symptom-relief
This retrospective audit aimed to assess the clinical effectiveness of telehealth interventions in an out-patient, individualized homeopathy clinical setting for 305 individuals with symptoms of positive or probable COVID-19
by a team of professional homeopaths working together in the United States during spring and summer of
2020.
The audit lasted from March to August 2020. It examined the merits of the initiative considering accessibility, effectiveness, safety, efficiency, and appropriateness of the care model.
Positive intervention outcomes were found in every measure:
- individual remedy prescriptions (83.4% positive),
- final outcomes of interventions (76.2% positive),
- degree of recovery following homeopathic interventions (74.4%).
Additionally, ease of access for a range of users, a high level of safety of the interventions, and efficiency of care and team resources indicated consistently positive outcomes.
The authors concluded that, given the significant strain on conventional healthcare systems during the early stages of the pandemic, the complementary medicine interventions studied here offer important considerations for meeting the demands for COVID-19 acute care with agile and adaptive complementary medicine models.
If one were to look for ridiculously poor studies in the realm of homeopathy, one would be spoilt for choice. Amongst the many such papers, this one would achieve a very high ranking. The investigation is nonsensical in:
- concept,
- design,
- endpoints,
- write-up,
- conclusion.
The paper prompts me to ask a few questions (and some answers):
Whoever had the notion that an audit can “assess the clinical effectiveness” of a therapy?
Do the authors even know what an audit is?
What institutions are behind such embarrassingly poor work? They are:
- ‘HOHM Foundation’, New York,
- the ‘Academy of Homeopathy Education,
- HOHM Foundation, Philadelphia.
Which journal publishes such rubbish?
It’s INTEGRATIVE MEDICINE REPORTS, a publication that claims to be a “high-quality open access journal”.
And who sponsors such idiocy?
This study was funded by donations to HOHM Partners and to Homeopathy Help Network by clients and community members.
Say no more!
The BBC has repeatedly misled the public on matters related to so-called alternative medicine (SCAM). Examples include:
- Dangerous BS from the BBC
- The BBC, Michael Mosely, air ionization, depression, and an appalling lack of critical thinking.
Recently the BBC published an article about Ashwagandha. Here it is in its untouched beauty:
Ashwagandha is a herb (Withania somnifera) in the nightshade family, which also includes tomatoes and chilli peppers. It has been used in traditional Indian medicine (Ayurveda) for thousands of years to make preparations for treating various ailments, from infectious diseases, like tuberculosis, to pain and inflammation, baldness and hiccups. In classic Ayurvedic texts, it’s also described as a ‘mental strength promoter’ (or ‘Balya’).
While lots of research has been done on ashwagandha, studies for specific conditions can be sparser. Perhaps the most recent assessment of its use for stress and anxiety comes from a 2022 review of studies by the Cochrane Collaboration, which is internationally recognised for its high-standard medical reviews. Although the Cochrane researchers were only able to find 12 studies on the subject, which together tested the herb on just 1,002 participants, their findings did suggest that ashwagandha can lower stress and anxiety. The researchers rated the ‘certainty’ of the evidence as ‘low’ and called for more detailed studies, though.
The benefits of ashwagandha are thought to be related to natural steroids called withanolides, but this group includes hundreds of compounds, with tens having been isolated from ashwagandha so far. As with any herbal remedy, the combination of compounds and the exact concoction you get depends on how and where the plant is grown, and how it’s prepared. This means that not all supplements based on the same plant are equal.
Remember, too, that herbal doesn’t mean risk-free. For some people, ashwagandha causes drowsiness and more serious side effects aren’t unknown. It’s best to treat it like a drug and not ‘just’ a herb.
The review cited in the article is this one:
Clinical trial studies revealed conflicting results on the effect of Ashwagandha extract on anxiety and stress. Therefore, we aimed to evaluate the effect of Ashwagandha supplementation on anxiety as well as stress. A systematic search was performed in PubMed/Medline, Scopus, and Google Scholar from inception until December 2021. We included randomized clinical trials (RCTs) that investigate the effect of Ashwagandha extract on anxiety and stress. The overall effect size was pooled by random-effects model and the standardized mean difference (SMD) and 95% confidence interval (CIs) for outcomes were applied. Overall, 12 eligible papers with a total sample size of 1,002 participants and age range between 25 and 48 years were included in the current systematic review and meta-analysis. We found that Ashwagandha supplementation significantly reduced anxiety (SMD: −1.55, 95% CI: −2.37, −0.74; p = .005; I2 = 93.8%) and stress level (SMD: −1.75; 95% CI: −2.29, −1.22; p = .005; I2 = 83.1%) compared to the placebo. Additionally, the non-linear dose–response analysis indicated a favorable effect of Ashwagandha supplementation on anxiety until 12,000 mg/d and stress at dose of 300–600 mg/d. Finally, we identified that the certainty of the evidence was low for both outcomes. The current systematic review and dose–response meta-analysis of RCTs revealed a beneficial effect in both stress and anxiety following Ashwagandha supplementation. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.
This review is NOT a Cochrane Review; what is more (and more important), it seem rather uncritical.
The BBC article seems to down-play the safety issue related to Ashwagandha. As we have discussed on this blog, Ashwagandha is far from harmless. In fact, Ashwagandha has been shown to be a herb with a high risk of hepatobiliary toxicity as well as heart problems.
So, why does the BBC misinform the public?
Search me.
What is it about Reiki that fascinates me?
It must be the exemplary poor science that its proponents use trying to convince us that it is valid.
This randomized controlled trial investigated the effect of Reiki on pain, functional status, and holistic well-being in patients with knee osteoarthritis (OA). The sample consisted of 42 patients.
- The control group received standardized treatment only.
- The intervention group received face-to-face Reiki (nine positions; 39 minutes) and distance Reiki on two consecutive days in addition to standardized treatment in addition to standard treatment.
The results show that the Reiki group had lower pain scores than the control group as measured by the Visual Analog Scale (p < .001) and the Western Ontario and McMaster Universities Arthritis Index pain score (p < .001). Those participating in the Reiki group had improved holistic well-being scores specifically for the subscales of Sadness, Perception of Sadness, Spiritual Disruption, Cognitive Awareness, and General mood.
The authors concluded that Reiki is a safe, noninvasive, and cost-effective alternative treatment technique that has the potential to reduce symptoms of pain and improve holistic well-being in patients with knee OA.
So many falsehoods in one sentence!
Is this a new record?
Let’s analyse these conclusions a little, shall we?
- Reiki is safe: this does not follow from the data because the sample was far too small for assessing rare safety issues, safety was not measured, and half of the Reiki group might have dropped dead a week after the study.
- Reiki is non-invasive: that might be true.
- Reiki is cost-effective: cost-effectiveness was not an endpoint; the statement is thus not supported by the data.
- Reiki reduces the symptoms of pain and improve holistic well-being in patients with knee OA: I disagree! The observed outcomes are much more likely caused by the considerable amount of extra attention and treatment time given to the Reiki group, and the results were entirely unrelated to any specific effects of the therapy.
So, I feel the need for re-phrasing the conclusions as follows:
Reiki is an implausible treatment and the outcomes of this study are unrelated to any alleged specific effects of this therapy.
Several years ago, I reported on the range of conditions which, according to homeopaths, “respond best to homeopathic treatment” (basically any condition imaginable). To remind you, here is the list again:
ENT and bronchial problems
- Ear infections,
- rhinitis,
- sinusitis,
- pharyngitis,
- tonsillitis,
- tracheitis,
- bronchitis,
- asthma.
Digestive problems
- Stomach complaints
- acidity,
- heartburn,
- fullness,
- poor digestion,
- flatulence,
- duodenal ulcer,
- diarrhoea,
- constipation,
- nausea,
- vomiting,
- canker sores.
Cardiovascular problems
- High blood pressure,
- peripheral arterial disease,
- Venous problems,
- varicose veins,
- leg heaviness.
Osteoarticular complaints
All types of muscle and/or joint pain due to arthrosis or arthritis:
- neck pain,
- shoulder pain,
- elbow pain,
- wrist pain,
- Back pain,
- sciatica,
- knee pain,
- ankle pain,
- Sprains,
- contractures etc.
Traumas
- All types of trauma
- falls,
- knocks,
- contusions,
- bone fractures etc.
Urological disorders
- Recurrent urinary infections,
- prostatism.
Gynaecological problems
- Period pains,
- period disorders,
- PMT,
- menopausal complaints,
- infertility.
Dermatological problems
- Eczema, hives,
- Acne vulgaris, acne rosacea,
- Recurrent boils, verucas, plantar warts,
- Molluscum contagiosum,
- Herpes simple and zoster
- Psoriasis
Neurological disorders
- Headaches and migraines.
- Eye problems
- Conjunctivitis,
- blepharitis,
- styes, dacryocistitis,
- uveitis.
Behavioural and psychiatric disorders
- Anxiety,
- depression,
- stress,
- mental fatigue,
- Pediatric problems,
- Ear infections,
- tonsillitis,
- bronchitis,
- asthma,
- diarrhoea,
- vomiting,
- skin complaints,
- canker sores,
- teething problems,
- sleep disorders,
- educational attainment issues,
- behavioural issues.
Endocrine disorders
- Obesity,
- hypothyroidism,
- hyperthyroidism,
- Depleted immune defences,
- Recurrent infections affecting the throat,
- sinuses, nose, ears,
- connective tissue, larynx,
- bronchial tubes,
- lungs,
- skin,
- bladder etc.
Palliative care
For the treatment of the diverse symptoms that appear over the course of the illness. Homeopathy can improve the patient’s general wellbeing and counteract the side effects of other treatments.
These are just a few examples, but the list could be endless – it is important to stress that homeopathy is very effective in pathologies that are difficult to establish or those with contradictory or paradoxical symptoms.
In recurrent illnesses, homeopathic medicines can boost the defences and help to regulate the sufferer’s body in order to prevent further relapses.
Homeopathy is an excellent preventive medicine.
_______________________
You will notice that SCIATICA is on the list.
Would they really be as daft as to use homeopathy for sciatica?
Not only that, they would even conduct a study on the subject. Here is this recently published trial:
Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings.
So, homeopathy does not work for sciatica.
Surprise, surprise!
Why not?
Simple: because homeopathy does not work for any condition.
International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. This study aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.
In the PROSPER-FM randomised clinical trial conducted at 25 US community sites, adult participants aged 22–75 years with fibromyalgia were recruited and randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Randomisation was done with a web-based system in permuted blocks of four at the site level. We used a blind-to-hypothesis approach in which participants were informed they would be randomly assigned to one of two potentially effective therapies under evaluation. Research staff were not masked to group allocation, with the exception of a masked statistics group while preparing statistical programming for the interim analysis. The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat. The trial was registered with ClinicalTrials.gov, NCT05243511 (now fully closed).
Between Feb 8, 2022, and Feb 2, 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135). At 12 weeks, 99 (71%) of 140 ACT participants reported improvement on PGIC versus 30 (22%) of 135 active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9–58·9; p<0·0001). No device-related safety events were reported.
The authors concluded that digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients.
___________________
These conclusions might well be valid – but then again, they might not!
Here is why I have my doubts:
- The patients treated with digital ACT knew that they were getting a novel and thus exciting treatment.
- The patients randomised to the control group, on the other hand, would most likely be disappointed not to receive this therapy. In other words, there were high expectations in the experimental group and disappointment in the control group.
- In addition, the unmasked researchers would have had the ambition that their innovation would be successful. Thus they would have used verbal and non-verbal communications with the ACT patients to bring about the desired result.
It is therefore conceivable – I think even likely – that these factors would add up to generate a false-positive finding, particularly since the endpoint was entirely subjective.
In view of all this, I am surprised that a journal like THE LANCET has published such a flimsy study with such a over-optimistic conclusion, and I suggest re-phrasing the conclusions as follows:
Digital ACT seemed safe and effective compared with digital symptom tracking in managing fibromyalgia in adult patients. However, due to the design of the study, it is possible that digital ACT is entirely ineffective and the positive outcome is caused by a number of context effects.
For many years, Dale Thompson has been one of our most loyal commentators, often defending the indefensible, or willfully misleading us, or deliberately distracting us from the topic at hand. He has made his comments under several names or pseudomyms, sometimes with and sometines without using the doctor-title, sometimes disclosing that he is a chiropractor and someimes not disclosing either this information or his most obvious conflicts of interest.
Recently, several readers became more interested in Dale and his activities. I therefore thought it would be relevant to find out how he is being presented on the Internet. Here are the mentions I found that include some relevant information about Dale:
- Dr. Dale Thompson. Over 20 years of delivering a conservative approach to muscle and joint issues. Trained in approaches that don’t require the typical adjustment but it is available when needed. Use a whole body approach and consider other factors that may be contributing to problems such as diet, ergonomics, lifestyles, etc.
- Dr. Dale Thompson is a Stratford, Iowa based male chiropractor with 22 years of experience in General Chiropractor. He completed his graduation from Logan College Of Chiropractic in 2002. He accepts the Medicare-approved amount. Patients will not be billed for any more than the Medicare deductible and coinsurance. Active license number of Dr. Dale Thompson as General Chiropractor is 06631 in Iowa. Dr. Dale Thompson is qualified as a Doctor of Chiropractic (D.C.), licensed by the State and who practices chiropractic medicine -that discipline within the healing arts which deals with the nervous system and its relationship to the spinal column and its interrelationship with other body systems.
- Dr. Thompson graduated from the Logan College of Chiropractic in 2002. He works in Stratford, IA and specializes in Chiropractor.
- DALE THOMPSON, D.C. practices at 813 SHAKESPEARE AVE, STRATFORD, IA 50249. Chiropractors diagnose and treat common spinal misalignments that can occur from lifestyle or injuries causing pain, discomfort and degenerative conditions. DALE THOMPSON, D.C. may be able to treat; back pain, sciatica, neck pain, shoulder pain, headaches, sports injuries, and auto accident injuries.
- Dr. Dale Thompson – Why I Like Being An Evidence-Based Chiropractor. Today we’re going to talk about being an evidence-based chiropractor. What does it mean to be practicing evidence-based chiropractic and we’re going to be talking about with Dr. Dale Thompson from Iowa. USA.
As we see, these texts are not always entirely clear about the fact that Dale has no medical degree. Dale recently posted: “Here in the USA it would be a board violation to ‘conceal’ that one is a doctor of chiropractic.” And in August 2021, he made this comment: “There are several professions that use the title doctor which aren’t earned from a medical college: dentists, optometrists, physical therapists. Within chiropractic, when we advertise, at least in the USA, we are required to identify that we are a doctor of chiropractic. Of course the word doctor originally was used by a religious sect but the medical profession decided they wanted it … “Several authors have recently lamented the continued chiropractic inclination to use outdated and anatomically incorrect language to describe the nature of the manipulable lesion (“subluxation”) and the method of treatment (“adjustment”).2,3,11 J Chiropr Educ. 2020 Oct; 34(2): 172–176.”
Next, I looked on Medline to find out wether Dale has ever published any research on his subject. I failed to find a single article in his name. This is remarkable because, all too often, he presents himself as THE expert in research.
Subsequently, I looked at some of the claims made by Dale. Here are a few of them:
- I can go to a conference and know if the speaker is generally telling the truth or is trying to sell a lie.
- I can read a research paper and know if it’s good or bad and how it may apply to what I do.
- I can take the best evidence and apply it and yet also have the freedom to find novel ways to approach a problem.
- I can take a seemly complex problem and find a simple solution as well as understand the complexity of an apparently simple problem.
- I know my clinical strengths and limitations as well as the strengths and limitations of other healthcare professionals.
- I do not have to jump on board the latest health fad but I can, and may, scrutinize it using logic, reasoning and supporting evidence.
- I can respect my colleagues desire to practice different than me but I still demand they do so in an evidence-based chiropractor and ethical manner.
- My patients come first, my profession second and I am last.
So, what should we conclude about Dale Thompson?
I don’t know about you, but I get the impression that Dale lacks the ability to be critical of his own abilities and of the value of chiropractic. He likes to post comments that are aimed at misleading us. He might not be a ‘straight chiropractor‘ in the usual sense of the term, but in my view he also is still far from straight. Personally, I have not taken much notice of his deeply biased, often pompous and smug comments for some time. I suggest you consider doing the same.
But Dale is just one chiro!
He hardly has any wider significance.
So, why even bother and write a whole blog post about him?
I certainly agree that such a man does not deserve the attention we have been giving him. But Dale stand for so many of his colleagues. In fact, he is a prime example of a chiro victim of the ‘Dunning Kruger Effect‘. These people have a thin veneer of respectability which allows them to pretend to be veritable ‘know alls’. They remain entirely oblivious to the fact that they have been brain-washed at chiro school and have become a life-time members of a cult unable to see how deluded they truly are. As such they are dangerous, and I feel that the public needs to be aware of the danger.
And here you have the true reason why I am writing these lines.
The comment sections of this blog have provided plenty of reason to suspect that chiropractic is a cult, a health cult to be precise. A health cult is defined as a system for the cure of disease based on dogma set forth by its promulgator. The promulgator, in this case, is DD Palmer. As discussed previously, he ‘invented’ chiropractic and promoted many extraordinary claims and ideas, e.g.:
- I was the first to adjust the cause of disease
- Chiropractors adjust causes instead of treating effects
- 95% of all diseases are caused by subluxations of the spine
- Vaccination and inoculation are pathological; chiropractic is physiological
- It was my ingenious brain which discovered [chiropractic’s] first principle; I was its source; I gave it birth; to me all chiropractors trace their chiropractic lineage
- Among the wonderful achievements of this century, the discovery and development of chiropractic is preeminent; it is destined to replace all methods which treat effects
- Dis-ease is a condition of not ease, lack of ease
- His magnetic cure for cancer involved freeing the stomach and spleen of poisons
- Chiropractic is a science of healing without drugs
- Wants to turn chiropractic into a religion (as this would avoid chiropractors being sued for practising medicine without a license)
Since DD Palmer, the chiro-cult has changed. In fact, it has split into two camps. The ‘straights’ have become a Palmer worship cult, while the rest delude themselves of being based on evidence. That the former are cultists is impossible to deny. The latter reject such allegations but, in my mind, they too belong to a cult.
Let me explain.
The criteria for a cult can be defines as follows:
- Charismatic Leader: the ‘mixers’ might no longer worship Palmer, yet they are far from free of his ‘philosophy’; after all, they went to chiro-school where they were educated in the Palmer tradition.
- Isolation: chiropractors seek surprisingly little co-operation with other healthcare professionals and thus tend to be isolated.
- Control: chiropractors are under tight control of their professional bodies, peers, journals, etc. which all make sure that heretic ideas are kept at bay.
- Deception: chiropractors are masters of deception in persuading the public and their patients of the value of spinal manipulations, regardless of the actual evidence.
- Us vs. Them Mentality: chiropractors tend to create an “us vs. them” mentality, demonizing real doctors and promoting group cohesion.
- Exploitation: chiropractors have a long history of exploiting their patients; maintenance care is just one of many examples.
- Fear Tactics: chiropractors are scare mongers, for instance, when they diagnose subluxations even in perfectly healthy people and claim that this invented diagnosis needs urgent adjustments.
What, you don’t agree with these arguments?
In this case let me quote a different set criteria that might help to decide whether chiropractic might be a cult. Here they are:
- Absolute authoritarianism without accountability
- Zero tolerance for criticism or questions
- Lack of meaningful financial disclosure regarding budget
- Unreasonable fears about the outside world that often involve evil conspiracies and persecutions
- A belief that former followers are always wrong for leaving and there is never a legitimate reason for anyone else to leave
- Abuse of members
- Records, books, articles, or programs documenting the abuses of the leader or group
- Followers feeling they are never able to be “good enough”
- A belief that the leader is right at all times
- A belief that the leader is the exclusive means of knowing “truth” or giving validation
Bearing in mind that not all of the 10 criteria need to be fulfilled, I ask you: is chiropractic a cult?
This review was aimed at quantifying the proportion attributable to contextual effects of physical therapy interventions for musculoskeletal pain. Randomized placebo-controlled trials evaluating the effect of physical therapy interventions on musculoskeletal pain.
Risk of bias was evaluated using the Cochrane risk-of-bias tool for randomized trials (ROB 2.0). The proportion of physical therapy interventions effect that is explained by contextual effects was calculated, and a quantitative summary of the data from the studies was conducted using the random-effects inverse-variance model (Hartung-Knapp-Sidik-Jonkman method).
Sixty-eight studies were included in the systematic review (total number of participants: n=5,238), and 54 placebo-controlled trials informed our meta-analysis (participants: n=3,793). Physical therapy interventions included:
- soft tissue techniques,
- mobilization,
- manipulation,
- taping,
- exercise therapy,
- dry needling.
Placebo interventions included manual, non-manual interventions, or both.
The results show the following:
- The type of treatment with the largest proportion not attributable to the specific effects (PCE) for pain intensity assessed immediately after the intervention was mobilization, which represented 87% of the overall treatment effect (PCE = 0.87, 95% CI: 0.54, 1.19).
- For soft tissue techniques, the PCE was 81% of the overall treatment effect (PCE = 0.81, 95% CI: 0.64, 0.97).
- For dry needling, the PCE was 75% (PCE = 0.75, 95% CI: 0.36, 1.15).
- For manipulation techniques the PCE was 74% (PCE = 0.74, 95% CI: 0.33, 1.14).
- For taping the PCE was 69% of the overall treatment effect (PCE = 0.69, 95% CI: 0.48, 0.89).
- The smallest proportion not attributable to the specific intervention itself for pain intensity was exercise therapy accounting for 46% of the overall treatment effect (PCE = 0.46, 95% CI: 0.41, 0.52).
The authors concluded that the outcomes of physical therapy interventions for musculoskeletal pain were significantly influenced by contextual effects. Boosting contextual effects consciously to enhance therapeutic outcomes represents an ethical opportunity that could benefit patients.
This sounds as though most of the treatments in question rely mainly on placebo effects. But what about conventional therapies? The authors point out that the PCEs of general medicine and surgery in pain-related conditions are also large. In particular, the overall proportion not attributable to the specific effects of general medicine interventions is high (PCE = 65%), with higher values observed in semi-objective and objective outcomes (PCE = 78 and 94%, respectively) than in subjective outcomes (PCE = 50%).
What does that mean for healthcare routine?
As placebo and other context effects are unreliable, usually short-lived, and not normally affecting the cause of the problem (but merely the symptoms), I would say that those treatments with a very high PCE are of limited value, paticularly if they are also expensive or burdened with risks. Of the treatments studied here, I would – based on the current analysis – avoid the following therapies for pain management:
- mobilization,
- soft tissue techniques,
- dry needling,
- manipulation,
- taping.
By and large, these are also the conclusions drawn from various other strands of evidence that we have repeatedly discussed in previous posts.
Post-COVID-19 fatigue is becoming increasingly common as the pandemic evolves. Plenty of so-called alternative medicines (SCAMs) are on offer, including homeopathy. But is homeopathy really helpful?
This trial attempted to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults.
A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences.
Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups.
The authors concluded that IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.
A glance at the authors’ affiliations is, I think, revealing:
- 1Department of Organon of Medicine and Homeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.
- 2Department of Pathology and Microbiology, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
- 3The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
- 4Department of Practice of Medicine, The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India.
- 5Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, India.
We are currently being bombarded with false-positive homeopathy trials from India. Why am I sure that the trial is false-positive? Well, I am not sure, of course. But I have suspicions:
- Homeopathy is not a plausible form of SCAM.
- The most reliable studies fail to show that is is more than a placebo.
- The journal that published this paper is 3rd class; if the findings were valid, they would get published in one of the top science journals.
- The authors were clearly biased and even admitted as much; they stated that they wanted “to identify the preliminary evidence of the efficacy” of IHM. But this is not how unbiased researcher conduct clinical trials. Such investigations are for testing hypotheses and not for identifying effects.
- Most importantly, the trial design is flawed. Even the authors realize this, and the 1st sentence of the conclusions should therefore have been far less definitive.
And what are the main flaws?
As far as I can see they were:
- The sample size was to small for a far-reaching conclusion.
- The study was not double blind. In other words the therapists had the opportunity to exert their influence on the patient to produce the desired outcome. Occam’s Razor demands that we assume this to be the real explanation of the positive effects observed here.
In view of all this, I suggest to change the conclusions as follows:
IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults which most likely is not due to the efficacy of the treatment applied but to the residual bias not controlled for in this study.
This study aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.
WalkBack was a two-armed, randomised clinical trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112)
Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60–0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149–295) in the intervention group and 112 days (89–140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group).
The authors concluded that an individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed.
Rigorous clinical trials of excercise therapy are difficult to conceive and conduct because of a range of methodological issues. For instance, there is no obvious placebo and thus it is hardly possible to control for placebo effects. Nonetheless, the benefits of exercise therapy for back pain is undoubted. As previously discussed on this blog, a recent systematic review concluded that “the relative benefit of individualized exercise therapy on chronic low back pain compared to other active treatments is approximately 38% which is of clinical importance.”
I have always been convinced of the health benefits of excercise. In fact, 40 years ago, when I did my inaugural lecture at the University of Munich (LMU), excercise was its topic and I concluded that, if exercise were a pharmaceutical product, it would out-sell any drug. The new study only confirms my view. It adds to our knowledge by suggesting that exercise also reduces the risk of recurrences.
Forget about spinal manipulation, acupuncture, etc., despite the undeniable weaknesses in the evidence, exercise is by far the most promissing treatment for back pain
