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Study ReferenceStudy CharacteristicsInclusion/ExclusionCONSORT NumbersRetentionParticipant Characteristics Orlistat TrialsAcharya, 2006133Perrio, 2007134Design: Observational Cohort study/Prescription event monitoringLocation: UKRecruitment Setting: Patients identified from dispensed NHS prescription dataSelf-Selected: NRInclusion: Prescribed orlistat from Dec 1998-Nov 1999; questionnaire returned by GPExclusion: Questionnaires returned with no information or not returnedN Randomized: NAN Analyzed: Total: 16,021 (45.4% of forms sent)Age (median): 45Sex (% female): 80.1Race/Ethnicity: NRSES (income, education): NR% Hypertension: NR% Diabetes: NR% Dyslipidemia: NROther health problems: NRBakris, 2002126Design: RCTLocation: 41 centers, USRecruitment Setting: 41 referral centersSelf-Selected: NRInclusion: BMI 28-43 kg/m2; taking at lease one antihypertensive medication (stable dose for at least 12 weeks prior); had a sitting DBP 96 - 109 mmHg on 2 consecutive visits; easily controlled & stable diabetes allowedExclusion: unstable medical and/or psychiatric illness; recent (within 12 wks) initiation or change in diuretic therapy; previous gastrointestinal surgery for weight reduction, and any active GI disorders such as malabsorption syndrome except more than mild lactose intolerance, diarrhea or constipation; history of bulimia or laxative abuse, substance abuse (including alcohol), and unwillingness or inability to comply with protocol requirements; pregnant or lactating women; the use of nicotine replacement therapy, appetite suppressants, fish-oil supplements, oral retinoids, chronic systemic steriods other than sex hormone replacement & gonadotropin releasing hormone, and acute antidepressant or anxiolytic therapy were prohibited during the studyN Randomized: Total: 554 IG: 278 CG: 276N Analyzed: Total: 535 (calc) IG: 267 CG: 265 Age (mean): 52.9 (calc)Sex (% female): 61.1 (calc)Race/Ethnicity: (calc)% African American: 11.5% Caucasian: 85.5% Hispanic: 2.4% Other: 0.6SES (income, education): NR% Hypertension: 100% Diabetes: 8% Dyslipidemia: 38 (calc)Other health problems: NRBroom, 2002132Design: RCTLocation: UKRecruitment Setting: 12 outpatient clinics in the UK specializing in obesity and/or dyslipidaemiaSelf-Selected: NRInclusion: BMI ≥30 kg/m2; aged ≥ 18 yrs; total plasma cholesterol ≥ 6.5 mmol/L or LDL-C ≥ 4.2 mmol/L; women of childbearing age who were using adequate contraceptionExclusion: myocardial infarction or major surgery within previous 3 mo; active GI or pancreatic disease; type 1 diabetes; uncontrolled hypertension; history of carcinoma, GI surgery for weight loss, post-surgical lesions, bulimia or laxative abuse, drug or alcohol abuse; using drugs altering appetite or lipid concentrations, fish oil supplements, retinoids, systemic steroids (other than sex hormone replacements), or anticoagulantsN Randomized: Total: 142 IG: 71 CG: 71N Analyzed: Total: 137 (calc) IG: 66 CG: 71Age (mean): 51.5 (calc)Sex (% female): 60.6 (calc)Race/Ethnicity: NRSES (income, education): NR% Hypertension: NR% Diabetes: 24.8 (calc)% Dyslipidemia: 100Other health problems: NRKelley, 2002127Design: RCTLocation: 43 centers, USRecruitment Setting: NRSelf-Selected: NRInclusion: Age 40-65 yrs; BMI 28-43 kg/m2; type 2 diabetes; stable weight (<3 kg weight change) for previous 3 mo; treatment with stable daily dose (±10%) of insulin in previous 6 wks; HbA1c of 7.5-12.0% at screening; women required to have negative serum pregnancy test & use an acceptable form of contraception during study periodExclusion: Diabetes treatment that included thiazolidinedione or if diabetic meds (except insulin) had changed during previous 12 wks; medical history or presence of renal, hepatic, or endocrine disorder that could affect results of study; previous bariatric surgery; use of approved or experimental weight reduction meds or treatments; presence of malabsorp-tion syndrome, bulimia or laxative abuse, or disorders that could affect study complianceN Randomized: Total: 550 IG: 274 CG: 276N Analyzed (ITT): Total: 535 (calc) IG: 266 CG: 269Age (mean): 57.9 (calc)Sex (% female): 56.3 (calc)Race/Ethnicity: (calc)% Caucasian: 72.0% African American: 16.4% Asian: 1.3% Other: 10.3SES (income, education): NR% Hypertension: NR% Diabetes: 100% Dyslipidemia: NROther health problems: NRMuls, 2001130Design: RCTLocation: 19 centers, BelgiumRecruitment Setting: NRSelf-Selected: NRInclusion: BMI 27-40 kg/m2; age 18-70 yrs; fasting serum LDL 4.1-6.7 mmol/l and TG <4.5 mmol/l (<400 mg/dl); >75% compliance with therapy and <1 kg weight gain during run in were eligible for randomizationExclusion: Patients with serious diseases, diabetes or uncontrolled hypertension; women of childbearing age without adequate contra-ception; previous bariatric surgery; use of appetite suppressants or lipid lowering meds; evidence of alcohol or substance abuseN Randomized: Total: 294 IG: 147 CG: 147N Analyzed: Total: 290 IG: 147 CG: 143Age (mean): 48.6 (calc)Sex (% female): 80.7 (calc)Race/Ethnicity: NRSES (income, education): NR% Hypertension: NR% Diabetes: 0% Dyslipidemia: 100Other health problems: NRData for ITT population at BL (n=290)Van Gaal, 1998129Design: RCTLocation: 14 centers, Austria, Belgium, Brazil, Finland, Germany, Italy, Sweden, Switzerland, and UKRecruitment Setting: NRSelf-Selected: NRInclusion: Age ≥18 yrs; BMI 28-43 kg/m2; to be randomized had to have ≥70% compliance with test medication (placebo)Exclusion: weight loss >4 kg in past 3 mo; history/presence of significant medical disorder (diabetes, CVD, uncontrolled hyper-tension); pancreatic disease; previous GI surgery for weight loss; history of postsurgical adhesions or presence of cancer (except treated basal cell carcinoma); psychiatric or neurological disorder requiring chronic meds or liable to prejudice compliance; alcohol or substance abuse; bulimia or laxative abuse; pregnancy or lactation; postmenopausal women who had amenorrhia for <1 yr; taking meds likely to influence body weight or plasma lipids during past mo; use of anti-coagulants, digoxin, antiarrhythmics and lipid-soluble vitamin supplements; gallstones or symptomatic cholelithiasis; lipid-soluable vitamin levels not in clinical reference range or a clinically significant GI disorderIG1: 30 mg, IG2: 60mg, IG3: 120 mg, IG4: 240 mgN Randomized: Total: 613 (calc) IG1: 122 IG2: 124 IG3: 122 IG4: 120 CG: 125N Analyzed: (used numbers from table 3) Total: 606 (calc) IG1: 122 IG2: 123 IG3: 120 IG4: 117 CG: 124Age (mean): 42 (calc)Sex (% female): 77 (calc)Race/Ethnicity: NRSES (income, education): NR% Hypertension: NR% Diabetes: 0% Dyslipidemia: NROther health problems: NRNote: Data from ITT before the start of the double-blind treatment (n=605)Metformin TrialsTrolle, 2007131Design: RCTLocation: DenmarkRecruitment Setting: Patients referred to the outpatient clinic in HolstebroSelf-Selected: NRInclusion: Women aged 18-45 years; referred to the outpatient clinic from Sept 2001-Dec 2002 with symptoms indicating Polycystic Ovary Syndrome (PCOS); testosterone value above the upper normal limit and olig- or amnorrhea; taking antihypertensive agents was permittedExclusion: periclimacteric gonadotrophin values; hyperprolactinaemia; diabetes mellitus; impaired thyroid, renal, or hepatic function; hormonal treatment; pregnancy, lactation, or wish for fertility treatmentN Randomized: Total: 60 IG: 29 CG: 31N Analyzed: Per protocol Total: 38 IG: 19 CG: 19ITT Analysis Total: 56 IG: 27 CG: 29ITTAge (mean): 32Sex (% female): 100Race/Ethnicity: NRSES (income, education): NR% Hypertension: NR% Diabetes: 0% Dyslipidemia: NROther health problems: PCOSCombination TrialsGokcel, 2002136Design: RCTLocation: Adana, TurkeyRecruitment Setting: Outpatients at the Baskent University Endocrinology and Metabolism Clinic in TurkeySelf-Selected: NRInclusion: Females with BMI > 30 kg/m2Exclusion: existence of endocrine diseases other than type 2 diabetes; uncontrolled hypertension or secondary hypertension; renal or hepatic insufficiency; GI disease; autoimmune disease; isch heart disease; glaucoma; dysrhythmia; lactation/ pregnancy; psychosis & requirement for any drug with central nervous system effects; cathartics, thyroids supplements, or diureticsN Randomized: Total: 150 (calc) IG1: 50 IG2: 50 IG3: 50N Analyzed: NRIG1: SibutramineIG2: OrlistatIG3: MetforminAge (mean): 42.7 (calc)Sex (% female): 100Race/Ethnicity: NRSES (income, education): NR% Hypertension: NR% Diabetes: 10 (calc)% Dyslipidemia: NROther health problems: NR ................
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