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A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Leber Hereditary Optic Neuropathy

Authors

  • Wanicha Chuenkongkaew Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Nopasak Phasukkijwatana Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Patcharee Wichyanuwat Department of Biochemistry, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Rataya Luechapudiporn Department of Pharmacology and Physiology, Faculty of Pharmaceutical Sciences, Chulalongkorn University
  • Chada Phisalaphong Government Pharmaceutical Organization
  • Visanu Thamlikitkul Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Niphon Chirapapaisan Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University
  • Siriwan Loket Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University

Keywords:

Leber hereditary optic neuropathy (LHON), 11778 mutation, curcuminoids

Abstract

Purpose: To investigate the role of curcuminoids, an antioxidant property, in vision and blood oxidative status
in G11778A Leber hereditary optic neuropathy (LHON) patients.

Methods: A total of 49 G11778A LHON patients (97 eyes) were randomly assigned to receive either 250 mg of
oral curcuminoids capsules (500 mg/day) or placebo capsules twice a day for 48 weeks. The visual parameters including
visual acuity, Humphrey visual field, visual evoked potential and electroretinogram were assessed at 0, 12, 24, 36 and
48 weeks after the intervention. The marker for oxidative stress, malondialdehyde (MDA) in plasma, and endogenous
antioxidants in erythrocytes comprising superoxide dismutase (SOD), catalase, glutathione peroxidase (GSH-Px) and
total glutathione (GSH) were measured at 0, 12, 24, and 48 weeks. Adverse events were recorded.

Results: Twenty-seven (53 eyes) and 22 (44 eyes) patients were randomized to the curcuminoids and placebo
groups, respectively. The two groups were comparable in age of onset, baseline VA and duration of LHON. There
were no significant changes in any visual or oxidative parameters between the two groups. There seemed to be slight
improvement of the mean deviation of HVF from baseline at week 36 and 48 (P = 0.027), which was statistically
significant in the curcuminoids group but not in the placebo groups. A trend of reduction of erythrocyte GSH-Px,
indicating improvement of oxidative status, was observed in curcuminoids but not in the placebo group. No significant
difference of adverse events between both groups was found.

Conclusions: Curcuminoids at this dose did not have significant effects on the visual and blood oxidative status
compared to the placebo. However, the slight improvement of HVF-MD, a trend of reduction of GSH-Px in the
curcuminoids group and the safety of curcuminoids suggested that further studies with higher doses and especially in
the acute stage of LHON should be considered.

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2022-08-23

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