| Efficacy and Tolerability of Theobromine in Patients with Upper Airway Cough Syndrome: A Multicenter, Double-Blind, Randomized, Active Drug Comparative Study |
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Young Ha Kim, Soo Whan Kim, Chang Hoon Kim, Kyung Soo Kim, Tae Hoon Kim, Heung Man Lee, Jin Hee Cho |
1Department of Otorhinolaryngology Head & Neck Surgery, Yeouido St. Mary's Hospital, Korea. entcho@catholic.ac.kr
2Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
3Department of Otorhinolaryngology Head & Neck Surgery, Severance Hospital, Korea.
4Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
5Department of Otorhinolaryngology Head & Neck Surgerym Korea University Anam Hospital, Korea.
6Korea University College of Medicine, Guro Hospital, Seoul, Korea. |
| 상기도 기침 증후군 환자에서 Theobromine의 유효성과 안전성을 평가하기 위한 다기관, 이중맹검, 무작위 배정, 활성대조약 비교 연구 |
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김영하, 김수환, 김창훈, 김경수, 김태훈, 이흥만, 조진희 |
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가톨릭대학교 의과대학 여의도성모병원,1 서울성모병원 이비인후-두경부외과학교실2연세대학교 의과대학 세브란스병원,3 강남세브란스병원 이비인후-두경부외과학교실,4고려대학교 의과대학 안암병원,5 구로병원 이비인후-두경부외과학교실6 |
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| Abstract |
OBJECTIVES: The objective of this study is to evaluate the efficacy and tolerability of theobromine in patients with upper airway cough syndrome compared to those of levocloperastine.
Materials and Method
This was a randomized, double-blind study. One hundred sixty-five patients with upper airway cough syndrome participated in a 5 day treatment; 85 subjects were included in the theobromine treatment group and 80 in the levocloperastine control group. Cough severity score, daytime cough symptom (DCS), nighttime cough symptom (NCS) and cough quality of life questionnaire (CQLQ) were analyzed for symptom analysis, and vital signs and laboratory study were performed for safety evaluation before and after medication administration.
Results
The primary efficacy analysis showed that the mean change in cough grade between baseline and follow-up in the treatment group was lower than that in the control group. This led to the conclusion that theobromine has similar efficacy to control treatment. The secondary efficacy analysis of changes in DCS, NCS and CQLQ verified this conclusion. Considering safety, only one case of dyspepsia was considered to be probably related to theobromine. Other tests conducted before and after treatment confirmed the safety of treatment medications.
Conclusion
Theobromine is a novel natural antitussive medication that has similar efficacy to levocloperastine and adequate safety. |
| Key Words:
Cough;Theobromine;Levocloperastine;Upper airway cough syndrome;Postnasal drip syndrome |
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