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

acupuncture

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The authors of this review start their paper with the following statement:

Acupuncture has demonstrated effectiveness for symptom management among breast cancer survivors.

This, I think, begs the following question: if they already know that, why do they conduct a systematic review of the subject?

The answer becomes clear as we read thier article: they want to add another paper to the literature that shows they are correct in their assumption.

So, they do the searches and found 26 trials (2055 patients), of which 20 (1709 patients) could be included in the meta-analysis. Unsurprisingly, their results show that acupuncture was more effective than control groups in improving pain intensity [standardized mean difference (SMD) = -0.60, 95% confidence intervals (CI) -1.06 to -0.15], fatigue [SMD = -0.62, 95% CI -1.03 to -0.20], and hot flash severity [SMD = -0.52, 95% CI -0.82 to -0.22].  Compared with waitlist control and usual care groups, the acupuncture groups showed significant reductions in pain intensity, fatigue, depression, hot flash severity, and neuropathy. No serious adverse events were reported related to acupuncture intervention. Mild adverse events (i.e., bruising, pain, swelling, skin infection, hematoma, headache, menstrual bleeding) were reported in 11 studies.

The authors concluded that this systematic review and meta-analysis suggest that acupuncture significantly reduces multiple treatment-related symptoms compared with the usual care or waitlist control group among breast cancer survivors. The safety of acupuncture was inadequately reported in the included studies. Based on the available data, acupuncture seems to be generally a safe treatment with some mild adverse events. These findings provide evidence-based recommendations for incorporating acupuncture into clinical breast cancer symptom management. Due to the high risk of bias and blinding issues in some RCTs, more rigorous trials are needed to confirm the efficacy of acupuncture in reducing multiple treatment-related symptoms among breast cancer survivors.

Yes, I agree: this is an uncritical white-wash of the evidence. So, why do I bother to discuss this paper? After all, the acupuncture literature is littered with such nonsense.

Well, to my surprise, the results did contain a little gem after all.

A subgroup analysis of the data indicated that acupuncture showed no significant effects on any of the treatment-related symptoms compared with the sham acupuncture groups.

In other words, this paper confirms what has been discussed repeatedly on this blog (see for instance here, here, and here):

Acupuncture seems to be a placebo therapy!

Acupuncture is usually promoted as a safe therapy. This may be good marketing but, sadly, it is not the truth. About 10% of all patients experience mild to moderate adverse effects such as pain or bleeding. In addition, there are well-documented complications, for instance:

However, there have been few reports of deaths due to pneumothorax after acupuncture treatment, especially focused on electroacupuncture.

Japanese authors recently reported an autopsy case of a man in his 60s who went into cardiopulmonary arrest and died immediately after receiving electroacupuncture. Postmortem computed tomography (PMCT) showed bilateral pneumothoraces, as well as the presence of numerous gold threads embedded subcutaneously. An autopsy revealed two ecchymoses in the right thoracic cavity and a pinhole injury on the lower lobe of the right lung, suggesting that the needles had penetrated the lung. There were marked emphysematous changes in the lung, suggesting that rupture of bullae might also have contributed to bilateral pneumothoraces and fatal outcomes. The acupuncture needles may have been drawn deeper into the body than at the time of insertion due to electrical pulses and muscle contraction, indicating the need for careful determination of treatment indications and technical safety measures, such as fail-safe mechanisms.

This is the first case report of fatal bilateral pneumothoraces after electroacupuncture reported in the English literature. This case sheds light on the safety of electroacupuncture and the need for special care when administering it to patients with pulmonary disease who may be at a higher risk of pneumothorax. This is also the first report of three-dimensional reconstructed PMCT images showing the whole-body distribution of embedded gold acupuncture threads, which is unusual.

One-sided pneumothoraxes are common events after acupuncture. Several hundred cases have been published and the vast majority of such incidents remain unpublished or even unnoticed. These events are not normally life-threatening. If ‘only’ one lung is punctured, the patient may experience breathing difficulties, but in many cases these are temporary and the patient soon recovers.

Yet a bilateral pneumothorax is an entirely different affair. If both lungs malfunction, the patient’s chances of survival are slim unless he/she is close to an intensive care unit.

You might think that it needs an especially ungifted acupuncturist to manage to puncture both lungs simultaneously. I might agree, but we need to consider that acupuncture needles are often inserted in a symmetrical fashion into the patient’s body. This means that, if the therapist puts a needle at one point of the thorax that is close to a lung, he is not unlikely to do the same on the other side.

And how does one prevent such disasters?

Easy:

  • train acupuncturists properly,
  • avoid needles on the upper thorax,
  • or refuse acupuncture altogether.

 

 

This multicenter, randomized, sham-controlled trial was aimed at assessing the long-term efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Men with moderate to severe CP/CPPS were recruited, regardless of prior exposure to acupuncture. They received sessions of acupuncture or sham acupuncture over 8 weeks, with a 24-week follow-up after treatment. Real acupuncture treatment was used to create the typical de qi sensation, whereas the sham acupuncture treatment (the authors state they used the Streitberger needle, but the drawing looks more as though they used our device) does not generate this feeling.

The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points.

A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were:

  • 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group
  • 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001).

At week 32, the proportions were:

  • 61.5% (CI, 54.5% to 68.1%) in the acupuncture group
  • 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001).

Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. No significant difference was found in changes in the International Index of Erectile Function 5 score at all assessment time points or in peak and average urinary flow rates at week 8.

The authors concluded that, compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.

Previous studies of acupuncture for CP/CPPS have been unconvincing. Our own systematic review of 2012 included 9 RCTs and all suggested that acupuncture is as effective as a range of control interventions. Their methodologic quality was variable; most were associated with major flaws. Only one RCT had a Jadad score of more than 3. We concluded that the evidence that acupuncture is effective for chronic prostatitis/chronic pelvic pain syndrome is encouraging but, because of several caveats, not conclusive. Therefore, more rigorous studies seem warranted.
This new study looks definitely more rigorous than the previous ones. But is it convincing? To answer this question, we need to consider a few points.

The study was sponsored by the China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine. The trialists originate from the following institutions:

  • 1Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).
  • 2Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (Y.L.).
  • 3ThedaCare Regional Medical Center – Appleton, Appleton, Wisconsin (K.Z.).
  • 4Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China (Z.Y.).
  • 5The First Hospital of Hunan University of Chinese Medicine, Changsha, China (W.Z.).
  • 6Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China (W.F.).
  • 7The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China (J.Y.).
  • 8West China Hospital of Sichuan University, Chengdu, China (N.L.).
  • 9China Academy of Chinese Medical Sciences, Beijing, China (L.H.).
  • 10Yantai Hospital of Traditional Chinese Medicine, Yantai, China (Z.Z.).
  • 11Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi’an, China (T.S.).
  • 12The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China (J.F.).
  • 13Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, China (Y.D.).
  • 14Xi’an TCM Brain Disease Hospital, Xi’an, China (H.S.).
  • 15Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China (H.H.).
  • 16Luohu District Hospital of Traditional Chinese Medicine, Shenzhen, China (H.Z.).
  • 17Guizhou University of Traditional Chinese Medicine, Guiyang, China (Q.M.).

These facts, together with the previously discussed notion that clinical trials from China are notoriously unreliable, do not inspire confidence. Moreover, one might well wonder about the authors’ claim that patients were blinded. As pointed out above, the real and sham acupuncture were fundamentally different: the former did generate de qi, while the latter did not! A slightly pedantic point is my suspicion that the trial did not test the efficacy but the effectiveness of acupuncture, if I am not mistaken. Finally, one might wonder what the rationale of acupuncture as a treatment of CP/CPPS might be. As far as I can see, there is no plausible mechanism (other than placebo) to explain the effects.

So, is the evidence that emerged from the new study convincing?

No, in my view, it is not!

In fact, I am surprised that a journal as reputable as the Annals of Internal Medicine published it.

Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?

Let’s find out.

This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).

A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.

Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.

At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.

The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.

The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?

No!

We have discussed Marma massage, we have repeatedly discussed acupuncture, of course, but we have so far never considered marmapuncture. The ‘British Institute of Marmapuncture‘ explains what it is:

Marmapuncture is traditionally known as Bhedan karma (meaning the action of piercing through) is a time tested therapeutic intervention, which treats the energetic body through an elaborate network of channels known as srotas.

Despite the widely held belief that Marmapuncture is a derivative of Chinese Acupuncture, that was popularised in 200-400 BC in text of the Yellow Emperor) modern archaeological evidence points to the fact that Suchi Bhaden, Shira Bhedan and Bhadhan Karma where practised in Sri Lanka well before this time. Finds discovered in caves in the Balangoda region of Sri Lanka, suggest there has been continuous habitation for over 37,000 years. Micro lithic tools were crafted from flint, fish bones and a type of rock known as Chert. These where used to penetrate the skin, which affected a therapeutic response in the body.

Another website informs us what marmapuncture can achieve:

Marmapuncture can relieve a wide range of symptoms associated with musculoskeletal pain or injury, chronic fatigue, bowel complaints (IBS) and indigestion, stress, depression, anxiety, panic attacks, skin complaints, asthma and breathing disorders, low/excessive appetite and infertility (male and female).

And why do I mention all this? Last weekend, I read the Guardian (3/7/2021) and there it was: a half-page article entitled MARMAPUNCTURE. THIS INNOVATIVE FACIAL TREATMENT IS MORE THAN SKIN DEEP. WE FIND OUT HOW IT IS USED IN AYURVEDIC MEDICINE AND PUT IT TO THE TEST. In the article, Mattie Lacey-Davidson had the treatment and found that marmapuncture (dubbed ‘natural Botox’) is not truly comparable to botox. Then Mattie mentioned a 2013 study that allegedly reported ‘promising results as a therapy for facial elasticity with evidence of skin tightening across the face’. I think I found the study; here it is:

Background. The use of acupuncture for cosmetic purposes has gained popularity worldwide. Facial cosmetic acupuncture (FCA) is applied to the head, face, and neck. However, little evidence supports the efficacy and safety of FCA. We hypothesized that FCA affects facial elasticity by restoring resting mimetic muscle tone through the insertion of needles into the muscles of the head, face, and neck. Methods. This open-label, single-arm pilot study was implemented at Kyung Hee University Hospital at Gangdong from August through September 2011. Participants were women aged 40 to 59 years with a Glogau photoaging scale III. Participants received five treatment sessions over three weeks. Participants were measured before and after FCA. The primary outcome was the Moire topography criteria. The secondary outcome was a patient-oriented self-assessment scale of facial elasticity. Results. Among 50 women screened, 28 were eligible and 27 completed the five FCA treatment sessions. A significant improvement after FCA treatment was evident according to mean change in Moire topography criteria (from 1.70 ± 0.724 to 2.26 ± 1.059, P < 0.0001). The most common adverse event was mild bruising at the needle site. Conclusions. In this pilot study, FCA showed promising results as a therapy for facial elasticity. However, further large-scale trials with a controlled design and objective measurements are needed.

As we see, it is neither a study of marmapuncture or a controlled trial. Its results are utterly meaningless. But is there any evidence at all to support the many claims made for marmapuncture?

No!

Last question: who is Mattie Lacey-Davidson?

She is a blogger/influencer/content creator based in London.

Say no more!

Neuropathic pain is difficult to treat. Luckily, we have acupuncture! Acupuncturists leave us in no doubt that their needles are the solution. But are they correct or perhaps victims of wishful thinking?

This review was aimed at determining the proportion of patients with neuropathic pain who achieve a clinically meaningful improvement in their pain with the use of different pharmacologic and nonpharmacologic treatments.

Randomized controlled trials were included that reported a responder analysis of adults with neuropathic pain-specifically diabetic neuropathy, postherpetic neuralgia, or trigeminal neuralgia-treated with any of the following 8 treatments: exercise, acupuncture, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), topical rubefacients, opioids, anticonvulsant medications, and topical lidocaine.

A total of 67 randomized controlled trials were included. There was moderate certainty of evidence that anticonvulsant medications (risk ratio of 1.54; 95% CI 1.45 to 1.63; number needed to treat [NNT] of 7) and SNRIs (risk ratio of 1.45; 95% CI 1.33 to 1.59; NNT = 7) might provide a clinically meaningful benefit to patients with neuropathic pain. There was low certainty of evidence for a clinically meaningful benefit for rubefacients (ie, capsaicin; NNT = 7) and opioids (NNT = 8), and very low certainty of evidence for TCAs. Very low-quality evidence demonstrated that acupuncture was ineffective. All drug classes, except TCAs, had a greater likelihood of deriving a clinically meaningful benefit than having withdrawals due to adverse events (number needed to harm between 12 and 15). No trials met the inclusion criteria for exercise or lidocaine, nor were any trials identified for trigeminal neuralgia.

The authors concluded that there is moderate certainty of evidence that anticonvulsant medications and SNRIs provide a clinically meaningful reduction in pain in those with neuropathic pain, with lower certainty of evidence for rubefacients and opioids, and very low certainty of evidence for TCAs. Owing to low-quality evidence for many interventions, future high-quality trials that report responder analyses will be important to strengthen understanding of the relative benefits and harms of treatments in patients with neuropathic pain.

This review was published in a respected mainstream journal and conducted by a multidisciplinary team with the following titles and affiliations:

  • Associate Professor in the College of Pharmacy at the University of Manitoba in Winnipeg.
  • Pharmacist in Edmonton, Alta, and Clinical Evidence Expert for the College of Family Physicians of Canada.
  • Family physician and Assistant Professor at the University of Alberta.
  • Family physician and Associate Professor in the Department of Family Medicine at the University of Alberta.
  • Pharmacist, Clinical Evidence Expert Lead for the College of Family Physicians of Canada, and Associate Clinical Professor in the Department of Family Medicine at the University of Alberta.
  • Pharmacist in Edmonton and Clinical Evidence Expert for the College of Family Physicians of Canada.
  • Pharmacist and Clinical Evidence Expert at the College of Family Physicians of Canada.
  • Family physician, Director of Programs and Practice Support at the College of Family Physicians of Canada, and Adjunct Professor in the Department of Family Medicine at the University of Alberta.
  • Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia in Vancouver.
  • Pharmacist at the CIUSSS du Nord-de-l’lle-de-Montréal and Clinical Associate Professor in the Faculty of Pharmacy at the University of Montreal in Quebec.
  • Care of the elderly physician and Assistant Professor in the Department of Family Medicine at the University of Alberta.
  • Family physician and Professor in the Department of Family Medicine at the University of Alberta.
  • Assistant Professor in the Department of Family Medicine at Queen’s University in Kingston, Ont.
  • Research assistant at the University of Alberta.
  • Medical student at the University of Alberta.
  • Nurse in Edmonton and Clinical Evidence Expert for the College of Family Physicians of Canada.

As far as I can see, the review is of sound methodology, it minimizes bias, and its conclusions are therefore trustworthy. They suggest that acupuncture is not effective for neuropathic pain.

But how can this be? Do the authors not know about all the positive evidence on acupuncture? A quick search found positive recent reviews of acupuncture for all of the three indications in question:

  1. Diabetic neuropathy: Acupuncture alone and vitamin B combined with acupuncture are more effective in treating DPN compared to vitamin B.
  2. Herpes zoster: Acupuncture may be effective for patients with HZ.
  3. Trigeminal neuralgia: Acupuncture appears more effective than pharmacotherapy or surgery.

How can we explain this obvious contradiction?

Which result should we trust?

Do we believe pro-acupuncture researchers who published their papers in pro-acupuncture journals, or do we believe the findings of researchers who could not care less whether their work proves or disproves the effectiveness of acupuncture?

I think that these papers offer an exemplary opportunity for us to study how powerful the biases of researchers can be. They also remind us that, in the realm of so-called alternative medicine (SCAM), we should always be very cautious and not accept every conclusion that has been published in supposedly peer-reviewed medical journals.

Thread embedding acupuncture therapy (TEAT) involves the insertion of thread at specific points on the body surface. The claim is that TEAT provides a sustained stimulation of acupoints and is therefore superior to needle acupuncture. Initially, TEAT was used in China to treat obesity, today it is employed to treat many conditions, including musculoskeletal conditions such as ankle sprain, shoulder pain, lumbar intervertebral disc herniation, and plantar fasciitis. Its effectiveness is, however, doubtful and so is its safety.

This review evaluated the safety of thread embedding acupuncture therapy (TEAT) and discuss the prevention and treatment of some adverse events (AEs).

Databases, including China National Knowledge Infrastructure (CNKI), CBMdisc, Wanfang, VIP databases and PubMed, MEDLINE, EMBASE, and Web of Science, were searched from their inception to January 2020. Included were randomized controlled trials (RCTs) and case reports in which AEs with TEAT were reported. Cochrane Collaboration’s tool and RevMan V.5.3.3 software were used to evaluate the quality of the studies.

A total of 61 articles (45 RCTs and 16 case reports) with a total of 620 cases of AEs were included in this review. These studies were published in two countries: China and South Korea. Twenty-eight kinds of AEs were noted. The most common AEs were induration, bleeding and ecchymosis, redness and swelling, fever, and pain. They accounted for 75.35% of all AEs.  Most AEs were mild.; The rarest AEs were epilepsy, irregular menstruation, skin ulcer, thread malabsorption, and fat liquefaction, with 1 case each. Not all of them had a clear causal relationship with TEAT. Most of the AEs were local reactions and systemic reactions accounted for only 1.27%. Although the included studies showed that AEs were very commonly encountered (11.09%), only 5 cases of severe AEs reported from 2013 to 2017 (0.1%) by using catgut thread, which is rarely employed nowadays with new absorbable surgical suture being more popular. All of the patients with severe AEs were recovered after symptomatic treatment with no sequelae.

The authors concluded that the evidence showed that TEAT is a relatively safe and convenient therapy especially since application of new absorbable surgical suture. Improving practitioner skills, regulating operations, and paying attention to the patients’ conditions may reduce the incidence of AEs and improve safety of TEAT.

TEAT was initially used in China only but recently it has become popular elsewhere as well. Therefore the question about its risks has become relevant. The present paper is interesting in that it demonstrates that AEs do occur with some regularity. The authors’ conclusion that TEAT is “relatively safe” is, however, not justified because:

  1. the total sample size was not large enough for a generalizable conclusion;
  2. only RCTs and case reports were included, whereas case series and case-control studies (which would provide more relevant data) were excluded or might not even exist;
  3. RCTs of acupuncture often fail to mention or under-report AEs;
  4. acupuncture papers from China are notoriously unreliable.

So, all we can conclude from the evidence presented here is that AEs after TEAT do occur and do not seem to be all that rare. As the efficacy of TEAT has not been shown beyond doubt, this must inevitably lead to the conclusion that the risk-benefit balance of TEAT is not positive. In turn, that means that TEAT cannot be recommended as a treatment for any condition.

 

Battlefield Acupuncture (BFA) – I presume the name comes from the fact that it is so simple, it could even be used under combat situations – is a form of ear acupuncture developed 20 years ago by Dr Richard Niemtzow. BFA employs gold semipermanent needles that are placed at up to 5 specific sites in one or both ears.  The BFA needles are small conical darts that pierce the outer ear in designated locations and remain in place until they fall out typically within 3–4 days.

The US Defense and Veterans Center for Integrative Pain Management and the Veterans Health Administration National Pain Management Program Office recently completed a 3-year acupuncture education and training program, which deployed certified BFA trainers for the Department of Defense and Veterans Administration medical centers. Over 2800 practitioners were thus trained to provide BFA. The total costs amounted to $ 5.4 million.

This clearly begs the question:

DOES IT WORK?

 This review aims to investigate the effects and safety of BFA in adults with pain. Electronic databases were searched for randomized controlled trials (RCTs) published in English evaluating efficacy and safety of BFA in adults with pain, from database inception to September 6, 2019. The primary outcome was pain intensity change, and the secondary outcome was safety. Nine RCTs were included in this review, and five trials involving 344 participants were analyzed quantitatively. Compared with no intervention, usual care, sham BFA, and delayed BFA interventions, BFA had no significant improvement in the pain intensity felt by adults suffering from pain. Few adverse effects (AEs) were reported with BFA therapy, but they were mild and transitory.

The authors of this review concluded that BFA is a safe, rapid, and easily learned acupuncture technique, mainly used in acute pain management, but no significant efficacy was found in adult individuals with pain, compared with the control groups. Given the poor methodological quality of the included studies, high-quality RCTs with rigorous evaluation methods are needed in the future.

And here are my comments:

  • SAFE? Impossible to tell on the basis of 344 patients.
  • RAPID? True, but meaningless, as it does not work.
  • EASILY LEARNT? True, it’s simple and seems ever so stupid.
  • NO SIGNIFICANT EFFICACY? That I can easily believe.

I am amazed that anyone would fall for an idea as naive as BFA. That it should be the US military is simply hilarious, in my view. I am furthermore baffled that anyone recommends more study of such monumental nonsense.

Why, oh why?

Acupuncture is far-fetched (to put it mildly). Ear acupuncture is positively ridiculous. BFA seems beyond ridiculous and must be the biggest military hoax since general Grigory Aleksandrovich Potemkin painted façades to fool Catherine the Great into thinking that an area was far richer than it truly was.

 

The new NICE draft guideline on acupuncture for chronic pain has been published several months ago, and we discussed it here. Now the final document entitled ‘Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain‘ has been published on 7/4/2021. Like the draft, it includes quite a bit about acupuncture. Let me just quote three essential sections:

Recommendations: Acupuncture for chronic primary pain

Consider a single course of acupuncture or dry needling, within a traditional Chinese or Western acupuncture system, for people aged 16 years and over to manage chronic primary pain, but only if the course:

  • is delivered in a community setting and
  • is delivered by a band 7 (equivalent or lower) healthcare professional with appropriate training and
  • is made up of no more than 5 hours of healthcare professional time (the number and length of sessions can be adapted within these boundaries) or
  • is delivered by another healthcare professional with appropriate training and/or in another setting for equivalent or lower cost.

_____________________________

Many studies (27 in total) showed that acupuncture reduced pain and improved quality of life in the short term (up to 3 months) compared with usual care or sham acupuncture. There was not enough evidence to determine longer-term benefits. The committee acknowledged the difficulty in blinding for sham procedures, but agreed that the benefit compared with a sham procedure indicated a specific treatment effect of acupuncture. There was a wide variation among the studies in the type and intensity of the intervention used, and the studies were from many different countries. The committee agreed that the type of acupuncture or dry needling should depend on the individual needs of the person with pain.

Two economic evaluations (1 in the UK) showed that acupuncture offered a good balance of benefits and costs for people with chronic neck pain. However, both studies had limitations; a notable limitation being that the costs of acupuncture seemed low. Threshold analysis based on these studies indicated the maximum number of hours of a band 6 and 7 healthcare professional’s time that would make the intervention cost effective.

An original economic model was developed for this guideline, which compared acupuncture with no acupuncture. The model used data from studies with usual care comparisons, not comparisons with sham acupuncture, because the committee agreed that a usual care comparison in an economic model better reflects the real world benefit of the intervention. The model showed that acupuncture was likely to be cost effective. The committee considered the results to be robust, and agreed that the studies used in the model were representative of the whole evidence review. Acupuncture remained cost effective when the assumed benefits and costs were varied (sensitivity analysis).

Overall, the committee agreed that there was a large evidence base showing acupuncture to be clinically effective in the short term (3 months); the original economic modelling also showed it is likely to be cost effective. However, they were uncertain whether the beneficial effects would be sustained long term and were aware of the high resource impact of implementation. Taking these factors into account, the committee made a recommendation to consider acupuncture or dry needling for chronic primary pain, caveated by the factors likely to make the intervention cost effective. These were: only if delivered in the community, and with a maximum of 5 treatment hours (based on the average resource use in the trials in the model and on the threshold analysis), and from a band 7 (equivalent cost or lower) healthcare professional (based on the threshold analysis). It was agreed there may be different ways of delivering the service that enable acupuncture to be delivered for the same costs, which would equally be appropriate. The committee agreed that discontinuing before this total amount of course time would be an option if the person finds that the first few sessions are not effective.

_______________________________

Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.

Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.

______________END OF QUOTES____________

I will leave this here without a comment for the moment and look forward to reading what you think about this.

This study was aimed at determining the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.

The Personalized Electroacupuncture vs Auricular Acupuncture Comparativeness Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).

Patients were randomized 2:2:1 to:

  1. electroacupuncture (n = 145),
  2. auricular acupuncture (n = 143),
  3. or usual care (n = 72).

Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.

The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.

Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).

The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.

I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:

In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.

I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.

Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:

As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…

Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.

This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.

It is hard not to conclude that they deliberately try to mislead us.

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