Abstract
BackgroundAutism spectrum disorder (ASD) is characterized by continuous impairment in communication and social interaction and by limited and repetitive behaviors, interests, or activities. Behavioral, educational, and pharmaceutical interventions have been shown to reduce behavioral disabilities, improve verbal/non-verbal communication, and help patients acquire self-reliance skills. However, there has been a lack of systematic verification and consensus regarding the treatment of the core symptoms of ASD because of its unclear etiology. Ukgansangajinpibanha (UGSJB), a legitimately prescribed herbal medicine for nervousness, insomnia, night crying, and malnutrition in South Korea and Japan, has been used for angry, sensitive, nervous, and unsettled children with ASD.Methods/designThis trial is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial. The 4- to 6-year-old children with ASD will be randomly assigned to following groups:A UGSJB granule with acupuncture, twice daily (n = 120)A placebo group with acupuncture, twice daily (n = 120).The following outcome measures will be used: behavior by the Childhood Autism Rating Scale, Autism Behavior Checklist, and Aberrant Behavior Checklist; social maturity by the Social Maturity Scale; quality of life by the Child Health Questionnaire and EuroQoL Five-dimension Five-level Youth; and parental stress by the Parenting Stress Index at baseline and at 6, 12, and 24 weeks after the beginning of treatment.In addition, to evaluate safety, we will investigate the adverse reactions that may be caused by UGSJB granule. Finally, we will make an economic evaluation of UGSJB for the treatment of ASD.DiscussionWe prepared a well-designed clinical trial to investigate the safety and effectiveness of UGSJB on ASD symptoms compared with placebo treatment. The results from this study will provide clinical evidence on the safety, effectiveness, and economic value of UGSJB combined with acupuncture in children with ASD.Trial registrationClinical Research Information Service: KCT0003007 (registered on April 5, 2018)
Highlights
Autism spectrum disorder (ASD) is characterized by continuous impairment in communication and social interaction and by limited and repetitive behaviors, interests, or activities
Acupuncture, a treatment supported by the National Health Service in South Korea, will be provided to every participant for an economic evaluation
Herbal medicines which have been shown to be effective for ASD in Randomized controlled trial (RCT) include Jiawei Wendan decoction, modified Yinhuo decoction, and supplemented Lizhong decoction [34]
Summary
Herbal medicines which have been shown to be effective for ASD in RCTs include Jiawei Wendan decoction, modified Yinhuo decoction, and supplemented Lizhong decoction [34]. Our study will be the first prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group clinical trial assessing the safety, effectiveness, and economics of an herbal medicine combined to acupuncture in the treatment of ASD. We decided to verify the effects of herbal medicine added to acupuncture while maintaining existing treatments throughout the clinical trial, which is similar to the management protocols of clinical Korean medicine. UGSJB has some neuronal effects and was reported to improve symptoms of ASD in a case report [41] These effects have not been demonstrated in a clinical trial. Our RCT will provide results on the safety, effectiveness, and economic value of UGSJB for ASD, and treatment options with higher evidence may be provided to children with ASD. Approximate date when recruitment will be completed: Dec. 31, 2020
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