Chinese studies
As pointed out previously on this blog, unethical research practices are prevalent in China, but little research has focused on the causes of these practices.
Drawing on the criminology literature on organisational deviance, as well as the concept of cengceng jiama, which illustrates the increase of pressure in the process of policy implementation within a top-down bureaucratic hierarchy, this article develops an institutional analysis of research misconduct in Chinese universities. It examines both universities and the policy environment of Chinese universities as contexts for research misconduct. Specifically, this article focuses on China’s Double First-Class University Initiative and its impact on elite universities that respond to the policy by generating new incentive structures to promote research quality and productivity as well as granting faculties and departments greater flexibility in terms of setting high promotion criteria concerning research productivity. This generates enormous institutional tensions and strains, encouraging and sometimes even compelling individual researchers who wish to survive to decouple their daily research activities from ethical research norms. The article is written based on empirical data collected from three elite universities as well as a review of policy documents, universities’ internal documents, and news articles.
The interviewer, sociologist Zhang Xinqu, and his colleague Wang Peng, a criminologist, both at the University of Hong Kong, suggest that researchers felt compelled, and even encouraged, to engage in misconduct to protect their jobs. This pressure, they conclude, ultimately came from a Chinese programme to create globally recognized universities. The programme prompted some Chinese institutions to set ambitious publishing targets, they say. In 2015, the Chinese government introduced the Double First-Class Initiative to establish “world-class” universities and disciplines. Universities selected for inclusion in the programme receive extra funding, whereas those that perform poorly risk being delisted, says Wang.
Between May 2021 and April 2022, Zhang conducted anonymous virtual interviews with 30 faculty members and 5 students in the natural sciences at three of these elite universities. The interviewees included a president, deans and department heads. The researchers also analysed internal university documents.
The university decision-makers who were interviewed at all three institutes said they understood it to be their responsibility to interpret the goals of the Double First-Class scheme. They determined that, to remain on the programme, their universities needed to increase their standing in international rankings — and that, for that to happen, their researchers needed to publish more articles in international journals indexed in databases such as the Science Citation Index. As the directive moved down the institutional hierarchy, pressure to perform at those institutes increased. University departments set specific and hard-to-reach publishing criteria for academics to gain promotion and tenure. Some researchers admitted to engaging in unethical research practices for fear of losing their jobs. In one interview, a faculty head said: “If anyone cannot meet the criteria [concerning publications], I suggest that they leave as soon as possible.”
Zhang and Wang describe researchers using services to write their papers for them, falsifying data, plagiarizing, exploiting students without offering authorship and bribing journal editors. One interviewee admitted to paying for access to a data set. “I bought access to an official archive and altered the data to support my hypotheses.” An associate dean emphasized the primacy of the publishing goal. “We should not be overly stringent in identifying and punishing research misconduct, as it hinders our scholars’ research efficiency.”
The larger problem, says Xiaotian Chen, a library and information scientist at Bradley University in Peoria, Illinois, is a lack of transparency and of systems to detect and deter misconduct in China. Most people do the right thing, despite the pressure to publish, says Chen, who has studied research misconduct in China. The pressure described in the paper could just be “an excuse to cheat”.
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It is hard not to be reminded of what I reported in a recent post where it has been announced that a Chinese acupuncture review was retracted:
The research “Acupuncture for low back and/or pelvic pain during pregnancy: a systematic review and meta-analysis of randomised controlled trials,” published in the open access journal BMJ Open in 2022, has been retracted.
This research was press released in November 2022 under the title of “Acupuncture can relieve lower back/pelvic pain often experienced during pregnancy.”
Following publication of the research, various issues concerning its design and reporting methods came to light, none of which was amenable to correction, prompting the decision to retract.
The full wording of the retraction notice, which will be published at 23.30 hours UK (BST) time Tuesday 11 June 2024, is set out below:
“After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.” doi:10.1136/bmjopen-2021-056878ret
Please ensure that you no longer cite this research in any future reporting.
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After studying Chinese TCM papers for more than 30 years, I feel increasingly concerned about the tsumani of either very poor quality or fabricated research coming out of China. For more details, please read the following posts:
- Beware of Chinese acupuncture trials!
- More compelling reasons for distrusting Chinese research papers
- ‘WORST PAPER OF 2022 COMPETITION’ Entry No 5: “Chinese Herbal Medicine … Improves the Survival Rate of Patients with Ischemic Heart Disease”
- Reviews of Chinese Herbal Medicine: It’s a process akin to money laundering
- The ‘WORST PAPER OF 2022’ COMPETITION. Entry No 2: the safety differences between Chinese medicine and Western medicine
- “Traditional Chinese Medicine Enhances Survival in Patients with Gastric Cancer” – oh really?
- Paying the price for questioning Traditional Chinese Medicine – Beware!
- The scandal of Chinese acupuncture research and its publication in seemingly reputable journals
- This RCT of a Chinese herbal mixture makes a mockery of science and medical ethics
- Chinese herbs for Alzheimer’s disease? An excellent example of how fatally flawed research misleads us all
- And this is why we might as well forget about Chinese acupuncture trials
- Do Chinese reviews summarising Chinese clinical trials of TCM send us up the garden path?
- Increasing concerns about SCAM research originating from China
In November 2022, we discussed a dodgy acupuncture review. Let me show you my post from back then again:
Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.
The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.
Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture
- relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
- improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
- improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).
There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).
The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.
What should we make of this paper?
In case you are in a hurry: NOT A LOT!
In case you need more, here are a few points:
- many trials were of poor quality;
- there was evidence of publication bias;
- there was considerable heterogeneity within the studies.
The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.
Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.
Dishonest researchers?
Biased reviewers?
Incompetent editors?
Truly unbelievable!!!
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.
PS
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!
Now, it has been announced that the paper has been retracted:
The research “Acupuncture for low back and/or pelvic pain during pregnancy: a systematic review and meta-analysis of randomised controlled trials,” published in the open access journal BMJ Open in 2022, has been retracted.
This research was press released in November 2022 under the title of “Acupuncture can relieve lower back/pelvic pain often experienced during pregnancy.”
Following publication of the research, various issues concerning its design and reporting methods came to light, none of which was amenable to correction, prompting the decision to retract.
The full wording of the retraction notice, which will be published at 23.30 hours UK (BST) time Tuesday 11 June 2024, is set out below:
“After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.” doi:10.1136/bmjopen-2021-056878ret
Please ensure that you no longer cite this research in any future reporting.
One down, dozens of further SCAM papers to go!
I know, I have mentioned my concerns before about research into so-called alternative medicine (SCAM) from China, e.g.:
- Concerning developments in acupuncture research: is there something rotten in the state of China?
- Data fabrication in China is an ‘open secret’
- Beware of Chinese acupuncture trials!
- My concerns about the current research activity in so-called alternative medicine (SCAM)
- More compelling reasons for distrusting Chinese research papers
- Widespread fraud in natural health products research
- Reviews of Chinese Herbal Medicine: It’s a process akin to money laundering
- Disgracefully low methodological quality of systematic reviews on acupuncture
In 2018, China became the country that produces more scientific papers than any other. At present, China’s output stands at over one million articles per year. Yes, I do find this worrying!
On 2/4/2024, I did a few very simple Medline searches. I feel that the findings are remarkable.
Clinical trials of TCM
Between 2000 and 2023 ~ 8000
2000 = 8
2010 = 157
2020 = 1 192
Systematic reviews of TCM
2000 = 1
2010 = 26
2020 = 1 222
This near explosive rate of growth could, of course, be good news. But it isn’t because – as shown here so often before – the findings of Chinese research are worringly unreliable.
As if to confirm my point about the dominance of China, this paper has just been published:
Background: Neuropathic pain (NP) is a common type of pain in clinic. Due to the limited effect of drug treatment, many patients with NP are still troubled by this disease. In recent years, complementary and alternative therapy (CAT) has shown good efficacy in the treatment of NP. As the interest in CAT for NP continues to grow, we conducted a bibliometric study of publications on CAT treatment for NP. The aim of this study is to analyze the development overview, research hotspots and future trends in the field of CAT and NP through bibliometric methodology, so as to provide a reference for subsequent researchers.
Methods: Publications on CAT in the treatment of NP from 2002 to 2022 were retrieved from the Web of Science Core Collection. Relevant countries, institutions, authors, journals, keywords, and references were analyzed bibliometrically using Microsoft Excel 2021, bibliometric platform, VOSviewer, and CiteSpace.
Results: A total of 898 articles from 46 countries were published in 324 journals, and they were contributed by 4455 authors from 1102 institutions. The most influential country and institution are China (n = 445) and Kyung Hee University (n = 63), respectively. Fang JQ (n = 27) and Evidence-Based Complementary and Alternative Medicine (n = 63) are the author and journal with the most publications in this field. The clinical efficacy, molecular biological mechanisms and safety of CAT for NP are currently hot directions. Low back pain, postherpetic neuralgia, acupuncture, and herbal are the hot topics in CAT and NP in recent years.
Conclusion: This study reveals the current status and hotspots of CAT for NP. The study also indicates that the effectiveness and effect mechanism of acupuncture or herbs for treating emotional problems caused by low back pain or postherpetic neuralgia may be a trend for future research.
China is increasingly dominating SCAM research and we all know – or should know by now (see above) – that the results of this research are misleading. I cannot understand why so few people seem to think this is alarming.
Whenever a journalist wants to discuss the subject of acupuncture with me, he or she will inevitably ask one question:
DOES ACUPUNCTURE WORK?
It seems a legitimate, obvious and simple question, particularly during ‘Acupuncture Awareness Week‘, and I have heard it hundreds of times. Why then do I hesitate to answer it?
Journalists – like most of us – would like a straight answer, like YES or NO. But straight answers are in short supply, particularly when we are talking about acupuncture.
Let me explain.
Acupuncture is part of ‘Traditional Chinese Medicine’ (TCM). It is said to re-balance the life forces that determine our health. As such it is seen as a panacea, a treatment for all ills. Therefore, the question, does it work?, ought to be more specific: does it work for pain, obesity, fatigue, hair-loss, addiction, anxiety, ADHA, depression, asthma, old age, etc.etc. As we are dealing with virtually thousands of ills, the question, does it work?, quickly explodes into thousands of more specific questions.
But that’s not all!
The question, does acupuncture work?, assumes that we are talking about one therapy. Yet, there are dozens of different acupuncture traditions and sites:
- body acupuncture,
- ear acupuncture,
- tongue acupuncture,
- scalp acupuncture,
- etc., etc.
Then there are dozens of different ways to stimulate acupuncture points:
- needle acupuncture,
- electroacupuncture,
- acupressure,
- moxibustion,
- ultrasound acupuncture,
- laser acupuncture,
- etc., etc.
And then there are, of course, different acupuncture ‘philosophies’ or cultures:
- TCM,
- ‘Western’ acupuncture,
- Korean acupuncture,
- Japanese acupuncture,
- etc., etc.
If we multiply these different options, we surely arrive at thousands of different variations of acupuncture being used for thousands of different conditions.
But this is still not all!
To answer the question, does it work?, we today have easily around 10 000 clinical trials. One might therefore think that, despite the mentioned complexity, we might find several conclusive answers for the more specific questions. But there are very significant obstacles that are in our way:
- most acupuncture trials are of lousy quality;
- most were conducted by lousy researchers who merely aim at showing that acupuncture works rather that testing whether it is effective;
- most originate from China and are published in Chinese which means that most of us cannot access them;
- they get nevertheless included in many of the systematic reviews that are currently being published without non-Chinese speakers ever being able to scrutinise them;
- TCM is a hugely important export article for China which means that political influence is abundant;
- several investigators have noted that virtually 100% of Chinese acupuncture trials report positive results regardless of the condition that is being targeted;
- it has been reported that about 80% of studies emerging from China are fabricated.
Now, I think you understand why I hesitate every time a journalist asks me:
DOES ACUPUNCTURE WORK?
Most journalists do not have the patience to listen to all the complexity this question evokes. Many do not have the intellectual capacity to comprehend an exhaustive reply. But all want to hear a simple and conclusive answer.
So, what do I say in this situation?
Usually, I respond that the answer would depend on who one asks. An acupuncturist is likely to say: YES, OF COURSE, IT DOES! An less biased expert might reply:
IT’S COMPLEX, BUT THE MOST RELIABLE EVIDENCE IS FAR FROM CONVINCING.
The origin of coronavirus 2 (SARS-CoV-2) has been the subject of intense speculation and several conspiracy theories, not least amongst the enthusiasts of so-called alternative medicine. Now Australian scientists have attempted to identify the origin of the coronavirus 2 (SARS-CoV-2). As this is undoubtedly a most sensitive subject, let me show you the unadulterated abstract of their paper:
The origin of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is contentious. Most studies have focused on a zoonotic origin, but definitive evidence such as an intermediary animal host is lacking. We used an established risk analysis tool for differentiating natural and unnatural epidemics, the modified Grunow–Finke assessment tool (mGFT) to study the origin of SARS-COV-2. The mGFT scores 11 criteria to provide a likelihood of natural or unnatural origin. Using published literature and publicly available sources of information, we applied the mGFT to the origin of SARS-CoV-2. The mGFT scored 41/60 points (68%), with high inter-rater reliability (100%), indicating a greater likelihood of an unnatural than natural origin of SARS-CoV-2. This risk assessment cannot prove the origin of SARS-CoV-2 but shows that the possibility of a laboratory origin cannot be easily dismissed.
The somewhat clumsy wording harbours explosive potential. It is more likely that the pandemic was started by a laboratory accident than by a zoonosis. In this case, it would be man-made rather than natural. The authors of the paper do, however, caution that their analysis does not prove the origin of the coronavirus. They merely speak of likelihoods. Moreover, it seems important to stress that there is no scientific evidence that Sars-CoV-2 was deliberately developed as a biological warfare agent.
Will this paper put an end to speculation and conspiracy?
I doubt it!
There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.
A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.
43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).
The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.
Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:
- 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
- 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
- 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
- 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
- 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
Sadly, this assumption is evidently mistaken.
The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.
The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.
Clinical trials should be about contributing to our knowledge and not about contributing to confusion.
Motor aphasia is common among patients with stroke. Acupuncture is recommended by TCM enthusiasts as a so-called alternative medicine (SCAM) for poststroke aphasia, but its efficacy remains uncertain.
JAMA just published a study that investigated the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.
The study was designed as a multicenter, sham-controlled, randomized clinical trial. It was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.
Eligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.
The primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale–39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.
Among 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.
The authors concluded that in this randomized clinical trial, patients with poststroke motor
aphasia who received 6 weeks of MA compared with those who received SA demonstrated
statistically significant improvements in language function, quality of life, and neurological
impairment from week 6 of treatment to the end of follow-up at 6 months after onset.
I was asked by the SCIENCE MEDIC CENTRE to provide a short comment. This is what I stated:
Superficially, this looks like a rigorous trial. We should remember, however, that several groups, including mine, have shown that very nearly all Chinese acupuncture studies report positive results. This suggests that the reliability of these trials is less than encouraging. Moreover, the authors state that real acupuncture induced ‘de chi’, while sham acupuncture did not. This shows that the patients were not blinded and the outcomes might easily be due to a placebo response.
Here, I’d like to add two further points:
- We have learnt that the vast majority of research coming out of China is fabricated.
- I think it is lamentable that a journal of high standing is not more critical and repeatedly falls for such suspect acupuncture studies.
This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.
Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.
Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.
The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.
Tongxinluo is mixture of various active ingredients, including
- ginseng,
- leech,
- scorpion,
- Paeonia lactiflora,
- cicada slough,
- woodlouse bug,
- centipede,
- sandalwood.
With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.
Tongxinluo is by no means a mixture that has not been studied before.
A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.
A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.
A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.
Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.
So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.
Let’s not forget:
if it sound too good to be true, it probably is!
This systematic review aimed to assess the impact of Tai Chi on individuals with essential hypertension and to compare the effects of Tai Chi with other therapies. The researchers conducted a systematic literature search of the Medline, Scholar, Elsevier, Wiley Online Library, Chinese Academic Journal (CNKI) and Wanfang databases from January 2003 to August 2023. Using the methods of the Cochrane Collaboration Handbook, a meta-analysis was conducted to assess the collective impact of Tai Chi exercise in controlling hypertension. The primary outcomes measured included blood pressure and nitric oxide levels.
A total of 32 RCTs were included. The participants consisted of adults with an average age of 57.1 years who had hypertension (mean ± standard deviation systolic blood pressure at 148.2 ± 12.1 mmHg and diastolic blood pressure at 89.2 ± 8.3 mmHg). Individuals who practiced Tai Chi experienced reductions in systolic blood pressure of 10.6 mmHg, diastolic blood pressure of 4.7 mmHg and an increase in nitric oxide levels.
The authors concluded that Tai Chi can be a viable lifestyle intervention for managing hypertension. Greater promotion of Tai Chi by medical professionals could extend these benefits to a larger patient population.
Tai Chi allegedly incorporates principles rooted in the Yin and Yang theory, Chinese medicine meridians and breathing techniques, and creates a unique form of exercise characterized by its inward focus, continuous flow, the balance of strength and gentleness, and alternation between fast and slow movements. What sets Tai Chi apart from other forms of excercise is the requirement for mindful guidance during practice. This aspect may, according to the authors, be the reason why Tai Chi also outperforms general aerobic exercise in managing hypertension.
I can well imagine that any form of relaxation reduces blood pressure. What I find hard to believe is that Tai Chi is better than any other relaxing SCAMs. The 32 RCTs included in this new review fail to impress me because they are all from China, and – as we have often mentioned before – studies from China are to be taken with a pinch of salt.
Yet, the subject is important enough, in my view, to merit a few rigorous trials conducted by independent researchers. Until such data are available, I think, I prefer to rely on our own systematic review which conculded that the evidence for tai chi in reducing blood pressure … is limited. Whether tai chi has benefits over exercise is still unclear. The number of trials and the total sample size are too small to draw any firm conclusions.
Manual therapy is considered a safe and less painful method and has been increasingly used to alleviate chronic neck pain. However, there is controversy about the effectiveness of manipulation therapy on chronic neck pain. Therefore, this systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to determine the effectiveness of manipulative therapy for chronic neck pain.
A search of the literature was conducted on seven databases (PubMed, Cochrane Center Register of Controlled Trials, Embase, Medline, CNKI, WanFang, and SinoMed) from the establishment of the databases to May 2022. The review included RCTs on chronic neck pain managed with manipulative therapy compared with sham, exercise, and other physical therapies. The retrieved records were independently reviewed by two researchers. Further, the methodological quality was evaluated using the PEDro scale. All statistical analyses were performed using RevMan V.5.3 software. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment was used to evaluate the quality of the study results.
Seventeen RCTs, including 1190 participants, were included in this meta-analysis. Manipulative therapy showed better results regarding pain intensity and neck disability than the control group. Manipulative therapy was shown to relieve pain intensity (SMD = -0.83; 95% confidence interval [CI] = [-1.04 to -0.62]; p < 0.0001) and neck disability (MD = -3.65; 95% CI = [-5.67 to – 1.62]; p = 0.004). However, the studies had high heterogeneity, which could be explained by the type and control interventions. In addition, there were no significant differences in adverse events between the intervention and the control groups.
The authors concluded that manipulative therapy reduces the degree of chronic neck pain and neck disabilities.
Only a few days ago, we discussed another systematic review that drew quite a different conclusion: there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
How can this be?
Systematic reviews are supposed to generate reliable evidence!
How can we explain the contradiction?
There are several differences between the two papers:
- One was published in a SCAM journal and the other one in a mainstream medical journal.
- One was authored by Chinese researchers, the other one by an international team.
- One included 17, the other one 23 RCTs.
- One assessed ‘manual/manipulative therapies’, the other one spinal manipulation/mobilization.
The most profound difference is that the review by the Chinese authors is mostly on Chimese massage [tuina], while the other paper is on chiropractic or osteopathic spinal manipulation/mobilization. A look at the Chinese authors’ affiliation is revealing:
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China.
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
What lesson can we learn from this confusion?
Perhaps that Tuina is effective for neck pain?
No!
What the abstract does not tell us is that the Tuina studies are of such poor quality that the conclusions drawn by the Chinese authors are not justified.
What we do learn – yet again – is that
- Chinese papers need to be taken with a large pintch of salt. In the present case, the searches underpinning the review and the evaluations of the included primary studies were clearly poorly conducted.
- Rubbish journals publish rubbish papers. How could the reviewers and the editors have missed the many flaws of this paper? The answer seems to be that they did not care. SCAM journals tend to publish any nonsense as long as the conclusion is positive.
