TCM
This study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.
The authors selected from a United States (US) commercial claims database (25% random sample of IQVIA PharMetrics® Plus for Academics) 18–63 years old malignant breast cancer survivors who were experiencing pain and were ≥ 1 year removed from cancer diagnosis. Using the difference-in-difference technique, annualized changes in analgesics [prevalence, rates of short-term (< 30-day supply) and long-term (≥ 30-day supply) prescription fills] and healthcare resource utilization (healthcare costs, hospitalizations, and emergency department visits) were compared between acupuncture-treated and non-treated patients.
Among 495 (3%) acupuncture-treated patients (median age: 55 years, stage 4: 12%, average 2.5 years post cancer diagnosis), most had commercial health insurance (92%) and experiencing musculoskeletal pain (98%). Twenty-seven percent were receiving antidepressants and 3% completed ≥ 2 long-term prescription fills of opioids. Prevalence of opioid usage reduced from 29 to 19% (P < 0.001) and NSAID usage reduced from 21 to 14% (P = 0.001) post-acupuncture. The relative prevalence of opioid and NSAID use decreased by 20% (P < 0.05) and 19% (P = 0.07), respectively, in the acupuncture-treated group compared to non-treated patients (n = 16,129). However, the reductions were not statistically significant after adjustment for confounding. Patients receiving acupuncture for pain (n = 264, 53%) were found with a relative decrease by 47% and 49% (both P < 0.05) in short-term opioid and NSAID fills compared to those treated for other conditions. High-utilization patients (≥ 10 acupuncture sessions, n = 178, 36%) were observed with a significant reduction in total healthcare costs (P < 0.001) unlike low-utilization patients.
The authors concluded that, although adjusted results did not show that patients receiving acupuncture had better outcomes than non-treated patients, exploratory analyses revealed that patients treated specifically for pain used fewer analgesics and those with high acupuncture utilization incurred lower healthcare costs. Further studies are required to examine acupuncture effectiveness in real-world settings.
Oh, dear!
Which institutions support such nonsense?
- School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA.
- School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA.
- College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
- Integrative Medicine Program, Departments of Supportive Care Medicine and Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
- School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA. [email protected].
- School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA. [email protected].
And which journal is not ashamed to publish it?
It’s the BMC Med!
The conclusion is, of course, quite wrong.
Please let me try to formulate one that comes closer to what the study actually shows:
This study failed to show that a ‘real world impact’ of acupuncture exists. Since the authors were dissatisfied with a negative result, subsequent data dredging was undertaken until some findings emerged that were in line with their expectations. Sadly, no responsible scienctist will take this paper seriously.
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!!!
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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.
Advocates of so-called alternative medicine (SCAM) almost uniformly stress the importance of prevention and pride themselves to make much use of SCAM for the purpose of prevention. SCAM, they often claim, is effective for prevention, while conventional medicine tends to neglect it. Therefore, it seems timely to ponder a bit about the subject.
It makes sense to differentiate three types of prevention:
- Primary prevention aims to prevent disease or injury before it ever occurs.
- Secondary prevention aims to reduce the impact of a disease or injury that has already occurred.
- Tertiary prevention aims to soften the impact of an ongoing illness or injury that has lasting effects.
Here I will includes all three and I will ask what SCAM has to offer in any form of prevention. I will do this by looking at what we have previously discussed on this blog in relation to several specific SCAM and add in each case a very brief evaluation of the evidence.
Acupuncture
- Acupuncture for the prevention of headache? How to fool (almost) everyone with an RCT – NO CONVINCING EVIDENCE
- Acupuncture for chronic migraine prevention? Two new systematic reviews yield encouraging evidence – ENCOURAGING EVIDENCE
Chiropractic
- Chiropractic manipulation and primary prevention. It’s time that chiropractors stop misleading the public in order to fill their pockets – NO CONVINCING EVIDENCE
- ‘Maintenance care’ is very good for chiropractic economics … but not for anything else! – NO CONVINCING EVIDENCE
- No evidence that spinal manipulation improves immune function – NO CONVINCING EVIDENCE
- Chiropractic maintenance care: boosting chiropractic cash flow in perpetuity – NO CONVINCING EVIDENCE
- Birth-trauma: a diagnosis that richly fills the pockets of many chiropractors – NO CONVINCING EVIDENCE
- If you don’t want to get the flu…consult your chiropractor urgently! – NO CONVINCING EVIDENCE
Herbal medicine
- Prevention of acute radiation-induced proctitis with Aloe vera – ENCOURAGING EVIDENCE
- Can Chinese Medicine Be Used for Prevention of Corona Virus Disease? – NO CONVINVING EVIDENCE
Homeopathy
- Effectiveness of Homeopathic Arsenicum album 30C in the Prevention of COVID-19 – NO CONVINCING EVIDENCE
- Disturbing news on the recent trial of homeopathy for COVID prevention – NO CONVINCING EVIDENCE
- A new study of homeopathy for the prevention of COVID-19 infections – NO CONVINCING EVIDENCE
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19 – NO CONVINCING EVIDENCE
- Homeopathic Prevention and Management of Epidemic Diseases – NO CONVINCING EVIDENCE
- Influenzinum: the homeopathic flu prevention that does not prevent flu – NO CONVINCING EVIDENCE
- Homeopathy for preventing and treating acute respiratory tract infections in children – NO CONVINCING EVIDENCE
- A new trial of homeopathy for preventing COVID-19 infections – NO CONVINCING EVIDENCE
- Oscillococcinum, the homeopathic solution to the coronavirus threat? – NO CONVINCING EVIDENCE
- An RCT suggests that homeopathy can prevent epidemics!!! But how reliable is this evidence? – NO CONVINCING EVIDENCE
- HOMEOPATHS LOVE IT: the epidemiological evidence suggesting that homeopathy works – NO CONVINCING EVIDENCE
- Understanding homeoprophylaxis: it is dangerous nonsense!!! – NO CONVINCING EVIDENCE
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.” NO CONVINCING EVIDENCE
- Boiron’s new study of homeopathy NO GOOD EVIDENCE
Mind-body therapies
- Meditation for the primary and secondary prevention of cardiovascular disease – NO CONVINCING EVIDENCE
- Transcendental meditation (TM) for the primary prevention of cardiovascular disease? – NO CONVINCING EVIDENCE
Osteopathy
Does Osteopathy Prevent Motion Sickness? – NO CONVINCING EVIDENCE
Supplements
- Multivitamins in the prevention of cancer and cardiovascular disease – NO CONVINCING EVIDENCE
- Zinc for the prevention or treatment of acute viral respiratory tract infections in adults? A new systematic review – NO CONVINCING EVIDENCE
- Vitamin D for the prevention or treatment of COVID-19? NO CONVINCING EVIDENCE
- Supplements for the prevention of cardiovascular disease and cancer – NO CONVINCING EVIDENCE
- Do Vitamin, Mineral, and Multivitamin Supplements Prevent Cardiovascular Disease and Cancer? – NO CONVINCING EVIDENCE
- Does vitamin D supplementation lower the risk of cancer and precancers? – NO CONVINCING EVIDENCE
- Glucosamine is associated with decreased risk of lung cancer – ENCOURAGING EVIDENCE
Yoga
- Yoga for the prevention of cardiovascular disease: more than wishful thinking? – NO CONVINCING EVIDENCE
- Who says it’s all negative? The addition of yoga to aerobic exercise programs reduces global cardiovascular risk – ENCOURAGING EVIDENCE
I hope you agree: this list is impressive!
- Impressive in the way of showing how often we have discussed SCAM for prevention in one form or another.
- Impressive also to see how little positive evidence there is for effective prevention with SCAM
Of course, this is merely based on posts that were published on my blog. Some will argue that I missed out on some effective SCAMs for prevention. Others might claim that I judged some of the the above cited articles too harshly. If you share such sentiments, I invite you to show me the evidence – and I promise to look at it and evaluate it critically.
Meanwhile, I will draw the following conclusion:
Despite the prominent place prevention assumes in discussions about SCAM, the actual evidence fails to show that it has an important role to play in primary, secondary or tertiary prevention.
Osteoarthritis of the knee (OAK) is a chronic degenerative musculoskeletal disorder that strongly affects the elderly population and decreases their quality of life. Pain, stiffness, and restricted knee movements are the major characteristic features of OAK. There are no studies available on the effect of the liver 7 (LR 7) acupuncture point on pain and range of motion. This study therefore tested the effectiveness of the LR 7 acupuncture point on pain and range of motion in chronic OAK patients.
Thirty-five subjects aged between 40 and 65 years were recruited from Government Yoga and Naturopathy Medical College, Chennai. Participants were included in the study after they fulfilled the eligibility criteria. The duration of acupuncture was 20 minutes (5 days/week) for 2 weeks. Baseline and post-intervention assessments were performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the degree of knee flexion and extension was measured using a goniometer.
Pre- and post-trial outcomes were compared using paired t-tests. LR 7 acupuncture reduced the WOMAC score from 49 to 30 (p < 0.001), indicating that pain was alleviated. Treatment increased the range of knee flexion from 110 to 115 degrees and reduced knee extension (p < 0.01) from 16 to 9 degrees (p < 0.001). These findings indicate that acupuncture treatment improved the range of knee movement.
The authors concluded that the present study showed that 10 sessions of LR 7 acupuncture for people with OAK significantly reduced pain and increased range of motion. We conclude that LR 7 acupuncture is an adjuvant therapy for alleviating pain and managing OAK.
On several levels, this is a shocking paper:
- There already are many controlled clinical trials of acupuncture for OAK; thus there is no reason whatsoever to conduct and publish a trial that is methodolagically inferior to this body of evidence.
- The conclusions are incorrect; as the study had no control group, it is impossible to establish causaality between the treatment and the outcome. The pain reduction might have been caused by phenomena that are unrelated to acupuncture, e.g. placebo effect, regression towards the mean, social desirability.
- The authors state that they are “grateful to principal and faculities of government of yoga and naturopathy medical college and hospital for their support”. This means that they were misguided by a governmental medical college and hospital in planning and running a study that is a waste of resources and thus arguably unethical.
Research of this nature is dangerous:
- It undermines the trust people put in science.
- It makes a laughing stock of more serious attempts to test the value of acupuncture.
- It misuses the cooperation of patients who give their time and good will to advance our knowledge.
- It wasts precious resources.
- It is an incentive for others to do similarly nonsensical pseudo-science.
- It misleads patients and carers into believing in quackery.
The only valid conclusion that can be drawn from this paper is, I think, this:
The people involed in planning, conducting, supporting and publishing this study have little understanding of clinical research and should receive adequate education and training before they are allowed to continue.
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.
To date, two open-label clinical trials have indicated that acupuncture may be more effective than standard medication for chronic migraine. However, drawing definitive conclusions from these trials is challenging. Studies employing a double-dummy design can eliminate the placebo effect and offer more unbiased estimates of efficacy.
This double-dummy, single-blind, randomized controlled trial compared the efficacy and safety of acupuncture and topiramate for chronic migraine. Participants, aged 18–65 years and diagnosed with chronic migraine, were randomly assigned (1:1) to receive:
- acupuncture (three sessions/week) plus topiramate placebo (acupuncture group),
- or topiramate (50–100 mg/day) plus sham acupuncture (topiramate group) over 12 weeks.
The primary outcome was the mean change in monthly migraine days during weeks 1–12.
Of 123 screened patients, 60 (mean age 45.8, 81.7% female) were randomly assigned to the acupuncture or topiramate groups. Acupuncture demonstrated significantly greater reductions in monthly migraine days than topiramate. No severe adverse events were reported.
The authors concluded that acupuncture may be safe and effective for treating chronic migraine. The efficacy of 12 weeks of acupuncture was sustained for 24 weeks and superior to that of topiramate. Acupuncture can be used as an optional preventive therapy for chronic migraine.
I beg to differ!
The authors claim that the participants, outcome assessors, and statistical analysts were blinded (masked) to the group allocations. However, the success of patient blinding was not tested. Why?
The authors state that, in the acupuncture group, “twirling, lifting, and thrusting were performed to produce deqi (a sensation of soreness, numbness, distention, or heaviness that indicates effective needling)… In the topiramate group, sham acupuncture was administered on non-effective acupoints, without manual deqi manipulations.” In other words, patients could very easily tell to which group they had been randomised.
This, in turn, means that a placebo effect – possibly enhanced by verbal or non-verbal communication from the (non-blinded) actupuncturists – has most likely caused the observed outcomes. I therefore feel the need to re-phrase the authors’ conclusions:
This study confirms that acupuncture produces a large placebo effect. Whether it has any effects beyond placebo cannot be determined by this study. Until this point has been clarified, acupuncture should not be used as a preventive therapy for chronic migraine.
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”.
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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
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.
