HL301 in the treatment of acute bronchitis: a phase 2b, randomized, double-blind, placebocontrolled, multicenter study
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (17)
- Park MJ, "Efficacy and safety of HL301 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: a phase 2, randomized, double-blind, placebo-controlled, multicenter study", Curr Med Res Opin, 33, pp.919~925 (2017)
- Clark TW, "Adults hospitalised with acute respiratory illness rarely have detectable bacteria in the absence of COPD or pneumonia; viral infection predominates in a large prospective UK sample", J Infect, 69, pp.507~515 (2014)
- Harris AM, "Appropriate antibiotic use for acute respiratory tract infection in adults: advice for high-value care from the American College of Physicians and the Centers for Disease Control and Prevention", Ann Intern Med, 164, pp.425~434 (2016)
- Nseir S, "Factors predicting bacterial involvement in severe acute exacerbations of chronic obstructive pulmonary disease", Respiration, 76, pp.253~260 (2008)
- Nair S, "A randomized controlled trial to assess the optimal dose and effect of nebulized albuterol in acute exacerbations of COPD", Chest, 128, pp.48~54 (2005)
- Roh GS, "Efficacy of a traditional Korean medicine, Chung-Sang-Bo-Ha-Tang, in a mu-rine model of chronic asthma", Int Immunopharmacol, 5, pp.427~436 (2005)
- Lee H, "Herbal formula, PM014, attenuates lung inflammation in a murine model of chronic obstructive pulmonary disease", Evid Based Complement Alternat Med, 2012, pp.769830~ (2012)
- Jung KH, "The effects of the standardized herbal formula PM014 on pulmonary inflammation and airway responsiveness in a murine model of cockroach allergen-induced asthma", J Ethnopharmacol, 155, pp.113~122 (2014)
- Jung KH, "The standardized herbal formula, PM014, ameliorated cigarette smoke-induced lung inflammation in a murine model of chronic obstructive pulmonary disease", BMC Complement Altern Med, 13, pp.219~ (2013)
- Chung HS, "Thirteen-week study of PM014subchronic oral toxicity in rats", Evid Based Complement Alternat Med, 2014, pp.189673~ (2014)
- 이진국, "The Korean Cough Guideline: Recommendation and Summary Statement", Tuberculosis and Respiratory Diseases, 79(1), pp.14~21 (2016), 대한결핵및호흡기학회
- 권재우, "Korean version of the Cough Symptom Score: clinical utility and validity for chronic cough", The Korean Journal of Internal Medicine, 32(5), pp.910~915 (2017), 대한내과학회[DOI]
- Little P, "Amoxicillin for acute lower-respiratory-tract infection in primary care when pneumonia is not suspected: a 12-country, randomised, placebo-controlled trial", Lancet Infect Dis, 13, pp.123~129 (2013)
- Park JY, "Microorganisms causing community-acquired acute bronchitis : the role of bacterial infection", PLoS One, 11, pp.e0165553~ (2016)
- 박성훈, "Role of Atypical Pathogens and the Antibiotic Prescription Pattern in Acute Bronchitis: A Multicenter Study in Korea", Journal of Korean Medical Science, 30(10), pp.1446~1452 (2015), 대한의학회
- Little P, "Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection: a randomized controlled trial", JAMA, 293, pp.3029~3035 (2005)
- McKay R, "Systematic review of factors associated with antibiotic prescribing for respiratory tract infections", Antimicrob Agents Chemother, 60, pp.4106~4118 (2016)