Jianqiao Zhong1, Dehai Xian, Yang Xu, Junxiang Liu. 1. Department of Dermatology, Affiliated Hospital of Luzhou Medical College, Tai Ping Jie 25, Luzhou, China. zjq7632@hotmail.com
Abstract
OBJECTIVES: The study objectives were to evaluate the efficacy and safety of Tripterygium hypoglaucum Hutch (THH) in adult with severe chronic urticaria (CU) by performing a randomized, double-blind, placebo-controlled clinical trial. METHODS:Seventy-eight (78) adult patients with severe CU, 21-58 years of age, responding poorly to antihistamines alone, were randomly divided into two groups: the therapeutic group with THH 3 tablets 3 times daily (n = 40) and the control group with placebo 3 tablets 3 times daily (n = 38). Meanwhile, all patients jointly received cetirizine hydrochloride (HCl) 10 mg once daily throughout the study period. The efficacy of THH was assessed by the scoring system of 4-point scale and the subject's global assessment of relief. RESULTS:Sixty-nine (69) of 78 patients (37 in the therapeutic group, 32 in the control group) completed the study. By the end of the fourth week, there was a 67% improvement of total effective rate (TER) with THH compared with a 28% improvement with placebo by per-protocol analysis (χ(2) = 10.68, p = 0.0011), while by intention-to-treat analysis, 63% and 24% improvements of TER were respectively observed in the therapeutic group and the control group (χ(2) = 11.36, p = 0.001). THH with cetirizine showed statistical superiority to placebo with cetirizine during each study week for changes in total severity scores (p ≤ 0.001). In weekly analyses, THH was also statistically superior to placebo in reducing the mean pruritus scores during each study week (p ≤ 0.005). CONCLUSIONS: This study shows that the therapeutic effect of THH with cetirizine is predominant over that of cetirizine alone in adult CU. THH with cetirizine may play an important role in the therapy of CU and be a useful treatment for CU.
RCT Entities:
OBJECTIVES: The study objectives were to evaluate the efficacy and safety of Tripterygium hypoglaucum Hutch (THH) in adult with severe chronic urticaria (CU) by performing a randomized, double-blind, placebo-controlled clinical trial. METHODS: Seventy-eight (78) adult patients with severe CU, 21-58 years of age, responding poorly to antihistamines alone, were randomly divided into two groups: the therapeutic group with THH 3 tablets 3 times daily (n = 40) and the control group with placebo 3 tablets 3 times daily (n = 38). Meanwhile, all patients jointly received cetirizine hydrochloride (HCl) 10 mg once daily throughout the study period. The efficacy of THH was assessed by the scoring system of 4-point scale and the subject's global assessment of relief. RESULTS: Sixty-nine (69) of 78 patients (37 in the therapeutic group, 32 in the control group) completed the study. By the end of the fourth week, there was a 67% improvement of total effective rate (TER) with THH compared with a 28% improvement with placebo by per-protocol analysis (χ(2) = 10.68, p = 0.0011), while by intention-to-treat analysis, 63% and 24% improvements of TER were respectively observed in the therapeutic group and the control group (χ(2) = 11.36, p = 0.001). THH with cetirizine showed statistical superiority to placebo with cetirizine during each study week for changes in total severity scores (p ≤ 0.001). In weekly analyses, THH was also statistically superior to placebo in reducing the mean pruritus scores during each study week (p ≤ 0.005). CONCLUSIONS: This study shows that the therapeutic effect of THH with cetirizine is predominant over that of cetirizine alone in adult CU. THH with cetirizine may play an important role in the therapy of CU and be a useful treatment for CU.
Authors: Liu Liu; Huaibo Zhao; Xiaoying Sun; Qi Zheng; Ying Luo; Yi Ru; Ying Zhang; Xi Chen; Bo Zhu; Chengqian Yin; Bin Li; Xin Li Journal: BMC Complement Altern Med Date: 2018-08-31 Impact factor: 3.659