conflict of interest
Absurd claims about spinal manipulative therapy (SMT) improving immune function have increased substantially during the COVID-19 pandemic. Is there any basis at all for such notions?
The objective of this systematic review was to identify, appraise, and synthesize the scientific literature on the efficacy and effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes in patients with infectious disease and to examine the association between SMT and selected immunological, endocrine, and other physiological biomarkers.
A literature search of MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Index to Chiropractic Literature, the Cochrane Central Register of Controlled Trials, and Embase was conducted. Randomized clinical trials and cohort studies were included. Eligible studies were critically appraised, and evidence with high and acceptable quality was synthesized using the Synthesis Without Meta-Analysis guideline.
A total of 2593 records were retrieved; after exclusions, 50 full-text articles were screened, and 16 articles reporting the findings of 13 studies comprising 795 participants were critically appraised. No clinical studies were located that investigated the efficacy or effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes among patients with infectious disease. Eight articles reporting the results of 6 high- and acceptable-quality RCTs comprising 529 participants investigated the effect of SMT on biomarkers. Spinal manipulative therapy was not associated with changes in lymphocyte levels or physiological markers among patients with low back pain or participants who were asymptomatic compared with sham manipulation, a lecture series, and venipuncture control groups. Spinal manipulative therapy was associated with short-term changes in selected immunological biomarkers among asymptomatic participants compared with sham manipulation, a lecture series, and venipuncture control groups.
The authors concluded that no clinical evidence was found to support or refute claims that SMT was efficacious or effective in changing immune system outcomes. Although there were limited preliminary data from basic scientific studies suggesting that SMT may be associated with short-term changes in immunological and endocrine biomarkers, the clinical relevance of these findings is unknown. Given the lack of evidence that SMT is associated with the prevention of infectious diseases or improvements in immune function, further studies should be completed before claims of efficacy or effectiveness are made.
I fully agree with the data as summarised in this paper. Yet, I find the conclusions a bit odd. The authors of this paper are chiropractors who declare the following conflicts of interest: Dr Côté reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Research Foundation, travel expenses from the World Federation of Chiropractic, and personal fees from the Canadian Chiropractic Protective Association outside the submitted work. Dr Cancelliere reported receiving grants from the Canadian Chiropractic Research Foundation outside the submitted work. Dr Mior reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Association and the Ontario Chiropractic Association outside the submitted work. Dr Hogg-Johnson reported receiving grants from the College of Chiropractors of British Columbia during the conduct of the study and grants from the Canadian Chiropractic Research Foundation outside the submitted work. No other disclosures were reported. The research was supported by funding from the College of Chiropractors of British Columbia to Ontario Tech University, the Canada Research Chairs program (Dr Côté), and the Canadian Chiropractic Research Foundation (Dr Cancelliere).
Would authors independent of chiropractic influence have drawn the same conclusions? I doubt it! While I do appreciate that chiropractors published these negative findings prominently, I feel the conclusions could easily be put much clearer:
There is no clinical evidence to support claims that SMT is efficacious or effective in changing immune system outcomes. Further studies in this area are not warranted.
Battlefield Acupuncture (BFA) – I presume the name comes from the fact that it is so simple, it could even be used under combat situations – is a form of ear acupuncture developed 20 years ago by Dr Richard Niemtzow. BFA employs gold semipermanent needles that are placed at up to 5 specific sites in one or both ears. The BFA needles are small conical darts that pierce the outer ear in designated locations and remain in place until they fall out typically within 3–4 days.
The US Defense and Veterans Center for Integrative Pain Management and the Veterans Health Administration National Pain Management Program Office recently completed a 3-year acupuncture education and training program, which deployed certified BFA trainers for the Department of Defense and Veterans Administration medical centers. Over 2800 practitioners were thus trained to provide BFA. The total costs amounted to $ 5.4 million.
This clearly begs the question:
DOES IT WORK?
This review aims to investigate the effects and safety of BFA in adults with pain. Electronic databases were searched for randomized controlled trials (RCTs) published in English evaluating efficacy and safety of BFA in adults with pain, from database inception to September 6, 2019. The primary outcome was pain intensity change, and the secondary outcome was safety. Nine RCTs were included in this review, and five trials involving 344 participants were analyzed quantitatively. Compared with no intervention, usual care, sham BFA, and delayed BFA interventions, BFA had no significant improvement in the pain intensity felt by adults suffering from pain. Few adverse effects (AEs) were reported with BFA therapy, but they were mild and transitory.
The authors of this review concluded that BFA is a safe, rapid, and easily learned acupuncture technique, mainly used in acute pain management, but no significant efficacy was found in adult individuals with pain, compared with the control groups. Given the poor methodological quality of the included studies, high-quality RCTs with rigorous evaluation methods are needed in the future.
And here are my comments:
- SAFE? Impossible to tell on the basis of 344 patients.
- RAPID? True, but meaningless, as it does not work.
- EASILY LEARNT? True, it’s simple and seems ever so stupid.
- NO SIGNIFICANT EFFICACY? That I can easily believe.
I am amazed that anyone would fall for an idea as naive as BFA. That it should be the US military is simply hilarious, in my view. I am furthermore baffled that anyone recommends more study of such monumental nonsense.
Why, oh why?
Acupuncture is far-fetched (to put it mildly). Ear acupuncture is positively ridiculous. BFA seems beyond ridiculous and must be the biggest military hoax since general Grigory Aleksandrovich Potemkin painted façades to fool Catherine the Great into thinking that an area was far richer than it truly was.
Low back pain must be one of the most frequent reasons for patients to seek out some so-called alternative medicine (SCAM). It would therefore be important that the information they get is sound. But is it?
The present study sought to assess the quality of web-based consumer health information available at the intersection of LBP and CAM. The investigators searched Google using six unique search terms across four English-speaking countries. Eligible websites contained consumer health information in the context of CAM for LBP. They used the DISCERN instrument, which consists of a standardized scoring system with a Likert scale from one to five across 16 questions, to conduct a quality assessment of websites.
Across 480 websites identified, 32 were deemed eligible and assessed using the DISCERN instrument. The mean overall rating across all websites 3.47 (SD = 0.70); Summed DISCERN scores across all websites ranged from 25.5-68.0, with a mean of 53.25 (SD = 10.41); the mean overall rating across all websites 3.47 (SD = 0.70). Most websites reported the benefits of numerous CAM treatment options and provided relevant information for the target audience clearly, but did not adequately report the risks or adverse side-effects adequately.
The authors concluded that despite some high-quality resources identified, our findings highlight the varying quality of consumer health information available online at the intersection of LBP and CAM. Healthcare providers should be involved in the guidance of patients’ online information-seeking.
In the past, I have conducted several similar surveys, for instance, this one:
Background: Low back pain (LBP) is expected to globally affect up to 80% of individuals at some point during their lifetime. While conventional LBP therapies are effective, they may result in adverse side-effects. It is thus common for patients to seek information about complementary and alternative medicine (CAM) online to either supplement or even replace their conventional LBP care. The present study sought to assess the quality of web-based consumer health information available at the intersection of LBP and CAM.
Methods: We searched Google using six unique search terms across four English-speaking countries. Eligible websites contained consumer health information in the context of CAM for LBP. We used the DISCERN instrument, which consists of a standardized scoring system with a Likert scale from one to five across 16 questions, to conduct a quality assessment of websites.
Results: Across 480 websites identified, 32 were deemed eligible and assessed using the DISCERN instrument. The mean overall rating across all websites 3.47 (SD = 0.70); Summed DISCERN scores across all websites ranged from 25.5-68.0, with a mean of 53.25 (SD = 10.41); the mean overall rating across all websites 3.47 (SD = 0.70). Most websites reported the benefits of numerous CAM treatment options and provided relevant information for the target audience clearly, but did not adequately report the risks or adverse side-effects adequately.
Conclusion: Despite some high-quality resources identified, our findings highlight the varying quality of consumer health information available online at the intersection of LBP and CAM. Healthcare providers should be involved in the guidance of patients’ online information-seeking.
Or this one:
Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).
Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.
Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,
Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.
The findings were invariably disappointing and confirmed those of the above paper. As it is nearly impossible to do much about this lamentable situation, I can only think of two strategies for creating progress:
- Advise patients not to rely on Internet information about SCAM.
- Provide reliable information for the public.
Both describe the raison d’etre of my blog pretty well.
Previous studies have shown inconclusive results of homeopathy in the treatment of warts. A team of Indian homeopaths aimed to assess the feasibility of a future definitive trial, with a preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in the treatment of cutaneous warts.
A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of warts; the secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample.
Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes-both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported.
The Indian homeopaths draw the following conclusion: As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted.
No, the findings are not inconclusive at all! Read the results again: they confirm that homeopathy is a placebo therapy.
So, why is this trial worth writing about?
Surely, we did not expect anything else than a negative outcome from such a study?!
No, we didn’t.
But there is still something quite remarkable about this study: I have previously noted that virtually all studies of homeopathy by Indian researchers report positive results. AND THIS ONE DOESN’T!!!
Alright, it tries to hide the fact that the findings were negative, but this already seems to be a step in the right direction. So, well done, my Indian friends!!!
Perhaps one day, you will be able to admit that homeopathy is a placebo therapy?
The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.
The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.
Here are 6 results that I found noteworthy:
- Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
- Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
- Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
- Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
- Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
- Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.
Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:
- Do you believe in the concept of subluxation?
- Do you treat conditions other than spinal problems?
- How frequently do you use spinal manipulations?
- How often do you see adverse effects of spinal manipulation?
- Do you obtain informed consent from all patients?
- How often do you refer patients to medical doctors?
- Do you advise in favour of vaccinations?
- Do you follow the rules of evidence-based medicine?
- Do you offer advice about prescribed medications?
- Which supplements do you recommend?
- Do you recommend maintenance treatment?
I wonder why they were not included.
After yesterday’s post entitled ‘What does a holistic doctor do that a traditional doctor doesn’t?‘, I thought it would only be fair to turn the question around and ask: What does a proper doctor do that a holistic healer doesn’t? The answers will upset a lot of practitioners of alternative medicine (SCAM), but so be it.
So, what does a proper doctor do that a holistic healer doesn’t?
I suggest several answers and hope that the readers of this blog will contribute to further points. Many of them center around safeguarding the public:
- Proper doctors avoid confusing or misleading the public with titles they do not have.
- They do have rigorous education and training.
- They avoid making false therapeutic claims.
- They adhere to the ethical standards of their profession.
- They resist the temptation to advertise their services to the consumer.
- They do their best to identify the cause of their patient’s symptoms.
- They treat the causes of disease whenever possible.
- They avoid pretending that they always have all the answers.
- They abide by the rules of evidence-based medicine.
- They are aware that almost any effective treatment comes with adverse effects.
- They try to keep abreast with the rapid advances in medicine.
- They know that a patient is more than a diagnostic label.
- They try to treat patients holistically.
At this stage, I can hear some readers shout in anger:
- Ahh, but that is rubbish!
- I know doctors who are not at all like that!
- You are idealizing your profession!
- This is little more than wishful thinking!
Yes, I know that many patients are disappointed and have had a bad experience with conventional medicine. That is one of the reasons many try SCAM. I know that many doctors occasionally fail to live up to the ideal that I depicted above. And I fear that some do so more often than just occasionally.
This is regrettable and occasionally it is unacceptable. Medicine is populated not by perfect people; it is run by humans like you and me. Humans are fallible. Doctors have bad days just like you and me. If that happens regularly, we need to address the problems that may the cause of the deficit. If necessary, the case has to go before a disciplinary hearing. There are thousands of experts who are dedicated to improving healthcare in the hope of generating progress.
The point I was trying to make is that there is such a thing as an ideal physician. It relies on:
- rigorous training,
- ethical codes,
- post-graduate education,
- swift disciplinary procedures,
- advances brought about through colossal research efforts,
- etc., etc.
Do ‘holistic healers’ offer all of these safeguards?
The sad answer is no.
For those who disagree, let’s briefly look at a recent example.
- Mr. Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by a considerable external force.
- The pathologist’s report also showed that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
- This is a common abnormality in elderly patients and limits the range of movement of the neck.
- There was no adequately informed consent by Mr. Lawler.
- Mr. Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
- There is no reason to assume that the treatment of Mr. Lawler’s neck would be effective for his pain located in his leg.
- The chiropractor used an ‘activator’ that applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.
As far as I can see, most of the safeguards and standards that apply to conventional medicine were not in place to safeguard Mr. Lawler. And that includes a timely disciplinary hearing of the case. Mr. Lawler died in 2017! The CCG has been dragging its feet ever since, and, as far as I know, the chiropractor was meanwhile allowed to practise. The HEARING BEFORE THE PROFESSIONAL CONDUCT COMMITTEE OF THE GENERAL CHIROPRACTIC COUNCIL has now been scheduled to commence on 19 April 2021.
I know, it’s just an example. But it should make us think.
In the world of homeopathy, Prof Michael Frass is a famous man. He is the First Chairman of the Scientific Society for Homeopathy (WissHom), the president of the Umbrella organization of Austrian Doctors for Holistic Medicine, and the Vicepresident of the Doctors Association for Classical Homeopathy. Frass has featured on this blog before, not least because he has published numerous studies of homeopathy, none of which has ever failed to produce a positive result.
This is not just remarkable, in my view, it defies logic and the laws of nature. Even if homeopathy were a supremely effective therapy – a very broad consensus holds that it is not! – one would occasionally expect some negative results. No treatment works under all circumstances
… that is no treatment except homeopathy, according to Frass.
Recently Frass amazed even the world of oncology by publishing a study suggesting that homeopathy can prolong the survival of lung cancer patients. Every oncologist I know was flabbergasted.
Can this be true? This is the question, many people have been asking for some time in relation to Frass’s research.
In my quest to shine more light on it, I was recently alerted to an article by the formidable Austrian investigative journalist, Alwin Schönberger. In 2015, he came across a press release announcing that “HOMEOPATHY HAD BEEN PROVEN TO WORK AFTER ALL” (strikingly similar to one issued in 2018). It came from Austria’s leading manufacturer who was giving an award to an apparently outstanding thesis supervised by Frass. Even today, this piece of research has not been published in the peer-reviewed literature.
Yet, after some difficulties, Schönberger managed to obtain a copy. What he found was surprising, and he thus published his findings in the respected Austrian journal ‘Profil’ (2. Mai 2015 • profil 22).
Frass’s student had been given the task to systematically review all the homeopathy trials published between 2008 and 2012. Contrary to the hype of the press release, the meta-analysis merely suggested a very small effect. When digging deeper, Schönberger found several inconsistencies and mistakes in the analysis. They all were such that they produced a false-positive picture for homeopathy. Upon their correction, homeopathy turned out to be no longer significantly superior to placebo. Frass was then interviewed about it and claimed that the inconsistencies were only ‘errors’ but insisted that homeopathy is not a placebo therapy.
Yes, of course, errors happen in research. But if they all go in one direction and if that direction coincides with the interests of the researchers, we have the right, perhaps even the duty, to be suspicious. The questions that arise from this story are, I think, as follows:
- Have the errors been corrected?
- Are there perhaps other errors in Frass’s research?
- Can we trust anything that Frass says?
- Is it time to consider an official investigation into Frass’s studies of homeopathy?
There are plenty of people who find it hard to accept that highly diluted homeopathic remedies are placebos. They religiously believe in the notion that homeopathy works and studiously ignore the overwhelming evidence (plus a few laws of nature). Yet, they pretend to staunchly believe in science and keep on conducting (pseudo?) scientific studies of homeopathy. To me, this seems oddly schizophrenic because, on the one hand, they seem to accept science by conducting trials, while, on the other hand, they reject science by negating the scientific consensus.
The objective of this recent study was to evaluate the quality of life (QoL) of women treated with homeopathy within the Public Health System of Belo Horizonte, Brazil.
The study was designed as a prospective randomized controlled pragmatic trial. The patients were divided into two independent groups, one group underwent homeopathic treatment during a 6-month period, while the other did not receive any homeopathic treatment. In both randomized groups, patients maintained their conventional medical treatment as necessary. The World Health Organization Quality of Life abbreviated questionnaire (WHOQOL-BREF) was used for QoL analysis prior to treatment and 6 months later.
Randomization was successful in that it resulted in similar baseline results in three domains of QoL analysis for both groups. After 6 months’ treatment, the investigators noted a statistically significant difference between groups in the physical domain of WHOQOL-BREF: the average score improved to 63.6 ± (SD) 15.8 in the homeopathy group, compared with 53.1 ± (SD) 16.7 in the control group.
The authors concluded that homeopathic treatment showed a positive impact at 6 months on the QoL of women with chronic diseases. Further studies should be performed to determine the long-term effects of homeopathic treatment on QoL and its determinant factors.
I would not be surprised if the world of homeopathy were to celebrate this trial as yet another proof that homeopathy is effective. I am afraid, however, that I might have to put a damper on their excitement:
THIS STUDY DOES NOT SHOW WHAT YOU THINK IT DOES.
Regular readers of this blog will have already guessed it: the trail follows the infamous ‘A+B versus B’ design. Some people will think that I am obsessed with this theme – but I am not; it’s just that, in SCAM, it comes up with such depressing regularity. And as this blog is mainly about commenting on newly published research, I am unable to avoid the subject.
So, let me explain it again.
Think of it in monetary terms: you have an amount X, your friend has the same amount X plus an extra sum Y. Who do you think has more money? You don’t need to be a genius to guess, do you?
The same happens in the above ‘A+B versus B’ trial:
- the patients in group 1 received homeopathy (A) plus usual care (B);
- the patients in group 2 received usual care (B) and nothing else.
You don’t need to be a genius to guess who might have the better outcomes.
Because of homeopathy?
No! Because of the patients’ expectation, the placebo effect, and the extra attention of the homeopaths. They call this trial design ‘pragmatic’. I feel it is an attempt to mislead the public.
So, allow me to re-write the authors’ conclusion as follows:
The effect of a homeopathic consultation and the administration of a placebo generated a positive impact at 6 months on the QoL of women with chronic diseases. This was entirely predictable and totally unrelated to homeopathy. Further studies to determine the long-term effects of homeopathic treatment on QoL and its determinant factors are not needed.
The Chinese have made several attempts to persuade us that their traditional remedies are effective for COVID-19 infections. Here is yet another one. This review summarised the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. All clinical studies of the therapeutic effects and safety of CHM for COVID-19 were included. The authors
- summarized the general characteristics of included studies,
- evaluated the methodological quality of the randomized controlled trials (RCTs) using the Cochrane risk of bias tool,
- analyzed the use of CHM,
- used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM.
A total of 58 clinical studies were identified including;
- 10 RCTs,
- 1 non-randomized controlled trials,
- 11 retrospective studies with a control group,
- 12 case-series,
- 24 case-reports.
All of the studies had been performed in China. No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection, or prescribed herbal decoction were:
- Lianhua Qingwen granule/capsule,
- Xuebijing injection,
- Maxing Shigan Tang.
The pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), indicating that CHM plus conventional western therapy appeared to be better than conventional western therapy alone in reducing aggravation rate.
In addition, compared with conventional western therapy, CHM plus conventional western therapy had the potential advantages in increasing the recovery rate and shortening the duration of fever, cough, and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement.
For adverse events, the pooled data showed that there were no statistical differences between the CHM and the control groups.
The authors concluded that current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.
One of the principles to remember here is this: RUBBISH IN, RUBBISH OUT. If you meta-analyze primary data that are rubbish, your findings can only be rubbish as well.
All one needs to know about the primary data entered into the present analysis is that there were no rigorous RCTs… not one! That means the evidence is, as the authors rightly but modestly conclude of LOW CERTAINTY. My conclusions would have been a little different:
- In terms of safety, the dataset is too small and unreliable to make any judgment.
- In terms of efficacy, there is no sound data that CHM has a positive effect.
This study was aimed at determining the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.
The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).
Patients were randomized 2:2:1 to:
- electroacupuncture (n = 145),
- auricular acupuncture (n = 143),
- or usual care (n = 72).
Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.
The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.
Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).
The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.
I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:
In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.
I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.
Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:
As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…
Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.
Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.
This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.
It is hard not to conclude that they deliberately try to mislead us.