Chinese studies
Two years ago, I reported about an acupuncture review that was, in my view, a fairly clear case of scientific misconduct. To remind you, here is my from 22/11/22 about it:
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 – 2 years later! – the journal (BMJ-Open) has retracted the article and posted the following notice about the decision:
BMJ Open has retracted this article.1 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.
I am delighted that this misleading paper is now officially discredited. Yet, I do have some concerns:
WHY DOES IT TAKE 2 YEARS TO IDENTIFY SOMETHING AS FRAUDULENT RUBBISH, WHEN IT TOOK ME ALL OF ~30 MINUTES?
Instead of just insisting on a triumphant ‘I TOLD YOU SO’, let me provide some constructive advice to reviewers and journal editors.
- Many journal editors are to lazy to find reviewers themselves and ask the submitting author to name a few. Having myself published in the BMJ Open (the journal that published the paper in question) I fear that this might have been the case in the present instance. This habit invites poor reviews, e.g. reviews from colleagues who owe a favour to the submitting authors. It does not promote objective reviews and should be abandonned.
- Papers on acupuncture originating from China (as the one in question) are very likely to be biased (or worse), as we have so often discussed on this blog. Editors should be extra careful with such submissions.
- Reviewers who have in the past overlooked obvious flaws in a paper should be banned from further reviewing in future.
- Editors should understand the reviewers’ comments only as guidelines and still have an obligation to check the actual submissions themselves. the responsibility for publishing an article lies with them alone.
- Editors who repeatedly make such mistakes should be dismissed.
I think that adhering to these suggestions might improve the quality of published research … and, by Jove, this would be badly needed in the realm of so-called alternative medicine!!!
In China, acupuncture has been employed as an adjunctive therapy for coronavirus disease 2019 (COVID-19). Press needle acupuncture is a special type of acupuncture that provides prolonged stimulation to acupuncture points. This study assessed the effectiveness of integrating press needles alongside pharmacologic treatment in patients with mild-to-moderate COVID-19.
Patients hospitalized with mild-to-moderate COVID-19 symptoms between December 2022 and January 2023 were included in the study. The enrolled patients were randomly assigned to receive:
- pharmacologic treatment alone (control group),
- or both pharmacologic treatment and press needle acupuncture (intervention group).
Patients were evaluated for clinical outcomes, including symptom scores, deterioration rates, fever durations, and nucleic acid test results. The patients’ complete blood count and C-reactive protein levels were also analyzed using venous blood samples both before and after treatment.
Both groups exhibited a reduction in clinical symptom scores, but symptoms regressed faster in the intervention group. Nucleic acid test negativity was achieved faster in the intervention group than in the control group. The intervention group also had a lower deterioration rate. Furthermore, the increase in the lymphocyte count and decrease in C-reactive protein levels following treatment were more pronounced in the intervention group than in the control group.
The authors concluded that this study suggests that utilizing press needle acupuncture as an adjunct to pharmacologic treatment can be effective in patients with mild-to-moderate COVID-19 symptoms.
To understand this study better, we need to comprehend the nature of the therapeutic ritual. This is how the authors describe it:
For each session, press needles were inserted into acupoints and kept in place for approximately 24 hours. Only 1 side of the body (left or right) was treated in each session. The following day, press needles were removed from 1 side of the body, and new press needles were placed on acupoints on the other side of the body. Press needle acupuncture was performed by a qualified physician who had completed comprehensive acupuncture training. By contrast, patients in the control group solely received daily pharmacologic treatment, such as Lianhua Qingwen granules, with ibuprofen added as needed for fever management. Study participants were instructed to notify researchers of the appearance of clinical symptoms, and they were prohibited from participating in other studies during the trial period.
So, neither the patients nor the therapists were blinded. To call such a study “single-blind” is a bit odd! And are we really supposed to assume that the verum therapy did not generate placebo effects?
What we have here, I fear, is a classic example of a study designed such that it cannot possibly produce a negative result. It followed the A+B versus B design and employed a treatment that is bound to generate a sizable placebo response. What is even worse, the authors do discuss the limitations of their study but ignore the ‘elefant in the room’: ” this study had several limitations. The sample size was modest, and basic randomization was used without stratification based on comorbidities, which could have introduced bias.”
What do we call a study that cannot possibly produce a negative result?
- A waste of resources?
- Fraud?
- Misleading?
- Naive?
- Unethical?
I leave the answer to you.
The Canadian Kwantlen Polytechnic University (KPU) has announced that it will launch Canada’s first bachelor’s degree in Traditional Chinese Medicine (TCM). Greenlit by the B.C. government to fill what it calls rising demand in the labour market, the new program marks a major step in Canadian recognition of TCM. However, skeptics of TCM and other so-called alternative medicine (SCAM) remain wary of movement in this direction.
TCM is regulated in British Columbia, Alberta, Quebec, Ontario and Newfoundland and Labrador, with more than 7,000 licensed practitioners working in these provinces.
John Yang has worked for nearly a decade toward KPU’s bachelor’s degree, which will welcome its inaugural cohort starting September 2025. As chair of KPU’s TCM program, he hopes the new offering will boost its acceptance and encourage more integration with the Canadian health-care system. “The degree program can let the public [feel] more confident that we can train highly qualified TCM practitioners. Then there will be more mainstream public acceptance,” he said. “Currently we are not there yet, but I hope in the future there’s an integrated model.”
The degree will add topic areas like herbology and more advanced TCM approaches to the current diploma’s acupuncture-focused study, as well as courses in health sciences, arts and humanities, ethics and working with conventional health practitioners, says Sharmen Lee, dean of the B.C. school’s faculty of health. “You’re getting a much broader, deeper education that allows you to develop additional competencies, such as being able to critically think, to evaluate and participate in research, and all of those other things that a university-based education can provide.” Lee believes future graduates will be able to work alongside with biomedical professionals, with some becoming researchers as well — able to pursue post-grad studies abroad. “They start to understand the fundamentals of conducting research, of reviewing published studies and then … to critically analyze what that means so that they can apply that to their practice,” Lee said. “It’s going to help to elevate the practice of traditional Chinese medicine … in our province.”
With the World Health Organization (WHO) encouraging governments toward integrating traditional and complementary medicine into their health-care systems, there’s a need for researchers to develop strong evidence to guide policy-makers, says Nadine Ijaz, an assistant professor at Carleton University in Ottawa and president of the International Society for Traditional, Complementary and Integrative Medicine Research. “Most Canadians at some point in their lifetime are using some form of what we call traditional and complementary medicine: that might be acupuncture, chiropractic, massage therapy, vitamins, yoga … people who are participating in Indigenous healing ceremonies within their own communities,” she said. “How are governments to make good determinations about what to include? What is rigorous? What is safe? What is effective and what is cost effective, in addition to what is culturally appropriate?”
More research and scientific inquiry is a good thing, but it depends on the type of research, says Jonathan Jarry, a science communicator for the McGill Office of Science and Society and co-host of the health and medicine podcast Body of Evidence. Jarry said many studies on SCAM are low quality: too few participants, too short in duration, lacking follow-up or a proper control group. It’s an issue that plagues research on conventional therapies too, he acknowledged. “I’m all for doing research on things that are plausible enough that they could realistically have a benefit, but then you have to also do very good, rigorous studies. Otherwise you’re just creating noise in the research literature.”
Ijaz and a group of colleagues around the globe are working toward determining strong research parameters without forcing alternative approaches “into a box where they don’t fit.” For instance, a randomized controlled trial is the gold standard of research in biomedicine and excellent for studying pharmaceutical drugs and their effects, because participants in the control group get a placebo, perhaps a sugar pill, that means they can’t tell if they’re being treated with medication or not. But it doesn’t work for studying acupuncture treatment, chiropractic or even psychotherapy, Ijaz pointed out. “If you’re getting an acupuncture treatment, you usually know that you’re getting a treatment…. It’s a little bit challenging to develop a placebo control for for those approaches,” said Ijaz. “When we apply that particular gold standard to researching all therapeutic approaches … it sort of privileges the issue in favour of pharmaceutical drugs immediately.”
“A randomized controlled trial is the gold standard of research in biomedicine and excellent for studying pharmaceutical drugs … but it doesn’t work for studying acupuncture treatment, chiropractic or even psychotherapy.” When I hear nonsensical drivel like this, I know what to think of a university course led or influenced by people who believe this stuff. They should themselves go on a course of research methodology for beginners rather that try brainwashing naive students into believing falsehoods.
This study evaluated the effects of acupuncture and/or nicotine patches on smoking cessation. Eighty-eight participants were randomly allocated into four groups:
- acupuncture combined with nicotine patch (ACNP),
- acupuncture combined with sham nicotine patch (ACSNP),
- sham acupuncture combined with nicotine patch (SACNP),
- sham acupuncture combined with sham nicotine patch (SACSNP).
The primary outcome was self-reported smoking abstinence verified with expiratory Carbon Monoxide (CO) after 8 weeks of treatment. The modified Fagerstrom Test for Nicotine Dependence (FTND) score, Minnesota Nicotine Withdrawal Scale (MNWS), and the Brief Questionnaire of Smoking Urge (QSU-Brief) score were used as secondary indicators. SPSS 26.0 and Prism 9 software were used for statistical analyses.
Seventy-eight participants completed the study. There were no significant differences in patient characteristics at baseline across the four groups. At the end of treatment, there was a statistically significant difference (χ2 = 8.492, p = 0.037) in abstaining rates among the four groups favoring acupuncture combined with nicotine replacement patch. However, there were no significant differences in the reduction in the number of cigarettes smoked daily (p = 0.111), expiratory CO (p = 0.071), FTND score (p = 0.313), and MNWS score (p = 0.088) among the four groups. There was a statistically significant difference in QUS-Brief score changes among the four groups (p = 0.005). There was no statistically significant interaction between acupuncture and nicotine patch.
The authors concluded that acupuncture combined with nicotine replacement patch therapy was more effective for smoking cessation than acupuncture alone or nicotine replacement patch alone. No adverse reactions were found in the acupuncture treatment process.
Let’s look at this trial a little closer. The authors reveal that “the sham acupuncture targeted corresponding shoulder, eye, knee, and elbow acupoints on the auricle that are unrelated to smoking cessation”. Thus, the therapists were not ‘blind’ (the authers nevertheless call their study a double-blind trial which is confusing). This means that the acupuncturists (who had a vested interest in the trial generating positive results) had plenty of opportunity to influence the trial participants via verbal and non-verbal communication. In turn, this means that the observed positive outcome might be due to this influence rather than any postulated effect of acupuncture.
But there is a further caveat: the study originates from China. The researchers come from:
- 1Hospital Infection-Control Department, Xi‘an Aerospace General Hospital, Xi’an, Shaanxi, China
- 2School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
- 3Department of Psychosomatic and Sleep Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
- 4Library, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
- 5School of Acupuncture and Tuina, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
- 6Department of Chinese Medicine, Health Center of Hekou Town, Lanzhou, Gansu, China
As we have discussed ad nauseam on this blog, Chinese researchers as good as never publish a negative study of acupuncture.
Enough reason not to take this study seriously?
Yes, I think so.
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”.
_________________________
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.
____________________________
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.
