Placebo in Nonalcoholic Steatohepatitis: Insight Into Natural History and Implications for Future Clinical Trials

Clinical Gastroenterology and Hepatology

Volumn 6, Issue 11, 2008, Pages 1243-1248

  Loomba, Rohit ^a,d   Wesley, Robert ^b   Pucino, Frank ^b   Liang, T Jake ^a   Kleiner, David E ^c   Lavine, Joel E ^d  

^a NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA TOCOPHEROL; ASPARTATE AMINOTRANSFERASE; PIOGLITAZONE; PLACEBO; PROBUCOL; ROSIGLITAZONE; URSODEOXYCHOLIC ACID;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CHEMICAL ANALYSIS; CLINICAL RESEARCH; CLINICAL TRIAL; DATA EXTRACTION; DEGENERATIVE DISEASE; HEPATITIS; HISTOPATHOLOGY; HISTORY; HUMAN; INFORMATION RETRIEVAL; LIVER FIBROSIS; META ANALYSIS; NONALCOHOLIC FATTY LIVER; STEATOSIS; SYSTEMATIC REVIEW; TREATMENT DURATION;

ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; CLINICAL TRIALS AS TOPIC; FATTY LIVER; HUMANS; LIVER; PLACEBOS; SEVERITY OF ILLNESS INDEX;

EID: 55149115873     PISSN: 15423565     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cgh.2008.07.013     Document Type: Article

References (17)

1. Greenfield S., Kravitz R., Duan N., et al. Heterogeneity of treatment effects: implications for guidelines, payment, and quality assessment. Am J Med 120 (2007) S3-S9
2. Hrobjartsson A., and Gotzsche P.C. Is the placebo powerless?. An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 344 (2001) 1594-1602
3. Su C., Lewis J.D., Goldberg B., et al. A meta-analysis of the placebo rates of remission and response in clinical trials of active ulcerative colitis. Gastroenterology 132 (2007) 516-526
4. Su C., Lichtenstein G.R., Krok K., et al. A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease. Gastroenterology 126 (2004) 1257-1269
5. Kleiner D.E., Brunt E.M., Van Natta M., et al. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology 41 (2005) 1313-1321
6. Promrat K., Lutchman G., Uwaifo G.I., et al. A pilot study of pioglitazone treatment for nonalcoholic steatohepatitis. Hepatology 39 (2004) 188-196
7. Brunt E.M., Janney C.G., Di Bisceglie A.M., et al. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol 94 (1999) 2467-2474
8. Neuschwander-Tetri B.A., and Caldwell S.H. Nonalcoholic steatohepatitis: summary of an AASLD single topic conference. Hepatology 37 (2003) 1202-1219
9. Suzuki A., Lymp J., Sauver J.S., et al. Values and limitations of serum aminotransferases in clinical trials of nonalcoholic steatohepatitis. Liver Int 26 (2006) 1209-1216
10. Littell R.F.J. Asymptotic optimality of Fisher's method of combining independent tests. J Am Stat Assoc 66 (1971) 802-806
11. Chande N., Laidlaw M., Adams P., et al. Yo Jyo Hen Shi Ko (YHK) improves transaminases in nonalcoholic steatohepatitis (NASH): a randomized pilot study. Dig Dis Sci 51 (2006) 1183-1189
12. Zelber-Sagi S., Kessler A., Brazowsky E., et al. A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol 4 (2006) 639-644
13. Lindor K.D., Kowdley K.V., Heathcote E.J., et al. Ursodeoxycholic acid for treatment of nonalcoholic steatohepatitis: results of a randomized trial. Hepatology 39 (2004) 770-778
14. Belfort R., Harrison S.A., Brown K., et al. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med 355 (2006) 2297-2307
15. Dufour J.F., Oneta C.M., Gonvers J.J., et al. Randomized placebo-controlled trial of ursodeoxycholic acid with vitamin E in nonalcoholic steatohepatitis. Clin Gastroenterol Hepatol 4 (2006) 1537-1543
16. Merat S., Malekzadeh R., Sohrabi M.R., et al. Probucol in the treatment of non-alcoholic steatohepatitis: a double-blind randomized controlled study. J Hepatol 38 (2003) 414-418
17. Ratziu V., Giral P., Jacqueminet S., et al. Rosiglitazone for nonalcoholic steatohepatitis: one-year results of the randomized placebo-controlled Fatty Liver Improvement With Rosiglitazone Therapy (FLIRT) Trial. Gastroenterology 135 (2008) 100-110