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HL301 in the treatment of acute bronchitis: a phase 2b, randomized, double-blind, placebocontrolled, multicenter study

Korean Journal of Internal Medicine 2020년 35권 1호 p.133 ~ 141
윤상원 ( Yoon Sang-Won ) - Chung-Ang University College of Medicine Department of Internal Medicine

박명재 ( Park Myung-Jae ) - Kyung Hee University School of Medicine Department of Internal Medicine
이진국 ( Rhee Chin-Kook ) - Catholic University College of Medicine Seoul St. Mary’s Hospital Department of Internal Medicine
박주헌 ( Park Joo-Hun ) - Ajou University School of Medicine Department of Pulmonary and Critical Care Medicine
이상엽 ( Lee Sang-Yeub ) - Korea University College of Medicine Department of Internal Medicine
김도진 ( Kim Do-Jin ) - Soonchunhyang University Bucheon Hospital Department of Internal Medicine
김동규 ( Kim Dong-Gyu ) - Hallym University Sacred Heart Hospital Department of Internal Medicine
김재열 ( Kim Jae-Yeol ) - Chung-Ang University College of Medicine Department of Internal Medicine

Abstract


Background/Aims: There is insufficient quality data to recommend the use of herbs for the treatment of acute bronchitis. Small number of randomized trials of plant extracts for this purpose were determined to be low quality and there are concerns for the safety. HL301 is a combined product of seven medicinal plants. In the present study, we tried to evaluate the efficacy and safety of HL301 for the treatment of acute bronchitis with a randomized, double-blind, placebo-controlled, multicenter trial design.

Methods: A total of 166 patients with acute bronchitis were randomized to receive placebo or HL301 (600 mg/day) for 7 days. The primary endpoint was change in bronchitis severity score (BSS) from baseline visit (visit 2) to the end of treatment (visit 3). Other efficacy variables were the change of each component of the BSS (cough, sputum, dyspnea, chest pain, and crackle) with treatment, response rate, improvement rate, satisfaction rate and number of rescue medications taken.

Results: Changes in the BSS from visit 2 to visit 3 were higher in the HL301 group than in the placebo group both in the full analysis set (4.57 ± 1.82 vs. 3.15 ± 3.08, p < 0.01) and in the per protocol set (4.62 ± 1.81 vs. 3.30 ± 3.03, p < 0.01). Four BSS components (cough, sputum, dyspnea, and chest pain) improved more with HL301 treatment than with placebo treatment. Participants treated with HL301 showed higher response, improvement, and satisfaction rates and less use of rescue medication than the placebo group.

Conclusions: HL301 (600 mg/day) was effective and safe for symptomatic treatment of acute bronchitis.

키워드

HL301; Acute bronchitis; Bronchitis severity score; Herb
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