{"title":"中心性浆液性脉络膜视网膜病变患者补充巴豆苷的有效性和安全性--一项随机双盲临床试验","authors":"Mohammadkarim Johari, Alireza Attar, Mojtaba Heydari","doi":"10.1016/j.phanu.2024.100422","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Central Serous Chorioretinopathy (CSCR) is a vision-threatening condition characterized by serous retinal detachment. Crocin, a carotenoid compound found in saffron, has demonstrated antioxidant and anti-inflammatory properties in various retinal diseases, but its efficacy in CSCR remains understudied.</div></div><div><h3>Methods</h3><div>In this randomized controlled trial, 40 patients with CSCR were assigned to receive either crocin (n=20) or placebo (n=20) over an eight-weeks period. Visual acuity, anatomical outcomes measured by optical coherence tomography (OCT), and adverse events were assessed at baseline and at the end of the intervention period.</div></div><div><h3>Results</h3><div>There were no significant differences observed in age, weight, body mass index, or gender distribution between the two groups (p > 0.05 for all comparisons). The changes in mean ETDRS letter score were significantly more in crocin group compared to the placebo group (4.27±3.63 vs 0.57±7.23, respectively, p=0.024). In the crocin group, 20 %, 40 % and 80 % of patients showed an improvement of 10,5 and 1 ETDRS letters, compared to only 7 %, 21 % and 29 % in the placebo group (p=0.316, p=0.280, p=0.005, respectively). While the crocin group exhibited greater mean reductions in sub-retinal fluid height, central macular thickness, and choroidal thickness compared to the placebo group, these differences did not reach statistical significance (p > 0.05 for all comparisons). No adverse events associated with the trial intervention were reported by any patient in either the crocin or placebo group.</div></div><div><h3>Conclusion</h3><div>The findings of this pilot study suggest that crocin supplementation may lead to improvements in visual acuity in patients with CSCR. Differences in anatomical outcomes between crocin and placebo groups did not reach statistical significance in this pilot study.</div></div>","PeriodicalId":20049,"journal":{"name":"PharmaNutrition","volume":"30 ","pages":"Article 100422"},"PeriodicalIF":2.4000,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of crocin supplementation in patients with central serous chorioretinopathy, a pilot randomized double blinded clinical trial\",\"authors\":\"Mohammadkarim Johari, Alireza Attar, Mojtaba Heydari\",\"doi\":\"10.1016/j.phanu.2024.100422\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Central Serous Chorioretinopathy (CSCR) is a vision-threatening condition characterized by serous retinal detachment. Crocin, a carotenoid compound found in saffron, has demonstrated antioxidant and anti-inflammatory properties in various retinal diseases, but its efficacy in CSCR remains understudied.</div></div><div><h3>Methods</h3><div>In this randomized controlled trial, 40 patients with CSCR were assigned to receive either crocin (n=20) or placebo (n=20) over an eight-weeks period. Visual acuity, anatomical outcomes measured by optical coherence tomography (OCT), and adverse events were assessed at baseline and at the end of the intervention period.</div></div><div><h3>Results</h3><div>There were no significant differences observed in age, weight, body mass index, or gender distribution between the two groups (p > 0.05 for all comparisons). The changes in mean ETDRS letter score were significantly more in crocin group compared to the placebo group (4.27±3.63 vs 0.57±7.23, respectively, p=0.024). In the crocin group, 20 %, 40 % and 80 % of patients showed an improvement of 10,5 and 1 ETDRS letters, compared to only 7 %, 21 % and 29 % in the placebo group (p=0.316, p=0.280, p=0.005, respectively). While the crocin group exhibited greater mean reductions in sub-retinal fluid height, central macular thickness, and choroidal thickness compared to the placebo group, these differences did not reach statistical significance (p > 0.05 for all comparisons). No adverse events associated with the trial intervention were reported by any patient in either the crocin or placebo group.</div></div><div><h3>Conclusion</h3><div>The findings of this pilot study suggest that crocin supplementation may lead to improvements in visual acuity in patients with CSCR. Differences in anatomical outcomes between crocin and placebo groups did not reach statistical significance in this pilot study.</div></div>\",\"PeriodicalId\":20049,\"journal\":{\"name\":\"PharmaNutrition\",\"volume\":\"30 \",\"pages\":\"Article 100422\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-11-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"PharmaNutrition\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2213434424000483\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"NUTRITION & DIETETICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"PharmaNutrition","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2213434424000483","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}
Efficacy and safety of crocin supplementation in patients with central serous chorioretinopathy, a pilot randomized double blinded clinical trial
Background
Central Serous Chorioretinopathy (CSCR) is a vision-threatening condition characterized by serous retinal detachment. Crocin, a carotenoid compound found in saffron, has demonstrated antioxidant and anti-inflammatory properties in various retinal diseases, but its efficacy in CSCR remains understudied.
Methods
In this randomized controlled trial, 40 patients with CSCR were assigned to receive either crocin (n=20) or placebo (n=20) over an eight-weeks period. Visual acuity, anatomical outcomes measured by optical coherence tomography (OCT), and adverse events were assessed at baseline and at the end of the intervention period.
Results
There were no significant differences observed in age, weight, body mass index, or gender distribution between the two groups (p > 0.05 for all comparisons). The changes in mean ETDRS letter score were significantly more in crocin group compared to the placebo group (4.27±3.63 vs 0.57±7.23, respectively, p=0.024). In the crocin group, 20 %, 40 % and 80 % of patients showed an improvement of 10,5 and 1 ETDRS letters, compared to only 7 %, 21 % and 29 % in the placebo group (p=0.316, p=0.280, p=0.005, respectively). While the crocin group exhibited greater mean reductions in sub-retinal fluid height, central macular thickness, and choroidal thickness compared to the placebo group, these differences did not reach statistical significance (p > 0.05 for all comparisons). No adverse events associated with the trial intervention were reported by any patient in either the crocin or placebo group.
Conclusion
The findings of this pilot study suggest that crocin supplementation may lead to improvements in visual acuity in patients with CSCR. Differences in anatomical outcomes between crocin and placebo groups did not reach statistical significance in this pilot study.