Acupuncture is often recommended for relieving symptoms of fibromyalgia syndrome (FMS). The aim of this systematic review was to ascertain whether verum acupuncture is more effective than sham acupuncture in FMS.
Ten RCTs with a total of 690 participants were eligible, and 8 RCTs were eventually included in the meta-analysis. Its results showed a sizable effect of verum acupuncture compared with sham acupuncture on pain relief, improving sleep quality and reforming general status. Its effect on fatigue was insignificant. When compared with a combination of simulation and improper location of needling, the effect of verum acupuncture for pain relief was the most obvious.
The authors concluded that verum acupuncture is more effective than sham acupuncture for pain relief, improving sleep quality, and reforming general status in FMS posttreatment. However, evidence that it reduces fatigue was not found.
I have a much more plausible conclusion for these findings: in (de-randomised) trials comparing real and sham acupuncture, patients are regularly de-blinded and therapists are invariably not blind. The resulting bias and not the alleged effectiveness of acupuncture explains the outcome.
And why do I think that this conclusion is much more plausible?
Firstly, because of Occam’s Razor.
Secondly, because this is roughly what my own systematic review of the subject found (The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia). This view is also shared by other critical reviews of the evidence (Current literature does not support the routine use of acupuncture for improving pain or quality of life in FM). Perhaps more crucially, the current Cochrane review seems to concur: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.
The journal NATURE has just published an excellent article by Andrew D. Oxman and an alliance of 24 leading scientists outlining the importance and key concepts of critical thinking in healthcare and beyond. The authors state that the Key Concepts for Informed Choices is not a checklist. It is a starting point. Although we have organized the ideas into three groups (claims, comparisons and choices), they can be used to develop learning resources that include any combination of these, presented in any order. We hope that the concepts will prove useful to people who help others to think critically about what evidence to trust and what to do, including those who teach critical thinking and those responsible for communicating research findings.
Here I take the liberty of citing a short excerpt from this paper:
Claims about effects should be supported by evidence from fair comparisons. Other claims are not necessarily wrong, but there is an insufficient basis for believing them.
Claims should not assume that interventions are safe, effective or certain.
- Interventions can cause harm as well as benefits.
- Large, dramatic effects are rare.
- We can rarely, if ever, be certain about the effects of interventions.
Seemingly logical assumptions are not a sufficient basis for claims.
- Beliefs alone about how interventions work are not reliable predictors of the presence or size of effects.
- An outcome may be associated with an intervention but not caused by it.
- More data are not necessarily better data.
- The results of one study considered in isolation can be misleading.
- Widely used interventions or those that have been used for decades are not necessarily beneficial or safe.
- Interventions that are new or technologically impressive might not be better than available alternatives.
- Increasing the amount of an intervention does not necessarily increase its benefits and might cause harm.
Trust in a source alone is not a sufficient basis for believing a claim.
- Competing interests can result in misleading claims.
- Personal experiences or anecdotes alone are an unreliable basis for most claims.
- Opinions of experts, authorities, celebrities or other respected individuals are not solely a reliable basis for claims.
- Peer review and publication by a journal do not guarantee that comparisons have been fair.
Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance).
Comparisons of interventions should be fair.
- Comparison groups and conditions should be as similar as possible.
- Indirect comparisons of interventions across different studies can be misleading.
- The people, groups or conditions being compared should be treated similarly, apart from the interventions being studied.
- Outcomes should be assessed in the same way in the groups or conditions being compared.
- Outcomes should be assessed using methods that have been shown to be reliable.
- It is important to assess outcomes in all (or nearly all) the people or subjects in a study.
- When random allocation is used, people’s or subjects’ outcomes should be counted in the group to which they were allocated.
Syntheses of studies should be reliable.
- Reviews of studies comparing interventions should use systematic methods.
- Failure to consider unpublished results of fair comparisons can bias estimates of effects.
- Comparisons of interventions might be sensitive to underlying assumptions.
Descriptions should reflect the size of effects and the risk of being misled by chance.
- Verbal descriptions of the size of effects alone can be misleading.
- Small studies might be misleading.
- Confidence intervals should be reported for estimates of effects.
- Deeming results to be ‘statistically significant’ or ‘non-significant’ can be misleading.
- Lack of evidence for a difference is not the same as evidence of no difference.
What to do depends on judgements about the problem, the relevance (applicability or transferability) of evidence available and the balance of expected benefits, harm and costs.
Problems, goals and options should be defined.
- The problem should be diagnosed or described correctly.
- The goals and options should be acceptable and feasible.
Available evidence should be relevant.
- Attention should focus on important, not surrogate, outcomes of interventions.
- There should not be important differences between the people in studies and those to whom the study results will be applied.
- The interventions compared should be similar to those of interest.
- The circumstances in which the interventions were compared should be similar to those of interest.
Expected pros should outweigh cons.
- Weigh the benefits and savings against the harm and costs of acting or not.
- Consider how these are valued, their certainty and how they are distributed.
- Important uncertainties about the effects of interventions should be reduced by further fair comparisons.
END OF QUOTE
I have nothing to add to this, except perhaps to point out how very relevant all of this, of course, is for SCAM and to warmly recommend you study the full text of this brilliant paper.
George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.
Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?
1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)
2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place [14–16]. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)
This factor was also ignored in most trials . At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study , where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo . (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)
3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies . Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)
4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case , the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)
5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)
In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.
First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)
Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)
Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles . (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)
Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)
Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.
I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:
- A well-designed study of homeopathy can always be recognised by its positive result.
- Any trial that fails to yield a positive finding is, by definition, wrongly designed.
“Eating elderberries can help minimise influenza symptoms.” This statement comes from a press release by the University of Sydney. As it turned out, the announcement was not just erroneous but it also had concealed that the in-vitro study that formed the basis for the press-release was part-funded by the very company, Pharmacare, which sells elderberry-based flu remedies.
“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” A University of Sydney spokeswoman confirmed Pharmacare was shown a copy of the press release before it was published.
This is an embarrassing turn of events, no doubt. But what about elderberry (Sambucus nigra) and the flu? Is there any evidence?
A systematic review quantified the effects of elderberry supplementation. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. The authors concluded that these findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.
The alternative to antibiotic misuse can only be the correct use of antibiotics. And, in the case of viral infections such as the flu, this can only be the non-use of antibiotics. My trust in this review, published in a SCAM journal of dubious repute, has instantly dropped to zero.
Perhaps a recent overview recently published in THE MEDICAL LETTER provides a more trustworthy picture:
No large randomized, controlled trials evaluating the effectiveness of elderberry for prevention or treatment of influenza have been conducted to date. Elderberry appears to have some activity against influenza virus strains in vitro. In two small studies (conducted outside the US), adults with influenza A or B virus infection taking elderberry extract reported a shorter duration of symptoms compared to those taking placebo. Consuming uncooked blue or black elderberries can cause nausea and vomiting. The rest of the plant (bark, stems, leaves, and root) contains sambunigrin, which can release cyanide. No data are available on the safety of elderberry use during pregnancy or while breastfeeding. CONCLUSION — Prompt treatment with an antiviral drug such as oseltamivir (Tamiflu, and generics) has been shown to be effective in large randomized, controlled trials in reducing the duration of influenza symptoms, and it may reduce the risk of influenza-related complications. There is no acceptable evidence to date that elderberry is effective for prevention or treatment of influenza and its safety is unclear.
Any take-home messages?
- Elderberry supplements are not of proven effectiveness against the flu.
- The press officers at universities should be more cautious when writing press-releases.
- They should involve the scientists and avoid the sponsors of the research.
- In-vitro studies can never tell us anything about clinical effectiveness.
- SCAM-journals’ articles must be taken with a pinch of salt.
- Consumers are being misled left, right and centre.
Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.
But is it effective?
The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.
Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).
The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.
I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:
- Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
- The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
- There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
- There seemed to be a sizable publication bias hidden in the data.
- All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
- Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.
I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.
Did we not have a flurry of systematic reviews of homeopathy in recent months?
And were they not a great disappointment to homeopaths and their patients?
Just as we thought that this is more than enough evidence to show that homeopathy is not effective, here comes another one.
This new review evaluated RCTs of non-individualised homeopathic treatment (NIHT) in which the control group received treatments other than placebo (OTP). Specifically, its aim was to determine the comparative effectiveness of NIHT on health-related outcomes for any given condition.
For each eligible trial, published in the peer-reviewed literature up to the end of 2016, the authors assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. The researchers grouped RCTs by whether these examined homeopathy as an alternative treatment (study design 1a), adjunctively with another intervention (design 1b), or compared with no intervention (design 2). RCTs were sub-categorised as superiority trials or equivalence/non-inferiority trials. For each RCT, a single ‘main outcome measure’ was selected to use in meta-analysis.
Seventeen RCTs, representing 15 different medical conditions, were eligible for inclusion. Three of the trials were more pragmatic than explanatory, two were more explanatory than pragmatic, and 12 were equally pragmatic and explanatory. Fourteen trials were rated ‘high risk of bias’ overall; the other three trials were rated ‘uncertain risk of bias’ overall. Ten trials had data that were extractable for meta-analysis. Significant heterogeneity undermined the planned meta-analyses or their meaningful interpretation. For the three equivalence or non-inferiority trials with extractable data, the small, non-significant, pooled effect size was consistent with a conclusion that NIHT did not differ from treatment by a comparator (Ginkgo biloba or betahistine) for vertigo or (cromolyn sodium) for seasonal allergic rhinitis.
The authors concluded that the current data preclude a decisive conclusion about the comparative effectiveness of NIHT. Generalisability of findings is restricted by the limited external validity identified overall. The highest intrinsic quality was observed in the equivalence and non-inferiority trials of NIHT.
I do admire the authors’ tenacity in meta-analysing homeopathy trials and empathise with their sadness of the multitude of negative results they thus have to publish. However, I do disagree with their conclusions. In my view, at least two firm conclusions ARE possible:
- This dataset confirms yet again that the methodological quality of homeopathy trials is lousy.
- The totality of the trial evidence analysed here fails to show that non-individualised homeopathy is effective.
In case you wonder why the authors are not more outspoken about their own findings, perhaps you need to read their statement of conflicts of interest:
Authors RTM, YYYF, PV and AKLT are (or were) associated with a homeopathy organisation whose significant aim is to clarify and extend an evidence base in homeopathy. RTM holds an independent research consultancy contract with the Deutsche Homöopathie-Union, Karlsruhe, Germany. YYYF and AKLT belong to Living Homeopathy Ltd., which has contributed funding to some (but not this current) HRI project work. RTM and PV have no other relationships or activities that could appear to have influenced the submitted work. JRTD had no support from any organisation for the submitted work; in the last 3 years, and for activities outside the submitted study, he received personal fees, royalties or out-of-pocket expenses for advisory work, invitational lectures, use of rating scales, published book chapters or committee membership; he receives royalties from Springer Publishing Company for his book, A Century of Homeopaths: Their Influence on Medicine and Health. JTRD has no other relationships or activities that could appear to have influenced the submitted study.
If one had wanted to add insult to injury, one could have added that, if, despite such conflicts of interest, the overall result of this new review turned out to be not positive, the evidence must be truly negative.
The Spanish Ministries of Health and Sciences have announced their ‘Health Protection Plan against Pseudotherapies’. Very wisely, they have included chiropractic under this umbrella. To a large degree, this is the result of Spanish sceptics pointing out that alternative therapies are a danger to public health, helped perhaps a tiny bit also by the publication of two of my books (see here and here) in Spanish. Unsurprisingly, such delelopments alarm Spanish chiropractors who fear for their livelihoods. A quickly-written statement of the AEQ (Spanish Chiropractic Association) is aimed at averting the blow. It makes the following 11 points (my comments are below):
1. The World Health Organization (WHO) defines chiropractic as a healthcare profession. It is independent of any other health profession and it is neither a therapy nor a pseudotherapy.
2. Chiropractic is statutorily recognised as a healthcare profession in many European countries including Portugal, France, Italy, Switzerland, Belgium, Denmark, Sweden, Norway and the United Kingdom10, as well as in the USA, Canada and Australia, to name a few.
3. Chiropractic members of the AEQ undergo university-level training of at least 5 years full-time (300 ECTS points). Chiropractic training is offered within prestigious institutions such as the Medical Colleges of the University of Zurich and the University of Southern Denmark.
4. Chiropractors are spinal health care experts. Chiropractors practice evidence-based, patient-centred conservative interventions, which include spinal manipulation, exercise prescription, patient education and lifestyle advice.
5. The use of these interventions for the treatment of spine-related disorders is consistent with guidelines and is supported by high quality scientific evidence, including multiple systematic reviews undertaken by the prestigious Cochrane collaboration15, 16, 17.
6. The Global Burden of Disease study shows that spinal disorders are the leading cause of years lived with disability worldwide, exceeding depression, breast cancer and diabetes.
7. Interventions used by chiropractors are recommended in the 2018 Low Back Pain series of articles published in The Lancet and clinical practice guidelines from Denmark, Canada, the European Spine Journal, American College of Physicians and the Global Spine Care Initiative.
8. The AEQ supports and promotes scientific research, providing funding and resources for the development of high quality research in collaboration with institutions of high repute, such as Fundación Jiménez Díaz and the University of Alcalá de Henares.
9. The AEQ strenuously promotes among its members the practice of evidence-based, patient-centred care, consistent with a biopsychosocial model of health.
10. The AEQ demands the highest standards of practice and professional ethics, by implementing among its members the Quality Standard UNE-EN 16224 “Healthcare provision by chiropractors”, issued by the European Committee of Normalisation and ratified by AENOR.
11. The AEQ urges the Spanish Government to regulate chiropractic as a healthcare profession. Without such legislation, citizens of Spain cannot be assured that they are protected from unqualified practitioners and will continue to face legal uncertainties and barriers to access an essential, high-quality, evidence-based healthcare service.
END OF QUOTE
I think that some comments might be in order (they follow the numbering of the AEQ):
- The WHO is the last organisation I would consult for information on alternative medicine; during recent years, they have published mainly nonsense on this subject. How about asking the inventor of chiropractic? D.D. Palmer defined it as “a science of healing without drugs.” Chiropractors nowadays prefer to be defined as a profession which has the advantage that one cannot easily pin them down for doing mainly spinal manipulation; if one does, they indignantly respond “but we also use many other interventions, like life-style advice, for instance, and nobody can claim this to be nonsense” (see also point 4 below).
- Perfect use of a classical fallacy: appeal to authority.
- Appeal to authority, plus ignorance of the fact that teaching nonsense even at the highest level must result in nonsense.
- This is an ingenious mix of misleading arguments and lies: most chiros pride themselves of treating also non-spinal conditions. Very few interventions used by chiros are evidence-based. Exercise prescription, patient education and lifestyle advice are hardy typical for chiros and can all be obtained more authoratively from other healthcare professionals.
- Plenty of porkies here too. For instance, the AEQ cite three Cochrane reviews. The first concluded that high-quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. The second stated that combined chiropractic interventions slightly improved pain and disability in the short term and pain in the medium term for acute/subacute LBP. However, there is currently no evidence that supports or refutes that these interventions provide a clinically meaningful difference for pain or disability in people with LBP when compared to other interventions. And the third concluded that, although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices. Hardly the positive endorsement implied by the AEQ!
- Yes, but that is not an argument for chiropractic; in fact, it’s another fallacy.
- Did they forget the many guidelines, institutions and articles that do NOT recommend chiropractic?
- I believe the cigarette industry also sponsors research; should we therefore all start smoking?
- I truly doubt that the AEQ strenuously promotes among its members the practice of evidence-based healthcare; if they did, they would have to discourage spinal manipulation!
- The ‘highest standards of practice and professional ethics’ are clearly not compatible with chiropractors’ use of spinal manipulation. In our recent book, we explained in full detail why this is so.
- An essential, high-quality, evidence-based healthcare service? Chiropractic is certainly not essential, rarely high-quality, and clearly not evidence-based.
Nice try AEQ.
But not good enough, I am afraid.
The primary objective of this paper was to assess the efficacy of homeopathy by systematically reviewing existing systematic reviews and meta-analyses and to systematically review trials on open-label placebo (OLP) treatments. A secondary objective was to understand whether homoeopathy as a whole may be considered as a placebo treatment. Electronic databases and previously published papers were systematically searched for systematic reviews and meta-analyses on homoeopathy efficacy. In total, 61 systematic reviews of homeopathy were included.
The same databases plus the Journal of Interdisciplinary Placebo Studies (JIPS) were also systematically searched for randomised controlled trials (RCTs) on OLP treatments, and 10 studies were included.
Qualitative syntheses showed that homoeopathy efficacy can be considered comparable to placebo. Twenty‐five reviews demonstrated that homoeopathy efficacy is comparable to placebo, 20 reviews did not come to a definite conclusion, and 16 reviews concluded that homoeopathy has some effect beyond placebo (in some cases of the latter category, authors drew cautious conclusions, due to low methodological quality of included trials, high risk of bias and sparse data).
Qualitative syntheses also showed that OLP treatments may be effective in some health conditions.
The authors concluded that, if homoeopathy efficacy is comparable to placebo, and if placebo treatments can be effective in some conditions, then homoeopathy as a whole may be considered as a placebo treatment. Reinterpreting homoeopathy as a placebo treatment would define limits and possibilities of this practice. This perspective shift suggests a strategy to manage patients who seek homoeopathic care and to reconcile them with mainstream medicine in a sustainable way.
The authors also mention in their discussion section that one of the most important work which concluded that homoeopathy has some effect beyond placebo is the meta‐analysis performed by Linde et al. (1997), which included 119 trials with 2,588 participants and aimed to assess the efficacy of homoeopathy for many conditions. Among these ones, there were conditions with various degrees of placebo responsiveness. This work was thoroughly re‐analysed by Linde himself and other authors (Ernst, 1998; Ernst & Pittler, 2000; Linde et al., 1999; Morrison et al., 2000; Sterne et al., 2001), who, selecting high‐quality extractable data and taking into consideration some methodological issues and biases of included trials (like publication bias and biases within studies), underscored that it cannot be demonstrated that homoeopathy has effects beyond placebo.
I agree with much of what the authors state. However, I fail to see that homeopathy should be used as an OLP treatment. I have several reasons for this, for instance:
- Placebo effects are unreliable and do occur only in some but not all patients.
- Placebo effects are usually of short duration.
- Placebo effects are rarely of a clinically relevant magnitude.
- The use of placebo, even when given as OLP, usually involves deception which is unethical.
- Placebos might replace effective treatments which would amount to neglect.
- One does not need a placebo for generating a placebo effect.
The idea that homeopathic remedies could be used in clinical practice as placebos to generate positive health outcomes is by no means new. I know that many doctors have used it that way. The idea that homeopathy could be employed as OLP, might be new, but it is neither practical, nor ethical, nor progressive.
Regardless of this particular debate, this new review confirms yet again:
HOMEOPATHY = PLACEBO THERAPY
This systematic review was aimed at evaluating the effects of acupuncture on the quality of life of migraineurs. Only randomized controlled trials that were published in Chinese and English were included. In total, 62 trials were included for the final analysis; 50 trials were from China, 3 from Brazil, 3 from Germany, 2 from Italy and the rest came from Iran, Israel, Australia and Sweden.
Acupuncture resulted in lower Visual Analog Scale scores than medication at 1 month after treatment and 1-3 months after treatment. Compared with sham acupuncture, acupuncture resulted in lower Visual Analog Scale scores at 1 month after treatment.
The authors concluded that acupuncture exhibits certain efficacy both in the treatment and prevention of migraines, which is superior to no treatment, sham acupuncture and medication. Further, acupuncture enhanced the quality of life more than did medication.
The authors comment in the discussion section that the overall quality of the evidence for most outcomes was of low to moderate quality. Reasons for diminished quality consist of the following: no mentioned or inadequate allocation concealment, great probability of reporting bias, study heterogeneity, sub-standard sample size, and dropout without analysis.
Further worrisome deficits are that only 14 of the 62 studies reported adverse effects (this means that 48 RCTs violated research ethics!) and that there was a high level of publication bias indicating that negative studies had remained unpublished. However, the most serious concern is the fact that 50 of the 62 trials originated from China, in my view. As I have often pointed out, such studies have to be categorised as highly unreliable.
In view of this multitude of serious problems, I feel that the conclusions of this review must be re-formulated:
Despite the fact that many RCTs have been published, the effect of acupuncture on the quality of life of migraineurs remains unproven.
Often referred to as “Psychological acupressure”, the emotional freedom technique (EFT) works by releasing blockages within the energy system which are the source of emotional intensity and discomfort. These blockages in our energy system, in addition to challenging us emotionally, often lead to limiting beliefs and behaviours and an inability to live life harmoniously. Resulting symptoms are either emotional and/ or physical and include lack of confidence and self esteem, feeling stuck anxious or depressed, or the emergence of compulsive and addictive behaviours. It is also now finally widely accepted that emotional disharmony is a key factor in physical symptoms and dis-ease and for this reason these techniques are being extensively used on physical issues, including chronic illness with often astounding results. As such these techniques are being accepted more and more in medical and psychiatric circles as well as in the range of psychotherapies and healing disciplines.
An EFT treatment involves the use of fingertips rather than needles to tap on the end points of energy meridians that are situated just beneath the surface of the skin. The treatment is non-invasive and works on the ethos of making change as simple and as pain free as possible.
EFT is a common sense approach that draws its power from Eastern discoveries that have been around for over 5,000 years. In fact Albert Einstein also told us back in the 1920’s that everything (including our bodies) is composed of energy. These ideas have been largely ignored by Western Healing Practices and as they are unveiled in our current times, human process is reopening itself to the forgotten truth that everything is Energy and the potential that this offers us.
END OF QUOTE
If you ask me, this sounds as though EFT combines pseudo-psychological with acupuncture-BS.
But I may be wrong.
What does the evidence tell us?
A systematic review included 14 RCTs of EFT with a total of 658 patients. The pre-post effect size for the EFT treatment group was 1.23 (95% confidence interval, 0.82-1.64; p < 0.001), whereas the effect size for combined controls was 0.41 (95% confidence interval, 0.17-0.67; p = 0.001). Emotional freedom technique treatment demonstrated a significant decrease in anxiety scores, even when accounting for the effect size of control treatment. However, there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioural therapy, and further research is needed to establish the relative efficacy of EFT to established protocols. Meta-analyses indicate large effect sizes for posttraumatic stress disorder, depression, and anxiety; however, treatment effects may be due to components EFT shares with other therapies.
Another, more recent analysis reviewed whether EFTs acupressure component was an active ingredient. Six studies of adults with diagnosed or self-identified psychological or physical symptoms were compared (n = 403), and three (n = 102) were identified. Pretest vs. posttest EFT treatment showed a large effect size, Cohen’s d = 1.28 (95% confidence interval [CI], 0.56 to 2.00) and Hedges’ g = 1.25 (95% CI, 0.54 to 1.96). Acupressure groups demonstrated moderately stronger outcomes than controls, with weighted posttreatment effect sizes of d = -0.47 (95% CI, -0.94 to 0.0) and g = -0.45 (95% CI, -0.91 to 0.0). Meta-analysis indicated that the acupressure component was an active ingredient and outcomes were not due solely to placebo, nonspecific effects of any therapy, or non-acupressure components.
From these and other reviews, one could easily get the impression that my above-mentioned suspicion is erroneous and EFT is an effective therapy. But I still do have my doubts.
These reviews conveniently forget to mention that the primary studies tend to be of poor or even very poor quality. The most common flaws include tiny sample sizes, wrong statistical approach, lack of blinding, lack of control of placebo and other nonspecific effects. Reviews of such studies thus turn out to be a confirmation of the ‘rubbish in, rubbish out’ principle: any summary of flawed studies are likely to produce a flawed result.
Until I have good quality trials to convince me otherwise, EFT is in my view:
- implausible and
- not of proven effectiveness for any condition.