causation
This case report aims to describe the effects of craniosacral therapy and acupuncture in a patient with chronic migraine.
A 33-year-old man with chronic migraine was treated with 20 sessions of craniosacral therapy and acupuncture for 8 weeks. The number of migraine and headache days were monitored every month. The pain intensity of headache was measured on the visual analog scale (VAS). Korean Headache Impact Test-6 (HIT-6) and Migraine Specific Quality of Life (MSQoL) were also used.
The number of headache days per month reduced from 28 to 7 after 8 weeks of treatment and to 3 after 3 months of treatment. The pain intensity of headache based on VAS reduced from 7.5 to 3 after 8 weeks and further to < 1 after 3 months of treatment. Furthermore, the patient’s HIT-6 and MSQoL scores improved during the treatment period, which was maintained or further improved at the 3 month follow-up. No side effects were observed during or after the treatment.
The authors concluded that this case indicates that craniosacral therapy and acupuncture could be effective treatments for chronic
migraine. Further studies are required to validate the efficacy of craniosacral therapy for chronic migraine.
So, was the treatment period 8 weeks long or was it 3 months?
No, I am not discussing this article merely for making a fairly petty point. The reason I mention it is diffteren. I think it is time to discuss the relevance of case reports.
What is the purpose of a case report in medicine/healthcare. Here is the abstract of an article entitled “The Importance of Writing and Publishing Case Reports During Medical Training“:
Case reports are valuable resources of unusual information that may lead to new research and advances in clinical practice. Many journals and medical databases recognize the time-honored importance of case reports as a valuable source of new ideas and information in clinical medicine. There are published editorials available on the continued importance of open-access case reports in our modern information-flowing world. Writing case reports is an academic duty with an artistic element.
An article in the BMJ is, I think, more informative:
It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.
It usually falls to the junior to write up the case, so here are a few simple tips to get you started.
First steps
Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.
Getting consent
Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.
Information gathering
Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.
Writing up
Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.
Coming up with a title
Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.
Background research
Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.
How your case is different
Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.
Conclusion
Finish by explaining why your case report adds to the medical literature and highlight any learning points.
Writing an abstract
The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.
What next
Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!
Both papers agree that case reports can be important. They may provide valuable resources of unusual information that may lead to new research and advances in clinical practice and should offer an interesting case with an unusual presentation or a surprise twist.
I agree!
But perhaps it is more constructive to consider what a case report cannot do.
It cannot provide evidence about the effectiveness of a therapy. To publish something like:
- I had a patient with the common condition xy;
- I treated her with therapy yz;
- this was followed by patient feeling better;
is totally bonkers – even more so if the outcome was subjective and the therapy consisted of more than one intervention, as in the article above. We have no means of telling whether it was treatment A, or treatment B, or a placebo effect, or the regression towards the mean, or the natural history of the condition that caused the outcome. The authors might just as well just have reported:
WE RECENTLY TREATED A PATIENT WHO GOT BETTER
full stop.
Sadly – and this is the reason why I spend some time on this subject – this sort of thing happens very often in the realm of SCAM.
Case reports are particularly valuable if they enable and stimulate others to do more research on a defined and under-researched issue (e.g. an adverse effect of a therapy). Case reports like the one above do not do this. They are a waste of space and tend to be abused as some sort of indication that the treatments in question might be valuable.
The US ‘Public Citizen‘ is an American non-profit, progressive consumer rights advocacy group, and think tank based in Washington, D.C. They recently published an article entitled “FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure“. Here are a few excerpts:
In December 2022, the U.S. Food and Drug Administration (FDA) issued new guidance on homeopathic drug products. The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”
Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:
- products with reports of injury that, after evaluation, raise potential safety concerns
- products containing or purportedly containing ingredients associated with potentially significant safety concerns (for example, infectious agents or controlled substances)
- products that are not administered orally or topically (for example, injectable drug products and ophthalmic drug products)
- products intended to be used to prevent or treat serious or life-threatening diseases
- products for vulnerable populations, such as immunocompromised individuals, infants and the elderly
- products with significant quality issues (for example, products that are contaminated with foreign materials or objectionable microorganisms)
But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications. However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality…
… there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.
The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
_____________________
I fully agree with these sentiments. The harm caused by homeopathy is considerable and multi-facetted. Many previous posts have discudded these problems, e.g.:
- Nine cases of severe homeopathy-induced liver injuries
- Another death by homeopathy
- HOMEOPATHY – “It is not just irresponsible, it’s downright dangerous.”
- Adverse effects of homeopathy and aggravations at NAFKAM
- Homeopathy: it’s time to stop the double standards
- Homeopathy can cause serious harm – and finally, the NHS England has realised it
- Vidatox, homeopathy’s answer to cancer or outright fraud?
- Another child has died because of homeopathy
- Doctor homeopaths violate fundamental rules of ethics when practising homeopathy
- ‘Best homeopathy doctor in Delhi’ offers treatment for HIV/AIDS
- DIY-Homeopathy: how to kill your entire family
- The risks of homeopathy?
- The FDA has warned 4 manufacturers of unapproved injectable homeopathic drugs
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19
- The FDA has sent more warning letters to homeopathic manufacturers
- Walmart is being sued for selling homeopathic products
- Homoeopathic remedies may be safe, but do all homeopaths merit this attribute?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- FDA: homeopathic teething remedies were toxic
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.”
- A truly dangerous homeopath
- The scandalous attitude of some homeopaths and their supporters towards immunisations
- Oh yes, let’s have homeopaths as primary care practitioners! But only in a parallel universe,please.
Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.
It has been reported that a UK Conservative candidate for the next general election reportedly claimed she healed a man’s hearing through the power of prayer. Kristy Adams has been chosen to represent the Conservatives in Mid Sussex at the next general UK election, which is expected to take place in May or the autumn of next year. Mrs Adams previously stood as the Tory candidate in Hove in 2017, placing a distant second behind Labour MP Peter Kyle.
In a recording from 2010, the Conservative hopeful reportedly told the King’s Arms Church in Bedford how she healed a deaf man by placing her hands over his ears and saying: “Be healed in Jesus’s name”. Mrs Adams is reported to have said: “He had hearing aids in both ears and I just thought that wasn’t right. It just annoyed me. I said ‘can I pray for you?’ and his eyes lit up, which is unusual when you offer to pray for someone’s healing.” After removing her hands, she claims the man could hear without his hearing aids. “I don’t know if he was more surprised or me,” she reportedly said.
Speaking to The Argus during her 2017 election campaign, Mrs Adams said she had asked the Daily Mirror to remove a story about the alleged recording but refused to answer whether she believed non-scientific medical miracles can happen. She said: “Millions of Christians around the world pray every day to help people.”
- Daily prayer against severe COVID – an update of a study started two years ago
- Resolution of blindness after prayer?
- Prayer as a therapy: a new randomised study
- Prayer as a medical therapy? Time to stop this nonsense!
- When an undercover journalist tests alternative cancer healers
- Biblical Naturopathy, another SCAM that is new to me
- The ‘Association of Catholic Doctors’ and homeopathic conversion therapy
- Prof Harald Walach’s new ground breaking study of praying the Rosary
- Higher religiousness/spirituality is associated with a more frequent use of so-called alternative medicine (SCAM)
- ‘The power of all religions’ is being tested in a study with severely ill corona-virus patients
- Does religiosity influence post-operative survival?
- Daniel P Wirth, his dubious research, and the remarkable apathy of some medical journals
Suffice to say, perhaps, that the evidence for prayer as a therapy is not positive.
Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non–liver-related systemic side effects. Here is the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute or chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
The authors also cite our own work on this subject:
A detailed systematic review of homeopathic remedies-induced adverse events from published case reports and case series by Posadzski and colleagues showed that severe side effects, some leading to fatality, are possible with classic and unspecified homeopathic formulations. The total number of patients included was 1159, of which 1142 suffered adverse events directly related to homeopathy. The direct adverse events had acute pancreatitis, severe allergic reactions, arsenical keratosis, bullous pemphigoid, neurocognitive disorders, sudden cardiac arrest and coma, severe dyselectrolytemia, interstitial nephritis, kidney injury, thallium poisoning, syncopal attacks, and focal neurological deficits as well as movement disorders. Fatal events involved advanced renal failure requiring dialysis, toxic polyneuropathy, and quadriparesis. The duration of adverse events ranged from a few hours to 7 months, and 4 patients died. The authors state that in most cases, the mechanism of action for side effects of homeopathy involved allergic reactions or the presence of toxic substances—the use of strong mother tinctures, drug contaminants, adulterants, or poor manufacturing (incorrect dilutions).
When we published our paper back in 2012, it led to a seies of angry responses from defenders of homeopathy who claimed that one cannot ‘have the cake and eat it’; either homeopathic remedies are placebos and thus harmless, or they have effects and thus also side-effects, they claimed. As the new publication by Indian researchers yet again shows, they were mistaken. In fact, homeopathy is dangerous in more than one way:
- the homeopathic remedies can do harm if not diluted or wrongly manufactured;
- the homeopaths can do harm through their often wrong advice in health matters;
- homeopathy erodes rational thinking (as, for instance, the resopnses to our 2012 paper demonstrated).
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
The aim of this systematic review was to update the current level of evidence for spinal manipulation in influencing various biochemical markers in healthy and/or symptomatic population.
Various databases were searched (inception till May 2023) and fifteen trials (737 participants) that met the inclusion criteria were included in the review. Two authors independently screened, extracted and assessed the risk of bias in included studies. Outcome measure data were synthesized using standard mean differences and meta-analysis for the primary outcome (biochemical markers). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used for assessing the quality of the body of evidence for each outcome of interest.
There was low-quality evidence that spinal manipulation influenced various biochemical markers (not pooled). There was low-quality evidence of significant difference that spinal manipulation is better (SMD -0.42, 95% CI – 0.74 to -0.1) than control in eliciting changes in cortisol levels immediately after intervention. Low-quality evidence further indicated (not pooled) that spinal manipulation can influence inflammatory markers such as interleukins levels post-intervention. There was also very low-quality evidence that spinal manipulation does not influence substance-P, neurotensin, oxytocin, orexin-A, testosterone and epinephrine/nor-epinephrine.
The authors concluded that spinal manipulation may influence inflammatory and cortisol post-intervention. However, the wider prediction intervals in most outcome measures point to the need for future research to clarify and establish the clinical relevance of these changes.
The majority of the studies were of low or very low quality. This means that the collective evidence is less than reliable. In turn, this means, I think, that the conclusions are misleading. A more honest conclusion would be this:
There is no reliable evidence that spinal manipulation influences inflammatory and cortisol levels.
As for the clinical relevance, I would like to point out that it would not be surprising if chiropractors could one day convincingly show that spinal manipulation do influence various biochemical markers. Many things do! If you fall down a staircase, for instance, plenty of biochemical markers will be affected. This, however, does not mean that throwing our patients down the stairs is of therapeutic value.
This study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).
In a single-blind randomized clinical trial, the researchers randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). They evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. Mixed-model ANOVA was used to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.
CFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.
The authors concluded that this study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.
To understand this study, we need to know what CFT and MSI exactly entailed. Here is the information that the authors provide:
Movement system impairment-based treatment
The movement system impairment-based treatment group received 11 sessions of MSI-based treatment over the 8 weeks for 60 min per session with a supervision of a native speaker experienced (above 5 years) physical therapist with the knowledge of MSI-based treatment. The researchers designed the MSI-based treatment uniquely for each patient based on the interview, clinical examination, and questionnaires, just like they did with the CFT intervention. First, they administered standardized tests to characterize changes in the patient’s low back pain symptoms, and then they modified the treatment to make it more specific based on the participant’s individual symptoms. Depending on the participant’s direction-specific low back pain classification, they performed the intervention following one of the five MSI subgroups namely [1] rotation, [2] extension, [3] flexion, [4] rotation with extension, and [5] rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows: [1] education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down; [2] education regarding exercises to perform trunk movements as painlessly as possible; and [3] prescription of functional exercises to improve trunk movement [32].
Cognitive functional therapy
Cognitive functional therapy was prescribed for each patient in CFT group based the CFT protocol conducted by O’Sullivan et al. (2015). Patients received supervised 12 sessions of training over the 8-week period with 60 min per session provided with another physical therapist who had been trained in CFT treatment. In this protocol, a physical therapist with more than 5 years of experience conducted an interview and physical examination of the patients to determine their own unique training programs, considering modifiable cognitive, biopsychosocial, functional, and lifestyle behavior factors. The intervention consists of the following 3 main stages: [1] making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs [2] exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and [3] lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context. Assessing the individual’s body mass, nutrition, quality of sleep, levels of physical activity or sedentary lifestyle, smoking, and other factors via video calls. Identifying such lifestyle factors helped us to individually advise and design exercise programs, rebuild self-confidence and self-efficacy, promote changes in lifestyle, and design coping strategies.
I must admit that I am not fully convinced.
Firstly, the study was not large and we need – as the authors state – more evidence. Secondly, I am not sure that the results show CFT to be more effective that MSI. They might merely indicate 1) that the bulk of the improvement is due to non-specific effects (e.g. reression towards the mean, natural history of the condition, placebo) and 2) that CFT is less harmful than MSI.
My conclusion:
we need not just more but better evidence.
This study aimed to compare the effectiveness of three distinct interventions – Yoga, Naturopathy, and Conventional medical management – in alleviating pain, reducing disability, enhancing spinal mobility, and improving the quality of life in individuals with low back pain. Ninety participants were recruited and randomly divided into three groups.
- The first group (group 1) received Yoga,
- the second group (group 2) received Naturopathy treatments,
- the third group served as the control and received conventional medications.
Visual Analogue Scale (VAS) scores, Oswestry Disability Index (ODI), Flexion Test-Finger to Floor Test (FTFT) results, and Quality of Life (QOL) were assessed at baseline and after a 10-day intervention period for all groups.
Overall comparisons between the groups, utilizing ANOVA, revealed marked differences in pain severity, disability index, daily functional capacity, and Quality of Life (QoL) improvements following respective interventions. Substantial improvements were also noted within the yoga and naturopathic medicine groups across multiple variables.
The authors concluded that the results of this comparative analysis emphasize the effectiveness of Yoga, Naturopathy, and Conventional Medical Treatment in managing low back pain. All three interventions demonstrated significant improvements in pain intensity, disability, spinal mobility, and quality of life. This study contributes valuable insights into the diverse therapeutic approaches for low back pain management, highlighting the potential of holistic and alternative treatments to enhance patients’ well-being.
__________________
This is a remarkably poor study. Its flaws are too numerous to account for them all here. Let me focus on just a three that stand out.
- All we learn about the 3 treatment regimen is this (and it clearly not enough to do an independent replication of this trial):
Yoga Group:
Participants in the Yoga Group underwent a specifically designed integrated approach of Yoga therapy (IAYT) for back pain, incorporating relaxation techniques, spinal movements, breathing exercises, pranayama, and deep relaxation techniques. The intervention was conducted by qualified yoga instructors at SDM College of Naturopathy and Yogic Sciences.
Naturopathy Group:
Participants in the Naturopathy Group received neutral spinal baths and partial massages. The spinal bath was administered at Government Yoga & Nature Cure Out Patient Center, Puttur, and massages were performed by trained naturopathy therapists.
Conventional Medicine Group:
Participants in the Conventional Medicine Group received standard medical treatments for low back pain as recommended by orthopedic physicians from S.D.M Medical College, Dharward
- As an equivalence trial, the sample size of this study is far too small. This means that its findings are most likely caused by coincidence and not by the interventions applied.
- There was no attempt of blinding the patients. Therefore, the results – if they were otherwise trustworthy – would be dominated by expectations and not by the effects of the treatments.
Altogether, this study is, I think, a good example for the fact that
poor research often is worse than no research at all.
The KFF provides reliable, accurate, and non-partisan information to help inform health policy in the US. The KFF has just released its ‘Health Misinformation Tracking Poll Pilot‘ examining the public’s media use and trust in sources of health information and measuring the reach of specific false and inaccurate claims surrounding three health-related topics: COVID-19 and vaccines, reproductive health, and gun violence. It makes grimm reading indeed. Here are but a few excerpts pertaining to health/vaccination:
Health misinformation is widespread in the US with 96% of adults saying they have heard at least one of the ten items of health-related misinformation asked about in the survey. The most widespread misinformation items included in the survey were related to COVID-19 and vaccines, including that the COVID-19 vaccines have caused thousands of deaths in otherwise healthy people (65% say they have heard or read this) and that the MMR vaccines have been proven to cause autism in children (65%).
Regardless of whether they have heard or read specific items of misinformation, the survey also asked people whether they think each claim is definitely true, probably true, probably false, or definitely false. For most of the misinformation items included in the survey, between one-fifth and one-third of the public say they are “definitely” or “probably true.” The most frequently heard claims are related to COVID-19 and vaccines.
Uncertainty is high when it comes to health misinformation. While fewer than one in five adults say each of the misinformation claims examined in the survey are “definitely true,” larger shares are open to believing them, saying they are “probably true.” Many lean towards the correct answer but also express uncertainty, saying each claim is “probably false.” Fewer tend to be certain that each claim is false, with the exception of the claim that more people have died from the COVID-19 vaccines than from the virus itself, which nearly half the public (47%) recognizes as definitely false.
Across the five COVID-19 and vaccine related misinformation items, adults without a college degree are more likely than college graduates to say these claims are definitely or probably true. Notably, Black adults are at least ten percentage points more likely than White adults to believe some items of vaccine misinformation, including that the COVID-19 vaccines have caused thousands of sudden deaths in otherwise healthy people, and that the MMR vaccines have been proven to cause autism in children. Black (29%) and Hispanic (24%) adults are both more likely than White adults (17%) to say that the false claim that “more people have died from the COVID-19 vaccine than have died from the COVID-19 virus” is definitely or probably true. Those who identify as Republicans or lean towards the Republican Party and pure independents stand out as being more likely than Democratic leaning adults to say each of these items is probably or definitely true. Across community types, rural residents are more likely than their urban and suburban counterparts to say that some false claims related to COVID vaccines are probably or definitely true, including that the vaccines have been proven to cause infertility and that more people have died from the vaccine than from the virus.
Educational attainment appears to play a particularly important role when it comes to susceptibility to COVID-19 and vaccine misinformation. Six in ten adults with college degrees say none of the five false COVID-19 and vaccine claims are probably or definitely true, compared to less than four in ten adults without a degree. Concerningly, about one in five rural residents (19%), adults with a high school education or less (18%), Black adults (18%), Republicans (20%), and independents (18%) say four or five of the false COVID-19 and vaccine misinformation items included in the survey are probably or definitely true.
________________________________
If you have followed some of the comments on this blog, you might find it hard to be surprised!
I do encourage you to read the full article.
The case of a 91-year old male patient developing acute neuropathic pain along the sciatic nerve distribution following spinal manipulation has been reported. Manipulative treatment with an Activator Adjusting Instrument (AAI) had been performed. During this treatment, three applications of the AAI were administered. The applications were bilateral (1) over the sacroiliac joint, (2) gluteal area, and (3) paraspinal region just above the iliac crest.
Within 24 hours, the patient developed severe 10/10 pain originating from the left gluteal area at the site of one of the activator deployments with radiation all the way down his left leg to the foot. He was able to maintain distal left leg strength and sensation. Subsequently, the patient developed insomnia, confusion, and adrenal gland dysfunction in response to changes in steroids, gabapentin, and other drugs, thus highlighting some nuances of managing elderly patients with back pain.
Relief was achieved with subsequent physical therapy techniques aimed at relaxing the patient’s deep gluteal muscles, raising the hypothesis of temporary injury to the deep gluteal muscles, with painful contractions resulting in gluteal region pain as well as sciatic nerve inflammation as the nerve passed through that region.
The authors concluded that this clinical case illustrates some of the perils and risks of spinal manipulation, particularly in the elderly, and the need for careful patient selection.
The authors of this (stranely incomplete) case report discuss whether any manipulation was truly necessary or indicated as part of his initial chiropractic treatment plan. They state that, given that complications associated with similar practices are not often reported in the literature, this case highlights important considerations to be made in the elderly given the potential impact of transient/permanent neuropathic pain in that population subset.
Somehow, I doubt that we can be certain that the patient improved due to the physical therapy and not due to the drugs he received. Moreover, I question the authors’ repeated assertions that such adverse effects of chiropractic spinal manipulation are truly rare. Here is a section from our own 2002 systematic review of the subject:
A systematic review of five prospective investigations of the risks of spinal manipulation concluded that mild-to moderate transient adverse reactions occur in approximately half of patients who undergo spinal manipulation. The largest of these studies involved 1058 patients who received a total of 4712 treatments from 102 chiropractors in Norway. At least one adverse reaction was reported by 55% (n 580) of patients. About one quarter (n 1174) of treatments resulted in at least one adverse reaction. The most common reaction reported was local discomfort. Eighty-five percent (n 824) of reactions were described as “mild or moderate” and 1% (n 14) as “unbearable.” Seventy-four percent (n 1052) of reactions disappeared within 24 hours. No serious, permanent complications of spinal manipulation were reported, but follow-up was not described. These results were confirmed by a similar study in Sweden with 625 patients and a smaller one (68 patients) from the United Kingdom …
Non-life-threatening adverse effects after spinal manipulations are not rare – they are merely rarely reported!
