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Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

ABSTRACT: Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism.Prospective, randomized, placebo-controlled, double-masked clinical trial conducted at the University of Minnesota.Forty-five subjects with albinism.Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76?mg/kg with 25% carbidopa, levodopa 0.51?mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side-effects were recorded with a symptom survey. Blood was drawn for genotyping.Side-effects and best-corrected visual acuity 20 weeks after enrolment.All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow up was 100% and compliance was good. Minor side-effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa.Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism.

SUBMITTER: Summers CG

PROVIDER: S-EPMC4169362 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

Summers C Gail CG Connett John E JE Holleschau Ann M AM Anderson Jennifer L JL De Becker Inge I McKay Brian S BS Brilliant Murray H MH

Clinical & experimental ophthalmology 20140505 8

<h4>Background</h4>Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism.<h4>Design</h4>Prospective, randomized, placebo-controlled, double-masked clinical trial conduct ...[more]

PMID: 24641678

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Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundScreening colonoscopy has been associated with reduced mortality from colorectal cancer by means of early detection and timely treatment. However, visualization during colonoscopy is often impaired since the colon is naturally prone to peristalsis and spasm. There is evidence to suggest benefit of topical peppermint oil in causing smooth muscle relaxation, thereby decreasing peristalsis. The aim of our study was to determine if peppermint oil helps reduce colonic spasticity so as to allow for better visualization during screening colonoscopy.MethodsWe performed a randomized controlled, double-blinded, clinical trial where patients undergoing screening colonoscopy were assigned to receive either peppermint oil or placebo. Once cecum was reached, 50 mL of either solution was directly injected via the working channel of the colonoscope. Colonic peristalsis, spasticity and bowel visibility were documented. Bowel preparation quality, withdrawal time and adenoma detection rate (ADR) were also assessed. Continuous variables were analyzed using t-test or Wilcoxon rank-sum test while categorical variables were compared using the two-way Chi-square test.ResultsForty-eight patients were included, of whom 24 patients received peppermint oil and 24 received placebo. Mean Boston bowel preparation score (BBPS) was excellent for both groups (8 points vs. 7.9 points; P = 0.98). Both mean total colonoscopy time (17.8 min vs. 21.9 min; P = 0.07) and mean cecal intubation time (7.2 min vs. 10.3 min; P = 0.04) were shorter with peppermint oil as compared to placebo. Complete absence of bowel spasticity was observed among 58.3% patients in the peppermint oil group as compared to 45.8% patients in the placebo group (P = 0.05). More than 75% of bowel was visualized in 83% of patients in both groups (P = 0.56). Mean ADR was higher in the peppermint group as compared to the placebo group (45.8% vs. 37.5%; P = 0.56).ConclusionOur study suggests that topical peppermint oil reduces bowel wall spasticity, which could lead to better visualization of the bowel during screening colonoscopy. Although use of peppermint oil was associated with better ADRs, these results did not achieve statistical significance. Larger sample size and use of alternative methods of peppermint oil administration allowing for more absorption time may establish stronger results.

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Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

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Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

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