Edzard Ernst

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

Yesterday, it was announced that UK universities are not doing well according to international league tables. Of the UK’s 84 ranked universities, 66 saw their staff to student ratio decline while 59 had a drop in research citations. International student numbers at 51 universities also fell.

No reason to despair; help is on the way!

The University of Exeter reported that “as International Education Champion, Sir Steve will have a leading role in a 10-year strategy to both increase the number of international students choosing to study in the UK higher education system to 600,000 and increase the value of education exports to £35 billion per year by 2030. The University of Exeter is delighted and proud with this appointment…

The role of International Education Champion will be to work with organisations across the breadth of the education sector, including universities, schools, the EdTech industry, vocational training, and early years schooling providers. Steve will also help target priority regions worldwide to build networks and promote the UK as the international education partner of choice. The role will additionally help to boost the numbers of international students in the UK.

The appointment of Sir Steve Smith fulfils a priority action from the International Education Strategy, published by the Department for Education and the Department for International Trade. Sir Steve will spearhead overseas activity and address a number of market access barriers on behalf of the whole education sector, including concerns over the global recognition of UK degrees and other qualifications. Sir Steve’s experience, knowledge and global connections will help to develop long-term relationships with international governments and overseas stakeholders…”

Shortly after becoming VC at Exeter, Prof Smith closed two Departments: Music and Chemistry. Apparently, they were not bringing in enough cash. Several years later, he had a key role in closing my unit. It had attracted a complaint from Prince Charles’ 1st private secretary (full story here, in case you are interested).

I hope Sir Steve is more productive in boosting international education. One thing seems certain to me: post-Brexit/post-COVID academia in the UK will need a boost after what our current government has done to it.

In the wake of both the NEJM and the LANCET withdrawing two potentially influential papers due unanswered questions about the source and reliability of the data, one has to ask how good or bad the process of peer review is.

Peer review is the evaluation of work by one or more people with similar competences as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. It normally involves multiple steps:

  1. Authors send their manuscript to a journal of their choice for publication.
  2. The journal editor has a look at it and decides whether to reject it straight away (for instance, because the subject area is not of interest) or whether to send it out to referees for examination (often to experts suggested by the authors of the submission).
  3. The referees (usually 2 or 3) have the opportunity to reject or accept the invitation to review the submission.
  4. If they accept, they review the paper and send their report to the editor (usually following a deadline).
  5. The editor tries to come to a decision about publication; often the referees are not in agreement, and a further referee has to be recruited.
  6. Even if the submission is potentially publishable, the referees will have raised several points that need addressing. In such cases, the editor sends the submission back to the original authors asking them to revise the article.
  7. The authors do their revision (often following a deadline) and re-submit their paper.
  8. Now the editor can decide to either publish it or send it back to the referees asking them whether they feel their criticisms have been adequately addressed.
  9. Depending on the referees’ verdicts, the editor makes the final decision and informs all the involved parties accordingly.
  10. If the paper was accepted, it then goes into production.
  11. When this process is finished, the authors receive the proofs for final a check.
  12. Eventually, the paper is published and the readers of the journal may scrutinise it.
  13. Often this prompts comment which may get published.
  14. In this case, the authors of the original paper may get invited to write a reply.
  15. Finally the comments and the reply are published in the journal side by side.

The whole process takes time, sometimes lots of time. I have had papers that took almost two years from submissions to publications. This delay seems tedious and, if the paper is important, unacceptable (if it is not important, it should arguably not be published at all). Equally unacceptable is the fact that referees are expected to do their reviewing for free. The consequence is that many referees do their reviewing less than well.

When I was still at Exeter, I had plenty of opportunity to see the problems of peer review from the reviewers perspective. At a time, I accepted about 5 reviews per week, and in total I surely have reviewed over 1000 papers. I often recommended inviting a statistician to do a specialist review of the stats. Only rarely were such suggestions accepted by the journal editors. Very often I recommended rejecting a submission because it was rubbish, and occasionally, I told the editor that there was a strong suspicion of the paper being fraudulent. The editors very often (I estimate in about 50% of cases) ignored my suggestions and comments and published the papers nonetheless. If the editor did follow my advice to reject a paper, I regularly saw it published elsewhere later (usually in a less well-respected journal). Several times, an author of a submission contacted me directly after seeing my criticism of his paper. Occasionally this resulted in unpleasantness, once or twice even in threats. Eventually I realised that improving the publications in the realm of SCAM was a Sisyphean task, became quite disenchanted with all this and accepted less and less reviews. Today, I do only very few.

I had even more opportunity to see the peer review process from the author’s perspective. All authors must have suffered from unfair or incompetent reviews and most will have experienced the frustrations of the endless delays. Once (before my time in alternative medicine) a reviewer rejected my paper and soon after published results that were uncannily similar to mine. In alternative medicine, researchers tend to be rather emotional about their subject. Imagine, for instance, the review you might get from Dana Ullmann of a trial of homeopathy that fails to show what he believes in.

Finally, since 40 years, I have also had the displeasure of experiencing peer review as an editor. This often seemed like trying to sail between the devil and the deep blue sea. Editors want to fill their journals with the best science they can find. But all too often, they receive the worst science they can imagine. They are constantly torn by tensions pulling them in opposite directions. And they have to cope not just with poor quality submissions but also with reviewers who miss deadlines and do their work badly.

So, peer review is fraught with problems! The trouble is that there are few solutions that would keep a better check on the reliability of science. Peer review, it often seemed to me, is the worst idea, except for all others. If peer review is to survive (and I think it probably will), there are a few things that could, from my point of view, be done to improve it:

  1. Make it much more attractive for the referees. Payment would be the obvious thing – and by Jove, the big journals like the LANCET and NEJM could afford it. But recognising refereeing academically would be even more important. At present, academic careers depend largely of publications; if they also depended on reviewing, experts would queue up to do it.
  2. The reports of the referees should get independently evaluated according to sensible criteria. These data could be conflated an published as a criterion of academic standing. Referees who fail to to a good job would spoil their chances to get re-invited for this task.
  3. Speed up the entire process. Waiting months on months is hugely counter-productive for all concerned.
  4. Today many journals ask authors for the details of experts who are potential reviewers of their submission and then send the paper in question to them for review. I find this ridiculous! No author I know of has ever resisted the temptation to name people who are friends or owe a favour. Journals should afford the extra work to find who the best independent experts on any particular subject are.

None of this is simple or fool-proof or even sure to work well, of course. But surely it is worth trying to get peer-review right. The quality of future science depends on it.

By guest blogger Loretta Marron

Although assumed to be traditional, what we know today as ‘Traditional Chinese Medicine’ (TCM) was invented in the 1950s for political reasons by then Chairman Mao. It has since been proclaimed by Xi Jinping, now life-President of the People’s Republic of China, as the “jewel” in the millennia of Chinese civilization.

In May this year, Xi “announced plans to criminalise criticism of traditional Chinese medicine”. Speaking out against TCM could land you years in prison, prosecuted for “picking fights to disturb public order” and “defaming” the practice.

With the industry expected to earn $420 billion by the end of 2020, covid-19 has provided Xi with a platform to promote unproven, potentially harmful TCM. To keep these profits filling Chinese coffers, the World Health Organization (WHO) remains silent and those challenging TCM are silenced.

In January, the late Dr Li Wenliang was arrested and gaoled for warning China about covid-19. Li was one of up to nine people who were disciplined for spreading rumours about it. As the virus silently spread around the world, Beijing told the WHO that there was ‘no clear evidence’ of spread between humans.

As their death toll passed 1,000, Beijing’s response was to remove senior officials and to sack hundreds over their handling of the outbreak. With the support of the WHO, claims continue to be made that TCM “has been proved effective in improving the cure rate”, denying the simple fact that “patients would have recovered even if they hadn’t taken the Chinese medicine”.

With cases now heading for 8 million, and over four hundred thousand people confirmed dead world-wide and with economies in free-fall, Beijing continues, “to protect its interests and people overseas; to gain leadership of international governance”,for financial gain, to aggressively use its national power. Under the guise of ‘International Aid’, during the pandemic, Beijing promoted treatments based on unproven traditional medicine, sending TCM practitioners to countries including Italy, France and Iran.

Countries challenging Beijing can expect claims of racism and financial retaliation.

Back in 2016, the Chinese State Council released a “Strategic Development Plan for Chinese Medicine (2016-2030)”, seeking to spread ‘knowledge’ into campuses, homes and abroad.

In July 2017, a law promising equal status for TCM and western medicine came into effect. Provisions included encouragement to China’s hospitals to set up TCM centres. “The new law on traditional Chinese medicine will improve global TCM influence, and give a boost to China’s soft power”.

In 2019, after strong lobbying by the Chinese Communist Party (CCP), WHO added a chapter on TCM to their official International Classification of Diseases (ICD-11).  In China, doctors are now instructed to prescribe traditional medicine to most patients.

While Chinese herbs might have exotic names, they are, once translated, often the same as western herbs, many of which might have significant interactions. WHO fails to acknowledge any drug interactions.

In 1967, Mao launched Project 523 to find a cure for chloroquine-resistant malaria. Over 240,000 compounds had already been tested and none had worked. Trained in pharmacology and modern western methods, Tu Youyou used the scientific method to test sweet wormwood, a herb traditionally used in China for fever, where she developed a useful artemisinin derivative for resistant malaria. The drug has saved millions of lives. In 2015 she won the Nobel Prize for her work. However, Tu’s work is not a blanket endorsement of TCM: without the years of research, she would not have been successful.

TCM is commercially driven. Criticism of remedies is often blocked on the Internet in China, and critics have been jailed.  The majority of TCM’s are not tested for efficacy in randomized clinical trials. Clinical trials are usually of poor quality and serious side effects are underreported.   China has even rolled back regulations as Beijing forcefully promotes TCM’s as an alternative to proven western medicine. An increasing number of prestigious research hospitals now prescribe and dispense herbs that may cause drug interactions alongside western medicine for major illness patients.

TCM’s are not safe. Most systematic reviews suggest that there is no good or consistent evidence for effectiveness, negative results aren’t published, research data are fabricated and TCM-exports are of dubious quality.

If the benefits of herbal remedies are to be realised, good clinical studies must be encouraged.

TCM is not medicine. It’s little more than a philosophy or a set of traditional beliefs, about various concoctions and interventions and their alleged effect on health and diseases.

To stop misleading the world with what Mao himself saw as nonsense, and to mitigate future pandemics, WHO can and should remove all mention of TCM other than to state that it is unproven and could be dangerous.

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!

Homeopathy has had its fair share of declarations, and now there is another one. I find this new one important because it is from German medical students and might thus indicate where German homeopathy is heading.

The ‘Bundesvertretung der Medizinstudenten in Deutschland’ – the German Medical Students’ Association – has recently looked into the evidence for and against homeopathy and came up with this poignant declaration:

Here is my translation for those who cannot read German; I have added a few footnotes to explain the German context:

  • Homeopathy does not work beyond placebo [1].
  • The legal health insurances should not reimburse homeopathy [2].
  • The law stating that homeopathy can only be sold in pharmacies should be abolished [3].
  • Medicines should only be licenced, if there is a valid proof of efficacy [4].
  • In public debates, it must be made clear that homeopathy is not part of naturopathy [5].
  • The medical degree in homeopathy must be scrapped [6].
  • The teaching of homeopathy must be evidence-based and context-related [7].

_______________________________

  1. This seems to refer to the wording a German manufacturer of homeopathic preparations tried to suppress.
  2. At the moment most German health insurances do pay for homeopathy.
  3. In Germany, pharmacies have a monopoly on homeopathic remedies.
  4. Since many years, there has been a special regulation in Germany whereby homeopathics could get a licence without proof of efficacy.
  5. German homeopaths tend to be keen on muddying the water by claiming homeopathy is part of naturopathy.
  6. All German students are being taught (and examined on) some rudimentary knowledge of homeopathy.

The new declaration is ‘spot on’. I congratulate the students for their courage and wisdom to publish it. They are the future of German medicine, a future where homeopathy’s place is exclusively in the history books as a bizarre episode of anti-science.

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?

To update my article of 2008, I have searched the Cochrane Library for all Cochrane reviews specifically targeted at acupuncture or related interventions such as acupressure, electro-acupuncture and moxibustion (on 1/6/2020). More general reviews which included some evidence on acupuncture but were not specifically on this topic (e.g. complementary therapies for enuresis) were omitted.

It turned out that almost all the 32 reviews available in 2008 had been updated (some several times), a few had been abandoned and many new reviews have been added. In fact, the 32 reviews of 2008 have today grown into 54.

Here are the conclusions of and links to these papers:

  1. BELL’S PALSY The quality of the included trials was inadequate to allow any conclusion about the efficacy of acupuncture. More research with high quality trials is needed.
  2. PRIMARY DYSMENORRHOEA There is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.
  3. PREVENTION OF EPISODIC MIGRAINE The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long‐term studies, more than one year in duration, are lacking.
  4. RHEUMATOID ARTHRITIS Although the results of the study on electroacupuncture show that electroacupuncture may be beneficial to reduce symptomatic knee pain in patients with RA 24 hours and 4 months post treatment, the reviewers concluded that the poor quality of the trial, including the small sample size preclude its recommendation. The reviewers further conclude that acupuncture has no effect on ESR, CRP, pain, patient’s global assessment, number of swollen joints, number of tender joints, general health, disease activity and reduction of analgesics. These conclusions are limited by methodological considerations such as the type of acupuncture (acupuncture vs electroacupuncture), the site of intervention, the low number of clinical trials and the small sample size of the included studies.
  5. PREVENTION OF TENSION TYPE HEADACHE: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension‐type headaches, but further trials ‐ particularly comparing acupuncture with other treatment options ‐ are needed.
  6. SHOULDER PAIN Due to a small number of clinical and methodologically diverse trials, little can be concluded from this review. There is little evidence to support or refute the use of acupuncture for shoulder pain although there may be short‐term benefit with respect to pain and function. There is a need for further well designed clinical trials.
  7. EPILEPSY Available RCTs are small, heterogeneous and have high risk of bias. The current evidence does not support acupuncture for treating epilepsy.
  8. CHRONIC ASTHMA There is not enough evidence to make recommendations about the value of acupuncture in asthma treatment. Further research needs to consider the complexities and different types of acupuncture.
  9. POLYCYSTIC OVARIAN SYNDROME For true acupuncture versus sham acupuncture we cannot exclude clinically relevant differences in live birth rate, multiple pregnancy rate, ovulation rate, clinical pregnancy rate or miscarriage. Number of intermenstrual days may improve in participants receiving true acupuncture compared to sham acupuncture. True acupuncture probably worsens adverse events compared to sham acupuncture. No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane‐35 did not measure fertility outcomes as the women in these trials did not seek fertility.We are uncertain whether acupuncture improves ovulation rate (measured by ultrasound three months post treatment) compared to relaxation or Diane‐35. The other comparisons did not report on this outcome.Adverse events were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane‐35. These included dizziness, nausea and subcutaneous haematoma. Evidence was very low quality with very wide CIs and very low event rates.There are only a limited number of RCTs in this area, limiting our ability to determine effectiveness of acupuncture for PCOS.
  10. CHRONIC HEPATITIS B The clinical effects of acupuncture for chronic hepatitis B remain unknown. The included trials lacked data on all‐cause mortality, health‐related quality of life, serious adverse events, hepatitis‐B related mortality, and hepatitis‐B related morbidity. The vast number of excluded trials lacked clear descriptions of their design and conduct. Whether acupuncture influences adverse events considered not to be serious is uncertain. It remains unclear if acupuncture affects HBeAg, and if it is associated with reduction in detectable HBV DNA. Based on available data from only one or two small trials on adverse events considered not to be serious and on the surrogate outcomes HBeAg and HBV DNA, the certainty of evidence is very low. In view of the wide usage of acupuncture, any conclusion that one might try to draw in the future should be based on data on patient and clinically relevant outcomes, assessed in large, high‐quality randomised sham‐controlled trials with homogeneous groups of participants and transparent funding.
  11. ENDOMETRIOSIS The evidence to support the effectiveness of acupuncture for pain in endometriosis is limited, based on the results of only a single study that was included in this review. This review highlights the necessity for developing future studies that are well‐designed, double‐blinded, randomised controlled trials that assess various types of acupuncture in comparison to conventional therapies.
  12. VASCULAR DEMENTIA The effectiveness of acupuncture for vascular dementia is uncertain. More evidence is required to show that vascular dementia can be treated effectively by acupuncture. There are no RCTs and high quality trials are few. Randomized double‐blind placebo‐controlled trials are urgently needed.
  13. FUNCTIONAL DYSPEPSIA It remains unknown whether manual acupuncture or electroacupuncture is more effective or safer than other treatments for patients with FD.
  14. SMOKING CESSATION Although pooled estimates suggest possible short‐term effects there is no consistent, bias‐free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well‐designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence‐based interventions.
  15. RESTLESS LEG SYNDROME There is insufficient evidence to determine whether acupuncture is an efficacious and safe treatment for RLS. Further well‐designed, large‐scale clinical trials are needed.
  16. COCAINE DEPENDENCE There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
  17. LABOUR PAIN Acupuncture in comparison to sham acupuncture may increase satisfaction with pain management and reduce use of pharmacological analgesia. Acupressure in comparison to a combined control and usual care may reduce pain intensity. However, for other comparisons of acupuncture and acupressure, we are uncertain about the effects on pain intensity and satisfaction with pain relief due to very low‐certainty evidence. Acupuncture may have little to no effect on the rates of caesarean or assisted vaginal birth. Acupressure probably reduces the need for caesarean section in comparison to a sham control. There is a need for further high‐quality research that include sham controls and comparisons to usual care and report on the outcomes of sense of control in labour, satisfaction with the childbirth experience or satisfaction with pain relief.
  18. ISCAEMIC ENCEPHALOPATHY The rationale for acupuncture in neonates with HIE is unclear and the evidence from randomized controlled trial is lacking. Therefore, we do not recommend acupuncture for the treatment of HIE in neonates. High quality randomized controlled trials on acupuncture for HIE in neonates are needed.
  19. LOW BACK PAIN The data do not allow firm conclusions about the effectiveness of acupuncture for acute low‐back pain. For chronic low‐back pain, acupuncture is more effective for pain relief and functional improvement than no treatment or sham treatment immediately after treatment and in the short‐term only. Acupuncture is not more effective than other conventional and “alternative” treatments. The data suggest that acupuncture and dry‐needling may be useful adjuncts to other therapies for chronic low‐back pain. Because most of the studies were of lower methodological quality, there certainly is a further need for higher quality trials in this area.
  20. AUTISM Current evidence does not support the use of acupuncture for treatment of ASD. There is no conclusive evidence that acupuncture is effective for treatment of ASD in children and no RCTs have been carried out with adults. Further high quality trials of larger size and longer follow‐up are needed.
  21. CARPAL TUNNEL SYNDROME Acupuncture and laser acupuncture may have little or no effect in the short term on symptoms of CTS in comparison with placebo or sham acupuncture. It is uncertain whether acupuncture and related interventions are more or less effective in relieving symptoms of CTS than corticosteroid nerve blocks, oral corticosteroids, vitamin B12, ibuprofen, splints, or when added to NSAIDs plus vitamins, as the certainty of any conclusions from the evidence is low or very low and most evidence is short term. The included studies covered diverse interventions, had diverse designs, limited ethnic diversity, and clinical heterogeneity. High‐quality randomised controlled trials (RCTs) are necessary to rigorously assess the effects of acupuncture and related interventions upon symptoms of CTS. Based on moderate to very‐low certainty evidence, acupuncture was associated with no serious adverse events, or reported discomfort, pain, local paraesthesia and temporary skin bruises, but not all studies provided adverse event data.
  22. ADHA A comprehensive search showed that there is no evidence base of randomised or quasi‐randomised controlled trials to support the use of acupuncture as a treatment for ADHD in children and adolescents. Due to the lack of trials, we cannot reach any conclusions about the efficacy and safety of acupuncture for ADHD in children and adolescents. This review highlights the need for further research in this area in the form of high quality, large scale, randomised controlled trials.
  23. FIBROMYALGIA There is low to moderate‐level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate‐level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well‐being. EA is probably better than MA for pain and stiffness reduction and improvement of global well‐being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow‐up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.
  24. GLAUCOMA At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
  25. UTERINE FIBROIDS The effectiveness of acupuncture for the management of uterine fibroids remains uncertain. More evidence is required to establish the efficacy and safety of acupuncture for uterine fibroids. There is a continued need for well designed RCTs with long term follow up.
  26. HIP OSTEOARTHRITIS Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.
  27. HYPERTENSION At present, there is no evidence for the sustained BP lowering effect of acupuncture that is required for the management of chronically elevated BP. The short‐term effects of acupuncture are uncertain due to the very low quality of evidence. The larger effect shown in non‐sham acupuncture controlled trials most likely reflects bias and is not a true effect. Future RCTs must use sham acupuncture controls and assess whether there is a BP lowering effect of acupuncture that lasts at least seven days.
  28. GASTROPARESISThere is very low‐certainty evidence for a short‐term benefit with acupuncture alone or acupuncture combined with gastrokinetic drugs compared with the drug alone, in terms of the proportion of people who experienced improvement in diabetic gastroparesis. There is evidence of publication bias and a positive bias of small study effects. The reported benefits should be interpreted with great caution because of the unclear overall risk of bias, unvalidated measurements of change in subjective symptoms, publication bias and small study reporting bias, and lack of data on long‐term outcomes; the effects reported in this review may therefore differ significantly from the true effect. One sham‐controlled trial provided low‐certainty evidence of no difference between real and sham acupuncture in terms of short‐term symptom improvement in diabetic gastroparesis, when measured by a validated scale. No studies reported changes in quality of life or the use of medication.Due to the absence of data, no conclusion can be made regarding effects of acupuncture on gastroparesis of other aetiologies. Reports of harm have remained largely incomplete, precluding assessments of the safety of acupuncture in this population. Future research should focus on reducing the sources of bias in the trial design as well as transparent reporting. Harms of interventions should be explicitly reported.
  29. ACUTE STROKE This updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long‐term functional outcomes.
  30. INSOMNIA Due to poor methodological quality, high levels of heterogeneity and publication bias, the current evidence is not sufficiently rigorous to support or refute acupuncture for treating insomnia. Larger high‐quality clinical trials are required.
  31. SCHIZOPHRENIA Limited evidence suggests that acupuncture may have some antipsychotic effects as measured on global and mental state with few adverse effects. Better designed large studies are needed to fully and fairly test the effects of acupuncture for people with schizophrenia.
  32. ACUTE HORDEOLUM Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum when compared with conventional treatments alone. The certainty of the evidence was low to very low mainly due to small sample sizes, inadequate allocation concealment, lack of masking of the outcome assessors, inadequate or unclear randomization method, and a high or unreported number of dropouts. All RCTs were conducted in China, which may limit their generalizability to non‐Chinese populations.Because no RCTs included a valid sham acupuncture control, we cannot rule out a potential expectation/placebo effect associated with acupuncture. As resolution is based on clinical observation, the outcome could be influenced by the observer’s knowledge of the assigned treatment. Adverse effects of acupuncture were reported sparsely in the included RCTs, and, when reported, were rare. RCTs with better methodology, longer follow‐up, and which are conducted among other populations are warranted to provide more general evidence regarding the benefit of acupuncture to treat acute hordeolum.
  33. STROKE REHABILITATION From the available evidence, acupuncture may have beneficial effects on improving dependency, global neurological deficiency, and some specific neurological impairments for people with stroke in the convalescent stage, with no obvious serious adverse events. However, most included trials were of inadequate quality and size. There is, therefore, inadequate evidence to draw any conclusions about its routine use. Rigorously designed, randomised, multi‐centre, large sample trials of acupuncture for stroke are needed to further assess its effects.
  34. DEPRESSION The reduction in severity of depression was less when acupuncture was compared with control acupuncture than when acupuncture was compared with no treatment control, although in both cases, results were rated as providing low‐quality evidence. The reduction in severity of depression with acupuncture given alone or in conjunction with medication versus medication alone is uncertain owing to the very low quality of evidence. The effect of acupuncture compared with psychological therapy is unclear. The risk of adverse events with acupuncture is also unclear, as most trials did not report adverse events adequately. Few studies included follow‐up periods or assessed important outcomes such as quality of life. High‐quality randomised controlled trials are urgently needed to examine the clinical efficacy and acceptability of acupuncture, as well as its effectiveness, compared with acupuncture controls, medication, or psychological therapies.
  35. GAG REFLEX We found very low‐certainty evidence from four trials that was insufficient to conclude if there is any benefit of acupuncture, acupressure or laser at P6 point in reducing gagging and allowing successful completion of dental procedures. We did not find any evidence on any other interventions for managing the gag reflex during dental treatment. More well‐designed and well‐reported trials evaluating different interventions are needed.
  36. PERIPHERAL JOINT OSTEOARTHRITIS Sham‐controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre‐defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list‐controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.
  37. ELBOW PAIN There is insufficient evidence to either support or refute the use of acupuncture (either needle or laser) in the treatment of lateral elbow pain. This review has demonstrated needle acupuncture to be of short term benefit with respect to pain, but this finding is based on the results of 2 small trials, the results of which were not able to be combined in meta‐analysis. No benefit lasting more than 24 hours following treatment has been demonstrated. No trial assessed or commented on potential adverse effect. Further trials, utilising appropriate methods and adequate sample sizes, are needed before conclusions can be drawn regarding the effect of acupuncture on tennis elbow.
  38. MUMPS There is no evidence to determine the efficacy and safety of acupuncture in the treatment of children with mumps, although the excluded studies suggest that acupuncture is effective in improving swelling and pain of the parotid gland and assisting the body temperature to return to normal. We cannot make any recommendations for practice and nor can the results be generalised to clinical practice.
  39. MENOPAUSAL HOT FLUSHES We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
  40. ASSISTED CONCEPTION There is no evidence that acupuncture improves live birth or pregnancy rates in assisted conception.
  41. HICCUPS A total of four studies (305 participants) met the inclusion criteria. All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups. Due to methodological differences we were unable to perform a meta‐analysis of the results. No studies investigating pharmacological interventions for persistent and intractable hiccups met the inclusion criteria.
  42. DYSPHAGIA IN ACUTE STROKE There is not enough evidence to make any conclusion about the therapeutic effect of acupuncture for dysphagia after acute stroke. High quality and large scale randomised controlled trials are needed.
  43. MOXIBUSTION FOR BREECH PRESENTATION This review found limited evidence to support the use of moxibustion for correcting breech presentation. There is some evidence to suggest that the use of moxibustion may reduce the need for oxytocin. When combined with acupuncture, moxibustion may result in fewer births by caesarean section; and when combined with postural management techniques may reduce the number of non‐cephalic presentations at birth, however, there is a need for well‐designed randomised controlled trials to evaluate moxibustion for breech presentation which report on clinically relevant outcomes as well as the safety of the intervention.
  44. CANCER PAIN There is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.
  45. URINARY INCONTINENCE The effect of acupuncture for stress urinary incontinence for adults is uncertain. There is not enough evidence to determine whether acupuncture is more effective than drug treatment.
  46. INDUCTION OF LABOUR Overall, there was no clear benefit from acupuncture or acupressure in reducing caesarean section rate. The quality of the evidence varied between low to high. Few trials reported on neonatal morbidity or maternal mortality outcomes. Acupuncture showed some benefit in improving cervical maturity, however, more well‐designed trials are needed. Future trials could include clinically relevant safety outcomes.
  47. NEUROPATHIC PAIN Due to the limited data available, there is insufficient evidence to support or refute the use of acupuncture for neuropathic pain in general, or for any specific neuropathic pain condition when compared with sham acupuncture or other active therapies. Five studies are still ongoing and seven studies are awaiting classification due to the unclear treatment duration, and the results of these studies may influence the current findings.
  48. PREMENSTRUAL SYNDROME The limited evidence available suggests that acupuncture and acupressure may improve both physical and psychological symptoms of PMS when compared to a sham control. There was insufficient evidence to determine whether there was a difference between the groups in rates of adverse events. There is no evidence comparing acupuncture or acupressure versus current ISPMD recommended treatments for PMS such as selective serotonin reuptake inhibitors (SSRIs). Further research is required, using validated outcome measures for PMS, adequate blinding and suitable comparator groups reflecting current best practice.
  49. IRRITABLE BOWEL SYNDROME Sham‐controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS‐related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients’ preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy.
  50. ANKLE SPRAIN The currently available evidence from a very heterogeneous group of randomised and quasi‐randomised controlled trials evaluating the effects of acupuncture for the treatment of acute ankle sprains does not provide reliable support for either the effectiveness or safety of acupuncture treatments, alone or in combination with other non‐surgical interventions; or in comparison with other non‐surgical interventions. Future rigorous randomised clinical trials with larger sample sizes will be necessary to establish robust clinical evidence concerning the effectiveness and safety of acupuncture treatment for acute ankle sprains.
  51. MYOPAIA Two trials are included in this review but no conclusions can be drawn for the benefit of co‐acupressure for slowing progress of myopia in children. Further evidence in the form of RCTs are needed before any recommendations can be made for the use of acupuncture treatment in clinical use. These trials should compare acupuncture to placebo and have large sample sizes. Other types of acupuncture (such as auricular acupuncture) should be explored further as well as compliance with treatment for at least six months or longer. Axial length elongation of the eye should be investigated for at least one year. The potential to reduce/eliminate pain from acupuncture experienced by children should also be reviewed.
  52. CHRONIC KIDNEY DISEASE There was very low quality of evidence of the short‐term effects of manual acupressure as an adjuvant intervention for fatigue, depression, sleep disturbance and uraemic pruritus in patients undergoing regular haemodialysis. The paucity of evidence indicates that there is little evidence of the effects of other types of acupuncture for other outcomes, including pain, in patients with other stages of CKD. Overall high or unclear risk of bias distorts the validity of the reported benefit of acupuncture and makes the estimated effects uncertain. The incomplete reporting of acupuncture‐related harm does not permit us to assess the safety of acupuncture and related interventions. Future studies should investigate the effects and safety of acupuncture for pain and other common symptoms in patients with CKD and those undergoing dialysis.
  53. REHABILITATION OF BRAIN INJURY The low methodological quality of the included studies does not allow us to make conclusive judgments on the efficacy and safety of acupuncture in either the acute treatment and/or rehabilitation of TBI. Its beneficial role for these indications remains uncertain. Further research with high quality trials is required.
  54. POST-OPERATIVE NAUSEA AND VOMITING There is low‐quality evidence supporting the use of PC6 acupoint stimulation over sham. Compared to the last update in 2009, no further sham comparison trials are needed. We found that there is moderate‐quality evidence showing no difference between PC6 acupoint stimulation and antiemetic drugs to prevent PONV. Further PC6 acupoint stimulation versus antiemetic trials are futile in showing a significant difference, which is a new finding in this update. There is inconclusive evidence supporting the use of a combined strategy of PC6 acupoint stimulation and antiemetic drug over drug prophylaxis, and further high‐quality trials are needed.

The next and last part of this series will provide a few short comments on the current evidence.

Stay tuned!

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

“Unless positive evidence emerges, the risk/benefit balance of ozone therapy for any condition fails to be positive.”  This is the conclusion I recently drew after assessing the evidence for or against this therapy. Now a new review has just been published. Does it change my verdict?

This review evaluated the available literature on the application of oxygen-ozone therapy (OOT) in the treatment of knee osteoarthritis (KOA) to understand its therapeutic potential and to compare it with other conservative treatment options.

Eleven studies involving 858 patients met the inclusion criteria. Patients in the control groups received different treatments:

  • placebo in 1 trial;
  • hyaluronic acid in 2 studies;
  • hyaluronic acid and PRP in 1 trial;
  • corticosteroids in 4;
  • hypertonic dextrose, radiofrequency, or celecoxib + glucosamine in the remaining 3 trials.

The quality of these studies was poor; none of the studies included reached “good quality” standard, 2 were ranked as “fair,” and the rest were considered “poor.” No major complications or serious adverse events were reported following intra-articular OOT, which provided encouraging pain relief at short term. On the basis of the available data, no clear indication emerged from the comparison of OOT with other established treatments for KOA.

The authors concluded that the analysis of the available RCTs on OOT for KOA revealed poor methodologic quality, with most studies flawed by relevant bias, thus severely limiting the possibility of drawing conclusions on the efficacy of OOT compared with other treatments. On the basis of the data available, OOT has, however, proven to be a safe approach with encouraging effects in pain control and functional recovery in the short-middle term.

The use of ozone for treatment of KOA is highly controversial. The mechanism of action of ozone therapy for the treatment of KOA is unclear. Some studies have suggested that ozone injections results in pain relief, reduction of oedema, and improved mobility. The above review might be valuable in summarising the evidence, however, I fing its conclusion odd:

  • The authors write that they cannot arrive at a verdict about efficacy because of the poor quality of the primary studies. I think the conclusion is very clear and should have been expressed bluntly. THE AVAILABLE DATA FAIL TO SHOW EFFICACY; THE THERAPY IS THUS UNPROVEN AND SHOULD THEREFORE NOT BE USED. Simple!
  • I also disagree that OOT was proven to be safe. No treatment can be proven to be safe on the basis of just a few studies. This would require a much, much greater sample size.

This leaves us with the following situation:

  1. OOT is not plausible.
  2. OOT is unproven.
  3. The risks of OOT are unknown.

To me this means that we should stop using it (and I don’t need to change my above-quotes verdict).

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.

If you want to be able to edit your comment for five minutes after you first submit it, you will need to tick the box: “Save my name, email, and website in this browser for the next time I comment.”

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives

Categories