Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
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Comparison of the effect of diclofenac with hyoscine-N-butylbromide in the symptomatic treatment of acute biliary colic.

BACKGROUND: Although non-steroidal anti-inflammatory drugs (NSAID) and spasmolytics have been used to relieve biliary colic, the role of these drugs in the natural history of biliary colic has not been clarified. The objective of the present study is to compare the efficacy of intramuscular diclofenac with intramuscular hyoscine in the treatment of pain of acute biliary colic, and to study their role in the natural history of biliary colic and in the prevention of cholelithiasis-related complications.

METHODS: Seventy-two consecutive patients with biliary colic were enrolled in this prospective, randomized, double-blind study. They received either a single 75 mg intramuscular dose of diclofenac (n = 36) or similarly administered 20 mg of hyoscine (n = 36). Pain severity was recorded on a visual analogue scale 30 min, 1 h, 2 h and 4 h after injection of the drug. Patients were then followed closely for the next 72 h for persistence or relapse of pain, or development of acute cholecystitis, or drug related complications.

RESULTS: Diclofenac provided much more rapid relief of pain than hyoscine, as shown by significantly lesser pain scores after injection of the drug. 91.7% of patients on diclofenac were completely relieved of pain at 4 h as compared to 69.4% with hyoscine (P = 0.037). Progression to acute cholecystitis was seen in only 16.66% of patients on diclofenac as compared to 52.77% on hyoscine (P = 0.003).

CONCLUSIONS: In patients with biliary colic, diclofenac gives much faster and more effective pain relief in a significantly larger number of patients as compared with hyoscine. Most remarkably, diclofenac can prevent progression of biliary colic to acute cholecystitis in a significant number of patients.

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