Li Geng, Han Ruxue, Cao Wencong, Wen Zehuai, Chen Xiankun
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong, China.
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, Guangdong, China.
Evid Based Complement Alternat Med. 2021 Jun 10;2021:8822215. doi: 10.1155/2021/8822215. eCollection 2021.
Hyperlipidemia is an underlying process behind cardiovascular disease. Chinese medicine (CM) may be effective in treating hyperlipidemia, but there is a lack of studies with high methodological quality. A major reason for this is heterogeneity in outcome reporting. Therefore, this study explores the degree of outcome reporting variation in CM trials for hyperlipidemia. It then generates a list of potentially important outcomes for developing a core outcome set (COS).
A systematic review of literature focusing on studies of CM for hyperlipidemia was conducted. Outcomes were listed verbatim and grouped into 8 domains. Outcome frequency and definition uniformity were analyzed.
3,702 studies and 452 individual outcomes were identified. These outcomes were reported 27,328 times, of which 1.6% were reported as primary outcomes, and 13.3% were defined. The most frequent outcome was total triglyceride, represented in 86.7% of the studies, followed by total cholesterol (86.0%), total effective rate (75.1%), high-density lipoprotein cholesterol (73.2%), and low-density lipoprotein cholesterol (60.5%). However, 43.6% of outcomes were reported only once. The largest outcome domain was "pathological or pathophysiological outcomes," which included 67.0% of outcomes. Of the "response rate related outcomes" domain, total effective rate was the most frequently reported outcome ( = 2,780), and 95.3% of the studies gave a clear definition. However, these definitions were often contradictory. Only 10 papers reported cardiovascular events, 3 of which referred to them as primary outcomes. Moreover, ten patient-reported outcomes were reported in the retrieved literature 19 times in total. The majority of the outcomes did not report measurement instruments (MIs) (269/453, 59.4%). MIs of the surrogate outcomes were reported more frequently.
Outcome reporting in CM trials for hyperlipidemia is inconsistent and ill-defined, creating barriers to data synthesis and comparison. Thus, we propose and are developing a COS for CM trials for hyperlipidemia.
高脂血症是心血管疾病背后的一个潜在过程。中医可能对治疗高脂血症有效，但缺乏方法学质量高的研究。造成这种情况的一个主要原因是结局报告的异质性。因此，本研究探讨了中医治疗高脂血症试验中结局报告的差异程度。然后生成一份潜在重要结局清单，用于制定核心结局集（COS）。
对聚焦于中医治疗高脂血症研究的文献进行系统评价。逐字列出结局并分为8个领域。分析结局频率和定义一致性。
共识别出3702项研究和452个个体结局。这些结局被报告了27328次，其中1.6%被报告为主要结局，13.3%有定义。最常出现的结局是总甘油三酯，在86.7%的研究中出现，其次是总胆固醇（86.0%）、总有效率（75.1%）、高密度脂蛋白胆固醇（73.2%）和低密度脂蛋白胆固醇（60.5%）。然而，43.6%的结局仅被报告过一次。最大的结局领域是“病理或病理生理结局”，占结局的67.0%。在“与反应率相关的结局”领域，总有效率是报告最频繁的结局（=2780），95.3%的研究给出了明确的定义。然而，这些定义往往相互矛盾。只有10篇论文报告了心血管事件，其中3篇将其作为主要结局。此外，检索到的文献中总共报告了10个患者报告结局19次。大多数结局未报告测量工具（MIs）（269/453，59.4%）。替代结局的测量工具报告得更频繁。
中医治疗高脂血症试验中的结局报告不一致且定义不明确，给数据综合和比较造成了障碍。因此，我们提出并正在制定中医治疗高脂血症试验的核心结局集。
