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PAPER Pharmacotherapy for Obesity: a Quantitative Analysis of Four Decades of Published Randomized Clinical Trials

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PAPER Pharmacotherapy for Obesity: a Quantitative Analysis of Four Decades of Published Randomized Clinical Trials International Journal of Obesity (2002) 26, 262–273 ß 2002 Nature Publishing Group All rights reserved 0307–0565/02 $25.00 www.nature.com/ijo PAPER Pharmacotherapy for obesity: a quantitative analysis of four decades of published randomized clinical trials CK Haddock1*, WSC Poston1, PL Dill1, JP Foreyt2 and M Ericsson3 1University of Missouri-Kansas City and Mid America Heart Institute, St Luke’s Hospital, Kansas City, Missouri, USA; 2Baylor College of Medicine, USA; and 3University of Umea˚, Sweden and University of Missouri-Kansas City, Missouri, USA AIM: This article provides the first comprehensive meta-analysis of randomized clinical trials of medications for obesity. METHOD: Based on stringent inclusionary criteria, a total of 108 studies were included in the final database. Outcomes are presented for comparisons of single and combination drugs to placebo and for comparisons of medications to one another. RESULT: Overall, the medications studied produced medium effect sizes. Four drugs produced large effect sizes (ie d > 0.80; amphetamine, benzphetamine, fenfluramine and sibutramine). The placebo-subtracted weight losses for single drugs vs placebo included in the meta-analysis never exceeded 4.0 kg. No drug, or class of drugs, demonstrated clear superiority as an obesity medication. Effects of methodological factors are also presented along with suggestions for future research. International Journal of Obesity (2002) 26, 262 – 273. DOI: 10.1038=sj=ijo=0801889 Keywords: pharmacotherapy; meta-analysis; clinical trials Introduction Task Force on the Prevention and Treatment of Obesity.8 No comprehensive meta-analytic studies of obesity pharma- Goldstein and Potvin7 conducted a detailed review of 20 cotherapy have been published to date, but three meta- long-term (ie those lasting 6 months or longer) phenter- analyses have been published on single drugs. Lijesen et al1 mine, mazindol, fenfluramine, dexfenfluramine and fluox- meta-analyzed eight controlled and 16 uncontrolled trials of etine studies from 1967 to 1993. While they presented a human chorionic gonadotropin and concluded that it was comprehensive review of clinical trials on these drugs and not effective for the treatment of obesity. Four placebo- concluded that extended treatment was beneficial for those controlled, double-blind studies of sibutramine efficacy for patients unable to lose weight without pharmacotherapy, reducing visceral fat were meta-analyzed by Van Gaal et al,2 they did not provide a quantitative synthesis of these drugs’ who concluded that it was effective in reducing waist cir- efficacy. The National Task Force on the Prevention and cumference and visceral fat when compared to placebo. Treatment of Obesity8 also provided a comprehensive Greenway3 examined phenylpropanolamine (PPA) trials review of the safety and efficacy of FDA-approved and since 1973, including trials that were reviewed by previous selected non-approved anti-obesity medications, ie (bold investigators4,5 and concluded that the average weight loss drugs are those that were identified as FDA-approved) in excess of placebo (kg=week) at the end of studies had amphetamine=dexamphetamine, benzphetamine hydro- decreased since 1985. chloride, dexfenfluramine, diethylpropion, fenfluramine, Two multi-drug reviews that have been cited as meta- fluoxetine, mazindol, methamphetamine hydrochloride, analytic confirmation of obesity pharmacotherapy’s efficacy6 phendimetrazine tartrate, phentermine (hydrochloride were authored by Goldstein and Potvin7 and the National and resin), phenlypropanolamine, the combination of phentermine – fenfluramine, sibutramine and sertraline, but they also did not quantitively synthesize outcomes of the drug therapies. The Task Force reviewed English-language *Correspondence: CK Haddock, Health Research Group, University of trials that evaluated drug safety and efficacy that lasted for a Missouri-Kansas City, 4825 Troost, Room 124, Kansas City, MO 64110, minimum of 24 weeks and concluded that pharmacotherapy USA. for obesity, when combined with appropriate behavioral E-mail: [email protected] Received 5 January 2001; revised 14 August 2001; approaches, helped many obese patients lose weight or accepted 1 October 2001 maintain their weight loss.8 Obesity medication meta-analysis CK Haddock et al 263 The purpose of this study is to provide a comprehensive mocriptine, buspar, cimetidine, fluvoxamine, human chor- meta-analytic review of anti-obesity agents, both prescrip- ionic gonadotropin, human growth hormone, leptin, tion and over-the-counter (OTC), and drugs that are=were naloxone=naltrexone or synthyroid. We also did not include FDA-approved and are=were used off-label for obesity.8 The dietary supplements, which are defined by the Dietary Sup- specific aims are to evaluate the clinical efficacy of obesity plement Health and Education Act of 19949 as products medications and determine whether methodological factors intended to supplement the diet that contain one or more (eg length of treatment, year of publication) are system- of the following ingredients: (1) a vitamin; (2) a mineral; (3) atically related to treatment outcome. In addition, based a herb or other botanical; (4) an amino acid; (5) a dietary on the results of this meta-analysis, suggestions for future substance for use to supplement the diet by increasing the research are discussed. total dietary intake; or (6) a concentrate, metabolite, consti- tuent, extract, or combination of any of the previously described ingredients. Examples of substances in this cate- Methods gory include 5-hydroxytryptophan (5-HTP), ma huang (ephe- Literature search drine), guarana (caffeine), chitosan, chromium (picolinate Inclusion criteria. For this meta-analysis, we evaluated and nicotinate), dehydroepiandrosterone (DHEA), garcinia only anti-obesity agents that are=were FDA-approved for cambogia=hydroxycitric acid, pyruvate and St John’s Wort the treatment of obesity, both prescription and OTC, and (hypericin). drugs that are FDA-approved and are used off-label for Studies which met the following stringent criteria were obesity (see Table 1). We compiled this list by examining included in the review: (1) the data were contained in those that were highlighted by the National Task Force on published reports in peer-reviewed journals; (2) only the Prevention and Treatment of Obesity8 as being currently human studies were included; (3) an English version of the approved for the treatment of obesity in the United States, study was available; (4) a direct comparison between an those that were used off-label, and including recently obesity drug therapy designed to produce weight loss and approved drugs that were not reviewed by the Task Force.8 another treatment modality or a control group of obese In addition, we based our selection of drugs on extensive individuals was provided; (5) participants were assigned consultation with several experts in the field of obesity randomly to treatment groups and the randomization research. scheme was not broken during assignment (ie some partici- We retained fenfluramine and dexfenfluramine in the pants assigned randomly, some haphazardly); (6) groups review because they were widely studied and used in clinical were distinguishable on relevant parameters (eg drug type, settings even though they were removed from the market in use of lifestyle intervention); (7) the study provided suffi- 1997. We did not include experimental obesity agents such cient outcome data to compute an effect size based on as acarbose, beta-adrenoreceptor agonist (BRL 26830A), bro- weight loss (see effect size definition below); (8) the study Table 1 Anti-obesity agents Generic name Example trade name DEA schedule Number of studiesa Years of publications (range) Amphetamine (dexamphetamine)b Biphetamine II 6 1969 – 1974 Benzocaine Slim Mint, Trocaine OTC 1 1999 Benzphetamineb Didrex III 3 1960 – 1987 Dexfenfluramineb,c Redux IV 18 1989 – 1998 Diethylpropionb Tenuate, Tenuate Dospan IV 13 1965 – 1983 Fenfluramineb,c Pondimin IV 15 1966 – 1992 Fluoxetined Prozac None 11 1987 – 1995 Mazindolb Sanorex, Mazanor IV 28 1969 – 1982 Methamphetamineb Desoxyn II 1 1960 Orlistate Xenical None 6 1995 – 1999 Phendimetrazineb Bontril, Plegine, Prelu-2, X-Trozine III — f — f Phentermine (HCL and resin)b Adipex-P, Fastin, Oby trim, Ionamin IV 9 1969 – 1992 Phenylpropanolamine (PPA)b Dexatrim, Acutrim OTC 9 1975 – 1999 Sertralined Zoloft None — f — f Sibutraminee Meridia IV 5 1991 – 1998 Note: FDA, Food and Drug Administration; DEA, Drug Enforcement Agency; OTC, over the counter. aNumber of studies in our database that address each drug. Because some studies address more than one drug, the sum of these numbers is greater than the total number of studies included in the database. bDrugs highlighted by the National Task Force on the Prevention and Treatment of Obesity (1996). cRemoved from the market in 1997. dFDA-approved drugs that have been used off-label for obesity. eApproved by the FDA after the 1996 report by the National Task Force on the Prevention and Treatment of Obesity. fNo studies of these drugs met our inclusionary criteria. International Journal of Obesity Obesity medication meta-analysis CK Haddock et al 264 was published on or before December 1999 (to provide a DXti À DXci di ¼ point to begin coding and data analysis). Unfortunately, we DXsi were not able to code a large number of studies that address where DXti is the mean weight loss in the treatment group drug treatments for obesity. Uncodable studies typically did D of the ith
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