University of Oxford, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, New Radcliffe Houses, Radcliffe Observatory Quarter, Oxford, UK.
University of Oxford, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, New Radcliffe Houses, Radcliffe Observatory Quarter, Oxford, UK.
Clin Nutr. 2015 Dec;34(6):1109-14. doi: 10.1016/j.clnu.2015.01.004. Epub 2015 Jan 13.
BACKGROUND & AIMS: Hundreds of dietary supplements are marketed as weight loss pills, but the evidence for effectiveness for most is unproven. The objective of this review was to critically appraise and evaluate the evidence from published randomized clinical trials (RCTs) examining the effectiveness of polyglycoplex (PGX), a novel functional fibre, on body weight and metabolic parameters.
We conducted electronic searches in Medline, Embase, Amed, Cinahl and The Cochrane Library. Only double-blinded RCTs were considered for inclusion. The reporting quality of included studies was assessed using the Cochrane criteria. Two reviewers independently determined eligibility, assessed the quality of reporting, and extracted the data.
We included four RCTs with a total of 217 participants. The RCTs varied in the quality of their reporting. The evidence from the RCTs suggested that PGX has no significant effects on body weight; however, significant reductions were noted for total and LDL cholesterol. Adverse events reported included diarrhea and abdominal bloating.
The evidence from available RCTs does not indicate that PGX intake causes reductions in body weight. PGX may cause reductions in total and LDL cholesterol. Few trials examining the effects of PGX have been conducted; they are characterized by small sample sizes, deficiencies in reporting quality, and are funded by a single manufacturer. Future clinical trials evaluating its effect should be adequately powered and better reported.
数以百计的膳食补充剂被作为减肥药销售,但大多数的有效性证据未经证实。本综述的目的是批判性地评估和评价已发表的随机临床试验(RCT)中关于新型功能性纤维聚葡萄糖(PGX)对体重和代谢参数的有效性的证据。
我们在 Medline、Embase、Amed、Cinahl 和 The Cochrane Library 中进行了电子检索。仅考虑纳入双盲 RCT。使用 Cochrane 标准评估纳入研究的报告质量。两名评审员独立确定合格性、评估报告质量,并提取数据。
我们纳入了四项共 217 名参与者的 RCT。这些 RCT 在报告质量上存在差异。RCT 的证据表明 PGX 对体重没有显著影响;然而,总胆固醇和 LDL 胆固醇显著降低。报告的不良事件包括腹泻和腹胀。
现有 RCT 的证据表明 PGX 摄入不会导致体重减轻。PGX 可能会降低总胆固醇和 LDL 胆固醇。已经进行了少数试验来研究 PGX 的影响;这些试验的特点是样本量小、报告质量存在缺陷,并且由单一制造商资助。未来评估其效果的临床试验应具有足够的效力并得到更好的报告。