I have often called out unreliable or fraudulent research in the realm of Traditional Chinese Medicine (TCM). I think it is important to do so because the abundance of scientific misconduct is such that it has become a danger to public health. Today, I present yet another example:
This recent review claimed to summarize the evidence on TCM in treating MI, the clinical evaluations of TCM in treating male infertility (MI), and the molecular mechanisms of TCM effects. I was alerted to the fact that the authors cite a paper on acupuncture that I had co-authored. Here is the section in question from the review:
Acupuncture is one of the therapeutic techniques that are part of TCM. Acupuncture is a non-invasive technique and is regarded as free of risk if performed by trained personnel . One of the advantages of acupuncture was that the incidence of adverse effects was substantially lower than that of many drugs or other accepted . Acupuncture has been used in the treatment of male and female infertility and in assisted reproductive technology treatments for many years. A total of 100 patients with MI who met the diagnostic criteria were randomly divided into two groups . Half of the patients received acupuncture treatment, and the other half received placebo acupuncture. After 10 weeks treatment, acupuncture successfully improved the indicators of the semen, including the spermatozoa survival rate, b-level activity rate, sperm density, sperm activity rate. A total of 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of acupuncture and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture . Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler essence injection to acupoints and oral administration of Chinese materia medica, 142 cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective and 21 cases (7.1%) ineffective . The therapeutic effect of the combination of these three treatments was satisfactory.
Emerging evidence has shown that cell-cell interactions between testicular cells, in particular at the Sertoli cell-cell and Sertoli-germ cell interface, are crucial to support spermatogenesis. The unique ultrastructures that support cell-cell interactions in the testis are the basal ES (ectoplasmic specialization) and the apical ES. The basal ES is found between adjacent Sertoli cells near the basement membrane that also constitute the blood-testis barrier (BTB). The apical ES is restrictively expressed at the Sertoli-spermatid contact site in the apical (adluminal) compartment of the seminiferous epithelium. These ultrastructures are present in both rodent and human testes, but the majority of studies found in the literature were done in rodent testes. As such, our discussion herein, unless otherwise specified, is focused on studies in testes of adult rats. Studies have shown that the testicular cell-cell interactions crucial to support spermatogenesis are mediated through distinctive signaling proteins and pathways, most notably involving FAK, Akt1/2 and Cdc42 GTPase. Thus, manipulation of some of these signaling proteins, such as FAK, through the use of phosphomimetic mutants for overexpression in Sertoli cell epithelium in vitro or in the testis in vivo, making FAK either constitutively active or inactive, we can modify the outcome of spermatogenesis. For instance, using the toxicant-induced Sertoli cell or testis injury in rats as study models, we can either block or rescue toxicant-induced infertility through overexpression of p-FAK-Y397 or p-FAK-Y407 (and their mutants), including the use of specific activator(s) of the involved signaling proteins against pAkt1/2. These findings thus illustrate that a potential therapeutic approach can be developed to manage toxicant-induced male reproductive dysfunction. In this review, we critically evaluate these recent findings, highlighting the direction for future investigations by bringing the laboratory-based research through a translation path to clinical investigations.
This paper does not relate to the statement it is meant to support by the review authors.
The review by Qin et al (1) includes 5 trials none of which should have been included in a quality metaanalysis as the methodology was unconvincing: In the trial by Alraek et al., patients were randomised to receive either acupuncture or no treatment. This means that no attempt was made to control for the effects of placebo or extra attention. Therefore, this study does not demonstrate an effect of acupuncture as the outcome could be due to non-specific effects unrelated with this therapy. By contrast, the trial by Aune et al. did attempt to control for placebo effects by using a sham control group. Sham acupuncture was given using six needles superficially inserted in the calves, thighs or abdomen outside known acupuncture points or meridians. Needles were not manipulated in the sham group. Sham or placebo controls have the purpose of rendering patients unaware of whether they receive the real or the sham treatment. The method used here cannot achieve this aim; patients would be easily able to tell which intervention they received. In other words, this study also did not adequately control for placebo effects. The remaining three trials are all not Medline-listed, authored by Chinese investigators and published in inaccessible journals. This should disqualify them from inclusion as they were unverifiable by the peer review process. According to the published table, they were equivalence trials of acupuncture versus antibiotics with a sample size around 30. This means they are grossly underpowered and thus unable to generate reliable results. Unless BJOG peer reviewers could see the primary articles, or be provided with translations from Chinese, the systematic review should not have been accepted. The “many eyes of science” requires transparency, testing, challenge and verification. Although in the past, inconclusive results of acupuncture have not been thought to be due to Chinese influence (2), it has been noted that virtually all recent published acupuncture trials are “positive” (3), raising questions of publication and other biases. Our colleagues are under tremendous pressure to publish, but we do them no favours by effectively lowering the standard of scientific peer review. Elite journals too have an obligation to train and reiterate about publication ethics and sound scientific writing (4). As none of the primary studies convincingly demonstrated that acupuncture is an effective therapy for recurrent urinary tract infections, no positive conclusion was warranted. Although Qin et al. did state that the risk of bias of the included trials was generally high or unclear (1), the BJOG nevertheless allowed them to turn massive uncertainty into relatively firm, positive conclusions in the abstract (“Acupuncture appeared to be beneficial for treatment and prophylaxis of rUTIs”) and tweetable abstract (“This review found that acupuncture may improve treatment and prevent recurrence of urinary tract infection in women”), thus leading to excited media headlines that inevitably mislead the public. ‘May’ is a weasel word which should be avoided as it is unfalsifiable (for example, pigs do not fly but they ‘may’ fly in the future). The definite, straightforward conclusion must be “There is no good evidence to support the use of acupuncture for the treatment and prophylaxis of recurrent UTIs”. It is not acceptable to give international credibility to an implausible modality that no objective, independent high-quality review has found effective beyond placebo (5). The dampening accompanying mini-commentary (6) does not undo the damage.
The review should be withdrawn while the primary papers are translated for peer reviewers to examine, the above limitations discussed in the text, and the positive ‘spin’ in conclusions corrected. These improvements would consolidate the researchers’ probity and justify the accolade of BJOG publication.
Our letter to the editor does not bear any relation to the statement it is meant to support by the review authors.
In this first prospective, randomized, single-blind, placebo-controlled study, 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of traditional Chinese medicine (TCM) and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A–C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.
This small study is far from convincing and does not lend itself to far-reaching conclusions
Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler
essence injection to acupoints and oral administration of Chinese materia medica, 142
cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective
and 21 cases (7.1%) ineffective. The therapeutic effect of the combination of these three
treatments was satisfactory.
This study had no control group and used two different therapies. Therefore, it does not allow any conclusion about the effectiveness of acupuncture.
Perhaps you feel that these errors are trivial. But I would disagree. The review authors’ praise of acupuncture for MI is misplaced and will mislead the public. There are plenty of reviews on the subject, and those that are not overtly biased arrive at conclusions like these:
- The current evidence on acupuncture for oligoasthenozoospermia is inadequate to draw a solid conclusion due to the poor methodological quality. Rigorous full-scale RCTs are needed to validate the therapeutic efficacy and safety of acupuncture in treating oligoasthenozoospermia.
- The current evidence showing that acupuncture might improve poor semen quality is insufficient because of the small number of studies, inadequacy of procedures and/or insufficient information for semen analysis, high levels of heterogeneity, high risk of bias, and poor quality of reporting. Further large, well-designed RCTs are required.
So, how did this sloppy review come about?
Its authors are affiliated to the TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China, and the Tea Research Institute, Sichuan Academy of Agricultural Sciences, Chengdu 610066, China. A footnote tells us that their review was supported by the National Natural Science Foundation of China [No. 81973647] and the Xinglin scholar discipline promotion talent program of Chengdu University of traditional Chinese medicine [No. BSH2021018]. This sounds respectable enough.
The journal that published the review is ‘Pharmacological Research – Modern Chinese Medicine‘. Its stated aims are as follows: The journal publishes articles reporting on advances in our comprehension of mechanism and safety in experimental pharmacology and clinical efficacy and safety of pharmacologically active substances, including compound prescriptions, utilized in Traditional Chinese Medicine applying modern scientific research methods. Studies reporting also on the mechanisms of actions of the active substance(s) investigated are encouraged.
The editors in chief of the journal are Guan-Hua Du, PhD, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica, Beijing, China and Emilio Clementi, M.Mus, MD, PhD, University of Milan, Milan, Italy. No doubt, these are respectable scientists. And because they are, they should make sure that what they publish is correct – a criterion this recent review clearly does not meet.
Bee venom acupuncture (BVA) is a bizarre form of acupuncture where bee venom is applied via a bee sting or an injection into acupuncture points. The paper below starts with the sentence: “BVA is an effective treatment method for various diseases.” This clearly is not true. In fact, there is no convincing evidence that it is effective for any condition. In addition, it can cause serious harm, even life-threatening anaphylaxis.
With this review, Korean authors tried to estimate the incidence rate of anaphylaxis in response to BVA.
The investigators searched eight databases (MEDLINE (Pubmed), EMBASE, Cochrane Central Register of Controlled, KISS, KMBASE, Koreamed, OASIS, and NDSL) and systematically reviewed the articles that met the inclusion/exclusion criteria.
Among 225 potentially relevant articles, 49 were selected for this study. The overall incidence rate of anaphylaxis in response to BVA was 0.045% (95% CI 0.028-0.062). Women (0.083%, 95% CI 0.010-0.157) showed a higher incidence rate than men (0.019%, 95% CI -0.018 to 0.055), while the incidence for patients who had a skin test conducted (0.041%, 95% CI 0.011-0.072) was not significantly different compared to that obtained for patients for which there was no information about a skin test (0.047%, 95% CI 0.026-0.067). The publication year affected the incidence rate: it was highest before 1999 (1.099%, 95% CI -1.043 to 3.241), lower between 2000 and 2009 (0.049%, 95% CI 0.025-0.073), and lowest between 2010 and 2021 (0.037% 95% CI 0.014-0.060).
The authors concluded that, in this study, we provide reference data about risk size and factors of BVA-related anaphylaxis, which is essentially required for BVA application in clinics.
I fail to understand why this review included only observational studies and RCTs. Why not case reports? We would need a proper post-marketing surveillance system to obtain reliable incidence figures. Yet, such a system does not exist. Therefore, the data generated by this paper are next to worthless.
All this article does, is confirm that anaphylactic reactions after BVA are a reality. As the treatment has not been proven to be effective for any condition, its risk/benefit balance turns out to be negative. In other words, we should therefore not use BVA.
This study used a US nationally representative 11-year sample of office-based visits to physicians from the National Ambulatory Medical Care Survey (NAMCS), to examine a comprehensive list of factors believed to be associated with visits where complementary health approaches were recommended or provided.
NAMCS is a national health care survey designed to collect data on the provision and use of ambulatory medical care services provided by office-based physicians in the United States. Patient medical records were abstracted from a random sample of office-based physician visits. The investigators examined several visit characteristics, including patient demographics, physician specialty, documented health conditions, and reasons for a health visit. They ran chi-square analyses to test bivariate associations between visit factors and whether complementary health approaches were recommended or provided to guide the development of logistic regression models.
Of the 550,114 office visits abstracted, 4.43% contained a report that complementary health approaches were ordered, supplied, administered, or continued. Among complementary health visits, 87% of patient charts mentioned nonvitamin nonmineral dietary supplements. The prevalence of complementary health visits significantly increased from 2% in 2005 to almost 8% in 2015. Returning patient status, survey year, physician specialty and degree, menopause, cardiovascular, and musculoskeletal diagnoses were significantly associated with complementary health visits, as was seeking preventative care or care for a chronic problem.
The authors concluded that these data confirm the growing popularity of complementary health approaches in the United States, provide a baseline for further studies, and inform subsequent investigations of integrative health care.
The authors used the same dataset for a 2nd paper which examined the reasons why office-based physicians do or do not recommend four selected complementary health approaches to their patients in the context of the Andersen Behavioral Model. Descriptive estimates were employed of physician-level data from the 2012 National Ambulatory Medical Care Survey (NAMCS) Physician Induction Interview, a nationally representative survey of office-based physicians (N = 5622, weighted response rate = 59.7%). The endpoints were the reasons for the recommendation or lack thereof to patients for:
- other non-vitamin supplements,
- chiropractic/osteopathic manipulation,
- mind-body therapies (including meditation, guided imagery, and progressive relaxation).
Differences by physician sex and medical specialty were described.
For each of the four complementary health approaches, more than half of the physicians who made recommendations indicated that they were influenced by scientific evidence in peer-reviewed journals (ranging from 52.0% for chiropractic/osteopathic manipulation [95% confidence interval, CI = 47.6-56.3] to 71.3% for herbs and other non-vitamin supplements [95% CI = 66.9-75.4]). More than 60% of all physicians recommended each of the four complementary health approaches because of patient requests. A higher percentage of female physicians reported evidence in peer-reviewed journals as a rationale for recommending herbs and non-vitamin supplements or chiropractic/osteopathic manipulation when compared with male physicians (herbs and non-vitamin supplements: 78.8% [95% CI = 72.4-84.3] vs. 66.6% [95% CI = 60.8-72.2]; chiropractic/osteopathic manipulation: 62.3% [95% CI = 54.7-69.4] vs. 47.5% [95% CI = 42.3-52.7]).
For each of the four complementary health approaches, a lack of perceived benefit was the most frequently reported reason by both sexes for not recommending. Lack of information sources was reported more often by female versus male physicians as a reason to not recommend herbs and non-vitamin supplements (31.4% [95% CI = 26.8-36.3] vs. 23.4% [95% CI = 21.0-25.9]).
The authors concluded that there are limited nationally representative data on the reasons as to why office-based physicians decide to recommend complementary health approaches to patients. Developing a more nuanced understanding of influencing factors in physicians’ decision making regarding complementary health approaches may better inform researchers and educators, and aid physicians in making evidence-based recommendations for patients.
I am not sure what these papers really offer in terms of information that is not obvious or that makes a meaningful contribution to progress. It almost seems that, because the data of such surveys are available, such analyses get done and published. The far better reason for doing research is, of course, the desire to answer a burning and relevant research question.
A problem then arises when researchers, who perceive the use of so-called alternative medicine (SCAM) as a fundamentally good thing, write a paper that smells more of SCAM promotion than meaningful science. Having said that, I find it encouraging to read in the two papers that
- the prevalence of SCAM remains quite low,
- more than 60% of all physicians recommended SCAM not because they were convinced of its value but because of patient requests,
- the lack of perceived benefit was the most frequently reported reason for not recommending it.
Acupuncture is often promoted as a therapeutic option for obesity and weight control. The aim of this study was to investigate the effects of electroacupuncture (EA) on body weight, body mass index (BMI), skin fold thickness, waist circumference and skin temperature of the abdominal region in non-obese women with excessive abdominal subcutaneous fat.
A total of 50 women with excessive abdominal subcutaneous fat (and average BMI of 22) were randomly assigned to one of two groups:
- an EA group (n = 25) receiving 10 EA sessions (insertion of needles connected to an electrical stimulator at a frequency of 40 Hz for 40 min),
- a control group (n = 25) that received no treatment.
Outcome measures evaluated included waist circumference, supra-iliac and abdominal skinfolds, body composition and superficial skin temperature (measured by cutaneous thermography) before and after treatment.
Compared with the untreated group, women in the EA group exhibited decreased supra-iliac and abdominal skin folds (p < 0.001), waist circumference (p < 0.001), percentage body fat (p = 0.001) and percentage abdominal fat (p < 0.001). In addition, the EA group showed an elevated skin temperature at the site of the treatment. However, EA did not significantly impact body weight (p = 0.01) or BMI (p = 0.2).
The authors concluded that EA promoted a reduction in abdominal waist circumference, supra-iliac and abdominal skin folds, and percentage body and abdominal fat in women of normal BMI with excessive abdominal subcutaneous fat, as well as an increase in the superficial skin temperature of the abdominal region.
If we did not know that acupuncture researchers were all honest investigators testing hypotheses the best they can, we could almost assume that some are trying to fool us. The set-up of this study is ideally suited to introduce a proper placebo treatment. All one has to do is to not switch on the electrical stimulator in the control group. Why did the researchers not do that? Surely not because they wanted to increase the chances of generating a positive result; that would have been dishonest!!!
So, as it stands, what does the study tell us? I think it shows that, compared to patients who receive no treatment, patients who do receive the ritual of EA are better motivated to adhere to calorie restrictions and dietary advice. Thus, I suggest to re-phrase the conclusions of this trial as follows:
The extra attention of the EA treatment motivated obese patients to eat less which caused a reduction in abdominal waist circumference, supra-iliac and abdominal skin folds, and percentage body and abdominal fat in women of normal BMI with excessive abdominal subcutaneous fat.
This meta-analysis was conducted by researchers affiliated to the Evangelical Clinics Essen-Mitte, Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Germany. (one of its authors is an early member of my ALTERNATIVE MEDICINE HALL OF FAME). The paper assessed the safety of acupuncture in oncological patients.
The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool.
Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated with an increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or dropout because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.
The authors concluded that the current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology.
You might think this article is not too bad. So, why do I feel that this paper is so bad?
One reason is that the authors included evidence up to August 2020. Since then, there must have been hundreds of further papers on acupuncture. The article was therefore out of date before it was published.
But that is by no means my main reason. We know from numerous investigations that acupuncture studies often fail to report AEs (and thus violate publication ethics). This means that this new analysis is merely an amplification of the under-reporting. It is, in other words, a means of perpetuating a wrong message.
Yes, you might say, but the authors acknowledge this; they even state in the abstract that “The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.” True, but this fact does not erase the mistake, it merely concedes it. At the very minimum, the authors should have phrased their conclusion differently, e.g.: the current review confirms that AEs of acupuncture are under-reported in RCTs. Therefore, a meta-analysis of RCTs is unable to verify whether acupuncture is safe. From other types of research, we know that it can cause serious AEs.
An even better solution would have been to abandon or modify the research project when they first came across the mountain of evidence showing that RCTs often fail to mention AEs.
As it stands, the conclusion that acupuncture is as safe as sham acupuncture is simply not true. Since the article probably looks sound to naive readers, I feel that is a particularly good candidate for the WORST PAPER OF 2022 COMPETITION.
For those who are interested, here are 4 of my own peer-reviewed articles on the safety of acupuncture (much more can, of course, be found on this blog):
- Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency – PubMed (nih.gov)
- Acupuncture–a critical analysis – PubMed (nih.gov)
- Prospective studies of the safety of acupuncture: a systematic review – PubMed (nih.gov)
- The risks of acupuncture – PubMed (nih.gov)
Given the high prevalence of burdensome symptoms in palliative care (PC) and the increasing use of so-called alternative medicine (SCAM) therapies, research is needed to determine how often and what types of SCAM therapies providers recommend to manage symptoms in PC.
This survey documented recommendation rates of SCAM for target symptoms and assessed if, SCAM use varies by provider characteristics. The investigators conducted US nationwide surveys of MDs, DOs, physician assistants, and nurse practitioners working in PC.
Participants (N = 404) were mostly female (71.3%), MDs/DOs (74.9%), and cared for adults (90.4%). Providers recommended SCAM an average of 6.8 times per month (95% CI: 6.0-7.6) and used an average of 5.1 (95% CI: 4.9-5.3) out of 10 listed SCAM modalities. Respondents recommended mostly:
- mind-body medicines (e.g., meditation, biofeedback),
The most targeted symptoms included:
- mood disturbances,
Recommendation frequencies for specific modality-for-symptom combinations ranged from little use (e.g. aromatherapy for constipation) to occasional use (e.g. mind-body interventions for psychiatric symptoms). Finally, recommendation rates increased as a function of pediatric practice, noninpatient practice setting, provider age, and proportion of effort spent delivering palliative care.
The authors concluded that to the best of our knowledge, this is the first national survey to characterize PC providers’ SCAM recommendation behaviors and assess specific therapies and common target symptoms. Providers recommended a broad range of SCAM but do so less frequently than patients report using SCAM. These findings should be of interest to any provider caring for patients with serious illness.
Initially, one might feel encouraged by these data. Mind-body therapies are indeed supported by reasonably sound evidence for the symptoms listed. The evidence is, however, not convincing for many other forms of SCAM, in particular massage or acupuncture/acupressure. So encouragement is quickly followed by disappointment.
Some people might say that in PC one must not insist on good evidence: if the patient wants it, why not? But the point is that there are several forms of SCAMs that are backed by good evidence for use in PC. So, why not follow the evidence and use those? It seems to me that it is not in the patients’ best interest to disregard the evidence in medicine – and this, of course, includes PC.
Today is WORLD ASTHMA DAY, a good opportunity perhaps to revisit a few of our own evaluations of so-called alternative medicine (SCAM) for asthma. Here are the abstracts of some of our systematic reviews on the subject:
Objective: The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for asthma.
Method: Seven databases were searched from their inception to October 2010. Randomized clinical trials (RCTs) and non-randomized clinical trials (NRCTs) were considered, if they investigated any type of yoga in patients with asthma. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Six RCTs and one NRCT met the inclusion criteria. Their methodological quality was mostly poor. Three RCTs and one NRCT suggested that yoga leads to a significantly greater reduction in spirometric measures, airway hyperresponsivity, dose of histamine needed to provoke a 20% reduction in forced expiratory volume in the first second, weekly number of asthma attacks, and need for drug treatment. Three RCTs showed no positive effects compared to various control interventions.
Conclusions: The belief that yoga alleviates asthma is not supported by sound evidence. Further, more rigorous trials are warranted.
Some clinicians believe that spinal manipulation is an effective treatment for asthma. The aim of this systematic review was to critically evaluate the evidence for or against this claim. Four electronic databases were searched without language restrictions from their inceptions to September 2008. Bibliographies and departmental files were hand-searched. The methodological quality of all included studies was assessed with the Jadad score. Only randomised clinical trials of spinal manipulation as a treatment of asthma were included. Three studies met these criteria. All of them were of excellent methodological quality (Jadad score 5) and all used sham-manipulation as the control intervention. None of the studies showed that real manipulation was more effective than sham-manipulation in improving lung function or subjective symptoms. It is concluded that, according to the evidence of the most rigorous studies available to date, spinal manipulation is not an effective treatment for asthma.
Contradictory results from randomised controlled trials of acupuncture in asthma suggest both a beneficial and detrimental effect. The authors conducted a formal systematic review and meta-analysis of all randomised clinical trials in the published literature that have compared acupuncture at real and placebo points in asthma patients. The authors searched for trials published in the period 1970-2000. Trials had to measure at least one of the following objective outcomes: peak expiratory flow rate, forced expiratory volume in one second (FEV1) and forced vital capacity. Estimates of the standarised mean difference, between acupuncture and placebo were computed for each trial and combined to estimate the overall effect. Hetereogeneity was investigated in terms of the characteristics of the individual studies. Twelve trials met the inclusion criteria but data from one could not be obtained. Individual patient data were available in only three. Standardised differences between means ranging from 0.071 to 0.133, in favour of acupuncture, were obtained. The overall effect was not conventionally significant and it corresponds to an approximate difference in FEV1 means of 1.7. After exploring hetereogenenity, it was found that studies where bronchoconstriction was induced during the experiment showed a conventionally significant effect. This meta-analysis did not find evidence of an effect of acupuncture in reducing asthma. However, the meta-analysis was limited by shortcomings of the individual trials, in terms of sample size, missing information, adjustment of baseline characteristics and a possible bias against acupuncture introduced by the use of placebo points that may not be completely inactive. There was a suggestion of preferential publication of trials in favour of acupuncture. There is an obvious need to conduct a full-scale randomised clinical trial addressing these limitations and the prognostic value of the aetiology of the disease.
Background: Emotional stress can either precipitate or exacerbate both acute and chronic asthma. There is a large body of literature available on the use of relaxation techniques for the treatment of asthma symptoms. The aim of this systematic review was to determine if there is any evidence for or against the clinical efficacy of such interventions.
Methods: Four independent literature searches were performed on Medline, Cochrane Library, CISCOM, and Embase. Only randomised clinical trials (RCTs) were included. There were no restrictions on the language of publication. The data from trials that statistically compared the treatment group with that of the control were extracted in a standardised predefined manner and assessed critically by two independent reviewers.
Results: Fifteen trials were identified, of which nine compared the treatment group with the control group appropriately. Five RCTs tested progressive muscle relaxation or mental and muscular relaxation, two of which showed significant effects of therapy. One RCT investigating hypnotherapy, one of autogenic training, and two of biofeedback techniques revealed no therapeutic effects. Overall, the methodological quality of the studies was poor.
Conclusions: There is a lack of evidence for the efficacy of relaxation therapies in the management of asthma. This deficiency is due to the poor methodology of the studies as well as the inherent problems of conducting such trials. There is some evidence that muscular relaxation improves lung function of patients with asthma but no evidence for any other relaxation technique.
Background: Asthma is one of the most common chronic diseases in modern society and there is increasing evidence to suggest that its incidence and severity are increasing. There is a high prevalence of usage of complementary medicine for asthma. Herbal preparations have been cited as the third most popular complementary treatment modality by British asthma sufferers. This study was undertaken to determine if there is any evidence for the clinical efficacy of herbal preparations for the treatment of asthma symptoms.
Methods: Four independent literature searches were performed on Medline, Pubmed, Cochrane Library, and Embase. Only randomised clinical trials were included. There were no restrictions on the language of publication. The data were extracted in a standardised, predefined manner and assessed critically.
Results: Seventeen randomised clinical trials were found, six of which concerned the use of traditional Chinese herbal medicine and eight described traditional Indian medicine, of which five investigated Tylophora indica. Three other randomised trials tested a Japanese Kampo medicine, marihuana, and dried ivy leaf extract. Nine of the 17 trials reported a clinically relevant improvement in lung function and/or symptom scores.
Conclusions: No definitive evidence for any of the herbal preparations emerged. Considering the popularity of herbal medicine with asthma patients, there is urgent need for stringently designed clinically relevant randomised clinical trials for herbal preparations in the treatment of asthma.
Breathing techniques are used by a large proportion of asthma sufferers. This systematic review was aimed at determining whether or not these interventions are effective. Four independent literature searches identified six randomized controlled trials. The results of these studies are not uniform. Collectively the data imply that physiotherapeutic breathing techniques may have some potential in benefiting patients with asthma. The safety issue has so far not been addressed satisfactorily. It is concluded that too few studies have been carried out to warrant firm judgements. Further rigorous trials should be carried out in order to redress this situation.
So, if you suffer from asthma, my advice is to stay away from SCAM. This might be easier said than done because SCAM practitioners are only too willing to lure asthma patients into their cult. In 2003, we have demonstrated this phenomenon by conducting a survey with chiropractors. Here is our short paper in full:
Classic chiropractic theory claims that vertebral subluxation blocks the flow of ‘‘innate intelligence’’ which, in turn, affects the health of asthma patients (1). Chiropractictors often use spinal manipulation (SM) to correct such malalignments and treat asthma (2). Several clinical trials of chiropractic SM exist, but the most rigorous ones are clearly negative (3,4). Chronic medication with corticosteroids can lead to osteoporosis, a condition, which is a contra-indication to chiropractic SM (5). Given this background, we aimed to determine whether chiropractors would advise an asthma patient on long-term corticosteroids (5 years) to try chiropractic as a treatment for this condition.
All 350 e-mail addresses listed at www.interadcom.com/chiro/html were randomised into two groups. A (deceptive) letter from a (fictitious) patient was sent to group A while group B was asked for advice on chiropractic treatment for asthma as part of a research project. Thus, groups A and B were asked the same question in di¡erent contexts: is chiropractic safe and e¡ective for an asthma patient on long-term steroids. After data collection, respondents from group A were informed that the e-mail had been part of a research project.
Of 97 e-mails in group A, we received 31 responses (response rate = 32% (95% CI, 0.23^ 0.41)). Seventy-four per cent (23 respondents) recommended visiting a chiropractor (95% CI, 0.59^ 0.89). Thirty-five per cent (11 respondents) mentioned minimal or no adverse effects of SM (95% CI, 0.18 ^ 0.52). Three chiropractors responded that some adverse e¡ects exist, e.g. risk of bone fracture, or stroke. Two respondents noted that other investigations (X-rays, spinal and neurological examination) were required before chiropractic treatment. Three respondents suggested additional treatments and one warned about a possible connection between asthma and the measles vaccine. Of 77 e-mails sent to group B, we received 16 responses (response rate = 21% (95% CI, 0.17^ 0.25)). Eleven respondents (69%) recommended visiting a chiropractor (95% CI, 0.46 ^ 0.91). Ten respondents mentioned minimal or no adverse effects of SM (95% CI, 0.39^ 0.87). Five chiropractors responded that adverse effects of SM exist (e.g. bone fracture). Five respondents suggested pre-testing the patient to check bone density, allergy, diet, exercise level, hydration and blood. Additional treatments were recommended by three respondents. The pooled results of groups A and B suggested that the majority of chiropractors recommend chiropractic treatment for asthma and the minority mention any adverse effects.
Our results demonstrate that chiropractic advice on asthma therapy is as readily available over the Internet as it is likely to be misleading. The majority of respondents from both groups (72%) recommended chiropractic treatment. This usually entails SM, a treatment modality which has been demonstrated to be ineffective in rigorous clinical trials (3,4,6). The advice may also be dangerous: the minority of the respondents of both groups (17%) caution of the risk of bone fracture. Our findings also suggest that, for the research question asked, a degree of deception is necessary. The response rate in group B was 12% lower than that of group A, and the answers received differed considerably between groups. In group A, 10% acknowledged the possibility of adverse e¡ects, this figure was 33% in group B. In conclusion, chiropractors readily provide advice regarding asthma treatment, which is often not evidence-based and has the potential to put patients at risk.
As I stated above: if you suffer from asthma, my advice is to
stay away from SCAM.
Acupuncture for animals has a long history in China. In the West, it was introduced in the 1970s when acupuncture became popular for humans. A recent article sums up our current knowledge on the subject. Here is an excerpt:
Acupuncture is used mainly for functional problems such as those involving noninfectious inflammation, paralysis, or pain. For small animals, acupuncture has been used for treating arthritis, hip dysplasia, lick granuloma, feline asthma, diarrhea, and certain reproductive problems. For larger animals, acupuncture has been used for treating downer cow syndrome, facial nerve paralysis, allergic dermatitis, respiratory problems, nonsurgical colic, and certain reproductive disorders.Acupuncture has also been used on competitive animals. There are veterinarians who use acupuncture along with herbs to treat muscle injuries in dogs and cats. Veterinarians charge around $85 for each acupuncture session.Veterinary acupuncture has also recently been used on more exotic animals, such as chimpanzees (Pan troglodytes) and an alligator with scoliosis, though this is still quite rare.
How can I be so sure?
Because ref 1 in the text above refers to our paper. Here is its abstract:
Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.
This evidence is in sharp contrast to the misinformation published by the ‘IVAS’ (International Veterinary Acupuncture Society). Under the heading “For Which Conditions is Acupuncture Indicated?“, they propagate the following myth:
Acupuncture is indicated for functional problems such as those that involve paralysis, noninfectious inflammation (such as allergies), and pain. For small animals, the following are some of the general conditions which may be treated with acupuncture:
- Musculoskeletal problems, such as arthritis, intervertebral disk disease, or traumatic nerve injury
- Respiratory problems, such as feline asthma
- Skin problems such as lick granulomas and allergic dermatitis
- Gastrointestinal problems such as diarrhea
- Selected reproductive problems
For large animals, acupuncture is again commonly used for functional problems. Some of the general conditions where it might be applied are the following:
- Musculoskeletal problems such as sore backs or downer cow syndrome
- Neurological problems such as facial paralysis
- Skin problems such as allergic dermatitis
- Respiratory problems such as heaves and “bleeders”
- Gastrointestinal problems such as nonsurgical colic
- Selected reproductive problems
In addition, regular acupuncture treatment can treat minor sports injuries as they occur and help to keep muscles and tendons resistant to injury. World-class professional and amateur athletes often use acupuncture as a routine part of their training. If your animals are involved in any athletic endeavor, such as racing, jumping, or showing, acupuncture can help them keep in top physical condition.
And what is the conclusion?
Never trust the promotional rubbish produced by SCAM organizations.
For quite some time now, I have had the impression that the top journals of general medicine show less and less interest in so-called alternative medicine. So, I decided to do some Medline searches to check. Specifically, I searched for 4 different SCAMs:
- herbal medicine
I wanted to see how often 7 leading medical journals from the US, UK, Australia, Germany, and Austria carried articles indexed under these headings:
- JAMA – US
- NEJM – US
- BMJ – UK
- Lancet – UK
- Aust J Med – Australia
- Dtsch Med Wochenschrift – Germany
- Wien Med Wochenschrift – Austria
This is what I found (the 1st number is the total number of articles ever listed; the 2nd number is the maximum number in any year; the 3rd number in brackets is the year when that maximum occurred)
Homeopathy: 17, 3 (1998)
Acupuncture: 176, 21 (2017)
Chiropractic: 49, 4 (1998)
Herbal medicine: 43, 5 (2001)
Homeopathy: 6, 3 (1986)
Acupuncture: 49, 8 (1974)
Chiropractic: 43, 13 (1980)
Herbal medicine: 29, 12 (1999)
Homeopathy: 122, (10, 1995)
Acupuncture: 405, 31 (2021)
Chiropractic: 99, 11 (2021)
Herbal medicine: 158, 13 (2018)
Homeopathy: 75, 11 (2005)
Acupuncture: 93, 12 (1973)
Chiropractic: 20, 5 (1993)
Herbal medicine: 46, 6 (1993)
Aust J Med
Homeopathy: 9, 2 (2010)
Acupuncture: 78, 13 (1974)
Chiropractic: 34, 4 (1985)
Herbal medicine: 20, 2 (2017)
Deutsche Medizinische Wochenschrift
Homeopathy: 27, 4 (1999)
Acupuncture: 34, 6 (1978)
Chiropractic: 14, 3 (1972)
Herbal medicine: 6, 1 (2020)
Wiener Medizinische Wochenschrift
Homeopathy: 11, 4 (2005)
Acupuncture: 32, 8 (1998)
Chiropractic: 8, 2 (1956)
Herbal medicine: 16, 3 (2002)
These figures need, of course, to be taken with a rather large pinch of salt. There are many pitfalls in interpreting them, e.g. misclassifications by Medline. Yet they are, I think, revealing in that they suggest several interesting trends.
- All in all, my suspicion that the top journals of various countries are less and less keen on SCAM seems to be confirmed. The years where the maximum of papers on specific SCAMs was published are often long in the past.
- The UK journals seem to be by far more open to SCAM that the publications from other countries. This is mostly due to the BMJ – in fact, it turns out to be the online journal ‘BMJ-open’. And this again is to a great part caused by the BMJ-open carrying a sizable amount of acupuncture papers in recent months.
- The two US journals seem particularly cautious about SCAM papers. When looking at the type of articles in the US journals (and especially the NEJM), one realizes that most of them are ‘letters to the editor’ which seems to confirm the dislike of these journals for publishing original research into SCAM. Another interpretation of this phenomenon, of course, would be that only very few SCAM studies are of a high enough quality to make it into these two top journals.
- I was amazed to see how little SCAM was published in the two German-language journals. Vis a vis the high popularity of SCAM in these countries, I find this not easy to understand. Perhaps, one also needs to consider that these two journals publish considerably less original research than the other publications
- If we look at the differences between the 4 types of SCAM included in my assessment, we find that acupuncture is by far the most frequently published modality. The other 3 are on roughly the same level, with chiropractic being the least frequent – which I thought was surprising.
- Overall, the findings do not generate the impression that – despite the many billions spent on SCAM research during the last decades – SCAM has made important inroads into science or medicine.
I have often commented on the dismal state of the many SCAM journals; these days, they seem to publish almost exclusively poor-quality papers with misleading conclusions. It can therefore be expected that these journals will be more and more discarded by everyone (except the few SCAM advocates who publish their rubbish in them) as some sort of cult publications. In turn, this means that only SCAM studies published in mainstream journals will have the potential of generating any impact at all.
For this reason, my little survey might be relevant. It is far from conclusive, of course, yet it might provide a rough picture of what is happening in the area of SCAM research.
The Lancet is a top medical journal, no doubt. But even such journals can make mistakes, even big ones, as the Wakefield story illustrates. But sometimes, the mistakes are seemingly minor and so well hidden that the casual reader is unlikely to find them. Such mistakes can nevertheless be equally pernicious, as they might propagate untruths or misunderstandings that have far-reaching consequences.
A recent Lancet paper might be an example of this phenomenon. It is entitled “Management of common clinical problems experienced by survivors of cancer“, unquestionably an important subject. Its abstract reads as follows:
Improvements in early detection and treatment have led to a growing prevalence of survivors of cancer worldwide.
Models of care fail to address adequately the breadth of physical, psychosocial, and supportive care needs of those who survive cancer. In this Series paper, we summarise the evidence around the management of common clinical problems experienced by survivors of adult cancers and how to cover these issues in a consultation. Reviewing the patient’s history of cancer and treatments highlights potential long-term or late effects to consider, and recommended surveillance for recurrence. Physical consequences of specific treatments to identify include cardiac dysfunction, metabolic syndrome, lymphoedema, peripheral neuropathy, and osteoporosis. Immunotherapies can cause specific immune-related effects most commonly in the gastrointestinal tract, endocrine system, skin, and liver. Pain should be screened for and requires assessment of potential causes and non-pharmacological and pharmacological approaches to management. Common psychosocial issues, for which there are effective psychological therapies, include fear of recurrence, fatigue, altered sleep and cognition, and effects on sex and intimacy, finances, and employment. Review of lifestyle factors including smoking, obesity, and alcohol is necessary to reduce the risk of recurrence and second cancers. Exercise can improve quality of life and might improve cancer survival; it can also contribute to the management of fatigue, pain, metabolic syndrome, osteoporosis, and cognitive impairment. Using a supportive care screening tool, such as the Distress Thermometer, can identify specific areas of concern and help prioritise areas to cover in a consultation.
You can see nothing wrong? Me neither! We need to dig deeper into the paper to find what concerns me.
In the actual article, the authors state that “there is good evidence of benefit for … acupuncture …”; the same message was conveyed in one of the tables. In support of these categorical statements, the authors quote the current Cochrane review entitled “Acupuncture for cancer pain in adults”. Its abstract reads as follows:
Background: Forty per cent of individuals with early or intermediate stage cancer and 90% with advanced cancer have moderate to severe pain and up to 70% of patients with cancer pain do not receive adequate pain relief. It has been claimed that acupuncture has a role in management of cancer pain and guidelines exist for treatment of cancer pain with acupuncture. This is an updated version of a Cochrane Review published in Issue 1, 2011, on acupuncture for cancer pain in adults.
Objectives: To evaluate efficacy of acupuncture for relief of cancer-related pain in adults.
Search methods: For this update CENTRAL, MEDLINE, EMBASE, PsycINFO, AMED, and SPORTDiscus were searched up to July 2015 including non-English language papers.
Selection criteria: Randomised controlled trials (RCTs) that evaluated any type of invasive acupuncture for pain directly related to cancer in adults aged 18 years or over.
Data collection and analysis: We planned to pool data to provide an overall measure of effect and to calculate the number needed to treat to benefit, but this was not possible due to heterogeneity. Two review authors (CP, OT) independently extracted data adding it to data extraction sheets. Data sheets were compared and discussed with a third review author (MJ) who acted as arbiter. Data analysis was conducted by CP, OT and MJ.
Main results: We included five RCTs (285 participants). Three studies were included in the original review and two more in the update. The authors of the included studies reported benefits of acupuncture in managing pancreatic cancer pain; no difference between real and sham electroacupuncture for pain associated with ovarian cancer; benefits of acupuncture over conventional medication for late stage unspecified cancer; benefits for auricular (ear) acupuncture over placebo for chronic neuropathic pain related to cancer; and no differences between conventional analgesia and acupuncture within the first 10 days of treatment for stomach carcinoma. All studies had a high risk of bias from inadequate sample size and a low risk of bias associated with random sequence generation. Only three studies had low risk of bias associated with incomplete outcome data, while two studies had low risk of bias associated with allocation concealment and one study had low risk of bias associated with inadequate blinding. The heterogeneity of methodologies, cancer populations and techniques used in the included studies precluded pooling of data and therefore meta-analysis was not carried out. A subgroup analysis on acupuncture for cancer-induced bone pain was not conducted because none of the studies made any reference to bone pain. Studies either reported that there were no adverse events as a result of treatment, or did not report adverse events at all.
Authors’ conclusions: There is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.
This conclusion is undoubtedly in stark contrast to the categorical statement of the Lancet authors: “there is good evidence of benefit for … acupuncture …“
What should be done to prevent people from getting misled in this way?
- The Lancet should correct the error. It might be tempting to do this by simply exchanging the term ‘good’ with ‘some’. However, this would still be misleading, as there is some evidence for almost any type of bogus therapy.
- Authors, reviewers, and editors should do their job properly and check the original sources of their quotes.
In case someone argued that the Cochrane review is just one of many, here is the conclusion of an overview of 15 systematic reviews on the subject: The … findings emphasized that acupuncture and related therapies alone did not have clinically significant effects at cancer-related pain reduction as compared with analgesic administration alone.