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Saffron therapy for the treatment of mild/moderate age-related macular degeneration: a randomised clinical trial

Abstract

Purpose

To assess the efficacy and safety of oral saffron, a natural antioxidant, in treating mild/moderate age-related macular degeneration (AMD).

Methods

Randomised, double-blinded, placebo-controlled crossover trial of 100 adults (> 50 years) with mild/moderate AMD and vision > 20/70 Snellen equivalent in at least one eye. Exclusion criteria included confounding visual lesions, or significant gastrointestinal disease impairing absorption. Participants were given oral saffron supplementation (20 mg/day) for 3 months or placebo for 3 months, followed by crossover for 3 months. Participants already consuming Age-Related Eye Diseases Study (AREDS) supplements or equivalent maintained these. Primary outcomes included changes in best-corrected visual acuity (BCVA) and changes in multifocal electroretinogram (mfERG) response density and latency. Secondary outcomes included safety outcomes and changes in mfERG and BCVA amongst participants on AREDS supplements.

Results

Mean BCVA improved 0.69 letters (p = 0.001) and mean-pooled mfERG latency reduced 0.17 ms (p = 0.04) on saffron compared to placebo. Amongst participants on AREDS supplements, mean BCVA improved 0.73 letters p = 0.006) and mean-pooled mfERG response density improved 2.8% (p = 0.038). There was no significant difference in adverse event occurrence (p > 0.10).

Conclusion

Saffron supplementation modestly improved visual function in participants with AMD, including those using AREDS supplements. Given the chronic nature of AMD, longer-term supplementation may produce greater benefits.

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Acknowledgments

No authors have any conflicts of interest to declare. One previous researcher associated with this study who had no participant contact, was previously required to withdraw his involvement from the study due to a conflict of interest. This individual is not an author on this manuscript. Preliminary data from this study was presented at the Royal Australian College of Ophthalmologists Annual Congress, Melbourne, Victoria, Australia, November 2016.

Funding

No funding was received for this research. No funding was associated with the design, conduct or data analysis of this trial. Dr. Chang has previously acted as a consultant for Novartis, Bayer and Alcon.

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Correspondence to Andrew A. Chang.

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All authors certify that they have no affiliations with or involvement in any organisation or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licencing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Cite this article

Broadhead, G.K., Grigg, J.R., McCluskey, P. et al. Saffron therapy for the treatment of mild/moderate age-related macular degeneration: a randomised clinical trial. Graefes Arch Clin Exp Ophthalmol 257, 31–40 (2019). https://doi.org/10.1007/s00417-018-4163-x

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Keywords

  • Clinical trials
  • Age-related macular degeneration
  • Saffron
  • Electroretinogram
  • Nutritional supplementation