Dry needling (DN), also known as myofascial trigger point dry needling, is a SCAM similar to acupuncture. It involves the use of solid filiform needles or hollow-core hypodermic needles and is usually employed for treating muscle pain. Instead of sticking them into acupuncture points, like with acupuncture, they are inserted into myofascial trigger points usually identified by palpation. There are some theories how DN might work, but whether it is clinically effective remains unclear.
This single-blind RCT determined, if the addition of upper quarter DN to a rehabilitation protocol is more effective in improving ROM, pain, and functional outcome scores when compared to a rehabilitation protocol alone after shoulder stabilization surgery. Thirty-nine post-operative shoulder patients were randomly allocated into two groups: (1) standard of care rehabilitation (control group) (2) standard of care rehabilitation plus dry needling (experimental group). Patient’s pain, ROM, and functional outcome scores were assessed at baseline (4 weeks post-operative), and at 8 weeks, 12 weeks, and 6 months post-operative.
Of 39 enrolled patients, 20 were allocated to the control group and 19 to the experimental group. At six-month follow up, there was a statistically significant improvement in shoulder flexion ROM in the control group. Aside from this, there were no significant differences in outcomes between the two treatment groups. Both groups showed improvement over time. No adverse events were reported.
The authors concluded that dry needling of the shoulder girdle in addition to standard of care rehabilitation after shoulder stabilization surgery did not significantly improve shoulder ROM, pain, or functional outcome scores when compared with standard of care rehabilitation alone. Both group’s improvement was largely equal over time. The significant difference in flexion at the six-month follow up may be explained by additional time spent receiving passive range of motion (PROM) in the control group. These results provide preliminary evidence that dry needling in a post-surgical population is safe and without significant risk of iatrogenic infection or other adverse events.
This trial followed the infamous A+B versus B design. As [A+B] is more than [B] alone, one would have expected that the experimental group has a better outcome than the control group.
But this was not the case!
Theoretically it can mean one of two things:
- DN did not even convey a placebo effect.
- DN had a negative effect on the outcome.
The website of this organisation is always good for a surprise. A recent announcement relates to a course of Thought Field Therapy (TFT):
As part of our ongoing programme to explore prospects for improved healthcare, the College is pleased to announce a course on TFT – a “Tapping” therapy – independently provided by Janet Thomson MSc.
In healthcare we may find ourselves exhausting the evidence-based options and still looking for ways to help our patients. So when trusted practitioners suggest simple and safe approaches that appear to have benefit we are interested.
TFT is a simple non-invasive, technique that anyone can learn, for themselves or to pass on to their patients, to help cope with negative thoughts and emotions. It was developed by Roger Callahan who discovered that tapping on certain meridian points could help counter negative emotions. Janet trained with Roger and has become an accomplished exponent of the technique.
Janet has contracted her usual two-day course into one: to get the most from this will require access to her Tapping For Life book and there will be pre-course videos demonstrating some of the key techniques. The second consecutive day is available for advanced TFT training, to help in dealing with difficult cases, as well as how to integrate TFT with other modalities.
How much does it cost (excluding booking fee)? Day One only – £195; Day Two only – £195 (only available if you have previously completed day one); Both Days – £375.
When is it? Saturday & Sunday 7th-8th March – 09:30-17:30
What, you don’t know what TFT is? Let me fill you in.
According to Wiki, TFT is a fringe psychological treatment developed by an American psychologist, Roger Callahan. Its proponents say that it can heal a variety of mental and physical ailments through specialized “tapping” with the fingers at meridian points on the upper body and hands. The theory behind TFT is a mixture of concepts “derived from a variety of sources. Foremost among these is the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body”. Callahan also bases his theory upon applied kinesiology and physics. There is no scientific evidence that TFT is effective, and the American Psychological Association has stated that it “lacks a scientific basis” and consists of pseudoscience.
Other assessments are even less complimentary: Thought field therapy (TFT) is a New Age psychotherapy dressed up in the garb of traditional Chinese medicine. It was developed in 1981 by Dr. Roger Callahan, a cognitive psychologist. While treating a patient for water phobia:
He asked her to think about water, tap with two fingers on the point that connected with the stomach meridian and much to his surprise, her fear of water completely disappeared.*
Callahan attributes the cure to the tapping, which he thinks unblocked “energy” in her stomach meridian. I don’t know how Callahan got the idea that tapping on a particular point would have anything to do with relieving a phobia, but he claims he has developed taps for just about anything that ails you, including a set of taps that can cure malaria (NPR interview).
TFT allegedly “gives immediate relief for post traumatic stress disorder (PTSD ), addictions, phobias, fears, and anxieties by directly treating the blockage in the energy flow created by a disturbing thought pattern. It virtually eliminates any negative feeling previously associated with a thought.”*
The theory behind TFT is that negative emotions cause energy blockage and if the energy is unblocked then the fears will disappear. Tapping acupressure points is thought to be the means of unblocking the energy. Allegedly, it only takes five to six minutes to elicit a cure. Dr. Callahan claims an 85% success rate. He even does cures over the phone using “Voice Technology” on infants and animals; by analyzing the voice he claims he can determine what points on the body the patient should tap for treatment.
Yes, TFT seems utterly implausible – but what about the clinical evidence?
There are quite a few positive controlled clinical trials of TFT. They all have one thing in common: they smell fishy to me! I know, that’s not a very scientific judgement. Let me rephrase it: I am not aware of a single trial that proves TFT to have effects beyond placebo (if you know one, please post the link).
And Janet Thomson, MSc (the therapist who runs the course), who is she? Her website is revealing; have a look if you are interested. If not, it might suffice to say that she modestly claims that she is an outstanding Life Coach, Therapist & Trainer.
So, considering that TFT is so very implausible and unproven, why does the ‘College of Medicine and Integrated Healthcare’ promote it in such strong terms?
I have to admit, I do not know the answer – perhaps they want at all costs to become known as the ‘College of Quack Medicine’?
Today is Valentine’s Day, a good moment to take a critical look at some of the libido-boosters so-called alternative medicine (SCAM) has to offer. The Internet offers plenty; this website, for instance, advertises over 20 different natural (mostly botanical) products. But such sites are typically thin on evidence.
A quick Medline search locates plenty of research. Much of it seems to be on rats which is not so relevant – unless, of course, your husband is a rat. In terms of clinical trials, Medline too is not all that informative. Here are some of the studies I found:
Eurycoma longifolia is reputed as an aphrodisiac and remedy for decreased male libido. A randomized, double-blind, placebo controlled, parallel group study was carried out to investigate the clinical evidence of E. longifolia in men. The 12-week study in 109 men between 30 and 55 years of age consisted of either treatment of 300 mg of water extract of E. longifolia (Physta) or placebo. Primary endpoints were the Quality of Life investigated by SF-36 questionnaire and Sexual Well-Being investigated by International Index of Erectile Function (IIEF) and Sexual Health Questionnaires (SHQ); Seminal Fluid Analysis (SFA), fat mass and safety profiles. Repeated measures ANOVA analysis was used to compare changes in the endpoints. The E. longifolia (EL) group significantly improved in the domain Physical Functioning of SF-36, from baseline to week 12 compared to placebo (P = 0.006) and in between group at week 12 (P = 0.028). The EL group showed higher scores in the overall Erectile Function domain in IIEF (P < 0.001), sexual libido (14% by week 12), SFA- with sperm motility at 44.4%, and semen volume at 18.2% at the end of treatment. Subjects with BMI ≥ 25 kg/m(2) significantly improved in fat mass lost (P = 0.008). All safety parameters were comparable to placebo.
Yoga is a popular form of complementary and alternative treatment. It is practiced both in developing and developed countries. Use of yoga for various bodily ailments is recommended in ancient ayvurvedic (ayus = life, veda = knowledge) texts and is being increasingly investigated scientifically. Many patients and yoga protagonists claim that it is useful in sexual disorders. We are interested in knowing if it works for patients with premature ejaculation (PE) and in comparing its efficacy with fluoxetine, a known treatment option for PE. Aim: To know if yoga could be tried as a treatment option in PE and to compare it with fluoxetine. Methods: A total of 68 patients (38 yoga group; 30 fluoxetine group) attending the outpatient department of psychiatry of a tertiary care hospital were enrolled in the present study. Both subjective and objective assessment tools were administered to evaluate the efficacy of the yoga and fluoxetine in PE. Three patients dropped out of the study citing their inability to cope up with the yoga schedule as the reason. Main outcome measure: Intravaginal ejaculatory latencies in yoga group and fluoxetine control groups. Results: We found that all 38 patients (25-65.7% = good, 13-34.2% = fair) belonging to yoga and 25 out of 30 of the fluoxetine group (82.3%) had statistically significant improvement in PE. Conclusions: Yoga appears to be a feasible, safe, effective and acceptable nonpharmacological option for PE. More studies involving larger patients could be carried out to establish its utility in this condition.
Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) are known to cause secondary sexual dysfunction with prevalence rates as high as 50%-90%. Emerging research is establishing that acupuncture may be an effective treatment modality for sexual dysfunction including impotence, loss of libido, and an inability to orgasm. Objectives: The purpose of this study was to examine the potential benefits of acupuncture in the management of sexual dysfunction secondary to SSRIs and SNRIs. Subjects: Practitioners at the START Clinic referred participants experiencing adverse sexual events from their antidepressant medication for acupuncture treatment at the Mood and Anxiety Disorders, a tertiary care mood and anxiety disorder clinic in Toronto. Design: Participants received a Traditional Chinese Medicine assessment and followed an acupuncture protocol for 12 consecutive weeks. The acupuncture points used were Kidney 3, Governing Vessel 4, Urinary Bladder 23, with Heart 7 and Pericardium 6. Participants also completed a questionnaire package on a weekly basis. Outcomes measured: The questionnaire package consisted of self-report measures assessing symptoms of depression, anxiety, and various aspects of sexual function. Results: Significant improvement among male participants was noted in all areas of sexual functioning, as well as in both anxiety and depressive symptoms. Female participants reported a significant improvement in libido and lubrication and a nonsignificant trend toward improvement in several other areas of function. Conclusions: This study suggests a potential role for acupuncture in the treatment of the sexual side-effects of SSRIs and SNRIs as well for a potential benefit of integrating medical and complementary and alternative practitioners.
The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Participants and design: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan®, Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants’ sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. Results: 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared with the placebo group (Р<0.0001). For intention-to-treat (ITT) there was a statistically significant difference in change from baseline of IIEF scores. The difference between TT and placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically significant difference between TT and placebo was found for Intercourse Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour of TT. There were no differences in the incidence of adverse events (AEs) between the two groups and the therapy was well tolerated. There were no drug-related serious AEs. Following the 12-week treatment period, significant improvement in sexual function was observed with TT compared with placebo in men with mild to moderate ED. TT was generally well tolerated for the treatment of ED.
What makes me suspicious about these trials is that:
- they are mostly on the flimsy side,
- there are as good as no independent replications,
- they all report positive outcomes. I was unable to find a single study where the authors concluded: SORRY, BUT THIS STUFF IS USELESS!
Disappointed with the quality and the content of the existing trials, I am now off to buy some oysters!
The University College London Hospitals (UCLH) include the ‘Royal London Hospital for Integrated Medicine’ (RLHIM). The RLHIM offers a range of so-called alternative medicines (SCAMs), including acupuncture.
This is how they advertise traditional acupuncture to the unsuspecting public:
Acupuncture is a part of Traditional Chinese Medicine (TCM). This is a system of healing which has been practised in China and other Eastern countries for thousands of years.
Although often used as a means of pain relief, it can treat people with other illnesses. The focus is on improving the overall well-being of the patient, rather than the isolated treatment of specific symptoms.
You will be seen individually and assessed by an acupuncturist trained in TCM. They will use traditional Chinese techniques including pulse, tongue and abdominal diagnosis. They will also ask you about your medical history and lifestyle.
The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance.
The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs. It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms.
We will assess your individual needs and discuss a treatment plan with you during your initial consultation.
The treatment may include the use of the following:
- The use of fine acupuncture needles
- Moxibustion (burning of the herb mugwort close to the surface of the skin)
- Cupping therapy (to create local suction on the skin)
- Acupressure (pressure applied to acu-points to stimulate energy flow)
- Electro-acupuncture (a low voltage current is passed between 2 needles)
How reliable is this information? I will try to answer this question by discussing the 6 statements that, in my view, are most questionable.
Although often used as a means of pain relief, it can treat people with other illnesses
Whether acupuncture is effective for pain relief is debatable. A recent analysis cast considerable doubt on the assumption. The notion that acupuncture ‘can treat people with other illnesses’ seems like a ‘carte blanche’ for treating virtually any condition regardless of evidence.
Improving the overall well-being of the patient
I am not aware of sound evidence that acupuncture is an effective treatment for improving overall well-being.
Traditional Chinese techniques including pulse, tongue and abdominal diagnosis
These diagnostic techniques have not been adequately validated and have no place in evidence-based healthcare.
The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance
I am not aware of sound evidence to show that acupuncture stimulates healing. The statement seems like another ‘carte blanche’ for treating anything the therapist feels like, regardless of evidence.
The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs
The claim that acupuncture is a holistic treatment is based on little more than wishful thinking by acupuncturists.
It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms
I am not aware of sound evidence that acupuncture is effective in treating any of the named conditions. The end of the sentence (‘as well as improving symptoms’) is another ‘carte blanche’ for doing anything the acupuncturists feels like.
The UCLH are firmly committed to EBM. The RLHIM claims to be ‘a centre for evidence-based practice’. This claim is not supported by the above advertisement of acupuncture which is clearly not based on good evidence. Moreover, it has the potential to mislead vulnerable patients and thus cause considerable harm. In my view, it is high time that the UCLH address this problem.
It has been reported that Brazil and India will collaborate in the promotion of quackery! Brazil’s president Jair Bolsonaro and India’s Prime Minister Narendra Modi, have just signed several agreements on collaboration. Agreement 8 is particularly intriguing:
8. Memo of agreement for cooperation in Traditional Medicine and Homeopathy
We seek to promote and develop bilateral cooperation in the field of traditional medicine and homeopathy. The areas of cooperation provided for in the instrument include exchange of experience in teaching regulations, practices, medicines and non-medicine therapies; knowledge promotion, exchange of training for therapists, health professionals, scientists, teaching professionals and students; and development of joint research, besides educational and training programs.
Homeopathy, already a recognized medical specialty in Brazil, is currently offered for free by the Brazilian national healthcare system. Other so-called alternative medicines (SCAMs) employed in the Brazilian healthcare system include:
- spiritual healing,
- crystal healing,
Homeopathy and acupuncture are also recognized by the Brazilian Federal Council and both are taught in the most prestigious public Universities, in medical, veterinary, public health and nursing schools.
India has gone one step further by establishing its AYUSH ministry. It registers SCAM practitioners considered ‘indigenous’ by the Indian government under a separate board. The SCAMs thus regulated are:
- Yoga and Naturopathy,
- Unani and Tibbi,
In India, practitioners are taught some of these subjects as MBBS ( Bachelor of Medicine and Surgery). The graduates are then considered to be ‘doctors’. In Brazil, homeopathy and acupuncture are practiced by medical doctors. Brazilian citizens are thus misled to believe that these SCAMs are evidence-based.
So, what this ‘bilateral co-operation’ is going to achieve? Narendra Nayak (President of the Federation of Indian Rationalist Associations and former Assistant Professor of Biochemistry in Mangalore) and Natalia Pasternak (President of the Instituto Questão de Ciência in São Paulo) are less than optimistic:
Exchange of ‘technology’ of so called ‘psychic surgery’ of quacks like the late José Arigo, “the surgeon with the rusty knife”, with specialists of gaumutra (urine of India’s allegedly indigenous cows) whose concoction is supposed to be a panacea for 440 diseases? Is Brazil going to export to India the peculiar surgical techniques of the “medium” John of God, recently arrested, not for years of practicing unlicensed medicine and hurting people, but for sexual harassment and rape? Don’t get the wrong message, we are very glad John of God was convicted, and very glad for the brave women who came forward, but we cannot ignore the fact that he was never bothered by the authorities for placing people under his (usually not quite clean) knife.
Since India and Brazil are leaders in sugar production, are they going to support Homeopathy? Also the use of alcohol to produce their tinctures?
Again, we wonder why India and Brazil are going for an alleged system of medicine called homeopathy which is nowhere in the mainstream in the country of its origin -Germany. And why do they embrace it while the rest of the world is pushing back against homeopathy, after several scientific papers, reviews and meta-analyses showed beyond any reasonable doubt that it doesn’t work?
Brazil and India have much in common, both are rising developing economies, with a diverse population, trying to be true to their democratic ideals. Unfortunately, another similarity comes to light: the fact that presently both our countries are governed by rulers that have shown total disregard by scientific knowledge and evidence in many of their public policy decisions.
As heads of organizations that promote science and rational thinking in Brazil and India, we regret the decision of our governments to promote quackery as a legitimate subject of an international agreement.
I feel that individuals and organisations promoting critical thinking in other parts of the world should lend their support to these two courageous people.
Every now and then, I come across a SCAM paper that is so ‘far out’ that, when reading it, my mind wants to boggle. This one (recently published in ‘Medical Acupuncture’) is about ‘paediatric scupuncture’ – no, not acupuncture performed by kids – it’s acupuncture for kids. The temptation to show you the full, unaltered abstract is too strong to resist:
Background: Approaching pediatric acupuncture from a spiritual perspective is the most effective means for providing a valuable holistic relatively noninvasive approach to pediatric acupuncture, as well as preventive treatments for the repulsion of disease and the correction of Qi (i.e., vital energy) imbalances.
Objectives: Parents may be taught to apply acupressure to their children with an excellent response, especially when given with loving kindness.
Materials and Methods: Methods include the use of acupressure, laser techniques, and acupuncture for children who do not display fear toward the shallow insertion of needles.
Results: Owing to the young age of the patients, children will display fast and effective positive responses to therapy, just as they are susceptible to negative effects in similar timeframes. Children will respond faster than adults to such treatments, which can also increase immune system functionality and bolster resistance to invasive forms of Qi imbalances and disease. Such treatments will also relieve pain and distress and improve concentration and mental attitudes in children. Difficult conditions such as attention-deficit/hyperactivity disorder (ADHD) and attention deficit disorder (ADD) can also be effectively treated through a spiritual approach to pediatric acupuncture.
Conclusions: Pediatric acupuncture from a spiritual perspective provides a specific, safe, and effective therapy for a wide variety of painful and nonpainful conditions through Qi balancing in children. Moreover, parents may be taught to apply acupressure to their children with an excellent response, especially when given with loving kindness. Such techniques not only resolve acute symptoms but also provide preventive measures and enable parent–child relationships to thrive. Overall, medical acupuncture from a spiritual perspective is one of the best complementary therapies in pediatrics.
Of course, you now wonder who is the genius able to produce such deep wisdom. It is Dr. Steven K.H. Aung. He says of himself that he is a pioneer in the integration of western, traditional Chinese and complementary medicine. His efforts have helped to make Alberta and Canada an active centre in the field of integrated and complementary medicine. His unique approach to medicine, combined with the remarkable compassion he brings to all that he does, has made him a highly respected teacher, researcher and physician.
Doctor Aung’s affiliations are impressive:
- Clinical Professor, Departments of Medicine & Family Medicine Faculty of Medicine and Dentistry, University of Alberta (Edmonton, Alberta, Canada)
- Adjunct Professor, Faculty of Rehabilitation Medicine, University of Alberta (Edmonton, Alberta, Canada)
- Chief instructor, examiner and curriculum consultant for the Medical Acupuncture Program (MAP), Faculty of Medicine and Dentistry, Continous Professional Learning, University of Alberta (Edmonton, Alberta, Canada)
In addition, he holds visiting professor appointments at:
- Beijing University of TCM and Research Institute,
- Capital University of Medical Sciences (Beijing),
- Heilongjiang University of TCM (Harbin, China),
- Showa University School of Medicine (Tokyo),
- California Institute for Human Science (Encinitas, California),
- Royal Melbourne Institute of Technology (Melbourne, Australia).
And now my mind truly boggles!
Yesterday, we discussed a paper concluding (amongst other things) that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain. Today, we are looking at one that overtly contradicts this verdict.
This systematic review (published in JAMA Oncology) evaluated the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale.
A total of 17 RCTs (with 1111 patients) were included, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity. A favourable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity and in 2 RCTs for reducing opioid dose. The evidence grade was moderate because of the substantial heterogeneity among studies.
The authors concluded that this systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.
So, which of the two conclusions should we trust?
Personally, I find the JAMA paper unimpressive to the point of being suspect. Here are some of my reasons:
- About half of the primary studies are Chinese; and we have seen repeatedly that they are unreliable and report only positive results.
- Many of the trials are published in Chinese and can thus not be checked by non-Chinese readers (nor, presumably, by the experts who acted as peer-reviewers for JAMA Oncology).
- I have my doubts about the rigor of the peer-review of some of the journals that published the primary studies included in the review.
- One paper included in the review is even a mere doctoral thesis which usually is not peer-reviewed in the usual sense.
- The authors state that they included only clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care. However, this is evidently not true; many of the studies had the infamous A+B versus B design comparing acupuncture plus a conventional therapy against the conventional therapy. As we have discussed ad nauseam on this blog, such trials cannot produce a negative finding even if ‘A’ is a placebo.
- Contrary to what the authors claim, the quality of most of the included studies was extremely poor, as far as I can see.
- One included paper which I cannot access is entitled ‘Clinical observation on 30 cases of moderate and severe cancer pain of bone metastasis treated by auricular acupressure‘. Are the review authors seriously claiming that this is an RCT?
The more I study the details of the JAMA Oncology paper, the more I feel it might be worth a complaint to the editor with a view of initiating a thorough investigation and a possible retraction.
The aim of this review is to synthesise systematic reviews (SRs) of randomised clinical trials (RCTs) evaluating the efficacy of acupuncture to alleviate chronic pain. A total of 177 reviews of acupuncture from 1989 to 2019 met the eligibility criteria. The majority of SRs found that RCTs of acupuncture had methodological shortcomings, including inadequate statistical power with a high risk of bias. Heterogeneity between RCTs was such that meta-analysis was often inappropriate.
Having (co-) authored 13 of these SRs myself, I am impressed with the amount of work that went into this synthesis. The authors should be congratulated for doing it – and for doing it well! The paper itself differentiates the findings according to various types of pain. Here I reproduce the authors’ conclusion regarding different pain entities:
- Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for chronic pain associated with various medical conditions. There is no specific NICE guidance about the use of acupuncture for chronic pain conditions irrespective of aetiology or pathophysiology, although some guidance exists for specific pain conditions (see respective sections below). Guidance by NICE on chronic pain assessment and management is currently being developed (GIDNG10069) with publication expected in August 2020.
- Evidence from the SRs suggests that acupuncture prevents episodic or chronic tension‐type headaches and episodic migraine, although long‐term studies and studies comparing acupuncture with other treatment options are still required. The current NICE guidance (clinical guideline CG150) is that a course of up to 10 sessions of acupuncture over 5–8 weeks is recommended for tension‐type headache and migraine.
- The most recent evidence from a Cochrane review of 16 RCTs suggests that acupuncture is not superior to sham acupuncture for OA of the hip, although in contrast, evidence from nonCochrane reviews suggests that there is moderate‐quality evidence that acupuncture may be effective in the symptomatic relief of pain from OA of the knee. Why there should be a difference in evidence between the knee and the hip is not known. Interestingly, guidance from NICE (CG177) states: “Do not offer acupuncture for the management of osteoarthritis”.
- Evidence suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for low back pain. In 2009, NICE published guidance for the management of nonspecific low back pain that recommended a course of acupuncture as part of first line treatment. This guidance produced much debate. Subsequently, NICE have updated guidance for the management of low back pain and sciatica in people over 16 (NG59) and currently recommend in Section 1.2.8 “Do not offer acupuncture for managing low back pain with or without sciatica”, even though the evidence had not significantly changed.
- Evidence from SRs suggests that dry needling acupuncture might be effective in alleviating pain associated with myofascial trigger points, at least in the short‐term, although there are insufficient high‐quality RCTs to judge the efficacy with any degree of certainty. There is no guidance from NICE on the management of myofascial pain syndrome.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain and more high‐quality, appropriately designed and adequately powered studies are needed. The most recent guidance from NICE (CSG4) recognises that patients who are receiving palliative care often seek complementary therapies, but it does not specifically recommend acupuncture. It recognises that “Many studies have a considerable number of methodological limitations, making it difficult to draw definitive conclusions”.
- Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for fibromyalgia pain. There is no NICE guidance on the treatment of fibromyalgia.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for primary dysmenorrhea or chronic pelvic pain. There is NICE guidance on endometriosis (NG73)  but this does not recommend any form of Chinese medicine for this type of pelvic pain, although acupuncture is not specifically mentioned.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for pain in inflammatory arthritis. There is a NICE guideline (NG100)  for the treatment of rheumatoid arthritis but this does not recommend acupuncture.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for neuropathic pain or neuralgia. There is NICE guidance (CG173) on the management of neuropathic pain, but acupuncture is not included in the list of recommended/not recommended treatments.
- Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for a variety of other painful conditions, including lateral elbow pain, shoulder pain and labour pain. There is no guidance available from NICE on the treatment of any of these conditions.
So, what should we make of all this?
Maybe I just point out two things:
- This is a most valuable addition to the literature about acupuncture. It can serve as a reference for all who are interested in an honest account of the (lack of) value of acupuncture in the management of chronic pain.
- If a therapy has been tested in hundreds of (sadly often flawed) trials and the conclusions fail to come out clearly in favour of it, it is most likely not a very effective treatment.
Until we have data to the contrary, acupuncture should not be considered to be an effective therapy for chronic pain management.
So-called alternative medicine (SCAM) could easily be described as a business that exists mainly because it profits from the flaws of conventional medicine. I know, this is not a good definition, and I don’t want to suggest it as one, but I think it highlights an important aspect of SCAM.
Let me explain.
If we ask ourselves why consumers feel attracted to SCAM, we can identify a range of reasons, and several of them relate to the weaknesses of conventional medicine as it is practised today. For instance:
- People feel the need to have more time with their clinician in order to discuss their problems more fully. This means that their GP does not offer them sufficient time, empathy and compassion they crave.
- Patients are weary of the side-effects of drugs and prefer treatments that are gentle and safe. This shows that they realise that conventional medicine can cause harm and they hope to avoid this risk.
- Patients find it often hard to accept that their symptoms are ‘nothing to worry about’ and does not require any treatment at all. They prefer to hear that the clinician knows exactly what is wrong and can offer a therapy that puts it right.
Conventional medicine and the professionals who administer it have many flaws. Most doctors have such busy schedules that there is little time for building an empathetic therapeutic relationship with their patients. Thus they often palm them off with a prescription and fail to discuss the risks in sufficient detail. Even worse, they sometimes prescribe drugs in situations where none are needed and where a reassuring discussion would be more helpful. It is too easy to excuse such behaviours with work pressures; such flaws are serious and cannot be brushed under the carpet in this way.
Recently, the flawed behaviour of doctors has become the focus of media attention in the form of
- opioid over-prescribing
- over-use of anti-biotics.
In both cases, SCAM providers were quick to offer the solution.
- Acupuncturists and chiropractors claim that their treatments are sensible alternatives to opioids. Yet, there is no good evidence that either acupuncture or chiropractic have analgesic effects that are remotely comparable to those of opioids. They only are seemingly successful in cases where opioids were not needed in the first place.
- Homeopaths claim that their remedies can easily replace antibiotics. Yet, there is not a jot of evidence that homeopathics have antibiotic activity. They only are seemingly successful in cases where the antibiotic was not needed in the first place.
In both instances, SCAM is trying to profit from the weaknesses of conventional medicine. In both cases, the offered solutions are clearly bogus. Yet, in both cases, scientifically illiterate politicians are seriously considering the alleged solutions. Few seem to be smart enough to take a step backwards and contemplate the only viable solution to these problems. If doctors over-prescribe, they need to be stopped; and the best way to stop them is to give them adequate support, more time with their patients and adequate recognition of the importance of reassuring and talking to patients when they need it.
To put it differently:
The best way to reduce the use of bogus SCAMs is to make conventional medicine less flawed.
Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.
The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.
Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).
The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.
In essence this two-centre study shows that:
- real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
- real acupuncture is not significantly better than sham acupuncture;
- the findings differ remarkably between the US and the Chinese centre.
I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.
In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.
Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”
Who do you think is closer to the truth?