MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

causation

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The aim of this systematic review and network meta-analysis was to identify the optimal dose and modality of exercise for treating major depressive disorder, compared with psychotherapy, antidepressants, and control conditions.

The screening, data extraction, coding, and risk of bias assessment were performed independently and in duplicate. Bayesian arm based, multilevel network meta-analyses were performed for the primary analyses. Quality of the evidence for each arm was graded using the confidence in network meta-analysis (CINeMA) online tool. All randomised trials with exercise arms for participants meeting clinical cut-offs for major depression were included.

A total of 218 unique studies with a total of 495 arms and 14 170 participants were included. Compared with active controls (eg, usual care, placebo tablet), moderate reductions in depression were found for

  • walking or jogging,
  • strength training,
  • mixed aerobic exercises,
  • and tai chi or qigong.

The effects of exercise were proportional to the intensity prescribed. Strength training and yoga appeared to be the most acceptable modalities. Results appeared robust to publication bias, but only one study met the Cochrane criteria for low risk of bias. As a result, confidence in accordance with CINeMA was low for walking or jogging and very low for other treatments.

The authors concluded that exercise is an effective treatment for depression, with walking or jogging, yoga, and strength training more effective than other exercises, particularly when intense. Yoga and strength training were well tolerated compared with other treatments. Exercise appeared equally effective for people with and without comorbidities and with different baseline levels of depression. To mitigate expectancy effects, future studies could aim to blind participants and staff. These forms of exercise could be considered alongside psychotherapy and antidepressants as core treatments for depression.

As far as I can see, there are two main problems with these findings:

  1. Because too many of the studies are less than rigorous, the results are not quite as certain as the conclusions would seem to imply.
  2. Patients suffering from a major depressive disorder are often unable (too fatigued, demotivated, etc.) to do and/or keep up vigorous excerise over any length of time.

What I find furthermore puzzling is that, on the one hand, the results show that – as one might expect – the effects are proportional to the intensity of the excercise but, on the other hand tai chi and qugong which are both distinctly low-intensity turn out to be effective.

Nonetheless, this excellent paper is undoubtedly good news and offers hope for patients who are in desperate need of effective, safe and economical treatments.

This pilot study is “delving into the potential benefits of Reiki therapy as a complementary intervention for the treatment and management of stress and anxiety”.

A total of 31 volunteers self-reporting stress, anxiety, or psychological disorders were enrolled. Health-related quality of life (HRQoL) was assessed using the 36-Item Short Form Health Survey (SF-36) Questionnaire for anxiety and depression. Pre- and post-treatment HRQoL scores were meticulously compared, and the significance of the disparities in these scores was meticulously computed.

Analysis was restricted to volunteers who completed the 3-day Reiki sessions. Statistically significant enhancements were discerned across all outcome measures, encompassing positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (P<0.0001).

The authors concluded that the constancy and extensive scope of these improvements suggest that Reiki therapy may not only address specific symptoms but also contribute significantly to a predominant escalation of mental and physical health.

This study is almost comical.

Amongst all the many forms of so-called alternative medicine (SCAM), Reiki is perhaps the most ridiculous scam. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy. It is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind. There is no scientific basis for such notions, and reiki is therefore not plausible.

Reiki is used for a number of conditions, including the relief of stress, tension and pain. There have been several clinical trials testing its effectiveness. Those that are rigorous fail to show that the treatment is effective – and those that are dripping with bias, like the one discussed here, tend to produce false-positive results.

The present study has many flaws that are too obvious to even mention. While reading it, I asked myself the following questions:

  • How could a respectable university ever allow this pseudo-research to go ahead?
  • How could a respectable ethics committee ever permit it?
  • How could a respectable journal ever publish it?

The answers must be that, quite evidently, they are not respectable.

 

This study tested whether trigger point acupuncture (TrPA) is beneficial for office workers who have reduced job performance (presenteeism) due to chronic neck and shoulder pain (katakori).

A 4-week single-center randomized clinical trial was conducted on 20 eligible female office workers with chronic neck and shoulder pain of at least 3-month duration. The control group implemented only workplace-recommended presenteeism measures, whereas the intervention group received TrPA up to 4 times per month in addition to the presenteeism measures recommended by each workplace. The major outcome measure was the relative presenteeism score on the World Health Organization Health and Work Performance (WHO-HPQ). The secondary outcome measures were pain intensity (numerical rating scale), absolute presenteeism (WHO-HPQ), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), catastrophic thoughts related to pain (Pain Catastrophizing Scale; PCS), and sleep (Athens Insomnia Scale; AIS).

All 9 cases in the intervention group and 11 cases in the control group were analyzed. TrPA up to 4 times per month reduced the intensity of neck and shoulder pain by 20% (P < .01, d = 1.65) and improved labor productivity (relative presenteeism value) by 0.25 (P < .01, d = 1.33) compared with the control group over 1 month. No significant differences were observed between the 2 groups in terms of absolute presenteeism score, HADS, PCS, or AIS.

The authors concluded that these results suggest that regular intervention with TrPA may be effective in the relative presenteeism score before and after the intervention and the degree of neck and shoulder pain over 28 days compared with the control group.

Sure, TrPA may be effective.

But is it?

I thought the trial was aimed at answering that question!

But it didn’t!

Why not?

Because, as we have discussed ad nauseam on this blog, the A+B versus B study design cannot answer it. On the contrary, it will always generate a positive result without determining whether the treatment or a nonspecific (placebo) effect caused the outcome (which, of course, is the reason why this study design is so popular in SCAM research).

In view of this, I suggest to re-formulate the conclusions as follows:

The study suggests that the researchers were ill-informed when designing it. Therefore, the findings show nothing of value.

Supportive care is often assumed to be beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. The authors of this study hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited.

The main objective of this study therefore was to show that anxiety could be reduced after a touch-massage performed by a nurse trained in this therapy.

A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks. They were randomized into either a group receiving 15-minute touch-massage sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks.

In the treated group, anxiety was assessed before and after each touch-massage session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session.

Sixty-two patients were randomized. Touch-massage significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant.

The authors concluded that this study provides convincing evidence for integrating touch-massage in the treatment of patients in sterile hematology unit.

I find this conclusion almost touching (pun intended). The wishful thinking of the amateur researchers is almost palpable.

Yes, I mean AMATEUR, despite the fact that, embarrassingly, the authors are affiliated with prestigeous institutions:

  • 1Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France.
  • 2Université Paris Est, EA4391 Therapeutic and Nervous Excitability, Creteil, F-93000, France.
  • 3Nantes Université, CHU Nantes, Hematology Department, Nantes, F-44000, France.
  • 4Nantes Université, CHU Nantes, CRCI2NA – INSERM UMR1307, CNRS UMR 6075, Equipe 12, Nantes, F-44000, France.
  • 5Institut Curie, Paris, France.
  • 6Université Paris Versailles Saint-Quentin, Versailles, France.
  • 7Nantes Université, CHU Nantes, Direction de la Recherche et l’Innovation, Coordination Générale des Soins, Nantes, F-44000, France.
  • 8Methodology and Biostatistics Unit, DRCI CHU Nantes CHD Vendée, La Roche Sur Yon, F-85000, France.
  • 9Nantes Université, CHU Nantes, Service Interdisciplinaire Douleur, Soins Palliatifs et de Support, Médecine intégrative, UIC 22, Nantes, F-44000, France. [email protected].

So, why do I feel that they must be amateurs?

  • Because, if they were not amateurs, they would know that a clinical trial should not aim to show something, but to test something.
  • Also, if they were not amateurs, they would know that perhaps the touch-massage itself had nothing to do with the outcome, but that the attention, sympathy and empathy of a therapist or a placebo effect can generate the observed effect.
  • Lastly, if they were not amateurs, they would not speak of convincing evidence based on a single, small, and flawed study.

After the nationwide huha created by the BBC’s promotion of auriculotherapy and AcuSeeds, it comes as a surprise to learn that, in Kent (UK), the NHS seems to advocate and provide this form of quackery. Here is the text of the patient leaflet:

Kent Community Health, NHS Foundation Trust

Auriculotherapy

This section provides information to patients who might benefit from auriculotherapy, to complement their acupuncture treatment, as part of their chronic pain management plan.

What is auriculotherapy?

In traditional Chinese medicine, the ear is seen as a microsystem representing the entire body. Auricular acupuncture focuses on ear points that may help a wide variety of conditions including pain. Acupuncture points on the ear are stimulated with fine needles or with earseeds and massage (acupressure).

How does it work?

Recent research has shown that auriculotherapy stimulates the release of natural endorphins, the body’s own feel good chemicals, which may help some patients as part of their chronic pain management plan.

What are earseeds?

Earseeds are traditionally small seeds from the Vaccaria plant, but they can also be made from different types of metal or ceramic. Vaccaria earseeds are held in place over auricular points by a small piece of adhesive tape, or plaster. Applying these small and barely noticeable earseeds between acupuncture treatments allows for patient massage of the auricular points. Earseeds may be left in place for up to a week.

Who can use earseeds?

Earseeds are sometimes used by our Chronic Pain Service to prolong the effects of standard acupuncture treatments and may help some patients to self manage their chronic pain.

How can I get the most out my treatment with earseeds?

It is recommended that the earseeds are massaged two to three times a day or when symptoms occur by applying gentle pressure to the earseeds and massaging in small circles.

Will using earseeds cure my chronic pain?

As with any treatment, earseeds are not a cure but they can reduce pain levels for some patients as part of their chronic pain management programme.

________________________

What the authors of the leaflet forgot to tell the reader is this:

  • Auriculotherapy is based on ideas that fly in the face of science.
  • The evidence that auriculotherapy works is flimsy, to say the least.
  • The evidence earseeds work is even worse.
  • To arrive at a positive recommendation, the NHS had to heavily indulge in the pseudo-scientific art of cherry-picking.
  • The positive experience that some patients report is due to a placebo response.
  • For whichever condition auriculotherapy is used, there are treatments that are much more adequate.
  • Advocating auriculotherapy is therefore not in the best interest of the patient.
  • Arguably, it is unethical.
  • Definitely, it is not what the NHS should be doing.
The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic low back pain (LBP). It was designed as a single-blinded, crossover, randomized trial (RCT) and conducted at a university-based health system. Participants were adults, 21–65 years old, with non-specific LBP. Eligible participants (n=80) were randomized to two trial arms:
  • an immediate osteopathic manipulative therapy (OMT) intervention group,
  • a delayed OMT (waiting period) group.

The intervention consisted of three to four OMT sessions over 4–6 weeks, after which the participants switched (crossed-over) groups. The OMT techniques included a mandatory HVLA thrust technique to the lumbar spine region and any (or none) combination of the following four techniques: (i) soft tissue, (ii) muscle energy, (iii) myofascial, and (iv) articulatory. For patients who could not tolerate the HVLA treatment, a physician had to attempt this technique, minimally by attempting to place the patient in the position to perform this maneuver.

The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values.

Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively.
After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported.
The authors concluded that OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.The authors stared their abstract by stating that “the evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak … because it is generally based on low-quality studies.” This is undoubtedly true – but why then did they add one more low-quality study?, I ask myself. To mention just some of the most obvious flaws:

  • This study is far too small to allow conclusions about safety.
  • The trial compared OMT with no therapy; it is likely that the observed outcomes have little to do with OMT but are due to a placebo response.
  • The primary outcome measure showed no effect which essentially means that the study finding was that OMT is ineffective.

My conclusion:

a poor study conducted by wishful thinkers.

 

This review aimed to investigate and categorize the causes and consequences of ‘quack medicine’ in the healthcare.

A scoping review, using the 5 stages of Arksey and O’Malley’s framework, was conducted to retrieve and analyze the literature. International databases including the PubMed, Scopus, Embase and Web of Science and also national Iranian databases were searched to find peer reviewed published literature in English and Persian languages. Grey literature was also included. Meta-Synthesis was applied to analyze the findings through an inductive approach.

Out of 3794 initially identified studies, 30 were selected for this review. Based on the findings of this research, the causes of quackery in the health were divided into six categories:

  • political,
  • economic,
  • socio-cultural,
  • technical-organizational,
  • legal,
  • and psychological.

Additionally, the consequences of this issue were classified into three categories:

  • health,
  • economic,
  • and social.

Economic and social factors were found to have the most significant impact on the prevalence of quackery in the health sector. Legal and technical-organizational factors played a crucial role in facilitating fraudulent practices, resulting in severe health consequences.

The authors concluded that it is evident that governing bodies and health systems must prioritize addressing economic and social factors in combating quackery in the health sector. Special attention should be paid to the issue of cultural development and community education to strengthen the mechanisms that lead to the society access to standard affordable services. Efforts should be made also to improve the efficiency of legislation, implementation and evaluation systems to effectively tackle this issue.

The authors point out that, in the health systems, particularly those of developing countries, a phenomenon known as “Quack Medicine” has been a persistent problem, causing harm in various branches of health care services. They define quackery as unproven or fraudulent medical practices that have no scientifically plausible rationale behind them. Someone who does not have professional qualification, formal registration from a legitimated institution, or required knowledge of a particular branch of medicine but practices in the field of medicine, is a quack, according to the authors’ definition. Finally, they define quack medicine as a fraudulent practice of quacks claiming to possess the ability and experience to diagnose and treat diseases, and pretending that the medicine or treatment they provide are effective, generally for personal and financial gain.

The authors rightly point out that, in some countries, there may be a lack of willpower, determination and effort among political leaders to deal with and prevent fraud and charlatanism in various fields, especially in the health system. This can be due to conflict of interests, corruption network, or insufficient infrastructure and resources, such as financial capacity and human resources. In some cases, they stress, policy makers may choose to tolerate small levels of unproven medical practices if the cost of prosecuting and correcting the situation outweigh the financial benefits. This can lead to a cycle of continued fraud and a lack of effective interventions to address the issue. In many countries laws against quack medicine do exist. However, their effectiveness depends on proper and strict implementation. More efforts and measures must be taken to implement the existing laws. Inadequate enforcement of laws and approval of pseudo-medicine can result in people receiving improper care.

The authors recommend that the healthcare systems, prioritize addressing economic and sociocultural factors in order to effectively combat this issue. In developing solutions, attention must be given to cultural development and community education, and efforts should be made to strengthen mechanisms that provide access to affordable, standard healthcare services for all. Lastly, it is crucial to enhance the performance of systems responsible for legislation, implementation and evaluation of laws and regulations related to quack medicine.

I had the rare pleasure to give an interview for the ‘Frankfurter Allgemeine’. As it was, of course, in German, I took the liberty to translate it for my non-German speaking readers:

You have researched so-called alternative medicine over several decades, including homeopathy. What is your conclusion?

We are talking about far more than 400 methods – to draw one conclusion about all of them
is completely impossible. Except perhaps for this one: if something sounds too good to be true, it probably is.

Does this apply to homeopathy?

Highly diluted homeopathic remedies are popular because they have no side-effects. But there is also no effect. They are touted as a panacea. This is certainly not the case, on the contrary, they are
ineffective. And any therapy that is ineffective and promoted as a panacea is also dangerous.

How do you explain the fact that so many people swear by homeopathy?

There are several reasons for this. In Germany, homeopathy has an unbroken tradition, it was, for instance, promoted by the Nazis and later in the Federal Republic of Germany. It has a reputation for being gentle and effective. It might be gentle, but it is certainly not effective. It is also supported by lobby groups such as the manufacturers. And most people who use it don’t even understand what it actually is.

In any case, the placebo effect helps. What’s so bad about that??

Nothing at all, on the contrary: it is to be advocated. When we talk about placebo effects, we subsume many things under this umbrella that do not actually belong to it, such as the extensive, empathetic conversation that homeopaths often have with their patients. Besides, a common cold goes away whether you treat it or not. If you then use homeopathy, you can easily get the impression that it worked. Every good, empathetic doctor tries to maximize the placebo effect. To put it bluntly: you don’t need a placebo to generate a placebo effect. Patients also benefit from it when I give an effective remedy with empathy. In addition they benefit from the specific effect of my therapy, which should make up the lion’s share of the therapeutic response. If I withhold the most important thing I mistreat my patient.

But there are diseases for which there are no good remedies.

I often hear that argument. But there is practically always something we can do that at least
improves symptoms. Otherwise you should also say that instead of lying and recommending homeopathy – and thinking that, although there is nothing in it and it doesn’t work, but the patient, being an idiot, should take it nevertheless. It is unethical to use placebos as much as it is to use homeopathy.

Neurophysiologically, the placebo effect is becoming better and better understood.

The Italian neuroscientist Fabrizio Benedetti in particular has done very good work.  But he also warns that this does not justify the use of homeopathy, for example.

Are there any studies on whether the placebo effect of homeopathy with its esoteric superstructure is greater than that giving just a piece of sugar?

There are analyses of what makes a particularly effective placebo. From this, we can learn that effective therapies in evidence-based medicine must be applied with empathy and sufficient time in order to maximize the ever-present placebo effect. So-called alternative medicine often does this quite well, and we can learn something from it. But the reason is that it often has nothing else. Homeopaths are a serious danger because they see homeopathy as a panacea. If someone has homeopathically treated their cold “successfully” for years and then gets cancer, they might think of turning to homeopathy for their cancer. It sounds crazy, but many homeopaths do offer cancer treatments on the internet, for instance. That sends shivers down my spine.

How should doctors and pharmacists react to the demand for homeopathic remedies?

Pharmacists are not primarily salespeople, they are a medical profession – they have to adhere to ethical guidelines. In this respect, evidence-based information of their clients/patients is very important.

Thomas Benkert, President of the German Federal Chamber of Pharmacists, has stated that he would not be able to stop giving advice if he always had to explain the lack of proof of efficacy.

He should perhaps read up on what his ethical duty to patients is.

What if doctors or pharmacists themselves believe in the effect?

Belief should not play a role, but evidence should.

Are you pleased with Lauterbach’s plan to no longer reimburse homeopathy?

I think it’s a shame that he justifies it by saying it’s ineffective. That is true. But the justification should be that it’s esoteric nonsense and therefore ineffective – and dangerous.

In the end, the Bundestag will decide.

I think Lauterbach has a good chance because things have started to move. Medical associations in Germany have spoken out against the additional designation of homeopathy, for example, and overall the wind has changed considerably.

What is it like in the UK, where you live?

The UK healthcare system, NHS, said goodbye to reimbursement of homeopathy about five years ago, even before France. The pharmacists’ association has distanced itself very clearly from homeopathy. However, most pharmacists still sell the remedies and many continue to support them.

You have also had disputes with the current head of state, King Charles. How did that come about?

A few years ago, he commissioned a paper claiming that so-called alternative medicine could save the British health service a lot of money. I protested against this – Charles accused me of leaking it to The Times before it was published. My university launched an investigation, which eventually found me innocent, but it led to the demise of my department. That caused me to retire two years early.

So Charles managed to close down the only research unit in the world that conducted critical and systematic research into so-called alternative medicine. Most researchers in this field only want to confirm their own prejudices and not disprove hypotheses. This is a serious misunderstanding of how science works. If someone reports only positive results for their favorite therapy in all conditions, something is wrong.

Some people say that homeopathy should not be researched because nothing positive can come out of it anyway.

There are certainly some SCAMs that are so nonsensical that they should not be researched, as is currently the case with homeopathy. I put it this way because I have researched homeopathy myself and, from my point of view, the situation was not so crystal clear 30 years ago.

Would you say that you have approached the matter with a sufficiently open mind?

No one can be completely unbiased. That’s why it’s important to do science properly, then you minimize bias as much as possible. When I took up my position at Exeter in 1993, I was perhaps somewhat biased towards homeopathy in a positive sense, because I had learned and used it myself, as well as other alternative medicine methods. The fact that the results then turned out to be negative in the vast majority of cases initially depressed me. But I have to live with that.

Every researcher prefers positive results, also because they are easier to publish. It was clear to me that, if I had succeeded in proving homeopathy right, I wouldn’t get one Nobel Prize, but two. Who wouldn’t want that?

(The interview was conducted by Hinnerk Feldwisch-Drentrup.)

I am sure that I am not the only one who feels with or friend, regular contributor, and expert in uncritical thinking, Dana Ullman. His heart-warming defence of homeopathy entirely depends on the notion that homeopathy is nano-medicine. As Dana’s views are more and more discredited, the poor man understandably gets more and more desperate. This development has now gone so far that Dana seems on the brink of cracking up.

Who would not feel with him?

What we urgently need to save Dana’s sanity is a new concept that could be used to defend the indefensible.

In the nick of time, here comes a lone researcher of homeopathy from India. Amarnath Sen has just published his hypothesis that will surely save the endangered mental stage of our friend, Dana Ullman. Here is the abstract:

The apparent absence of drugs in ultra-diluted homeopathic medicines and contested clinical trial results plague homeopathy. In this paper, it is argued that other than drugs, homeopathic medicines contain proteins as components of microbial lysates (products of lysis or disintegration of microbial cells), given that ubiquitous microorganisms from the surrounding environment are unknowingly and unavoidably incorporated into the homeopathic medicines during their preparation and are killed and lysed in ethanol/water drug vehicle forming immunomodulatory microbial lysates during ‘potentization’ (dilution and vigorous shaking) of the medicines. The drugs present in the homeopathic medicines bind to the proteins, which are the major ingredients of the microbial lysates. The drug/protein interaction modulates the conformations and in effect, the immunogenicity of the proteins (designated as modulated proteins). In ultra-diluted medicines even in the absence of drugs, unmodulated proteins are modulated through interactions with allosterically coupled modulated proteins (protein-protein interaction). The modulated proteins of characteristic immunogenicity present in the homeopathic medicines mediate antigen-specific mucosal (sublingual) immunotherapy like vaccine therapy via ‘similia principle’. In addition, immunomodulatory microbial lysates present in the homeopathic medicines mediate non-specific immunotherapy and also provide adjuvants for antigen-specific immunotherapy. The proposed hypothesis without invoking any controversial concept can explain the basic ‘laws’ of homeopathy. Incidentally, immunomodulatory activities of homeopathic medicines reported by different workers support the hypothesis. As immunotherapy in homeopathy is accidental and hence, in crude form, clinical trial results may occasionally show inconsistencies. However, probing and refining homeopathy from the perspective of immunotherapy may bring forth a simple, reliable and affordable immunotherapy for various diseases.

Convinced?

Me neither!

The concept is clearly as bonkers as all the others trying to explain homeopathy. Yet, I am optimistic that it might save our friend Dana Ullman. After all, it is not more silly than the notion that homeopathy is nano-medicine – and remeber: even an US judge certified Dana:

The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted.

So, there is hope!

Amarnath Sen and is ‘concept’ might just do the trick and restore Dana’s state of mind.

Craniosacral therapy (CST) is a widely taught component of osteopathic medical education. It is included in the standard curriculum of osteopathic medical schools, despite controversy surrounding its use. This paper seeks to systematically review randomized clinical trials (RCTs) assessing the clinical effectiveness of CST compared to standard care, sham treatment, or no treatment in adults and children.

A search of Embase, PubMed, and Scopus was conducted on 10/29/2023 with no restriction placed on the date of publication. Additionally, a Google Scholar search was conducted to capture grey literature. Backward citation searching was also implemented. All RCTs employing CST for any clinical outcome were included. Studies not available in English as well as any studies that did not report adequate data for inclusion in a meta-analysis were excluded. Multiple reviewers were used to assess for inclusions, disagreements were settled by consensus. PRISMA guidelines were followed in the reporting of this meta-analysis. Cochrane’s Risk of Bias 2 tool was used to assess for risk of bias. All data were extracted by multiple independent observers. Effect sizes were calculated using a Hedge’s G value (standardized mean difference) and aggregated using random effects models.

The primary study outcome was the effectiveness of CST for selected outcomes as applied to non-healthy adults or children and measured by standardized mean difference effect size. Twenty-four RCTs were included in the final meta-analysis with a total of 1,613 participants. When results were analyzed by primary outcome, no significant effects were found. When secondary outcomes were included, results showed that only Neonate health, structure (g = 0.66, 95% CI [0.30; 1.02], Prediction Interval [-0.73; 2.05]) and Pain, chronic somatic (g = 0.34, 95% CI [0.18; 0.50], Prediction Interval [-0.41; 1.09]) showed statistically significant effects. However, wide prediction intervals and high bias limit the real-world implications of this finding.

The authors concluded that CST did not demonstrate broad significance in this meta-analysis, suggesting limited usefulness in patient care for a wide range of indications.

To this, one should perhaps add that CST is one of those forms of so-called alternative medicine (SCAM) that is utterly implausible; there is not conceivable mechanism by which CST might work other than a placebo effects. Therefore, the finding that it is ineffective (positive effects on secondary outcomes are most likely due to residual bias and possibly fraud) is hardly surprising. The most sensible conclusion, in my view, is that CST too ridiculous to merit further research because that would, in effect, be an unethical waste of resources.

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