MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

acupuncture

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Yesterday, I received a tweet from a guy called Bart Huisman (“teacher beekeeping, nature, biology, classical homeopathy, agriculture, health science, social science”). I don’t know him and cannot remember whether I had previous contact with him. His tweet read as follows:

“Why should anyone believe what Professor Edzard Ernst says, after he put his name to a BBC programme, he now describes as “deception”.”

This refers to a story that I had almost forgotten. It’s a nice one with a ‘happy ending’, so let me recount it here briefly.

In 2005, the BBC had hired me as an advisor for their 4-part TV series on alternative medicine.

The first part of the series was on acupuncture, and Prof Kathy Sykes presented the opening scene taking place in a Chinese operation theatre. In it a Chinese women was having open heart surgery with the aid of acupuncture. Kathy’s was visibly impressed and said on camera that the patient was having the surgery “with only needles to control the pain.”  However, the images clearly revealed that the patient was receiving all sorts of other treatments given through intra-venous lines. So, Prof Sykes was telling the UK public a bunch of porkies. This was bound to confuse many viewers.

One of them was Simon Singh. At the time, I did not know Simon (to be honest, I did not even know of him) and was surprised to receive a phone call from him. He politely asked me to confirm that I had been the adviser of the BBC on this production. I was happy to confirm this fact. Then he asked why I had missed such a grave error. I replied that I could not possibly have spotted it, because all I had been asked to do was to review and correct the text of the programme which the BBC had sent to me by email. Before it was broadcast, I had not seen a single passage of the film.

Correcting the text had already led to several problems (not so much regarding the acupuncture part but mostly the other sections), because the BBC was reluctant to change several of the mistakes I had identified. When I told them that, in this case, I would quit, they finally found a way to alter them. But the cooperation had been far from easy. I explained all this to Simon and eventually he asked me whether I would be willing to support the official complaint he was about to file with the BBC. I agreed. This is probably where I used the term ‘deception’ that Mr Huisman mentioned in his tweet.

So, Simon submitted his complaint and eventually won the case.

But this is not the happy ending I was referring to.

During the course of the complaint, Simon and I realised that we were thinking alike and were getting on well. A few months later, he suggested that the two of us write a book together about alternative medicine. At first, I was hesitant. Simon said, “let’s try just one chapter, and see how it works out.” So we did. It turned out to be fun and instructive for both of us. So we did the other chapters as well. The book was published in 2008 and is called TRICK OR TREATMENT. It was published in about 20 different languages and the German version became ‘science book of the year in 2011 (I think).

And that’s not the happy ending either (in fact, it caused a lot of hardship for Simon who was sued by the BCA; luckily, he won that case too).

The real happy ending is the fact that Simon and I became friends for life.

Thank you Bart Huisman for reminding me of this rather lovely story.

 

Cochrane reviews have the reputation to be the most reliable evidence available anywhere. They are supposed to be independent, rigorous, transparent and up-to-date. Usually, this reputation is justified, in my view. But do the 54 Cochrane reviews of acupuncture quoted in my previous post live up to it?

If one had to put the entire body of evidence in a nutshell, it would probably look something  like this:

TOTAL NUMBER OF SYSTEMATIC REVIEWS = 54

POSITIVE CONCLUSIONS BASED ON MORE THAN ONE HIGH QUALITY STUDY = 2

FAILURE TO REACH CONVINCINGLY POSITIVE CONCLUSIONS = 52

The two positive reviews are on:

1) prevention of migraine

2) prevention of tension-type headache

Both of the positive reviews are by Linde et al.

Allow me to raise just a few further critical points:

  1. If I counted correctly, 19 of the 54 reviews are authored entirely by Chinese authors. Why could this be a problem? One reason could be that many Chinese authors seem to be biased in favour of acupuncture. Another reason could be that data fabrication is rife in China.
  2. Many if not most of the primary studies are published in Chinese. This means that it is impossible for most non-Chinese co-authors of the review as well as for the referees of the paper to check the accuracy of the data extraction.
  3. I counted a total of 15 reviews which were by authors who one could categorise as outspoken enthusiasts of acupuncture. In these cases, one might be concerned about the trustworthiness of the review’s conclusion.
  4.  Many (some would say most) of the reviews cover subject areas which are frankly bizarre. Who would, for instance, consider acupuncture a plausible treatment for Glaucoma, Mumps or chronic hepatitis B?
  5. Despite almost all of the reviews demonstrating that there is no good reason to recommend acupuncture for the condition in question, hardly any of them draw a transparent, helpful and clear conclusion. One example might suffice: the review of acupuncture for hordeolum concluded that “Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum…” Its Chinese authors reached this conclusion on the basis of 6 primary studies (all from China) which were all of lousy quality. In such a case, the only justified conclusion would be, in my view, something like this: THERE IS NO RELIABLE EVIDENCE …

Despite these serious limitations and avoidable confusions, the totality of the evidence from these 54 Cochrane reviews does send an important message: there is hardly a single condition for which acupuncture is clearly, convincingly and indisputably effective. What I find most regrettable, however, is that the Cochrane Collaboration allowed the often biased review authors to obscure this crucial message so thoroughly. One needs a healthy portion of critical thinking to get through to the truth here – and how many fans of acupuncture possess such a thing?

To update my article of 2008, I have searched the Cochrane Library for all Cochrane reviews specifically targeted at acupuncture or related interventions such as acupressure, electro-acupuncture and moxibustion (on 1/6/2020). More general reviews which included some evidence on acupuncture but were not specifically on this topic (e.g. complementary therapies for enuresis) were omitted.

It turned out that almost all the 32 reviews available in 2008 had been updated (some several times), a few had been abandoned and many new reviews have been added. In fact, the 32 reviews of 2008 have today grown into 54.

Here are the conclusions of and links to these papers:

  1. BELL’S PALSY The quality of the included trials was inadequate to allow any conclusion about the efficacy of acupuncture. More research with high quality trials is needed.
  2. PRIMARY DYSMENORRHOEA There is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.
  3. PREVENTION OF EPISODIC MIGRAINE The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long‐term studies, more than one year in duration, are lacking.
  4. RHEUMATOID ARTHRITIS Although the results of the study on electroacupuncture show that electroacupuncture may be beneficial to reduce symptomatic knee pain in patients with RA 24 hours and 4 months post treatment, the reviewers concluded that the poor quality of the trial, including the small sample size preclude its recommendation. The reviewers further conclude that acupuncture has no effect on ESR, CRP, pain, patient’s global assessment, number of swollen joints, number of tender joints, general health, disease activity and reduction of analgesics. These conclusions are limited by methodological considerations such as the type of acupuncture (acupuncture vs electroacupuncture), the site of intervention, the low number of clinical trials and the small sample size of the included studies.
  5. PREVENTION OF TENSION TYPE HEADACHE: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension‐type headaches, but further trials ‐ particularly comparing acupuncture with other treatment options ‐ are needed.
  6. SHOULDER PAIN Due to a small number of clinical and methodologically diverse trials, little can be concluded from this review. There is little evidence to support or refute the use of acupuncture for shoulder pain although there may be short‐term benefit with respect to pain and function. There is a need for further well designed clinical trials.
  7. EPILEPSY Available RCTs are small, heterogeneous and have high risk of bias. The current evidence does not support acupuncture for treating epilepsy.
  8. CHRONIC ASTHMA There is not enough evidence to make recommendations about the value of acupuncture in asthma treatment. Further research needs to consider the complexities and different types of acupuncture.
  9. POLYCYSTIC OVARIAN SYNDROME For true acupuncture versus sham acupuncture we cannot exclude clinically relevant differences in live birth rate, multiple pregnancy rate, ovulation rate, clinical pregnancy rate or miscarriage. Number of intermenstrual days may improve in participants receiving true acupuncture compared to sham acupuncture. True acupuncture probably worsens adverse events compared to sham acupuncture. No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane‐35 did not measure fertility outcomes as the women in these trials did not seek fertility.We are uncertain whether acupuncture improves ovulation rate (measured by ultrasound three months post treatment) compared to relaxation or Diane‐35. The other comparisons did not report on this outcome.Adverse events were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane‐35. These included dizziness, nausea and subcutaneous haematoma. Evidence was very low quality with very wide CIs and very low event rates.There are only a limited number of RCTs in this area, limiting our ability to determine effectiveness of acupuncture for PCOS.
  10. CHRONIC HEPATITIS B The clinical effects of acupuncture for chronic hepatitis B remain unknown. The included trials lacked data on all‐cause mortality, health‐related quality of life, serious adverse events, hepatitis‐B related mortality, and hepatitis‐B related morbidity. The vast number of excluded trials lacked clear descriptions of their design and conduct. Whether acupuncture influences adverse events considered not to be serious is uncertain. It remains unclear if acupuncture affects HBeAg, and if it is associated with reduction in detectable HBV DNA. Based on available data from only one or two small trials on adverse events considered not to be serious and on the surrogate outcomes HBeAg and HBV DNA, the certainty of evidence is very low. In view of the wide usage of acupuncture, any conclusion that one might try to draw in the future should be based on data on patient and clinically relevant outcomes, assessed in large, high‐quality randomised sham‐controlled trials with homogeneous groups of participants and transparent funding.
  11. ENDOMETRIOSIS The evidence to support the effectiveness of acupuncture for pain in endometriosis is limited, based on the results of only a single study that was included in this review. This review highlights the necessity for developing future studies that are well‐designed, double‐blinded, randomised controlled trials that assess various types of acupuncture in comparison to conventional therapies.
  12. VASCULAR DEMENTIA The effectiveness of acupuncture for vascular dementia is uncertain. More evidence is required to show that vascular dementia can be treated effectively by acupuncture. There are no RCTs and high quality trials are few. Randomized double‐blind placebo‐controlled trials are urgently needed.
  13. FUNCTIONAL DYSPEPSIA It remains unknown whether manual acupuncture or electroacupuncture is more effective or safer than other treatments for patients with FD.
  14. SMOKING CESSATION Although pooled estimates suggest possible short‐term effects there is no consistent, bias‐free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well‐designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence‐based interventions.
  15. RESTLESS LEG SYNDROME There is insufficient evidence to determine whether acupuncture is an efficacious and safe treatment for RLS. Further well‐designed, large‐scale clinical trials are needed.
  16. COCAINE DEPENDENCE There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
  17. LABOUR PAIN Acupuncture in comparison to sham acupuncture may increase satisfaction with pain management and reduce use of pharmacological analgesia. Acupressure in comparison to a combined control and usual care may reduce pain intensity. However, for other comparisons of acupuncture and acupressure, we are uncertain about the effects on pain intensity and satisfaction with pain relief due to very low‐certainty evidence. Acupuncture may have little to no effect on the rates of caesarean or assisted vaginal birth. Acupressure probably reduces the need for caesarean section in comparison to a sham control. There is a need for further high‐quality research that include sham controls and comparisons to usual care and report on the outcomes of sense of control in labour, satisfaction with the childbirth experience or satisfaction with pain relief.
  18. ISCAEMIC ENCEPHALOPATHY The rationale for acupuncture in neonates with HIE is unclear and the evidence from randomized controlled trial is lacking. Therefore, we do not recommend acupuncture for the treatment of HIE in neonates. High quality randomized controlled trials on acupuncture for HIE in neonates are needed.
  19. LOW BACK PAIN The data do not allow firm conclusions about the effectiveness of acupuncture for acute low‐back pain. For chronic low‐back pain, acupuncture is more effective for pain relief and functional improvement than no treatment or sham treatment immediately after treatment and in the short‐term only. Acupuncture is not more effective than other conventional and “alternative” treatments. The data suggest that acupuncture and dry‐needling may be useful adjuncts to other therapies for chronic low‐back pain. Because most of the studies were of lower methodological quality, there certainly is a further need for higher quality trials in this area.
  20. AUTISM Current evidence does not support the use of acupuncture for treatment of ASD. There is no conclusive evidence that acupuncture is effective for treatment of ASD in children and no RCTs have been carried out with adults. Further high quality trials of larger size and longer follow‐up are needed.
  21. CARPAL TUNNEL SYNDROME Acupuncture and laser acupuncture may have little or no effect in the short term on symptoms of CTS in comparison with placebo or sham acupuncture. It is uncertain whether acupuncture and related interventions are more or less effective in relieving symptoms of CTS than corticosteroid nerve blocks, oral corticosteroids, vitamin B12, ibuprofen, splints, or when added to NSAIDs plus vitamins, as the certainty of any conclusions from the evidence is low or very low and most evidence is short term. The included studies covered diverse interventions, had diverse designs, limited ethnic diversity, and clinical heterogeneity. High‐quality randomised controlled trials (RCTs) are necessary to rigorously assess the effects of acupuncture and related interventions upon symptoms of CTS. Based on moderate to very‐low certainty evidence, acupuncture was associated with no serious adverse events, or reported discomfort, pain, local paraesthesia and temporary skin bruises, but not all studies provided adverse event data.
  22. ADHA A comprehensive search showed that there is no evidence base of randomised or quasi‐randomised controlled trials to support the use of acupuncture as a treatment for ADHD in children and adolescents. Due to the lack of trials, we cannot reach any conclusions about the efficacy and safety of acupuncture for ADHD in children and adolescents. This review highlights the need for further research in this area in the form of high quality, large scale, randomised controlled trials.
  23. FIBROMYALGIA There is low to moderate‐level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate‐level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well‐being. EA is probably better than MA for pain and stiffness reduction and improvement of global well‐being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow‐up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.
  24. GLAUCOMA At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
  25. UTERINE FIBROIDS The effectiveness of acupuncture for the management of uterine fibroids remains uncertain. More evidence is required to establish the efficacy and safety of acupuncture for uterine fibroids. There is a continued need for well designed RCTs with long term follow up.
  26. HIP OSTEOARTHRITIS Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.
  27. HYPERTENSION At present, there is no evidence for the sustained BP lowering effect of acupuncture that is required for the management of chronically elevated BP. The short‐term effects of acupuncture are uncertain due to the very low quality of evidence. The larger effect shown in non‐sham acupuncture controlled trials most likely reflects bias and is not a true effect. Future RCTs must use sham acupuncture controls and assess whether there is a BP lowering effect of acupuncture that lasts at least seven days.
  28. GASTROPARESISThere is very low‐certainty evidence for a short‐term benefit with acupuncture alone or acupuncture combined with gastrokinetic drugs compared with the drug alone, in terms of the proportion of people who experienced improvement in diabetic gastroparesis. There is evidence of publication bias and a positive bias of small study effects. The reported benefits should be interpreted with great caution because of the unclear overall risk of bias, unvalidated measurements of change in subjective symptoms, publication bias and small study reporting bias, and lack of data on long‐term outcomes; the effects reported in this review may therefore differ significantly from the true effect. One sham‐controlled trial provided low‐certainty evidence of no difference between real and sham acupuncture in terms of short‐term symptom improvement in diabetic gastroparesis, when measured by a validated scale. No studies reported changes in quality of life or the use of medication.Due to the absence of data, no conclusion can be made regarding effects of acupuncture on gastroparesis of other aetiologies. Reports of harm have remained largely incomplete, precluding assessments of the safety of acupuncture in this population. Future research should focus on reducing the sources of bias in the trial design as well as transparent reporting. Harms of interventions should be explicitly reported.
  29. ACUTE STROKE This updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long‐term functional outcomes.
  30. INSOMNIA Due to poor methodological quality, high levels of heterogeneity and publication bias, the current evidence is not sufficiently rigorous to support or refute acupuncture for treating insomnia. Larger high‐quality clinical trials are required.
  31. SCHIZOPHRENIA Limited evidence suggests that acupuncture may have some antipsychotic effects as measured on global and mental state with few adverse effects. Better designed large studies are needed to fully and fairly test the effects of acupuncture for people with schizophrenia.
  32. ACUTE HORDEOLUM Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum when compared with conventional treatments alone. The certainty of the evidence was low to very low mainly due to small sample sizes, inadequate allocation concealment, lack of masking of the outcome assessors, inadequate or unclear randomization method, and a high or unreported number of dropouts. All RCTs were conducted in China, which may limit their generalizability to non‐Chinese populations.Because no RCTs included a valid sham acupuncture control, we cannot rule out a potential expectation/placebo effect associated with acupuncture. As resolution is based on clinical observation, the outcome could be influenced by the observer’s knowledge of the assigned treatment. Adverse effects of acupuncture were reported sparsely in the included RCTs, and, when reported, were rare. RCTs with better methodology, longer follow‐up, and which are conducted among other populations are warranted to provide more general evidence regarding the benefit of acupuncture to treat acute hordeolum.
  33. STROKE REHABILITATION From the available evidence, acupuncture may have beneficial effects on improving dependency, global neurological deficiency, and some specific neurological impairments for people with stroke in the convalescent stage, with no obvious serious adverse events. However, most included trials were of inadequate quality and size. There is, therefore, inadequate evidence to draw any conclusions about its routine use. Rigorously designed, randomised, multi‐centre, large sample trials of acupuncture for stroke are needed to further assess its effects.
  34. DEPRESSION The reduction in severity of depression was less when acupuncture was compared with control acupuncture than when acupuncture was compared with no treatment control, although in both cases, results were rated as providing low‐quality evidence. The reduction in severity of depression with acupuncture given alone or in conjunction with medication versus medication alone is uncertain owing to the very low quality of evidence. The effect of acupuncture compared with psychological therapy is unclear. The risk of adverse events with acupuncture is also unclear, as most trials did not report adverse events adequately. Few studies included follow‐up periods or assessed important outcomes such as quality of life. High‐quality randomised controlled trials are urgently needed to examine the clinical efficacy and acceptability of acupuncture, as well as its effectiveness, compared with acupuncture controls, medication, or psychological therapies.
  35. GAG REFLEX We found very low‐certainty evidence from four trials that was insufficient to conclude if there is any benefit of acupuncture, acupressure or laser at P6 point in reducing gagging and allowing successful completion of dental procedures. We did not find any evidence on any other interventions for managing the gag reflex during dental treatment. More well‐designed and well‐reported trials evaluating different interventions are needed.
  36. PERIPHERAL JOINT OSTEOARTHRITIS Sham‐controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre‐defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list‐controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.
  37. ELBOW PAIN There is insufficient evidence to either support or refute the use of acupuncture (either needle or laser) in the treatment of lateral elbow pain. This review has demonstrated needle acupuncture to be of short term benefit with respect to pain, but this finding is based on the results of 2 small trials, the results of which were not able to be combined in meta‐analysis. No benefit lasting more than 24 hours following treatment has been demonstrated. No trial assessed or commented on potential adverse effect. Further trials, utilising appropriate methods and adequate sample sizes, are needed before conclusions can be drawn regarding the effect of acupuncture on tennis elbow.
  38. MUMPS There is no evidence to determine the efficacy and safety of acupuncture in the treatment of children with mumps, although the excluded studies suggest that acupuncture is effective in improving swelling and pain of the parotid gland and assisting the body temperature to return to normal. We cannot make any recommendations for practice and nor can the results be generalised to clinical practice.
  39. MENOPAUSAL HOT FLUSHES We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
  40. ASSISTED CONCEPTION There is no evidence that acupuncture improves live birth or pregnancy rates in assisted conception.
  41. HICCUPS A total of four studies (305 participants) met the inclusion criteria. All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups. Due to methodological differences we were unable to perform a meta‐analysis of the results. No studies investigating pharmacological interventions for persistent and intractable hiccups met the inclusion criteria.
  42. DYSPHAGIA IN ACUTE STROKE There is not enough evidence to make any conclusion about the therapeutic effect of acupuncture for dysphagia after acute stroke. High quality and large scale randomised controlled trials are needed.
  43. MOXIBUSTION FOR BREECH PRESENTATION This review found limited evidence to support the use of moxibustion for correcting breech presentation. There is some evidence to suggest that the use of moxibustion may reduce the need for oxytocin. When combined with acupuncture, moxibustion may result in fewer births by caesarean section; and when combined with postural management techniques may reduce the number of non‐cephalic presentations at birth, however, there is a need for well‐designed randomised controlled trials to evaluate moxibustion for breech presentation which report on clinically relevant outcomes as well as the safety of the intervention.
  44. CANCER PAIN There is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.
  45. URINARY INCONTINENCE The effect of acupuncture for stress urinary incontinence for adults is uncertain. There is not enough evidence to determine whether acupuncture is more effective than drug treatment.
  46. INDUCTION OF LABOUR Overall, there was no clear benefit from acupuncture or acupressure in reducing caesarean section rate. The quality of the evidence varied between low to high. Few trials reported on neonatal morbidity or maternal mortality outcomes. Acupuncture showed some benefit in improving cervical maturity, however, more well‐designed trials are needed. Future trials could include clinically relevant safety outcomes.
  47. NEUROPATHIC PAIN Due to the limited data available, there is insufficient evidence to support or refute the use of acupuncture for neuropathic pain in general, or for any specific neuropathic pain condition when compared with sham acupuncture or other active therapies. Five studies are still ongoing and seven studies are awaiting classification due to the unclear treatment duration, and the results of these studies may influence the current findings.
  48. PREMENSTRUAL SYNDROME The limited evidence available suggests that acupuncture and acupressure may improve both physical and psychological symptoms of PMS when compared to a sham control. There was insufficient evidence to determine whether there was a difference between the groups in rates of adverse events. There is no evidence comparing acupuncture or acupressure versus current ISPMD recommended treatments for PMS such as selective serotonin reuptake inhibitors (SSRIs). Further research is required, using validated outcome measures for PMS, adequate blinding and suitable comparator groups reflecting current best practice.
  49. IRRITABLE BOWEL SYNDROME Sham‐controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS‐related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients’ preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy.
  50. ANKLE SPRAIN The currently available evidence from a very heterogeneous group of randomised and quasi‐randomised controlled trials evaluating the effects of acupuncture for the treatment of acute ankle sprains does not provide reliable support for either the effectiveness or safety of acupuncture treatments, alone or in combination with other non‐surgical interventions; or in comparison with other non‐surgical interventions. Future rigorous randomised clinical trials with larger sample sizes will be necessary to establish robust clinical evidence concerning the effectiveness and safety of acupuncture treatment for acute ankle sprains.
  51. MYOPAIA Two trials are included in this review but no conclusions can be drawn for the benefit of co‐acupressure for slowing progress of myopia in children. Further evidence in the form of RCTs are needed before any recommendations can be made for the use of acupuncture treatment in clinical use. These trials should compare acupuncture to placebo and have large sample sizes. Other types of acupuncture (such as auricular acupuncture) should be explored further as well as compliance with treatment for at least six months or longer. Axial length elongation of the eye should be investigated for at least one year. The potential to reduce/eliminate pain from acupuncture experienced by children should also be reviewed.
  52. CHRONIC KIDNEY DISEASE There was very low quality of evidence of the short‐term effects of manual acupressure as an adjuvant intervention for fatigue, depression, sleep disturbance and uraemic pruritus in patients undergoing regular haemodialysis. The paucity of evidence indicates that there is little evidence of the effects of other types of acupuncture for other outcomes, including pain, in patients with other stages of CKD. Overall high or unclear risk of bias distorts the validity of the reported benefit of acupuncture and makes the estimated effects uncertain. The incomplete reporting of acupuncture‐related harm does not permit us to assess the safety of acupuncture and related interventions. Future studies should investigate the effects and safety of acupuncture for pain and other common symptoms in patients with CKD and those undergoing dialysis.
  53. REHABILITATION OF BRAIN INJURY The low methodological quality of the included studies does not allow us to make conclusive judgments on the efficacy and safety of acupuncture in either the acute treatment and/or rehabilitation of TBI. Its beneficial role for these indications remains uncertain. Further research with high quality trials is required.
  54. POST-OPERATIVE NAUSEA AND VOMITING There is low‐quality evidence supporting the use of PC6 acupoint stimulation over sham. Compared to the last update in 2009, no further sham comparison trials are needed. We found that there is moderate‐quality evidence showing no difference between PC6 acupoint stimulation and antiemetic drugs to prevent PONV. Further PC6 acupoint stimulation versus antiemetic trials are futile in showing a significant difference, which is a new finding in this update. There is inconclusive evidence supporting the use of a combined strategy of PC6 acupoint stimulation and antiemetic drug over drug prophylaxis, and further high‐quality trials are needed.

The next and last part of this series will provide a few short comments on the current evidence.

Stay tuned!

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

The US ‘Agency for Healthcare Research and Quality (AHRQ) have published a most comprehensive review update entitled ‘Noninvasive Nonpharmacological Treatment for Chronic Pain‘. It followed the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness. The conditions included were:

  • Chronic low back pain
  • Chronic neck pain
  • Osteoarthritis (knee, hip, hand)
  • Fibromyalgia
  • Chronic tension headache

Here are the main findings related to acupuncture:

LOW BACK PAIN

  • Acupuncture was associated with a small improvement in short-term function compared with sham acupuncture or usual care (4 trials); there was no difference between acupuncture and controls in intermediate-term (3 trials) or long-term (1 trial) function (: low). Acupuncture was associated with small improvements in short-term (5 trials) and long-term (1 trial) pain compared with sham acupuncture, usual care, an attention control, or a placebo intervention but there was no difference in intermediate-term pain (5 trials) (SOE: moderate for short term, low for intermediate term and long term).

NECK PAIN

  • Acupuncture was associated with small improvements in short-term (5 trials) and intermediate-term (3 trials) function versus sham acupuncture, a placebo (sham laser), or usual care; one trial reported no difference in function in the long term (: low for all time periods). For pain, there were no differences for acupuncture versus sham acupuncture or placebo interventions in the short (4 trials), intermediate (3 trials), or long (1 trial) term (SOE: low for all time periods).

PAIN FROM KNEE OSTEOARTHRITIS

  • No differences were seen between acupuncture and control interventions (sham acupuncture, waitlist, or usual care) for function in the short term (4 trials) or the intermediate term (4 trials) (: low for short term; moderate for intermediate term). Stratified analysis showed no differences between acupuncture and sham treatments (4 trials) but moderate improvement in function compared with usual care (2 trials) short term. For pain, there were no differences between acupuncture versus control interventions in the short term (6 trials) or clinically meaningful differences in the intermediate term (4 trials) (SOE: low for short term; moderate for intermediate term). Short-term differences in pain were significant for acupuncture versus usual care but not for acupuncture versus sham acupuncture.

CHRONIC TENSION HEADACHE

  • Laser acupuncture was associated with small, short-term improvements in pain intensity and in the number of headache days per month versus sham in one trial (: low).

FIBROMYAGGIA

  • Acupuncture was associated with a small improvement in function compared with sham acupuncture at short-term (3 trials [1 new]) and intermediate-term (2 trials) follow-up (: moderate). There was no effect for acupuncture versus sham acupuncture on pain in the short term (4 trials [1 new]) or intermediate term (3 trials) (SOE: low) or based on pooled estimates across control conditions (sham or attention control, 5 trials [2 new]) SOE: low).

HARMS

Treatment-related SAEs were rare (across 5 , 5 neck pain, 4 , 1 knee , and 1  trial); only one event (needle insertion site pain lasting1 month) in a LBP patient (<1%) in one trial was considered related to treatment,

SAEs not considered to be related to acupuncture or the study conditions (range 0% to 9% across 5 , 5 neck pain, 4 , 1 knee , and 1  trial). These included hospitalization (primarily) or outpatient treatment; reasons were not specified.

The most commonly reported non-serious AEs: swelling, bruising, bleeding or pain at the acupuncture site (1% to 61%, 12 RCTs; or 1% to 18% excluding an outlier trial)); numbness, discomfort, pain or increase in symptoms (1% to 14%; 11 RCTs), dizziness, nausea, fainting (1% to 7%, 7 RCTs), headache (1% to 2%; 4 RCTs), vasovagal symptoms (1% to 4%; 2 RCTs), respiratory problems, chest discomfort (1%; 2 neck pain RCTs), and infection at needle insertion site [1%; 1  (knee )]

____________________

I find this interesting, especially if we consider that chronic pain is THE domain for acupuncture (as practised in the West). It shows that, contrary to what so many enthusiasts try to tell us, the evidence for acupuncture is very weak. It also demonstrates that, contrary to what some sceptics assume, the evidence is not totally negative.

As far as harms are concerned, we need to be aware of the fact that the above conclusions are based on clinical trials. We and others have repeatedly shown that in the real of SCAM many, if not most clinical studies fail to mention adverse effects. This means two things: firstly, the trialists violate research ethics; secondly, the above information is woefully incomplete.

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.

How odd!

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!

Why?

Theoretically it can mean one of two things:

  1. DN did not even convey a placebo effect.
  2. 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.[2] 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.[3] 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.[2]

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:

  • acupuncture,
  • Reiki,
  • spiritual healing,
  • crystal healing,
  • aromatherapy.

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:

  • Ayurveda,
  • Yoga and Naturopathy,
  • Unani and Tibbi,
  • Siddha,
  • Homeopathy.

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.

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