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

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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.