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

clinical trial

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Aromatherapy is currently one of the most popular of all alternative therapies. It consists of the use of essential oils for medicinal purposes. Aromatherapy usually involves the application of diluted essential oils via a gentle massage of the body surface. Less frequently, the essential oils are applied via inhalation. The chemist Rene-Maurice Gattefosse (1881-1950) coined the term ‘aromatherapy’ after experiencing that lavender oil helped to cure a serious burn. In 1937, he published a book on the subject: Aromathérapie: Les Huiles Essentielles, Hormones Végétales. Later, the French surgeon Jean Valnet used essential oils to help heal soldiers’ wounds in World War II.

This Iranian study aimed to investigate the effect of inhalation aromatherapy with damask rose essence on pain and anxiety in burn patients. This three group clinical trial was conducted on 120 patients with burns less than 30% of total body surface area (TBSA). The patients were randomly allocated into three groups, aromatherapy damask rose essence, placebo, and control. The pain intensity was assessed using visual analogue scale prior to intervention, immediately before, and 15 min after dressing. Anxiety was measured using Spielberger Inventory at before intervention and 15 min after dressing, also the prolonged effect of intervention on pain was assessed by number of the analgesics drugs received for four hours after dressing change. The intervention included inhalation of 6 drops of 40% damask rose essential oil in the damask group, and six drops of distilled water in placebo group one hour before dressing change. The control group received no additional intervention. All groups also received standard care.

Baseline state-trait anxiety and pain intensity were similar in these three groups. A significant reduction was found in pain intensity immediately before and after dressing and state anxiety after dressing in the damask group compared to the placebo and control groups. The researchers found no significant difference between the placebo and control groups in terms of these variables at these times. No significant difference was noted among the three groups in frequency of analgesics drugs and trait anxiety after intervention.

The authors concluded that inhaled aromatherapy with Damask rose essence reduces subjective pain intensity and state anxiety in burned patients. Therefore, it is recommended considering use of damask rose essence, as an easy and affordable method along with other treatments.

These are interesting findings for sure. Aromatherapy is far less implausible than many other so-called alternative medicines (SCAMs). It furthermore has the advantages of being safe and inexpensive.

I have no reason to doubt the validity of the study. Yet, I nevertheless think it is prudent to insist on an independent replication before issuing a general recommendation.

When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.

This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.

In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:

Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.

Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.

Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.

Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

In their paper, the authors state this:

It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.

My comments to this are as follows:

  1. Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
  2. Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
  3. Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
  4. Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.

Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:

  • We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
  • Observational studies cannot easily determine cause and effect between the therapy and the outcome.
  • Observational studies cannot be a substitute for RCTs.
  • Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
  • Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
  • If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
  • SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.

In 2012, we evaluated the efficacy/effectiveness of lavender for the reduction of stress/anxiety.

Our systematic review included 15 RCTs. Two trials scored 4 points on the 5-point Jadad scale, the remaining 13 scored two or less. Results from seven trials appeared to favour lavender over controls for at least one relevant outcome. We concluded that methodological issues limit the extent to which any conclusions can be drawn regarding the efficacy/effectiveness of lavender. The best evidence suggests that oral lavender supplements may have some therapeutic effects. However, further independent replications are needed before firm conclusions can be drawn.

Since 2012, more evidence has emerged. The latest study on the subject aimed to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. It was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL).

For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (p < 0.001) as well as the scores of the placebo group (p < 0.001). See the source image

The authors of the new study concluded that that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.

Hurray, this seems to be a decent trial with a positive result for SCAM!

And why not? It is not at all implausible that lavender has hypnotic effects. There are now quite a few reasonably sound trials that suggest it works. Moreover, it is safe and not very expensive (or even free, if you can grow it yourself).

I for one am more than happy to report a positive finding for a SCAM and merely regret that I cannot do so more often.

Pisa syndrome (PS) is a condition in which there is sustained involuntary flexion of the body and head to one side and slight rotation of the trunk so the person appears to lean like the Leaning Tower of Pisa. The PS can occur as a complication of Parkinson’s disease (PD). It can also be an adverse effect of some medications. It is characterized by a trunk lateral flexion higher than 10 degrees which is reversible when lying. The underlying pathophysiological mechanisms responsible for the development of PS are poorly understood. One pathophysiological hypothesis is that PS in PD is caused by an altered verticality perception, due to a somatosensory impairment.

The management of PS remains a challenge. Physiotherapy with early rehabilitation emphasising stretching exercises for the external oblique and paraspinal muscles is usually recommended. Therapy is also needed to improve static, dynamic posture and the control of pain symptoms. Osteopathic Manipulative Treatment (OMT) is also sometimes advocated for PS, but does it work?

The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry. In this single-blinded trial the investigators studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received OMT plus MIRT for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) was also performed.

At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT – 326.00±491.24 mm2, p = 0.01). The experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).

The authors concluded that among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.

The authors entitled their paper ‘Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: A Pilot Randomized Placebo-Controlled Trial’. As a pilot study, it should not test efficacy but explore the feasibility of a definitive trial. The fact the authors report outcome data, indicates to me that this is, in fact, not a pilot study, but a hopelessly underpowered clinical trial. This means that the findings could be due merely to chance alone. And this, in turn, means that the researchers owe it to their patients to conduct a properly powered RCT.

Siddha medicine is based on a combination of ancient medicinal practices and spiritual disciplines as well as alchemy and mysticism. It is thought to be one of the oldest system of healthcare of India that developed during the Indus civilization, which flourished between 2500 and 1700 BCE.

It has been reported that the Indian ‘National Institute of Siddha’ (NIS) claim to have successfully treated 160 COVID-19 positive patients. Subsequently, they have requested the government to hand over all COVID-19 Care Centres in Chennai and let Siddha doctors treat all COVID-patients. They say they are confident of flattening the curve in Chennai and convert it into a safe zone in just matter of days.

The NIS claim to have three potent combinations of Siddha drugs. “Depending upon the availability and quantity required for treating Coronavirus positive patients, we have after thorough research, come out with three different effective combinations of the Siddha preparations,” Dr R Meenakumari, Director of NIS, said. The treatment low-cost compared to the prohibitive cost in corporate hospitals and all the Siddha medicines are locally available, she added. “We have requested the state government to hand over all the COVID-19 Care Centres to us and allow us to treat all the patients. Our Siddha drug combination is potent enough to convert a positive patient into Coronavirus negative in three days’ time,” she claimed.

Her confidence stems from the fact that the Siddha doctors here have “successfully” treated 160 patients besides
23 inmates of the Puzhal Central Prison. “Initially, we treated 85 patients with SRM Medical College and Hospital and another 75 at the Greater Chennai Corporation… They all recovered and tested negative after five days of successful treatment,” she claimed. “The combination that we have prepared will help to cure the infected patient within three days… Siddha medicine has huge potential to treat the patients and there are possibilities to use the medicine to save precious human lives”.

The combination drug in question seems to be similar to or identical with Kabasura KudineerAlso termed ‘Nilavembu Kudineer‘, this drug is a powder form of medicine mainly used in the treatment of respiratory problems such as fever, cold, severe phlegm and flu. This polyherbal Siddha medicine is also widely used as a prophylactic during times of viral epidemics. To get the proper benefits, it should be made into a decoction and then consumed. 
Kabasura Kudineer
is made up of 15 different ingredients:

  1. ginger,
  2. cloves,
  3. aakarkara,
  4. harad,
  5. oregano,
  6. giloy,
  7. chiretta,
  8. nagarmotha,
  9. kali mirch
  10. tragiainvolucrata,
  11. vajradanti,
  12. malabar nut,
  13. kuth,
  14. ajwain,
  15. leghupatha.

In 2009, it allegedly helped containing the spread of swine flu and, in 2012, the then Chief Minister Jayalalithaa had requested public to use Nilavembu Kudineer prepared by the Institute to prevent dengue.

Meanwhile, the ‘Central Council for Research in Siddha’ has sent a proposal to the state government to include the
traditional medicine in the treatment protocols at the state-run CCCs. “We have also urged the state government to include the Brahmananda Bhairava Mathirai a herbo-mineral preparation, which has already been approved by the AYUSH ministry to treat persons with COVID-19 related fever, at all the COVID-19 wards,” a senior doctor at the CCRS said.

Of course, we all wish that an effective treatment against COVID-19 will be found soon. However, what the NIS calls THOROUGH RESEARCH looks like a flimsy bit of pseudo-research. And their assertion that their herbal mixture turns positive into negative patients within three days is a claim that sounds far too good to be true.

I have no reason to doubt that the NIS is full of good intentions. But I am reminded of Bert Brecht’s bon mot: ‘the opposite of good is not evil, but good intentions’.

Am I the only one who is tired of hearing that, in India, homeopathy is doing wonders for the current pandemic? All of the reports that I have seen are based on little more than hearsay, anecdotes or pseudo-science. If anyone really wanted to find out whether homeopathy works, they would need more than that; in fact, they would need to conduct a clinical trial.

But wait!

As it happens, there are already ~500 clinical trials of homeopathy. Many show positive effects, but the reliable ones usually don’t. Crucially, the totality of the evidence fails to be positive. So, running further studies is hardly a promising exercise. In fact, considering how utterly implausible homeopathy is, it even seems like an unethical waste of resources.

But many homeopaths disagree, particularly those in India. And it has been reported that several trials have been given the go-ahead in India and are now up and running. This regrettable fact is being heavily exploited for swaying public opinion in favour of homeopathy. The way I see it, the situation is roughly this:

  • a few trials of homeopathy are being set up;
  • they are designed by enthusiasts of homeopathy who lack research expertise;
  • therefore their methodology is weak and biased towards generating a false-positive result;
  • while this is going on, the homeopathic propaganda machine is running overtime;
  • when the results will finally emerge, they will get published in a 3rd rate journal;
  • homeopaths worldwide will celebrate them as a triumph for homeopathy;
  • critical thinkers will be dismayed at their quality and will declare that the conclusions drawn by over-enthusiastic homeopaths are not valid;
  • in the end, we will be exactly where we were before: quasi-religious believers in homeopathy will feel vexed because their findings are not accepted in science, and everyone else will be baffled by the waste of time, opportunity and resources as well as by the tenacity of homeopaths to make fools of themselves.

But criticising is easy; doing it properly is often more difficult.

So, how should it be done?

The way I see it, one should do the following:

  • carefully consider the implausibility of homeopathy;
  • thoroughly study the existing evidence on homeopathy;
  • abandon all plans to study homeopathy in the light of the above.

But this hardly is inconceivable considering the current situation in India. If further studies of homeopathy are unavoidable, the following procedure might therefore be reasonable:

  1. assemble a team of experts including trial methodologists, statisticians, epidemiologists and homeopaths;
  2. ask them to design a rigorous protocol of one or two studies that would provide a definitive answer to the research question posed;
  3. make sure that, once everyone is happy with the protocol, all parties commit to abiding by the findings that will emerge from these trials;
  4. conduct the studies under adequately strict supervision;
  5. evaluate the results according to the protocol;
  6. publish them in a top journal;
  7. do the usual press-releases, interviews etc.

In India, it seems that the last point in this agenda came far too early. This is because, in this and several other countries, homeopathy has become more a belief system than a medicine. And because it is about belief, the believers will avert any truly meaningful and rigorous test of homeopathy’s efficacy.

 

 

This was essentially the question raised in a correspondence with a sceptic friend. His suspicion was that statistical methods might produce false-positive overall findings, if the research is done by enthusiasts of the so-called alternative medicine (SCAM) in question (or other areas of inquiry which I will omit because they are outside my area of expertise). Consciously or inadvertently, such researchers might introduce a pro-SCAM bias into their work. As the research is done mostly by such enthusiasts; the totality of the evidence would turn out to be heavily skewed in favour of the SCAM under investigation. The end-result would then be a false-positive overall impression about the SCAM which is less based on reality than on the wishful thinking of the investigators.

How can one deal with this problem?

How to minimise the risk of being overwhelmed by false-positive research?

Today, we have several mechanisms and initiatives that are at least partly aimed at achieving just this. For instance, there are guidelines on how to conduct the primary research so that bias is minimised. The CONSORT statements are an example. As many studies pre-date CONSORT, we need a different approach for reviews of clinical trials. The PRISMA guideline or the COCHRANE handbook are attempts to make sure systematic reviews are transparent and rigorous. These methods can work quite well in finding the truth, but one needs to be aware, of course, that some researchers do their very best to obscure it. I have also tried to go one step further and shown that the direction of the conclusion correlates with the rigour of the study (btw: this was the paper that prompted Prof Hahn’s criticism and slander of my work and person).

So, problem sorted?

Not quite!

The trouble is that over-enthusiastic researchers may not always adhere to these guidelines, they may pretend to adhere but cut corners, or they may be dishonest and cheat. And what makes this even more tricky is the possibility that they do all this inadvertently; their enthusiasm could get the better of them, and they are doing research not to TEST WHETHER a treatment works but to PROVE THAT it works.

In the realm of SCAM we have a lot of this – trust me, I have seen it often with my own eyes, regrettably sometimes even within my own team of co-workers. The reason for this is that SCAM is loaded with emotion and quasi-religious beliefs; and these provide a much stronger conflict of interest than money could ever do, in my experience.

And how might we tackle this thorny issue?

After thinking long and hard about it, I came up in 2012 with my TRUSTWORTHYNESS INDEX:

If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his TI would be 1.

Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.

An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.

Of course, this is all a bit simplistic, and, like all other citation metrics, my TI provides us not with any level of proof; it merely is a vague indicator that something might be amiss. And, as stressed already, the cut-off point for any scientist’s TI very much depends on the area of clinical research we are dealing with. The lower the plausibility and the higher the uncertainty associated with the efficacy of the experimental treatments, the lower the point where the TI might suggest  something  to be fishy.

Based on this concept, I later created the ALTERNATIVE MEDICINE HALL OF FAME. This is a list of researchers who manage to go through life researching their particular SCAM without ever publishing a negative conclusion about it. In terms of TI, these people have astronomically high values. The current list is not yet long, but it is growing:

John Weeks (editor of JCAM)

Deepak Chopra (US entrepreneur)

Cheryl Hawk (US chiropractor)

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

The logical consequence of a high TI would be that researchers of that nature are banned from obtaining research funds and publishing papers, because their contribution is merely to confuse us and make science less reliable.

I am sure there are other ways of addressing the problem of being mislead by false-positive research. If you can think of one, I’d be pleased to hear about it.

 

Well, they did not directly admit that homeopathic remedies have no effects, of course. But, on 5/6/2020, they tweeted this :

DHU Arzneimittel
@dhu_de Jun 5
#Homöopathie Wissen
‘Pille’ und #Globuli – geht das? Ja, das geht, #Schwangerschaftsverhütung mit der #Pille und homöopathische Arzneimittel beeinflussen sich nicht gegenseitig.

Let me translate the text of this tweet for you:

The pill and homeopathy – is that ok? Yes, it is. Contraceptives and homeopathic medicines do not interact.

Let me translate the text of this tweet for you:

The pill and homeopathy – is that ok? Yes, it is. Contraceptives and homeopathic medicines do not interact.

And in what way is this an admission that homeopathic remedies have no effect?

Let me explain:

To issue such a categorical assurance, any responsible pharmaceutical company must have sound evidence. If not they would be open to expensive legal action, compensation, etc., in case a woman believed them and did get pregnant while taking both the contraceptive pill and a homeopathic remedy. Claiming that no interactions exist without evidence would be unwise, illegal and unethical. That means, there must be a published trial plus several independent replications demonstrating the absence of interactions between the contraceptive pill and homeopathic remedies.

German homeopathic manufacturers are, of course, responsible; I would never dare to doubt it! Ergo, such trials must be available, I thought. Therefore, I quickly conducted a few literature searches in an attempt to locate them.

Here are my findings:

No study on interactions of homeopathics with contraceptives.

No study on interactions of homeopathics with any drug.

(Should anyone have different information, please contact me without delay)

As I said, I do not doubt for a second that the largest German manufacturer, the ‘Deutsche Homöopathische Union’ (DHU), is a highly responsible company. So, how can they responsibly assure the public that there are no contraceptive/homeopathy interactions? How can they be so sure? Why are they not afraid of legal consequences?

There is really only one plausible explanation: they know very well that homeopathic remedies have no actions, and what has no actions cannot possibly cause any interactions!

Am I right, my dear friends at the DHU?

Please do respond if you have a minute!

Cochrane reviews have the reputation to be the most reliable evidence available anywhere. They are supposed to be independent, rigorous, transparent and up-to-date. Usually, this reputation is justified, in my view. But do the 54 Cochrane reviews of acupuncture quoted in my previous post live up to it?

If one had to put the entire body of evidence in a nutshell, it would probably look something  like this:

TOTAL NUMBER OF SYSTEMATIC REVIEWS = 54

POSITIVE CONCLUSIONS BASED ON MORE THAN ONE HIGH QUALITY STUDY = 2

FAILURE TO REACH CONVINCINGLY POSITIVE CONCLUSIONS = 52

The two positive reviews are on:

1) prevention of migraine

2) prevention of tension-type headache

Both of the positive reviews are by Linde et al.

Allow me to raise just a few further critical points:

  1. If I counted correctly, 19 of the 54 reviews are authored entirely by Chinese authors. Why could this be a problem? One reason could be that many Chinese authors seem to be biased in favour of acupuncture. Another reason could be that data fabrication is rife in China.
  2. Many if not most of the primary studies are published in Chinese. This means that it is impossible for most non-Chinese co-authors of the review as well as for the referees of the paper to check the accuracy of the data extraction.
  3. I counted a total of 15 reviews which were by authors who one could categorise as outspoken enthusiasts of acupuncture. In these cases, one might be concerned about the trustworthiness of the review’s conclusion.
  4.  Many (some would say most) of the reviews cover subject areas which are frankly bizarre. Who would, for instance, consider acupuncture a plausible treatment for Glaucoma, Mumps or chronic hepatitis B?
  5. Despite almost all of the reviews demonstrating that there is no good reason to recommend acupuncture for the condition in question, hardly any of them draw a transparent, helpful and clear conclusion. One example might suffice: the review of acupuncture for hordeolum concluded that “Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum…” Its Chinese authors reached this conclusion on the basis of 6 primary studies (all from China) which were all of lousy quality. In such a case, the only justified conclusion would be, in my view, something like this: THERE IS NO RELIABLE EVIDENCE …

Despite these serious limitations and avoidable confusions, the totality of the evidence from these 54 Cochrane reviews does send an important message: there is hardly a single condition for which acupuncture is clearly, convincingly and indisputably effective. What I find most regrettable, however, is that the Cochrane Collaboration allowed the often biased review authors to obscure this crucial message so thoroughly. One needs a healthy portion of critical thinking to get through to the truth here – and how many fans of acupuncture possess such a thing?

The Lightning Process  (LP) is a commercial programme developed by Phil Parker based on ideas from osteopathy, life coaching and neuro-linguistic programming. It has been endorsed by celebrities like Martine McCutcheon and Esther Rantzen, who credits it for her daughter’s recovery from ME. Parker claims that LP works by teaching people to use their brain to “stimulate health-promoting neural pathways”. One young patient once described it as follows: “Whenever you get a negative thought, emotional symptom, you are supposed to turn on one side and with your arm movements in a kind if stop motion, just say STOP very firmly and that is supposed to cut off the adrenaline response.”

Allegedly, the LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations. The LP involves three group sessions on consecutive days where participants are taught theories and skills, which are then practised through simple steps, posture and coaching.

A few days ago, someone asked my help writing to me: Norwegian newspaper is attacking patients for objecting to a clinical trial of the lightning process which is horrible quackery. LP is being backed by some people in Norwegian health authorities. Could you bring attention to how disgraceful this is please? I promised to look into it. Hence this post.

My searches located just one single trial. It seems to be the only controlled clinical study available. Here it is:

Design: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.

Setting: Specialist paediatric CFS/ME service.

Patients: 12-18 year olds with mild/moderate CFS/ME.

Main outcome measures: The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.

Results: We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.

Conclusion: The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.

The trial was designed as an ‘A+B versus B’ study which practically always generates a positive outcome. It did not control for placebo effects and is, in my humble view, worthless and arguably unethical. It certainly does not warrant the conclusion that LB is effective or cost-effective.

I do not doubt that the LP-children improved, but I see no reason to believe that this had anything to do with LP. It could have been (and most likely was) caused by the intense attention that these kids received over three days. Giving them a daily ice-cream and some kindness might (and probably would) have produced even better outcomes.

So, what do we call a therapy for which numerous, far-reaching claims are being made, which is based on implausible assumptions, which is unproven, and for which people have to pay dearly?

The last time I looked, it was called quackery.

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