A randomized, placebo-controlled, croover clinical trial of uper blue-green algae in patient with eential blepharopam or Meige yndrome

Purpoe To evaluate the effectivene of uper blue-green algae (BGA) upplement on the everity of eential blepharopam treated with botulinum toxin A injection. Deign Double-maked, placebo-controlled, two-period, croover randomized trial. Patient and method The tudy wa carried out in patient with eential blepharopam or Meige yndrome undergoing routine treatment with botulinum toxin A injection. Intervention Patient were randomly aigned to either BGA capule or placebo. After 6 month of treatment, patient underwent a 6-month wahout period with no treatment, then were adminitered the alternate treatment for an additional 6 month, thu erving a their own control. Main outcome meaure Video documentation of blink rate and involuntary facial movement, time between botulinum toxin A injection, and patientʹ ubjective aement of the impact of blepharopam on functioning were obtained at the beginning and end of the firt and econd (croover) treatment period. Reult A total of 24 patient (10 men, 14 women; aged 42 to 83 year) completed both treatment period. Mean within-patient difference in blink rate between BGA and placebo period wa −2.1 blink per 2 minute (95% confidence interval [CI]: −20.8–+31.9), not tatitically different from zero (P = .83). Mean within-patient difference in time between injection between BGA and placebo period wa 4.6 day (95% CI: −13.3–+22.5), not tatitically different from zero (P = .62). The lack of tatitical ignificance may have been becaue of mall ample ize. There were no ignificant difference in everity of involuntary movement between BGA and placebo treatment period. However, patient were more likely to report limitation in function during the period they took BGA than during the period they took placebo (odd ratio, 0.2; P = .03). Concluion Overall, we found no evidence of a beneficial effect of BGA a an adjunct to botulinum toxin A injection; however, a few patient, all younger than 60 year, did appear to benefit from BGA