Chinese studies

JAMA just published another truly awful acupuncture study

Published Tuesday 03 January 2023

This pilot study tested the feasibility of using US Food and Drug Administration (FDA)–recommended endpoints to evaluate the efficacy of acupuncture in the treatment of IBS. It was designed as a multicenter randomized clinical trial, conducted in 4 tertiary hospitals in China from July 1, 2020, to March 31, 2021, and 14-week data collection was completed in March 2021. Individuals with a diagnosis of IBS with diarrhea (IBS-D) were randomized to 1 of 3 groups:

acupuncture groups 1 (using specific acupoints [SA])
acupuncture group 2 (using nonspecific acupoints [NSA])
sham acupuncture group (non-acupoints [NA])

Patients in all groups received twelve 30-minute sessions over 4 consecutive weeks at 3 sessions per week, ideally every other day.

The primary outcome was the response rate at week 4, which was defined as the proportion of patients whose worst abdominal pain score (score range, 0-10, with 0 indicating no pain and 10 indicating unbearable severe pain) decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater.

Ninety patients (54 male [60.0%]; mean [SD] age, 34.5 [11.3] years) were enrolled, with 30 patients in each group. There were substantial improvements in the primary outcomes for all groups

response rates in the SA group = 46.7% [95% CI, 28.8%-65.4%]
response rate in the NSA group = 46.7% [95% CI, 28.8%-65.4%]
response rate in the NA group = 26.7% [95% CI, 13.0%-46.2%]

The difference between the groups was not statistically significant (P = .18). The response rates of adequate relief at week 4 were 64.3% (95% CI, 44.1%-80.7%) in the SA group, 62.1% (95% CI, 42.4%-78.7%) in the NSA group, and 55.2% (95% CI, 36.0%-73.0%) in the NA group (P = .76). Adverse events were reported in 2 patients (6.7%) in the SA group and 3 patients (10%) in NSA or NA group.

The authors concluded that acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups. These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy.

WHAT A LOAD OF TOSH!

Here are some of the most obvious issues I have with this new study:

A pilot study is not about reporting effectiveness/efficacy but about testing the feasibility of a study.
That acupuncture is feasible has been known for ~2000 years.
The conclusion that acupuncture is safe is not warranted on the basis of the data; for that we would need a much larger investigation.
The authors seem to have used our sham needle without acknowledging it.
The authors are affiliated with the International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, yet they state that they have no conflicts of interest.
The results are clearly negative, yet the authors seem to attempt to draw a positive conclusion.

The main question that occurs to me is this: how low has the JAMA sunk to publish such junk?

Posted in acupuncture, alternative medicine, bias, bogus claims, bullshit, Chinese studies, conflict of interest, critical thinking, evidence, fraud, gullible consumer, IBS, medical ethics, methodology, pseudo-science, quackery, symptom-relief, TCM | 5 Comments

WORST PAPER OF 2022 COMPETITION, entry No 9: How to improve traditional Chinese medicine learning internationally

Published Tuesday 06 December 2022

Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. As a prize, I am offering the winner (that is the lead author of the winning paper) one of my books that best fits his/her subject. I am sure this will overjoy him or her. I hope to identify about 10 candidates for the prize, and towards the end of the year, I let my readers decide democratically on who should be the winner. In this spirit of democratic voting, let me suggest to you entry No 9. Here is the unadulterated abstract:

Background

With the increasing popularity of traditional Chinese medicine (TCM) by the global community, how to teach basic knowledge of TCM to international students and improve the teaching quality are important issues for teachers of TCM. The present study was to analyze the perceptions from both students and teachers on how to improve TCM learning internationally.

Methods

A cross-sectional national survey was conducted at 23 universities/colleges across China. A structured, self-reported on-line questionnaire was administered to 34 Chinese teachers who taught TCM course in English and to 1016 international undergraduates who were enrolled in the TCM course in China between 2017 and 2021.

Results

Thirty-three (97.1%) teachers and 900 (88.6%) undergraduates agreed Chinese culture should be fully integrated into TCM courses. All teachers and 944 (92.9%) undergraduates thought that TCM had important significance in the clinical practice. All teachers and 995 (97.9%) undergraduates agreed that modern research of TCM is valuable. Thirty-three (97.1%) teachers and 959 (94.4%) undergraduates thought comparing traditional medicine in different countries with TCM can help the students better understand TCM. Thirty-two (94.1%) teachers and 962 (94.7%) undergraduates agreed on the use of practical teaching method with case reports. From the perceptions of the undergraduates, the top three beneficial learning styles were practice (34.3%), teacher’s lectures (32.5%), case studies (10.4%). The first choice of learning mode was attending to face-to-face teaching (82.3%). The top three interesting contents were acupuncture (75.5%), Chinese herbal medicine (63.8%), and massage (55.0%).

Conclusion

To improve TCM learning among international undergraduates majoring in conventional medicine, integration of Chinese culture into TCM course, comparison of traditional medicine in different countries with TCM, application of the teaching method with case reports, and emphasization of clinical practice as well as modern research on TCM should be fully considered.

I am impressed with this paper mainly because to me it does not make any sense at all. To be blunt, I find it farcically nonsensical. What precisely? Everything:

the research question,
the methodology,
the conclusion
the write-up,
the list of authors and their affiliations: Department of Chinese Integrative Medicine, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China, Department of Traditional Chinese Medicine, School of Basic Medicine, Qingdao University, Qingdao, China, Department of Chinese Integrative Medicine, The Second Affiliated Hospital of Kunming Medical University, Kunming, China, Department of Traditional Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China, Department of Traditional Chinese Medicine, Medical College, China Three Gorges University, Yichang, China, Basic Teaching and Research Department of Acupuncture and Moxibustion, College of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi, China, Institute of Integrative Medicine, Dalian Medical University, Dalian, China, Department of Chinese and Western Medicine, Chongqing Medical University, Chongqing, China, Department of Chinese and Western Medicine, North Sichuan Medical College, Nanchong, China, Department of Chinese and Western Medicine, School of Medicine, Xiamen University, Xiamen, China, School of Traditional Chinese Medicine, Capital Medical University, Beijing, China, School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China, Department of Traditional Chinese Medicine, The First Affiliated Hospital of Soochow University, Suzhou, China, Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen, China, Department of Chinese Medicine/Department of Chinese Integrative Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei, China, Department of Traditional Chinese Medicine, Shengjing Hospital Affiliated to China Medical University, Shenyang, China, Department of Acupuncture, Affiliated Hospital of Jiangsu University, Zhenjiang, China, Teaching and Research Section of Traditional Chinese Medicine, The Second Affiliated Hospital of Soochow University, Suzhou, China, Department of Traditional Chinese Medicine, The Second Affiliated Hospital of Harbin Medical University, Harbin, China, Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei, China, Department of Chinese Medicine, The First Affiliated Hospital of Kunming Medical University, Kunming, China, Department of Traditional Chinese Medicine, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China, Department of Chinese Medicine, The First Affiliated Hospital of Jinzhou Medicine University, Jinzhou, China, Department of Integrated Traditional and Western Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin, China, Department of Chinese Medicine, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, Department of Traditional Chinese Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
the journal that had this paper peer-reviewed and published.

But what impressed me most with this paper is the way the authors managed to avoid even the slightest hint of critical thinking. They even included a short paragraph in the discussion section where they elaborate on the limitations of their work without ever discussing the true flaws in the conception and execution of this extraordinary example of pseudoscience.

Posted in alternative medicine, alternative therapist, bias, bullshit, charlatan, Chinese studies, commercial interests, conflict of interest, critical thinking, education, malpractice, medical ethics, politics, pseudo-science, quackery, satire, study design, survey, TCM | 1 Comment

Dire news for acupuncture fans

Published Monday 05 December 2022

Is acupuncture more than a theatrical placebo? Acupuncture fans are convinced that the answer to this question is YES. Perhaps this paper will make them think again.

A new analysis mapped the systematic reviews, conclusions, and certainty or quality of evidence for outcomes of acupuncture as a treatment for adult health conditions. Computerized search of PubMed and 4 other databases from 2013 to 2021. Systematic reviews of acupuncture (whole body, auricular, or electroacupuncture) for adult health conditions that formally rated the certainty, quality, or strength of evidence for conclusions. Studies of acupressure, fire acupuncture, laser acupuncture, or traditional Chinese medicine without mention of acupuncture were excluded. Health condition, number of included studies, type of acupuncture, type of comparison group, conclusions, and certainty or quality of evidence. Reviews with at least 1 conclusion rated as high-certainty evidence, reviews with at least 1 conclusion rated as moderate-certainty evidence and reviews with all conclusions rated as low- or very low-certainty evidence; full list of all conclusions and certainty of evidence.

A total of 434 systematic reviews of acupuncture for adult health conditions were found; of these, 127 reviews used a formal method to rate the certainty or quality of evidence of their conclusions, and 82 reviews were mapped, covering 56 health conditions. Across these, there were 4 conclusions that were rated as high-certainty evidence and 31 conclusions that were rated as moderate-certainty evidence. All remaining conclusions (>60) were rated as low- or very low-certainty evidence. Approximately 10% of conclusions rated as high or moderate-certainty were that acupuncture was no better than the comparator treatment, and approximately 75% of high- or moderate-certainty evidence conclusions were about acupuncture compared with a sham or no treatment.

Three evidence maps (pain, mental conditions, and other conditions) are shown below

The authors concluded that despite a vast number of randomized trials, systematic reviews of acupuncture for adult health conditions have rated only a minority of conclusions as high- or moderate-certainty evidence, and most of these were about comparisons with sham treatment or had conclusions of no benefit of acupuncture. Conclusions with moderate or high-certainty evidence that acupuncture is superior to other active therapies were rare.

These findings are sobering for those who had hoped that acupuncture might be effective for a range of conditions. Despite the fact that, during recent years, there have been numerous systematic reviews, the evidence remains negative or flimsy. As 34 reviews originate from China, and as we know about the notorious unreliability of Chinese acupuncture research, this overall result is probably even more negative than the authors make it out to be.

Considering such findings, some people (including the authors of this analysis) feel that we now need more and better acupuncture trials. Yet I wonder whether this is the right approach. Would it not be better to call it a day, concede that acupuncture generates no or only relatively minor effects, and focus our efforts on more promising subjects?

Posted in acupuncture, alternative medicine, bias, Chinese studies, clinical trial, commercial interests, conflict of interest, critical thinking, evidence, fraud, medical ethics, methodology, pain, panacea, placebo, politics, progress, pseudo-science, quackery, risk/benefit, symptom-relief, TCM | 5 Comments

More compelling reasons for distrusting Chinese research papers

Published Saturday 03 December 2022

An international team of researchers described retracted papers originating from paper mills, including their characteristics, visibility, and impact over time, and the journals in which they were published. The term paper mill refers to for-profit organizations that engage in the large-scale production and sale of papers to researchers, academics, and students who wish to, or have to, publish in peer-reviewed journals. Many paper mill papers included fabricated data.

All paper mill papers retracted from 1 January 2004 to 26 June 2022 were included in the study. Papers bearing an expression of concern were excluded. Descriptive statistics were used to characterize the sample and analyze the trend of retracted paper mill papers over time, and to analyze their impact and visibility by reference to the number of citations received.

In total, 1182 retracted paper mill papers were identified. The publication of the first paper mill paper was in 2004 and the first retraction was in 2016; by 2021, paper mill retractions accounted for 772 (21.8%) of the 3544 total retractions. Overall, retracted paper mill papers were mostly published in journals of the second highest Journal Citation Reports quartile for impact factor (n=529 (44.8%)) and listed four to six authors (n=602 (50.9%)). Of the 1182 papers, almost all listed authors of 1143 (96.8%) paper mill retractions came from Chinese institutions, and 909 (76.9%) listed a hospital as a primary affiliation. 15 journals accounted for 812 (68.7%) of 1182 paper mill retractions, with one journal accounting for 166 (14.0%). Nearly all (n=1083, 93.8%) paper mill retractions had received at least one citation since publication, with a median of 11 (interquartile range 5-22) citations received.

The authors concluded that papers retracted originating from paper mills are increasing in frequency, posing a problem for the research community. Retracted paper mill papers most commonly originated from China and were published in a small number of journals. Nevertheless, detected paper mill papers might be substantially different from those that are not detected. New mechanisms are needed to identify and avoid this relatively new type of misconduct.

China encourages its researchers to publish papers in return for money and career promotions. Furthermore, medical students at Chinese universities are required to produce a scientific paper in order to graduate. Paper mills openly advertise their services on the Internet and maintain a presence on university campuses. The authors of this analysis reference another recent article (authored by two Chinese researchers) that throws more light on the problem:

This study used data from the Retraction Watch website and from published reports on retractions and paper mills to summarize key features of research misconduct in China. Compared with publicized cases of falsified or fabricated data by authors from other countries of the world, the number of Chinese academics exposed for research misconduct has increased dramatically in recent years. Chinese authors do not have to generate fake data or fake peer reviews for themselves because paper mills in China will do the work for them for a price. Major retractions of articles by authors from China were all announced by international publishers. In contrast, there are few reports of retractions announced by China’s domestic publishers. China’s publication requirements for physicians seeking promotions and its leniency toward research misconduct are two major factors promoting the boom of paper mills in China.

As the authors of the new analysis point out: “Fraudulent papers have negative consequences for the scientific community and the general public, engendering distrust in science, false claims of drug or device efficacy, and unjustified academic promotion, among other problems.” On this blog, I have often warned of research originating from China (some might even think that this is becoming an obsession of mine but I do truly think that this is very important). While such fraudulent papers may have a relatively small impact in many areas of healthcare, their influence in the realm of TCM (where the majority of research comes from China) is considerable. In other words, TCM research is infested by fraud to a degree that prevents drawing meaningful conclusions about the value of TCM treatments.

I feel strongly that it is high time for us to do something about this precarious situation. Otherwise, I fear that in the near future no respectable scientist will take TCM seriously.

Posted in acupuncture, alternative medicine, bias, bogus claims, charlatan, Chinese studies, commercial interests, conflict of interest, conspiracy, critical thinking, evidence, fraud, gullible consumer, herbal medicine, malpractice, medical ethics, politics, prevention, pseudo-science, quackery, research, risk, scientific misconduct | 14 Comments

A new acupuncture trial with a positive result – alas, it seems too good to be true

Published Tuesday 29 November 2022

Electroacupuncture (EA) is often advocated for depression and sleep disorders but its efficacy remains uncertain. The aim of this study was, therefore, to “assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression.”

A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive

EA treatment and standard care,
sham acupuncture (SA) treatment and standard care,
standard care only as control.

Patients in the EA or SA groups received a 30-minute treatment 3 times per week (usually every other day except Sunday) for 8 consecutive weeks. All treatments were performed by licensed acupuncturists with at least 5 years of clinical experience. A total of 6 acupuncturists (2 at each center; including X.Y. and S.Z.) performed EA and SA, and they received standardized training on the intervention method before the trial. The regular acupuncture method was applied at the Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), and SanYinjiao (SP6) acupuncture points, with 0.25 × 25-mm and 0.30 × 40-mm real needles (Wuxi Jiajian Medical Device Co, Ltd), or 0.30 × 30-mm sham needles (Streitberger sham device [Asia-med GmbH]).

For patients in the EA group, rotating or lifting-thrusting manipulation was applied for deqi sensation after needle insertion. The 2 electrodes of the electrostimulator (CMNS6-1 [Wuxi Jiajian Medical Device Co, Ltd]) were connected to the needles at GV20 and GV29, delivering a continuous wave based on the patient’s tolerance. Patients in the SA group felt a pricking sensation when the blunt needle tip touched the skin, but without needle insertion. All indicators of the nearby electrostimulator were set to 0, with the light switched on. Standard care (also known as treatment as usual or routine care) was used in the control group. Patients receiving standard care were recommended by the researchers to get regular exercise, eat a healthy diet, and manage their stress level during the trial. They were asked to keep the regular administration of antidepressants, sedatives, or hypnotics as well. Psychiatrists in the Shanghai Mental Health Center (including X.L.) guided all patients’ standard care treatment and provided professional advice when a patient’s condition changed.

The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score.

Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported.

The result of the blinding assessment showed that 56 patients (62.2%) in the SA group guessed wrongly about their group assignment (Bang blinding index, −0.4 [95% CI, −0.6 to −0.3]), whereas 15 (16.7%) in the EA group also guessed wrongly (Bang blinding index, 0.5 [95% CI, 0.4-0.7]). This indicated a relatively higher degree of blinding in the SA group.

The authors concluded that, in this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32.

This trial seems rigorous, it has a sizable sample size, uses a credible placebo procedure, and is reported in sufficient detail. Why then am I skeptical?

Perhaps because we have often discussed how untrustworthy acupuncture studies from China are?
Perhaps because I fail to see a plausible mechanism of action?
Perhaps because the acupuncturists could not be blinded and thus might have influenced the outcome?
Perhaps because the effects of sham acupuncture seem unreasonably small?
Perhaps because I cannot be sure whether the acupuncture or the electrical current is supposed to have caused the effects?
Perhaps because the authors of the study are from institutions such as the Shanghai Municipal Hospital of Traditional Chinese Medicine, the Department of Acupuncture and Moxibustion, Huadong Hospital, Fudan University, Shanghai,
Perhaps because the results seem too good to be true?

If you have other and better reasons, I’d be most interested to hear them.

Posted in acupuncture, alternative medicine, anxiety, bias, Chinese studies, clinical trial, conflict of interest, critical thinking, depression, fraud, insomnia, medical ethics, quackery, study design, symptom-relief, TCM | 1 Comment

Does regular tea consumption reduce the risk of diabetes?

Published Tuesday 20 September 2022

Even though most people do not think about it in this way, tea is a herbal remedy. We know that it is pleasant, but is it also effective?

This study explored the associations between tea drinking and the incident risk of type 2 diabetes mellitus(T2 DM). A dynamic prospective cohort study among a total of 27 841 diabetes-free permanent adult residents randomly selected from 2, 6, and 7 rural communities between 2006-2008, 2011-2012, and 2013-2014, respectively. Questionnaire survey, physical examination, and laboratory test were carried out among the participants. In 2018, the researchers conducted a follow-up through the electronic health records of residents. Cox regression models were applied to explore the association between tea drinking and the incident risk of T2 DM and estimate the hazard ratio(HR), and its 95%CI.

Among the 27 841 rural community residents in Deqing County, 10 726(39%) were tea drinkers, 8215 (77%) of which were green tea drinkers. A total of 883 new T2 DM incidents were identified until December 31, 2018, and the incidence density was 4.43 per 1000 person-years (PYs). The incidence density was 4.07/1000 PYs in those with tea drinking habits and 4.71/1000 PYs in those without tea drinking habits. The incidence density was 3.79/1000 PYs in those with green tea drinking habits. After controlling for sex, age, education, farming, smoking, alcohol consumption, dietary preference, body mass index, hypertension, impaired fasting glucose, and family history of diabetes, the risk of T2 DM among rural residents with tea drinking habits was 0.79 times higher than that among residents without tea drinking habits(HR=0.79, 95%CI 0.65-0.96), and the risk of T2 DM among residents with green tea drinking habits was 0.72 times higher than that among residents without tea drinking habits(HR=0.72, 95%CI 0.58-0.89). No significant associations were found between other kinds of tea and the risk of T2 DM, nor the amount of green tea-drinking.

The authors concluded that drinking green tea may reduce the risk of T2 DM among adult population in rural China.

Epidemiological studies of this nature resemble big fishing expeditions that can bring up all sorts of rubbish and – if lucky – also some fish. The question thus is whether this study identified an interesting association or just some odd rubbish.

A quick look into Medline seems to suggest great caution. Here are the conclusions from a few further case-control studies:

Thus the question of whether tea drinking might prevent diabetes remains open, in my view.

Yet, the paper might teach us two important lessons:

Case-control studies must be taken with a pinch of salt.
Correlation is not the same as causation.

Posted in alternative medicine, antioxidants, case-control study, causation, Chinese studies, critical thinking, diabetes, diet, evidence, herbal medicine, naturopathy, prevention, study design | 1 Comment

The ‘WORST PAPER OF 2022 COMPETITION’ entry No 8: Acupuncture for the Treatment of Female Sexual Dysfunction

Published Tuesday 13 September 2022

Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. As a competition without a prize is no fun, I am offering the winner (that is the lead author of the winning paper) one of my books that best fits his/her subject. I am sure this will overjoy him or her.

And how do we identify the winner? I will continue blogging about nominated papers (I hope to identify about 10 in total), and towards the end of the year, I let my readers decide democratically.

In this spirit of democratic voting, let me suggest to you ENTRY No 8 (it is so impressive that I must show you the unadulterated abstract):

Introduction

Female sexual dysfunction (FSD) seriously affects the quality of life of women. However, most women do not have access to effective treatment.

Aim

This study aimed to determine the feasibility and effectiveness of the use of acupuncture in FSD treatment based on existing clear acupuncture protocol and experience-supported face-to-face therapy.