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
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:
- electroacupuncture (n = 145),
- auricular acupuncture (n = 143),
- or usual care (n = 72).
Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.
The primary outcome was a change in the average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.
Among 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).
The authors of this study concluded that, in this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.
I think the authors made a mistake in formulating their conclusions. Perhaps they allow me to correct it:
In this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture plus usual care and auricular acupuncture plus usual care produced greater pain reduction than usual care alone.
I know, I must sound like a broken record, but – because it followed the often-discussed ‘A+B versus B’ design – this study does simply not show what the authors conclude. In fact, it tells us very little about any effects caused by the two acupuncture versions per se. The study does not control for placebo effects and therefore its results are consistent with acupuncture itself having no effect at all.
Here is an attempt at explaining the ‘A+B versus B’ study design I posted previously:
As regularly mentioned on this blog, there are several ways to design a study such that the risk of producing a negative result is minimal. The most popular one in SCAM research is the ‘A+B versus B’ design…
Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual alone, and the former is therefore more than likely to produce a better result. This will be true, even if acupuncture is a pure placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.
Imagine the two interventions had been a verbal encouragement or pat on the shoulder or a pat on the right shoulder for group 1 and one on the left for group 2. The findings could well have been very similar. To provide evidence that acupuncture PRODUCES PAIN REDUCTION, we need proper tests of the hypothesis. And to ‘determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors’, we need a different methodology.
This is, of course, all very elementary. Nothing elaborate or complicated! Scientists know it; editors know it; reviewers know it. Or at least they should know it. Therefore, I am at a loss trying to understand why even journals of high standing publish IMPROPER tests, better known as pseudo-science.
It is hard not to conclude that they deliberately try to mislead us.
Osteopathic manipulative treatment (OMT) is popular, but does it work? On this blog, we have often discussed that there are good reasons to doubt it.
This study compared the efficacy of standard OMT vs sham OMT for reducing low back pain (LBP)-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. It was designed as a prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial. 400 patients with nonspecific subacute or chronic LBP were recruited from a tertiary care center in France starting and randomly allocated to interventions in a 1:1 ratio.
Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by osteopathic practitioners. For both
experimental and control groups, each session lasted 45 minutes and consisted of 3 periods: (1) interview focusing on pain location, (2) full osteopathic examination, and (3) intervention consisting of standard or sham OMT. In both groups, practitioners assessed 7 anatomical regions for dysfunction (lumbar spine, root of mesentery, diaphragm, and atlantooccipital, sacroiliac, temporomandibular, and talocrural joints) and applied sham OMT to all areas or standard OMT to those that were considered dysfunctional.
The primary endpoint was the mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index. Secondary outcomes were the mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leave, as well as the number of LBP episodes at 12 months, and the consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.
A total of 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode had been 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months.
The mean (SD) Quebec Back Pain Disability Index scores were:
- 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months in the OMT-group,
- 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months in the sham group.
The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.
The authors concluded that standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.
This study was funded the French Ministry of Health and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique-Hôpitaux de Paris. It is of exceptionally good quality. Its findings are important, particularly in France, where osteopaths have become as numerous as their therapeutic claims irresponsible.
In view of what we have been repeatedly discussing on this blog, the findings of the new trial are unsurprising. Osteopathy is far less well supported by sound evidence than osteopaths want us to believe. This is true, of course, for the plethora of non-spinal claims, but also for LBP. The French authors cite previously published evidence that is in line with their findings: In a systematic review, Rubinstein and colleagues compared the efficacy of manipulative treatment to sham manipulative treatment on LBP-specific activity limitations and did not find evidence of differences at 3 and 12 months (3 RCTs with 573 total participants and 1 RCT with 63 total participants). Evidence was considered low to very low quality. When merging the present results with these findings, we found similar standardized mean difference values at 3months (−0.11 [95% CI, −0.24 to 0.02]) and 12 months (−0.11 [95% CI, −0.33 to 0.11]) (4 RCTs with 896 total participants and 2 RCTs with 320 total participants).
So, what should LBP patients do?
The answer is, as I have often mentioned, simple: exercise!
And what will the osteopaths do?
The answer to this question is even simpler: they will find/invent reasons why the evidence is not valid, ignore the science, and carry on making unsupported therapeutic claims about OMT.
Two recent reviews have evaluated the evidence for acupuncture as a means of preventing migraine attacks.
The first review assessed the efficacy and safety of acupuncture for the prophylaxis of episodic or chronic migraine in adult patients compared to pharmacological treatment.
The authors included randomized controlled trials published in western languages that compared any treatment involving needle insertion (with or without manual or electrical stimulation) at acupuncture points, pain points or trigger points, with any pharmacological prophylaxis in adult (≥18 years) with chronic or episodic migraine with or without aura according to the criteria of the International Headache Society.
Nine randomized trials were included encompassing 1,484 patients. At the end of the intervention, a small reduction was found in favor of acupuncture for the number of days with migraine per month: (SMD: -0.37; 95% CI -1.64 to -0.11), and for response rate (RR: 1.46; 95% CI 1.16-1.84). A moderate effect emerged in the reduction of pain intensity in favor of acupuncture (SMD: -0.36; 95% CI -0.60 to -0.13), and a large reduction in favor of acupuncture in both the dropout rate due to any reason (RR 0.39; 95% CI 0.18 to 0.84) and the dropout rate due to adverse event (RR 0.26; 95% CI 0.09 to 0.74). The quality of the evidence was moderate for all these primary outcomes. Results at longest follow-up confirmed these effects.
The authors concluded that, based on moderate certainty of evidence, we conclude that acupuncture is mildly more effective and much safer than medication for the prophylaxis of migraine.
The second review aimed to perform a network meta-analysis to compare the effectiveness and acceptability between topiramate, acupuncture, and Botulinum neurotoxin A (BoNT-A).
The authors searched OVID Medline, Embase, the Cochrane register of controlled trials (CENTRAL), the Chinese Clinical Trial Register, and clinicaltrials.gov for randomized controlled trials (RCTs) that compared topiramate, acupuncture, and BoNT-A with any of them or placebo in the preventive treatment of chronic migraine. A network meta-analysis was performed by using a frequentist approach and a random-effects model. The primary outcomes were the reduction in monthly headache days and monthly migraine days at week 12. Acceptability was defined as the number of dropouts owing to adverse events.
A total of 15 RCTs (n = 2545) could be included. Eleven RCTs were at low risk of bias. The network meta-analyses (n = 2061) showed that acupuncture (2061 participants; standardized mean difference [SMD] -1.61, 95% CI: -2.35 to -0.87) and topiramate (582 participants; SMD -0.4, 95% CI: -0.75 to -0.04) ranked the most effective in the reduction of monthly headache days and migraine days, respectively; but they were not significantly superior over BoNT-A. Topiramate caused the most treatment-related adverse events and the highest rate of dropouts owing to adverse events.
The authors concluded that Topiramate and acupuncture were not superior over BoNT-A; BoNT-A was still the primary preventive treatment of chronic migraine. Large-scale RCTs with direct comparison of these three treatments are warranted to verify the findings.
Unquestionably, these are interesting findings. How reliable are they? Acupuncture trials are in several ways notoriously tricky, and many of the primary studies were of poor quality. This means the results are not as reliable as one would hope. Yet, it seems to me that migraine prevention is one of the indications where the evidence for acupuncture is strongest.
A second question might be practicability. How realistic is it for a patient to receive regular acupuncture sessions for migraine prevention? And finally, we might ask how cost-effective acupuncture is for that purpose and how its cost-effectiveness compares to other options.
Since Gwyneth Paltrow, as well as US Olympic swimmers, were publicly sporting their cupping marks, cupping has repeatedly occupied the pages of this blog. Now, cupping is in the news yet again. It has been reported that an image of a self-proclaimed ‘cupping’ expert performing treatment on a newborn baby has caused a major outcry. The photo shows a three-month-old baby’s skin on its back being sucked into a cup with the skin deformed and bright red.
The man, known as Mustafa, who refers to himself as an ‘expert’ at a ’cupping centre’ in the city of Istanbul, recently shared the images on social media where he was apparently treating the baby for ‘gas’. “We provide cupping for everyone from three-month-old babies to 70-year-olds. We do it since it is an Islamic tradition and we believe that everyone should take part in it,“ Mustafa said. “I am not a swindler. I do not demand money from people. They give as much as they choose.”
Child and adolescent psychiatrist associate, Dr Veysi Ceri, slammed the parents who allowed the procedure to be performed on their children. “Children cannot be left at the mercy of their parents,” Dr Ceri said. “Cupping is something that is not based on scientific evidence and children are physically harmed from it.”
On social media, people expressed their fury, labelling the practice as “questionable”. One commenter wrote: “Are these people crazy? They don’t read or learn anything.” But there were also those who shared their positive experiences. “I congratulate the family who had cupping performed on their baby,” one person wrote. “I also do cupping regularly and I haven’t had a headache in years. I do not take any medicine either. It is also beneficial for children to have cupping.“
So, is there any reliable evidence about dry cupping for children?
Is it demonstrably effective for any paediatric condition?
Is it harmful?
Believe it or not, there has been at least one clinical trial of dry cupping as a treatment of constipation in children:
One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation.
Results: There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period.
Conclusion: This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.
This study is squarely negative, yet the conclusions are clearly positive. I have stopped being amazed by such contradictions. After all, we are dealing with so-called alternative medicine (SCAM)!
For what it’s worth, here is our 2011 overview of all systematic reviews of cupping:
Several systematic reviews (SRs) have assessed the effectiveness of cupping for a range of conditions. Our aim was to provide a critical evaluation and summary of these data. Electronic searches were conducted to locate all SRs concerning cupping for any condition. Data were extracted by two authors according to predefined criteria. Five SRs met our inclusion criteria, which related to the following conditions: pain conditions, stroke rehabilitation, hypertension, and herpes zoster. The numbers of studies included in each SR were small. Relatively clear evidence emerged only for one indication, that cupping may be effective for reducing pain. Based on evidence from the currently available SRs, the effectiveness of cupping has been demonstrated only as a treatment for pain, and even for this indication doubts remain.
And here is our 2011 SR of cupping as a treatment of pain:
The objective of this study was to assess the evidence for or against the effectiveness of cupping as a treatment option for pain. Fourteen databases were searched. Randomized clinical trials (RCTs) testing cupping in patients with pain of any origin were considered. Trials using cupping with or without drawing blood were included, while trials comparing cupping with other treatments of unproven efficacy were excluded. Trials with cupping as concomitant treatment together with other treatments of unproven efficacy were excluded. Trials were also excluded if pain was not a central symptom of the condition. The selection of studies, data extraction and validation were performed independently by three reviewers. Seven RCTs met all the inclusion criteria. Two RCTs suggested significant pain reduction for cupping in low back pain compared with usual care (P < .01) and analgesia (P < .001). Another two RCTs also showed positive effects of cupping in cancer pain (P < .05) and trigeminal neuralgia (P < .01) compared with anticancer drugs and analgesics, respectively. Two RCTs reported favorable effects of cupping on pain in brachialgia compared with usual care (P = .03) or heat pad (P < .001). The other RCT failed to show superior effects of cupping on pain in herpes zoster compared with anti-viral medication (P = .065). Currently there are few RCTs testing the effectiveness of cupping in the management of pain. Most of the existing trials are of poor quality. Therefore, more rigorous studies are required before the effectiveness of cupping for the treatment of pain can be determined.
The included trials frequently were silent about adverse effects. Others reported no adverse effects and one mentioned three cases of vaso-vagal shock. None of the studies was on children.
So, here are my answers to the questions above:
- Is there any reliable evidence about dry cupping for children? No
- Is it demonstrably effective for any paediatric condition? No
- Is it harmful? Probably not that much (other than undermining common sense and rationality).
The objective of this review (entitled ‘Systematic Review on the Use of Homeopathy in Dentistry:
Critical Analysis of Clinical Trials‘) was to map the literature on homeopathy in dentistry and to evaluate the effectiveness of using homeopathy in dental practice through the critical analysis of clinical studies.
The search for scientific articles in any language, year, and place of publication was made in the databases of Public Medline (PUBMED), Web of Science, Cochrane, and Virtual Health Library; the articles selected were later classified according to the type of study. Gray literature was accessed through Google Scholar. Clinical trials were analyzed for methodological quality. Two trained reviewers accomplished the entire process independently.
Of the 281 studies retrieved by means of the search, 44 met the eligibility criteria. The included papers were:
- literature reviews (56.8%),
- clinical trials (34.1%),
- cross-sectional studies (6.8%),
- laboratory research (6.8%),
- longitudinal observational studies (4.5%).
The clinical trials were published from 1965 to 2019, using homeopathy in several dental specialties:
- Orofacial Pain,
- Pediatric Dentistry,
- dental anxiety.
Qualitative failures, in all criteria investigated, and positive influences of the individual prescriptions on the results of treatments reported were observed.
The authors concluded that there is still a scarcity of studies about homeopathy and dentistry. The clinical trials selected showed positive effects on oral health; however, when they were critically evaluated, it was possible to recognize qualitative failures, mainly relative to double-blinding. It is necessary to encourage research on the subject, using standardized methodological procedures, to obtain better evaluation of the clinical applicability.
According to the authors, their review adhered to the PRISMA guideline of systematic reviews. This is, however, not the case. The authors correctly point out that the primary studies had many flaws: methodological failures were observed in the clinical trials, mainly related to double-blinding (66.7%). Significant failures were also observed in similarity (61.1%), randomization (27.8%), description of losses and exclusions (27.8%), and exclusion criteria (27.8%). They do not seem to realize that flaws of this nature and frequency should prevent positive conclusions.
So, what does this paper actually demonstrate? In my view, it shows that:
- the peer-review process at the JACM continues to be a joke;
- poor quality trials run by enthusiasts tend to produce false-positive results;
- in so-called alternative medicine (SCAM), people get away with publishing even the most obvious falsehoods.
Who does not like a nice fragrance?
Who would object to aromatherapy?
Nobody, I suppose.
But, if its called THERAPY, we surely must ask whether it is therapeutic. And is aromatherapy therapeutic? Let’s see:
This randomized, placebo-controlled clinical trial tested whether patients with post-dural puncture headache (PDPH) caused by spinal anesthesia would benefit from aromatherapy. A total od 50 patients received 15-minute inhalations of either lavender oil or liquid paraffin as placebo. The severity of headache was scored before (baseline) and after the intervention – immediately, 30, 60, 90, and 120 minutes after – using a visual analog scale. In addition, the dosage and frequency of the pain killers as well as adverse effects of the intervention were recorded.
Both groups showed a reduction in headache scores post intervention. However, the headache scores between the groups was significantly different immediately after the intervention in favor of lavender oil (difference: 1.60 ± 0.63, P = .015). Furthermore, it was observed that the mean changes of the headache scores compared to the baseline were significant at each time interval in favor of the placebo group (P < .05), except immediately after the intervention. No significant difference was observed in Diclofenac intake between groups (P = .440), and no adverse effects were noted.
The authors concluded that aromatherapy with lavender oil was observed to reduce the severity of PDPH only immediately after the intervention, while only minimal effects were observed at successive time intervals. However, it is noted that the study was likely underpowered and further studies are recommended to better understand the effects of lavender oil on PDPH and compare its effects to other herbal products or pharmacological agents commonly used for managing headaches.
I find it laudable that some researchers conduct clinical trials even of so-called alternative medicines (SCAMs) which many of us might view as trivial. I find it more laudable that they try to do this rigorously by adding a placebo control group to the study. And I would find it even more laudable, if they did this adequately.
Considering parafin oil to be a placebo in a study of lavender oil inhalation can hardly be called adequate. Placebos are used in clinical trials mostly to account for the expectation of patients. This means that, whenever possible, patients need to be blinded to the group aloocation and the placebo must be indistinguishable from the verum. In the present trial, the patients could obviously tell the difference between the smell of lavender and the absence of any smell in the control group. Thus, their expectation could easily suffice to bring about the findings observed in the study. This means that the trial does not neccessarily demonstrate the effects of armoatherapy, but might (and most probably does) merely show the power of expectation.
How can one design such a trial more rigorously? you will ask.
There are several options. For instance, for the control group, one could use an artificial fragrance not made from natural lavender. Alternatively, one could include only patients who are unfamiliar with the smell of lavender and use a similaryly pleasant fragrance from a different plant as the control intervention.
As it stands, the study – even though aimed at testing the hypothesis that aromatherpy with lavender has specific effects on pain – tells us next to nothing.
… except, of course that it is always worth thinking very carefully about the adequate way to conduct a clinical trial.
This systematic review and meta-analysis was aimed at investigating the effect and safety of acupuncture for the treatment of chronic spinal pain.
The authors included 22 randomized controlled trials (RCTs) involving patients with chronic spinal pain treated by acupuncture versus sham acupuncture, no treatment, or another treatment were included. Chronic spinal pain was defined as:
- chronic neck pain,
- chronic low back pain,
- or sciatica for more than 3 months.
Fourteen studies had a high risk of bias, 5 studies had a low risk of bias, and 5 studies had an unclear risk of bias. Pooled analysis revealed that:
- acupuncture can reduce chronic spinal pain compared to sham acupuncture (weighted mean difference [WMD] -12.05, 95% confidence interval [CI] -15.86 to -8.24),
- acupuncture can reduce chronic spinal pain compared to mediation control (WMD -18.27, 95% CI -28.18 to -8.37),
- acupuncture can reduce chronic spinal pain compared to usual care control (WMD -9.57, 95% CI -13.48 to -9.44),
- acupuncture can reduce chronic spinal pain compared to no treatment control (WMD -17.10, 95% CI -24.83 to -9.37).
In terms of functional disability, acupuncture can improve physical function at
- immediate-term follow-up (standardized mean difference [SMD] -1.74, 95% CI -2.04 to -1.44),
- short-term follow-up (SMD -0.89, 95% CI -1.15 to -0.62),
- long-term follow-up (SMD -1.25, 95% CI -1.48 to -1.03).
Trials assessed as having a high risk of bias (WMD −13.45, 95% CI −17.23 to −9.66, I 2 96.2%, moderate-quality evidence, including 14 studies and 1379 patients) found greater effects of acupuncture treatment than trials assessed as having a low risk of bias (WMD −11.99, 95% CI −13.94 to −10.03, I 2 44.6%, high-quality evidence, including 4 studies and 432 patients), but smaller effects than trials assessed as having an unclear risk of bias (WMD −14.51, 95% CI −17.25 to −11.78, I 2 0%, high-quality evidence, including 3 studies and 190 patients).
Only 6 trials provided information on adverse events. No trial reported data on serious adverse events during acupuncture treatment. The most frequent adverse events were temporarily worsened pain and needle pain at the acupuncture site, which can decrease quickly after a short period of rest.
The authors concluded that compared to no treatment, sham acupuncture, or conventional therapy such as medication, massage, and physical exercise, acupuncture has a significantly superior effect on the reduction in chronic spinal pain and function improvement. Acupuncture might be an effective treatment for patients with chronic spinal pain and it is a safe therapy.
I think this is a thorough review which produced interesting findings. I agree with most of what the authors report, except with their conclusions which I find too optimistic. In view of the facts that
- only 5 RCTs had a low risk of bias,
- collectively, the rigorous trials reported smaller effect sizes,
- the majority of trials failed to mention adverse effects which, in my view, casts considerable doubt on their quality and ethical standard,
I would have phrased the conclusion differently: compared to no treatment, sham acupuncture, or conventional therapies, acupuncture seems to have a significantly superior effect on pain and function. Due to the lack rigour of most studies, these effects are less certain than one would have wished. Many trials fail to report adverse effects which reflects poorly on their quality and ethics and prevents conclusions about the safety of acupuncture. In essence, this means that the effectiveness and safety of acupuncture as a treatment of chronic spinal pain remains uncertain.
Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.
This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.
Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.
Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.
The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.
I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.
It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
But why is this not so with the above-mentioned study?
Why is, in this instance, A even more that A+B?
There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.
But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).
My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.