Volume 114, Issue 1, Pages 15-22 (January 1998) Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis  Jonathan R.B. Green*, Alan J. Lobo‡, Charles D. Holdsworth‡, Roger J. Leicester§, John A. Gibson∥, Graeme D. Kerr¶, Humphrey J.F. Hodgson#, Katharine J. Parkins**, Michael D. Taylor**  Gastroenterology  Volume 114, Issue 1, Pages 15-22 (January 1998) DOI: 10.1016/S0016-5085(98)70627-4 Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 1 Percentage of patients achieving complete remission. Complete remission was defined as none or mild symptoms, sigmoidoscopic grade 0 or 1, and no use of rectal steroid foam. ■, Balsalazide; ▩, mesalamine. **P < 0.01, *P < 0.05. Four weeks, P = 0.005 (95% confidence interval [CI]: balsalazide, 24.5-51.5; mesalamine, 2.9-21.1); 8 weeks, P = 0.0018 (95% CI: balsalazine, 40.2-67.8; mesalamine, 10.4-33.6); and 12 weeks, P = 0.0159 (95% CI: balsalazine, 48.5-75.5; mesalamine, 23.5-50.5). Gastroenterology 1998 114, 15-22DOI: (10.1016/S0016-5085(98)70627-4) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 2 Overall symptom relief after treatment with balsalazide, 6.75 g daily, or mesalamine, 2.4 g daily, after 2, 4, 8, and 12 weeks of treatment. Distribution of symptom severity was similar in the two groups at entry. Symptoms: 2, none; ▩, mild; ▩, moderate; ■, severe. The last-value-extended principle was used to generate these data. Between-treatment comparisons of overall symptoms: 2 weeks, P = 0.0067; 4 weeks, P = 0.0481; 8 weeks, P = 0.0012; 12 weeks, P = 0.003. Symptomatic remission was defined as none or mild symptoms, based on patients' overall evaluation. Between-treatment comparisons of patients achieving symptomatic remission: 2 weeks, P = 0.0446 (95% confidence interval [CI]: balsalazide, 50.7-77.3; mesalamine, 29.1-56.9); 4 weeks, P = 0.0656 (95% CI: balsalazide, 57.3-82.7; mesalamine, 37.0-65.0); 8 weeks, P = 0.0009 (95% CI: balsalazide, 66.5-89.5; mesalamine, 31.1-58.9); 12 weeks, P = 0.0007 (95% CI: balsalazide, 79.0-97.0; mesalamine, 43.1-70.9). Gastroenterology 1998 114, 15-22DOI: (10.1016/S0016-5085(98)70627-4) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 3 Patient and investigator satisfaction with treatment. The last-value-extended principle was used to generate these data. *P < 0.05, **P < 0.01. Patient satisfaction: 4 weeks, P = 0.0014; 8 weeks, P = 0.0336; 12 weeks, P = 0.0038. Investigator satisfaction: 4 weeks, P = 0.0037, 8 weeks, P = 0.0044; 12 weeks, P = 0.0024. ■, Balsalazide patients; ▩, mesalamine patients; ▩, balsalazide investigators; ▩, mesalamine investigators. Gastroenterology 1998 114, 15-22DOI: (10.1016/S0016-5085(98)70627-4) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 4 Percentage of patients in complete remission after 12 weeks of treatment. Complete remission and sigmoidoscopic grade of UC at entry were identified as factors significantly associated with achieving complete remission after 12 weeks of treatment. ■, Balsalazide group; ▩, mesalamine group. Gastroenterology 1998 114, 15-22DOI: (10.1016/S0016-5085(98)70627-4) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 5 Time to complete relief of diary card symptoms. Median time to complete relief of diary card symptoms was calculated using survival analysis techniques. Balsalazide (bold line, 2.25 g three times daily), 10 days; mesalamine (thin line, 0.8 g three times daily), 25 days; P = 0.0039. Gastroenterology 1998 114, 15-22DOI: (10.1016/S0016-5085(98)70627-4) Copyright © 1998 American Gastroenterological Association Terms and Conditions