Date Published: June 29, 2018
Publisher: Public Library of Science
Author(s): Pierre Delion, Julien Labreuche, Dominique Deplanque, David Cohen, Alain Duhamel, Céline Lallié, Maud Ravary, Jean-Louis Goeb, François Medjkane, Jean Xavier, Andrea Martinuzzi.
The use of therapeutic body wraps (TBW) has been reported in small series or case reports, but has become controversial.
This is a feasibility, multicentre, randomized, controlled, open-label trial with blinded outcome assessment (PROBE design).
Children with autism and severe-injurious behaviours (SIB) were enrolled from 13 specialized clinics.
Dry-sheet TBW (DRY group) vs. wet-sheet TBW (WET group).
3-month change in the Aberrant Behaviour Checklist irritability score (ABC-irritability) within per-protocol (PP) sample.
From January 2008 to January 2015, we recruited 48 children (age range: 5.9 to 9.9 years, 78.1% male). Seven patients (4 in the DRY group, 3 in the WET group) were dropped from the study early and were excluded from PP analysis. At endpoint, ABC-irritability significantly improved in both groups (means (standard deviation) = -11.15 (8.05) in the DRY group and -10.57 (9.29) in the WET group), as did the other ABC scores and the Children Autism Rating scale score. However, there was no significant difference between groups. All but 5 patients were rated as much or very much improved. A repeated-measures analysis confirmed the significant improvement in ABC-irritability scores according to time (p < .0001), with no significant difference between the two groups (group effect: p = .55; interaction time x group: p = .27). Pooling both groups together, the mean 3-month change from baseline in ABC-irritability score was -10.90 (effect size = 1.59, p < .0001). We found that feasibility was overall satisfactory with a slow recruitment rate and a rather good attrition rate. TBW was a safe complementary therapy in this population. There was no difference between wet and dry TBW at 3 months, and ABC-irritability significantly decreased with both wet and dry sheet TBW. To assess whether TBW may constitute an alternative to medication or behavioural intervention for treating SIB in ASD patients, a larger randomized comparative trial (e.g. TBW vs. antipsychotics) is warranted. ClinicalTrials.gov NCT03164746.
Treatment of severe auto/hetero aggressive behaviours in children and adolescents with autism spectrum disorder (ASD) is a complex issue. It is useful to treat symptoms as well as underlying psychiatric conditions or behavioural dysfunction. Symptomatic treatments include behavioural and family interventions and psychotropic medications, mostly sedative drugs, mood stabilizers and antipsychotics. To date, only a few atypical antipsychotics have been approved for minors to treat irritability and behavioural impairment associated with intellectual disability and/or pervasive developmental disorder, and such drugs have numerous adverse effects . In some resistant cases, clozapine , intensive behavioural intervention , electro-convulsive therapy (ECT) [4–5] or inpatient stays with a multidisciplinary approach  have been recommended, even in children and adolescents. The search for other therapeutic options is urgent.
We investigated the use of TBW in children with SIB associated with ASD in the context of a feasibility study. We found that feasibility was overall satisfactory with a slow recruitment rate and a rather good attrition rate. Both wet and dry sheet TBWs were overall well tolerated. Regarding clinical response, we did not find any differences between wet and dry TBW at 3 months. However, ABC-irritability scores significantly decreased, and TBW provided with both wet and dry sheets had a significant similar effect size. Therefore, given the absence of significant adverse events, TBW should be investigated to ensure its efficacy. To assess whether TBW may constitute an alternative to medication for treating SIB in ASD patients, a larger randomized comparative trial (TBW vs. antipsychotics) is warranted. The recruitment of naïve patients would be more appropriate to adequately assess the efficacy of TBW versus medication.