medical ethics
You might think that the question asked in the title of this post is a bit impertinent. Let’s see whether you change your mind after reading on.
“Come along for a ten minute taster sessions and experience the Bowen Technique.
It is appropriate for a wide range of acute and chronic conditions, including back pain, sciatica, neck, shoulder and knee problems, arthritis, asthma, migraine, sports injuries and stress. Ten-minute taster sessions will be offered so that you can experience the therapy first hand. Many find their aches and pains melt away!”
It is with these exact words that the Royal College of Nursing advertises a session on Bowen Technique to be held during their major conference on Saturday 13 – Wednesday 17 May 2017, Liverpool Arena and Convention Centre.
You may not have heard of the Bowen Technique, one of the more exotic types of alternative medicine. So, let me fill you in:
According to proponents, it is “a system of subtle and precise mobilizations called “Bowen moves” over muscles, tendons, nerves and fascia. The moves are performed using the thumbs and fingers applying only gentle, non invasive pressure. A treatment consists of a series of specific sequences of moves called procedures, with frequent pauses to allow time for the body to respond.”
Wikipedia explains: “recipients are generally fully clothed. Each session typically involves gentle rolling motions along the muscles, tendons, and fascia. The therapy’s distinctive features are the minimal nature of the physical intervention and pauses incorporated in the treatment. Proponents claim these pauses allow the body to “reset” itself. In 2015 the Australian Government’s Department of Health published the results of a review of alternative therapies that sought to determine if any were suitable for being covered by health insurance; Bowen Technique was one of 17 therapies evaluated for which no clear evidence of effectiveness was found.”
Medline lists just one single trial of Bowen Technique; it is not a clinical trial with patients but a study with healthy volunteers; here is its abstract:
The hamstring muscles are regularly implicated in recurrent injuries, movement dysfunction and low back pain. Links between limited flexibility and development of neuromusculoskeletal symptoms are frequently reported. The Bowen Technique is used to treat many conditions including lack of flexibility. The study set out to investigate the effect of the Bowen Technique on hamstring flexibility over time. An assessor-blind, prospective, randomised controlled trial was performed on 120 asymptomatic volunteers. Participants were randomly allocated into a control group or Bowen group. Three flexibility measurements occurred over one week, using an active knee extension test. The intervention group received a single Bowen treatment. A repeated measures univariate analysis of variance, across both groups for the three time periods, revealed significant within-subject and between-subject differences for the Bowen group. Continuing increases in flexibility levels were observed over one week. No significant change over time was noted for the control group.
So, whichever way we look at it, there is no evidence whatsoever that Bowen Technique is helpful for patients suffering from any condition. This clearly means that therapeutic claims made for it are bogus, and that the way the Royal College of Nursing advertised it is misleading to the point of being unethical. By definition, the promotion of bogus treatments is quackery. Ergo, the Royal College of Nursing is promoting quackery.
If that is so, there is of course another question that needs an answer: Why does the Royal College of Nursing promote quackery?
As I see it, there are several possibilities, for instance:
- They see nothing wrong with the Bowen session.
- They don’t know better.
- They don’t adhere to EBM.
- They don’t care.
- They were asked to run the session by someone with influence.
- They believe that nurses want this sort of thing.
- They think it’s trendy.
I would be fascinated to hear from someone who knows the correct answer.
Shiatsu is one of those alternative therapies where there is almost no research. Therefore, every new study is of interest, and I was delighted to find this new trial.
Italian researchers tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive one of the following treatments:
- shiatsu plus amitriptyline,
- shiatsu alone,
- amitriptyline alone
The treatment period lasted 3 months and the primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month.
After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline.
The results show that all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers and there was no between-group difference in the primary endpoint. Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month. Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment.
The authors concluded that shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study.
Yes, I would advocate great caution indeed!
The results could easily be said to demonstrate that shiatsu is NOT effective. There is NO difference between the groups when looking at the primary endpoint. This plus the lack of a placebo-group renders the findings uninterpretable:
- If we take the comparison 2 versus 3, this might indicate efficacy of shiatsu.
- If we take the comparison 1 versus 3, it would indicate the opposite.
- If we finally take the comparison 1 versus 2, it would suggest that the drug was ineffective.
So, we can take our pick!
Moreover, I do object to the authors’ conclusion that “shiatsu is a safe”. For such a statement, we would need sample sizes that are about two dimensions greater that those of this study.
So, what might be an acceptable conclusion from this trial? I see only one that is in accordance with the design and the results of this study:
POORLY DESIGNED RESEARCH CANNOT LEAD TO ANY CONCLUSIONS ABOUT THERAPEUTIC EFFICACY OR SAFETY. IT IS A WASTE OF RESOURCES AND A VIOLATION OF RESEARCH ETHICAL.
We have discussed this notorious problem before: numerous charities (such as one that treats HIV and malaria with homeopathy in Botswana, or the one claiming that homeopathy can reverse cancer) are a clear danger to public health. I have previously chosen the example of ‘YES TO LIFE’ and explained that they promote unproven and disproven alternative therapies as cures for cancer (and if you want to get really sickened, look who act as their supporters and advisors). It is clear to me that such behaviour can hasten the death of many vulnerable patients.
Yet, many such charities get tax and reputational benefits by being registered charities in the UK. The question is CAN THIS SITUATION BE JUSTIFIED?
Currently, the UK Charity commission want to answer it. Specifically, they are asking you the following question:
- Question 1: What level and nature of evidence should the Commission require to establish the beneficial impact of CAM therapies?
- Question 2: Can the benefit of the use or promotion of CAM therapies be established by general acceptance or recognition, without the need for further evidence of beneficial impact? If so, what level of recognition, and by whom, should the Commission consider as evidence?
- Question 3: How should the Commission consider conflicting or inconsistent evidence of beneficial impact regarding CAM therapies?
- Question 4: How, if at all, should the Commission’s approach be different in respect of CAM organisations which only use or promote therapies which are complementary, rather than alternative, to conventional treatments?
- Question 5: Is it appropriate to require a lesser degree of evidence of beneficial impact for CAM therapies which are claimed to relieve symptoms rather than to cure or diagnose conditions?
- Question 6: Do you have any other comments about the Commission’s approach to registering CAM organisations as charities?
I am sure that most readers of this blog have something to say about these questions. So, please carefully study the full document, go on the commission’s website, and email your response to: [email protected] . Don’t delay it; do it now!
THANK YOU!
The aim of this pragmatic study was “to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone.”
Patients with allergic asthma were included in a controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months plus routine care, or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1–7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0–100). Outcome parameters were assessed at baseline and at 3 and 6 months.
A total of 1,445 patients were randomized and included in the analysis (184 patients randomized to acupuncture plus routine care and 173 to routine care alone, and 1,088 in the nonrandomized acupuncture plus routine care group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5–1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0–4.0]; mental 4.0 [2.1–6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group.
The authors concluded that in patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.
We have been over this so many times (see for instance here, here and here) that I am almost a little embarrassed to explain it again: it is fairly easy to design an RCT such that it can only produce a positive result. The currently most popular way to achieve this aim in alternative medicine research is to do a ‘A+B versus B’ study, where A = the experimental treatment, and B = routine care. As A always amounts to more than nothing – in the above trial acupuncture would have placebo effects and the extra attention would also amount to something – A+B must always be more than B alone. The easiest way of thinking of this is to imagine that A and B are both finite amounts of money; everyone can understand that A+B must always be more than B!
Why then do acupuncture researchers not get the point? Are they that stupid? I happen to know some of the authors of the above paper personally, and I can assure you, they are not stupid!
So, why?
I am afraid there is only one reason I can think of: they know perfectly well that such an RCT can only produce a positive finding, and precisely that is their reason for conducting such a study. In other words, they are not using science to test a hypothesis, they deliberately abuse it to promote their pet therapy or hypothesis.
As I stated above, it is fairly easy to design an RCT such that it can only produce a positive result. Yet, it is arguably also unethical, perhaps even fraudulent, to do this. In my view, such RCTs amount to pseudoscience and scientific misconduct.
CBC news (Canada) reported yesterday that, more than a decade ago, the Manitoba Chiropractic Health Care Commission had been tasked to review the cost effectiveness of chiropractic services. It therefore prepared a report in 2004 for the Manitoba province and the Manitoba Chiropractors Association. Since then, this report has been kept secret. The report makes 37 recommendations, including:
- Manitoba Health should limit its funding to “chiropractic treatment of acute lower back pain.”
- Manitoba Health should provide “limited coverage of the treatment of neck pain.” The report called the literature around the efficacy of chiropractic care for neck pain “ambiguous or at best weakly supportive” and noted such treatment carried a “not insignificant safety risk.”
- Manitoba Health should not fund chiropractic treatment anyone under 18 “as the literature does not unequivocally justify” the “efficacy or safety” of such treatment.
A Manitoba Ombudsman’s Office report from 2012 might shed some light on why the Manitoba Chiropractic Health Care Commission’s report was never made public. Someone had attempted to get a copy of the report, but large parts of it were redacted. “Access to this record was refused on the basis that disclosure would be harmful to a third party’s business interest,” the ombudsman report notes, “and harm the economic or financial interests or negotiating position of a public body.”
The report also challenged claims that chiropractic treatments can be address a wide variety of medical conditions. It stated that there was not enough evidence to conclude chiropractic treatments are effective in treating muscle tension, migraines, HIV, carpal tunnel syndrome, gastrointestinal problems, infertility or cancer, or as a preventive care treatment. It also said there was not enough evidence to conclude chiropractic treatments are effective for children.
The report urged Manitoba Health to establish a monitoring system to keep a closer eye on “the advertising practices of the Manitoba Chiropractors Association and its members to ensure claims regarding treatments are restricted to those for which proof of efficacy and safety exist.” It suggested the government should have regulatory powers over chiropractic ads.
A recent CBC I-Team investigation found Manitoba chiropractors advertising treatment for a wide range of conditions including Alzheimer’s, autism and pediatric services. The commission report contained sharp criticisms of previous reports that suggested funding chiropractic care could save the health-care system money. Dr. Pranlal Manga authored two widely cited reports which claim that by offering publicly funded chiropractic care, provinces can cut health-care costs. “The Manga study on Manitoba must be rejected as a guide to public policy,” the commission report states, “because its assumptions, methodology and costing of recommendations are all deeply flawed.” The reports states, “What limited evidence the Commission has suggests he [Manga] grossly exaggerates possible medical savings.” Dr. Manga did not respond to CBC’s repeated attempts to contact him.
The commission report also made recommendations around the use of X-ray machines by chiropractors. It suggested chiropractors not own and operate X-ray machines “Given the restrictive conditions under which X-rays are advisable, their poor correlation with low-back problems, their apparent limitation as a guide to appropriate treatment …[and] the apparent complete lack of monitoring [of] the use of X-ray by chiropractors.” Instead, it recommended consulting with radiologists when imaging is deemed necessary. “The Commission is of the view that the public interest, and even chiropractic itself, would be better served if chiropractors had access to radiologists for this service, rather than perform it themselves,” the report said.
All three report authors declined comment. Calls to Dave Chomiak, who was health minister at the time the report was prepared, were not returned. In an email to CBC, Manitoba Chiropractors Association president Perry Taylor said, “I personally have never seen this 13-year-old document and [it] pre-dates my time as President. As such I have no comment on this.” The CBC I-Team offered to go through the report with Taylor but he did not respond.
MY COMMENT:
This report seems to confirm much of what we have discussed repeatedly on this blog: Chiropractic is not nearly as effective and safe as chiropractors try to make us believe. To hide this fact is certainly dishonest and unethical, but it is in some ways understandable: this knowledge would directly threaten the income of most chiropractors.
Yesterday I commented on another post: “the conflict of interest seems obvious: if homeopaths speak the truth, they are out of business. therefore, they are taught untruths from the first day of their training and eventually end up believing them. there is only one solution, as far as I can see: regulators must prevent them from making false claims. if not, this will go on for another 200 years and damage many patients’ health”. In the light of the above report, I will now re-phrase this: the conflict of interest seems obvious: if chiropractors allowed the truth to be known, they would soon be out of business. Therefore, they are taught untruths from the first day of their training and many end up believing them. There is only one solution, as far as I can see: regulators must prevent chiropractors from making false claims. If not, this abuse will go on for another 120 years and damage many patients’ health.
“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 TELEGRAPH reported that “homeopathic medicines will escape an NHS prescribing ban even though the Chief Medical Officer Dame Sally Davies has dismissed the treatments as ‘rubbish’ and a waste of taxpayers money.”
But why?
This sounds insane!
Sorry, I do not know the answer either, but below I offer 10 possible options – so bear with me, please.
The NHS spends around £4 million a year on homeopathic remedies, the article claimed. Sandra Gidley, chairwoman of the Royal Pharmaceutical Society, said: “We are surprised that homeopathy, which has no scientific evidence of effectiveness, is not on the list for review. We are in agreement with NHS England that products with low or no clinical evidence of effectiveness should be reviewed with urgency.”
The NHS Clinical Commissioners, the body which was asked to review which medications should no longer be prescribed for NHS England, said it had included drugs with ‘little or no clinical value’, yet could not offer an explanation why homeopathic medicines had escaped the cut. Julie Wood, Chief Executive, NHS Clinical Commissioners said: “Clinical commissioners have always had to make difficult choices about prioritising how they spend their budget on services, but the finance and demand challenges we face at the moment are unprecedented. Clinical Commissioning Groups have been looking at their medicines spend, and many are already implementing policies to reduce spending on those prescribeable items that have little or no clinical value for patients, and are therefore not an effective use of the NHS pound.”
Under the new rules, NHS doctors will be banned from routinely prescribing items that are cheaply available in chemists. The list includes heartburn pills, paracetamol, hayfever tablets, sun cream, muscle rubs, Omega 3 fish oils, medicine for coughs and colds and travel vaccinations. Coeliacs will also be forced to buy their own gluten-free food.
So, why are homeopathic remedies excluded from this new cost-saving exercise?
I am puzzled!
Is it because:
- The NHS has recently found out that homeopathy is effective after all?
- The officials have forgotten to put homeopathics on the list?
- In times of Brexit, the government cannot be bothered about reason, science and all that?
- The NHS does not need the money?
- Homeopathic globuli look so pretty?
- Our Health Secretary is in love with homeopathy?
- Experts are no longer needed for decision-making?
- EBM has suddenly gone out of fashion?
- Placebos are now all the rage?
- Some influential person called Charles is against it?
Sorry, no prizes for the winner of this quiz!
