Department of Pharmacology, Research Center of Physiology, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran.
Department of Internal Medicine, Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran.
J Ethnopharmacol. 2021 Dec 5;281:114511. doi: 10.1016/j.jep.2021.114511. Epub 2021 Aug 11.
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the complications vexes patients treated with anti-cancer agents. Saffron has been demonstrated to attenuate symptoms of peripheral neuropathy in animal models. Also, there is a published clinical trial that investigated the pain relieving effect of saffron following nationally accepted rules and concluded that saffron was successful in alleviating pain symptoms in patients suffering from fibromyalgia.
We aimed to determine the efficacy of crocin as a constituent of saffron in CIPN as the first report.
One hundred and seventy-seven enrolled eligible patients (between December 2018 and March 2020) for study entry were cases demonstrating mild to severe symptomatic CIPN for at least a month. These cases were randomly assigned to two main groups including 15 mg crocin tablet, bid (30 mg total daily target dose) and placebo tablet for 8 weeks. A crossover study was performed with a 2-week washout period. Patient outcomes were measured once a week for 8 consecutive weeks.
Grade of sensory, motor and neuropathic pain decreased considerably and significantly in the crocin group compared with placebo (P < 0.05). Observed toxicities were mild and adverse effects had no significant differences between the two groups (P > 0.05).
Crocin considerably seems to be effective for relieving symptoms of CIPN in cancer patients receiving chemotherapy agents. However, further studies are needed about crocin with its beneficial neuropharmacological effects and lower adverse effects than the chemical agents such as antidepressants, lamotrigine, and gabapentin.
化疗引起的周围神经病变（CIPN）是接受抗癌药物治疗的患者的并发症之一。藏红花已被证明可减轻动物模型中周围神经病变的症状。此外，还有一项已发表的临床试验，根据国家认可的规则调查了藏红花的止痛效果，结论是藏红花成功缓解了纤维肌痛患者的疼痛症状。
我们旨在首次确定藏红花中的藏红花酸作为 CIPN 的一种成分的疗效。
177 名符合条件的入组患者（2018 年 12 月至 2020 年 3 月）患有至少一个月的轻度至重度有症状 CIPN。这些病例被随机分为两组，包括每天两次 15mg 藏红花酸片（每天总目标剂量 30mg）和安慰剂片，共 8 周。进行了为期 2 周洗脱期的交叉研究。患者的结局在 8 周内每周测量一次。
与安慰剂相比，藏红花酸组的感觉、运动和神经痛程度明显降低（P<0.05）。观察到的毒性轻微，两组之间不良反应无显著差异（P>0.05）。
藏红花酸似乎对缓解接受化疗药物的癌症患者 CIPN 的症状非常有效。然而，需要进一步研究藏红花及其有益的神经药理学作用，以及与抗抑郁药、拉莫三嗪和加巴喷丁等化学药物相比不良反应较低的问题。
