Fadai F, Mousavi B, Ashtari Z, Ali beigi N, Farhang S, Hashempour S, Shahhamzei N, Bathaie S Zahra
Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Clinical Psychiatry Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Pharmacopsychiatry. 2014 Jul;47(4-5):156-61. doi: 10.1055/s-0034-1382001. Epub 2014 Jun 23.
The aim of this study was to assess whether saffron aqueous extract (SAE) or its active constituent, crocin, prevents olanzapine-induced metabolic syndrome (MetS) and insulin resistance in patients with schizophrenia.
66 patients diagnosed with schizophrenia who were on olanzapine treatment (5-20 mg daily) were randomly allocated to receive a capsule of SAE (n=22; 30 mg daily), crocin (n=22; 30 mg daily) or placebo (n=22) in a 12-week triple-blind trial. Patients were screened not to have MetS at baseline and further assessment was done at weeks 6 and 12. Measurement of fasting blood glucose (FBS) and serum lipids were repeated at weeks 2, 6 and 12. Fasting blood levels of insulin and HbA1c were also measured at baseline and week 12. HOMA-IR and HOMA-β were determined to evaluate insulin resistance.
61 patients completed the trial and no serious adverse effects were reported. Time-treatment interaction showed a significant difference in FBS in both SAE and crocin groups compared to placebo (p=0.004). In addition, SAE could effectively prevent reaching the criteria of metabolic syndrome (0 patients) compared to crocin (9.1%) and placebo (27.3%) as early as week 6.
SAE could prevent metabolic syndrome compared to crocin and placebo. Furthermore, both SAE and crocin prevented increases in blood glucose during the study.
本研究旨在评估藏红花水提取物（SAE）或其活性成分藏红花素是否能预防精神分裂症患者中奥氮平诱导的代谢综合征（MetS）和胰岛素抵抗。
66例诊断为精神分裂症且正在接受奥氮平治疗（每日5 - 20毫克）的患者，在一项为期12周的三盲试验中被随机分配接受SAE胶囊（n = 22；每日30毫克）、藏红花素（n = 22；每日30毫克）或安慰剂（n = 22）。患者在基线时经筛查无MetS，并在第6周和第12周进行进一步评估。在第2周、第6周和第12周重复测量空腹血糖（FBS）和血脂。还在基线和第12周测量空腹血胰岛素水平和糖化血红蛋白（HbA1c）。通过计算稳态模型评估胰岛素抵抗指数（HOMA - IR）和稳态模型评估β细胞功能指数（HOMA - β）来评估胰岛素抵抗。
61例患者完成试验，未报告严重不良反应。时间 - 治疗交互作用显示，与安慰剂相比，SAE组和藏红花素组的FBS有显著差异（p = 0.004）。此外，早在第6周时，与藏红花素组（9.1%）和安慰剂组（27.3%）相比，SAE能有效预防达到代谢综合征标准（0例患者）。
与藏红花素和安慰剂相比，SAE可预防代谢综合征。此外，在研究期间，SAE和藏红花素均能预防血糖升高。
