The risks of consulting a chiropractor have regularly been the subject of this blog (see for instance here, here and here). My critics believe that I am alarmist and have a bee in my bonnet. I think they are mistaken and believe it is important to warn the public of the serious complications that are being reported with depressing regularity, particularly in connection with neck manipulations.
It has been reported that the American model Katie May died earlier this year “as the result of visiting a chiropractor for an adjustment, which ultimately left her with a fatal tear to an artery in her neck” This is the conclusion drawn by the L.A. County Coroner.
According to Wikipedia, Katie tweeted on January 29, 2016, that she had “pinched a nerve in [her] neck on a photoshoot” and “got adjusted” at a chiropractor. She tweeted on January 31, 2016 that she was “going back to the chiropractor tomorrow.” On the evening of February 1, 2016, May “had begun feeling numbness in a hand and dizzy” and “called her parents to tell them she thought she was going to pass out.” At her family’s urging, May went to Cedars Sinai Hospital; she was found to be suffering a “massive stroke.” According to her father, she “was not conscious when we got to finally see her the next day. We never got to talk to her again.” Life support was withdrawn on February 4, 2016.
Katie’s death certificate states that she died when a blunt force injury tore her left vertebral artery, and cut off blood flow to her brain. It also says the injury was sustained during a “neck manipulation by chiropractor.” Her death is listed as accidental.
Katie’s family is said to be aware of the coroner’s findings. They would not comment on whether they or her estate would pursue legal action.
The coroner’s verdict ends the uncertainty about Katie’s tragic death which was well and wisely expressed elsewhere:
“…The bottom line is that we don’t know for sure. We can’t know for sure. If you leave out the chiropractic manipulations of her neck, her clinical history—at least as far as I can ascertain it from existing news reports—is classic for a dissection due to neck trauma. She was, after all, a young person who suffered a seemingly relatively minor neck injury that, unbeknownst to her, could have caused a carotid artery dissection, leading to a stroke four or five days later… Thus, it seems to be jumping to conclusions for May’s friend Christina Passanisi to say that May “really didn’t need to have her neck adjusted, and it killed her.” … Her two chiropractic manipulations might well have either worsened an existing intimal tear or caused a new one that led to her demise. Or they might have had nothing to do with her stroke, her fate having been sealed days before when she fell during that photoshoot. There is just no way of knowing for sure. It is certainly not wrong to suspect that chiropractic neck manipulation might have contributed to Katie May’s demise, but it is incorrect to state with any degree of certainty that her manipulation did kill her.”
My conclusions are as before and I think they need to be put as bluntly as possible: avoid chiropractors – the possible risks outweigh the documented benefits – and if you simply cannot resist consulting one: DON’T LET HIM/HER TOUCH YOUR NECK!
The placebo response might be important in clinical practice, but it is certainly difficult to study and the findings of such investigations can be confusing. This seems to be exemplified by two new trials.
The first study examined the possibility of using theatrical performance tools, including stage directions and scripting, to reproducibly manipulate the style and content of a simulated doctor-patient encounter and influence the placebo response (defined as improvement of clinical outcome in individuals receiving inactive treatment) in experimental pain.
A total of 122 healthy volunteers were exposed to experimental pain using the cold pressor test and assessed for pain threshold and tolerance before and after receiving a placebo cream from a “doctor” impersonated by a trained actor. The actor alternated between two distinct scripts and stage directions. One script emulated a standard doctor-patient encounter (scenario A), while the other emphasized elements present in ritual healing such as attentiveness and strong suggestion (scenario B).
The placebo response size was calculated as the % difference in pain threshold and tolerance after exposure relative to baseline. Subjects demonstrating a ≥30% increase in pain threshold or tolerance relative to baseline were defined as responders. Each encounter was videotaped in its entirety.
Inspection of the videotapes confirmed the reproducibility and consistency of the distinct scenarios enacted by the “doctor”-performer. Furthermore, scenario B resulted in a significant increase in pain threshold relative to scenario A. This increase derived from the placebo responder subgroup; as shown by two-way analysis of variance (performance style, F = 4.30; p = 0.040; η(2) = 0.035; style × responder status interaction term, F = 5.21; p = 0.024) followed by post hoc analysis showing a ∼60% increase in pain threshold in responders exposed to scenario B (p = 0.020).
Performance style and response size in placebo responders and non-responders. Bars represent mean ± SE of % change in CPT threshold of 60 subjects in scenario A: 53 non-responders vs. 7 responders and 62 subjects in scenario B: 51 non-responders and 11 responders. Two-way ANOVA by performance style and responsiveness revealed significant effects of doctor’s performance (F = 4.30; p = 0.040; η2 = 0.035) and responsiveness (F = 134.71; p < 0.001) as well as a significant interaction term (F = 5.21; p = 0.024). ∗p = 0.020, Fisher’s least significant difference post hoc test.
The authors concluded that these results support the hypothesis that structured manipulation of physician’s verbal and non-verbal performance, designed to build rapport and increase faith in treatment, is feasible and may have a significant beneficial effect on the size of the response to placebo analgesia. They also demonstrate that subjects, who are not susceptible to placebo, are also not susceptible to performance style.
In the second study, the authors investigated if an implicit priming procedure, where participants were unaware of the intended priming influence, affected placebo analgesia.
In a double-blind experiment, healthy participants (n = 36) were randomized to different implicit priming types; one aimed at increasing positive expectations and one neutral control condition. First, pain calibration (thermal) and a credibility demonstration of the placebo analgesic device were performed. In a second step, an independent experimenter administered the priming task; Scrambled Sentence Test. Then, pain sensitivity was assessed while telling participants that the analgesic device was either turned on (placebo) or turned off (baseline). Pain responses were recorded on a 0-100 Numeric Response Scale.
Overall, there was a significant placebo effect (p < 0.001), however, the priming conditions (positive/neutral) did not lead to differences in placebo outcome. Prior experience of pain relief (during initial pain testing) correlated significantly with placebo analgesia (p < 0.001) and explained 34% of placebo variance. Trait neuroticism correlated positively with placebo analgesia (p < 0.05) and explained 21% of placebo variance.
The authors concluded that priming is one of many ways to influence behaviour, and non-conscious activation of positive expectations could theoretically affect placebo analgesia. Yet, we found no SST priming effect on placebo analgesia. Instead, our data point to the significance of prior experience of pain relief, trait neuroticism and social interaction with the treating clinician.
The two studies are similar but generate somewhat contradictory results. In the discussion section, the authors of the first paper stress that “replication of our findings in clinical populations; employing professional physicians of both sexes, are necessary in order to establish their generality and possible application in medical training, with the aim of improving patient outcome across diseases and treatment modalities.” This is certainly true. They continue by stating that “future studies using performance tools in clinical trial settings could demonstrate the potential of borrowing performance principles and techniques from traditional healing and applying them to physician–patient encounters in Western medicine, following certain necessary modifications. Performance tools could thus eventually be incorporated into the systematic training of physicians and medical students, possibly to complement programs in Narrative Medicine and Relational Medicine.”
These ideas are not dissimilar to what we have been discussing on this blog repeatedly. For instance, I have previously tried to explain that “the science and the art of medicine are essential elements of good medicine. In other words, if one is missing, medicine is by definition not optimal. In vast areas of alternative medicine, the science-element is woefully neglected or even totally absent. It follows, that these areas cannot be good medicine. In some areas of conventional medicine, the art-element is weak or neglected. It follows that, in these areas, medicine is not good either.”
The fact that the two studies above show contradictory findings is not easy to interpret. Possibly, this shows how fragile the placebo response can be. It can be influenced by a multitude of factors related to an experiment or the clinical setting. If that is so, and placebo effects are truly unreliable, it would be yet another argument for not relying on them in clinical routine. In my view, clinicians should try to maximize them where they can. Yet placebo effects are not normally a justification for employing placebo therapies in clinical practice. In other words, the fact that a bogus treatment can generate a placebo response is not a good reason for using it on patients who need help.
Good clinicians have probably always been good ‘performers’. Alternative practitioners tend to be excellent ‘performers’, and I am sure their success is mainly due to this ability. I see little reason why conventional practitioners should not (re-)learn the skills that once upon a time were called ‘good bed-side manners’. Maximizing the placebo effect in this way might maximize the benefit patients experience – and for that we do not require the placebo-therapies of alternative medicine.
Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.
Yet acupuncture is precisely the therapy such patients might be tempted to employ.
Because irresponsible or criminally naïve acupuncturists advertise it!
Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….
I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:
Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.
In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:
Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.
However, this does not deter them to conclude on a positive note:
In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.
So, why do I find this irresponsibly and dangerously misleading?
Here a just a few reasons why this meta-analysis should not be trusted:
- There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
- The primary studies all look extremely weak; this means they are likely to be false-positive.
- They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
- All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.
My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.
Antrodia cinnamomea (AC) is a fungus which is used in Taiwan as a remedy for cancer, hypertension, hangover and other conditions. There are several commercial AC products and the annual market is worth over $100 million in Taiwan alone.
Several studies have suggested anti-cancer properties in vitro but few clinical trials have been reported. Now Taiwanese researchers published a double-blind, randomized clinical study to investigate whether AC had acceptable safety and efficacy in advanced cancer patients receiving chemotherapy.
Patients with advanced and/or metastatic adenocarcinoma, performance status (PS) 0-2, and adequate organ function who had previously been treated with standard chemotherapy were randomly assigned to receive routine chemotherapy regimens with AC (20 ml twice daily) orally for 30 days or placebo. The primary endpoint was 6-month overall survival (OS); the secondary endpoints were disease control rate (DCR), quality of life (QoL), adverse event (AE), and biochemical features within 30 days of treatment.
A total of 37 subjects with gastric, lung, liver, breast, and colorectal cancer (17 in the AC group, 20 in the placebo group) were enrolled in the study. Disease progression was the primary cause of death in 4 (33.3 %) AC and 8 (66.7 %) placebo recipients. Mean OSs were 5.4 months for the AC group and 5.0 months for the placebo group (p = 0.340), and the DCRs were 41.2 and 55 %, respectively (p = 0.33). Most hematologic, liver, or kidney functions did not differ significantly between the two groups, but platelet counts were lower in the AC group than in the placebo group (p = 0.02). QoL assessments were similar in the two groups, except that the AC group showed significant improvements in quality of sleep (p = 0.04).
The above figure shows the survival curves for both groups.
The authors concluded as follows: Although we found a lower mortality rate and longer mean OS in the AC group than in the control group, AC combined with chemotherapy was not shown to improve the outcome of advanced cancer patients, possibly due to the small sample size. In fact, the combination may present a potential risk of lowered platelet counts. Adequately powered clinical trials will be necessary to address this question.
I agree, the survival curve looks promising. But we must not get carried away: this was a tiny sample size and a relatively short treatment period. Thus the difference could be a coincidence or an artefact.
The investigators are sufficiently cautious in the interpretation of their findings, and most of us would probably agree that it is necessary to submit such traditional remedies to proper scientific tests. Yet, I feel a sense of unease when I read such articles.
On the one hand, it is possible that such investigations meaningfully contribute to progress. On the other hand, I wonder whether they merely end up providing a significant boost to the trade of bogus remedies sold at high prices to desperate patients. Do the benefits really out-weigh the risks? We will probably never know.
But to minimize the risk, the authors should now swiftly conduct a more definitive trial and create some clarity about the value or otherwise of this traditional cancer remedy.
A new study tested the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3).
The RCT began with a one-month run-in followed by three months intervention. The outcome measures were quantified at the end of the intervention and at 3, 6 and 12 months of follow-up. The primary end-point was the number of migraine days per month. Secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.
The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.
The authors concluded that it is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.
Chiropractors often cite clinical trials which suggest that CSMT might be effective. The effects sizes are rarely impressive, and it is tempting to suspect that the outcomes are mostly due to bias. Chiropractors, of course, deny such an explanation. Yet, to me, it seems fairly obvious: trials of CSMT are not blind, and therefore the expectation of the patient is likely to have major influence on the outcome.
Because of this phenomenon (and several others, of course), sceptics are usually unconvinced of the value of chiropractic. Chiropractors often respond by claiming that blind studies of physical intervention such as CSMT are not possible. This, however, is clearly not true; there have been several trials that employed sham treatments which adequately mimic CSMT. As these frequently fail to show what chiropractors had hoped, the methodology is intensely disliked by chiropractors.
The above study is yet another trial that adequately controls for patients’ expectation, and it shows that the apparent efficacy of CSMT disappears when this source of bias is properly accounted for. To me, such findings make a lot of sense, and I suspect that most, if not all the ‘positive’ studies of CSMT would turn out to be false positive, once such residual bias is eliminated.
This new study is amazing in several respects. It was conducted in Spain by otolaryngologists, and one of its authors is an employee of Boiron, the world’s biggest manufacturer of homeopathic products. It was designed as a double blind, placebo-controlled RCT. Patients aged 2 months to 12 years suffering from otitis media with effusion (OME), as diagnosed by pneumatic otoscopy (PNO) and tympanometry, were randomized into two groups. Both groups received aerosol therapy (mucolytics and corticosteroids). In addition, the experimental group received a homeopathic remedy of Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum. The placebo group received placebos instead. Both of the treatments were continued for 3 months. Patients were evaluated by PNO examination and tympanometry at baseline, at 45 and 90 days.
A total of 97 patients were enrolled in this study. In the homeopathy group, 61.9% of individuals were cured according to PNO results by the 3rd visit compared with 56.8% of patients treated with placebo. 4.8% of patients in the homeopathy group suffered a recurrence (positive PNO in the 2nd visit changed to negative in the 3rd visit), while 11.4% did in the placebo group. These inter-group differences were not statistically significant. Adverse events were distributed similarly, except in the case of upper respiratory tract infections, which were less frequent in homeopathic group.
The authors of this new RCT concluded that the homeopathic scheme used as adjuvant treatment cannot be claimed to be an effective treatment in children with OME.
No surprises then – we already know that homeopathic remedies are placebos!
Sure, but at least two amazing features need to be pointed out:
- I am delighted that the authors did not try to spin the results such that they appear to be positive. Some investigators might have emphasised the fact that there was a (non-significant) trend in favour of homeopathy, and that, for a secondary outcome measure (upper respiratory infections), it even reached the level of statistical significance.
- Considering that this study was obviously Boiron-sponsored and its list of authors included an employee of this firm, such honesty can’t have been easy to maintain.
- The design of this RCT is also worth a mention: most alt med proponents seem to think that ‘adjunctive’ use of alt med needs to be tested via the infamous ‘A+B vs B’ design which fails to control for placebo effects and therefore invariably produces false positive findings. The authors of this trial did the right thing by randomising their patients into usual care + homeopathy vs usual care + placebo. This is very simple and has the advantage to actually provide a meaningful result.
In view of all this, I raise my hat to the Spanish researchers: very well done!!!
If all trials of homeopathy were conducted and reported in this honourable fashion, the collective evidence would be in a much better state and far less confusing.
I have blogged about the herbal antidepressant before; for instance about the fact that it can cause potentially dangerous herb-drug interactions. When taken alone, however, it seems to be both safe and efficacious in reducing the symptoms of depression. This notion has just been confirmed yet again.
A new systematic review evaluated St. John’s wort (SJW) for the treatment of Major Depressive Disorder (MDD). The objectives of this review were to (1) evaluate the efficacy and safety of SJW in adults with MDD compared to placebo and active comparator and (2) evaluate whether the effects vary by severity of MDD.
The authors searched 9 electronic databases and existing reviews to November 2014. Two independent reviewers screened the citations, abstracted the data, and assessed the risk of bias. They included randomized controlled trials (RCTs) examining the effect of at least a 4-week administration of SJW on depression outcomes against placebo or active comparator in adults with MDD. Risk of bias was assessed using the Cochrane Risk of Bias tool and USPSTF criteria. Quality of evidence (QoE) was assessed using the GRADE approach.
Thirty-five studies examining 6993 patients met inclusion criteria; 8 studies evaluated a SJW extract that combined 0.3 % hypericin and 1-4 % hyperforin. SJW was associated with more treatment responders than placebo (relative risk [RR] 1.53; 95 % confidence interval [CI] 1.19, 1.97; I(2) 79 %; 18 RCTs; N = 2922, moderate QoE; standardized mean differences [SMD] 0.49; CI 0.23, 0.74; 16 RCTs; I(2) 89 %, N = 2888, moderate QoE). Compared to antidepressants, SJW participants were less likely to experience adverse events (OR 0.67; CI 0.56, 0.81; 11 RCTs; moderate QoE) with no difference in treatment effectiveness (RR 1.01; CI 0.90, 1.14; 17 RCTs, I(2) 52 %, moderate QoE; SMD -0.03; CI -0.21, 0.15; 14 RCTs; I(2) 74 %; N = 2248, moderate QoE) in mild and moderate depression.
The authors concluded that SJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence. Adverse events reported in RCTs were comparable to placebo and fewer compared with antidepressants. However, assessments were limited due to poor reporting of adverse events and studies were not designed to assess rare events. Consequently, the findings should be interpreted with caution.
This is an excellent review from a reputable and independent team. The findings are therefore trustworthy.
Does that mean that we can now recommend SJW for patients suffering from depression?
Perhaps – but we need to keep an eye on the interaction issue. As a sole treatment, SJW is much safer than conventional antidepressants. But if a patient takes other medicines, we ought to be very careful.
Other currently unresolved issues are the questions of which extract and which dose. At present, there is not enough evidence to provide conclusive answers to either of these, and therefore the enthusiasm of many doctors for prescribing SJW is understandably limited.
Irrespective of these problems, I have to say that SJW is without question one of the biggest ‘success stories’ from the realm of alternative medicine. Pity that there are not more of them!
I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
END OF QUOTE
Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.
“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”
Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.
According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.
And what should we conclude from all this?
I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.
In a recent PJ article, Michael Marshall from the ‘Good Thinking Society’ asked “WHY ON EARTH IS THE NHS SPENDING EVEN A SINGLE PENNY ON HOMEOPATHY?”. A jolly good question, given the overwhelmingly negative evidence, I thought – but one that must be uncomfortable to homeopaths. Sure enough, a proponent of homeopathy, Jeanette Lindsay from Glasgow, has objected to Marshall’s arguments in a short comment which is a fairly typical defence of homeopathy; I therefore take the liberty of reproducing it here (the 12 references in her text were added by me and refer to my footnotes below):
I wonder if people such as Michael Marshall (The Pharmaceutical Journal 2016;297:101), who would refuse  patients the option of NHS homeopathic treatment, have considered the plight of people failed by evidence-based medicine ?  Where are those with chronic, disabling conditions to turn when the medicines available on the NHS do not work, or worse, are positively harmful? 
Take the instance of a woman with multiple drug allergies who has no means of treating her severe inflammatory arthritis and no suitable analgesia.  It has been demonstrated that disease states with immune system involvement are particularly susceptible to the placebo effect but how does one induce this? Current thinking precludes treatment with placebo medicines but it so happens that homeopathic remedies would appear, from the results of clinical trials , to be a good substitute.  Used properly, there is a good chance that in this case homeopathic treatment may achieve a real therapeutic effect. 
Patients who cannot tolerate allopathic  treatment do not just go away because they cannot take the prescribed medicine.  They suffer and surely deserve a better range of options  than those provided by the current obsession with evidence-based medicine.  The availability of homeopathic treatment is important and should not be denied until better alternatives become commonplace.  Michael Marshall does not ‘refuse’ homeopathy on the NHS; that is not in his power. He merely questions whether NHS funds should not be spent on treatments that demonstrably do more good than harm.  I am sure he as carefully considered such patients.  Depending on the exact circumstances, such patients have many options: for instance, they could change their physician, have their diagnosis re-considered, or try a non-drug treatment.  An allergy to one drug is rarely (I would even say never) associated with allergies to all drugs for any given condition. Even if this were the case, there are several non-drug treatments for arthritis or other diseases.  I think this is fantasy; there is no good evidence from clinical trials to show that homeopathy is efficacious for either inflammatory or degenerative arthritis.  Is this an admission that homeopathic remedies are placebos?  I am not aware of sound evidence to support this statement.  ‘Allopathic’ is a derogatory term introduced by Hahnemann to defame conventional medicine.  I have never seen a patient who could not tolerate any prescription medicine. I suspect this is fantasy again.  Patients deserve the optimal therapy available for their conditions – that is a therapy that demonstrably generates more good than harm. Homeopathy is clearly not in this category.  An obsession? Yes, perhaps it is an obsession for some dedicated healthcare professionals to provide the best possible treatments for their patients. But the way it is put here, it sounds as though this was something despicable. I would argue that such an ‘obsession’ would be most commendable.  For practically all conditions, symptoms, illesses and diseases that afflict mankind, better alternatives than homeopathy have been available since about 150 years.
It seems to me that Jeanette Lindsay has been harshly disappointed by conventional medicine. Perhaps this is why, one day, she consulted a homeopath and received the empathy, understanding and compassion that she needed to get better. Many homeopaths excel at these qualities; and this is the main reason why their patients swear by them, even though their remedies are pure placebos.
My advice to such patients is: find a physician who has time, empathy and compassion. They do exist! Once you have found such a doctor, you can benefit from the compassion and empathy just as you may have benefitted from the homeopath’s compassion and empathy. But in addition to these benefits (and contrary to what you got from your homeopath), you will also be able to profit from the efficacy of the treatments prescribed.
To put it simply: homeopaths can help patients via non-specific therapeutic effects; responsible physicians can help patients via non-specific therapeutic effects plus the specific effects of the treatments they prescribe.
Some osteopaths – similar to their chiropractic, naturopathic, homeopathic, etc. colleagues – claim they can treat almost any condition under the sun. Even gynaecological ones? Sure! But is the claim true? Let’s find out.
The aim of this recent review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review.
In total, 24 studies were included. They addressed the following conditions: back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT was considered to be effective for pregnancy related back pain. For all other gynaecological and obstetrical conditions the evidence was considered to be uncertain. Only three studies mentioned adverse events after OMT.
The authors concluded that, although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.
Given the fact that the lead authors of this review come from the “Accademia Italiana Osteopatia Tradizionale, Pescara, Italy, we can probably answer the question in the title of this blog with a straight NO. I see no reason why OMT should work for gynaecological conditions, and I am not in the least surprised to read that there is no clinical evidence for this notion. Sadly, this is unlikely to stop osteopaths to claim otherwise and continue to prey on the desperate and the gullible.
One might thus say that this review is totally unremarkable – but I would beg to differ: it highlights yet again one very important finding, namely the fact that trials of alternative therapies far too often fail to report adverse effects. I have stated this often already, but I will say it again: THIS OMISSION IS A VIOLATION OF RESEARCH ETHICS WHICH GIVES US A FALSE POSITIVE OVERALL PICTURE OF THE RISKS ASSOCIATED WITH ALTERNATIVE MEDICINE.