Shiva Narang1, Jitender Koli1. 1. Department of Medicine, University College of Medical Sciences (University of Delhi) and Guru Teg Bahadur Hospital, Delhi, India.
Abstract
BACKGROUND AND AIM: This randomized controlled trial was undertaken to assess efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (PCM) (500 mg). This was performed by comparison of mean pain intensity difference, total pain relief at 2 h, onset of pain relief, decrease in number of pain episodes, global improvement, and adverse effects. METHODS: A randomized double-blind controlled trial for adults between 18 and 59 years of either gender with acute infectious diarrhea (≥ 3 unformed, watery, or soft stools with symptoms at least within the last 24 h preceding randomization with duration of illness not more than 72 h) with moderate-to-severe abdominal pain. Participants were treated with either a fixed-dose combination of oral drotaverine hydrochloride (80 mg) and PCM (500 mg) or oral PCM (500 mg) three times a day for 3 days. RESULTS: Of 252 (126 in each group) participants, all received at least one dose of medication. Two hundred forty-two completed the study. Mean pain intensity difference at 60 min after administration of study medication by Visual Analogue Scale (VAS) and total pain relief at 2 h using both VAS and Verbal Rating Scale showed statistically significant improvement in drotaverine hydrochloride (80 mg) and PCM (500 mg) group. The onset of pain relief was also significantly better in drotaverine hydrochloride (80 mg) and PCM (500 mg) group when using VAS. CONCLUSION: Fixed-dose combination of drotaverine hydrochloride (80 mg) and PCM (500 mg) is an effective and safe antispasmodic agent in abdominal pain associated with acute infectious gastroenteritis.
RCT Entities:
BACKGROUND AND AIM: This randomized controlled trial was undertaken to assess efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (PCM) (500 mg). This was performed by comparison of mean pain intensity difference, total pain relief at 2 h, onset of pain relief, decrease in number of pain episodes, global improvement, and adverse effects. METHODS: A randomized double-blind controlled trial for adults between 18 and 59 years of either gender with acute infectious diarrhea (≥ 3 unformed, watery, or soft stools with symptoms at least within the last 24 h preceding randomization with duration of illness not more than 72 h) with moderate-to-severe abdominal pain. Participants were treated with either a fixed-dose combination of oral drotaverine hydrochloride (80 mg) and PCM (500 mg) or oral PCM (500 mg) three times a day for 3 days. RESULTS: Of 252 (126 in each group) participants, all received at least one dose of medication. Two hundred forty-two completed the study. Mean pain intensity difference at 60 min after administration of study medication by Visual Analogue Scale (VAS) and total pain relief at 2 h using both VAS and Verbal Rating Scale showed statistically significant improvement in drotaverine hydrochloride (80 mg) and PCM (500 mg) group. The onset of pain relief was also significantly better in drotaverine hydrochloride (80 mg) and PCM (500 mg) group when using VAS. CONCLUSION: Fixed-dose combination of drotaverine hydrochloride (80 mg) and PCM (500 mg) is an effective and safe antispasmodic agent in abdominal pain associated with acute infectious gastroenteritis.
Authors: Piotr Eder; Piotr Kowalski; Agnieszka Mastalerz-Migas; Barbara Skrzydlo-Radomanska; Wojciech Cichy; Katarzyna Proga Journal: J Clin Med Date: 2022-06-01 Impact factor: 4.964