is not confusing enough, osteopaths are doing similar things as chiropractors but are adamant that they are a distinct profession. Despite these assertions, I have seen little to clearly differentiate the two – with one exception perhaps: osteopaths tend to use techniques that are less frequently associated with severe harm.

Despite this confusion, or maybe because of it, we need to ask: DOES OMT WORK?

A recent study was aimed at assessing the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability. All patients admitted to the Department of Neurology of Ancona’s United Hospitals, Italy, with a diagnosis of migraine and without chronic illness, were considered eligible for this 3-armed RCT.

Patients were randomly divided into three (1) OMT+medication therapy, (2) sham+medication therapy and (3) medication therapy only and received 8 treatments during 6 months. Changes in the HIT-6 score were considered as the main outcome measure.

A total of 105 subjects were included. At the end of the study, OMT significantly reduced HIT-6 score, drug consumption, days of migraine, pain intensity and functional disability.

The investigators concluded that these findings suggest that OMT may be considered a valid procedure for the management of migraineurs.

Similar results have been reported elsewhere:

One trial, for instance, concluded: “This study affirms the effects of OMT on migraine headache in regard to decreased pain intensity and the reduction of number of days with migraine as well as working disability, and partly on improvement of HRQoL. Future studies with a larger sample size should reproduce the results with a control group receiving placebo treatment in a long-term follow-up.”

Convinced? No, I am not.

Why? Because the studies that do exist seem a little too good to be true; because they are few and far between, because the few studies tend to be flimsy and have been published in dodgy journals, because they lack independent replications, and because critical reviews seem to conclude that OMT is nowhere near as promising as some osteopaths would like us to believe: “Further studies of improved quality are necessary to more firmly establish the place of physical modalities in the treatment of primary headache disorders. With the exception of high velocity chiropractic manipulation of the neck, the treatments are unlikely to be physically dangerous, although the financial costs and lost treatment opportunity by prescribing potentially ineffective treatment may not be insignificant. In the absence of clear evidence regarding their role in treatment, physicians and patients are advised to make cautious and individualized judgments about the utility of physical treatments for headache management; in most cases, the use of these modalities should complement rather than supplant better-validated forms of therapy.”

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