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.
RCT Entities:
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.
Authors: H J Rogier Hoenders; Agna A Bartels-Velthuis; Nina K Vollbehr; Richard Bruggeman; Henderikus Knegtering; Joop T V M de Jong Journal: J Nerv Ment Dis Date: 2018-02 Impact factor: 2.254