Effect of Warm-Supplementing Kidney Yang (WSKY) added to risperidone on quality of life in patients with schizophrenia: a randomized controlled trial.

OBJECTIVE To evaluate the quality of life, efficacy and safety of Warm-Supplementing Kidney Yang (WSKY) added to risperidone in patients with schizophrenia. DESIGN A randomized controlled trial. SETTING The outpatient and inpatient departments of three hospitals. SUBJECTS One hundred and twenty patients with clinically diagnosed schizophrenia with predominantly negative symptoms were included in the study. INTERVENTION All 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 MEASURE The 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. RESULTS The 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. CONCLUSIONS The results suggest that WSKY added to risperidone significantly improved the quality of life, social function, depression symptom compared with placebo added to risperidone.