commercial interests
The ‘SOCIETY OF HOMEOPATHS’ (SoH) have published an official complaint they recently filed with the BBC. As it gives an intriguing insight into their mind-set, I could not resist reproducing it here (warts and all):
“Prompted by the interview with Simon Stevens of NHS England on the Today Programme, on 31st March, the Society of Homeopaths deplores the lack of balance in the BBC’s coverage of Homeopathy and urges you to review your approach to coverage of the subject.
During the Today interview, following wide-ranging discussion of issues around the future of the NHS, Sarah Montague suddenly threw in a question about the amount spent on Homeopathy within the NHS, evidently catching Mr Stevens unawares.
The annual budget of the NHS is approximately £110billion. Of this, £4million per year (0.0036 of the NHS budget) is spent on Homeopathy. This hardly justifies the unbalanced and hectoring approach from Sarah Montague.
We acknowledge that it is not always possible or necessary to achieve balance on a particular topic within a single programme but the BBC seems to have a consistent line across all of its platforms of opposition to, and disparagement of, Homeopathy. A recent example is a piece on the Health section of the BBC website in October 2106 by Nick Tiggle which displayed no balance at all and denigrated Homeopathy and Homeopaths with little or no space given to alternative views.
From these and other instances, it seems clear that the BBC has a biased attitude towards Homeopathy, which may be the result of relying too heavily on a small number of ‘experts’, who openly and persistently campaign against complementary and alternative medicine. These ‘experts’ operate in a similar way to climate change deniers, referring to a limited range of research, often of poor quality, to support their claims that there is ‘no evidence for homeopathy’.
We look forward to BBC programmes which fulfill its mission to explain and provide balance and coverage of the positive effects of Homeopathy.
Mark Taylor Chief Executive Society of Homeopaths”
END OF QUOTE
This hardly needs a comment – perhaps just 6 short points:
- To the best of my knowledge, the BBC has a policy of not being seen to be biased. The discussion referred to above was about the NHS stopping to pay for treatments that are either not effective (e. g. cough syrups) or cheaper to buy OTC than on prescription (e. g. paracetamol). Homeopathy is both. Therefore it would have even been biased NOT to bring homeopathy into the discussion.
- To claim the BBC-interviewer caught Stevens off guard is just silly: when you go on the radio to discuss such issues, homeopathy MUST be on your mind.
- To claim that the BBC is generally biased against homeopathy (on the basis of two anecdotes) is equally silly. The SoH should have done some systematic research on this – perhaps they did and found it failed to support their point? – this would have shown that there is plenty of (far too much) pro-homeopathy stuff on the BBC.
- To say or imply that homeopathy is of debatable or even no value to the NHS does not disclose bias; on the contrary, it is a reflection of the scientific truth which the BBC has an obligation to report.
- With their complaint, the SoH disclose an embarrassing degree of naivety and an alarming detachment from reality.
- Whichever way a rational observer might look at this, the BBC should in future become a much more outspoken defender of the scientific truth – on homeopathy and everything else!!!
The recent meta-analysis by Mathie et al for non-individualised homeopathy (recently discussed here) identified just 3 RCTs that were rated as ‘reliable evidence’. But just how rigorous are these ‘best’ studies? Let’s find out!
THE FIRST STUDY
The objective of the first trial was “to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.” Its design was that of a multicentre (35 centres in France), randomized, double-blind, placebo-controlled. One hundred and eight menopausal women, ≥50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥5 hot flashes per day with a significant negative effect on the women’s professional and/or personal life. Treatment was either BRN-01 tablets, a registered homeopathic medicine [not registered in the UK] containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards [available OTC in France]. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrolment and was continued for 12 weeks. The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. The authors concluded that BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication.
Laboratoires Boiron provided BRN-01, its matching placebo, and financial support for the study. Randomization and allocation were carried out centrally by Laboratoires Boiron. I would argue that the treatment time in this study was way too short for generating a therapeutic response. The evolution of the HFS in the two groups was assessed by analysis of the area under the curve (AUC) of the mean scores recorded weekly from each patient in each group over the duration of the study, including those at enrollment (before any treatment). I wonder whether this method was chosen only when the researchers noted that the HFS at the pre-defined time points did not yield a significant result or whether it was pre-determined (elsewhere in the methods section we are told that “The primary evaluation criterion was the effect of BRN-01 on the HFS, compared with placebo. The HFS was defined as the product of the daily frequency and intensity of all hot flashes experienced by the patient, graded by the women from 1 to 4 (1 = mild; 2 = moderate; 3 = strong; 4 = very strong). These data were recorded by the women on a self-administered questionnaire, assisted by a telephone call from a clinical research associate. Data were collected (i) during the first 2 days after enrolment and before any medication had been taken; (ii) then every Tuesday and Wednesday of each week until the 11th week of treatment, inclusive; and (iii) finally, every day of the 12th week of treatment.”). Two of the authors of this paper are employees of Boiron.
THE SECOND STUDY
The second trial was aimed at finding out “whether a well-known and frequently prescribed homeopathic preparation could mitigate post-operative pain.” It was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). The authors concluded that Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.
Traumeel is a mixture of 6 ingredients, 4 of which are in the D2 potency. Thus it neither is administered as a homeopathic remedy (no ‘like cures like’) nor is it highly diluted. In fact, it is not homeopathy at all but belongs to a weird offspring of homeopathy called ‘homotoxicology’ [this is an explanation from my book: Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel.] The HEEL Company (Baden-Baden, Germany) provided funding for the performance and monitoring of this project, supplied the study medication and placebo, and prepared the randomization list. The positive outcome mentioned in the authors’ conclusion refers to a secondary endpoint. I would argue that the authors should not have noted it there and should have made it clear that the trial generated a negative result.
THE THIRD STUDY
Finally, the third of the 3 ‘rigorous’ studies “evaluated the effectiveness of the homeopathic preparation Plumbum Metallicum (PM) in reducing the blood lead levels of workers exposed to this metal.” The Brazilian researchers recruited 131 workers to this RCT who took PM in the CH15 potency or placebo for 35 days (10 drops twice daily). Thereafter, the percentage of workers whose lead level had fallen by at least 25% did not differ between the groups, both on intention to treat and per protocol analyses. The authors concluded that PM “had no effect in this study in terms of reducing serum lead in workers exposed to lead.”
This study lacks a power calculation, and arguably the period might have been too short to show an effect. The trial was published in the journal HOMEOPATHY which, some might argue, has not the most rigorous of peer-review procedures.
CONCLUDING REMARKS
The third study seems the most rigorous by far, in my view. The other two trials are seriously under-whelming in several respects, primarily because we cannot be sure how much influence the commercial interests of the sponsor had on their findings. I am sure others will spot weaknesses in all three trials that I failed to see.
Mathie et al partly disagree with my assessment when they write in their paper: “We report separately our model validity assessments of these trials, evaluating consequently their overall quality based on a GRADE-like principle of ‘downgrading’ [14]: two trials [23, 25] rated here as reliable evidence were downgraded to ‘low quality’ overall due to the inadequacy of their model validity; the remaining trial with reliable evidence [24] was judged to have adequate model validity. The latter study [24] thus comprises the sole RCT that can be designated ‘high quality’ overall by our approach, a stark finding that reveals further important aspects of the preponderantly low quality of the current body of evidence in non-individualised homeopathy.”
What Mathie et al seem to forget entirely is that none of the 3 RCTs is a trial of homeopathy as defined by treatment according to the ‘like cures like’ principle. The authors of the second study acknowledge this fact by stating: “Homeopathic purists may find fault in the administration of a standardized combination homeopathic formula to all patients, based upon clinical diagnosis – as opposed to the individualized manner dictated by standard homeopathic practice.”
So, which ever way we look upon this evidence, we cannot possibly deny that the evidence for non-individualised homeopathy is rubbish.
D D Palmer was born on March 7, 1845; so, why do chiros celebrate the ‘CHIROPRACTIC AWARENESS WEEK’ from 10 – 16 of April? Perhaps out of sympathy with the homeopaths (many US chiros also use homeopathy) who had their ‘big week’ during the same period? Please tell me, I want to know!
Anyway, the HAW almost ‘drowned’ the CAW – but only almost.
The British Chiropractic Association did its best to make sure we don’t forget the CAW. On their website, we find an article that alerts us to their newest bit of research. Here are some excerpts:
The consumer survey by the British Chiropractic Association (BCA) of more than 2,000 UK adults who currently suffer from back or neck pain, or have done so in the past, found that almost three in five (56%) people experienced pain after using some form of technological device. Despite this, only 27% of people surveyed had limited or stopped using their devices due to concerns for their back or neck health and posture. The research showed people were most likely to experience back or neck pain after using the following technological devices:
• Laptop computer (35%)
• Desktop computer (35%)
• Smart phone (22%)
• Tablet (20%)
• Games console (17%)
The age group most likely to experience back or neck pain when using their smart phone were 16-24 year olds, while nearly half (45%) of young adults 25-34 year olds) admitted to experiencing back or neck pain after using a laptop. One in seven (14%) 16-24 year olds attributed their back or neck pain to virtual reality headsets.
As part of Chiropractic Awareness Week (10-16 April) the BCA is calling for technology companies to design devices with posture in mind, to help tech proof our back health. BCA chiropractor Rishi Loatey comments: “We all know how easy it is to remain glued to our smart phone or tablet, messaging friends or scrolling through social media. However, this addiction to technology could be causing changes to posture, which can lead to increased pressure on the muscles, joints and discs in the spine. Technology companies are now starting to issue older phone models which hark back to a time before smart phones enabled people to do everything from check emails and take pictures, to internet banking. Returning to a time of basic functionality, which may see people look to limit the time spent on their phone, can only be good news for our backs. Yet, in an age where people can now track their health and wellbeing using their phone, technology companies should also start looking at ways to make their devices posture friendly from the outset, encouraging us to take time away from our desks and breaks from our scrolling, gaming and messaging.”
END OF QUOTE
So, here we have it: another piece of compelling, cutting edge research by the BCA. They have made us giggle before but rarely have I laughed so heartily about a ‘professional’ organisation confusing so unprofessionally correlation with causation.
Considering the amount of highly public blunders they managed to inflict on the profession in recent years, I have come to the conclusion that the BCA is a cover organisation of BIG PHARMA with the aim of giving chiropractic a bad name!
Homeopathic remedies work for animals and therefore they cannot be placebos!!!
This argument is the standard reply of believers in homeopathy (not least of Prince Charles). It shows, I think, two things:
- Believers in homeopathy fail to understand the placebo effect.
- They are ill-informed or lying about the evidence regarding homeopathy in animals.
As we have explained on this blog over and over again: the evidence for homeopathy in animals is very much like that in humans: it fails to show that highly diluted homeopathic remedies are more than placebos (see, for instance here, here and here). Now a further study confirms this fact.
The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, the researchers also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. They recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. Cows were observed for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. No significant differences were noted in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk.
The authors concluded that the results indicated no additional effect of homeopathic treatment compared with placebo.
The question is HOW MUCH MORE EVIDENCE IS NEEDED BEFORE HOMEOPATHS ABANDON THEIR BOGUS CLAIM?
To honour Hahnemann’s birthday, a National Convention was held yesterday on ‘World Homeopathy Day’ in New Delhi. The theme of the convention is “Enhancing Quality Research in Homeopathy through scientific evidence and rich clinical experiences”. They could have done with this new study of Influenzinum 9C, it seems to me. This is a homeopathic remedy made from the current influenza vaccine. Influenzinum 9C, also known as homeopathic flu nosode. It is claimed to:
- strengthen the body and increase its resistance to the season’s flu viruses,
- protect against cold & flu symptoms such as body aches, nausea, chills, fever, headaches, sore throat, coughs, and congestion,
- enforce the flu vaccine’s action if you have opted for the flu shot,
- deal with aftereffects of the flu, and
- alleviate adverse effects of the flu shot.
As these are the claims made by homeopaths (here is but one example of many: “I’ve been using this for over 30 years for my family, and we have never had the flu!”), French researchers have tested whether Influenzinum works. They just published the results of the first study examining the effectiveness of Influenzinum against influenza-like illnesses.
They conducted a retrospective cohort study during winter 2014-2015. After influenza epidemic, a self-assessment questionnaire was offered to patients presenting for a consultation. The primary endpoint was the declaration of an influenza-like illness. The exposed patients (treated by Influenzinum) were matched to two non-exposed patients (untreated) with a propensity score. A conditional logistic model expressed influenza-like illness risk reduction provided by the Influenzinum.
The cohort included 3514 patients recruited from 46 general practitioners. After matching, the treated group (n=2041) and the untreated group (n=482) did not differ on variables collected. Thus Influenzinum preventive therapy did not significantly alter the likelihood of influenza-like illness.
The authors concluded that Influenzinum preventive therapy did not appear effective in preventing influenza-like illness.
This can be no surprise to anyone you knows what ‘C9’ means: it signifies a dilution of 1: 1 000 000 000 000 000 000 (plus 9 times vigorous shaking, of course).
I am sure that some homeopaths will now question whether Influenzinum is truly homeopathic. Is it based on the ‘like cures like’ principle? Before some clever Dick comments ‘THIS SHOWS THAT PROF ERNST HAS NOT GOT A CLUE ABOUT HOMEOPATHY’, please let me point out that it was not I but the homeopaths who insisted in labelling Influenzinum ‘homeopathic’ (see, for instance, here: “Influenzinum Dose is a homoeopathic medicine created by Laboratoire Boiron. Single dose to be consumed in one step. This homoeopathic medicine is generally used as a substitute for the flu vaccine”). AND WHO AM I TO QUESTION THE AUTHORITY OF BOIRON???
“Millions of people have adverse drug reactions to prescribed medicine; it is ranked as the third leading causes of death. In the US, health-care spending reached $1.6 trillion in 2003. Considering this enormous expenditure, we should have the best medicine in the world. But we don’t. Bottom line, people are suffering. The public is calling out for a reform in mainstream medicine.” These seem to be the conclusions of a new film about homeopathy entitled JUST ONE DROP. It was shown recently for the first time in London, and we already have a fascinating comment about it.
“This professional, eight-year effort attempted to be quite even-handed, while featuring many compelling and documented success stories”, states “The World’s No. 1 Authority on Intention, Spirituality and the New Science”, Lynne Mc Taggart. An ‘even-handed’ effort is worth pursuing, I thought, and so I read on.
When I reached the point where Lynne writes “The greatest revelation had to do with the dirty pool employed by the Australian government’s National Health and Medical Research Council (NHMRC), when it decided to assess the effectiveness of homeopathy by reviewing all research that had been done to date”, I got a little suspicious. We discussed the NHMRC report here and here and I had an entirely different impression of it.
Lynne also elaborated at length on the infamous ‘Swiss report’: “The Swiss team had comprehensively reviewed all the major evidence for homeopathy, everything from preclinical research to double-blind, placebo-controlled studies and meta-analyses. After assessing all the available data, the Swiss team concluded that the high-quality investigations of preclinical basic research proved that homeopathic high-potency remedies induce “regulative and specific changes in cells or living organisms”. Of the systematic reviews of human research, said the report, 20 out of 22 detected “at least a trend in favor of homeopathy”, and five showed “clear evidence for homeopathic therapy”. The report found particularly strong evidence for the use of homeopathy for upper respiratory tract infections and allergic reactions. Perhaps most significantly, the report concluded that the effectiveness of homeopathy “can be supported by clinical evidence” and “regarded as safe”.(Forsch Komple-mentmed, 2006; 13 Suppl 2: 19–29).”
This report has been evaluated by many experts (see for instance here). One expert even called it ‘research misconduct’ and concluded that “…the authors of this report adopted a very unusual strategy in what should have been an impartial evidence appraisal. It appears that their goal was not to provide an independent assessment but to choose criteria that would lead to their chosen conclusion that homeopathy is effective. To this end, they chose to adopt a highly questionable criterion of “real-world” effectiveness, ignore negative findings concerning homeopathy in favour of implausible reinterpretation of results, and attack RCTs. This use of a unique and suspect methodology in an appraisal designed to assess healthcare objectively gives cause for particular concern; one imagines that the Swiss government wanted homeopathy to be judged against existing standards rather than new ones created specially for the evaluation. In doing so the authors have distorted the evidence and misled the public; these actions, combined with their conflicts of interest, strongly suggest that they are guilty of research misconduct. It is extremely unfortunate that the Swiss government lent legitimacy to this report by attaching its name to it, and also unfair that the English-language text is not available free of charge to the public when it is being widely misrepresented all over the world as proof of the efficacy of homeopathy. It remains possible that homeopathy is effective, but the authors of this report do the practice a grave disservice.”
Could it be that Lynne does not know all this?
Or is she not interested in an ‘even-handed’ approach?
For me, the last drop arrived when Lynne started writing about my friend “Simon Singh, the self-appointed attack dog on all things alternative”, as she calls him. This is where I began to feel nauseous, so much so that I had to reach for my Nux Vomica C30. Alas, it did not help – Lynne’s writing was too overpoweringly sickening, particularly when she tried to motivate her readers to defend charities that endanger public health by promoting bogus treatments for life-threatening conditions: “If you value alternative medicine, here’s what to write the CC before the deadline: Tell them to read the Swiss report on homeopathy, the most contentious of alternative therapies, which shows very good evidence for it. Demand a level playing field. If they are going to challenge charities for alternative medicine based on scientific evidence, then they need to evaluate Cancer Research UK, Arthritis Research UK and every other charity partly or wholly funded by pharmaceutical companies, an estimated 75 percent of whose research is massaged, manipulated or fabricated.”
My only hope now is that the film JUST ONE DROP is less bonkers than Lynne’s comment about it!
Tui Na is a massage technique that is based on the Taoist principles of TCM. It involves a range of manipulations usually performed by an operator’s finger, hand, elbow, knee, or foot applied to muscle or soft tissue at specific parts of the body. According to one website of TCM-proponents “Tui Na makes use of various hand techniques in combination with acupuncture and other manipulation techniques. To enhance the healing process, the practitioner may recommend the use of Chinese herbs. Many of the techniques used in this massage resemble that of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing and shaking. In Tui Na massage, the muscles and tendons are massaged with the help of hands, and an acupressure technique is applied to directly affect the flow of Qi at different acupressure points of the body, thus facilitating the healing process. It removes the blockages and keeps the energy moving through the meridians as well as the muscles. A typical session of Tui Na massage may vary from thirty minutes to an hour. The session timings may vary depending on the patient’s needs and condition. The best part of the therapy is that it relaxes as well as energizes the person. The main benefit of Tui Na massage is that it focuses on the specific problem, whether it is an acute or a chronic pain associated with the joints, muscles or a skeletal system. This technique is very beneficial in reducing the pain of neck, shoulders, hips, back, arms, highs, legs and ankle disorders. It is a very effective therapy for arthritis, pain, sciatica and muscle spasms. Other benefits of this massage therapy include alleviation of the stress related disorders like insomnia, constipation, headaches and other disorders related to digestive, respiratory and reproductive systems. The greatest advantage of Tui Na is that it focuses on maintaining overall balance with both physical and mental health. Any one who wants to avoid the side effects of drugs or a chemical based treatment can adopt this effective massage technique to alleviate their pain. Tui Na massage therapy is now becoming a more common therapy method due to its focus on specific problems rather than providing a general treatment.”
This clearly begs the question IS IT EFFECTIVE?
This systematic review assessed the evidence of Tui Na for cervical radiculopathy. Seven databases were searched. Randomised controlled trials (RCTs) incorporating Tui Na alone or Tui Na combined with conventional treatment were included. Five studies involving 448 patients were found. The pooled analysis from the 3 trials indicated that Tui Na alone showed a significant lowering immediate effects on pain score with moderate heterogeneity compared to cervical traction. The meta-analysis from 2 trials revealed significant immediate effects of Tui Na plus cervical traction in improving pain score with no heterogeneity compared to cervical traction alone. None of the RCTs mentioned adverse effects. There was very low quality or low quality evidence to support the results.
The authors concluded that “Tui Na alone or Tui Na plus cervical traction may be helpful to cervical radiculopathy patients, but supportive evidence seems generally weak. Future clinical studies with low risk of bias and adequate follow-up design are recommended.”
In my view, this is a misleading conclusion. A correct one would have been: THE CURRENT EVIDENCE IS INSUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE EFFECTIVENESS OF TUI NA.
Why?
Here are some of the most obvious reasons:
- there are far too few studies for a firm conclusion,
- the included RCTs lack scientific rigour,
- all trials originate from China where reliability seems to be a serious problem,
- traction is not a useful therapy for radiculopathy,
- the primary studies violate research ethics by not reporting adverse effects.
Personally, I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.
Drug and alcohol dependencies are notoriously difficult to treat effectively. Patients and their families are often desperate and willing to try anything. This seems like an ideal ground for acupuncturists who are, in my experience, experts in putting up smokescreens hiding the true value of their treatment.
The best way to determine the value of any intervention is probably conducting a systematic review of the evidence from rigorous clinical trials. Today we are in the fortunate position to have not just one of those articles; but do they really tell us the truth?
This brand-new systematic review investigated the effects of acupuncture on alcohol-related symptoms and behaviors in patients with this disorder. The PubMed database was searched until 23 August 2016, and reference lists from review studies were also reviewed. The inclusion criteria were the following: (1) being published in a peer-reviewed English-language journal, (2) use of randomized controlled trials (RCTs), (3) assessing the effects of acupuncture on psychological variables in individuals with a primary alcohol problem, and (4) reporting statistics that could be converted to effect sizes.
Seventeen studies were identified for a full-text inspection, and seven (243 patients) of these met our inclusion criteria. The outcomes assessed at the last post-treatment point and any available follow-up data were extracted from each of the studies. Five studies treated patients by inserting a needle into several acupoints in each ear. Two studies stimulated body points with or without ear stimulation. Four studies treated control patients with a placebo needle or under a completely different type of intervention, such as relaxation or transdermal stimulation, whereas the remaining studies inserted needles into nonspecific points. The patients were treated for 2 weeks to 3 months, and the treatment duration per session was 15–45 min. The results of the meta-analysis demonstrated that an acupuncture intervention had a stronger effect on reducing alcohol-related symptoms and behaviours than did the control intervention. A beneficial but weak effect of acupuncture treatment was also found in the follow-up data.
The authors concluded that although our analysis showed a significant difference between acupuncture and the control intervention in patients with alcohol use disorder, this meta-analysis is limited by the small number of studies included. Thus, a larger cohort study is required to provide a firm conclusion.
I am used to reading poor research papers, but this one is like a new dimension. Here are just the most obvious flaws:
- by searching just one database, the likelihood of missing studies is huge,
- by excluding non-English papers, the review automatically becomes non-systematic,
- the included studies differed vastly in many respects and can therefore not be pooled.
As it happens, a further meta-analysis has just been published. Here is its abstract:
Acupuncture has been widely used as a treatment for alcohol dependence. An updated and rigorously conducted systematic review is needed to establish the extent and quality of the evidence on the effectiveness of acupuncture as an intervention for reducing alcohol dependence. This review aimed to ascertain the effectiveness of acupuncture for reducing alcohol dependence as assessed by changes in either craving or withdrawal symptoms.
Methods
In this systematic review, a search strategy was designed to identify randomised controlled trials (RCTs) published in either the English or Chinese literature, with a priori eligibility criteria. The following English language databases were searched from inception until June 2015: AMED, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and PubMed; and the following Chinese language databases were similarly searched: CNKI, Sino-med, VIP, and WanFang. Methodological quality of identified RCTs was assessed using the Jadad Scale and the Cochrane Risk of Bias tool.
Results
Fifteen RCTs were included in this review, comprising 1378 participants. The majority of the RCTs were rated as having poor methodological rigour. A statistically significant effect was found in the two primary analyses: acupuncture reduced alcohol craving compared with all controls (SMD = −1.24, 95% CI = −1.96 to −0.51); and acupuncture reduced alcohol withdrawal symptoms compared with all controls (SMD = −0.50, 95% CI = −0.83 to −0.17). In secondary analyses: acupuncture reduced craving compared with sham acupuncture (SMD = −1.00, 95% CI = −1.79 to −0.21); acupuncture reduced craving compared with controls in RCTs conducted in Western countries (SMD = −1.15, 95% CI = −2.12 to −0.18); and acupuncture reduced craving compared with controls in RCTs with only male participants (SMD = −1.68, 95% CI = −2.62 to −0.75).
Conclusion
This study showed that acupuncture was potentially effective in reducing alcohol craving and withdrawal symptoms and could be considered as an additional treatment choice and/or referral option within national healthcare systems.
This Meta-analysis is only a little better than the first, I am afraid. What its conclusions do not sufficiently reflect, in my view, is the fact that the quality of the primary studies was mostly very poor – too poor to draw conclusions from (other than ‘acupuncture research is usually lousy’; see figure below). Therefore, I fail to see how the authors could draw the relatively firm and positive conclusions cited above. In my view, they should have stated something like this: DUE TO THE RISK OF BIAS IN MANY TRIALS, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.
The authors of the first meta-analysis open the discussion by proudly declaring that “the present study is the first meta-analysis to examine the effect of acupuncture treatment on patients with alcohol use disorder and to provide data on the magnitude of this effect on alcohol-related clinical symptoms and behaviours.” They discretely overlook this meta-analysis from 2009 (and several others which even their rudimentary search would have identified):
Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook.
Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal.
The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues.
One does not need to be an expert in interpreting meta-analyses, I think, to see that this paper is more rigorous than the new ones (which incidentally were published in the very dubious journals). And this is why I trust the conclusions of this last-named meta-analysis more than those of the new one: the efficacy of acupuncture remains unproven. And this means that we should not employ or promote it for routine care.
Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.
The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.
A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.
The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.
This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!
The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”
To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:
- It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
- The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
- These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.
I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”
In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.
So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”
Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!
Perhaps you can agree with this statement then:
As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).
THE CHRONICLE OF CHIROPRACTIC is not a publication I usually read, I have to admit. But perhaps I should, because this article from its latest edition is truly fascinating. Here are the crucial excerpts:
“A so called “debate” on vertebral subluxation was held at the recent chiropractic educational conference held by the controlling factions of the Chiropractic Cartel: The World Federation of Chiropractic, the Association of Chiropractic Colleges and the American Chiropractic Association. Every few years this faction of the profession makes an attempt to disparage vertebral subluxation and those who practice in a subluxation model by trotting out its long list of Subluxation Deniers.
This year was no different.
David Newell, who is a Senior Lecturer at the Anglo European College of Chiropractic, made a number of unsubstantiated claims and engaged in logical fallacies that would shock even the casual observer. As an example, Newell made the statement:
“The subluxation as vitalistic concept, an impediment in and of itself to health and well being, impeding the expression of higher intelligence is not only entirely bereft of any evidence whatsoever but is a complete non starter even as a scientific question.”
…Newell claimed that what is dangerous about the use of vertebral subluxation are concepts and behavior associated with its use. Newell stated that subluxations are used by some in the profession to “scare or misinform patients” and gave the following examples of claims he has issues with:
- You cannot be healthy with them
- They will lead to serious disease
- Chiropractors are the only ones that can help
- A chiropractic manipulation is unique
- You need to come back for the rest of your life
- You need to bring your children otherwise they will not develop properly
Newell claimed that such statements are “confusing, un-evidenced and detrimental to our standing as a profession in the outside world” and that “at worse, sometimes used to justify approaches to care and practice models that are unacceptable both inside and outside of the profession.”
Newell … continued his tirade against his perceived threat to public health stating vertebral subluxation and the concepts attached to it are: “. . . used to generate dependancy through fear or coercion. Here, use of such words and concepts essentially as smoke screens for a model of care dominated by a coercive business ethic are strongly reputationally damaging and are not OK.” …Newell further claimed that the concept of ” . . . subluxation as an impediment to innate intelligence is bereft of science and evidence” and that “. . . this approach will be inadmissible to characterise a modern healthcare profession. Describing the profession in such language will further isolate and marginalise.”…”The irony” he states “. . . is of course that there are much better explanations, concepts and terms. Much of what is seen in practice can be explained by sound science and scientific language and so a subluxation model isn’t even needed.”
He went on to engage in further expressions of logical fallacies by stating: “Even on a simple level, science has yet to answer questions as to what a subluxation is as a defined entity, can it be validly and reliably identified, can it be validly and reliably shown to have gone post manipulation and is such disappearance associated with meaningful clinical change in patients.”
In reality, there is a rich evidence base that demonstrates the validity and reliability of numerous methods of measurements focused on the various components of vertebral subluxation as well as evidence demonstrating reduction or correction of it with resulting positive health outcomes.
Unfortunately, most simply go along with statements such as Newell’s either out of ignorance, simple aquiesence or collegiality.
Imagine the plight of students in a chiropractic program being exposed to Newell’s dogma, scientism and denial of even the existence of vertebral subluxation. That he is even given a stage and an audience is a failure of leadership within the ranks of those who purport to embrace the vitalistic concept of vertebral subluxation.
We laugh and mock those who contend the Earth is flat, yet Subluxation Deniers are given voice by schools and political organizations along with a role in determining the subluxation research agenda. And its the leadership on the traditional, conservative side of the profession that does this – as evidenced by his even being entertained at an educational conference billed as the largest and most important gathering of chiropractic educators and researchers.
Not a single objection to his, or any other Deniers, participation by the leadership in the vitalistic faction. In fact, quite the opposite – he was given the opportunity to spew his Flat Earth nonsense to a wide audience who educate the future of this profession.
Imagine a meeting at NASA where a Flat Earther is given a voice and a vote on the Mars Mission.
This was and is a failure of leadership within the vitalistic, conservative, traditional faction of the chiropractic profession.”
END OF EXCERTS
On this blog, we have heard again and again that the chiropractic profession is in the middle of a fundamental reform, that it has given up the idiotic concepts of its founders, that it has joined the 21st century, that it is becoming evidence-based, that progress is being made etc. etc. However, sceptics have always doubted these claims and pointed out that chiropractic minus its traditional concepts would merely become a limited type of physiotherapy.
From the above article, I get the impression that the notion of reform might be a bit optimistic. The old guard seems to be as alive and powerful as ever, fighting as fiercely as always to preserve chiropractic’s nonsensical cult.
Some will, of course, claim that the above article shows exactly the opposite of what I just stated. They will try to persuade us that it is evidence for the struggle of the new generation of chiropractors instilling reason into their brain-dead peers. It is evidence, they will claim, for the fact that there is a healthy discussion within the profession.
Yet this is simply not true: The maligned Mr Newell is NOT a chiropractor!
To me, the above article suggests that, for the foreseeable future, chiropractic will remain where it always has been: firmly anchored in the realm of quackery.
