Effect of a protein and energy dense n-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial
Effect of a protein and energy dense n-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial
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DOI：
10.1136/gut.52.10.1479
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发表时间：
2003-10-01
期刊：
影响因子：
24.5
通讯作者：
Tisdale, MJ
中科院分区：
文献类型：
--
作者：
Fearon, KCH;von Meyenfeldt, MF;Tisdale, MJ
目的：N-3 脂肪酸，尤其是二十碳五烯酸 (EPA)，可能具有抗恶病质特性。该试验比较了富含 n-3 脂肪酸和抗氧化剂的蛋白质和能量密集补充剂（实验性：E）与等热量等氮对照补充剂（C）对晚期胰腺癌恶病质患者的体重、去脂体重 (LBM)、饮食摄入量和生活质量的影响。方法：总共 200 名患者（95 E；105 C）被随机分配每天服用两罐 E 或 C 补充剂（480 毫升，在一项多中心、随机、双盲试验中，摄入 620 kcal、32 g 蛋白质 +/- 2.2 g EPA）为期八周。 结果：入组时，患者的平均体重减轻率为 3.3 kg/月。补充剂（E 或 C）的摄入量低于推荐剂量（2 罐/天），平均 1.4 罐/天。八周内，两组患者的体重（Deltaweight E：-0.25 kg/月 vs C：-0.37 kg/月；p = 0.74）和 LBM（Deltaweight E：+ 0.27 kg/月 vs C：+ 0.12 kg/月；p = 0.88）均停止相同程度的减轻（相对于基线 E 和 C 的变化，p < 0.001）。鉴于 E 组和 C 组均存在明显的不依从性，因此进行了相关分析以检查潜在的剂量反应关系。 E 患者的补充剂摄入量与体重增加 (r = 0.50, p, 0.001) 和 LBM 增加 (r = 0.33, p = 0.036) 之间存在显着相关性。这种相关性在 C 患者中不具有统计学意义。 E 型和 C 型患者的补充剂摄入量与 LBM 变化的关系存在显着差异 (p = 0.043)。 E 组血浆 EPA 水平升高与体重和 LBM 增加相关（r = 0.50，p，0.001；r = 0.51，p = 0.001）。仅在 E 组中，体重增加与生活质量改善相关（p<0.01）。 结论：意向治疗组比较表明，在平均服用剂量下，补充 n-3 脂肪酸并没有提供治疗优势，并且两种补充剂在阻止体重减轻方面同样有效。事后剂量反应分析表明，如果摄入足够的量，只有富含 n-3 脂肪酸的能量和蛋白质密集的补充剂才会导致体重、瘦肉组织的净增加和生活质量的改善。需要进一步的试验来检验富含 n-3 的补充剂在治疗癌症恶病质中的潜在作用。
Aim: N-3 fatty acids, especially eicosapentaenoic acid (EPA), may possess anticachectic properties. This trial compared a protein and energy dense supplement enriched with n-3 fatty acids and antioxidants ( experimental: E) with an isocaloric isonitrogenous control supplement ( C) for their effects on weight, lean body mass ( LBM), dietary intake, and quality of life in cachectic patients with advanced pancreatic cancer.Methods: A total of 200 patients ( 95 E; 105 C) were randomised to consume two cans/day of the E or C supplement ( 480 ml, 620 kcal, 32 g protein +/- 2.2 g EPA) for eight weeks in a multicentre, randomised, double blind trial.Results: At enrolment, patients' mean rate of weight loss was 3.3 kg/month. Intake of the supplements ( E or C) was below the recommended dose ( 2 cans/day) and averaged 1.4 cans/day. Over eight weeks, patients in both groups stopped losing weight (Deltaweight E: -0.25 kg/month versus C: -0.37 kg/month; p = 0.74) and LBM (DeltaLBM E: + 0.27 kg/month versus C: + 0.12 kg/month; p = 0.88) to an equal degree ( change from baseline E and C, p< 0.001). In view of evident non-compliance in both E and C groups, correlation analyses were undertaken to examine for potential dose-response relationships. E patients demonstrated significant correlations between their supplement intake and weight gain ( r = 0.50, p, 0.001) and increase in LBM ( r = 0.33, p = 0.036). Such correlations were not statistically significant in C patients. The relationship of supplement intake with change in LBM was significantly different between E and C patients ( p = 0.043). Increased plasma EPA levels in the E group were associated with weight and LBM gain ( r = 0.50, p, 0.001; r = 0.51, p = 0.001). Weight gain was associated with improved quality of life ( p< 0.01) only in the E group.Conclusion: Intention to treat group comparisons indicated that at the mean dose taken, enrichment with n-3 fatty acids did not provide a therapeutic advantage and that both supplements were equally effective in arresting weight loss. Post hoc dose-response analysis suggests that if taken in sufficient quantity, only the n-3 fatty acid enriched energy and protein dense supplement results in net gain of weight, lean tissue, and improved quality of life. Further trials are required to examine the potential role of n-3 enriched supplements in the treatment of cancer cachexia.