Integrative medicine rehabilitation for children with cerebral palsy: a study protocol for a multicenter pragmatic randomized controlled trial.

BACKGROUND: Traditional Korean medicine (TKM) has been employed for the treatment of children with cerebral palsy in Korea; however, the addition of TKM to usual rehabilitation (UR) treatment is hindered by insufficient evidence of clinical improvement with TKM in patients with cerebral palsy. In this study, we will evaluate the effectiveness and safety of integrative medicine rehabilitation (IMR) for cerebral palsy through a randomized controlled clinical study. METHODS: Eighty children (2-6 years old) diagnosed with cerebral palsy will be recruited and randomly divided into groups A and B. Patients in group A will receive IMR with UR, while those in group B will receive only UR during weeks 1-12 of the study. IMR includes acupuncture treatment (head and limb acupuncture) three times a week and the administration of herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts) twice a day in parallel with UR. Evaluations will be conducted at the beginning of the study and at 12 and 24 weeks (follow-up). The primary outcome is the Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events. DISCUSSION: This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea. The results will help to demonstrate if IMR is an effective therapeutic approach for cerebral palsy. TRIAL REGISTRATION: Ministry of Food and Drug Safety 31361 ( http://www.mfds.go.kr ). Registered on 29 June 2017. Clinical Research Information Service KCT0002620 ( https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819 ). Registered on 29 December 2017.

A cross-sectional survey of clinical factors that influence the use of traditional Korean medicine among children with cerebral palsy.

BACKGROUND: Traditional Korean medicine (TKM) is widely used to treat children with cerebral palsy (CP) in Korea; however, studies investigating factors that influence the use of TKM are scarce. Thus, we investigated the clinical factors that might influence the use of TKM. METHODS: A population-based, cross-sectional, multicenter survey was performed from August 2014 to May 2016. The history of TKM use, type and severity of CP, current treatment characteristics, presence of accompanying disabilities or other health problems not directly related to CP, and monthly cost for the treatment of CP were surveyed. RESULTS: In total, 182 children were recruited, and 78 children (42.9%) had used TKM. Among these 78 children, 50 (64.1% of the TKM-use group) had used both acupuncture and herbal medication, 15 (19.2%) had used acupuncture only, and 13 (16.7%) had used herbal medication only. Children with non-typical CP, accompanying disabilities and general health problems tended to use TKM. The monthly cost of treatment for CP was significantly higher in the TKM-use group than that in the no-TKM-use group, suggesting that economically disadvantaged children may have difficulty in accessing TKM. Dietary supplements, conventional pharmacological treatments, and rehabilitation therapies did not affect TKM use. CONCLUSION: Children with non-typical symptoms or those with poor overall health status are likely to use TKM. Additionally, TKM use leads to increased treatment costs. Studies investigating the motivation for starting or ceasing TKM therapy, socioeconomic factors and the attitude of parents towards complementary and alternative medicine should be performed.

Herbal Medicine Treatment for Children with Autism Spectrum Disorder: A Systematic Review.

OBJECTIVE: To summarize and evaluate the efficacy and safety of herbal medicines used for the treatment of autism spectrum disorder (ASD) in children. METHODS: Thirteen electronic databases were searched from their inception to November 2016. Randomized controlled trials (RCTs) that assessed the efficacy of herbal medicines alone or in combination with other Traditional Chinese Medicine treatments for ASD in children were included. The Cochrane Risk of Bias Tool was used and other data analyses were performed using RevMan (Version 5.3). RESULTS: Ten RCTs involving 567 patients with ASD were included for qualitative synthesis. In conjunction with conventional therapy, herbal medicines significantly improved the Childhood Autism Rating Scale (CARS) score, but the results of effects on total effective rate (TER) were different between the included studies. The use of herbal medicines with integrative therapy improved the CARS score and TER. In the studies that documented adverse events, no serious events were associated with herbal medicines. CONCLUSIONS: The efficacy of herbal medicines for the treatment of ASD appears to be encouraging but was inconclusive owing to low methodological quality, herbal medicine diversity, and small sample size of the examined studies.

Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy.

BACKGROUND: Cerebral palsy leads to many complications as well as delayed motor development, and early intensive rehabilitation in infancy, which is based on the theory of brain plasticity, is emphasized. In addition to conventional treatment, including physical, occupational, or speech-language therapies, children also have a demand for traditional Korean medicine interventions such as acupuncture or herbal medicine; however, a lack of evidence has made traditional Korean medicine difficult to implement in practice. We planned a multicentre, prospective, observational study to assess the effectiveness, safety and cost-effectiveness of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy. METHODS/DESIGN: Three hundred children with cerebral palsy aged 6 to 78 months will be recruited from six institutions. Data from each child are collected every month for a one-year period, during which time treatment might be changed or discontinued. A qualified investigator visits the sites to measure effectiveness variables, including Gross Motor Function Measure and Paediatric Evaluation of Disability Inventory. Adverse events and cost-effectiveness variables are collected using surveys conducted at baseline, mid-study, and end of study, as well as monthly tracking surveys. In the analyses, participants will be classified into two groups: group A children will be the conventional treatment group with physical, occupational, speech-language or other conventional rehabilitation therapies, whereas group B children will be the combination treatment group with traditional Korean medicine interventions, that is, herbal medicine, chuna, moxibustion and acupuncture, in addition to conventional treatment. DISCUSSION: Only a few clinical case reports have evaluated the effectiveness and safety of traditional Korean medicine; therefore, more data are required to provide optimal information to children with cerebral palsy and their guardians. We hypothesized that traditional Korean medicine combination treatment for children with cerebral palsy would have benefits compared with conventional therapy alone. The findings of this study might provide informative data for conducting economic evaluations and developing clinical research on combination treatment for cerebral palsy in South Korea. TRIAL REGISTRATION: NCT02223741.