Pharmacology Laboratory, Department of Medicine, University of Patras School of Health Sciences, Patras 26504, Greece.
Department of Internal Medicine, School of Medicine, University of Crete, Heraklion 71500, Greece.
Nutrients. 2023 Jan 24;15(3):606. doi: 10.3390/nu15030606.
We evaluated the quality of evidence from phase III/IV clinical trials of drugs against obesity using the principles of Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Our systematic review evaluates the quality of clinical evidence from existing clinical trials and not the pharmacological efficacy of anti-obesity therapies. A literature search using select keywords in separate was performed in PubMed and ClinicalTrials.gov databases for phase III/IV clinical trials during the last ten years. Our findings indicate that the quality of existing clinical evidence from anti-obesity trials generally ranges from low to moderate. Most trials suffered from publication bias. Less frequently, trials suffered from the risk of bias mainly due to lack of blindness in the treatment. Our work indicates that additional higher-quality clinical trials are needed to gain more confidence in the estimate of the effect of currently used anti-obesity medicines, to allow more informed clinical decisions, thus reducing the risk of implementing potentially ineffective or even harmful therapeutic strategies.
我们使用推荐评估、发展和评价(GRADE)工具的原则,评估了针对肥胖症的 III/IV 期临床试验药物的证据质量。我们的系统评价评估了现有临床试验的临床证据质量,而不是抗肥胖疗法的药理学疗效。我们在 PubMed 和 ClinicalTrials.gov 数据库中使用单独的选择关键字进行了文献检索,以检索过去十年中的 III/IV 期临床试验。我们的研究结果表明,抗肥胖试验的现有临床证据质量通常从低到中等不等。大多数试验存在发表偏倚。较少情况下,试验存在偏倚风险,主要是由于治疗中缺乏盲法。我们的研究表明,需要更多高质量的临床试验,以增加对当前使用的抗肥胖药物疗效估计的信心,从而做出更明智的临床决策,从而降低实施潜在无效甚至有害治疗策略的风险。