acupuncture
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.
There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.
A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.
43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).
The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.
Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:
- 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
- 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
- 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
- 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
- 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
Sadly, this assumption is evidently mistaken.
The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.
The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.
Clinical trials should be about contributing to our knowledge and not about contributing to confusion.
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.
Millions of US adults use so-called alternative medicine (SCAM). In 2012, 55 million adults spent $28.3 billion on SCAMs, comparable to 9% of total out-of-pocket health care expenditures. A recent analysis conducted by the US National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) suggests a substantial increase in the overall use of SCAM by American adults from 2002 to 2022. The paper published in the Journal of the American Medical Association, highlights a surge in the use of SCAM particularly for pain management.
Data from the 2002, 2012, and 2022 National Health Interview Surveys (NHISs) were employed to evaluate changes in the use of 7 SCAMs:
- yoga,
- meditation,
- massage therapy,
- chiropractic,
- acupuncture,
- naturopathy,
- guided imagery/progressive muscle relaxation.
The key findings include:
- The percentage of individuals who reported using at least one of the SCAMs increased from 19.2% in 2002 to 36.7% in 2022.
- The use of yoga, meditation, and massage therapy experienced the most significant growth.
- Use of yoga increased from 5% in 2002 to 16% in 2022.
- Meditation became the most popular SCAM in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
- Acupuncture saw an increase from 1% in 2002 to 2.2% in 2022.
- The smallest rise was noted for chiropractic, from 79 to 86%
The analyses also suggested a rise in the proportion of US adults using SCAMs specifically for pain management. Among participants using any SCAM, the percentage reporting use for pain management increased from 42% in 2002 to 49% in 2022.
Limitations of the survey include:
- decreasing NHIS response rates over time,
- possible recall bias,
- cross-sectional data,
- differences in the wording of the surveys.
The NCCIH researchers like such surveys and tend to put a positive spin on them, i.e. SCAM is becoming more and more popular because it is supported by better and better evidence. Therefore, SCAM should be available to everyone who wants is.
But, of course, the spin could also turn in the opposite direction, i.e. the risk/benefit balance for most SCAMs is either negative or uncertain, and their cost-benefit remains unclear – as seen regularly on this blog. Therefore, the fact that SCAM seems to be getting more popular is of increasing concern. In particular, more consideration ought to be given to the indirect risks of SCAM (think, for instance, only of the influence SCAM practitioners have on the vaccination rates) that we often discuss here but that the NCCIH conveniently tends to ignore.
Medical Acupuncture is the name of a quarterly journal published for the ‘American Academy of Medical Acupuncture’ that publishes around 60 pro-acupuncture articles every year. Its editor is Richard C. Niemtzow, M.D., Ph.D., M.P.H. Richard is a retired US Air Force colonel who was the first full-time physician acupuncturist in the US Armed Forces. He is probably best known for his invention called ‘BATTLE FIELD ACUPUNCTURE’, a form of ear-acupuncture allegedly reducing pain in emergency situations.
Medline lists 79 papers (mostly published in 3rd class journals such as ‘Medical Acupuncture’) in Niemtzow’s name. Only one of them – 21 years ago – was a clinical trial. Here it is:
Purpose: We performed a pilot trial to assess the response of lower urinary tract symptoms and prostate specific antigen (PSA) to acupuncture in a population of patients biopsy negative for prostate cancer.
Materials and methods: A total of 30 patients were randomly assigned to 1 of 3 study groups, including observation for 3 months with 6 blood samples for PSA at set intervals, 9 sessions of acupuncture in 3 months to points of the kidney-bladder distinct meridian expected to treat the prostate with 6 blood samples for PSA at set intervals and 9 sessions of acupuncture in 3 months to points not expected to treat the prostate with 6 blood samples for PSA at set intervals. The effect of acupuncture on lower urinary tract symptoms was assessed monthly using the International Prostate Symptom Score.
Results: Trend analysis (repeated measures ANOVA) revealed no significant changes in the 3-month period in the randomized arms. Statistical analysis showed p = 0.063 for the International Prostate Symptom Score, p = 0.945 for PSA and p = 0.37 for the free-to-total PSA ratio.
Conclusions: Acupuncture to the kidney-bladder distinct meridian neither relieves lower urinary tract symptoms nor impacts PSA.
Yes, an acupuncture study with a negative result!
Niemtzow has, as far as I can see, never himself conducted a study of ‘battle field acupuncture’. In fact, there only very few trials of ‘battle field acupuncture‘. The most recent (albeit lousy) study even suggest that it is less effective than electroacupuncture (EA): EA was more effective than ‘battle field auricular acupuncture’ at reducing pain severity, but both similarly improved physical and mental health scores.
This does not stop Niemtzow to continue praising acupuncture in dozens of papers, particularly his ‘battle field’ version and especially in his ‘own’ journal. The most recent example has just been published; allow me to present an excerpt to you:
In December of 2023, I had the opportunity to visit the Van Gogh Museum in Amsterdam. The only day I had for this visit was characterized by a pouring and chilling rain. This did not stop the crowds of people visiting this famous exhibition. I reminded myself that Van Gogh was a troubled spirit. He lived a short tumultuous life characterized by cutting off his left ear lobe and he spent a sojourn in an asylum. Yet, his art emerged in all its beauty and splendor to become famous in the world. Despite all his troubles, he contributed a precious collection of magnificent art. Many individuals would not have surfaced out of personal disorders to produce such a wonderful gift to society. However, history tells us that many sensational contributions originated from people embroiled in mental health illnesses.
Medical Acupuncture published more than 13 years ago the acupuncture ‘‘diagnosis’’ of Vincent Van Gogh. The article, which is worth rereading, discussed the Five-Element pattern associated with the artist’s hallucinations, alcoholism, severe depression, insomnia, anxiety, dizziness, headaches, nightmares, etc. The author, Vera Kaikobad, LAc, stated: ‘‘It is poignant to realize that a few needles in the hands of a skilled acupuncturist may have spared this great artist such torment and perhaps saved his life.’’ Feasibly, in 2024 we should not only examine our patients for their physical complaints; we should venture into their mental health status as well. A back or neck pain is important, but so is anxiety, insomnia, etc. In promoting mental health, we may assist many patients who are perhaps capable of contributing to the well-being of the world. It is our responsibility as acupuncturists not to think of our patients as a neck or back pain, etc.; instead, we must see them as whole persons having spiritual and physical needs that must be addressed.
I feel that, overall, this remarkable effort justifies Niemtzow’s admission to my ALTERNATIVE MEDICINE HALL OF FAME.
WELCOME, RICHARD!
And let me introduce you to the rest of the 24 laureates:
- Helmut Kiene (anthroposophical medicine)
- Helge Franke (osteopathy, Germany)
- Tery Oleson (acupressure , US)
- Jorge Vas (acupuncture, Spain)
- Wane Jonas (homeopathy, US)
- Harald Walach (various SCAMs, Germany)
- Andreas Michalsen ( various SCAMs, Germany)
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, US)
- Cheryl Hawk (chiropractor, US)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various SCAMs, Germany)
- Claudia Witt (homeopathy, Germany/Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
This study tested whether trigger point acupuncture (TrPA) is beneficial for office workers who have reduced job performance (presenteeism) due to chronic neck and shoulder pain (katakori).
A 4-week single-center randomized clinical trial was conducted on 20 eligible female office workers with chronic neck and shoulder pain of at least 3-month duration. The control group implemented only workplace-recommended presenteeism measures, whereas the intervention group received TrPA up to 4 times per month in addition to the presenteeism measures recommended by each workplace. The major outcome measure was the relative presenteeism score on the World Health Organization Health and Work Performance (WHO-HPQ). The secondary outcome measures were pain intensity (numerical rating scale), absolute presenteeism (WHO-HPQ), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), catastrophic thoughts related to pain (Pain Catastrophizing Scale; PCS), and sleep (Athens Insomnia Scale; AIS).
All 9 cases in the intervention group and 11 cases in the control group were analyzed. TrPA up to 4 times per month reduced the intensity of neck and shoulder pain by 20% (P < .01, d = 1.65) and improved labor productivity (relative presenteeism value) by 0.25 (P < .01, d = 1.33) compared with the control group over 1 month. No significant differences were observed between the 2 groups in terms of absolute presenteeism score, HADS, PCS, or AIS.
The authors concluded that these results suggest that regular intervention with TrPA may be effective in the relative presenteeism score before and after the intervention and the degree of neck and shoulder pain over 28 days compared with the control group.
Sure, TrPA may be effective.
But is it?
I thought the trial was aimed at answering that question!
But it didn’t!
Why not?
Because, as we have discussed ad nauseam on this blog, the A+B versus B study design cannot answer it. On the contrary, it will always generate a positive result without determining whether the treatment or a nonspecific (placebo) effect caused the outcome (which, of course, is the reason why this study design is so popular in SCAM research).
In view of this, I suggest to re-formulate the conclusions as follows:
The study suggests that the researchers were ill-informed when designing it. Therefore, the findings show nothing of value.
After the nationwide huha created by the BBC’s promotion of auriculotherapy and AcuSeeds, it comes as a surprise to learn that, in Kent (UK), the NHS seems to advocate and provide this form of quackery. Here is the text of the patient leaflet:
Kent Community Health, NHS Foundation Trust
Auriculotherapy
This section provides information to patients who might benefit from auriculotherapy, to complement their acupuncture treatment, as part of their chronic pain management plan.
What is auriculotherapy?
In traditional Chinese medicine, the ear is seen as a microsystem representing the entire body. Auricular acupuncture focuses on ear points that may help a wide variety of conditions including pain. Acupuncture points on the ear are stimulated with fine needles or with earseeds and massage (acupressure).
How does it work?
Recent research has shown that auriculotherapy stimulates the release of natural endorphins, the body’s own feel good chemicals, which may help some patients as part of their chronic pain management plan.
What are earseeds?
Earseeds are traditionally small seeds from the Vaccaria plant, but they can also be made from different types of metal or ceramic. Vaccaria earseeds are held in place over auricular points by a small piece of adhesive tape, or plaster. Applying these small and barely noticeable earseeds between acupuncture treatments allows for patient massage of the auricular points. Earseeds may be left in place for up to a week.
Who can use earseeds?
Earseeds are sometimes used by our Chronic Pain Service to prolong the effects of standard acupuncture treatments and may help some patients to self manage their chronic pain.
How can I get the most out my treatment with earseeds?
It is recommended that the earseeds are massaged two to three times a day or when symptoms occur by applying gentle pressure to the earseeds and massaging in small circles.
Will using earseeds cure my chronic pain?
As with any treatment, earseeds are not a cure but they can reduce pain levels for some patients as part of their chronic pain management programme.
________________________
What the authors of the leaflet forgot to tell the reader is this:
- Auriculotherapy is based on ideas that fly in the face of science.
- The evidence that auriculotherapy works is flimsy, to say the least.
- The evidence earseeds work is even worse.
- To arrive at a positive recommendation, the NHS had to heavily indulge in the pseudo-scientific art of cherry-picking.
- The positive experience that some patients report is due to a placebo response.
- For whichever condition auriculotherapy is used, there are treatments that are much more adequate.
- Advocating auriculotherapy is therefore not in the best interest of the patient.
- Arguably, it is unethical.
- Definitely, it is not what the NHS should be doing.
Motor aphasia is common among patients with stroke. Acupuncture is recommended by TCM enthusiasts as a so-called alternative medicine (SCAM) for poststroke aphasia, but its efficacy remains uncertain.
JAMA just published a study that investigated the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.
The study was designed as a multicenter, sham-controlled, randomized clinical trial. It was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.
Eligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.
The primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale–39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.
Among 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.
The authors concluded that in this randomized clinical trial, patients with poststroke motor
aphasia who received 6 weeks of MA compared with those who received SA demonstrated
statistically significant improvements in language function, quality of life, and neurological
impairment from week 6 of treatment to the end of follow-up at 6 months after onset.
I was asked by the SCIENCE MEDIC CENTRE to provide a short comment. This is what I stated:
Superficially, this looks like a rigorous trial. We should remember, however, that several groups, including mine, have shown that very nearly all Chinese acupuncture studies report positive results. This suggests that the reliability of these trials is less than encouraging. Moreover, the authors state that real acupuncture induced ‘de chi’, while sham acupuncture did not. This shows that the patients were not blinded and the outcomes might easily be due to a placebo response.
Here, I’d like to add two further points:
- We have learnt that the vast majority of research coming out of China is fabricated.
- I think it is lamentable that a journal of high standing is not more critical and repeatedly falls for such suspect acupuncture studies.
The aim of this study was to investigate whether there is a difference in outcome between participants with high compared to low pain self-efficacy (PSE) receiving manual therapy, acupuncture, and electrotherapy.
Participants were stratified into high or low baseline (i) PSE, (ii) shoulder pain and disability index (SPADI), and (iii) did or did not receive the treatment. Whether the effect of treatment differs for people with high compared to low PSE was assessed using the 95% confidence interval of the difference of difference (DoD) at a 5% significance level (p < 0.05).
Treatment was labelled using 3 categories, 2 of which were subcategories of the first
- “Any passive treatment” – any form of manual therapy and/or acupuncture and/or electrotherapy.
- “Any manual therapy” – shoulder or spine joint mobilisations, deep transverse frictions, capsular stretches, trigger point therapy, muscle facilitation, or other techniques listed by the treating physiotherapist.
- “Spinal/shoulder joint mobilisation” – for example, Maitland, Kaltenborn or Mulligan techniques.
To be categorised, treatment must have been delivered by the physiotherapist at least once and may have been delivered in conjunction with other treatments.
Six-month SPADI scores were consistently lower (less pain and disability) for those who did not receive passive treatments compared to those who did (statistically significant less pain and disability in 7 of 24 models). However, DoD was statistically insignificant.
The authors concluded that PSE did not moderate the relationship between treatment and outcome. However, participants who received passive treatment experienced equal or more pain and disability at 6 months compared to those who did not. Results are subject to confounding by indication but do indicate the need for further appropriately designed research.
This analysis suggests that manual therapy, electrotherapy, or acupuncture in addition to advice and exercise offered no improvement in pain or disability at six months, irrespective of PSE. Some patients who receive these treatments experienced more pain and disability at six months compared to those who do not.
I am not aware of compelling evidence that either of these treatments, all of which are often recommended, are effective for shoulder pain, and the results of this new study certainly do not suggest they are. However, as the design of the study was not primarily for this research question, these findings are, of course, merely tentative and need to be investigated further.
