We have discussed the diagnostic methods used by practitioners of alternative medicine several times before (see for instance here, here, here, here, here and here). Now a new article has been published which sheds more light on this important issue.
The authors point out that the so-called alternative medicine (SCAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes.
- The paper mentions the 4 key factors for evaluation of diagnostic methods:
Analytic validity of a test deﬁnes its ability to measure accurately and reliably the component of interest. Relevant parameters include analytical accuracy and precision, susceptibility to interferences and quality assurance.
- Clinical validity deﬁnes the ability to detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease. Relevant parameters include sensitivity, speciﬁcity, and an understanding of how these parameters change in different populations.
- Clinical utility refers to the likelihood that the test will lead to an improved outcome. What is the value of the information to the individual being tested and/or to the broader population?
- Ethical, legal and social implications (ELSI) of a test. Issues include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment and the cost-effectiveness of testing.
The tests used by SCAM-practitioners range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘SCAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in SCAM testing. Some SCAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories.
In their review, the authors explore SCAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. They also review proposed changed to in-vitro diagnostic device regulations and how these might impact on SCAM testing.
The authors conclude hat the common factor in all these tests is the lack of evidence for clinical validity and utility as used in SCAM practice. This should not be surprising since this is true for SCAM practice in general. Once there is a sound evidence base for an intervention, such as a laboratory test, then it generally becomes incorporated into conventional medical practice.
The paper also discusses possible reasons why SCAM-tests are appealing:
- Adding an element of science to the consultation. Patients know that conventional medicine relies heavily on laboratory diagnostics. If the SCAM practitioner orders laboratory tests, the patient may feel they are beneﬁting from a scientiﬁc approach.
- Producing material diagnostic data to support a diagnosis. SCAM lab reports are well presented in a format that is attractive to patients adding legitimacy to a diagnosis. Tests are often ordered as large proﬁles of multiple analytes. It follows that this will increase the probability of getting results outside of a given reference interval purely by chance. ‘Abnormal’ results give the SCAM practitioner something to build a narrative around if clinical ﬁndings are unclear. This is particularly relevant for patients who have chronic conditions, such as CFS or ﬁbromyalgia where a deﬁnitive cause has not been established and treatment options are limited.
- Generating business opportunities using abnormal results. Some practitioners may use abnormal laboratory results to justify further testing, supplements or therapies that they can offer.
- By offering tests that are not available through traditional healthcare services some SCAM practitioners may claim they are offering a unique specialist service that their doctor is unable to provide. This can be particularly appealing to patients with unexplained symptoms for which there are a limited range of evidenced-based investigations and treatments available.
Regulation of SCAM laboratory testing is clearly deﬁcient, the authors of this paper conclude. Where SCAM testing is regulated at all, regulatory authorities primarily evaluate analytical validity of the tests a laboratory offers. Clinical validity and clinical utility are either not evaluated adequately or not evaluated at all and the ethical, legal and social implications of a test may only be considered on a reactive basis when consumers complain about how tests are advertised.
I have always thought that the issue of SCAM tests is hugely important; yet it remains much-neglected. A rubbish diagnosis is likely to result in a rubbish treatment. Unreliable diagnostic methods lead to false-positive and false-negative diagnoses. Both harm the patient. In 1995, I thus published a review that concluded with this warning “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.
Sadly, my warning has so far had no effect whatsoever.
I hope this new paper is more successful.
The General Chiropractic Council (GCC) is the statutory body regulating all chiropractors in the UK. Their foremost aim, they claim, is to ensure the safety of patients undergoing chiropractic treatment. They also allege to be independent and say they want to protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession.
That sounds good and (almost) convincing.
But is the GCC truly fit for purpose?
In a previous post, I found good reason to doubt it.
In a recent article, the GCC claimed that they started thinking about a new five-year strategy and began to shape four key strategic aims. So, let’s have a look. Here is the crucial passage:
A clear strategy is vital but, of course, implementation and getting things changed are where the real work lie. With that in mind, we have a specific business plan for 2019 – the first year of the new strategic plan. You can read it here. This means you’ll see some really important changes and benefits including:
- Promote standards: review and improvements to CPD processes, supporting emerging new degree providers, a campaign to promote the public choosing a registered chiropractor
- Develop the profession: supporting and enabling work with the professional bodies
- Investigate and act: a full review of, and changes to, our Fitness to Practice processes to enable a more ‘right touch’ approach within our current legal framework, sharing more learning from the complaints we receive
- Deliver value: a focus on communication and engagement, further work on our culture, a new website, an upgraded registration database for an improved user experience.
The changes being introduced, backed by the GCC’s Council, will have a positive effect. I know Nick, the new Chief Executive and Registrar and the staff team will make this a success. You as chiropractors also have an important role to play – keep engaging with us and take your own action to develop the profession, share your ideas and views as we transform the organisation, and work with us to ensure we maintain public confidence in the profession of chiropractic.
END OF QUOTE
Am I the only one who finds this more than a little naïve and unprofessional? More importantly, this statement hints at a strategy mainly aimed at promoting chiropractors regardless of whether they are doing more good than harm. This, it seems, is not in line with the GCC’s stated aims.
- How can they already claim that the changes being introduced will have a positive effect?
- Where in this strategy is the GCC’s alleged foremost aim, the protection of the public?
- Where is any attempt to get chiropractic in line with the principles of EBM?
- Where is an appeal to chiropractors to adopt the standards of medical ethics?
- Where is an independent and continuous assessment of the effectiveness of chiropractic?
- Where is a critical evaluation of its safety?
- Where is an attempt to protect the public from the plethora of bogus claims made by UK chiropractors?
I feel that, given the recent history of UK chiropractic, these (and many other) points should be essential elements in any long-term strategy. I also feel that this new and potentially far-reaching statement provides little hope that the GCC is on the way towards getting fit for purpose.
Slowly, I seem to be turning into a masochist! Yes, I sometimes read publications like ‘HOMEOPATHY 360’. It carries articles that are enragingly ill-informed. But in my defence, I might say that some are truly funny. Here is the abstract of one that I found outstanding in that category:
The article explains about Gangrene and its associated amputations which is a clinically challenging condition, but Homeopathy offers therapy options. The case presented herein, details about how the Homeopathic treatment helped in the prevention of amputation of a body part. Homeopathy stimulates the body’s ability to heal through its immune mechanisms; consequently, it achieves wound healing and establishes circulation to the gangrenous part. Instead of focusing on the local phenomena of gangrene pathology, treatment focuses on the general indications of the immune system, stressing the important role of the immune system as a whole. The aim was to show, through case reports, that Homeopathic therapy can treat gangrene thus preventing amputation of the gangrenous part, and hence has a strong substitution for consideration in treating gangrene.
The paper itself offers no less than 13 different homeopathic treatments for gangrene:
- Arsenicum album– Medicine for senile gangrene;gangrene accompanied by foetid diarrhoea; ulcers extremely painful with elevated edges, better by warmth and aggravation from cold; great weakness and emaciation.
- Bromium – Hospital gangrene; cancerous ulcers on face; stony hard swelling of glands of lower jaw and throat.
- Carbo vegetabilis – Senile and humid gangrene in the persons who are cachectic in appearance; great exhaustion of vital powers; marked prostration; foul smell of secretions; indolent ulcers, burning pain; tendency to gangrene of the margins; varicose ulcers.
- Bothrops– Gangrene; swollen, livid, cold with hemorrhagic infiltration; malignant erysipelas.
- Echinacea– Enlarged lymphatics; old tibial ulcers; gangrene; recurrent boils; carbuncles.
- Lachesis– Gangrenous ulcers; gangrene after injury; bluish or black looking blisters; vesicles appearing here and there, violent itching and burning; swelling and inflammation of the parts; itching pain and painful spots appearing after rubbing.
- Crotalus Horridus– Gangrene, skin separated from muscles by a foetid fluid; traumatic gangrene; old scars open again.
- Secale cornatum– Pustules on the arms and legs, with tendency to gangrene; in cachectic, scrawny females with rough skin; skin shriveled, numb; mottled dusky-blue tinge; blue color of skin; dry gangrene, developing slowly; varicose ulcers; boils, small, painful with green contents; skin feels too cold to touch yet covering is not tolerated. Great aversion to heat;formication under skin.
- Anthracinum– Gangrene; cellular tissues swollen and oedematous; gangrenous parotitis; septicemia; ulceration, and sloughing and intolerable burning.
- Cantharis – Tendency to gangrene; vesicular eruptions; burns, scalds, with burning and itching; erysipelas, vesicular type, with marked restlessness.
- Mercurius– Gangrene of the lips, cheeks and gums; inflammation and swelling of the glands of neck; pains aggravated by hot or cold applications.
- Sulphuric acid– Traumatic gangrene; haemorrhages from wounds; dark pustules; blue spots like suggillations; bedsores.
- Phosphoric acid– Medicine for senile gangrene. Gunpowder, calendula are also best medicines.
But the best of all must be the article’s conclusion: “Homeopathy is the best medicine for gangrene.”
I know, there are many people who will not be able to find this funny, particularly patients who suffer from gangrene and are offered homeopathy as a cure. This could easily kill the person – not just kill, but kill very painfully. Gangrene is the death of tissue in part of the body, says the naïve little caption. What it does not say is that it is in all likelihood also the death of the patient who is treated purely with homeopathy.
And what about the notion that homeopathy stimulates the body’s ability to heal through its immune mechanisms?
Or the assumption that it might establish circulation to the gangrenous part?
Or the claim that through case reports one can show the effectiveness of an intervention?
Or the notion that any of the 13 homeopathic remedies have a place in the treatment of gangrene?
ALL OF THIS IS TOTALLY BONKERS!
Not only that, it is highly dangerous!
Since many years, I am trying my best to warn people of charlatans who promise bogus cures. Sadly it does not seem to stop the charlatans. This makes me feel rather helpless at times. And it is in those moments that I decide to look at from a different angle. That’s when I try to see the funny side of quacks who defy everything we know about healthcare and just keep on lying to themselves and their victims.
Benign prostate hypertrophy (BPH) affects many men aged 50 and older. It is caused by an enlargement of the prostate resulting in difficulties to urinate and to fully empty the bladder. There are several conventional treatment options, including life-style changes that are effective. In addition, a myriad of alternative therapies are being promoted, most of which are of doubtful effectiveness. Recently, a homeopathy-promoter, Dr Jens Behnke, triumphantly tweeted a trial of homeopathy for BPH allegedly proving that homeopathy does work after all. There is no conceivable reason why homeopathic remedies should have any effect on this (or any other) condition. Therefore, I decided to have a closer look at this paper.
The objective of this 5-centre, three-armed, open, randomised study was to evaluate the effectiveness of Homoeopathic Constitutional remedy (HC) and Homoeopathic Constitutional + Organ remedy (HCOM) in comparison to Placebo (PL) in patients suffering from BPH using International Prostate Symptom Score (IPSS), ultrasonographic changes in prostate volume, post-void residual urine, uroflowmetry and in WHO Quality of Life (QOL)-BREF. Patients were randomised into three groups in 2:2:1 ratio and were followed up for 6 months. The statistical analysis was done with modified intention-to-treat principle (mITT).
Of 461 patients screened, 254 patients were enrolled in the study and 241 patients were analysed as per mITT. The mean changes in IPSS and QOL due to urinary symptoms from baseline to end of study showed a positive trend in all the three groups. However, in the HC group, the changes were more prominent as compared to the other two groups. There was no difference between HC and HCOM groups and they were equally effective in terms of managing lower urinary tract symptoms due to BPH. With regard to secondary outcome, there was no difference between the groups. The psychological, social and environmental domains of WHOQOL-BREF have shown positive trend, but there was no statistically significant difference in intervention groups.
The authors concluded that statistical significance was found in the IPSS in all the three groups but only in HC and not in any of the objective parameters.
The paper is so badly written that I struggle to make sense of it. However, the above graph seems clear enough. The changes are perhaps statistically significant (which I find odd and cannot quite understand) but they are certainly not clinically relevant. Most likely, they are due to the fact that this study was not blind, meaning that patients and investigators were aware of the group allocations. This suggests to me that this study
- is dubious in more than one way,
- tests a hypothesis that lacks plausibility,
- yields a result that is clinically irrelevant.
In other words, it does not amount to anything remotely resembling a proof of homeopathy’s efficacy.
The most frequent of all potentially serious adverse events of acupuncture is pneumothorax. It happens when an acupuncture needle penetrates the lungs which subsequently deflate. The pulmonary collapse can be partial or complete as well as one or two sided. This new case-report shows just how serious a pneumothorax can be.
A 52-year-old man underwent acupuncture and cupping treatment at an illegal Chinese medicine clinic for neck and back discomfort. Multiple 0.25 mm × 75 mm needles were utilized and the acupuncture points were located in the middle and on both sides of the upper back and the middle of the lower back. He was admitted to hospital with severe dyspnoea about 30 hours later. On admission, the patient was lucid, was gasping, had apnoea and low respiratory murmur, accompanied by some wheeze in both sides of the lungs. Because of the respiratory difficulty, the patient could hardly speak. After primary physical examination, he was suspected of having a foreign body airway obstruction. Around 30 minutes after admission, the patient suddenly became unconscious and died despite attempts of cardiopulmonary resuscitation.
Whole-body post-mortem computed tomography of the victim revealed the collapse of the both lungs and mediastinal compression, which were also confirmed by autopsy. More than 20 pinprick injuries were found on the skin of the upper and lower back in which multiple pinpricks were located on the body surface projection of the lungs. The cause of death was determined as acute respiratory and circulatory failure due to acupuncture-induced bilateral tension pneumothorax.
The authors caution that acupuncture-induced tension pneumothorax is rare and should be recognized by forensic pathologists. Postmortem computed tomography can be used to detect and accurately evaluate the severity of pneumothorax before autopsy and can play a supporting role in determining the cause of death.
The authors mention that pneumothorax is the most frequent but by no means the only serious complication of acupuncture. Other adverse events include:
- central nervous system injury,
- epidural haematoma,
- subarachnoid haemorrhage,
- cardiac tamponade,
- gallbladder perforation,
No other possible lung diseases that may lead to bilateral spontaneous pneumothorax were found. The needles used in the case left tiny perforations in the victim’s lungs. A small amount of air continued to slowly enter the chest cavities over a long period. The victim possibly tolerated the mild discomfort and did not pay attention when early symptoms appeared. It took 30 hours to develop into symptoms of a severe pneumothorax, and then the victim was sent to the hospital. There he was misdiagnosed, not adequately treated and thus died. I applaud the authors for nevertheless publishing this case-report.
This case occurred in China. Acupuncturists might argue that such things would not happen in Western countries where acupuncturists are fully trained and aware of the danger. They would be mistaken – and alarmingly, there is no surveillance system that could tell us how often serious complications occur.
Many chiropractors tell new mothers that their child needs chiropractic adjustments because the birth is in their view a trauma for the new-born that causes subluxations of the baby’s spine. Without expert chiropractic intervention, they claim, the poor child risks serious developmental disorders.
This article (one of hundreds) explains it well: Birth trauma is often overlooked by doctors as the cause of chronic problems, and over time, as the child grows, it becomes a thought less considered. But the truth is that birth trauma is real, and the impact it can have on a mother or child needs to be addressed. Psychological therapy, physical therapy, chiropractic care, acupuncture, and other healing techniques should all be considered following an extremely difficult birth.
And another article makes it quite clear what intervention is required: Caesarian section or a delivery that required forceps or vacuum extraction procedures, in-utero constraint, an unusual presentation of the baby, and many more can cause an individual segment of the spine or a region to shift from its normal healthy alignment. This ‘shift’ in the spine is called a Subluxation, and it can happen immediately before, during, or after birth.
Thousands of advertisements try to persuade mothers to take their new-born babies to a chiropractor to get the problem sorted which chiropractors often call KISS (kinetic imbalance due to suboccipital strain-syndrome), caused by intrauterine-constraint or the traumas of birth.
This abundance of advertisements and promotional articles is in sharp contrast with the paucity of scientific evidence.
A review of 1993 concluded that birth trauma remains an underpublicized and, therefore, an undertreated problem. There is a need for further documentation and especially more studies directed toward prevention. In the meantime, manual treatment of birth trauma injuries to the neuromusculoskeletal system could be beneficial to many patients not now receiving such treatment, and it is well within the means of current practice in chiropractic and manual medicine.
A more critical assessment of … concluded that, given the absence of evidence of beneficial effects of spinal manipulation in infants and in view of its potential risks, manual therapy, chiropractic and osteopathy should not be used in infants with the kinetic imbalance due to suboccipital strain-syndrome, except within the context of randomised double-blind controlled trials.
So, what follows from all this?
How about this?
Chiropractors’ assumption of an obligatory birth trauma that causes subluxation and requires spinal adjustments is nothing more than a ploy by charlatans for filling their pockets with the cash of gullible parents.
Ginkgo biloba is a well-researched herbal medicine which has shown promise for a number of indications. But does this include coronary heart disease?
The aim of this systematic review was to provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection (GD) as one adjuvant therapy for treating angina pectoris (AP) and to evaluate the relevant randomized controlled trials (RCTs) with meta-analysis. (Ginkgo Leaf Extract and Dipyridamole Injection is a Chinese compound preparation, which consists of ginkgo ﬂavone glycosides (24%), terpene lactones (ginkgolide about 13%, ginkgolide about 2.9%) and dipyridamole.)
RCTs concerning AP treated by GD were searched and the Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine (WM) against AP was associated with a higher total effective rate [risk ratio (RR)=1.25, 95% confidence interval (CI): 1.21–1.29, P<0.01], total effective rate of electrocardiogram (RR=1.29, 95% CI: 1.21–1.36, P<0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference (MD)=–0.56, 95% CI:–0,81 to–0.30, P<0.01], fibrinogen [MD=–1.02, 95% CI:–1.50 to–0.54, P<0.01], whole blood low shear viscosity [MD=–2.27, 95% CI:–3.04 to–1.49, P<0.01], and whole blood high shear viscosity (MD=–0.90, 95% CI: 1.37 to–0.44, P<0.01).
The authors concluded that comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.
If one reads this conclusion, one might be tempted to use GD to cure AP. I would, however, strongly warn everyone from doing so. There are many reasons for my caution:
- All the 41 RCTs originate from China, and we have repeatedly discussed that Chinese TCM trials are highly unreliable.
- The methodological quality of the primary RCTs was, according to the review authors ‘moderate’. This is not true; it was, in fact, lousy.
- Dipyridamole is not indicated in angina pectoris.
- To the best of my knowledge, there is no good evidence from outside China to suggest that Ginkgo biloba is effective for angina pectoris.
- Angina pectoris is caused by coronary artery disease (a narrowing of one or more coronary arteries due to atherosclerosis), and it seems implausible that this condition can be ‘cured’ with any medication.
So, what we have here is yet another nonsensical paper, published in a dubious journal, employing evidently irresponsible reviewers, run by evidently irresponsible editors, hosted by a seemingly reputable publisher (Springer). This is reminiscent of my previous post (and many posts before). Alarmingly, it is also what I encounter on a daily basis when scanning the new publications in my field.
The effects of this incessant stream of nonsense can only have one of two effects:
- People take this ‘evidence’ seriously. In this case, many patients might pay with their lives for this collective incompetence.
- People conclude that alt med research cannot be taken seriously. In this case, we are unlikely to ever see anything useful emerging from it.
Either way, the result will be profoundly negative!
It is high time to stop this idiocy; but how?
I wish, I knew the answer.
Shiatsu has been mentioned here before (see for instance here, here and here). It is one of those alternative therapies for which a plethora of therapeutic claims are being made in the almost total absence of reliable evidence. This is why I am delighted each time a new study emerges.
This proof of concept study explored the feasibility of ‘hand self-shiatsu’ as an intervention to promote sleep onset and continuity for young adults with SRC. It employed a prospective case-series design, where participants, athletes who have suffered from concussion, act as their own controls. Baseline and follow-up data included standardized self-reported assessment tools and sleep actigraphy. Seven athletes, aged between 18 and 25 years, participated. Although statistically significant improvement in actigraphy sleep scores between baseline and follow-up was not achieved, metrics for sleep quality and daytime fatigue showed significant improvement.
The authors concluded from these data that these findings support the hypothesis that ‘hand self-shiatsu has the potential to improve sleep and reduce daytime fatigue in young postconcussion athletes. This pilot study provides guidance to refine research protocols and lays a foundation for further, large-sample, controlled studies.
How very disappointing! If this was truly meant to be a pilot study, it should not mention findings of clinical improvement at all. I suspect that the authors labelled it ‘a pilot study’ only when they realised that it was wholly inadequate. I also suspect that the study did not yield the result they had hoped for (a significant improvement in actigraphy sleep scores), and thus they included the metrics for sleep quality and daytime fatigue in the abstract.
In any case, even a pilot study of just 7 patients is hardly worth writing home about. And the remark that participants acted as their own controls is a new level of obfuscation: there were no controls, and the results are based on before/after comparisons. Thus none of the outcomes can be attributed to shiatsu; more likely, they are due to the natural history of the condition, placebo effects, concomitant treatments, social desirability etc.
What sort of journal publishes such drivel that can only have the effect of giving a bad name to clinical research? The Journal of Integrative Medicine (JIM) is a peer-reviewed journal sponsored by Shanghai Association of Integrative Medicine and Shanghai Changhai Hospital, China. It is a continuation of the Journal of Chinese Integrative Medicine (JCIM), which was established in 2003 and published in Chinese language. Since 2013, JIM has been published in English language. They state that the editorial board is committed to publishing high-quality papers on integrative medicine... I consider this as a bad joke! More likely, this journal is little more than an organ for popularising TCM propaganda in the West.
And which publisher hosts such a journal?
What a disgrace!
Professor Frass is well known to most people interested in homeopathy. He has also featured several times on this blog (see here, here and here). Frass has achieved what few homeopaths have: he has integrated homeopathy into a major medical school, the Medical School of the University of Vienna (my former faculty). In 2002, he started teaching homeopathy to medical students, and in 2004, he opened an out-patient clinic ‘Homeopathy for malignant diseases’ at the medical school.
This achievement was widely used for boosting the reputation of homeopathy; the often heard argument was that ‘homeopathy must be good and evidence-based, because a major medical school has adopted it’. This argument is now obsolete: Frass’ lectures have recently been axed!
Apparently, several students*** filed complaints with their dean about Frass’ lectures. This prompted the dean, Prof Mueller, to look into the matter and take drastic action. He is quoted stating that “the medical faculty rejects unscientific methods and quackery”.
Frass had repeatedly been seen on television claiming that homeopathy could be an effective adjuvant therapy for cancer, and that he had studies to prove it. Such statements had irritated Mueller who then instructed Frass in writing to abstain from such claims and to close his homeopathic out-patient clinic at the University. The matter was also brought to the attention of the University’s ethics committee which decided that Frass’ studies were not suited to provide a scientific proof.
Frass commented saying that he is not surprised about criticism because homeopathy is difficult to understand. He will retire next year from the University and will probably continue his homeopathic practice in a private setting.
(If you can read German, this article in the Austrian paper DER STANDARD has more details)
***as they had invited me to give a lecture on homeopathy some time ago, I like to think that I might have something to do with all this.
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.