Sibutramine 10mg capsules

Introduction: The World Health Organization has identified obesity as an escalating public health concern affecting millions globally, contributing to the increasing demand for anti-obesity supplements. Traditional medicinal systems, such as Ayurveda and Traditional Chinese Medicine, have historically incorporated botanicals for weight management within a holistic therapeutic framework. However, the widespread commercialization of herbal weight-loss products has resulted in misrepresentation of traditional knowledge and the frequent adulteration of these formulations with synthetic pharmaceuticals to enhance their effectiveness. This phenomenon not only raises ethical concerns regarding the exploitation of traditional medicine but also presents significant health risks to consumers. Objectives: In order to develop a longer-term strategy to overcome the challenges of poor quality and adulterated products making medical claims, this study aims to (1) estimate the prevalence of pharmaceutical adulteration in weight-loss natural products; and (2) examine the characteristics of such adulterations. Methods: A systematic search of PubMed, CINAHL, and Google Scholar was conducted to identify relevant studies up to July 2024. The Der Simonian-Laird random-effects model was used for data pooling. Subgroup analyses and a meta-regression model were utilized to explore potential sources of heterogeneity. The quality of the included studies was assessed using the Toxicological Data Reliability Assessment Tool (ToxRTool). Results: A total of 26 studies qualified for the systematic review, while 22 studies were included in the meta-analysis. The estimated prevalence of synthetic adulteration exhibited significant variability, ranging from 0% to 100%, with an overall pooled median estimate of 37.5% (Interquartile range (IQR) 25.9%-49.6%). The prevalence of sibutramine adulteration was found to have a median rate of 21.8% (IQR 11.9%-33.5%). The subgroup analysis revealed a high prevalence of synthetic adulteration in Europe, particularly during the years 2012-2014, with a notable occurrence in samples collected from local markets. Conclusion: This systematic review and meta-analysis highlights the high prevalence of intentional adulteration in weight-loss natural products, with sibutramine as the most common adulterant. To protect public health and market integrity, a global framework is needed, emphasizing harmonized regulations, international collaboration, and public awareness. Future research should assess long-term health effects to ensure sustainable and safe healthcare solutions worldwide.

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BACKGROUND: Obesity significantly impacts the health outcomes of children and adolescents, necessitating a comprehensive study to evaluate the effects of various anti-obesity medications (AOMs) on weight-related and metabolic outcomes. METHODS: PubMed, EMBASE, and CENTRAL were searched for studies published up to January 3, 2024. We performed a network meta-analysis on randomized clinical trials that compared various treatments for pediatric and adolescent obesity, such as phentermine/topiramate, semaglutide, exenatide, liraglutide, topiramate, metformin, fluoxetine, metformin/fluoxetine, sibutramine, and orlistat. The study evaluated body mass index (BMI), BMI percentage change, weight, BMI-SDS, waist circumference, metabolic, anthropometric, and safety outcomes. RESULTS: The study gathered 2733 studies, including 30 articles that involved 3822 participants. The results of our research showed that PHEN/TPM was better at lowering BMI than exenatide, liraglutide, metformin, fluoxetine, Met/Flu, topiramate, orlistat, and sibutramine, with mean differences (MD) ranging from -10.29 to -1.28. Additionally, semaglutide demonstrated superior efficacy over other AOMs (MD ranged from -8.28 to -1.24). Various levels of certainty, ranging from very low to moderate, supported the findings. Furthermore, semaglutide demonstrated superior efficacy over exenatide (MD-12.43, 95% CI -23.95 to -0.30) regarding percentage change in BMI. Semaglutide also showed enhanced weight reduction effectiveness compared to seven other AOMs except for PHEN/TPM (MD ranging from -15.56 to -12.65). Similarly, PHEN/TPM displayed greater weight reduction effectiveness than seven other AOMs, except for semaglutide (MD ranged from -12.17 to -9.27). Moreover, semaglutide proved more effective in decreasing waist circumference when compared with other AOMs apart from PHEN/TPM (MD ranged from -11.61 to -6.07). Similarly, we found that PHEN/TPM, excluding semaglutide and sibutramine, was more effective in reducing waist circumference (MD ranged from -8.64 to -5.51). CONCLUSIONS: The study found that semaglutide outperformed other AOMs in reducing BMI and additional weight-related outcomes in children and adolescents with obesity, while PHEN/TPM showed comparable efficacy.

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Abstract To synthesize the evidence about pharmacologic treatment of obesity and overweight and to define the options with the best risk-benefit using the stochastic analysis of multicriteria acceptability (SMAA). The analysis addresses a systematic review (PROSPERO CRD42023423308) whose research was realized in PubMed, Scopus, and Web of Science. Randomized controlled trials were included, which verified the effects of sibutramine, orlistat, liraglutide, and semaglutide in patients with IMC ≥ 26 Kg/ m². The risk of bias analysis was performed with RoB 2.0 and the outcomes evaluated were weight loss and serious adverse events. A total of 102 studies with 45.047 participants were included. The network meta-analysis revealed that all the treatments were significantly more effective than the placebo in weight reduction. The use of semaglutide (especially 0.4 mg/day) was associated with a bigger weight loss in comparison to all the other treatments (p<0.05) and the analysis of SMAA showed a risk-benefit of 95%. Besides that, we suggest re-evaluating of sibutramine 10mg/day as a therapeutic option for patients without hypertension or cardiovascular diseases, and we demonstrate the modest weight loss promoted by orlistat 120mg, sibutramine 5mg, and liraglutide 1,8mg and advise against its use, once the benefits do not outweigh the risks.

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The use of dietary supplements (DSs) has dramatically increased in recent decades. However, around 20% of these products are reported to contain pharmacologically active undeclared compounds, most of which could expose consumers to serious side effects. According to recent data, some of the most commonly detected undeclared compounds are also considered doping and are prohibited by the World Anti-Doping Agency (WADA). One of the most frequently detected undeclared substances in DSs used for promoting weight loss is sibutramine. In 2011, all medicines containing sibutramine were urgently withdrawn from Europe and US markets because of serious side effects. In the present study, in order to detect and quantify sibutramine in DSs, a rapid, sensitive, and reliable gas chromatography with mass spectrometry (GC-MS) method was developed. The method was validated according to the ICH guidelines and demonstrated good linearity, accuracy, precision, and robustness. The limits of detection and quantification were 0.181 μg/mL and 0.5488 μg/mL, respectively. The method was applied to analyze 50 DSs promoting weight loss, fat burning, and performance enhancement. Sibutramine was detected in six of them in a range of 16.59–14,854.94 μg/per capsule. The high concentrations of sibutramine detected in some samples raise concerns about the potential health risks associated with the use of adulterated DSs. The proposed GC-MS method could be used successfully in the quality control of DSs or in different research programs, contributing to safety and the prevention of associated side effects.

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