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. 2003 Oct 20;2003(4):CD004094. doi: 10.1002/14651858.CD004094.pub2
Study Reason for exclusion
Derosa 2002 Open‐label randomized trial (n=87) of orlistat alone, simvastatin alone, and orlistat plus simvastatin for the treatment of hypercholesterolemia. No placebo arm.
Gaciong 2005 Short‐term (12 weeks), open‐label cohort study of 2225 obese Polish patients.
Gilbert 1983 Pseudorandomized one‐year trial using diethylpropion
Hanefeld 2002 A trial of orlistat vs. placebo in patients with Type 2 diabetes. Follow‐up period after randomization too short (44 weeks). Results similar to trials included in the review.
Heymsfield 2000 Pooled results from three orlistat trials already included in the review.
Hill 1999 Orlistat weight maintenance trial lasting one year. Did not use intention‐to‐treat analysis. Results are not presented for 36% of patients randomized.
Hsieh 2005 One‐year placebo‐controlled RCT of orlistat. Unable to determine if the study was blinded. Attempts to contact the author to clarify were unsuccessful.
James 1997 Preliminary publication of Finer 2000
Lucas 2003 Subgroup analysis of 5 previous sibutramine trials. Unable to determine which trials. Trials may already have been included in review.
Poston 2003 Open‐label 1‐year trial of orlistat
Redmon 1999 Patients were randomized to phentermine plus fenfluramine vs. dual placebo for two years. Did not contain a phentermine only arm
Redmon 2003 Open‐label 1‐year trial involving sibutramine
Redmon 2005 Open‐label 1‐year trial involving sibutramine
Rossner 2001 Duplicate publication of James et al. Lancet 2000;356:2119‐25. (Swedish)
Scholze 2002 Non‐randomized cohort study of 12 weeks duration in 6360 obese Germans.
Toubro 2001 Duplicate publication of James et al. Lancet 2000;356:2119‐25. (Danish)
Wadden 2001 A 16‐week comparison of different dietary and lifestyle modification regimens in sibutramine treated patients. Not a comparison of sibutramine vs. placebo or another drug.
Wadden 2005 A three‐arm one‐year open‐label study of behavioural modification +/‐ pharmacotherapy with sibutramine in 224 adults. Excluded because open label. Results of sibutramine arm similar to this review.
Weintraub 1992 A mulitmodal intervention study lasting four years that included a comparison of combination therapy with phentermine/ fenfluramine and placebo. Only 24 weeks of this period was double‐blind.
Wirth 2001 Follow‐up period after randomization too short (44 weeks). Results showed slightly lower efficacy compared to sibutramine studies included in this review. Also included an intermittent sibutramine arm.
Wirth 2005 XXL trial. Study of 15 549 patients on orlistat. No control arm
Zavoral 1998 Pooled data from five randomized controlled trials of orlistat. It is not known how many of these studies were subsequently published (and included in the present review). Attempts to contact the author to clarify and obtain unpublished data were unsuccessful.