Volume 117, Issue 4, Pages (October 1999)

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Presentation transcript:

Volume 117, Issue 4, Pages 918-925 (October 1999) Oral budesonide and ursodeoxycholic acid for treatment of primary biliary cirrhosis: Results of a prospective double-blind trial Maria Leuschner*, Klaus–Peter Maier‡, Julia Schlichting*, Stefan Strahl‡, Günter Herrmann§, Hans Helmut Dahm∥, Hanns Ackermann¶, Joachim Happ#, Ulrich Leuschner* Gastroenterology Volume 117, Issue 4, Pages 918-925 (October 1999) DOI: 10.1016/S0016-5085(99)70351-3 Copyright © 1999 American Gastroenterological Association Terms and Conditions

Fig. 1 Decrease in (A) AP, (B) GLDH, (C) IgM, and (D) IgG (mean ± SEM) values during treatment with UDCA/placebo (○) or UDCA/budesonide (●). ○ or ●P < 0.05; ○○ or ●●P < 0.01; ○○○ or ●●●P < 0.001, for comparison between pretreatment values and values during therapy. ▴P < 0.05; ▴▴P < 0.01; ▴▴▴P < 0.001, for comparison between UDCA/placebo group and UDCA/budesonide group. Gastroenterology 1999 117, 918-925DOI: (10.1016/S0016-5085(99)70351-3) Copyright © 1999 American Gastroenterological Association Terms and Conditions

Fig. 2 Serum cortisol level before, during, and at end of the study (mean ± SEM). ●, UDCA/placebo; ○, UDCA/budesonide. Gastroenterology 1999 117, 918-925DOI: (10.1016/S0016-5085(99)70351-3) Copyright © 1999 American Gastroenterological Association Terms and Conditions

Fig. 3 ACTH-stimulated cortisol secretion before the end of study in (A) patients treated with UDCA/placebo and (B) patients treated with UDCA/budesonide for 2 years. ACTH is able to stimulate the adrenal gland in both groups, showing that budesonide does not completely suppress adrenal function. Gastroenterology 1999 117, 918-925DOI: (10.1016/S0016-5085(99)70351-3) Copyright © 1999 American Gastroenterological Association Terms and Conditions

Fig. 3 ACTH-stimulated cortisol secretion before the end of study in (A) patients treated with UDCA/placebo and (B) patients treated with UDCA/budesonide for 2 years. ACTH is able to stimulate the adrenal gland in both groups, showing that budesonide does not completely suppress adrenal function. Gastroenterology 1999 117, 918-925DOI: (10.1016/S0016-5085(99)70351-3) Copyright © 1999 American Gastroenterological Association Terms and Conditions

Fig. 4 Total score of liver histology improved significantly by 30.3% in group A and slightly deteriorated by 3.5% in group B (P < 0.001). Inflammation: periportal and lobular inflammation, piecemeal, and bridging necroses (A vs. B, P < 0.01). Bile ducts: proliferation and destruction of bile ducts and granulomas (NS). Connective tissue: portal and interlobular fibers and liver cirrhosis (A vs. B, P < 0.001). Gastroenterology 1999 117, 918-925DOI: (10.1016/S0016-5085(99)70351-3) Copyright © 1999 American Gastroenterological Association Terms and Conditions