TCM
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.
In the previous 3 parts of this series (see here, here and here), we have discussed 9 fake diagnoses of so-called alternative medicine (SCAM):
- adrenal fatigue,
- candidiasis hypersensitivity,
- chronic intoxications,
- chronic Lyme disease,
- electromagnetic hypersensitivity,
- homosexuality,
- leaky gut syndrome,
- multiple chemical sensitivity,
- neurasthenia.
Today I will briefly discuss three further fake diagnoses and list the treatments that SCAM practitioners might recommend for them.
Vaccine overload
Vaccine overload is a term for the notion that giving many vaccines at once may overwhelm or weaken a patient’s immune system which, in turn, is alleged to lead to adverse effects. Because children have an immature immune system, they are claimed to be afflicted most frequently.
There is no evidence that vaccine overload exists nor that it can lead to illness. This does not stop SCAM practitioners to apply or recommend all sorts of SCAMs for the imagined condition. Particular favourites are all sorts of detox diets, homeopathy and a wide range of dietary supplements. Such diets and supplements can be tricky for younger children. In this case, SCAM practitioners recommend, amongst many other things, smoothies or adding turmeric, ginger, and small amounts of Shillington’s adult supplements to the child’s food.
None of these recommendations are supported by anything resembling sound evidence, of course.
Vertebral subluxation
On this blog, we have discussed vertebral subluxations more often than I care to remember. Chiropractors claim that these figments of their imagination impair the flow of innate which, in turn, makes us ill. Straight chiros, those who adhere to the gospel of their guru DD Palmer, diagnose subluxations in 100% of their patients. They are undeterred by the fact that vertebral subluxations do not exist.
I can understand why! If they did aknowledge that the diagnosis is fake, they would have no reason to treat patients with spinal manipulations, and they would quickly go out of business.
Yin/Yang imbalance
According to the assumptions of practitioners of Traditional Chinese Medicine (TCM), all health problems arise from an imbalaance of the two life forces , yin and yang. To restore the balance, they employ a range of therapies such as acupuncture, herbal mixtures, massages, etc.
But these life forces do not exist. Thus they cannot be out of balance, and consequently the imbalance cannot cause illness. TCM practitioners don’t want to hear any of this. Why not? You guessed it: if they aknowledged these facts, they would need to stop practising.
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Fake diagnoses are the life-line of many SCAM practitioners:
- they tell you that something is wrong with you (despite the fact that you are entirely healthy);
- they make sure that this is a reason for serious concern;
- they claim they can put the alleged abnormality right again;
- they administer a lengthy series of treatments and/or sell you plenty of remedies;
- when they have earned enough money treating you, they give you the good news: you are back to narmal;
- gullible consumers are impressed by the unfailing competence of the SCAM practitioners.
My conclusion:
there is nothing easier and more profitably to heal that a condition that did not exist in the first place.
This study aims to appraise the utility, accuracy, and quality of information available on YouTube on acupuncture for chronic pain treatment. Using search terms such as “acupuncture for chronic pain” and “acupuncture pain relief”, the top 54 videos by view count were selected. Videos were included if they were:
- > 1 minute duration,
- contained audio in English,
- had > 7000 views,
- related to acupuncture.
Each video was categorised as either:
- useful,
- misleading,
- or neither.
Another primary outcome of interest was the quality and reliability of each video using validated instruments, including the modified DISCERN (mDISCERN) tool and the Global Quality Scale (GQS). The means were calculated for the video production characteristics, production sources, and mDISCERN and GQS scores. Continuous and categorical outcomes were compared using Student’s t-test and chi-square test, respectively.
The results show that, of the 54 videos,
- 57.4% were categorized as useful,
- 14.8% were misleading,
- and 27.8% were neither.
Useful videos had a mean GQS and mDISCERN score of 3.77± 0.67 and 3.48± 0.63, respectively, while misleading videos had mean GQS and mDISCERN score of 2.50± 0.53 and 2.38± 0.52, respectively. 41.8% of the useful videos were produced by a healthcare institution while none of the misleading videos were produced by a healthcare institution. However, 87.5% of the misleading videos were produced by health media compared to only 25.8% of useful videos from health media.
The authors concluded that their analysis of the highest viewed acupuncture videos for chronic pain reveals only about half provide useful information, indicating a significant misinformation challenge for viewers. This underscores the urgent need for more high-quality, unbiased videos from healthcare institutions and physicians on complementary health practices like acupuncture.
This new analysis confirms what we and others have shown numerous times before: information about so-called alternative medicine (SCAM), which is abundantly available on the Internet, needs to be taken with a healthy pinch of salt. Whenever we studied the issue, our conclusions were even less optimistic than those of the present authors. In fact, most of the time we concluded that following such advice is a risk factor to our health.
It has been reported that 5 people who took a Japanese health supplement have died and more than 100 have been hospitalized as of Friday, a week after a pharmaceutical company issued a recall of the products, officials said. Osaka-based Kobayashi Pharmaceutical Co. came under fire for not going public quickly with problems known internally as early as January. Yet the first public announcement came only on 22 March. Company officials said 114 people were being treated in hospitals after taking products — including Benikoji Choleste Help meant to lower cholesterol — that contain an ingredient called benikoji, a red species of mold. Some people developed kidney problems after taking the supplements, but the exact cause was still under investigation in cooperation with government laboratories, according to the manufacturer.
“We apologize deeply,” President Akihiro Kobayashi told reporters last Friday, bowing for a long time to emphasize the apology alongside three other top company officials. He expressed remorse to those who have died and have been taken ill and to their families. He also apologized for the troubles caused to the entire health food industry and the medical profession, adding that the company was working to prevent further damage and improve crisis management.
The company’s products have been recalled — as have dozens of other products that contain benikoji, including miso paste, crackers, and a vinegar dressing. Japan’s health ministry put up a list on its official site of all the recalled products, including some that use benikoji for food coloring. The ministry warned the deaths could keep growing. The supplements could be bought at drug stores without a prescription from a doctor, and some may have been purchased or exported before the recall, including by tourists who may not be aware of the health risks.
Kobayashi Pharmaceutical had been selling benikoji products for years, with a million packages sold over the past 3 fiscal years, but a problem crept up with the supplements produced in 2023. Kobayashi Pharmaceutical said it produced 18.5 tons of benikoji last year. Some analysts blame the recent deregulation initiatives, which simplified and sped up approval for health products to spur economic growth.
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Anouther source reported that Japanese authorities on Saturday raided a drug factory after a pharmaceutical company reported at least five deaths and 114 hospitalizations possibly linked to a health supplement. About a dozen Japanese health officials walked into the Osaka plant of the Kobayashi Pharmaceutical Co., as seen in footage of the raid widely telecasted on Japanese news. The health supplement in question is a pink pill called Benikoji Choleste Help. It is said to help lower cholesterol levels. A key ingredient is benikoji, a type of red mold. The company has said it knows little about the cause of the sickness, which can include kidney failure. It is currently investigating the effects in cooperation with Japan’s government.
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More recent reports update the figure of affected individuals: Japanese dietary supplements at the center of an expanding health scare have now been linked to at least 157 hospitalizations, a health ministry official said Tuesday.The figure reflects an increase from the 114 hospitalization cases that Kobayashi Pharmaceutical said on Friday were linked to its products containing red yeast rice, or beni kōji.
A Kobayashi Pharmaceutical spokeswoman confirmed the latest hospitalization cases without elaborating further.
Benikoji is widely sold and used; not just in Japan. It comes under a range of different names:
- red yeast rice,
- red fermented rice,
- red kojic rice,
- red koji rice,
- anka,
- angkak,
- Ben Cao Gang Mu.
It is a bright reddish purple fermented rice which acquires its color from being cultivated with the mold Monascus purpureus. Red yeast rice is used as food and as a medicine in Asian cultures, such as Kampo and TCM.
It contains lovastatin which, of course, became patented and is marketed as the prescription drug, Mevacor. Red yeast rice went on to become a non-prescription dietary supplement in the United States and other countries. In 1998, the U.S. FDA banned a dietary supplement containing red yeast rice extract, stating that red yeast rice products containing monacolin K are identical to a prescription drug, and thus subject to regulation as a drug.
Some abstracts of medical papers are so bizarre that they must not be tempered with, I find. This is one of them:
Rationale:
This case report aims to provide clinical evidence on the effectiveness of integrating chiropractic and moxibustion techniques for treating pseudomyopia accompanied by elevated intraocular pressure resulting from cervical spine issues because the application of complementary medicine modalities for managing such vision disorders currently lacks adequate investigations.
Patient concerns:
A 6-year-old patient presented with blurred vision, intermittent ocular discomfort, and upper cervical discomfort.
Diagnoses:
Spine-related increased intraocular pressure and pseudomyopia.
Interventions:
The patient received integrative treatment of chiropractic and walnut-shell moxibustion 3 times a week for a total of 10 treatment sessions.
Outcomes:
The patient exhibited progressive improvements in visual acuity and reductions in intraocular pressure over the treatment period, with unaided vision exceeding 2 lines of improvement in visual acuity charts and normalized intraocular pressure after 10 treatment sessions. These therapeutic effects were sustained at 3-month follow-up.
Lessons:
The integrative use of chiropractic and walnut-shell moxibustion demonstrates considerable potential in alleviating symptoms of pseudomyopia, reducing intraocular pressure, and restoring visual function in spine-related pseudomyopia cases.
Pseudomyopia is a spasm of the ciliary muscle that prevents the eye from focusing in the distance. It differs from myopia which is caused by the eye’s shape or other basic anatomy. Pseudomyopia may be either organic, through stimulation of the parasympathetic nervous system, or functional in origin, through eye strain or fatigue of ocular systems. It is common in young adults after a change in visual requirements, such as students preparing for an exam, or a change in occupation. The condition is often transitory and it is necessary to request psychiatric consultation in each case of pseudomyopia. Comorbidity of anxiety and depressive disorders is more common in pseudomyopia cases. In addition, as the severity of psychiatric symptoms increases, the amount of accommodation also appears to increase.
A few question, if I may:
- Walnut-shell moxibustion? Yes, it exists! Moxibustion with walnut shell spectacles is a characteristic therapy of Guang’anmen Hospital, developed on the basis of walnut shell moxibustion, and mainly composed of an eye moxibustion frame, a walnut shell soaked with wolfberry and chrysanthemum liquid, and moxibustion strips. Moxibustion with a walnut shell was first recorded by Shicheng Gu for treating surgical ulcers in the Qing dynasty. Then, moxibustion with walnut shell spectacles was reformed by us, combining Shicheng Gu’s experience with our clinical practice, and is mainly used for the treatment of optic nerve atrophy and myopia.
- The authors state that, “based on traditional Chinese medicine principles, moxibustion is known to warm meridians, dredge collaterals, relax tendons, and enhance blood circulation”. Is this true? Well, based on TCM, anything goes, but it does not make it true.
- How can we know whether chiropractic or walnut-shell moxibustion or both caused the outcome? We can’t!
- Can we be sure what caused the child’s problem? No!
- Do we know whether the outcome was not a spontaneous recovery? No!
- The authors claim that “cervical spine imbalance leads to visual impairment”. Is that correct? Not as far as I know.
- The authors state that “the patient in this case, presenting with pseudomyopia, elevated intraocular pressure, and neck pain, likely had a cervical spine-derived condition. Currently, such spine-derived vision disorders lack sufficient clinical recognition.” Is this true? No, I’d say such spine-derived vision disorders might not even exist.
- Why would anyone publish a paper about the case? Search me!
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.
According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).
The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.
After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.
The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.
It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.
One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.
Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.
Current interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an intervention with some positive preliminary but methodologically flawed data for PTSD. Therefore a new study compared verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.
This was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols.
Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions. The primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models.
A total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low.
The authors concluded that the acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted.
I am not sure that the authors’ enthusiastic verdict is correct. Its lead author was even quoted stating that his study, which used improved controls, was needed to “definitively” support acupuncture for PTSD. He noted that “acupuncture ought to be considered a potential first-line treatment for PTSD.”
While the study is an improvement on the previous research in this area, it is by no means compelling. My main point of criticism is the nature of the sham acupuncture. Such controls are used to account for placebo effects which, of course, can be considerable in the case of acupuncture.
For this concept to work adequately, the patient and the therapist need to be blinded. In the case of acupuncture, therapist blinding is difficult (but not impossible). In this study, therepists were not blinded. Thus they could have influenced the outcome by verbal and non-verbal clues given to the patient. As acupuncturists inevitably have an interest in the positive result of their study, this effect seems inevitable to me.
More important, however, is the adequate blinding of the patient. In this study, it was attempted by using shallow needling as a sham intervention. Yet, shallow needling can easily distinguished from real acupuncture by the patient. At the very least, patients should be asked what treatment – sham or real – they thought they had received. This did not happen, and we therefore might assume that the effect of patient de-blinding – combined with the confounder described above – was sufficient to bring about the relatively small effect sizes observed by the authors.
One might argue that this does not really matter; all that counts is to alleviate the suffering of the patients, never mind by what mechanism. I think, this would be erroneous. It matters because, if acupuncture itself is ineffective (which I suggest), settling for acupuncture as a first line therapy for PTSD is in nobody’s interest and a disservice to severely suffering patients. It would inhibit meaningful research aimed at finding an optimal therapy (one that works beyond placebo) and be a waste of resources.
This pilot study is “delving into the potential benefits of Reiki therapy as a complementary intervention for the treatment and management of stress and anxiety”.
A total of 31 volunteers self-reporting stress, anxiety, or psychological disorders were enrolled. Health-related quality of life (HRQoL) was assessed using the 36-Item Short Form Health Survey (SF-36) Questionnaire for anxiety and depression. Pre- and post-treatment HRQoL scores were meticulously compared, and the significance of the disparities in these scores was meticulously computed.
Analysis was restricted to volunteers who completed the 3-day Reiki sessions. Statistically significant enhancements were discerned across all outcome measures, encompassing positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (P<0.0001).
The authors concluded that the constancy and extensive scope of these improvements suggest that Reiki therapy may not only address specific symptoms but also contribute significantly to a predominant escalation of mental and physical health.
This study is almost comical.
Amongst all the many forms of so-called alternative medicine (SCAM), Reiki is perhaps the most ridiculous scam. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy. It is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.
Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind. There is no scientific basis for such notions, and reiki is therefore not plausible.
Reiki is used for a number of conditions, including the relief of stress, tension and pain. There have been several clinical trials testing its effectiveness. Those that are rigorous fail to show that the treatment is effective – and those that are dripping with bias, like the one discussed here, tend to produce false-positive results.
The present study has many flaws that are too obvious to even mention. While reading it, I asked myself the following questions:
- How could a respectable university ever allow this pseudo-research to go ahead?
- How could a respectable ethics committee ever permit it?
- How could a respectable journal ever publish it?
The answers must be that, quite evidently, they are not respectable.
