methodology
This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.
Nine trials with a total of 779 participants were included in the meta-analysis.
- low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
- moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
- low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).
The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.
Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):
- For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
- Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
- It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
- The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
- The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
- In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
- Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
- In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
- In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
- An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED
I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.
It follows that the main conclusion of the authors of the review should be modified:
There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.
Acute tonsillitis, which includes tonsillopharyngitis, is a common condition, particularly in childhood. It is mostly caused by a viral infection. Symptomatic treatment is of high importance. But which treatment is effective and which isn’t?
For this expert consensus, 53 physicians from Germany, Spain, Netherlands, Switzerland, Austria, and Hungary with at least one year of experience in anthroposophic paediatric medicine were invited to participate in an online Delphi process. The process comprised 5 survey rounds starting with open-ended questions and ending with final statements, which need 75% agreement of experts to reach consensus. Expert answers were evaluated by two independent reviewers using MAXQDA and Excel.
Response rate was between 28% and 45%. The developed recommendation included 15 subtopics. These covered clinical, diagnostic, therapeutic and psychosocial aspects of acute tonsillitis. Six subtopics achieved a high consensus (>90%) and nine subtopics achieved consensus (75-90%). The panel felt that AM was an adequate therapy for acute tonsillitis.
The authors of this paper concluded that the clinical recommendation for acute tonsillitis in children aims to simplify everyday patient care and provide decision-making support when considering and prescribing anthroposophic therapies. Moreover, the recommendation makes AM more transparent for physicians, parents, and maybe political stakeholders as well.
I found it hard to decide whether to cry or to laugh while reading this paper.
Experience in anthroposophic paediatric medicine does not make anyone an expert in anything other than BS.
Expert consensus and clinical guidelines are not conducted by assembling a few people who all are in favour of a certain therapy while ignoring the scientific evidence.
AM for acute tonsillitis in children is nonsense, whatever these pseudo-experts claim.
Imagine we run a Delphi process with a few long-standing members of ‘the flat earth society’ and ask them to tell us about the shape of the earth …
…I rest my case.
The Academy of Homeopathy Education is a US-based accredited teaching institution offering homeopathy education services to professional and medically licensed homeopathy students. This study reports on clinical outcomes from the teaching clinic from 2020 to 2021.
Data were collected using the patient-generated outcome measure, the Measure Yourself Concerns and Wellbeing (MYCaW). Mean MYCaW values for initial and subsequent consultations were analyzed for the degree of change across the intervention period in 38 clients. Each client listed up to two complaints. MYCaW scores between initial and subsequent consultations were analyzed for the degree of change (delta) across the intervention period.
A total of 95 body system-related symptoms were analyzed for change in intensity following the homeopathic intervention. Statistically significant improvements in the intensity of main symptoms were observed between initial and subsequent follow-ups. The main symptom scores showed a mean change in intensity (delta MYCaW) of −0.79 points (95% confidence interval (CI), −1.29 to −0.29; p = 0.003) at first follow-up, a mean change of −1.67 points (95% CI, −2.34 to −0.99; p = 0.001) at second follow-up compared with the initial visit, and a mean change of −1.93 points (95% CI, −3.0 to −0.86; p = 0.008) at third follow-up compared with the initial visit. For clients with four or more follow-ups, the mean delta MYCaW was −1.57 points (95% CI, −2.86 to −0.28; p = 0.039).
The authors concluded that statistically significant improvements as well as some clinically meaningful changes in symptom intensity were found across a diverse group of individuals with a variety of long-term chronic conditions. The improvement was evident across different body systems and different levels of chronicity. There are limitations to the generalizability of the study due to the research design. Further research and investigation are warranted given the promising results of this work.
There are, of course, not just limits to the generalizability of this study! I’d say there are limits to the interpretation of any of its findings.
What was the cause of the improvements?
Here are just a few questions that I asked myself while reading this paper:
- Are the guys from the Academy of Homeopathy Education not aware of the fact that even chronic conditions often get better by themselves?
- Have they heard of the placebo effect?
- Are they trying to tell us that the patients did not also use conventional treatments for their chronic conditions?
- What about regression towards the mean?
- What about social desirability?
- Why do they think that further research is needed?
- Are these really results that look ‘promising for homeopathy?
To answer just the last question: No, these findings are in perfect agreement with the fact that highly diluted homeopathic remedies are pure placebos (to be honest, they would even be in agreement with such remedies being mildly harmful).
This systematic review and meta-analysis aimed to evaluate the effectiveness of spiritually based interventions on blood pressure (BP) among adults. A systematic search was performed using the PubMed, Scopus, and Cochrane databases to identify studies evaluating spiritual interventions, including:
- meditation,
- transcendental meditation,
- mindfulness meditation,
- yoga,
for high BP among adults up to January 1, 2022.
The inclusion criteria were:
- (a) randomized controlled trials (RCTs),
- (b) studies in English or Persian,
- (c) studies conducted among adults (≥ 18 years),
- (d) studies reporting systolic or diastolic BP.
Given the high heterogeneity of these studies, a random effect model was used to calculate the effect sizes for the RCTs.
In total, the systematic review included 24 studies and the meta-analysis included 23 studies. As some of studies reported two or more outcome measurements, separate estimates of each outcome were extracted for that study (24 datasets). Fifteen trials reported the mean (SD) systolic blood pressure (SBP), and 13 trials reported the mean (SD) diastolic blood pressure (DBP). In addition, 13 studies reported means (SDs) and six trials reported mean changes in DBP. A significant decrease was found in systolic BP following intervention ((WMD (weighted mean difference) = − 7.63 [− 9.61 to − 5.65; P < 0.001]). We observed significant heterogeneity among the studies (I2 = 96.9; P < 0.001). A significant decrease was observed in DBP following the interventions (WMD = − 4.75 [− 6.45 to − 3.05; P < 0.001]).
The authors concluded that spiritually based interventions including meditation and yoga had beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.
Q: What do the RCTs of these interventions have in common?
A: They cannot normally be placebo-controlled because no adequate placebos exist for these therapies.
Q: What does that mean?
A: It means that patients could not be blinded and that patient expectations influenced the outcome.
In view of the fact that blood pressure is an endpoint that is extremely sensitive to expectation, I think, the conclusions of this paper might need to be re-formulated:
This analysis confirms that expectation can have beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.
Pre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75-78 per thousand persons per year.
The objective of this study was to test the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. It was designed as a ix-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial.
Sixty participants with pre-diabetes were treated either with:
- HMPs plus yoga therapy (YT; n = 30)
- or with identical-looking placebos plus YT (n = 30).
Pre-diabetes was defined as elevated fasting blood glucose (FBS) of 100-125 mg/dL, glycated hemoglobin (HbA1c) value of 5.7-6.4%, and/or an elevated blood glucose level 2 hrs. after an oral glucose tolerance test (OGTT) of 140-199 mg/dL (ICD-10-R73.03).
The primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months.
The proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum – 2/30 versus control – 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes.
The authors concluded that HMPs with YT produced significantly better effects than placebos plus YT with moderate to large effect sizes. Overall, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes.
This is an odd study with very odd results; it begs several questions and comments, e.g.:
- If the aim was to test the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes, why add yoga as a treatment?
- What were the influences of other factors such as diet and life-style, and were these the same in both groups?
- The sample size seems far too small for such firm conclusions.
- What might be the alleged mechanism of action?
- Why not publish such a study that has allegedly important results in one of the many established journals dealing with diabetes?
I fear that this trial is merely one in the long list of poor quality, false-positive homeopathy studies that are currently emerging from India. I predict that the findings will not even be taken seriously enough to be submitted to a replication by established diabetes researchers.
This study evaluated and compared the effectiveness of Reiki and Qi-gong therapy techniques in improving diabetic patients’ negative emotional states. This quas-experimental research design was carried out at the National Institute of Diabetes and Endocrinology’s Hospital in Cairo, Egypt. It included 200 Type 2 diabetes patients randomized into two equal groups, one for Qigong and one for Reiki techniques. A self-administered questionnaire with a standardized tool (Depression Anxiety Stress Scales [DASS[) was used in data collection. The intervention programs were administered in the form of instructional guidelines through eight sessions for each group.
The results showed that the two study groups had similar socio-demographic characteristics. After implementation of the intervention, most patients in the two groups were having no anxiety, no depression, and no stress. Statistically significant improvements were seen in all three parameters in both groups (p<0.001). The multivariate analysis identified the study intervention as the main statistically significant independent negative predictor of the patients’ scores of anxiety, depression, and stress. Reiki technique was also a statistically significant independent negative predictor of these scores.
The authors conclused that both Reiki and Qi-gong therapy techniques were effective in improving diabetic patients’ negative emotional states of anxiety, depression, and stress, with slight superiority of the Reiki technique. The inclusion of these techniques in the management plans of Type-2 diabetic patients is recommended.
This is an excellent example of how NOT to design a clinical trial!
- If your aim is to test the efficacy of Reiki, conduct a trial of Reiki versus sham-Reiki.
- If your aim is to test the efficacy of Qi-gong, conduct a trial of Qi-gong versus sham-Qi-gong.
- If you compare two therapies in one trial, one has to be of proven and undoubted efficacy.
- Comparing two treatments of unproven efficacy cannot normally lead to a meaningful result.
- It is like trying to solve a mathematical equasion with two unknowns.
- A study that cannot produce a meaningful result is a waste of resorces.
- It arguably also is a neglect of research ethics.
- Even if we disregarded all these flaws and problems, recommending therapies for routine use on the basis of one single study is irresponsible nonsense.
All this is truly elementary and should be known by any researcher (not to mention research supervisor). Yet, in the realm of so-called alternative medicine (SCAM), it needs to be stressed over and over again. The ‘National Institute of Diabetes and Endocrinology’s Hospital in Cairo’ (and all other institutions that produce such shameful pseudoscience) urgently need to get their act together:
you are doing nobody a favour!
Introduction
There has been accumulating interest in the application of biofield therapy as complementary and alternative medicine (CAM) to treat various diseases. The practices include reiki, qigong, blessing, prayer, distant healing, known as biofield therapies. This paper aims to state scientific knowledge on preclinical and clinical studies to validate its potential use as an alternative medicine in the clinic. It also provides a more in-depth context for understanding the potential role of quantum entanglement in the effect of biofield energy therapy.
Content
A comprehensive literature search was performed using the different databases (PubMed, Scopus, Medline, etc.). The published English articles relevant to the scope of this review were considered. The review gathered 45 papers that were considered suitable for the purpose. Based on the results of these papers, it was concluded that biofield energy therapy was effective in treating different disease symptoms in preclinical and clinical studies.
Summary
Biofield therapies offer therapeutic benefits for different human health disorders, and can be used as alternative medicine in clinics for the medically pluralistic world due to the growing interest in CAM worldwide.
Outlook
The effects of the biofield energy therapies are observed due to the healer’s quantum thinking, and transmission of the quantum energy to the subject leads to the healing that occurs spiritually through instantaneous communication at the quantum level via quantum entanglement.
The authors of this article are affiliated with Trivedi Global, an organisation that states this about ‘biofield energy’:
Human Biofield EBnergy has subtle energy that has the capacity to work in an effective manner. This energy can be harnessed and transmitted by the gifted into living and non-living things via the process of a Biofield Energy Healing Treatment or Therapy.
If they aleady know that “Biofield EBnergy has subtle energy that has the capacity to work in an effective manner”, I wonder why they felt the need to conduct this review. Even more wonderous is the fact that their review showed such a positive result.
How did they manage this?
The answer might lie in their methodology: they “gathered 45 papers that were considered suitable”. While scientists gather the totality of the available evidence (and assess it critically), they merely selected what was suitable for the purpose of generating a positive result. This must be the reason our two studies on the subject were discretely omitted:
Purpose: Distant healing, a treatment that is transmitted by a healer to a patient at another location, is widely used, although good scientific evidence of its efficacy is sparse. This trial was aimed at assessing the efficacy of one form of distant healing on common skin warts.
Subjects and methods: A total of 84 patients with warts were randomly assigned either to a group that received 6 weeks of distant healing by one of 10 experienced healers or to a control group that received a similar preliminary assessment but no distant healing. The primary outcomes were the number of warts and their mean size at the end of the treatment period. Secondary outcomes were the change in Hospital Anxiety and Depression Scale and patients’ subjective experiences. Both the patients and the evaluator were blinded to group assignment.
Results: The baseline characteristics of the patients were similar in the distant healing (n = 41) and control groups (n = 43). The mean number and size of warts per person did not change significantly during the study. The number of warts increased by 0.2 in the healing group and decreased by 1.1 in the control group (difference [healing to control] = -1.3; 95% confidence interval = -1.0 to 3.6, P = 0.25). Six patients in the distant healing group and 8 in the control group reported a subjective improvement (P = 0.63). There were no significant between-group differences in the depression and anxiety scores.
Conclusion: Distant healing from experienced healers had no effect on the number or size of patients’ warts.
Spiritual healing is a popular complementary and alternative therapy; in the UK almost 13000 members are registered in nine separate healing organisations. The present randomized clinical trial was designed to investigate the efficacy of healing in the treatment of chronic pain. One hundred and twenty patients suffering from chronic pain, predominantly of neuropathic and nociceptive origin resistant to conventional treatments, were recruited from a Pain Management Clinic. The trial had two parts: face-to-face healing or simulated face-to-face healing for 30 min per week for 8 weeks (part I); and distant healing or no healing for 30 min per week for 8 weeks (part II). The McGill Pain Questionnaire was pre-defined as the primary outcome measure, and sample size was calculated to detect a difference of 8 units on the total pain rating index of this instrument after 8 weeks of healing. VASs for pain, SF36, HAD scale, MYMOP and patient subjective experiences at week 8 were employed as secondary outcome measures. Data from all patients who reached the pre-defined mid-point of 4 weeks (50 subjects in part I and 55 subjects in part II) were included in the analysis. Two baseline measurements of outcome measures were made, 3 weeks apart, and no significant differences were observed between them. After eight sessions there were significant decreases from baseline in McGill Pain Questionnaire total pain rating index score for both groups in part I and for the control group in part II. However, there were no statistically significant differences between healing and control groups in either part. In part I the primary outcome measure decreased from 32.8 (95% CI 28.5-37.0) to 23.3 (16.8-29.7) in the healing group and from 33.1 (27.2-38.9) to 26.1 (19.3-32.9) in the simulated healing group. In part II it changed from 29.6 (24.8-34.4) to 24.0 (18.7-29.4) in the distant healing group and from 31.0 (25.8-36.2) to 21.0 (15.7-26.2) in the no healing group. Subjects in healing groups in both parts I and II reported significantly more ‘unusual experiences’ during the sessions, but the clinical relevance of this is unclear. It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.
In addition, they, of course, also omitted many further studies by other investigators that failed to be positive. Considering this amount of cherry-picking, it is easy to understand how they arrived at their conclusion. It is all a question of chosing the right methodology!
A few decades ago, the cigarette industry employed this technique to show that smoking did not cause cancer! Luckily, we have since moved away from such pseudo-scientific ‘research’ – except, of course, in the realm of SCAM where it is still hughely popular.
Some abstracts of medical papers are so bizarre that they must not be tempered with, I find. This is one of them:
Rationale:
This case report aims to provide clinical evidence on the effectiveness of integrating chiropractic and moxibustion techniques for treating pseudomyopia accompanied by elevated intraocular pressure resulting from cervical spine issues because the application of complementary medicine modalities for managing such vision disorders currently lacks adequate investigations.
Patient concerns:
A 6-year-old patient presented with blurred vision, intermittent ocular discomfort, and upper cervical discomfort.
Diagnoses:
Spine-related increased intraocular pressure and pseudomyopia.
Interventions:
The patient received integrative treatment of chiropractic and walnut-shell moxibustion 3 times a week for a total of 10 treatment sessions.
Outcomes:
The patient exhibited progressive improvements in visual acuity and reductions in intraocular pressure over the treatment period, with unaided vision exceeding 2 lines of improvement in visual acuity charts and normalized intraocular pressure after 10 treatment sessions. These therapeutic effects were sustained at 3-month follow-up.
Lessons:
The integrative use of chiropractic and walnut-shell moxibustion demonstrates considerable potential in alleviating symptoms of pseudomyopia, reducing intraocular pressure, and restoring visual function in spine-related pseudomyopia cases.
Pseudomyopia is a spasm of the ciliary muscle that prevents the eye from focusing in the distance. It differs from myopia which is caused by the eye’s shape or other basic anatomy. Pseudomyopia may be either organic, through stimulation of the parasympathetic nervous system, or functional in origin, through eye strain or fatigue of ocular systems. It is common in young adults after a change in visual requirements, such as students preparing for an exam, or a change in occupation. The condition is often transitory and it is necessary to request psychiatric consultation in each case of pseudomyopia. Comorbidity of anxiety and depressive disorders is more common in pseudomyopia cases. In addition, as the severity of psychiatric symptoms increases, the amount of accommodation also appears to increase.
A few question, if I may:
- Walnut-shell moxibustion? Yes, it exists! Moxibustion with walnut shell spectacles is a characteristic therapy of Guang’anmen Hospital, developed on the basis of walnut shell moxibustion, and mainly composed of an eye moxibustion frame, a walnut shell soaked with wolfberry and chrysanthemum liquid, and moxibustion strips. Moxibustion with a walnut shell was first recorded by Shicheng Gu for treating surgical ulcers in the Qing dynasty. Then, moxibustion with walnut shell spectacles was reformed by us, combining Shicheng Gu’s experience with our clinical practice, and is mainly used for the treatment of optic nerve atrophy and myopia.
- The authors state that, “based on traditional Chinese medicine principles, moxibustion is known to warm meridians, dredge collaterals, relax tendons, and enhance blood circulation”. Is this true? Well, based on TCM, anything goes, but it does not make it true.
- How can we know whether chiropractic or walnut-shell moxibustion or both caused the outcome? We can’t!
- Can we be sure what caused the child’s problem? No!
- Do we know whether the outcome was not a spontaneous recovery? No!
- The authors claim that “cervical spine imbalance leads to visual impairment”. Is that correct? Not as far as I know.
- The authors state that “the patient in this case, presenting with pseudomyopia, elevated intraocular pressure, and neck pain, likely had a cervical spine-derived condition. Currently, such spine-derived vision disorders lack sufficient clinical recognition.” Is this true? No, I’d say such spine-derived vision disorders might not even exist.
- Why would anyone publish a paper about the case? Search me!
This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.
Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.
Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.
The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.
It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.
I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.
According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).
The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.
After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.
The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.
It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.
One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.
Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.
