This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.
Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.
SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.
I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.
The medical literature is currently swamped with reviews of acupuncture (and other forms of TCM) trials originating from China. Here is the latest example (but, trust me, there are hundreds more of the same ilk).
The aim of this review was to evaluate the effectiveness of scalp, tongue, and Jin’s 3-needle acupuncture for the improvement of post-apoplectic aphasia. PubMed, Cochrane, Embase databases were searched using index words to identify qualifying randomized controlled trials (RCTs). Meta-analyses of odds ratios (OR) or standardized mean differences (SMD) were performed to evaluate the outcomes between investigational (scalp / tongue / Jin’s 3-needle acupuncture) and control (traditional acupuncture; TA and/or rehabilitation training; RT) groups.
Thirty-two RCTs (1310 participants in investigational group and 1270 in control group) were included. Compared to TA, (OR 3.05 [95% CI: 1.77, 5.28]; p<0.00001), tongue acupuncture (OR 3.49 [1.99, 6.11]; p<0.00001), and Jin’s 3-needle therapy (OR 2.47 [1.10, 5.53]; p = 0.03) had significantly better total effective rate. Compared to RT, scalp acupuncture (OR 4.24 [95% CI: 1.68, 10.74]; p = 0.002) and scalp acupuncture with tongue acupuncture (OR 7.36 [3.33, 16.23]; p<0.00001) had significantly better total effective rate. In comparison with TA/RT, scalp acupuncture, tongue acupuncture, scalp acupuncture with tongue acupuncture, and Jin’s three-needling significantly improved ABC, oral expression, comprehension, writing and reading scores.
The authors concluded that compared to traditional acupuncture and/or rehabilitation training, scalp acupuncture, tongue acupuncture, and Jin’ 3-needle acupuncture can better improve post-apoplectic aphasia as depicted by the total effective rate, the ABC score, and comprehension, oral expression, repetition, denomination, reading and writing scores. However, quality of the included studies was inadequate and therefore further high-quality studies with lager samples and longer follow-up times and with patient outcomes are necessary to verify the results presented herein. In future studies, researchers should also explore the efficacy and differences between scalp acupuncture, tongue acupuncture and Jin’s 3-needling in the treatment of post-apoplectic aphasia.
I’ll be frank: I find it hard to believe that sticking needles in a patient’s tongue restores her ability to speak. What is more, I do not believe a word of this review and its conclusion. And now I better explain why.
- All the primary studies originate from China, and we have often discussed how untrustworthy such studies are.
- All the primary studies were published in Chinese and cannot therefore be checked by most readers of the review.
- The review authors fail to provide the detail about a formal assessment of the rigour of the included studies; they merely state that their methodological quality was low.
- Only 6 of the 32 studies can be retrieved at all via the links provided in the articles.
- As far as I can find out, some studies do not even exist at all.
- Many of the studies compare acupuncture to unproven therapies such as bloodletting.
- Many do not control for placebo effects.
- Not one of the 32 studies reports findings that are remotely convincing.
I conclude that such reviews are little more than pseudo-scientific propaganda. They seem aim at promoting acupuncture in the West and thus serve the interest of the People’s Republic of China. They pollute our medical literature and undermine the trust in science.
I seriously ask myself, are the editors and reviewers all fast asleep?
The journal ‘BMC Complement Altern Med‘ has, in its 18 years of existence, published almost 4 000 Medline-listed papers. They currently charge £1690 for handling one paper. This would amount to about £6.5 million! But BMC are not alone; as I have pointed out repeatedly, EBCAM is arguably even worse.
And this is, in my view, the real scandal. We are being led up the garden path by people who make a very tidy profit doing so. BMC (and EBCAM) must put an end to this nonsense. Alternatively, PubMed should de-list these publications.
This has been going on for far too long; urgent action is required!
The aim of this update of a Cochrane review was to assess the effectiveness and safety of homeopathic treatment for irritable bowel syndrome (IBS). Hold on, the bit about safety is odd here and does not bode well: one cannot possibly assess the safety of an intervention on the basis of just a few trials.
Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. The Cochrane risk of bias tool was used to assess risk of bias.
Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care.
The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).
A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence).
In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence).
In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence).
The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence). In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence). None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.
The authors concluded that the results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
[The previous version of this review was published in 2013 and concluded: A pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.]
This is a thorough review that is technically well-done (no wonder, as it had to comply with Cochrane standards!). However, as with some other Cochrane reviews of homeopathy, acupuncture and other SCAMs, one might object to the phraseology used in the conclusions (the part that most people would focus on). Don’t get me wrong, the conclusions are technically correct; however, they are not as clear as they should be and hide the essence of the evidence, in my view.
Systematic reviews have one main purpose: they need to inform the reader whether there is or is not good evidence that the treatment in question works for the condition in question. This question is not well addressed by stating THE RESULTS ARE UNCERTAIN. The truth is that a firm conclusion can very well be drawn: THERE IS NO GOOD EVIDENCE THAT ANY FORM OF HOMEOPATHY IS EFFECTIVE FOR IBS!
Surely that’s correct and firm enough!!!
Why do the authors not dare to put this clearly?
Probably because some of them are well-known, long-term proponents of homeopathy.
Why does the Cochrane Collaboration allow them to get away with their petty attempt of obfuscation?
This systematic review was aimed at investigating the current evidence to determine whether there is an association between chiropractic use and opioid receipt.
Controlled studies, cohort studies, and case-control studies including adults with noncancer pain were eligible for inclusion. Studies reporting opioid receipt for both subjects who used chiropractic care and nonusers were included. Data extraction and risk of bias assessment were completed independently by pairs of reviewers. Meta-analysis was performed and presented as an odds ratio with 95% confidence interval.
In all, 874 articles were identified. After detailed selection, 26 articles were reviewed in full, and 6 met the inclusion criteria. Five studies focused on back pain and one on neck pain. The prevalence of chiropractic care among patients with spinal pain varied between 11.3% and 51.3%. The proportion of patients receiving an opioid prescription was lower for chiropractic users (range = 12.3-57.6%) than nonusers (range = 31.2-65.9%). In a random-effects analysis, chiropractic users had a 64% lower odds of receiving an opioid prescription than nonusers (odds ratio = 0.36, 95% confidence interval = 0.30-0.43, P < 0.001, I2 = 92.8%).
The authors concluded that this review demonstrated an inverse association between chiropractic use and opioid receipt among patients with spinal pain. Further research is warranted to assess this association and the implications it may have for case management strategies to decrease opioid use.
These results are in line with a previous study showing that among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.
The question is: what do such findings tell us?
I have no doubt that chiropractors will claim that using their services will reduce the opioid problem. But this is, of course, wishful thinking. The thing that will reduce it is not more chiro use but quite simply less opioid use!
The important thing to remember here is CORRELATION IS NOT CAUSATION!
People who drive a VW car are less likely to buy a Mercedes.
People who have ordered fish in a restaurant are unlikely to also order a steak.
People who use physiotherapy for back pain will probably use less opioids than those who don’t consult physios.
People who treat their back pain with massage therapy are less likely to also use opioids.
This is all very obvious, self-evident and perhaps even boring.
The most interesting finding here is in my view the fact that 31.2-65.9% of patients using chiropractic for their neck/back pain also took opioids. This seems to confirm what we often have discussed before:
CHIROPRACTIC TREATMENT IS NOT NEARLY AS EFFECTIVE AS CHIROS WANT US TO BELIEVE.
Hirudotherapy, also known as leech therapy, has been used to treat a wide range of disorders for thousands of years. It is also mentioned as a minimal invasive technique called Jalaukavacharana in the Sushruta Samhita, an ancient Sanskrit text of Ayurvedic medicine.
But a long history is a fallacious argument (appeal to tradition) when used to imply efficacy. So, does this treatment work?
A review located a total of 834 articles were found of which 89.8% were original articles. USA was the leading country with 280 publications, followed by UK, Germany and France (128, 101 and 41 items, respectively). The most productive countries regarding hirudotherapy were the UK (1.93), Slovenia (1.44), and Israel (1.32). The peak publication year for hirudotherapy literature was 2011 with 41 papers.
What does that tell us about the efficacy of leech therapy?
The authors of another review concluded that reached the following conclusion: ” Given the low number of reported adverse events, leech therapy may be a useful approach in treating this condition. Further high-quality RCTs are required for the conclusive judgment of its effectiveness and safety.”
The few clinical trials that were reviewed are mostly by one research group – and yes, you guessed it: it was also this group who published the review.
And anyway: why do they conclude that there is a low number of adverse events? Firstly, there is no reporting system for such events; so, a low number is next to meaningless. Secondly, there are several reports of adverse events. Here are three recent cases:
A 59-year-old woman was admitted to the emergency department with complaints of redness and swelling in both eyes and face. She had a long history of headache, therefore applied leech treatment occasionally. Swelling began on the face after the treatment of leech therapy. Vital signs were as follows; fever: 36.5°C, BP: 126/81 mmHg, heart rate: 84/min and sO2: 98%; respiratory rate: 12/min. In physical examination, GCS was 15, conscious, oriented cooperative. There was no lymphadenopathy in the palpation of the head and neck examination. Oropharynx was in natural appearance and no uvula edema. Facial palpation revealed redness, pain and heat rise. Other systemic findings were normal. Laboratory tests showed leukocytes: 11,000/mm3 (4,000-10,000/mm3), haemoglobin: 12.8 g/dL (12,00-14,00 g/dL) platelet: 271,000 (100,000-400,000/mm3) CRP: 3.45 mg/L (0-0.5mg/L). Other parameters were within normal limits. Computed tomography (CT) showed bilateral periorbital, frontal subcutaneous soft tissue oedema and lymphatic dilatations. She was hospitalized with the diagnosis of orbital cellulite due to leech therapy.
Anorectal sepsis usually presents with anal abscesses, which may evolve to become anorectal fistulas. Most of these cases are either of cryptoglandular origin, or they develop secondary to inflammatory bowel diseases. A 32-year-old male patient applied to our Proctology Unit with severe anal pain and swelling. Three days before admission, leeches were applied to the hemorrhoidal swellings in a medical center. The abscess was drained with appropriate unroofing and search for any compartments. The patient recovered rapidly. The abscess culture and microscopy revealed mix flora with predominant Escherichia coli. After 6 months, he has been symptom-free with perfect healing of the surgical site. We need to check up on possible handicaps in our modern patient care policies that divert people to such methods. Nevertheless, such alternative methods should be regarded as nonscientific and out of context unless their efficacy and safety are documented.
Pseudolymphoma, also known as Jessner’s lymphocytic infiltration, is a benign but usually chronic, T-cell infiltrating disease with erythematous papules and plaques usually seen on the skin of the face, neck, and back. The use of leech therapy also known as hirudotherapy has increased in recent years. Here, we report a 52-year-old male patient who had undergone hirudotherapy in his neck and developed infiltrating plaques after four months. A skin biopsy confirmed the diagnosis of Jessner’s lymphocytic infiltration. In parallel with the increasing use of hirudotherapy in recent years, the side-effect reports will likely to increase. Indications and contraindications of hirudotherapy, which is being used officially in hospitals, should be taken into consideration.
So, what do we make of this evidence?
I don’t know about you, but I am not likely to try or recommend leech therapy in a hurry.
A systematic review of the evidence for effectiveness and harms of specific spinal manipulation therapy (SMT) techniques for infants, children and adolescents has been published by Dutch researchers. I find it important to stress from the outset that the authors are not affiliated with chiropractic institutions and thus free from such conflicts of interest.
They searched electronic databases up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1–18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed risk of bias of included studies and quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, random-effects meta-analysis was performed.
Of the 1,236 identified studies, 26 studies were eligible. In all but 3 studies, the therapists were chiropractors. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.
The authors concluded that, based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.
We have often noted that, in chiropractic trials, harms are often not mentioned (a fact that constitutes a violation of research ethics). This was again confirmed in the present review; only 4 of the controlled clinical trials reported such information. This means harms cannot be evaluated by reviewing such studies. One important strength of this review is that the authors realised this problem and thus included other research papers for assessing the risks of SMT. Consequently, they found considerable potential for harm and stress that under-reporting remains a serious issue.
Another problem with SMT papers is their often very poor methodological quality. The authors of the new review make this point very clearly and call for more rigorous research. On this blog, I have repeatedly shown that research by chiropractors resembles more a promotional exercise than science. If this field wants to ever go anywhere, if needs to adopt rigorous science and forget about its determination to advance the business of chiropractors.
I feel it is important to point out that all of this has been known for at least one decade (even though it has never been documented so scholarly as in this new review). In fact, when in 2008, my friend and co-author Simon Singh, published that chiropractors ‘happily promote bogus treatments’ for children, he was sued for libel. Since then, I have been legally challenged twice by chiropractors for my continued critical stance on chiropractic. So, essentially nothing has changed; I certainly do not see the will of leading chiropractic bodies to bring their house in order.
May I therefore once again suggest that chiropractors (and other spinal manipulators) across the world, instead of aggressing their critics, finally get their act together. Until we have conclusive data showing that SMT does more good than harm to kids, the right thing to do is this: BEHAVE LIKE ETHICAL HEALTHCARE PROFESSIONALS: BE HONEST ABOUT THE EVIDENCE, STOP MISLEADING PARENTS AND STOP TREATING THEIR CHILDREN!
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.
Autologous whole blood (AWB) therapy is a treatment where a patients blood is first drawn from a vein and then (unmodified or treated in various bizarre ways) reinjected intra-muscularly. This sounds barmy, not least because there is no remotely plausible mode of action. Nonetheless, the therapy is popular in some countries (like Germany, where it is practised by many doctors and Heilpraktikers) and recommended for all sorts of illnesses, particularly for strengthening the immune system and fend off infections.
I have personally used it quite a bit and even conducted the first but very small double-blind, placebo-controlled RCT of AWB therapy which showed promising results. Now two systematic reviews of AWB therapy have become available almost simultaneously.
The first systematic review included our plus 7 more clinical studies. The authors included all prospective controlled trials concerning intra-muscular AWB therapy with the exception of trials using oxygenated, UV radiated or heated blood. Information was extracted on the indication, design, additions to AWB and outcome. Full texts were screened for information about the effector mechanisms.
Eight trials met their inclusion criteria. In three controlled trials with patients suffering from atopic dermatitis and urticaria, AWB therapy showed beneficial effects. In five randomized controlled trials (RCTs), two of which concerned respiratory tract infections, two urticaria and one ankylosing spondylitis, no efficacy could be found. A quantitative assessment was not possible due to the heterogeneity of the included studies. The authors found only 4 controlled trials with sample sizes bigger than 37 individuals per group. Only one study investigated the effector mechanisms of AWB.
The German authors concluded that there is some evidence for efficacy of AWB therapy in urticaria patients and patients with atopic eczema. Firm conclusions can, however, not be drawn. We see a great need for further RCTs with adequate sample sizes and for investigation of the effector mechanisms of AWB therapy.
The second systematic review had a slightly different focus in that it assessed AWB therapy as well as autologous serum therapy (AST) for patients suffering from chronic spontaneous urticaria (CSU). Its authors managed to include 8 clinical trials. AST was not more effective than the placebo treatment in alleviating CSU symptoms at the end of treatment (p = .161), and AWB injection was also not more effective in response rates than the placebo at the end of follow-up (p = .099). Furthermore, the efficacy of AST or AWB injection for CSU and the ASST status were not significantly related. No remarkable adverse events were recorded during therapy.
The Taiwanese authors concluded that their meta-analysis suggested that AWB therapy and AST are not significantly more effective in alleviating CSU symptoms than the placebo treatment.
These somewhat contradictory conclusions will confuse most readers. Personally, I think that caution is well-justified. The trials are mostly flawed, and even our positive study (which received the highest possible quality marks by the authors of the first review) can in no way be definitive, because it was far too small for allowing firm conclusions.
Yet, despite all this, I do think that AWB therapy merits further study.
“There is a ton of chiropractor journals. If you want evidence then read some.”
This was the comment by a defender of chiropractic to a recent post of mine. And it’s true, of course: there are quite a few chiro journals, but are they a reliable source of information?
One way of quantifying the reliability of medical journals is to calculate what percentage of its published articles arrive at negative conclusion. In the extreme instance of a journal publishing nothing but positive results, we cannot assume that it is a credible publication. In this case, it would be not a scientific journal at all, but it would be akin to a promotional rag.
Back in 1997, we published our first analysis of journals of so-called alternative medicine (SCAM). It showed that just 1% of the papers published in SCAM journals reported findings that were not positive. In the years that followed, we confirmed this deplorable state of affairs repeatedly, and on this blog I have shown that the relatively new EBCAM journal is similarly dubious.
But these were not journals focussing specifically on chiropractic. Therefore, the question whether chiro journals are any different from the rest of SCAM is as yet unanswered. Enough reason for me to bite the bullet and test this hypothesis. I thus went on Medline and assessed all the articles published in 2018 in two of the leading chiro journals.
- JOURNAL OF CHIROPRACTIC MEDICINE (JCM)
- CHIROPRACTIC AND MANUAL THERAPY (CMT)
I evaluated them according to
- TYPE OF ARTICLE
- DIRECTION OF CONCLUSION
The results of my analysis are as follows:
- The JCM published 39 Medline-listed papers in 2018.
- The CMT published 50 such papers in 2018.
- Together, the 2 journals published:
- 18 surveys,
- 17 case reports,
- 10 reviews,
- 8 diagnostic papers,
- 7 pilot studies,
- 4 protocols,
- 2 RCTs,
- 2 non-randomised trials,
- 2 case-series,
- the rest are miscellaneous types of articles.
4. None of these papers arrived at a conclusion that is negative or contrary to chiropractors’ current belief in chiropractic care. The percentage of publishing negative findings is thus exactly 0%, a figure that is almost identical to the 1% we found for SCAM journals in 1997.
I conclude: these results suggest that the hypothesis of chiro journals publishing reliable information is not based on sound evidence.
On this blog, we have often noted that (almost) all TCM trials from China report positive results. Essentially, this means we might as well discard them, because we simply cannot trust their findings. While being asked to comment on a related issue, it occurred to me that this might be not so much different with Korean acupuncture studies. So, I tried to test the hypothesis by running a quick Medline search for Korean acupuncture RCTs. What I found surprised me and eventually turned into a reminder of the importance of critical thinking.
Even though I found pleanty of articles on acupuncture coming out of Korea, my search generated merely 3 RCTs. Here are their conclusions:
The results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.
The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies.
Bee venom acupuncture combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.
So yes, according to this mini-analysis, 100% of the acupuncture RCTs from Korea are positive. But the sample size is tiny and I many not have located all RCTs with my ‘rough and ready’ search.
But what are all the other Korean acupuncture articles about?
Many are protocols for RCTs which is puzzling because some of them are now so old that the RCT itself should long have emerged. Could it be that some Korean researchers publish protocols without ever publishing the trial? If so, why? But most are systematic reviews of RCTs of acupuncture. There must be about one order of magnitude more systematic reviews than RCTs!
Why so many?
Perhaps I can contribute to the answer of this question; perhaps I am even guilty of the bonanza.
In the period between 2008 and 2010, I had several Korean co-workers on my team at Exeter, and we regularly conducted systematic reviews of acupuncture for various indications. In fact, the first 6 systematic reviews include my name. This research seems to have created a trend with Korean acupuncture researchers, because ever since they seem unable to stop themselves publishing such articles.
So far so good, a plethora of systematic reviews is not necessarily a bad thing. But looking at the conclusions of these systematic reviews, I seem to notice a worrying trend: while our reviews from the 2008-2010 period arrived at adequately cautious conclusions, the new reviews are distinctly more positive in their conclusions and uncritical in their tone.
Let me explain this by citing the conclusions of the very first (includes me as senior author) and the very last review (does not include me) currently listed in Medline:
penetrating or non-penetrating sham-controlled RCTs failed to show specific effects of acupuncture for pain control in patients with rheumatoid arthritis. More rigorous research seems to be warranted.
Electroacupuncture was an effective treatment for MCI [mild cognitive impairment] patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.
Now, you might claim that the evidence for acupuncture has overall become more positive over time, and that this phenomenon is the cause for the observed shift. Yet, I don’t see that at all. I very much fear that there is something else going on, something that could be called the suspension of critical thinking.
Whenever I have asked a Chinese researcher why they only publish positive conclusions, the answer was that, in China, it would be most impolite to publish anything that contradicts the views of the researchers’ peers. Therefore, no Chinese researcher would dream of doing it, and consequently, critical thinking is dangerously thin on the ground.
I think that a similar phenomenon might be at the heart of what I observe in the Korean acupuncture literature: while I always tried to make sure that the conclusions were adequately based on the data, the systematic reviews were ok. When my influence disappeared and the reviews were done exclusively by Korean researchers, the pressure of pleasing the Korean peers (and funders) became dominant. I suggest that this is why conclusions now tend to first state that the evidence is positive and subsequently (almost as an after-thought) add that the primary trials were flimsy. The results of this phenomenon could be serious:
- progress is being stifled,
- the public is being misled,
- funds are being wasted,
- the reputation of science is being tarnished.
Of course, the only right way to express this situation goes something like this:
BECAUSE THE QUALITY OF THE PRIMARY TRIALS IS INADEQUATE, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.