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Biomedical subjects
J Hendler
Publications and source records attributed to J Hendler.
Efficacy of a chlorine dioxide-containing mouthrinse in oral malodor.
Studies have suggested that when chlorine dioxide is contained in a mouthrinse, it neutralizes volatile sulfur compounds in mouth air. The efficacy of a chlorine dioxide-containing mouthrinse in the reduction of oral malodor was evaluated in a randomized, controlled, double-blind, parallel group study of 31 men and women. Subjects with a maximum odor pleasantness score of < or = -1 (slightly unpleasant/stale) on a 7-point ordinal scale at both screening and baseline were randomized to treatment with the chlorine dioxide-containing rinse (n = 16) or distilled water (negative control) (n = 15). Oral malodor was evaluated at baseline (prerinse) and at 2, 4, 8, 24, 48, 72, and 96 hours postrinse by both a trained, previously calibrated panel of organoleptic judges and a factory-calibrated portable sulfide monitor. The sulfide monitor measured concentrations of volatile sulfur compounds in the subjects' mouth air 3 minutes after completion of the organoleptic assessment at each time point. The correlation between the organoleptic assessments and log-transformed sulfide monitor values was evaluated. With the chlorine dioxide mouthrinse, a statistically significant improvement in odor pleasantness, reduction in odor intensity, and reduction in oral volatile sulfur compound concentrations compared to the water control were evident at 2 hours postrinse and persisted through 8 hours postrinse. The mean (+/- SD) odor pleasantness improved from -1.25 +/- 0.31 at baseline to -0.73 +/- 0.33 at 2 hours postrinse in the chlorine dioxide group compared to -1.40 +/- 0.38 at baseline to -1.31 +/- 0.67 at 2 hours in the control group (P < 0.01). Odor pleasantness reached its maximum change from baseline to 0.63 +/- 0.45 at 8 hours postrinse. The mean (+/- SD) log-transformed sulfide monitor measurement decreased from 5.40 +/- 0.29 at baseline to 5.17 +/- 0.13 at 2 hours postrinse in the chlorine dioxide group, but increased from 5.47 +/- 0.40 at baseline to 5.56 +/- 0.54 at 2 hours in the control group (P < 0.01). As measured by the sulfide monitor, the mean volatile sulfur compound concentration in the chlorine dioxide group reached its minimum level at 8 hours postrinse (change from baseline in the log-transformed Halimeter measurement of -0.35 +/- 0.31). Thus, this study demonstrates that a one-time use of a chlorine dioxide-containing mouthrinse significantly improves mouth odor pleasantness, reduces mouth odor intensity, and reduces volatile sulfur compound concentrations in mouth air for at least 8 hours after use.
Adult↗
Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam.
The Observer's Assessment of Alertness/Sedation (OAA/S) Scale was developed to measure the level of alertness in subjects who are sedated. This scale was tested in 18 subjects in a three-period crossover study to assess its reliability and its criterion, behavioral, and construct validity. After receiving either placebo or a titrated dose of midazolam to produce light or heavy sedation, each subject was administered two sedation scales (OAA/S Scale and a Visual Analogue Scale) and two performances tests (Digit Symbol Substitution Test and Serial Sevens Subtraction). Two raters individually evaluated the subject's level of alertness on each of the two sedation scales. The results obtained on the OAA/S Scale were reliable and valid as measured by high correlations between the two raters and high correlations between the OAA/S Scale and two of the three standard tests used in this study. The OAA/S Scale was sensitive to the level of midazolam administered; all pairwise comparisons were significant (p less than 0.05) for all three treatment levels at both test periods.
Adult↗
Flumazenil: US clinical pharmacology studies.
Flumazenil, a benzodiazepine antagonist, blocks the central effects of benzodiazepines by competitive interaction at the receptor site. Two double-blind, placebo-controlled, randomized studies in healthy volunteers (110/study) were performed to determine the minimal effective dose of flumazenil required to reverse the sedative, psychomotor and amnesic effects of benzodiazepines used to produce conscious sedation. Conscious sedation was produced by i.v. diazepam (12-30 mg) in one study and i.v. lorazepam (0.045 mg kg-1) in the other. Intravenous flumazenil (0.001, 0.003, 0.007 or 0.014 mg kg-1) or placebo was administered after diazepam or lorazepam. Assessment of sedation, psychomotor performance and recall/recognition were made both before and after the benzodiazepine as well as serially after flumazenil or placebo. Doses as low as 0.007 and 0.014 mg kg-1 flumazenil consistently reversed diazepam- and lorazepam-induced effects, respectively. The duration of reversal produced by varying doses of flumazenil (0.2, 0.6, 1.0 or 3 mg) was evaluated in 50 volunteers in a double-blind, placebo-controlled, parallel group study. A constant level of conscious sedation was produced by a continuous infusion of midazolam. Assessments of sedation and psychomotor performance were assessed both before and at varying times after the administration of flumazenil or placebo. Preliminary results indicate that the duration of reversal produced by 3.0 mg flumazenil was longer than that produced by any of the lower doses. While the mean duration of reversal produced by the lower doses was comparable, the 0.2 mg dose resulted in the greatest between subject variability and only partial rather than complete reversal. Two further double-blind, placebo-controlled studies were done in healthy volunteers (45/study) to evaluate the safety of flumazenil 1.0 mg or placebo given i.v. to reverse midazolam-induced sedation in subjects who had been treated for up to 14 days with either oral diazepam or triazolam. No clinically significant changes were noted in laboratory test values, electrocardiograms or vital signs monitored for up to 36 h after flumazenil or placebo in any pre-treatment group.
Adult↗
A comparison of clinical and self-report diagnoses of DSM-III personality disorders in 552 patients.
This report examines the relationship between clinicians' diagnoses of personality disorder and self-report diagnoses of personality disorder obtained from the Personality Diagnostic Questionnaire (PDQ). The results from 552 patients showed general lack of agreement between clinical and self-report diagnoses of DSM-III personality diagnoses. The best agreement obtained was for Borderline Personality Disorder: k = 0.46, and r = .51 for scaled ratings. Possible sources of disagreement including failings of the self-report questionnaire, difficulties in relying upon patients' self-reports, lack of reliability of clinical diagnoses of personality, and possible inherent lack of reliability of several of the DSM-III personality disorders are discussed.
Adolescent↗