“Time to say good-bye? Homeopathy, skeptics and thoughts on how to proceed” is the title of an article by two Swiss homeopaths which is almost touchingly naive. Here is its abstract:
Although homeopathy is frequently used by many health professionals, there are ongoing debates concerning its effectiveness. Currently no unifying explanation how homeopathy works exists. Homeopaths are frequently challenged by skeptics, and in public opinion, the swan song for homeopathy is frequently sung.
Content: Regarding the efficacy of homeopathy, several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy. Regarding its mode of action, the discovery of the working principle of homeopathy would be a major advance towards a thorough scientific recognition of homeopathy. Basic research has already discovered some milestones, e.g., significant and reproducible effects of homeopathic preparations in plants.
Summary: To overcome the distrust of skeptics and public opinion, the support of basic research is indispensable. Second, homeopaths should continue to design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy. Third, they should continue to publish their treatment outcomes, as these publications document clinical effectiveness beyond doubts about its mode of action.
Outlook: These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public.
To this, I might add the following comments:
- “ongoing debates concerning its effectiveness”: this debate has been ongoing for 200 years but it has now come to a conclusion, namely that homeopathy is a placebo therapy.
- “no unifying explanation how homeopathy works exists”: we do know, however, that the laws of nature, as we understand them today, must be wrong if homeopathy did work.
- “Homeopaths are frequently challenged by skeptics”: the main challenges currently come not from skeptics but from health experts who rightly insist on sound evidence.
- “several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy”: arguably, this might be correct but misses the crucial point that the totality of the reliable evidence fails to show that homeopathy is efficacious for any condition of humans or animals.
- “the discovery of the working principle of homeopathy would be a major advance”: yes, so much so that it would require rewriting whole sections of the textbooks of physics and chemistry.
- “Basic research has already discovered some milestones”: these ‘milestones’ are so imposing that nobody outside the realm of homeopathy has ever recognized them.
- “the support of basic research is indispensable”: not so much indispensable as non-existent, I would say.
- “design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy”: homeopaths believe research to be a tool for creating evidence that supports their creed; I have often tried to remind them that it is a tool for testing hypotheses – to no avail, it seems.
- “publish their treatment outcomes, as these publications document clinical effectiveness”: I have also often tried to explain to them that treatment outcomes can be due to many factors other than the specific effect of the applied therapy – again to no avail.
- “These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public”: these measures, if applied rigorously, will merely confirm what we already know, namely that homeopathy does not work beyond placebo.
The usage of so-called alternative medicine (SCAM) in pediatric settings has been high for some time. However, the risks of pediatric SCAM use remain under-investigated. Almost 20 years ago, I published this systematic review:
Unconventional therapies have become popular in paediatric and adolescent populations. It is therefore important to define their risks. The aim of this systematic review was to summarise the recent evidence. Computerised literature searches were carried out in five databases to identify all recent reports of adverse events associated with unconventional therapies in children. The reports were summarised in narrative and tabular form. The results show that numerous case reports and several case series have been published since 1990. Investigations of a more systematic nature are, however, rare. Most of the adverse events were associated with herbal medications. Inadequately regulated herbal medicines may contain toxic plant material, be contaminated with heavy metals, or be adulterated with synthetic drugs. The adverse events included bradycardia, brain damage, cardiogenic shock, diabetic coma, encephalopathy, heart rupture, intravascular haemolysis, liver failure, respiratory failure, toxic hepatitis and death. A high degree of uncertainty regarding a causal relationship between therapy and adverse event was frequently noted. The size of the problem and its importance relative to the well-documented risks of conventional treatments are presently unknown. Several unconventional therapies may constitute a risk to the health of children and adolescents. At present, it is impossible to provide reliable incidence figures. It seems important to be vigilant and investigate this area more systematically.
Nothing much has happened since in terms of systematic investigation. But now, a 3-year survey was carried out at the Dutch Pediatric Surveillance Unit. Pediatricians were asked to register cases of adverse events associated with pediatric SCAM usage.
In 3 years, 32 unique adverse events were registered. Twenty-two of these adverse events were indirect and not related to the specific SCAM therapy but due to delaying, changing, or stopping of regular treatment, a deficient or very restrictive diet, or an incorrect diagnosis by a SCAM therapist. These events were associated with many different SCAM therapies.
Nine events were deemed direct adverse events like bodily harm or toxicity and one-third of them occurred in infants. Only supplements, manual therapies, and (Chinese) herbs were involved in these nine events. In one case, there was a risk of a serious adverse event but the harm had not yet occurred.
The authors concluded that relatively few cases of adverse events associated with pediatric SCAM usage were found, mostly due to delaying or stopping conventional treatment. Nevertheless, parents, pediatricians, and SCAM providers should be vigilant for both direct and indirect adverse events in children using SCAM, especially in infants.
The number of cases seems small indeed, but there may be many further adverse events that went unreported. Here are 4 of the documented cases of severe and life-threatening consequences:
- An 8-year-old child with autoimmune hypothyroidism had his prescribed replaced with an ineffective herbal remedy.
- A 14-year-old child developed septic shock with multiple organ failure after receiving homeopathy for acute appendicitis.
- A 14-year-old child needed colectomy after ineffective naturopathic treatments for colitis.
- A 5-year-old developed secondary adrenal insufficiency after his eczema was treated with Chinese herbal remedies adulterated with large doses of corticosteroids.
In view of the risks – even if small – I suggest that, in pediatric settings, we employ only those SCAMs that are supported by solid evidence. And those are very few indeed.
Thread embedding acupuncture therapy (TEAT) involves the insertion of thread at specific points on the body surface. The claim is that TEAT provides a sustained stimulation of acupoints and is therefore superior to needle acupuncture. Initially, TEAT was used in China to treat obesity, today it is employed to treat many conditions, including musculoskeletal conditions such as ankle sprain, shoulder pain, lumbar intervertebral disc herniation, and plantar fasciitis. Its effectiveness is, however, doubtful and so is its safety.
This review evaluated the safety of thread embedding acupuncture therapy (TEAT) and discuss the prevention and treatment of some adverse events (AEs).
Databases, including China National Knowledge Infrastructure (CNKI), CBMdisc, Wanfang, VIP databases and PubMed, MEDLINE, EMBASE, and Web of Science, were searched from their inception to January 2020. Included were randomized controlled trials (RCTs) and case reports in which AEs with TEAT were reported. Cochrane Collaboration’s tool and RevMan V.5.3.3 software were used to evaluate the quality of the studies.
A total of 61 articles (45 RCTs and 16 case reports) with a total of 620 cases of AEs were included in this review. These studies were published in two countries: China and South Korea. Twenty-eight kinds of AEs were noted. The most common AEs were induration, bleeding and ecchymosis, redness and swelling, fever, and pain. They accounted for 75.35% of all AEs. Most AEs were mild.; The rarest AEs were epilepsy, irregular menstruation, skin ulcer, thread malabsorption, and fat liquefaction, with 1 case each. Not all of them had a clear causal relationship with TEAT. Most of the AEs were local reactions and systemic reactions accounted for only 1.27%. Although the included studies showed that AEs were very commonly encountered (11.09%), only 5 cases of severe AEs reported from 2013 to 2017 (0.1%) by using catgut thread, which is rarely employed nowadays with new absorbable surgical suture being more popular. All of the patients with severe AEs were recovered after symptomatic treatment with no sequelae.
The authors concluded that the evidence showed that TEAT is a relatively safe and convenient therapy especially since application of new absorbable surgical suture. Improving practitioner skills, regulating operations, and paying attention to the patients’ conditions may reduce the incidence of AEs and improve safety of TEAT.
TEAT was initially used in China only but recently it has become popular elsewhere as well. Therefore the question about its risks has become relevant. The present paper is interesting in that it demonstrates that AEs do occur with some regularity. The authors’ conclusion that TEAT is “relatively safe” is, however, not justified because:
- the total sample size was not large enough for a generalizable conclusion;
- only RCTs and case reports were included, whereas case series and case-control studies (which would provide more relevant data) were excluded or might not even exist;
- RCTs of acupuncture often fail to mention or under-report AEs;
- acupuncture papers from China are notoriously unreliable.
So, all we can conclude from the evidence presented here is that AEs after TEAT do occur and do not seem to be all that rare. As the efficacy of TEAT has not been shown beyond doubt, this must inevitably lead to the conclusion that the risk-benefit balance of TEAT is not positive. In turn, that means that TEAT cannot be recommended as a treatment for any condition.
Epidemiological studies on the association between coffee intake, arguably a herbal remedy, and cancer risk have yielded inconsistent results. To summarize and appraise the quality of the current evidence, researchers conducted an umbrella review of existing findings from meta-analyses of observational studies.
They searched PubMed, Embase, Web of Science and the Cochrane database to obtain systematic reviews and meta-analyses of associations between coffee intake and cancer incidence. For each association, they estimated the summary effect size using the fixed- and random-effects model, the 95% confidence interval, and the 95% prediction interval. We also assessed heterogeneity, evidence of small-study effects, and excess significance bias.
Twenty-eight individual meta-analyses including 36 summary associations for 26 cancer sites were retrieved for this umbrella review. A total of 17 meta-analyses were significant at P ≤ 0.05 in the random-effects model. For the highest versus lowest categories, 4 of 26 associations had a more stringent P value (P ≤ 10− 6). Associations for five cancers were significant in dose-response analyses. Most studies (69%) showed low heterogeneity (I2 ≤ 50%). Three and six associations had evidence of excessive significance bias and publication bias, respectively. Coffee intake was inversely related to the risk of liver cancer and endometrial cancer and was characterized by dose-response relationships. There were no substantial changes when the researchers restricted analyses to a meta-analysis of cohort studies.
The authors concluded that there is highly suggestive evidence for an inverse association between coffee intake and risk of liver and endometrial cancer. Further research is needed to provide more robust evidence for cancer at other sites.
This is an interesting analysis that begs many questions. Let me just make four brief points:
- Correlation is not causation! Epidemiological studies throw up all sorts of associations that are too often mistaken as causal relationships. The question of whether coffee causes a decrease in the risk of certain cancers is as yet unanswered. The authors mention dose relationships which would, of course, increase the likelihood of a causal effect. Yet, they do not prove it.
- Another argument that would strengthen the possibility of a causal effect would be a plausible mechanism of action. However, the biological mechanism of how coffee might affect the risk remains unclear. Coffee contains a range of biologically active chemicals, including caffeine and phenolic compounds. In so-called alternative medicine (SCAM), coffee is also claimed to be a ‘detox‘ remedy. Yet it is unclear how exactly they might reduce the risk.
- The studies were all about the oral consumption of coffee. None considered anal application, like in Gerson therapy.
- The only way to find out whether coffee does, in fact, reduce the risk of certain cancers is to conduct prospective controlled clinical trials. Such studies are, however, not easy to conduct, particularly if designed such that their findings are truly reliable.
So, the answer to the question DOES COFFEE CONSUMPTION PREVENT CANCER? will remain unanswered for some time, I am afraid. Meanwhile, I suggest we enjoy our coffee per oral (and avoid it per anal).
Some time ago, I published ‘The 10 commandments of quackery’. Since then, I discovered that there are several errors that occur with such regularity in the comment section of this blog as well as in most other discussions about so-called alternative medicine (SCAM), that – in the hope to improve the logical reasoning of my readers (and often times my own) – it seems timely to publish the
10 ‘commandments’ of rational thought
- Thou shalt not confuse popularity of a therapy with its efficacy or safety (appeal to popularity).
- Thou shalt not assume that the test of time is a valid substitute for evidence (appeal to tradition).
- Thou shalt not believe that natural therapies are necessarily harmless (appeal to nature).
- Thou shalt not think that those who question your claim need to prove that you are wrong (reversal of the burden of proof).
- Thou shalt not assume that a therapy administered before a symptomatic improvement was necessarily the cause of that outcome (post hoc ergo propter hoc).
- Thou shalt not suppose that, because you do not know or understand an issue, it cannot be true (appeal to ignorance).
- Thou shalt not misrepresent your opponent’s position in order to make it easier for you to defeat it (straw man fallacy).
- Thou shalt not argue that, because others do wrong, you are permitted to do the same (tu quoque fallacy).
- Thou shalt not assume that your argument is correct because some authority agrees with you (appeal to authority).
- Thou shalt not attack your opponents instead of their arguments (ad hominem).
Yes, I know, one could add a lot more. But these 10 ‘commandments’ relate to the errors in rational thought that I feel would, if taken on board, be most useful in our discussions about SCAM.
The new NICE draft guideline on acupuncture for chronic pain has been published several months ago, and we discussed it here. Now the final document entitled ‘Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain‘ has been published on 7/4/2021. Like the draft, it includes quite a bit about acupuncture. Let me just quote three essential sections:
Recommendations: Acupuncture for chronic primary pain
Consider a single course of acupuncture or dry needling, within a traditional Chinese or Western acupuncture system, for people aged 16 years and over to manage chronic primary pain, but only if the course:
- is delivered in a community setting and
- is delivered by a band 7 (equivalent or lower) healthcare professional with appropriate training and
- is made up of no more than 5 hours of healthcare professional time (the number and length of sessions can be adapted within these boundaries) or
- is delivered by another healthcare professional with appropriate training and/or in another setting for equivalent or lower cost.
Many studies (27 in total) showed that acupuncture reduced pain and improved quality of life in the short term (up to 3 months) compared with usual care or sham acupuncture. There was not enough evidence to determine longer-term benefits. The committee acknowledged the difficulty in blinding for sham procedures, but agreed that the benefit compared with a sham procedure indicated a specific treatment effect of acupuncture. There was a wide variation among the studies in the type and intensity of the intervention used, and the studies were from many different countries. The committee agreed that the type of acupuncture or dry needling should depend on the individual needs of the person with pain.
Two economic evaluations (1 in the UK) showed that acupuncture offered a good balance of benefits and costs for people with chronic neck pain. However, both studies had limitations; a notable limitation being that the costs of acupuncture seemed low. Threshold analysis based on these studies indicated the maximum number of hours of a band 6 and 7 healthcare professional’s time that would make the intervention cost effective.
An original economic model was developed for this guideline, which compared acupuncture with no acupuncture. The model used data from studies with usual care comparisons, not comparisons with sham acupuncture, because the committee agreed that a usual care comparison in an economic model better reflects the real world benefit of the intervention. The model showed that acupuncture was likely to be cost effective. The committee considered the results to be robust, and agreed that the studies used in the model were representative of the whole evidence review. Acupuncture remained cost effective when the assumed benefits and costs were varied (sensitivity analysis).
Overall, the committee agreed that there was a large evidence base showing acupuncture to be clinically effective in the short term (3 months); the original economic modelling also showed it is likely to be cost effective. However, they were uncertain whether the beneficial effects would be sustained long term and were aware of the high resource impact of implementation. Taking these factors into account, the committee made a recommendation to consider acupuncture or dry needling for chronic primary pain, caveated by the factors likely to make the intervention cost effective. These were: only if delivered in the community, and with a maximum of 5 treatment hours (based on the average resource use in the trials in the model and on the threshold analysis), and from a band 7 (equivalent cost or lower) healthcare professional (based on the threshold analysis). It was agreed there may be different ways of delivering the service that enable acupuncture to be delivered for the same costs, which would equally be appropriate. The committee agreed that discontinuing before this total amount of course time would be an option if the person finds that the first few sessions are not effective.
Acupuncture versus sham acupuncture
Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
______________END OF QUOTES____________
I will leave this here without a comment for the moment and look forward to reading what you think about this.
The use of so-called alternative medicine (SCAM) is common among breast cancer patients, but less is known about whether SCAM influences breast cancer survival. The primary aim of this recent study from Tunesia was to determine the impact of self-use of herbs on the overall survival of women with breast cancer.
The researchers conducted a prospective study including 110 patients with breast cancer. All patients were questioned about their usage of herbal remedies. The demographic data and the overall survival of the patients were then analyzed.
The average age was 51 years (30-80 years old). In total, 37 had metastatic disease (33.6%), and 48 patients had taken plant-based treatments (43.6%). Of those women, 19 patients consumed Graviola (39.6%) and 29 Alenda (60.4%). Overall survival rates at 3 years and at 5 years were 96.2% and 82.4% in the absence of herbal medicine usage versus 78.5% and 78.5% in the presence of herbal medicine use (p = 0.015).
The authors concluded that self-medication with Graviola or Alenda may be associated with an increase of death risk in patients with breast cancer. Further studies are needed to confirm these results.
This is only a small and not very rigorous case-control study. In itself, it would be far from conclusive. What renders it relevant, however, is the fact that its findings do by no means stand alone. We have seen several times on this blog that SCAM use can shorten the life of cancer patients, e.g.:
- More evidence that SCAM-use is associated with shorter survival of cancer patients
- Patients who received CM were more likely to refuse additional CCT, and had a higher risk of death. The results suggest that mortality risk associated with CM was mediated by the refusal of CCT.
- The use of CAM had significantly associated with delay in presentation and resolution of diagnosis.
- CAM did not provide any definite survival benefit, CAM users reported clinically significant worse health-related quality of life.
So, perhaps it is true? Perhaps using SCAM is not such a good idea, if you are suffering from cancer!
The mechanisms of such detrimental effects are not difficult to imagine. They might include direct effects on the cancer, interactions with prescribed drugs, delay of cancer diagnosis, or less strict adherence to the anti-cancer treatments.
The authors of this study claim that, in the aging brain, reduction in the pulsation of cerebral vasculature and fluid circulation causes impairment in the fluid exchange between different compartments and lays a foundation for the neuroinflammation that results in Alzheimer disease (AD). The knowledge that lymphatic vessels in the central nervous system play a role in the clearance of brain-derived metabolic waste products opens an unprecedented capability to increase the clearance of macromolecules such as amyloid β proteins. However, currently, there is no pharmacologic mechanism available to increase fluid circulation in the aging brain.
Based on these considerations, the authors conducted a study to demonstrate the influence of an osteopathic cranial manipulative medicine (OCMM) technique, specifically, compression of the fourth ventricle, on spatial memory and changes in substrates associated with mechanisms of metabolic waste clearance in the central nervous system using the naturally aged rat model of AD.
The rats in the OCMM group received the CV4 technique every day for 7 days for 4 to 7 minutes at each session. Rats were anesthetized with 1.5% to 3% isoflurane throughout the procedure. Rats in the UT group were also anesthetized to nullify any influence of isoflurane in spatial learning. During the CV4 procedure, the operator applied mechanical pressure over the rat’s occiput, medial to the junction of the occiput and temporal bone and inferior to the lambdoid suture to place tension on the dural membrane around the fourth ventricle. This gentle pressure was applied to resist cranial flexion with the aim of improving symmetry in the cranial rhythmic impulse (CRI), initiating a rhythmic fluctuation of the CSF, and improving mobility of the cranial bones and dural membranes. This rhythmic fluctuation is thought to be primarily due to flexion and extension that takes place at the synchondrosis between the sphenoid and basiocciput. The treatment end point was achieved when the operator identified that the tissues relaxed, a still point was reached, and improved symmetry or fullness of the CRI was felt. Currently, there is no quantitative measure for the pressure used in this treatment.
The results showed a significant improvement in spatial memory in 6 rats after 7 days of OCMM sessions. Live animal positron emission tomographic imaging and immunoassays revealed that OCMM reduced amyloid β levels, activated astrocytes, and improved neurotransmission in the aged rat brains.
The authors concluded that these findings demonstrate the molecular mechanism of OCMM in aged rats. This study and further investigations will help physicians promote OCMM as an evidence-based adjunctive treatment for patients with AD.
If there ever was an adventurous, over-optimistic extrapolation, this must be it!
Even assuming that all of the findings can be confirmed and replicated, they would be a very far shot from rendering OCMM an evidence-based treatment for AD:
- Rats are not humans.
- Aged rats do not have AD.
- OCMM is not a plausible treatment.
- An animal study is not a clinical trial.
I am at a complete loss to see how the findings of this bizarre animal experiment might help physicians promote OCMM as an evidence-based adjunctive treatment for patients with AD.
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.
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.