• Zhen-hua Chen, Gao-hua Wang, Xiao-ping Wang, Yun-xiang Huo, Ming-hua Yang, Li Li, and Hong-bing Mei.
• Psychiatry Department of Renmin Hospital of Wuhan University, Wuhan 430060, China.
• Clin Rehabil. 2009 Nov 1; 23 (11): 963-72.

ObjectiveTo evaluate the quality of life, efficacy and safety of Warm-Supplementing Kidney Yang (WSKY) added to risperidone in patients with schizophrenia.DesignA randomized controlled trial.SettingThe outpatient and inpatient departments of three hospitals.SubjectsOne hundred and twenty patients with clinically diagnosed schizophrenia with predominantly negative symptoms were included in the study.InterventionAll 120 patients were randomly assigned to double-blind treatment with WSKY group (n = 60) or placebo group (n = 60) added to risperidone for eight weeks.Main MeasureThe efficacy measures included the World Health Organization Quality of Life Scale (WHOQOL-100), the Positive and Negative Syndrome Scale (PANSS), the Social Disability Screening Schedule and the Hamilton Rating Scale for Depression. Safety and tolerability were assessed throughout the trial.ResultsThe scores of quality of life in the WSKY group showed statistically significant improvement at the end-point of treatment compared with those in the placebo group (WSKY, increasing 40.5 (29.4); placebo, increasing 14.4 (27.1); F =24.900, P<0.001), while the scores of social function and depression symptoms also showed statistically significant improvement. The response rates for the WHOQOL-100 total scores were 50.0% for the WSKY group versus 31.7% for placebo group (chi( 2) = 4.172, P=0.041). There were no significant differences in the safety/tolerability measures between the WSKY group and the placebo group during treatment.ConclusionsThe results suggest that WSKY added to risperidone significantly improved the quality of life, social function, depression symptom compared with placebo added to risperidone.

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