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Efficacy and safety of mixture of ivy leaf extract and coptidis rhizome in the treatment of acute bronchitis: multicenter, randomized, double-blinded, active-controlled, parallel, therapeutic confirmatory clinical trial.
Han, Kyung-Il; Kim, Tae-Hyung; Ra, Seung Won; Yoon, Hyoung Kyu; Kim, Deog Kyeom; Rhee, Chin Kook; Park, Jung Woong; Hwang, Yong-Il; Park, Hye Yun; Kim, Yee Hyung; Park, Yong Bum; Shin, Kyeong-Cheol; Lim, Seong Yong; Yoo, Kwang Ha.
Afiliação
  • Han KI; Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.
  • Kim TH; Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.
  • Ra SW; Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
  • Yoon HK; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
  • Kim DK; Department of Internal Medicine, Seoul National University-Seoul Metropolitan Government Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.
  • Rhee CK; Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
  • Park JW; Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.
  • Hwang YI; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, South Korea.
  • Park HY; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
  • Kim YH; Department of Pulmonary, Allergy and Critical Care Medicine, Kyung Hee University Hospital at Gangdong, Seoul, South Korea.
  • Park YB; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym Univeristy Kangdong Sacred Heart Hospital, Seoul, South Korea.
  • Shin KC; Division of Pulmonology and Allergy, Regional Center for Respiratory Disease, Yeungnam University Medical Center, Daegu, South Korea.
  • Lim SY; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
  • Yoo KH; Department of Internal Medicine, Konkuk University School of Medicine, Seoul, South Korea.
Curr Med Res Opin ; 40(7): 1235-1243, 2024 Jul.
Article em En | MEDLINE | ID: mdl-38889376
ABSTRACT

BACKGROUND:

Acute bronchitis is the most common respiratory disease. Mixture of Ivy Leaf Extract and Coptidis rhizome syrup has shown good treatment efficacy against chronic bronchitis and acute respiratory infections. This study aimed to evaluate the efficacy and safety of Mixture of Ivy Leaf Extract and Coptidis rhizome compared with those of Pelargonium sidoides extract, for the treatment of acute bronchitis.

METHODS:

We performed a multicenter, randomized, double-blind, active-controlled, parallel phase III study in 220 patients with acute bronchitis. The participants were offered either Mixture of Ivy Leaf Extract and Coptidis rhizome syrup (AGS) and placebo of P. sidoides tablet or placebo syrup and active tablet of P. sidoides (AGU) for 7 days. The primary endpoint was the change in the Bronchitis Severity Score (BSS) from the baseline visit (visit 2) to day 7 (visit 3).

RESULTS:

For the primary outcome, there was no significant difference in the change of total BSS between visits 2 and 3 (-4.10 ± 1.93 vs. -4.24 ± 1.85, p = 0.5125), and since the upper limit of the confidence interval (1.00) was smaller than the predetermined non-inferiority margin (1.17), it was confirmed that the AGS group was non-inferior to the AGU group. The changes in each symptom in the BSS between visits 2 and 3 also showed no significant differences. The overall improvement rate measured by the investigator (91.7 vs. 89.7%; p = 0.3506) and the satisfaction rate of the participants at visit 3 also showed no significant differences (97.2 vs. 94.4%; p = 0.4388). Regarding safety issues, adverse reactions were noted in both groups similarly, with no serious adverse events (4.55 vs. 3.64%, p > 0.999).

CONCLUSION:

Mixture of Ivy Leaf Extract and Coptidis rhizome syrup is as effective and safe as P. sidoides in controlling symptoms of acute bronchitis.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Bronquite / Extratos Vegetais Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Curr Med Res Opin Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Coréia do Sul País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Bronquite / Extratos Vegetais Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Curr Med Res Opin Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Coréia do Sul País de publicação: Reino Unido