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Treatment effects of traditional Chinese medicines Suoquan Pill and Wuling Powder on clozapine-induced hypersalivation in patients with schizophrenia: study protocol of a randomized, placebo-controlled trial.

Author(s): Hung CC, Fu PK, Wang HY, Chan CH, Lan TH.

Affiliation(s): Psychiatry Department, Taichung Veterans General Hospital, Taichung, Taiwan, China.

Publication date & source: 2011, Zhong Xi Yi Jie He Xue Bao. , 9(5):495-502

BACKGROUND: It is reported that 30% to 80% schizophrenia patients suffered from hypersalivation when taking clozapine. Some investigations of the use of formulas of traditional Chinese medicine (TCM) to treat clozapine-induced hypersalivation suggested their potential treatment effects. In these formulas, Suoquan Pill (SQP) and Wuling Powder (WLP) were suggested to have therapeutic effects in improving clozapine-induced hypersalivation. METHODS AND DESIGN: A prospective, double-blind, randomized, placebo-controlled study will be conducted to test the therapeutic effects of SQP and WLP in relieving hypersalivation in patients taking clozapine. A total of 45 patients will be enrolled into this study with 15 in each treatment group. Patients will receive medication according to their assigned group. Either SQP 10 g per oral dose twice daily, WLP 10 g per oral dose twice daily or placebo powder 10 g per oral dose twice daily will be prescribed to the patients for 8 weeks. The Drooling Severity Scale, Nocturnal Hypersalivation Rating Scale and sialoscintigraphy will be used as the primary outcome measures; the Clinical Global Impressions Severity, the Positive and Negative Syndrome Scale, the Abnormal Involuntary Movement Scale, the Simpson-Angus Scale and the TCM constitutional scale will be used as the secondary outcome measures DISCUSSION: It is hypothesized that SQP and WLP will have a beneficial effect in controlling clozapine-induced hypersalivation symptoms. It may also improve the life quality of psychotic patients by improving their mental status. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01045720).

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