Clinical evaluation of a sustained release belladonna preparation

Summary

• 1. A new sustained release dosage form of belladonna alkaloids called Prydonnal Spansule capsules was evaluated in 30 private patients with assorted gastrointestinal complaints, 12 of whom had proven peptic ulcers.

• 2. Excellent results were obtained in 18 patients; good results in 8; fair in 1; and poor in 3.

• 3. Night pain was controlled in 16 of 19 patients in whom it was a problem.

• 4. Side effects, consisting of 4 cases of drowsiness, 1 of blurring of vision, and 2 of dry mouth occurred in 6 patients.

• 5. On the basis of clinical observation, the preparation appeared to maintain effective therapeutic levels for from 8 to 10 hours following ingestion, to effectively control night pain in hypersecretors, and to produce an appreciably smaller incidence of side effects than conventional t.i.d. belladonna therapy.