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Balsalazide in the maintenance treatment of patients with ulcerative colitis, a double‐blind comparison with sulphasalazine

Balsalazide (BSZ) is a pro‐drug which releases 5‐aminosalicylic acid (5ASA) and 4‐aminobenzoyl‐β‐alanine (an inert carrier) in the colon of various species including man. BSZ was compared with sulphasalazine (SASP) (both 1 g b.d. orally) in the maintenance of remission in patients with ulcerative colitis (UC). Seventy‐nine patients (5.3 male, 26 female), mean age 49 years (range 19–79 years), with UC were randomly allocated to either treatment (41 BSZ, 38 SASP) for 6 months. The groups were similar in respect of age, sex, duration and extent of disease. Seven patients defaulted (3 BSZ, 4 SASP) leaving 38 on BSZ and 34 on SASP. Two male patients, both receiving SASP, were withdrawn because of severe side‐effects. One of these patients, with an exfoliative rash, was maintained satisfactorily on open BSZ. Remission rates at 6 months (51% BSZ, 63% SASP) were not significantly different (life‐table analysis P < 0.1). Twelve patients (15%) reported troublesome side‐effects (2 BSZ 5%, 10 SASP 26%, P= 0.017 Fisher Exact Test). Mean haemoglobin concentrations, similar on entry, increased after 6 months with BSZ (0.2 g/dl) but decreased with SASP (0.5 g/dl) (P < 0.0002). BSZ was not significantly different from SASP in maintaining remission in patients with UC but had fewer side‐effects.