Yesterday, we discussed a paper concluding (amongst other things) that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain. Today, we are looking at one that overtly contradicts this verdict.
This systematic review (published in JAMA Oncology) evaluated the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale.
A total of 17 RCTs (with 1111 patients) were included, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity. A favourable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity and in 2 RCTs for reducing opioid dose. The evidence grade was moderate because of the substantial heterogeneity among studies.
The authors concluded that this systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.
So, which of the two conclusions should we trust?
Personally, I find the JAMA paper unimpressive to the point of being suspect. Here are some of my reasons:
- About half of the primary studies are Chinese; and we have seen repeatedly that they are unreliable and report only positive results.
- Many of the trials are published in Chinese and can thus not be checked by non-Chinese readers (nor, presumably, by the experts who acted as peer-reviewers for JAMA Oncology).
- I have my doubts about the rigor of the peer-review of some of the journals that published the primary studies included in the review.
- One paper included in the review is even a mere doctoral thesis which usually is not peer-reviewed in the usual sense.
- The authors state that they included only clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care. However, this is evidently not true; many of the studies had the infamous A+B versus B design comparing acupuncture plus a conventional therapy against the conventional therapy. As we have discussed ad nauseam on this blog, such trials cannot produce a negative finding even if ‘A’ is a placebo.
- Contrary to what the authors claim, the quality of most of the included studies was extremely poor, as far as I can see.
- One included paper which I cannot access is entitled ‘Clinical observation on 30 cases of moderate and severe cancer pain of bone metastasis treated by auricular acupressure‘. Are the review authors seriously claiming that this is an RCT?
The more I study the details of the JAMA Oncology paper, the more I feel it might be worth a complaint to the editor with a view of initiating a thorough investigation and a possible retraction.
Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.
The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.
Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).
The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.
In essence this two-centre study shows that:
- real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
- real acupuncture is not significantly better than sham acupuncture;
- the findings differ remarkably between the US and the Chinese centre.
I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.
In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.
Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”
Who do you think is closer to the truth?
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!
Traditional Chinese Medicine (TCM) is a term created by Mao lumping together various modalities in an attempt to pretend that healthcare in the People’s Republic of China (PRC) was being provided despite the most severe shortages of conventional doctors, drugs and facilities. Since then, TCM seems to have conquered the West, and, in the PRC, the supply of conventional medicine has hugely increased. Today therefore, TCM and conventional medicine peacefully co-exist side by side in the PRC on an equal footing.
At least this is what we are being told – but is it true?
I have visited the PRC twice. The first time, in 1980, I was the doctor of a university football team playing several games in the PRC, including one against their national team. The second time, in 1991, I co-chaired a scientific meeting in Shanghai. On both occasions, I was invited to visit TCM facilities and discuss with colleagues issues related to TCM in the PRC. All the official discussions were monitored by official ‘minders’, and therefore fee speech and an uninhibited exchange of ideas are not truly how I would describe them. Yet, on both visits, there were occasions when the ‘minders’ were absent and a more liberal discussion could ensue. Whenever this was the case, I did not at all get the impression that TCM and conventional medicine were peacefully co-existing. The impression that I did get was that their co-existence resembled more a ‘shot-gun marriage’.
During my time running the SCAM research unit at Exeter, I had the opportunity to welcome several visiting researchers from the PRC. This experience seemed to confirm my impression that TCM in the PRC was less than free. As an example, I might cite one acupuncture project I was once working on with a scientist from the PRC. When it was nearing its conclusion and I mentioned that we should now think about writing it up to publish the findings, my Chinese colleague said that being a co-author was unfortunately not an option. Knowing how important publications in Western journals are for researchers from the PRC, I was most surprised by this revelation. The reason, it turned out, was that our findings failed to be favourable for TCM. My friend explained that such a paper would not advance but hinder an academic career, once back in the PRC.
Suspecting that the notion of a peaceful co-existence of TCM and conventional medicine in the PRC was far from true, I have always been puzzled how the myth could survive for so many years. Now, finally, it seems to crumble. This is from a recent journalistic article entitled ‘Chinese Activists Protest the Use of Traditional Treatments – They Want Medical Science’ which states that thousands of science activists in the PRC protest that the state neglects its duty to treat its citizens with evidence-based medicine (here is the scientific article this is based on):
Over a number of years, Chinese researcher Qiaoyan Zhu, who has been affiliated with the University of Copenhagen’s Department of Communication, has collected data on the many thousand science activists in China through observations in Internet forums, on social media and during physical meetings. She has also interviewed hundreds of activists. Together with Professor Maja Horst, who has specialized in research communication, she has analyzed the many data on the activists and their protests in an article that has just been published in the journal Public Understanding of Science:
“The activists are better educated and wealthier than the average Chinese population, and a large majority of them keep up-to-date with scientific developments. The protests do not reflect a broad popular movement, but the activists make an impact with their communication at several different levels,” Maja Horst explained and added: “Many of them are protesting individually by writing directly to family, friends and colleagues who have been treated with – and in some cases taken ill from – Traditional Chinese Medicine. Some have also hung posters in hospitals and other official institutions to draw attention to the dangers of traditional treatments. But most of the activism takes place online, on social media and blogs.
Activists operating in a regime like the Chinese are obviously not given the same leeway as activists in an open democratic society — there are limits to what the authorities are willing to accept in the public sphere in particular. However, there is still ample opportunity to organize and plan actions online.
“In addition to smaller groups and individual activists that have profiles on social media, larger online groups are also being formed, in some cases gaining a high degree of visibility. The card game with 52 criticisms about Traditional Chinese Medicine that a group of activists produced in 37,000 copies and distributed to family, friends and local poker clubs is a good example. Poker is a highly popular pastime in rural China so the critical deck of cards is a creative way of reaching a large audience,” Maja Horst said.
Maja Horst and Qiaoyan Zhu have also found examples of more direct action methods, where local activist groups contact school authorities to complain that traditional Chinese medicine is part of the syllabus in schools. Or that activists help patients refuse treatment if they are offered treatment with Traditional Chinese Medicine.
I am relieved to see that, even in a system like the PRC, sound science and compelling evidence cannot be suppressed forever. It has taken a mighty long time, and the process may only be in its infancy. But there is hope – perhaps even hope that the TCM enthusiasts outside the PRC might realise that much of what came out of China has led them up the garden path!?
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.
Acupuncture is effective in alleviating angina when combined with traditional antianginal treatment, according to a study published today in JAMA Internal Medicine. Researchers conducted a 20-week randomized clinical trial at 5 clinical centres in China. Patients with chronic, stable angina (a serious symptom caused by coronary heart disease) were randomly assigned to 4 groups:
- acupuncture on acupoints in the disease-affected meridian,
- acupuncture on a non-affected meridian,
- sham acupuncture,
- waitlist group that did not receive acupuncture.
All participants also received recommended antianginal medications. Acupuncture was given three times each week for 4 weeks. Patients were asked to keep a diary to record angina attacks. 398 patients were included in the intention-to-treat analysis. Greater reductions in angina attacks occurred in those who received acupuncture at acupoints in the disease-affected meridian compared with those in the nonaffected meridian group, the sham acupuncture group and the wait list group.
“Acupuncture was safely administered in patients with mild to moderate angina”, Zhao et al wrote. “Compared with the [control] groups, adjunctive acupuncture showed superior benefits … Acupuncture should be considered as one option for adjunctive treatment in alleviating angina.”
This study is well-written and looks good – almost too good to be true!
Let me explain: during the last 25 years, I must have studied several thousand clinical trials of SCAM, and I think that, in the course of this work, I have developed a fine sense for detecting trials that are odd or suspect. While reading the above RCT, my alarm-bells were ringing loud and clear.
The authors claim they have no conflicts of interest. This may well be true as far as financial conflicts of interest are concerned, but I have long argued that, in SCAM, ideological conflicts are much more powerful than financial ones. If we look at some of the authors’ affiliations, we get a glimpse of this possibility:
- Acupuncture and Tuina School, Chengdu University o fTraditional Chinese Medicine, Chengdu, Sichuan, China
- Department of Acupuncture, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
- Acupuncture and Tuina School, Hunan University of Traditional Chinese Medicine, Changsha, Hunan, China
- Acupuncture and Tuina School, Guiyang University of Traditional Chinese Medicine, Guiyang, Guizhou, China
- Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China
- Acupuncture and Tuina School, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China
I have reported repeatedly that several independent analyses have shown that as good as no TCM studies from China ever report negative results. I have also reported that data falsification is said to be rife in China.
I am aware, of course, that these arguments are hardly evidence-based and therefore amount to mere suspicions. So, let me also mention a few factual points about the new trial:
- The study was concluded 4 years ago; why is it published only now?
- The primary outcome measure was entirely subjective; an objective endpoint would have been valuable.
- Patient blinding was not checked but would have been important.
- The discussion is devoid of any critical input; this is perhaps best seen when looking at the reference list. The authors cite none of the many critical analyses of acupuncture.
- The authors did actually not use normal acupuncture but electroacupuncture. One would have liked to see a discussion of effects of the electrical current versus those of acupuncture.
- The therapists were not blinded (when using electroacupuncture, this would have been achievable). Therefore, one explanation for the outcome is lies in the verbal/non-verbal communication between therapists and patients.
- Acupuncture was used as an add-on therapy, and it is conceivable that patients in the acupuncture group were more motivated to take their prescribed medications.
- The costs for 12 sessions of acupuncture would have been much higher (in the UK) than those for an additional medication.
- The practicality of consulting an acupuncturist three times a week need to be addressed.
- The long-term effects of acupuncture on angina pectoris (which is a long-term condition) are unknown.
Coming back to my initial point about the reliability of the data, I feel that it is important to not translate these findings into clinical routine without independent replications by researchers from outside China who are not promoters of acupuncture. Until such data are available, I believe that acupuncture should NOT be considered as one option for adjunctive treatment in alleviating angina.
Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.
But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.
The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).
After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.
There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.
The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.
The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.
I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?
It is time to stop this nonsense!
It gives a bad name to science, misleads the public and inhibits progress.
Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.
But is it effective?
The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.
Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).
The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.
I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:
- Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
- The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
- There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
- There seemed to be a sizable publication bias hidden in the data.
- All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
- Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.
I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.
The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).
The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.
The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.
I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?
But why do SCAM-fans not get it?
Why do we see trial after trial and review after review ignoring this simple and obvious fact?
I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!
But that’s cheating!
And isn’t cheating unethical?
My answer is YES!
(If you want to read a more detailed answer, please read our in-depth analysis here)
The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.
A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:
- Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
- Conventional treatment alone (CT group).
The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].
A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).
The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.
What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.
The lessons here are simple:
- In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
- Flawed research is currently being used by many proponents of SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
- The integration of dubious treatments into routine care does not lead to better outcomes.
- Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.