Balsalazide is proven to be the superior treatment for ulcerative colitis

A study published in the January 1998 volume of Gastroenterology confirmed that balsalazide is more efficacious and better tolerated than the established therapy mesalamine, for the treatment of acute ulcerative colitis. Balsalazide produced extremely favourable results with more rapid and complete symptomatic relief and reductions in disease activity compared to mesalamine, regardless of the underlying disease severity. Balsalazide therefore offers a new, reliable first-line treatment to reduce the disease burden of ulcerative colitis.

Ulcerative colitis is a relatively common disease characterised by chronic inflammation of the large intestines which usually afflicts patients of 15-40 years of age. Morbidity associated with the disease can be quite severe with frequent episodes of bloody and mucus diarrhoea, abdominal pain and urgency. Extensive research has been conducted to identify treatments to reduce disease severity and duration of attacks. In the past many of these treatments were associated with significant side effects or insufficient symptomatic relief. However, aminosalicylates are well established treatments for ulcerative colitis, often used in combination with topical corticosteroids. The current study conducted at numerous gastroenterology units in the United Kingdom thus aimed to compare two such treatments namely balsalazide and mesalamine, for the treatment of acute ulcerative colitis.The mesalamine formulation used in this study was a delayed release formulation composed of the active moiety 5-aminosalicylic acid (5-ASA), coated with a pH-dependent resin. On the other hand, balsalazide is a newer preparation where the active moiety is combined with 4-aminobenzoyl-B-alanine by azo bonds. This essentially produces more reliable release of the active drug at the site of disease by breakdown of the bonds by colonic bacteria. This may at least partly explain the therapeutic benefits of balsalazide over mesalamine for the treatment of active ulcerative colitis demonstrated in numerous studies. The current study results were based on 101 (99 evaluable) patients with symptomatic ulcerative colitis confirmed by sigmoidoscopy, who were randomised to receive 2.25g of balsalazide or 0.8g of delayed-release mesalamine both three times daily. Patients were treated for 4, 8 or 12 weeks as necessary and followed up in terms of symptoms, adverse effects, satisfaction with treatment and sigmoidoscope extent of disease. Results were largely in favour of balsalazide which produced earlier and more complete symptomatic remission of acute ulcerative colitis and greater patient satisfaction. In addition, balsalazide patients were more likely to have sigmoidoscopic healing of disease and suffer far fewer adverse effects (48% versus 71%).Benefits of balsalazide were demonstrable in even severe cases (determined by sigmoidoscopy) suggesting it is a suitable treatment for virtually all patients regardless of disease severity and extent. This study has important therapeutic indications. Firstly it negates beliefs that the mechanism of delivery of mesalamine/5-ASA (the active moiety of both drugs) does not have therapeutic implications. As fore mentioned, the benefits of balsalazide are thought to be partly due to its reliable delivery of 5-ASA to the colon. In contrast, mesalamine may be prematurely activated in the ileum reducing the dose reaching the colon and leading to an increase in side effects. However, further research is required to determine the extent of this effect and whether other therapeutic factors are involved. A second benefit of this research is the identification of a new drug that is efficacious for the treatment of active ulcerative colitis without producing significant adverse effects like previous treatments such as sulfasalazine. It is therefore suitable to adopt balsalazide as a first line treatment for acute ulcerative colitis in clinical practice. Reference:Green J, Lobo A, Holdsworth C, Leicester R, Gibson J, Kerr G, Hodgson H, Parkins K, Taylor M & The Abacus Investigator Group, Balsalazide is More Effective and Better Tolerated Than Mesalamine in the Treatment of Acute Ulcerative Colitis, Gastroenterolgy 1998; 114: 15-22.