pain
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!!!
_________________________
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.
Chiropractic is a complementary medicine that has been growing increasingly in different countries over recent decades. It addresses the prevention, diagnosis and treatment of the neuromusculoskeletal system disorders and their effects on the whole body health.
This review aimed to evaluate the effectiveness of chiropractic in the treatment of different diseases. To gather data, scientific electronic databases, such as Cochrane, Medline, Google Scholar, and Scirus were searched and all systematic reviews in the field of chiropractic were obtained. Reviews were included if they were specifically concerned with the effectiveness of chiropractic treatment, included evidence from at least one clinical trial, included randomized studies and focused on a specific disease. The articles were excluded if:
- – they were concerned with a combination of chiropractic and other treatments (not specifically chiropractic treatment);
- – they lacked at least one clinical trial;
- – they lacked at least one randomized study;
- – and they studied chiropractic in the treatment of multiple diseases.
The research data including the article’s first author’s name, type of disease, intervention type, number and types of research used, meta-analysis, number of participants, and overall results of the study, were extracted, studied and analyzed.
Totally, 23 chiropractic systematic reviews were found, and 11 articles met the defined criteria. The results showed the influence of chiropractic on improvement of neck pain, shoulder and neck trigger points, and sport injuries. In the cases of asthma, infant colic, autism spectrum disorder, gastrointestinal problems, fibromyalgia, back pain and carpal tunnel syndrome, there was no conclusive scientific evidence. There is heterogeneity in some of the studies and also limited number of clinical trials in the assessed systematic reviews. Thus, conducting comprehensive studies based on more reliable study designs are highly recommended.
The authors stressed that three points should be emphasized. Firstly, there is a discrepancy between the development of chiropractic in different countries of the world and the quality and quantity of studies regarding the effectiveness and safety of chiropractic in treatment of diseases. Secondly, some of the systematic reviews regarding the effectiveness of chiropractic in treatment of diseases had a minimum quality of research methodology and were not useful for evaluation. Some of the excluded articles are examples of this problem. Finally, a limited number of studies (11 systematic review articles and 10 diseases) had the required criteria and were assessed in the study.
Assessment and analysis of the studies showed the impact of chiropractic on improvement of some upper extremity conditions including shoulder and neck trigger points, neck pain and sport injuries. In the case of asthma, infant colic and other studied diseases, further clinical trials with larger sample sizes and high quality research methodology are recommended.
So, is chiroprctic of proven effectiveness for any disease?
The conditions for which there is tentatively positive evidence (btw: most rely on my research!!!) are arguably not diseases but symptoms of undelying conditions. Therefore, the answer to my question above is:
NO.
Cauda equina syndrome (CES) is a lumbosacral surgical emergency that has been associated with chiropractic spinal manipulation (CSM) in numerous case reports. However, identifying if there is a potential causal effect is complicated by the heightened incidence of CES among those with low back pain (LBP). This study‘s hypothesis was that there would be no increase in the risk of CES in adults with LBP following CSM compared to a propensity-matched cohort following physical therapy (PT) evaluation without spinal manipulation over a three-month follow-up period.
A query of a United States network (TriNetX, Inc.) was conducted, searching health records of more than 107 million patients attending academic health centers, yielding data ranging from 20 years prior to the search date (July 30, 2023). Patients aged 18 or older with LBP were included, excluding those with pre-existing CES, incontinence, or serious pathology that may cause CES. Patients were divided into two cohorts:
- (1) LBP patients receiving CSM,
- (2) LBP patients receiving PT evaluation without spinal manipulation.
Propensity score matching controlled for confounding variables associated with CES.
67,220 patients per cohort (mean age 51 years) remained after propensity matching. CES incidence was 0.07% (95% confidence intervals [CI]: 0.05–0.09%) in the CSM cohort compared to 0.11% (95% CI: 0.09–0.14%) in the PT evaluation cohort, yielding a risk ratio and 95% CI of 0.60 (0.42–0.86; p = .0052). Both cohorts showed a higher rate of CES during the first two weeks of follow-up.
The authors concluded that the present study involving over 130,000 propensity-matched patients found that CSM is not a risk factor for CES. The incidence of CES in both CSM and PT evaluation cohorts aligns with previous estimates of CES incidence among patients with LBP, indicating a heightened risk of CES compared to asymptomatic individuals regardless of intervention. Moreover, these findings underscore the increased CES incidence within the first two weeks after either CSM or PT evaluation, emphasizing the need for clinicians’ vigilance in identifying and emergently referring patients with CES for surgical evaluation. Further real-world evidence is needed to corroborate these findings using alternative case-control and case-crossover designs, and different clinician comparators.
This is an interesting and well-reported investigation. Its particular strength is the huge sample size. Its weakness, on the other hand, is the fact that, despite the researchers best efforts, the two groups might not have been entirely comparable and that there could be a host of relevant factors that the propensity matching was unable to control for.
It is, I think, to the credit of the authors that they abstain from overrating their results and correctly emphasize in their conclusions that: Further real-world evidence is needed to corroborate these findings using alternative case-control and case-crossover designs, and different clinician comparators.
Cupping is a from of so-called alternative medicine (SCAM) that has featured already many times on this blog, e.g.:
- Wet cupping in the management of cervical spondylosis? No!
- The effectiveness of cupping therapy for low back pain
- Cupping: “the propagation of ancient, scientifically unsound techniques that may cause more harm than benefit”
- Cupping therapy for non-specific chronic low back pain
- Cupping for Olympic swimmers. Or: why breaking your shoulder is not necessarily good for writing a successful book
- Wet cupping and dry humour
- Cupping for athletes: rubbish trials, rubbish review, rubbish journal
- The future of cupping: it’s bright, profitable and vacuous
Now a new and interesting paper has been published on the subject
This review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included in this study. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).
Eleven trials involving 921 participants were included (6 on dry and 5 on wet cupping). Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p = 0.004). There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p = 0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p = 0.11). Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p = 0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p = 0.008) at the endpoint intervention. There was no evidence indicating the association between pain reduction and different types of cupping (p = 0.2). Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p = 0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p = 0.78) at the endpoint intervention. Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p < 0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p = 0.29). A potential association between pain reduction and different cupping locations (p = 0.05) was found. Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n = 8; d=1.8 [95% CI: 1.22 – 2.39], p < 0.001) and usual care (n = 5; d=1.07 [95% CI: 0.21- 1.93], p = 0.01). Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 h, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p < 0.001). Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p = 0.03). There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p = 0.39). A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).
The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The actual therapeutic effects of cupping could be confirmed by using objective pain assessments. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.
A crucial point here is that only 3 of the included studies were ‘patient-blind’, i.e. tried to control for placebo effects by using a sham procedure:
- The first of these used leaking vaccum cups that failed to create sucction. This would therefore not have resulted in the typical circular hematoma. In other words, patients were easily de-blinded.
- The second trial compared two different wet cupping techniques which involved different procedures. This would have been easily identifiable by the patients. In other words, patients were easily de-blinded.
- The third (which showed no effectiveness of cupping) supposedly patient-blind study used a similar method as the first. In other words, patients were easily de-blinded.
In addition, we ought to remember that in no study was it possible to blind the therapists. Thus there is a danger of verbal or non-verbal communications impacting on the outcomes.
In my view, it follows that the effectiveness of cupping is far lass certain than the authors of this paper try to make us believe.
This study aimed to determine the effects of Reiki on pain and biochemical parameters in patients undergoing bone marrow transplantation. This investigation was designed as a “single-blind, repeated measures, randomized prospective controlled study”. It was conducted between August 2022 and April 2023 with patients who underwent autologous bone marrow transplantation (BMT).
- In the Reiki group (n = 21), Reiki therapy was applied directly to the energy centers for 30 min on the 0th and 1st day of BMT, and from a distance for 30 min on the 2nd day.
- No intervention was performed on the control group (n = 21).
Data were collected using the Personal Information Form, Visual Analog Scale (VAS), and biochemical parameters. Pain and biochemical parameters were evaluated on days 0, 1, 2, and 10 before the Reiki application.
There were no statistically significant differences in pain scores between the groups before the intervention (p > .005). The Reiki group showed a significant improvement in the mean VAS score compared with the control group on days 1 and 2 (p = .002; p < .001, respectively). The measurement of procalcitonin showed a decrease in the Reiki group and an increase in the control group (p = .026, p = .001, p < .001, respectively). Although the Reiki group had better absolute neutrophil, thrombocyte, and C-reactive protein values than the control group, no significant difference was observed between the groups (p > .05).
The authors concluded that Reiki is effective for pain control and enhancing the immune system response.
For the following reasons, I beg to differ:
- The patients of the verum group were fully aware of receiving the therapy; thus they were expecting/hoping to benefit from it.
- The patients of the control group received no therapy; thus they were disappointed which may have influenced thie VAS ratings.
- The procalcitonin levels are of doubtful relevance; they changed only within the group which, in a controlled clinical trial that is supposed to compare groups is meaningless and most likely a chance finding.
- The only people who could have been blinded in this ‘single blind’ study were the evaluators of the results (even though the authors state that “patients were blinded to the group assignments”) which is meaningless if patients and therapists are not blinded.
Because of all this, I feel that the conclusions should be re-written:
Reiki is known to cause a placebo effect which most likely caused the observed outcomes.
“Is Chiropractic Worth the Taxpayer’s Expense?” is the interesting question asked in this article by Ikenna Idika Ogbu from the Department of Neurosurgery, University Hospitals of North Midlands, UK and Chandrasekaran Kaliaperumal from the Department of Clinical Neurosciences, Royal Infirmary of Edinburgh, UK. Here is the abstract:
Chiropractic remains a service provided outside the NHS in the United Kingdom and the argument for inclusion has been ongoing since the 90’s. There are significant patient-reported benefits from chiropractic backed by evidence in specific use-cases as cervicogenic headaches and there are significant potential cost-savings from the inclusion of chiropractic as an NHS service. The evidence, however, does not particularly favour the use case of chiropractic, especially in the context of Low Back Pain (LBP) and the benefits of chiropractic are unclear. Considering the potential cost-savings for the NHS and the society, there should be consideration for its inclusion. However, the evidence will need to be clearer to argue for inclusion of chiropractic in the NHS spectrum of services, especially for spinal services.
So, the authors confirm that, even for back pain, “the benefits of chiropractic are unclear”, and in the next sentence they advocate “consideration for its inclusion.”
Does that make sense?
No!
Let’s be clear: the least expensive way to proceed in the short term is usually to do nothing. No treatment is invariably less expensive than treatment! Yet, this logic obviously does not account for the two most important factors in this equation: risk and benefit.
- Not treating a condition can cause prolonged, needless suffering.
- Not treating a condition can cause significant follow-up costs.
- Treating it can cause adverse effects and additional suffering.
- Adverse effects can cause significant follow-up costs.
- Treating the condition effectively will result in less suffering.
- Treating the condition effectively will result in less follow-up costs.
It follows that we should treat health problems:
- effectively,
- with few risks of side-effects,
- as cheaply as possible.
It also follows that costs are by no means the only factor in this complex equation. Cost-effectiveness without effectiveness is not possible. Moreover, cost-effectiveness withoout an acceptable degree of safety is unlikely.
In the case of chiropractic, we have hardly reliable proof of effectiveness or safety. And this means that, before we can consider chiropractic to be paid for from public money, we first need solid evidence for its safey and efficacy – each for the relevant health problem to be treated. Once we have reliable data about all this – AND ONLY THEN – might we consider including chiropractic into the public healthcare budget.
In other words, the above cited paper is naive and ill-informed to the extreme.
This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA).
Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, along with derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS. The EQ-5D-5L questionnaire and Visual Analog Scale (VAS) were the secondary outcomes. All were measured at baseline and after 2 months. Group differences and effect sizes (Cohen’s d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant.
Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events.
The authors concluded that, although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are warranted in order to substantiate the findings.
Sorry, but I don’t understand this: the authors stated multiple times that this was a feasibility study (which tests feasibility and not effectiveness), and then they promptly report effectiveness data for which the trial was grossly under-powered (i.e. too small). Why are they doing such nonsense? Perhaps their affiliations provide a hint?
- 1Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India.
- 2Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 3Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 4Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 5Department of Surgery, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
- 6Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, India.
- 7Department of Community Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India.
I do symathise with the pressures of reporting positive findings, if your salary comes from homeopathic institutions. Yet, I cannot help but pointing out:
THESE FINDINGS ARE INVALID AND FALSE-POSITIVE!
