Abstract

Aim: To compare the efficacy and tolerability of oral hyoscine butylbromide tablets and capsules in Chinese patients with recurrent episodes of self-reported gastric or intestinal spasm-like pain and to show non-inferiority of both formulations. Methods: 302 patients were entered into a randomized, double-blind, double-dummy, active-controlled 2-arm parallel group study. They were randomized to 3 days of treatment with hyoscine butylbromide tablets or capsules. In patient diaries the pain intensity was assessed on 10 cm visual analogue scales on Day 1 (0, 30, 60, 90, 120, and 180 minutes after first dose), Days 2, and 3 (maximum pain intensity once daily). Pain frequency, overall efficacy, and tolerability were assessed on verbal rating scales. Results: In the per-protocol dataset 281 patients were analyzed. The change from baseline after 180 minutes was 59% in both treatment groups; the adjusted means of pain intensity on Day 1 were reduced by –2.36 cm (tablets) and –2.31 cm (capsules). Pain intensity decreased within 30 minutes by approximately 20%. The decrease of the peak pain intensity was approximately 55% after 3 days in both treatment groups; the adjusted means after 3 days were reduced by –2.48 cm (tablets) and by –2.45 cm (capsules). Abdominal pain frequency decreased by 50% (tablets) and 42% (capsules). Both treatments were well tolerated. Drug-related adverse events were infrequent (3.5%). No serious adverse event occurred. Conclusions: Hyoscine butylbromide is effective in the treatment of recurrent gastric or intestinal spasm-like pain and well tolerated. Non-inferiority of tablets and capsules was demonstrated.

Author Details

Authors

• Z. Ge¹
• Y. Yuan²
• S. Zhang³
• X. Hou⁴
• J. Wang⁵
• J. Cai⁶
• R. Shi⁷
• Y. Li⁸
• B. Wang⁹
• F. Ji¹⁰
• E. Richter¹¹
• E. Schaefer¹¹

Departments

• ¹ Renji Hospital,
• ² Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,
• ³ Beijing Friendship Hospital, Capital Medical University, Beijing,
• ⁴ Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan,
• ⁵ Zhongshan Hospital, Shanghai Medical College of Fudan University, Shanghai,
• ⁶ The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou,
• ⁷ The First Affiliated Hospital of Nanjing Medical University, Nanjing,
• ⁸ Qilu Hospital of Shandong University, Jinan,
• ⁹ Tianjin Medical University General Hospital, Tianjin,
• ¹ 
• ⁰ The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, and
• ¹ 
• ¹ Boehringer Ingelheim, Ingelheim, Germany

Address

Dr. E. Schaefer
Boehringer Ingelheim GmbH
Binger Straße 173
55216 Ingelheim am Rhein, Germany
Email: [email protected]

Citation