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

Ricardo Ghelman, Ivete Y Akiyama, Valeria T de Souza, Jussara Falcão, Vera Orgolini, Jorge K Hosomi, Abrahão A J Quadros, Acary S B Oliveira, Ricardo Ghelman, Ivete Y Akiyama, Valeria T de Souza, Jussara Falcão, Vera Orgolini, Jorge K Hosomi, Abrahão A J Quadros, Acary S B Oliveira

Abstract

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.

Keywords: anthroposophic medicine; motor system; neurodegenerative diseases; pain; postpolio syndrome.

Conflict of interest statement

None declared.

© 2020 The Authors. Brain and Behavior published by Wiley Periodicals, Inc.

Figures

FIGURE 1
FIGURE 1
Trial diagram
FIGURE 2
FIGURE 2
Pain evolution by VAS in the four groups during the 12 weeks of intervention

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