acupuncture
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.
When I still worked as a clinician, I have looked after athletes long enough to know that they go for everything that promises to improve their performance. It is thus hardly surprising that Olympians would try all sorts of so-called alternative medicine (SCAM) regardless of whether the therapy is supported by evidence or not. Skeptics are tempted to dismiss all of SCAM for improving fitness. But is that fair? Is it true that no evidence evists for any of them?
The short answer to this question is NO.
Here I have looked at some of the possibilities and show you some of the Medline-listed papers that seem to support SCAM as a means of improving fitness:
Acupuncture
Ashwagandha
Balneology
Cupping
Ginkgo biloba
Ice
Kinesiology tape
Massage guns
Percussion massage
Sports massage
Tai massage
Vibrational massage
Yoga
Please do not mistake this for anything resembling a systematic review of the evidence; it is merely a list to give you a flavour of what is out there. And please don’t assume that the list is complete; I am sure that there is much more.
Looking at the articles that I found, one could get the impression that there is plenty of good evidence to support SCAM for improving fitness. This, however, would be wrong. The evidence for almost every of the above listed therapies is flimsy to say the least. But – as I stated already at the beginning – in my experience, this will not stop athletes to use them.
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.
For many years, Dale Thompson has been one of our most loyal commentators, often defending the indefensible, or willfully misleading us, or deliberately distracting us from the topic at hand. He has made his comments under several names or pseudomyms, sometimes with and sometines without using the doctor-title, sometimes disclosing that he is a chiropractor and someimes not disclosing either this information or his most obvious conflicts of interest.
Recently, several readers became more interested in Dale and his activities. I therefore thought it would be relevant to find out how he is being presented on the Internet. Here are the mentions I found that include some relevant information about Dale:
- Dr. Dale Thompson. Over 20 years of delivering a conservative approach to muscle and joint issues. Trained in approaches that don’t require the typical adjustment but it is available when needed. Use a whole body approach and consider other factors that may be contributing to problems such as diet, ergonomics, lifestyles, etc.
- Dr. Dale Thompson is a Stratford, Iowa based male chiropractor with 22 years of experience in General Chiropractor. He completed his graduation from Logan College Of Chiropractic in 2002. He accepts the Medicare-approved amount. Patients will not be billed for any more than the Medicare deductible and coinsurance. Active license number of Dr. Dale Thompson as General Chiropractor is 06631 in Iowa. Dr. Dale Thompson is qualified as a Doctor of Chiropractic (D.C.), licensed by the State and who practices chiropractic medicine -that discipline within the healing arts which deals with the nervous system and its relationship to the spinal column and its interrelationship with other body systems.
- Dr. Thompson graduated from the Logan College of Chiropractic in 2002. He works in Stratford, IA and specializes in Chiropractor.
- DALE THOMPSON, D.C. practices at 813 SHAKESPEARE AVE, STRATFORD, IA 50249. Chiropractors diagnose and treat common spinal misalignments that can occur from lifestyle or injuries causing pain, discomfort and degenerative conditions. DALE THOMPSON, D.C. may be able to treat; back pain, sciatica, neck pain, shoulder pain, headaches, sports injuries, and auto accident injuries.
- Dr. Dale Thompson – Why I Like Being An Evidence-Based Chiropractor. Today we’re going to talk about being an evidence-based chiropractor. What does it mean to be practicing evidence-based chiropractic and we’re going to be talking about with Dr. Dale Thompson from Iowa. USA.
As we see, these texts are not always entirely clear about the fact that Dale has no medical degree. Dale recently posted: “Here in the USA it would be a board violation to ‘conceal’ that one is a doctor of chiropractic.” And in August 2021, he made this comment: “There are several professions that use the title doctor which aren’t earned from a medical college: dentists, optometrists, physical therapists. Within chiropractic, when we advertise, at least in the USA, we are required to identify that we are a doctor of chiropractic. Of course the word doctor originally was used by a religious sect but the medical profession decided they wanted it … “Several authors have recently lamented the continued chiropractic inclination to use outdated and anatomically incorrect language to describe the nature of the manipulable lesion (“subluxation”) and the method of treatment (“adjustment”).2,3,11 J Chiropr Educ. 2020 Oct; 34(2): 172–176.”
Next, I looked on Medline to find out wether Dale has ever published any research on his subject. I failed to find a single article in his name. This is remarkable because, all too often, he presents himself as THE expert in research.
Subsequently, I looked at some of the claims made by Dale. Here are a few of them:
- I can go to a conference and know if the speaker is generally telling the truth or is trying to sell a lie.
- I can read a research paper and know if it’s good or bad and how it may apply to what I do.
- I can take the best evidence and apply it and yet also have the freedom to find novel ways to approach a problem.
- I can take a seemly complex problem and find a simple solution as well as understand the complexity of an apparently simple problem.
- I know my clinical strengths and limitations as well as the strengths and limitations of other healthcare professionals.
- I do not have to jump on board the latest health fad but I can, and may, scrutinize it using logic, reasoning and supporting evidence.
- I can respect my colleagues desire to practice different than me but I still demand they do so in an evidence-based chiropractor and ethical manner.
- My patients come first, my profession second and I am last.
So, what should we conclude about Dale Thompson?
I don’t know about you, but I get the impression that Dale lacks the ability to be critical of his own abilities and of the value of chiropractic. He likes to post comments that are aimed at misleading us. He might not be a ‘straight chiropractor‘ in the usual sense of the term, but in my view he also is still far from straight. Personally, I have not taken much notice of his deeply biased, often pompous and smug comments for some time. I suggest you consider doing the same.
But Dale is just one chiro!
He hardly has any wider significance.
So, why even bother and write a whole blog post about him?
I certainly agree that such a man does not deserve the attention we have been giving him. But Dale stand for so many of his colleagues. In fact, he is a prime example of a chiro victim of the ‘Dunning Kruger Effect‘. These people have a thin veneer of respectability which allows them to pretend to be veritable ‘know alls’. They remain entirely oblivious to the fact that they have been brain-washed at chiro school and have become a life-time members of a cult unable to see how deluded they truly are. As such they are dangerous, and I feel that the public needs to be aware of the danger.
And here you have the true reason why I am writing these lines.
In November 2022, we discussed a dodgy acupuncture review. Let me show you my post from back then again:
Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.
The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.
Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture
- relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
- improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
- improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).
There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).
The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.
What should we make of this paper?
In case you are in a hurry: NOT A LOT!
In case you need more, here are a few points:
- many trials were of poor quality;
- there was evidence of publication bias;
- there was considerable heterogeneity within the studies.
The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.
Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.
Dishonest researchers?
Biased reviewers?
Incompetent editors?
Truly unbelievable!!!
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.
PS
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!
Now, it has been announced that the paper has been retracted:
The research “Acupuncture for low back and/or pelvic pain during pregnancy: a systematic review and meta-analysis of randomised controlled trials,” published in the open access journal BMJ Open in 2022, has been retracted.
This research was press released in November 2022 under the title of “Acupuncture can relieve lower back/pelvic pain often experienced during pregnancy.”
Following publication of the research, various issues concerning its design and reporting methods came to light, none of which was amenable to correction, prompting the decision to retract.
The full wording of the retraction notice, which will be published at 23.30 hours UK (BST) time Tuesday 11 June 2024, is set out below:
“After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.” doi:10.1136/bmjopen-2021-056878ret
Please ensure that you no longer cite this research in any future reporting.
One down, dozens of further SCAM papers to go!
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.
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.
