A Study of Adverse Events that Occurred after Taking Herbal Medicine - Focused on Children and Adolescents

Lee, Ji Hong; Sun, Yu; Lee, Seung Yeon

doi:10.7778/jpkm.2014.28.3.001

Cited by 1 publication

(1 citation statement)

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“…The AEs of acupuncture may include local inflammation, discomfort, sputum hemorrhage and bruising, pruritus, fever, and other acupuncture-related risks [24]. The AEs of herbal medicine may include indigestion, diarrhea, and urticaria [25]. To evaluate the safety of herbal medicine, blood and urine tests will be conducted for all participants at baseline and 24 weeks.…”

Section: Adverse Eventsmentioning

confidence: 99%

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

Lee

Yun

et al. 2020

Trials

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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.

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Section: Adverse Eventsmentioning

confidence: 99%