Romanian Society of Pharmaceutical Sciences
 

« Back to Farmacia Journal 1/2025

DROTAVERINE EFFICACY AND SAFETY IN PATIENTS WITH COLIC PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME-OBSERVATIONAL RETROSPECTIVE CLINICAL STUDY

DARIA ARINA GHEORGHE 1#, ALINA COVACI 2, ISABEL GHITA 3*, CLAUDIA MARIANA HANDRA 4#, AISA LAUDAT 5, MIHAI NEGUTU 6, MARINELA CHIRILA 7, LIANA GHEORGHE 1

1Department of Gastroenterology and Hepatology, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
2 Department of Pharmacology, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
3 Department of Pharmacology and Pharmacotherapy, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
4 Department of Occupational Medicine, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
5 Biofarm S.A., Bucharest, Romania
6 ATI, Elias Hospital, Bucharest, Romania
7 Medimun Consult SRL, Bucharest, Romania

Download Full Article PDF

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain and altered bowel habits without specific organic pathology. This study aimed to assess the efficacy and safety of drotaverine in patients with IBS. A multicenter, retrospective study analysed records of 200 IBS patients. Group A (n = 100) received Drotaverine (Antispasmin® Forte 80 mg Biofarm, Romania, 3 times daily for 14 days), and Group B (n = 100) followed a proper diet without medication. Efficacy parameters included pain relief, stool frequency, and improvement in general condition. Safety was assessed by adverse events and clinical evaluation. After 2 weeks, pain severity scores significantly decreased in 50 patients treated with Drotaverine compared to 32 controls (p < 0.05). After 4 weeks, 80 treated patients showed improvement in pain severity score versus 37 controls (p < 0.05). Mild adverse events occurred in 5 patients. Drotaverine significantly improved IBS symptoms without major adverse events.