% 100 80 60 40 20 Nam-Seok Joo, et al. P for trend = 0.068 P for trend = 0.075 < 5% ≥ 5% < 10% ≥ 10% % 100 80 60 40 20 0 0 Treatment Placebo Treatment Placebo Fig. 1. Response rate: weight reduction of ≥ 5% and ≥10% in the two groups. The top panel shows the response rate of ≥ 5% or < 5% weight reduction subjects after the 12-week intervention. The lower panel shows the response rate of ≥ 10% or < 10% weight reduction. 37.57 ± 1.11 in the placebo group, and the mean BMI was 31.02 ± 1.08 kg/m2 in the treatment group and 30.51 ± 1.94 kg/m2 in the placebo group. Besides the anthropometric mea- surements, other metabolic parameters [blood pressure, fast- ing blood sugar, lipid profiles, thyroid stimulating hormone, insulin, and homeostasis model assessment-Insulin Resis- tance (IR)], and several inflammatory markers including white blood cell count, hsCRP, homocysteine, fibrinogen, TNF-α, and adiponectin level were also measured; no differ- ences between the two groups were evident (Table 1). We had difficulty mentioning the two-way ANOVA test because we did not divide the time-dependent grouping. We only measured body composition and inflammatory markers at baseline and 12 weeks. Following the 12-week weight reduc- tion program the mean changes in body weight, BMI, and waist circumference were - 7.00 kg, - 2.51 kg/m2, and - 7.37 cm, respectively, in the treatment group, and - 4.64 kg, - 1.59 kg/m2, and - 4.42 cm, respectively, in the placebo group. The anthropometric comparison before and after intervention showed significant changes in both groups. A tendency to- wards more reduction in anthropometric parameters in the treatment group was observed, but there was no statistical difference between the two groups. In addition, there were no statistical differences in the changes of metabolic param- eters and calorie intake between the treatment and control groups (Table 2). We also evaluated the changes in inflam- matory markers between the two groups. Again, no statisti- cal differences were apparent. Although there were no dif- ferences between the two groups, hsCRP, and adiponectin showed more favorable change in the treatment group than in the placebo group. Other inflammatory markers were not shown as expected, but TNF-α was decreased in both groups after intervention (Table 3). Finally, we observed the re- sponse rate of ≥ 5% and ≥ 10% weight reduction between the two groups, in spite of the small sample size. Both re- sponse rates were higher in the treatment group than in the placebo group. Even though there were no statistical differ- ences between the two groups, P for trend showed weak cor- relation in more weight reduction tendency in the treatment group than in the placebo group (Fig. 1). In spite of these re- sults, we could not find any additional effects of Diacerein on weight loss and inflammatory variables in this study. DISCUSSION In this pilot study, we did not find any additional effects of Diacerein on weight loss and inflammatory variables. As mentioned above, two-way ANOVA may not be useful in this study. Therefore, we had only simple comparison by non-parametric test. The treatment group as compared to the placebo group showed a reduction in body weight (- 7.0 kg vs. 4.6 kg), BMI (- 2.51 kg/m2 vs. - 1.59 kg/m2), and waist circumference (- 7.3 cm vs. - 4.4 cm); however, there was no statistical significance between the two groups. Changes in levels of low-density lipoprotein, hsCRP, and adiponectin in the treatment group showed improvement, which were also not significant when compared to those in the placebo group. Other inflammatory markers such as white blood cells, homocysteine, fibrinogen, and TNF-α were not significantly different either. There have been many studies of changes of the inflam- mation and body weight in several different body weight control programs. For instance, studies on the changes in inflammatory markers after weight reduction reported dif- ferent results, which may have reflected the different study methods. One study showed that during the eucaloric phase, a low-fat, high-carbohydrate diet unfavorably influ- 246 Yonsei Med J http://www.eymj.org Volume 52 Number 2 March 2011