pain
We had to deal with Hongchi Xiao several times before:
- Slapping therapy? No thanks!
- China Power and Influence
- Slapping therapy: therapist arrested and charged with manslaughter by gross negligence
Slapping therapy is based on the notion that slapping patients at certain points of their body has positive therapeutic effects. Hongchi Xiao, a Chinese-born investment banker, popularised this SCAM which, he claims, is based on the principles of Traditional Chinese Medicine. It is also known as ‘Paida’—in Chinese, this means ‘to slap your body’. The therapy involves slapping the body surface with a view of stimulating the flow of ‘chi’, the vital energy postulated in Traditional Chinese Medicine. Slapping therapists believe that this ritual restores health and eliminates toxins. They also claim that the bruises which patients tend to develop after the treatment are the visible signs of toxins coming to the surface. Hongchi Xiao advocates slapping as “self-healing method” that should be continued until the skin starts looking bruised. He and his follows conduct workshops and sell books teaching the public which advocate slapping therapy as a panacea, a cure-all. The assumptions of slapping therapy fly in the face of science and are thus not plausible. There is not a single clinical trial testing whether slapping therapy is effective. It must therefore be categorised as unproven.
Now it has been reported that Hongchi Xiao has been sentenced to 10 years in prison for the death of a 71-year-old diabetic woman who stopped taking insulin during one of his workshops.
Hongchi Xiao, 61, was convicted of manslaughter by gross negligence for failing to get medical help for Danielle Carr-Gomm as she howled in pain and frothed at the mouth during the fourth day of a workshop in October 2016. The Californian healer promoted paida lajin therapy which entails getting patients to slap themselves repeatedly to release “poisonous waste” from the body. The technique has its roots in Chinese medicine and has no scientific basis and patients often end up with bruises, bleeding — or worse.
Xiao had extradited from Australia, where he had been convicted of manslaughter after a 6-year-old boy died when his parents withdrew his insulin medication after attending one of his workshops in Sydney. “I consider you dangerous even though you do not share the characteristics of most other dangerous offenders,” Justice Robert Bright said during sentencing at Winchester Crown Court. “You knew from late in the afternoon of day one of the fact that Danielle Carr-Gomm had stopped taking her insulin. Furthermore, you made it clear to her you supported this.” Bright added Xiao only made a “token effort” to get Carr-Gomm to take her insulin once it was too late and had shown no sign of remorse as he even continued to promote paida lajin in prison.
Carr-Gomm was diagnosed with type 1 diabetes in 1999 and was desperate to find a cure that didn’t involve injecting herself with needles, her son, Matthew, said. She sought out alternative treatments and had attended a previous workshop by Xiao in Bulgaria a few months before her death in which she also became seriously ill after ceasing her medication. However, she recorded a video testimonial, calling Xiao a “messenger sent by God” who was “starting a revolution to put the power back in the hands of the people to cure themselves and to change the whole system of healthcare.”
Xiao had congratulated Carr-Gomm when she told other participants at the English retreat that she had stopped taking her insulin. By day three, Carr-Gomm was “vomiting, tired and weak, and by the evening she was howling in pain and unable to respond to questions,” prosecutor Duncan Atkinson said.
A chef who wanted to call an ambulance said she deferred to those with holistic healing experience. “Those who had received and accepted the defendant’s teachings misinterpreted Mrs. Carr-Gomm’s condition as a healing crisis,” Atkinson said.
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A healing crisis?
A crisis of collective stupidity, I’d say!
The ‘Healy’ has featured on this blog before and is thus known to my regulars: The ‘Healy’: deep cellular healing with quantum bollocks. Now the ‘Healy’ has won an award … albeit a negative one: the Austrian Skeptiks necative prize ‘GOLDENES BRETT VORM KOPF’ (Golden Plank before the Head)
Other nomineed for the award were:
- The broadcaster AUF1 TV, which has been categorised as right-wing extremist.
- The Austrian Veterinary Association known to support homeopathy for animals.
At yesterday’s gala in the Vienna City Hall, it was announced that the ‘Healy’ is the proud winner.
A total of 160 nominations were received by the Vienna Sceptics (Gesellschaft für kritisches Denken, GkD), which awards the prize on behalf of the Gesellschaft zur Wissenschaftlichen Untersuchung von Parawissenschaften (GWUP). On the basis of all these nominations, a ‘shortlist’ of three was subsequently agreed upon by the jury.
The organisers explained in their press release that the ‘Healy’ is advertised as a medical device for the treatment of pain, including chronic pain and migraines, as well as for the supportive treatment of mental illnesses such as depression and anxiety with a lot of pseudo-scientific phraseology.
A ‘quantum sensor’ allegedly measures the ideal ‘frequency’ of the user and causes a ‘bioenergetic field harmonisation’. However, the ‘quantum sensor’ turns out to be nothing more than a simple infrared diode, available for 20 cents. By contrast, consumers are asked to pay up to 4,500 Euros for the ‘Healy’!
Several research platforms, medical information portals and consumer centres have come to damning conclusions about the device. There is talk of ‘bioresonance scams’, ‘dubious frequency therapy’ for which there is a lack of scientific evidence and an ‘esoteric scam’. In addition to the considerable commercial interest and widespread use, the jury said that the manufacturer’s way of dealing with critics was also decisive for the win.
Having recently favoured the Austrian Veterinary Association (AVA) to win the award, I am in two minds. On the one hand, I am disappointed that the AVA did not make it. On the other hand, having reported about the ‘Healy’s extraordinary quantum bollocks some time ago, I am delighted that a worthy winner has been found and crowned.
This update of a systematic review evaluated the effectiveness of spinal manipulations as a treatment for migraine headaches.
Amed, Embase, MEDLINE, CINAHL, Mantis, Index to Chiropractic Literature, and Cochrane Central were searched from inception to September 2023. Randomized clinical trials (RCTs) investigating spinal manipulations (performed by various healthcare professionals including physiotherapists, osteopaths, and chiropractors) for treating migraine headaches in human subjects were considered. Other types of manipulative therapy, i.e., cranial, visceral, and soft tissue were excluded. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the certainty of evidence.
Three more RCTs were published since our first review; amounting to a total of 6 studies with 645 migraineurs meeting the inclusion criteria. Meta-analysis of six trials showed that, compared with various controls (placebo, drug therapy, usual care), SMT (with or without usual care) has no superior effect on migraine intensity/severity measured with a range of instruments (standardized mean difference [SMD] − 0.22, 95% confidence intervals [CI] − 0.65 to 0.21, very low certainty evidence), migraine duration (SMD − 0.10; 95% CI − 0.33 to 0.12, 4 trials, low certainty evidence), or emotional quality of life (SMD − 14.47; 95% CI − 31.59 to 2.66, 2 trials, low certainty evidence) at post-intervention. A meta-analysis of two trials showed that compared with various controls, SMT (with or without usual care) increased the risk of adverse effects (risk ratio [RR] 2.06; 95% CI 1.24 to 3.41, numbers needed to harm = 6; very low certainty evidence). The main reasons for downgrading the evidence were study limitations (studies judged to be at an unclear or high risk of bias), inconsistency (for pain intensity/severity), imprecision (small sizes and wide confidence intervals around effect estimates) and indirectness (methodological and clinical heterogeneity of populations, interventions, and comparators).
We cocluded that the effectiveness of SMT for the treatment of migraines remains unproven. Future, larger, more rigorous, and independently conducted studies might reduce the existing uncertainties.
The only people who might be surprised by these conclusions are chiropractors who continue to advertise and use SMT to treat migraines. Here are a few texts by chiropractors (many including impressive imagery) that I copied from ‘X’ just now (within less that 5 minutes) to back up this last statement:
- So many people are suffering with Dizziness and migraines and do not know what to do. Upper Cervical Care is excellent at realigning the upper neck to restore proper blood flow and nerve function to get you feeling better!
- Headache & Migraine Relief! Occipital Lift Chiropractic Adjustment
- Are migraines affecting your quality of life? Discover effective chiropractic migraine relief at…
- Neck Pain, Migraine & Headache Relief Chiropractic Cracks
- Migraine Miracle: Watch How Chiropractic Magic Erases Shoulder Pain! Y-Strap Adjustments Unveiled
- Tired of letting migraines control your life? By addressing underlying issues and promoting spinal health, chiropractors can help reduce the frequency and severity of migraines. Ready to experience the benefits of chiropractic for migraine relief?
- Did you know these conditions can be treated by a chiropractor? Subluxation, Back Pain, Chronic Pain, Herniated Disc, Migraine Headaches, Neck Pain, Sciatica, and Sports Injuries.
- When a migraine comes on, there is not much you can do to stop it except wait it out. However, here are some holistic and non-invasive tips and tricks to prevent onset. Check out that last one! In addition to the other tips, chiropractic care may prevent migraines in your future!
Evidence-based chiropractic?
MY FOOT!
If you live in the UK, you could not possibly escape the discussion about the ‘Assisted Dying Bill’ which passed yesterday’s vote in the House of Commons (MPs have voted by 330 to 275 in favour of legalising voluntary assisted suicide). Once the bill passed all the further parliamentary hurdles – which might take several years – it will allow terminally ill adults who are
- expected to die within six months,
- of sound mind and capable of managing their own affairs
to seek help from specialised doctors to end their own life.
After listening to many debates about the bill, I still I have serious concerns about it. Here are just a few:
- Palliative care in the UK is often very poor. It was argued that the bill will be an incentive to improve it. But what, if this is wishful thinking? What if palliative care deteriorates to a point where it becomes an incentive to suicide? What if the bill should even turn out to be a reason for not directing maximum efforts towards improving palliative care?
- How sure can we be that an individual patient is going to die within the next six months? Lawmakers might believe that predicting the time someone has left to live is a more or less exact science. Doctors (should) know that it is not.
- How certain can we be that a patient is of sound mind and capable of managing their own affairs? By definition, we are dealing with very ill patients whose mind might be clouded, for example, by the effects of drugs or pain or both. Lawmakers might think that it is clear-cut to establish whether an individual patient is compos mentis, but doctors know that this is often not the case.
- In many religions, suicide is a sin. I am not a religious person, but many of the MPs who voted for the bill are or pretend to be. Passing a law that enables members of the public to commit what in the eyes of many lawmakers must be a deadly sin seems problematic.
In summary, I feel the ‘Assisted Dying Bill’ is a mistake for today; it might even be a very grave mistake for a future time, if we have a government that is irresponsible, neglects palliative care even more than we do today and views the bill as an opportunity to reduce our expenditure on pensions.
Dry needling (DN) is a treatment used by various healthcare practitioners, including physical therapists, physicians, and chiropractors. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. DN is mainly used to treat myofascial trigger points, but it is also used to target connective tissue, neural ailments, and muscular ailments. There is conflicting evidence regarding the effectiveness of DN for any condition.
Orofacial pain (OFP) typically has a musculoskeletal, dental, neural, or sinogenic origin. Our systematic review was aimed at evaluating the evidence base for the effectiveness of DN for OFP.
We searched Medline, Cochrane Central, and Web of Science (from their respective inceptions to February 2024) for RCTs evaluating the effectiveness of DN in patients with OFP. Studies with patients suffering from cervicogenic or tension type headaches as well as observational studies were excluded. Primary outcomes were pain intensity and severity; secondary outcomes were disability, quality of life, and adverse effects (AEs). The review adhered to the methods described by in the Cochrane Handbook.
Twenty-four RCTs with a total of 1,318 patients suffering from OFP could be included. Most had an unclear or high risk of bias, and the quality of the evidence ranged from very low to low for all comparisons and outcomes. A meta-analysis suggested that, compared with usual care alone, DN + usual care had no effect on pain intensity (visual analogue scale) (standardized mean difference = −1.89, 95% confidence intervals −5.81 to 2.02, very low certainty evidence) at follow-ups of up to 6 weeks. Only 6 RCTs (25%) mentioned AEs, and none of them reported that AEs had occurred. The remaining 18 (75%) studies failed to report AEs.
We concluded that DN cannot be considered as an effective treatment option for OFP. This is due to the uncertainties of the available evidence. We believe that larger, rigorous, and better reported trials with more homogeneous comparators might potentially reduce the current uncertainties. Such trials should strictly adhere to the classifications provided by the International Headache Society and published in the International Classification of Orofacial Pain.
Yet again, I need to stress that the vast majority od RCTs failed to mention AEs. When will the last (pseudo-) researcher have learnt that the non-reporting of AEs is a violation of research ethics?
It has been reported that the Dresden Higher Regional Court (OLG) examined the extent to which a doctor must inform his patient, if he/she uses so-called alternative medine (SCAM) that deviates from conventional medicine. To be precise, the case was about a detoxification therapy with so-called chelating agents. A patient had received ‘holistic treatment’ for symptoms of exhaustion with sleep disorders, headaches, concentration problems and general restlessness and became worse and worse during the course of the therapy. Eventually, he sued for compensation for pain and suffering and damages.
Initially, the patient had been treated conservatively with iron supplements. After carrying out ‘provocation test’, the doctor diagnosed a heavy metal load, which he treated with ‘elimination therapy’ in the form of an i.v. “detox therapy” (2-3-dimercaptopropane-1-sulfonate (DMPS)). The patient subsequently became increasingly unwell, leading to hospitalisation and treatment for severe thrombocytopenia with moderate liver damage.
The expert opinion obtained in the first-instance of the ensuing legal proceedings considered the cause of the patient’s complaints to be the administration of an inadmissibly excessive amount of alpha-lipoic acid during ‘detoxification therapy’. It became clear that the doctor had not properly informed the patient about this therapy and its risks.
The court considered that the basic information required under German law had not been provided. This basic information gives the patient a general idea of the severity of the procedure and the impact of the associated burdens on their lifestyle. The obligation to provide information also applies to practitioners who use SCAM. A doctor who offers SCAM must therefore clearly inform the patient that they are deviating from a conventional approach. He/she must also explain why he/she is doing this and what advantages and disadvantages the patient can expect as a result.
Detoxification therapy is indisputably such a SCAM, the costs of which are not covered by the health insurance companies. The patient must therefore not only be informed of the risks and the danger of failure of the procedure, but must also be informed that the planned therapy is not standard medical practice and that the effectiveness of the therapy is unproven.
The patient must be able to weigh up whether they want to take the risks of treatment with regard to the prospects of success in view of their state of health before the procedure. Such information was not provided in the present case. For this reason, the Regional Court awarded damages for pain and suffering amounting to EUR 15,000 for the damage to health suffered.
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On this blog, we have often discussed the problems of informed consent. Informed consent, I have previously stated, must usually include full information on:
- the diagnosis
- its natural history
- the most effective treatment options available
- the proposed therapy
- its effectiveness
- its risks
- its cost
- a rough treatment plan
Only when this information has been transmitted to and understood by the patient can informed consent be considered complete. I do understand why many SCAM practitioners do not like informed consent – it could stop many from practising: they are frequently unable to provide the required information. Yet, ALL clinicians have a moral, ethical and legal duty to obtain informed consent BEFORE starting a therapy. It is reassuring that the German court agrees.
This study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.
The authors selected from a United States (US) commercial claims database (25% random sample of IQVIA PharMetrics® Plus for Academics) 18–63 years old malignant breast cancer survivors who were experiencing pain and were ≥ 1 year removed from cancer diagnosis. Using the difference-in-difference technique, annualized changes in analgesics [prevalence, rates of short-term (< 30-day supply) and long-term (≥ 30-day supply) prescription fills] and healthcare resource utilization (healthcare costs, hospitalizations, and emergency department visits) were compared between acupuncture-treated and non-treated patients.
Among 495 (3%) acupuncture-treated patients (median age: 55 years, stage 4: 12%, average 2.5 years post cancer diagnosis), most had commercial health insurance (92%) and experiencing musculoskeletal pain (98%). Twenty-seven percent were receiving antidepressants and 3% completed ≥ 2 long-term prescription fills of opioids. Prevalence of opioid usage reduced from 29 to 19% (P < 0.001) and NSAID usage reduced from 21 to 14% (P = 0.001) post-acupuncture. The relative prevalence of opioid and NSAID use decreased by 20% (P < 0.05) and 19% (P = 0.07), respectively, in the acupuncture-treated group compared to non-treated patients (n = 16,129). However, the reductions were not statistically significant after adjustment for confounding. Patients receiving acupuncture for pain (n = 264, 53%) were found with a relative decrease by 47% and 49% (both P < 0.05) in short-term opioid and NSAID fills compared to those treated for other conditions. High-utilization patients (≥ 10 acupuncture sessions, n = 178, 36%) were observed with a significant reduction in total healthcare costs (P < 0.001) unlike low-utilization patients.
The authors concluded that, although adjusted results did not show that patients receiving acupuncture had better outcomes than non-treated patients, exploratory analyses revealed that patients treated specifically for pain used fewer analgesics and those with high acupuncture utilization incurred lower healthcare costs. Further studies are required to examine acupuncture effectiveness in real-world settings.
Oh, dear!
Which institutions support such nonsense?
- School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA.
- School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA.
- College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
- Integrative Medicine Program, Departments of Supportive Care Medicine and Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
- School of Pharmacy, Chapman University, RK 94-206, 9401 Jeronimo Road, Irvine, CA, 92618, USA. [email protected].
- School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 802 W Peltason Dr, Irvine, CA, 92697-4625, USA. [email protected].
And which journal is not ashamed to publish it?
It’s the BMC Med!
The conclusion is, of course, quite wrong.
Please let me try to formulate one that comes closer to what the study actually shows:
This study failed to show that a ‘real world impact’ of acupuncture exists. Since the authors were dissatisfied with a negative result, subsequent data dredging was undertaken until some findings emerged that were in line with their expectations. Sadly, no responsible scienctist will take this paper seriously.
Two years ago, I reported about an acupuncture review that was, in my view, a fairly clear case of scientific misconduct. To remind you, here is my from 22/11/22 about it:
Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.
The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.
Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture
- relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
- improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
- improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).
There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).
The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.
What should we make of this paper?
In case you are in a hurry: NOT A LOT!
In case you need more, here are a few points:
- many trials were of poor quality;
- there was evidence of publication bias;
- there was considerable heterogeneity within the studies.
The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.
Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.
Dishonest researchers?
Biased reviewers?
Incompetent editors?
Truly unbelievable!!!
In consideration of these points, let me rephrase the conclusions:
The well-documented placebo (and other non-specific) effects of acupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.
PS
I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!
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Now – 2 years later! – the journal (BMJ-Open) has retracted the article and posted the following notice about the decision:
BMJ Open has retracted this article.1 After publication, multiple issues were raised with the journal concerning the design and reporting of the study. The editors and integrity team investigated the issues with the authors. There were fundamental flaws with the research, including the control group selection and data extraction, not amenable to correction.
I am delighted that this misleading paper is now officially discredited. Yet, I do have some concerns:
WHY DOES IT TAKE 2 YEARS TO IDENTIFY SOMETHING AS FRAUDULENT RUBBISH, WHEN IT TOOK ME ALL OF ~30 MINUTES?
Instead of just insisting on a triumphant ‘I TOLD YOU SO’, let me provide some constructive advice to reviewers and journal editors.
- Many journal editors are to lazy to find reviewers themselves and ask the submitting author to name a few. Having myself published in the BMJ Open (the journal that published the paper in question) I fear that this might have been the case in the present instance. This habit invites poor reviews, e.g. reviews from colleagues who owe a favour to the submitting authors. It does not promote objective reviews and should be abandonned.
- Papers on acupuncture originating from China (as the one in question) are very likely to be biased (or worse), as we have so often discussed on this blog. Editors should be extra careful with such submissions.
- Reviewers who have in the past overlooked obvious flaws in a paper should be banned from further reviewing in future.
- Editors should understand the reviewers’ comments only as guidelines and still have an obligation to check the actual submissions themselves. the responsibility for publishing an article lies with them alone.
- Editors who repeatedly make such mistakes should be dismissed.
I think that adhering to these suggestions might improve the quality of published research … and, by Jove, this would be badly needed in the realm of so-called alternative medicine!!!
Spanish colleagues and I just published an article entitled “Is Osteopathic Manipulative Treatment Clinically Superior to Sham or Placebo for Patients with Neck or Low-Back Pain? A Systematic Review with Meta-Analysis”. Here is its abstract:
The aim of this systematic review and meta-analysis was to compare whether osteopathic manipulative treatment (OMT) for somatic dysfunctions was more effective than sham or placebo interventions in improving pain intensity, disability, and quality of life for patients with neck pain (NP) or low-back pain (LBP). Methods: A systematic review and meta-analysis was carried out. Searches were conducted in PubMed, Physiotherapy Evidence Database, Cochrane Library, and Web of Science from inception to September 2024. Studies applying a pragmatic intervention based on the diagnosis of somatic dysfunctions in patients with NP or LBP were included. The methodological quality was assessed with the PEDro scale. The quantitative synthesis was performed using random-effect meta-analysis calculating the standardized mean difference (SMD) with RevMan 5.4. The certainty of evidence was evaluated using GRADEPro. Results: Nine studies were included in the qualitative synthesis, and most of them showed no superior effect of OMTs compared to sham or placebo in any clinical outcome. The quantitative synthesis reported no statistically significant differences for pain intensity (SMD = −0.15; −0.38, 0.08; seven studies; 1173 patients) or disability (SMD = −0.09; −0.25, 0.08; six studies; 1153 patients). The certainty of evidence was downgraded to moderate, low, or very low. Conclusions: The findings of this study reveal that OMT is not superior to sham or placebo for improving pain, disability, and quality of life in patients with NP or LBP.
As always, it seems important to stress that our review has several limitations. Firstly, the searches were conducted in the most relevant databases; however, some studies not indexed in these sources may have been missed. Secondly, the diverse NP and LBP diagnosis, as well as the lack of data reported by some studies, complicates the interpretation of the results and may weaken our conclusion. Thirdly, the primary studies pragmatically applied interventions based on diagnoses of various somatic dysfunctions, resulting in a high degree of heterogeneity among the treatments applied.
Despite these limitations, it is fair to say, I think, that OMT is not nearlly as solidly supported by reliable evidence as most osteopaths try to make us believe. In essence, this means that, if you suffer from NP or LBP, you best concult a proper doctor or physiotherapist.
Some research have suggested that aromatherapy with lavender essential oil can be effective in reducing pain and anxiety in various medical settings. Yet, the efficacy of lavender aromatherapy in the postoperative setting after cesarean delivery is less well-studied. This study aimed to assess the effectiveness of lavender essential oil therapy in the management of pain and anxiety after cesarean delivery.
This was a monocentric randomized controlled double-blind trial conducted over a period of five months during 2023. A hundred women undergoing c-sections under spinal anesthesia were enrolled and randomly assigned; using block randomization of 4 items per block with allocation ratio 1:1, into two groups:
- The aromatherapy group received inhaled Lavender essential oil.
- The placebo group received distilled water instead.
The primary outcomes were pain (at rest and after mobilization) and anxiety levels and after the intervention.
A total of 100 women were included (50 women in each group aromatherapy and the placebo group). The two groups were comparable regarding baseline characteristics and pre-intervention parameters with no statistically significant difference. After the intervention, the pain at rest (38,76 ± 22,9 vs. 23,84 ± 18,01; p < 0.001), the pain after mobilization (60,28 ± 23,72 vs. 40,12 ± 22,18; p < 0.001), and degree of anxiety (46,76 ± 6,59 vs. 44,3 ± 5,17; p = 0.03) were all significantly lower in the aromatherapy group. No adverse effects were reported by participants in both groups.
The authors concluded that aromatherapy using Lavender essential oil is effective in reducing pain and anxiety after cesarean delivery without adverse effects.
I beg to differ!
The authors point out that, to address the potential for participants to differentiate between the lavender and the placebo based on olfactory cues, they were informed that they would receive a natural inhalation product; however, they were not informed that it was an essential oil or specifically lavender. This is a lame attemp to prevent patients from guessing in which group they were. I doubt that it was successful. As a minimum, the authors should have checked whether binding was achieved!
Yes, it is difficult to patient-blind such studies. But it is possible. For instance, the control arm might have received an arificial oil with a lavender scent which aromatherapists claim to be ineffective. Alternatively two different essential oils could have been tested – lavender against an oil that is not said to affect pain and anxiety. These options are fairly obvious and well-known to aromatherapists. Why then were they not incorporated? I suspect because the trialists suspect that this would not produce the desired result.
As it stands, the honest conclusion should be something like this: aromatherapy using Lavender essential oil might reduce pain and anxiety after cesarean delivery. Whether this is due to a specific effect of the oil or the non-specific effects of expectation needs to be seen.
