“缩泉丸和五苓散治疗氯氮平引起的精神分裂症患者唾液分泌过多的临床疗效评估”研究方案

doi:10.3736/jcim20110506

Abstract

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.

Key words: clozapine, schizophrenia, sialorrhea, therapeutic methods,traditional Chinese medicine, Suoquan Pill, Wuling Powder, study protocol

Chia-Chun Hung, Pin-Kuei Fu, Hsyn-Yi Wang, Chin-Hong Chan, Tsuo-Hung Lan. 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. Journal of Chinese Integrative Medicine, 2011, 9(5): 495-502.

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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

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