title: Alpha-lipoic acid for the prevention of diabetic macular edema.
abstract: BACKGROUND
  To evaluate the effect of α-lipoic acid (ALA) on the occurrence of diabetic macular edema.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, multicenter, multinational study. Patients were randomized to the treatment group with 600 mg ALA per day or the placebo group. Every 6 months stereo fundus photographs, HbA1c levels, and an ophthalmological examination were documented. The primary endpoint was the occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years.
  
  
  RESULTS
  We randomized 235 patients with type II diabetes mellitus into the treatment group (mean age 58.0 years) and 232 into the placebo group (mean age 57.9 years). Mean HbA1c level was 8.1, with no significant differences between the treatment (mean 8.2, SD ± 1.35) and placebo groups (mean 8.1, SD ± 1.29). HbA1c values remained constant over time. In the treatment and placebo groups, 84 and 86 patients (35.7 and 37.1%) had insulin-dependent diabetes mellitus (IDDM) with a median duration of diabetes of 9.3 versus 9.0 years in the placebo group. Visual acuity remained unchanged during the entire trial. Concerning the primary endpoint, the study provided a negative result, i.e. 26/235 patients in the treatment group and 30/232 patients in the placebo group developed CSME. Confirmatory intention-to-treat analysis of the primary endpoint revealed no statistically significant difference between groups (log-rank test, p = 0.7108, HR = 0.9057 with CI = 0.5355-1.5317). Median follow-up was identical (2.00 years).
  
  
  CONCLUSIONS
  A daily dosage of 600 mg ALA does not prevent the occurrence of CSME in IDDM patients.
authors.affiliation: Department of Ophthalmology, Ludwig Maximilian University, Munich, Germany. christos.haritoglou@med.uni-muenchen.de
authors.forename: Christos
authors.initials: C
authors.lastname: Haritoglou
authors.forename: Joachim
authors.initials: J
authors.lastname: Gerss
authors.forename: Hans P
authors.initials: HP
authors.lastname: Hammes
authors.forename: Anselm
authors.initials: A
authors.lastname: Kampik
authors.forename: Michael W
authors.initials: MW
authors.lastname: Ulbig
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008269:Macular Edema / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D013607:Tablets; D008063:Thioctic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D013607:Tablets; D008063:Thioctic Acid; C517652:hemoglobin A1c protein, human