Placebo‐ and paracetamol‐controlled study on the efficacy and tolerability of hyoscine butylbromide in the treatment of patients with recurrent crampy abdominal pain

• Published in: Alimentary pharmacology & therapeutics Vol. 23; no. 12; pp. 1741 - 1748
• Main Authors: MUELLER‐LISSNER, S., TYTGAT, G. N., PAULO, L. G., QUIGLEY, E. M. M., BUBECK, J., PEIL, H., SCHAEFER, E.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 15.06.2006; Blackwell
• Subjects: Abdominal Pain - drug therapy; Acetaminophen - therapeutic use; Adolescent; Adult; Aged; Analgesics, Non-Narcotic - therapeutic use; Biological and medical sciences; Butylscopolammonium Bromide - therapeutic use; Digestive system; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Recurrence; Treatment Outcome; Human; Relapse; Toxicity; Antimigrainous agent; Hyoscine butylbromide; Abdomen; Paracetamol; Analgesic; Pain; Treatment; Antispasmodic agent; Efficiency; Placebo; Antipyretic
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2006.02818.x

Summary Aim To compare the efficacy and tolerability of oral hyoscine butylbromide (hereafter hyoscine) 10 mg t.d.s., paracetamol 500 mg t.d.s. and their fixed combination against placebo in patients with recurrent crampy abdominal pain. Methods A total of 1637 patients were entered into a four‐arm double‐blind study. After a 1 week placebo run‐in, they were randomized to 3 weeks of treatment with one of the four therapies with assessments after 1, 2 and 3 weeks. Pain intensity (Visual Analogue Scale) and pain frequency (Verbal Rating Scale) were self‐assessed daily. Results Pain intensity on the Visual Analogue Scale decreased in all treatment groups; the adjusted mean changes from baseline were 2.3, 2.4 and 2.4 cm for the hyoscine, paracetamol and combination groups, respectively, compared with 1.9 cm for the placebo group (all P < 0.0001). The Verbal Rating Scale also showed a statistically significant decrease of 0.7, 0.7 and 0.7 in the hyoscine, paracetamol and combination groups compared with 0.5 in placebo (all P < 0.0001). All treatments were well tolerated: 16%, 14%, 17% and 11% of patients on hyoscine, paracetamol, combination and placebo reported at least one adverse event. Conclusions Hyoscine, paracetamol and their fixed combination are effective in the treatment of recurrent crampy abdominal pain and well tolerated if used three times daily continuously for 3 weeks.