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Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy.

ABSTRACT: To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment.Patients (n = 221, ages, 9-17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n = 114). The placebo therapy program was designed to appear to be real vergence/accommodative therapy, without stimulating vergence, accommodation, or fine saccades (beyond levels of daily visual activities). After treatment, patients in the office-based groups were asked whether they thought they had received real or placebo therapy and how confident they were in their answers.Ninety-three percent of patients assigned to real therapy and 85% assigned to placebo therapy thought they were in the real therapy group (P = 0.17). No significant differences were found between the two groups in adherence to the therapy (P >or= 0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, race, or ethnicity (P > 0.30 for all comparisons). No association was found between patients' perception of group assignment and symptoms or signs at outcome (P >or= 0.38 for all comparisons).The CITT placebo therapy program was effective in maintaining patient masking in this study and therefore may have potential for use in future clinical trials using vergence/accommodative therapy. Masking was not affected by demographic variables. Perception of group assignment was not related to symptoms or signs at outcome (ClinicalTrials.gov number, NCT00338611).

SUBMITTER: Kulp M

PROVIDER: S-EPMC2759605 | biostudies-literature | 2009 Jun

REPOSITORIES: biostudies-literature

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Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy.

Kulp Marjean M Mitchell G Lynn GL Borsting Eric E Scheiman Mitchell M Cotter Susan S Rouse Michael M Tamkins Susanna S Mohney Brian G BG Toole Andrew A Reuter Kathleen K

Investigative ophthalmology & visual science 20090117 6

<h4>Purpose</h4>To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment.<h4>Methods</h4>Patients (n = 221, ages, 9-17 years) were randomized to one of four treatment groups, two of wh ...[more]

PMID: 19151384

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Project description:AIM:The aim of this study was to explore associations between reduced stereoacuity and clinical measures of accommodation, vergences, and symptoms which could facilitate the development of quick and reliable screening tools. METHODS:Using a multi-stage random cluster sampling, 1211 high school students (481 males and 730 females) between 13 and 18 years of age, were selected and examined. Visual acuity, stereoacuity and suppression, refractive errors, near point of convergence, heterophoria and fusional vergences, as well as, amplitude of accommodation, accommodative response, facility and relative accommodation were evaluated. Correlations among variables and the validity of Randot stereoacuity to distinguish between children with and without defective clinical measures as well as symptomatic versus asymptomatic children were characterized by the sensitivity and specificity of the tests. RESULTS:The overall mean stereoacuity was 43.9?±?25.23?s arc, and 18.9% [95% Confidence Interval, 16.6-21.4%)] of the participants had reduced stereoacuity (defined as ?60). Stereoacuity values and symptoms scores were worse in children with defective clinical measures. The Receiver Operation Curve showed that maximum sensitivity and specificity was obtained with near point of convergence break (?10?cm) of (0.70 95% confidence interval: 0.63-0.77) with Randot stereoacuity test (defined as ?60?s arc). The correlations between reduced stereoacuity and symptoms scores was moderately strong and statistically significant (Pearson's, r?=?0.507, p?=?0.01). The Receiver Operation Curve showed that maximum sensitivity and specificity obtained with the Convergence Insufficiency Symptoms Survey was 0.57 (95% Confidence interval?=?0.53-0.62, p?=?0.001), sensitivity of 90.26%, and specificity 15.26% with the Randot stereoacuity test. CONCLUSION:Reduced stereoacuity, defective clinical measures and symptoms of asthenopia were prevalent among sample of school children studied. Randot stereoacuity test could fairly distinguish between defective and normal clinical measures; though the accuracy to differentiate between symptomatic and asymptomatic school children is poor. These findings highlight the need for validation of a simple and fast screening tool in school settings. Further studies to confirm above findings will be needed.

Project description:To assess progesterone treatment of intractable seizures in women with partial epilepsy.This randomized, double-blind, placebo-controlled, phase III, multicenter, clinical trial compared the efficacy and safety of adjunctive cyclic natural progesterone therapy vs placebo treatment of intractable seizures in 294 subjects randomized 2:1 to progesterone or placebo, stratified by catamenial and noncatamenial status. It compared treatments on proportions of ?50% responders and changes in seizure frequency from 3 baseline to 3 treated menstrual cycles.There was no significant difference in proportions of responders between progesterone and placebo in the catamenial and noncatamenial strata. Prespecified secondary analysis showed that the level of perimenstrual seizure exacerbation (C1 level) was a significant predictor of responders for progesterone but not placebo. With increasing C1 levels, responders increased from 21% to 57% with progesterone vs 19% to 20% with placebo. Reductions in seizure frequency correlated with increasing C1 levels for progesterone but not placebo, progressing from 26% to 71% for progesterone vs 25% to 26% for placebo. A prespecified clinically important separation between progesterone and placebo responders (37.8% vs 11.1%; p = 0.037) was realized among 21.4% of women who had C1 level ?3.There was no difference in the primary outcome of ?50% responder rates between progesterone vs placebo for catamenial or noncatamenial groups. Post hoc findings suggest that the level of perimenstrual seizure exacerbation is a significant predictor of responder rate with progesterone and that progesterone may provide clinically important benefit for a subset of women with perimenstrually exacerbated seizures.This study provides Class III evidence that cyclic progesterone is ineffective in women with intractable partial epilepsy. Post hoc analysis identified a subset of women with higher levels of perimenstrual seizure exacerbation that were responsive to treatment.

Project description:BackgroundThe objective of this randomized clinical trial was to evaluate Low-Level Laser Therapy (LLLT) effectiveness in spontaneous and chewing pain reduction following initial orthodontic archwire placement.Methods26 patients (mean age 20.07 ± 3.13 years) with maxillary Little's Irregularity Index (LII) of 7 mm or more that indicates first maxillary premolars extraction and no medications intake were eligible for this trial. Patients were randomly assigned with 1:1 ratio using simple randomization technique to receive either LLL or placebo treatment. Blinding was applicable for patients only. In the laser group, patients received a single LLL dose (wavelength 830 nm, energy 2 J/point) in four points (2 buccal, 2 palatal) for each maxillary anterior tooth root. Patients in the placebo group had the same laser application procedure without emitting the laser beam. Patients were asked to score spontaneous and chewing pain intensity by filling out a questionnaire with a 100-mm Visual Analogue Scale (VAS) after 1, 6, 24, 48, and 72 h of treatment application. Independent t-test was used to compare the mean pain scores between the laser and placebo groups for both spontaneous and chewing pain at each studied time point.ResultsNo dropout occurred so the results of the 26 patients were statistically analyzed. Despite some clinical differences observed between the two groups, no statistical significance was found for each studied time point (p > 0.05) for both spontaneous and chewing pain except after 72 h for chewing pain with a VAS score of (18.84 ± 13.44) mm for the laser group compared to (38.15 ± 27.06) mm for the placebo group.ConclusionsLLLT, with the suggested parameters, is not effective in pain reduction following initial orthodontic archwire placement.Trial registrationName of the registry: Clinicaltrials.gov Trial registration number: NCT02568436. Date of registration: 26 September 2015 'Retrospectively registered'.

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Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy.

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Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy.

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