Anti-Inflammatory Agent and Body Weight mature death.2 The increase in fat mass, particularly in the splanchnic re- gion (visceral fat) of the body, is associated with chronic el- evation of circulating levels of inflammatory mediators, in- cluding non-specific markers such as C-reactive protein (CRP), acute-phase inflammatory proteins, and proinflam- matory cytokines.3,4 The relationship between obesity, in- flammatory markers such as adipocytokines, phase reactant proteins, and insulin resistance has been investigated in several populations.5,6 Reviews on low grade inflammation have presented evidence indicating that the reversion of low grade inflammation and reduction of risk factors in obese individuals seems to coincide with reduced BMI and loss of adipose tissue.7 Reduced body weight could result in normalized inflammation and reduction in increased in- flammatory markers. Even a modest 5-10% loss of body weight in obese patients improves their cardiovascular risk profiles and reduces the future incidence of type 2 diabe- tes.8-10 Therefore, weight reduction is a key factor in reducing inflammation and thus the risk of cardiovascular disease. Diacerein is well-tolerated anti-inflammatory supplemen- tal agent, which acts by inhibiting tumor necrosis factor-al- phas (TNF-α) and interleukin-1 (IL-1) in rheumatoid and other forms of arthritis. This compound has also been used to reduce inflammation in addition to more conventional anti-inflammatory drugs.11-14 Furthermore, only two studies have addressed whether pharmacological intervention15-17 reduces inflammation. Diacerein is an anti-inflammatory agent, which is often used in some clinical-based office of the obesity clinic in Ko- rea. From a clinical view standpoint, obesity is equivalent to a status of low-grade inflammation; therefore, reduction of in- flammation may lead to a change in body weight. However, there have been no reports of Diacerein effects on body weight control. Therefore, we wondered if this medication had any real effect on body weight control or inflammatory marker changes. The aim of this study was to evaluate the additional effect on body weight reduction, metabolic parameters, and inflammatory markers by addition of an anti-inflammatory agent to a standard 12-week obesity treatment regimen. MATERIALS AND METHODS Study subjects We conducted a double-blind, placebo-controlled pilot study. Enrolled obese subjects were randomly allocated to take treatment medication (Diacerein) or placebo for 12 weeks. All subjects were enrolled following a private inter- view conducted at the Obesity Clinic of Ajou University Hospital, Suwon, South Korea, and all provided informed consent. We measured and compared the anthropometric changes of body weight and waist circumference), body pro- portion using Dual Energy X-ray Absorptiometry (DEXA), select metabolic parameters, and inflammatory markers be- fore and after the 12-week body weight control program. The Institutional Review Board of Ajou University Hospi- tal approved this study, and permission was received from the Korean Food and Drug Administration for the use of Diacerein. Inclusion criteria for the initial 26 obese subjects were age ≥ 20-years-of-age, BMI ≥ 27.0 kg/m2, or 27 kg/m2 ≥ BMI ≥ 25.0 kg/m2 with hypertension, type 2 diabetes, dys- lipidemia, and family history of coronary heart diseases. Exclusion criteria were uncontrolled type 2 diabetes, hyper- tension, habitual alcohol consumption, history and/or cur- rent presence of any cancer, old stroke, and renal disease. Seven subjects dropped out due to personal problems that were unrelated to an adverse drug reaction. The remaining 19 subjects (13 men, 6 women) completed the study. Weight reduction program and visit schedules Subjects visited an out-patient clinic every 4 weeks for a meeting with the principal investigator and the coordinating nurse. At each visit, each subject was assessed and prompted to continue their prescribed routine. Items addressed at each visit included information on diet, daily activity, types and frequency of exercise, encouragement, and advice concern- ing target frequency of exercise (at least 30 min daily, more than 3 or 4 times a week). Each subject underwent an initial nutrition assessment by a registered dietician, who provided instructions on a low-calorie diet aimed at producing a 400- 500 kcal daily energy deficit. Furthermore, a behavior modi- fication program encouraged increased calorie expenditure while reducing intake, with an emphasis on long-term behav- ior change. In addition, Sibutramine was prescribed as a stan- dard medical treatment for all subjects. Subjects were ran- domly assigned in a double-blind manner to the treatment group (n = 12) who additionally received the anti-inflamma- tory agent Diacerein, which is a TNF-α inhibitor, and to the placebo group (n = 7). Diacerein and placebo were made and provided by Myungmoon Pharmaceutical (Seoul, Korea). The capsules were identical in appearance; the placebo con- tained wheat flour instead of medication. Yonsei Med J http://www.eymj.org Volume 52 Number 2 March 2011 243