Saffron therapy for the ongoing treatment of age-related macular degeneration

IF 2 Q2 OPHTHALMOLOGY BMJ Open Ophthalmology Pub Date : 2024-03-01 DOI:10.1136/bmjophth-2023-001399
Geoffrey K Broadhead, John Grigg, Peter J McCluskey, Thomas Hong, Timothy E Schlub, Eugenia Chu, Andrew A Chang
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Abstract

Objective To assess the long-term efficacy and safety of oral saffron, a natural antioxidant, in treating mild/moderate age-related macular degeneration (AMD). Methods and analysis Open-label, extension trial of 93 adults (>50 years) with mild/moderate AMD and vision >20/70 Snellen equivalent in at least 1 eye. Exclusion criteria included confounding visual lesions or significant gastrointestinal disease impairing absorption. Participants were given oral saffron supplementation (20 mg/day) for 12 months. Those already consuming Age-Related Eye Diseases Study (AREDS) supplements or equivalent maintained these. Primary outcomes included changes in multifocal electroretinogram (mfERG) response density and latency, and changes in best-corrected visual acuity (BCVA). Secondary outcomes included safety outcomes, changes in mfERG and BCVA among participants on AREDS supplements and changes in microperimetry. Results At 12 months, mean mfERG response density was significantly higher in rings 1, 2 and overall (p<0.001 for all) but not in rings 3–6, and there was no difference in response between those taking AREDS supplements and those not (p>0.05). Mean mfERG latency was not significantly different in any of rings 1–6 or overall (p>0.05 for all), again with no difference between those taking AREDS supplements or not (p>0.05). Mean BCVA was 1.6 letters worse (p<0.05) with no difference between those on AREDS supplements or not, and this may have been related to cataract progression. No saffron-related serious adverse events were detected. Conclusion Saffron supplementation modestly improved mfERG responses in participants with AMD, including those using AREDS supplements. Given the chronic nature of AMD, longer-term supplementation may produce greater benefits. Data are available on reasonable request. Deidentified data used or analysed are available from the corresponding author on reasonable request.
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藏红花疗法用于老年黄斑变性的持续治疗
目的 评估天然抗氧化剂藏红花口服液治疗轻度/中度老年性黄斑变性(AMD)的长期疗效和安全性。方法和分析 对 93 名患有轻度/中度老年性黄斑变性且至少单眼视力大于 20/70 斯奈伦等效视力的成年人(年龄大于 50 岁)进行开放标签扩展试验。排除标准包括影响视力的病变或影响吸收的严重胃肠道疾病。参与者将连续 12 个月口服藏红花补充剂(20 毫克/天)。已经服用老年性眼病研究(AREDS)补充剂或同等补充剂的人继续服用。主要结果包括多焦视网膜电图(mfERG)反应密度和潜伏期的变化,以及最佳矫正视力(BCVA)的变化。次要结果包括安全性结果、AREDS补充剂参与者的mfERG和BCVA变化以及显微视力测定的变化。结果 12 个月时,1、2 环和整体的平均 mfERG 反应密度明显更高(P0.05)。1-6 环和整体的平均 mfERG 潜伏期没有明显差异(P>0.05),服用或未服用 AREDS 补充剂的患者之间也没有差异(P>0.05)。BCVA 平均值降低了 1.6 个字母(p<0.05),服用或未服用 AREDS 补充剂者之间没有差异,这可能与白内障进展有关。未发现与藏红花相关的严重不良事件。结论 补充藏红花可适度改善 AMD 患者的 mfERG 反应,包括使用 AREDS 补充剂的患者。鉴于 AMD 的慢性性质,长期补充可能会产生更大的益处。如有合理要求,可提供相关数据。如提出合理要求,可向通讯作者索取所使用或分析的去身份数据。
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来源期刊
BMJ Open Ophthalmology
BMJ Open Ophthalmology OPHTHALMOLOGY-
CiteScore
3.40
自引率
4.20%
发文量
104
审稿时长
20 weeks
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