Fuyong Jiao1, Xiaoyan Zhang2, Xipin Zhang2, Jing Wang2. 1. Department of Pediatrics, Shaanxi Provincial People's Hospital (3rd Affiliated Hospital of Xi'an, Jiaotong University), Xi'an 710068, China. Electronic address: jiaofy@yeah.net. 2. Department of Pediatrics, Shaanxi Provincial People's Hospital (3rd Affiliated Hospital of Xi'an, Jiaotong University), Xi'an 710068, China.
Abstract
OBJECTIVE: To evaluate the therapeutic effectiveness and safety of clonidine adhesive patch in treating Tourette syndrome (TS). METHODS:From July 2010 to July 2014,a total of 261 children, who met the Chinese Classification of Mental Disorders (third edition) diagnostic criteria for TS, aged 5-12 years, were referred to the department of Pediatrics, Shaanxi Provincial People's Hospital. The patients were divided randomly into a treatment group (clonidine adhesive patch, n = 128) and a control group (haloperidol, n = 116), 17cases dropped out. The clinical effectiveness was assessed by the Yale Global Tic Severity Scale (YGTSS) at the end of fourth week. The short-term effectiveness and adverse reaction to the treatment were assessed at the end of treatment. RESULTS: The YGTSS score in both groups decreased after 4 weeks of treatment, but the clonidine adhesive patch group showed a higher reduction in the overall tic symptom scores (40.05 ± 3.44%) than that of the control group (17.88 ± 4.40%; P < 0.05). In the clonidine adhesive patch group, the effectiveness was 81.3% (effective in 104 patients), while it was 66.4% in the control group (effective in 77 patients). The overall effectiveness rate showed no statistical significance between the two groups (p > 0.05). There were no severe adverse events in both groups, but mild side effects (decrease of blood pressure and dizziness) were observed in 3 patients in the clonidine adhesive patch group. 2 had mild cervical muscle tension and 4 had mild drowsiness and fatigue in the control group. CONCLUSION: In the treatment of TS in children and adolescents, the clonidine adhesive patch is superior to the standard treatment with haloperidol with a safer and better-tolerated profile.
RCT Entities:
OBJECTIVE: To evaluate the therapeutic effectiveness and safety of clonidine adhesive patch in treating Tourette syndrome (TS). METHODS: From July 2010 to July 2014,a total of 261 children, who met the Chinese Classification of Mental Disorders (third edition) diagnostic criteria for TS, aged 5-12 years, were referred to the department of Pediatrics, Shaanxi Provincial People's Hospital. The patients were divided randomly into a treatment group (clonidine adhesive patch, n = 128) and a control group (haloperidol, n = 116), 17cases dropped out. The clinical effectiveness was assessed by the Yale Global Tic Severity Scale (YGTSS) at the end of fourth week. The short-term effectiveness and adverse reaction to the treatment were assessed at the end of treatment. RESULTS: The YGTSS score in both groups decreased after 4 weeks of treatment, but the clonidine adhesive patch group showed a higher reduction in the overall tic symptom scores (40.05 ± 3.44%) than that of the control group (17.88 ± 4.40%; P < 0.05). In the clonidine adhesive patch group, the effectiveness was 81.3% (effective in 104 patients), while it was 66.4% in the control group (effective in 77 patients). The overall effectiveness rate showed no statistical significance between the two groups (p > 0.05). There were no severe adverse events in both groups, but mild side effects (decrease of blood pressure and dizziness) were observed in 3 patients in the clonidine adhesive patch group. 2 had mild cervical muscle tension and 4 had mild drowsiness and fatigue in the control group. CONCLUSION: In the treatment of TS in children and adolescents, the clonidine adhesive patch is superior to the standard treatment with haloperidol with a safer and better-tolerated profile.
Authors: Alexander J Sandweiss; Christopher M Morrison; Anne Spichler; John Rozich Journal: BMC Pharmacol Toxicol Date: 2018-02-13 Impact factor: 2.483