MD, PhD, FMedSci, FSB, FRCP, FRCPEd

clinical trial

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Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.

  1. Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
  2. We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
  3. Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
  4. The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
  5. The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
  6. Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
  7. Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.

Reiki is a form of energy healing that evidently has been getting so popular that, according to the ‘Shropshire Star’, even stressed hedgehogs are now being treated with this therapy. In case you argue that this publication is not cutting edge when it comes to reporting of scientific advances, you may have a point. So, let us see what evidence we find on this amazing intervention.

A recent systematic review of the therapeutic effects of Reiki concludes that the serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness. High-quality randomized controlled trials are needed to address the effectiveness of Reiki over placebo. Considering that this article was published in the JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, this is a fairly damming verdict. The notion that Reiki is but a theatrical placebo recently received more support from a new clinical trial.

This pilot study examined the effects of Reiki therapy and companionship on improvements in quality of life, mood, and symptom distress during chemotherapy. Thirty-six breast cancer patients received usual care, Reiki, or a companion during chemotherapy. Data were collected from patients while they were receiving usual care. Subsequently, patients were randomized to either receive Reiki or a companion during chemotherapy. Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4. Reiki was rated relaxing and caused no side effects. Both Reiki and companion groups reported improvements in quality of life and mood that were greater than those seen in the usual care group.

The authors of this study conclude that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.

This is an odd conclusion, if there ever was one. Clearly the ‘companionship’ group was included to see whether Reiki has effects beyond simply providing sympathetic attention. The results show that this is not the case. It follows, I think, that Reiki is a placebo; its perceived relaxing effects are the result of non-specific phenomena which have nothing to do with Reiki per se. The fact that the authors fail to spell this out more clearly makes me wonder whether they are researchers or promoters of Reiki.

Some people will feel that it does not matter how Reiki works, the main thing is that it does work. I beg to differ!

If its effects are due to nothing else than attention and companionship, we do not need ‘trained’ Reiki masters to do the treatment; anyone who has time, compassion and sympathy can do it. More importantly, if Reiki is a placebo, we should not mislead people that some super-natural energy is at work. This only promotes irrationality – and, as Voltaire once said: those who make you believe in absurdities can make you commit atrocities.

A special issue of Medical Care has just been published; it was sponsored by the Veterans Health Administration’s Office of Patient Centered Care and Cultural Transformation. A press release made the following statement about it:

Complementary and alternative medicine therapies are increasingly available, used, and appreciated by military patients, according to Drs Taylor and Elwy. They cite statistics showing that CAM programs are now offered at nearly 90 percent of VA medical facilities. Use CAM modalities by veterans and active military personnel is as at least as high as in the general population.

If you smell a bit of the old ad populum fallacy here, you may be right. But let’s look at the actual contents of the special issue. The most interesting article is about a study testing acupuncture for posttraumatic stress disorder (PTSD).

Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care (UPC) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone. Outcomes were assessed at baseline and 4, 8, and 12 weeks postrandomization. The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist (PCL) and the Clinician-administered PTSD Scale (CAPS) from baseline to 12-week follow-up between the two treatment groups. Secondary outcomes were depression, pain severity, and mental and physical health functioning. Mixed model regression and t test analyses were applied to the data.

The results show that the mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC. Acupuncture was also associated with significantly greater improvements in depression, pain, and physical and mental health functioning. Pre-post effect-sizes for these outcomes were large and robust.

The authors conclude from these data that acupuncture was effective for reducing PTSD symptoms. Limitations included small sample size and inability to parse specific treatment mechanisms. Larger multisite trials with longer follow-up, comparisons to standard PTSD treatments, and assessments of treatment acceptability are needed. Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment.

What shall we make of this?

I know I must sound like a broken record to some, but I have strong reservations that the interpretation provided here is correct. One does not even need to be a ‘devil’s advocate’ to point out that the observed outcomes may have nothing at all to do with acupuncture per se. A much more rational interpretation of the findings would be that the 8 times 60 minutes of TLC and attention have positive effects on the subjective symptoms of soldiers suffering from PTSD. No needles required for this to happen; and no mystical chi, meridians, life forces etc.

It would, of course, have been quite easy to design the study such that the extra attention is controlled for. But the investigators evidently did not want to do that. They seemed to have the desire to conduct a study where the outcome was clear even before the first patient had been recruited. That some if not most experts would call this poor science or even unethical may not have been their primary concern.

The question I ask myself is, why did the authors of this study fail to express the painfully obvious fact that the results are most likely unrelated to acupuncture? Is it because, in military circles, Occam’s razor is not on the curriculum? Is it because critical thinking has gone out of fashion ( – no, it is not even critical thinking to point out something that is more than obvious)? Is it then because, in the present climate, it is ‘politically’ correct to introduce a bit of ‘holistic touchy feely’ stuff into military medicine?

I would love to hear what my readers think.

Acute tonsillitis (AT) is an upper respiratory tract infection which is prevalent, particularly in children. The cause is usually a viral or, less commonly, a bacterial infection. Treatment is symptomatic and usually consists of ample fluid intake and pain-killers; antibiotics are rarely indicated, even if the infection is bacterial by nature. The condition is self-limiting and symptoms subside normally after one week.

Homeopaths believe that their remedies are effective for AT – but is there any evidence? A recent trial seems to suggest there is.

It aimed, according to its authors, to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa.

The double-blind, placebo-controlled RCT was a 6-day “pilot study” and included 30 children aged 6 to 12 years, with acute viral tonsillitis. Participants took two tablets 4 times per day. The treatment group received lactose tablets medicated with the homeopathic complex (Atropa belladonna D4, Calcarea phosphoricum D4, Hepar sulphuris D4, Kalium bichromat D4, Kalium muriaticum D4, Mercurius protoiodid D10, and Mercurius biniodid D10). The placebo consisted of the unmedicated vehicle only. The Wong-Baker FACES Pain Rating Scale was used for measuring pain intensity, and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms.

The results showed that the treatment group had a statistically significant improvement in the following symptoms compared with the placebo group: pain associated with tonsillitis, pain on swallowing, erythema and inflammation of the pharynx, and tonsil size.

The authors drew the following conclusions: the homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis. No patients reported any adverse effects. These preliminary findings are promising; however, the sample size was small and therefore a definitive conclusion cannot be reached. A larger, more inclusive research study should be undertaken to verify the findings of this study.

Personally, I agree only with the latter part of the conclusion and very much doubt that this study was able to “determine the efficacy” of the homeopathic product used. The authors themselves call their trial a “pilot study”. Such projects are not meant to determine efficacy but are usually designed to determine the feasibility of a trial design in order to subsequently mount a definitive efficacy study.

Moreover, I have considerable doubts about the impartiality of the authors. Their affiliation is “Department of Homoeopathy, University of Johannesburg, Johannesburg, South Africa”, and their article was published in a journal known to be biased in favour of homeopathy. These circumstances in itself might not be all that important, but what makes me more than a little suspicious is this sentence from the introduction of their abstract:

“Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children, offering earlier symptom resolution, cost-effectiveness, and fewer adverse effects.”

A useful alternative to conventional medications (there are no conventional drugs) for earlier symptom resolution?

If it is true that the usefulness of homeopathic remedies has been established, why conduct the study?

If the authors were so convinced of this notion (for which there is, of course, no good evidence) how can we assume they were not biased in conducting this study?

I think that, in order to agree that a homeopathic remedy generates effects that differ from those of placebo, we need a proper (not a pilot) study, published in a journal of high standing by unbiased scientists.

Rigorous research into the effectiveness of a therapy should tell us the truth about the ability of this therapy to treat patients suffering from a given condition — perhaps not one single study, but the totality of the evidence (as evaluated in systematic reviews) should achieve this aim. Yet, in the realm of alternative medicine (and probably not just in this field), such reviews are often highly contradictory.

A concrete example might explain what I mean.

There are numerous systematic reviews assessing the effectiveness of acupuncture for fibromyalgia syndrome (FMS). It is safe to assume that the authors of these reviews have all conducted comprehensive searches of the literature in order to locate all the published studies on this subject. Subsequently, they have evaluated the scientific rigor of these trials and summarised their findings. Finally they have condensed all of this into an article which arrives at a certain conclusion about the value of the therapy in question. Understanding this process (outlined here only very briefly), one would expect that all the numerous reviews draw conclusions which are, if not identical, at least very similar.

However, the disturbing fact is that they are not remotely similar. Here are two which, in fact, are so different that one could assume they have evaluated a set of totally different primary studies (which, of course, they have not).

One recent (2014) review concluded that acupuncture for FMS has a positive effect, and acupuncture combined with western medicine can strengthen the curative effect.

Another recent review concluded that a small analgesic effect of acupuncture was present, which, however, was not clearly distinguishable from bias. Thus, acupuncture cannot be recommended for the management of FMS.

How can this be?

By contrast to most systematic reviews of conventional medicine, systematic reviews of alternative therapies are almost invariably based on a small number of primary studies (in the above case, the total number was only 7 !). The quality of these trials is often low (all reviews therefore end with the somewhat meaningless conclusion that more and better studies are needed).

So, the situation with primary studies of alternative therapies for inclusion into systematic reviews usually is as follows:

  • the number of trials is low
  • the quality of trials is even lower
  • the results are not uniform
  • the majority of the poor quality trials show a positive result (bias tends to generate false positive findings)
  • the few rigorous trials yield a negative result

Unfortunately this means that the authors of systematic reviews summarising such confusing evidence often seem to feel at liberty to project their own pre-conceived ideas into their overall conclusion about the effectiveness of the treatment. Often the researchers are in favour of the therapy in question – in fact, this usually is precisely the attitude that motivated them to conduct a review in the first place. In other words, the frequently murky state of the evidence (as outlined above) can serve as a welcome invitation for personal bias to do its effect in skewing the overall conclusion. The final result is that the readers of such systematic reviews are being misled.

Authors who are biased in favour of the treatment will tend to stress that the majority of the trials are positive. Therefore the overall verdict has to be positive as well, in their view. The fact that most trials are flawed does not usually bother them all that much (I suspect that many fail to comprehend the effects of bias on the study results); they merely add to their conclusions that “more and better trials are needed” and believe that this meek little remark is sufficient evidence for their ability to critically analyse the data.

Authors who are not biased and have the necessary skills for critical assessment, on the other hand, will insist that most trials are flawed and therefore their results must be categorised as unreliable. They will also emphasise the fact that there are a few reliable studies and clearly point out that these are negative. Thus their overall conclusion must be negative as well.

In the end, enthusiasts will conclude that the treatment in question is at least promising, if not recommendable, while real scientists will rightly state that the available data are too flimsy to demonstrate the effectiveness of the therapy; as it is wrong to recommend unproven treatments, they will not recommend the treatment for routine use.

The difference between the two might just seem marginal – but, in fact, it is huge: IT IS THE DIFFERENCE BETWEEN MISLEADING PEOPLE AND GIVING RESPONSIBLE ADVICE; THE DIFFERENCE BETWEEN VIOLATING AND ADHERING TO ETHICAL STANDARDS.

One of the problems regularly encountered when evaluating the effectiveness of chiropractic spinal manipulation is that there are numerous chiropractic spinal manipulative techniques and clinical trials rarely provide an exact means of differentiating between them. Faced with a negative studies, chiropractors might therefore argue that the result was negative because the wrong techniques were used; therefore they might insist that it does not reflect chiropractic in a wider sense. Others claim that even a substantial body of negative evidence does not apply to chiropractic as a whole because there is a multitude of techniques that have not yet been properly tested. It seems as though the chiropractic profession wants the cake and eat it.

Amongst the most commonly used is the ‘DIVERSIFIED TECHNIQUE’ (DT) which has been described as follows: Like many chiropractic and osteopathic manipulative techniques, Diversified is characterized by a high velocity low amplitude thrust. Diversified is considered the most generic chiropractic manipulative technique and is differentiated from other techniques in that its objective is to restore proper movement and alignment of spine and joint dysfunction.

Also widely used is a technique called ‘FLEXION DISTRACTION’ (FD) which involves the use of a specialized table that gently distracts or stretches the spine and which allows the chiropractor to isolate the area of disc involvement while slightly flexing the spine in a pumping rhythm.

The ‘ACTIVATOR TECHNIQUE’ (AT) seems a little less popular; it involves having the patient lie in a prone position and comparing the functional leg lengths. Often one leg will seem to be shorter than the other. The chiropractor then carries out a series of muscle tests such as having the patient move their arms in a certain position in order to activate the muscles attached to specific vertebrae. If the leg lengths are not the same, that is taken as a sign that the problem is located at that vertebra. The chiropractor treats problems found in this way moving progressively along the spine in the direction from the feet towards the head. The activator is a small handheld spring-loaded instrument which delivers a small impulse to the spine. It was found to give off no more than 0.3 J of kinetic energy in a 3-millisecond pulse. The aim is to produce enough force to move the vertebrae but not enough to cause injury.

There is limited research comparing the effectiveness of these and the many other techniques used by chiropractors, and the few studies that are available are usually less than rigorous and their findings are thus unreliable. A first step in researching this rather messy area would be to determine which techniques are most frequently employed.

The aim of this new investigation was to do just that, namely to provide insight into which treatment approaches are used most frequently by Australian chiropractors to treat spinal musculoskeletal conditions.

A questionnaire was sent online to the members of the two main Australian chiropractic associations in 2013. The participants were asked to provide information on treatment choices for specific spinal musculoskeletal conditions.

A total of 280 responses were received. DT was the first choice of treatment for most of the included conditions. DT was used significantly less in 4 conditions: cervical disc syndrome with radiculopathy and cervical central stenosis were more likely to be treated with AT. FD was used almost as much as DT in the treatment of lumbar disc syndrome with radiculopathy and lumbar central stenosis. More experienced Australian chiropractors use more AT and soft tissue therapy and less DT compared to their less experienced chiropractors. The majority of the responding chiropractors also used ancillary procedures such as soft tissue techniques and exercise prescription in the treatment of spinal musculoskeletal conditions.

The authors concluded that this survey provides information on commonly used treatment choices to the chiropractic profession. Treatment choices changed based on the region of disorder and whether neurological symptoms were present rather than with specific diagnoses. Diversified technique was the most commonly used spinal manipulative therapy, however, ancillary procedures such as soft tissue techniques and exercise prescription were also commonly utilised. This information may help direct future studies into the efficacy of chiropractic treatment for spinal musculoskeletal disorders.

I am a little less optimistic that this information will help to direct future research. Critical readers might have noticed that the above definitions of two commonly used techniques are rather vague, particularly that of DT.

Why is that so? The answer seems to be that even chiropractors are at a loss coming up with a good definition of their most-used therapeutic techniques. I looked hard for a more precise definition but the best I could find was this: Diversified is characterized by the manual delivery of a high velocity low amplitude thrust to restricted joints of the spine and the extremities. This is known as an adjustment and is performed by hand. Virtually all joints of the body can be adjusted to help restore proper range of motion and function. Initially a functional and manual assessment of each joint’s range and quality of motion will establish the location and degree of joint dysfunction. The patient will then be positioned depending on the region being adjusted when a specific, quick impulse will be delivered through the line of the joint in question. The direction, speed, depth and angles that are used are the product of years of experience, practice and a thorough understanding of spinal mechanics. Often a characteristic ‘crack’ or ‘pop’ may be heard during the process. This is perfectly normal and is nothing to worry about. It is also not a guide as to the value or effectiveness of the adjustment.

This means that the DT is not a single method but a hotchpotch of techniques; this assumption is also confirmed by the following quote: The diversified technique is a technique used by chiropractors that is composed of all other techniques. It is the most commonly used technique and primarily focuses on spinal adjustments to restore function to vertebral and spinal problems.

What does that mean for research into chiropractic spinal manipulation? It means, I think, that even if we manage to define that a study was to test the effectiveness of one named chiropractic technique, such as DT, the chiropractors doing the treatments would most likely do what they believe is required for each individual patient.

There is, of course, nothing wrong with that approach; it is used in many other area of health care as well. In such cases, we need to view the treatment as something like a ‘black box'; we test the effectiveness of the black box without attempting to define its exact contents, and we trust that the clinicians in the trial are well-trained to use the optimal mix of techniques as needed for each individual patient.

I would assume that, in most studies available to date, this is precisely what already has been implemented. It is simply not reasonable to assume that a trial the trialists regularly instructed the chiropractors not to use the optimal treatments.

What does that mean for the interpretation of the existing trial evidence? It means, I think, that we should interpret it on face value. The clinical evidence for chiropractic treatment of most conditions fails to be convincingly positive. Chiropractors often counter that such negative findings fail to take into account that chiropractors use numerous different techniques. This argument is not valid because we must assume that in each trial the optimal techniques were administered.

In other words, the chiropractic attempt to have the cake and eat it has failed.

A reader of this blog recently sent me the following message: “Looks like this group followed you recent post about how to perform a CAM RCT!” A link directed me to a new trial of ear-acupressure. Today is ‘national acupuncture and oriental medicine day’ in the US, a good occasion perhaps to have a critical look at it.

The aim of this study was to assess the effectiveness of ear acupressure and massage vs. control in the improvement of pain, anxiety and depression in persons diagnosed with dementia.

For this purpose, the researchers recruited a total of 120 elderly dementia patients institutionalized in residential homes. The participants were randomly allocated, to three groups:

  • Control group – they continued with their routine activities;
  • Ear acupressure intervention group – they received ear acupressure treatment (pressure was applied to acupressure points on the ear);
  • Massage therapy intervention group – they received relaxing massage therapy.

Pain, anxiety and depression were assessed with the Doloplus2, Cornell and Campbell scales. The study was carried out during 5 months; three months of experimental treatment and two months with no treatment. The assessments were done at baseline, each month during the treatment and at one and two months of follow-up.

A total of 111 participants completed the study. The ear acupressure intervention group showed better improvements than the two other groups in relation to pain and depression during the treatment period and at one month of follow-up. The best improvement in pain was achieved in the last (3rd) month of ear acupressure treatment. The best results regarding anxiety were also observed in the last month of treatment.

The authors concluded that ear acupressure and massage therapy showed better results than the control group in relation to pain, anxiety and depression. However, ear acupressure achieved more improvements.

The question is: IS THIS A RIGOROUS TRIAL?

My answer would be NO.

Now I better explain why, don’t I?

If we look at them critically, the results of this trial might merely prove that spending some time with a patient, being nice to her, administering a treatment that involves time and touch, etc. yields positive changes in subjective experiences of pain, anxiety and depression. Thus the results of this study might have nothing to do with the therapies per se.

And why would acupressure be more successful than massage therapy? Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc. Features like that have the potential to maximise the placebo-response. Therefore it is conceivable that they have contributed to the superiority of acupressure over massage.

What I am saying is that the results of this trial can be interpreted in not just one but several ways. The main reason for that is the fact that the control group were not given an acceptable placebo, one that was indistinguishable from the real treatment. Patients were fully aware of what type of intervention they were getting. Therefore their expectations, possibly heightened by the therapists, determined the outcomes. Consequently there were factors at work which were totally beyond the control of the researchers and a clear causal link between the therapy and the outcome cannot be established.

An RCT that is aimed to test the effectiveness of a therapy but fails to establish such a causal link beyond reasonable doubt cannot be characterised as a rigorous study, I am afraid.

Sorry! Did I spoil your ‘national acupuncture and oriental medicine day’?

After the usually challenging acute therapy is behind them, cancer patients are often desperate to find a therapy that might improve their wellbeing. At that stage they may suffer from a wide range of symptoms which can seriously limit their quality of life. Any treatment that can be shown to restore them to their normal mental and physical health would be more than welcome.

Most homeopaths believe that their remedies can do just that, particularly if they are tailored not to the disease but to the individual patient. Sadly, the evidence that this might be so is almost non-existent. Now, a new trial has become available; it was conducted by Jennifer Poole, a chartered psychologist and registered homeopath, and researcher and teacher at Nemeton Research Foundation, Romsey.

The aim of this study was to explore the benefits of a three-month course of individualised homeopathy (IH) for survivors of cancer.  Fifteen survivors of any type of cancer were recruited from a walk-in cancer support centre. Conventional treatment had to have taken place within the last three years. Patients saw a homeopath who prescribed IH. After three months of IH, they scored their total, physical and emotional wellbeing using the Functional Assessment of Chronic Illness Therapy for Cancer (FACIT-G). The results show that 11 of the 14 women had statistically positive outcomes for emotional, physical and total wellbeing.
The conclusions of the author are clear: Findings support previous research, suggesting CAM or IH could be beneficial for survivors of cancer.

This article was published in the NURSING TIMES, and the editor added a footnote informing us that “This article has been double-blind “.

I find this surprising. A decent peer-review should have picked up the point that a study of that nature cannot possibly produce results which tell us anything about the benefits of IH. The reasons for this are fairly obvious:

  • there was no control group,
  • therefore the observed outcomes are most likely due to 1) natural history, 2) placebo, 3) regression towards the mean and 4) social desirability; it seems most unlikely that IH had anything to do with the result
  • the sample size was tiny,
  • the patients elected to receive IH which means that had high expectations of a positive outcome,
  • only subjective outcome measures were used,
  • there is no good previous research suggesting that IH benefits cancer patients.

On the last point, a recent systematic review showed that the studies available on this topic had mixed results either showing a significantly greater improvement in QOL in the intervention group compared to the control group, or no significant difference between groups. The authors concluded that there existed significant gaps in the evidence base for the effectiveness of CAM on QOL in cancer survivors. Further work in this field needs to adopt more rigorous methodology to help support cancer survivors to actively embrace self-management and effective CAMs, without recommending inappropriate interventions which are of no proven benefit.

All this new study might tell us is that IH did not seem to harm these patients  – but even this finding is not certain; to be sure, we would need to include many more patients. Any conclusions about the effectiveness of IH are totally unwarranted. But are there ANY generalizable conclusions that can be drawn from this article? Yes, I can think of a few:

  • Some cancer patients can be persuaded to try the most implausible treatments.
  • Some journals will publish any rubbish.
  • Some peer-reviewers fail to spot the most obvious defects.
  • Some ‘researchers’ haven’t got a clue.
  • The attempts of misleading us about the value of homeopathy are incessant.

One might argue that this whole story is too trivial for words; who cares what dodgy science is published in the NURSING TIMES? But I think it does matter – not so much because of this one silly article itself, but because similarly poor research with similarly ridiculous conclusions is currently published almost every day. Subsequently it is presented to the public as meaningful science heralding important advances in medicine. It matters because this constant drip of bogus research eventually influences public opinion and determines far-reaching health care decisions.

An international team of researchers wanted to determine the efficacy of laser and needle acupuncture for chronic knee pain. They conducted a Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists.

The treatments consisted of A) no acupuncture (control group, n = 71), B) needle (n = 70), C) laser (n = 71), and D) sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial.

Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data.

At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events.

The authors drew the following conclusions: In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients.

This is one of the methodologically best acupuncture studies that I have seen so far.

  • its protocol has been published when the trial started thus allowing maximum transparency
  • it is adequately powered
  • it has a very clever study-design
  • it minimizes bias in all sorts of ways
  • it tests acupuncture for a condition that it is widely used for
  • it even manages to blind acupuncturists by using one treatment arm with laser acupuncture

The results show quite clearly that acupuncture does have mild effects on pain and function that entirely rely on a placebo response.

Will acupuncturists learn from this study and henceforward stop treating knee-patients? Somehow I doubt it! The much more likely scenario is that they will claim the trial was, for this or that reason, not valid. Acupuncture, like most of alternative medicine, seems unable to revise its dogma.

Many proponents of alternative medicine seem somewhat suspicious of research; they have obviously understood that it might not produce the positive result they had hoped for; after all, good research tests hypotheses and does not necessarily confirm beliefs. At the same time, they are often tempted to conduct research: this is perceived as being good for the image and, provided the findings are positive, also good for business.

Therefore they seem to be tirelessly looking for a study design that cannot ‘fail’, i.e. one that avoids the risk of negative results but looks respectable enough to be accepted by ‘the establishment’. For these enthusiasts, I have good news: here is the study design that cannot fail.

It is perhaps best outlined as a concrete example; for reasons that will become clear very shortly, I have chosen reflexology as a treatment of diabetic neuropathy, but you can, of course, replace both the treatment and the condition as it suits your needs. Here is the outline:

  • recruit a group of patients suffering from diabetic neuropathy – say 58, that will do nicely,
  • randomly allocate them to two groups,
  • the experimental group receives regular treatments by a motivated reflexologist,
  • the controls get no such therapy,
  • both groups also receive conventional treatments for their neuropathy,
  • the follow-up is 6 months,
  • the following outcome measures are used: pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities,
  • the results show that the reflexology group experience more improvements in all outcome measures than those of control subjects,
  • your conclusion: This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

Mission accomplished!

This method is fool-proof, trust me, I have seen it often enough being tested, and never has it generated disappointment. It cannot fail because it follows the notorious A+B versus B design (I know, I have mentioned this several times before on this blog, but it is really important, I think): both patient groups receive the essential mainstream treatment, and the experimental group receives a useless but pleasant alternative treatment in addition. The alternative treatment involves touch, time, compassion, empathy, expectations, etc. All of these elements will inevitably have positive effects, and they can even be used to increase the patients’ compliance with the conventional treatments that is being applied in parallel. Thus all outcome measures will be better in the experimental compared to the control group.

The overall effect is pure magic: even an utterly ineffective treatment will appear as being effective – the perfect method for producing false-positive results.

And now we hopefully all understand why this study design is so very popular in alternative medicine. It looks solid – after all, it’s an RCT!!! – and it thus convinces even mildly critical experts of the notion that the useless treatment is something worth while. Consequently the useless treatment will become accepted as ‘evidence-based’, will be used more widely and perhaps even reimbursed from the public purse. Business will be thriving!

And why did I employ reflexology for diabetic neuropathy? Is that example not a far-fetched? Not a bit! I used it because it describes precisely a study that has just been published. Of course, I could also have taken the chiropractic trial from my last post, or dozens of other studies following the A+B versus B design – it is so brilliantly suited for misleading us all.

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