..an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome, 2020, Ghelman et al

[Andy]

Full title: A twelve‐week, four‐arm, randomized, double‐blind, placebo‐controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome

Introduction

Chronic pain and fatigue are the main symptoms of postpoliomyelitis syndrome (PPS). This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for chronic pain in PPS outpatients.

Methods
A twelve‐week, four‐arm, randomized, double‐blind, placebo‐controlled, phase 2 prospective clinical trial was designed to compare four groups (n = 48): groups A and B received daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG, respectively. The pain symptoms were evaluated through a visual analogue scale (VAS), the McGill questionnaire, and thermography. Quality of life and resilience were evaluated by the WHOQOL‐BREF and Antonovsky sense of coherence questionnaires applied at baseline and after the interventions.

Results
No related adverse events occurred, and 10% of the patients reports dysphagia improvement. In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035). However, following the week‐to‐week evolution of pain with the concomitant use of the ETG, this significant pain reduction occurred earlier from the 4th week and continued to decrease (p = .016, d = 1.369). In the group that received the complete multimodal treatment, the greatest significant benefit in increasing quality of life occurred in the physical domain and elevation in resilience with an emphasis on meaning and comprehension domains.

Conclusions
The anthroposophic multimodal treatment group presented both safety and efficacy as an analgesic in the groups that received the nonpharmacological therapies, much earlier when associated with the ETG. The multimodal approach corresponded to the pattern of better efficacy for both pain reduction and improvement in quality of life and resilience.

Open access, https://onlinelibrary.wiley.com/doi/full/10.1002/brb3.1590

 

[Snow Leopard]

I'd like to tell these authors that "double blind" doesn't mean what you think it means.

The only interesting bit of the study, the transcutaneous thermography:

The thermographic examinations showed a pattern of alterations that was observed in almost all of the patients. These alterations were maintained before and after the interventions and practically characterized the thermal signature of PPS.

The main findings were a pattern of thermal asymmetry between the upper and lower regions of the body, which showed significant hypothermia in the affected limb and hyperthermal signals of osteoarthritis and sacroiliitis of the hip. In addition to these mechanical components that were linked to an imbalance of the musculoskeletal structure, we found systemic signs such as hyper‐radiation in palpebral region due to venous congestion, hyper‐radiation in the abdominal area, and also in the cervicothoracic regions including interscapular area of trapezius, rhomboid, and supraclavicular muscles, which characterized the signal of mantle.

I still wonder whether the temperature dysregulation is due to venous dysregulation due to nerve damage to the smooth muscles.

 

[Hutan]

The main findings were a pattern of thermal asymmetry between the upper and lower regions of the body, which showed significant hypothermia in the affected limb and hyperthermal signals of osteoarthritis and sacroiliitis of the hip. In addition to these mechanical components that were linked to an imbalance of the musculoskeletal structure

I still wonder whether the temperature dysregulation is due to venous dysregulation due to nerve damage to the smooth muscles.

Presumably the limb affected by polio is wasted, that is, it doesn't have the musculature of a healthy limb. I would have thought that alone might account for 'hypothermia' compared to a healthy limb. The smaller limb would have a higher surface to volume ratio. Also, if there are fewer muscle cells doing less work, there will be less metabolic activity and lower respiration. But, as you say, nerve damage could cause all sorts of issues, including gut dysfunction.

I'd like to tell these authors that "double blind" doesn't mean what you think it means.

Yes, I think it would have been obvious to everyone whether they were receiving the gel-only treatment or the gel + range of therapies including

• art therapy (water colour painting);

AAT: The technique used was watercolor painting, according to the guidelines of the Brazilian, Dutch, and Swiss Association of Art Therapists. These sensorimotor exercises were performed with the seated patients, who applied nontoxic inks on A3 paper using a No. 20 brush. The first and last two sessions were used to evaluate the condition of each participant in terms of a comparative constitutional diagnosis through the use of a free painting exercise. The therapeutic activity was directed to the color transition using two primary colors to obtain the secondary color (green, violet, and orange).

• a therapy that sounds like a form of speech therapy

conducted by licensed speech therapists and was performed in two stages, including body and oral exercises of reflex‐vegetative functions. Each stage had its own sequence of exercises, which recapitulated the neuromotor development of infants.

• other physical therapy - warm foot baths, massage, bandaging

Once the massage was finished, each patient, in the dorsal decubitus position, was wrapped with the dry flannel and wool sheets, with the sheets covering the body from the neck down.

 

[Hutan]

The gel with active ingredients had the following:

The ETG vials had a final concentration of 10% of the active ingredient. The potencies and concentrations that were used followed the safety standards of the German and Brazilian homeopathic and anthroposophic pharmacopoeias, which are regulated by the National Agency of Sanitary Vigilance (ANVISA). The industrialized ETG was developed and dispensed by the Weleda Laboratory of Brazil and obeyed the blinding rules. The active ingredients of the 10% ETG were Rhus toxicodendrum D4 (1.66%), Arnica montanaD3 (1.66%), Apis mellifica/ Atropa belladonna D3 (0.83%/0.83%), Mandragora officinarum D3 (1.66%), Aconitum napellus D4 (1.66%), and Hypericum perforatum D3 (1.66%).

There was no difference in pain outcome for the gel with active ingredients + no extra treatments (ETG) compared to the gel without active ingredients + no extra treatments (PTG):

In the groups without therapies, there was a reduction in the amount of pain of approximately 20.7% in the ETG group (p = .268) and approximately 24.8% in the PTG group (p = .317), but these reductions were not statistically significant

 

[Cheshire]

anthroposophic multimodal treatment

Either the threatment is efficient or not. No need to mention that it is an "anthroposophic" remedy unless you want to promote this cult.

 

[Hutan]

There's a lot more that could be said about this study, but I'll just summarise a few more points:

They discarded the data of participants with no end data or who didn't attend enough of the therapy sessions. And then they discarded the data from additional participants in order to reduce the sample size evenly, from 12 per treatment arm to 10 per treatment arm. They don't say how they chose the participants whose data was discarded just to create the even sample sizes.

They probably claim the study is blinded, but it was only blinded for the gel. The physical therapy arms showed a substantial reduction in pain compared to baselines, but it's impossible to know how much of that was a placebo effect (e.g. wanting to please the therapists, wanting to justify the effort made) and a short term effect following warm water bath of limb, massage and rest with compression.

They claim that the combination of physical therapy and the gel with active ingredients (the green line) resulted in a faster reduction in pain than the physical therapy with placebo gel (blue line). I think that might be termed 'clutching at straws'.

 

[rvallee]

Uh uh. Yeah... pass.

Anthroposophic medicine (or anthroposophical medicine) is a form of alternative medicine.[1] Devised in the 1920s by Rudolf Steiner (1861–1925) in conjunction with Ita Wegman (1876–1943), anthroposophical medicine is based on occult notions and draws on Steiner's spiritual philosophy, which he called anthroposophy. Practitioners employ a variety of treatment techniques based upon anthroposophic precepts, including massage, exercise, counselling, and substances.[2]

Many drug preparations used in anthroposophic medicine are ultra-diluted substances, similar to those used in homeopathy. Homeopathic remedies are not medically effective and are generally considered harmless, except when used as a substitute for a scientifically proven and effective cure.[3] In certain European countries, people with cancer are sometimes prescribed remedies made from specially harvested mistletoe, but research has found no convincing evidence of clinical benefit.[4][5] Some anthroposophic doctors oppose childhood vaccination, and this has led to preventable outbreaks of disease.[6]

Anthroposophic medicine departs from fundamental biological principles in several respects. For example, Steiner said that the heart does not pump blood but that blood propels itself along.[7] Anthroposophic medicine also proposes that patients' past lives may influence their illness[8] and that the course of an illness is subject to karmic destiny.[9] Professor of complementary medicine Edzard Ernst and other physicians and scientists including Simon Singh and David Gorski have characterized anthroposophic medicine as pseudoscientific quackery[10][11] with no basis in reason or logic.[12][13][14][15]

Barely distinguishable from BPS, to be honest, just with a few extra steps, or maybe different steps is more appropriate.