Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease.

OBJECTIVE: To evaluate the efficacy and tolerability of lubiprostone (Amitiza) for constipation in Parkinson disease (PD) in a double-blind, randomized, controlled study. METHODS: Patients with PD and clinically meaningful constipation (constipation rating scale score > 10 [range: 0-28]) were recruited from 2 academic movement disorder centers to participate in the study. After enrollment, patients were initially followed for 2 weeks and then were randomly assigned 1:1 to lubiprostone, and the dose was titrated up to 48 µg/day. They returned 4 weeks later for a final assessment. Data included stool diaries and global impressions (co-primary endpoints), demographics, Unified Parkinson's Disease Rating Scale scores, constipation scale scores, visual analog scale (VAS) scores, a stool diary, and adverse events. RESULTS: Fifty-four subjects (39 male, mean age 67.0 ± 10.1 years, and mean duration of PD 8.3 ± 5.4 years) were randomly assigned to lubiprostone or placebo. One patient in the drug group discontinued the study because of logistics, and one patient in the placebo group discontinued the study because of lack of efficacy. A marked or very marked clinical global improvement was reported by 16 of 25 (64.0%) subjects receiving drug vs 5 of 27 (18.5%) subjects receiving placebo (p = 0.001). The constipation rating scale (p < 0.05), VAS (p = 0.001), and stools per day in the diary (p < 0.001) all improved with drug compared with placebo. Adverse events with drug were mild, most commonly intermittent loose stools. CONCLUSION: In this randomized controlled trial, lubiprostone seemed to be well tolerated and effective for the short-term treatment of constipation in PD.

The nature of interparental conflict of married and divorced parents: implications for young adolescents.

While research has demonstrated that interparental conflict is associated with poor child and adolescent functioning, studies have not yet addressed the characteristics of such conflict. The purpose of this study was twofold: (1) to report reliability and validity data of a questionnaire, the Interparental Conflict Questionnaire (ICQ), designed to assess the nature of interparental conflict more thoroughly than has been done previously, and (2) to compare the nature of such conflict in a married and divorced sample. Fifty-five married and 46 divorced parents, all of whom had a young adolescent, participated by completing two questionnaires: the O'Leary-Porter Scale and the ICQ. Validity (e.g., correlation with the O'Leary-Porter Scale) was generally acceptable for the ICQ, whereas test-retest reliability tended to be moderate to low. Additional findings indicated that heated arguments rarely occurred. Furthermore, in comparing married and divorced parents, the former discussed issues more and, to some extent, the latter argued more. However, one of the most striking aspects of the findings was the similarity of the married and divorced samples in terms of their conflict. Implications of the findings for understanding and explaining the role of interparental conflict in child and adolescent functioning are explored.

Interparental conflict and adolescent problem behavior: an examination of mechanisms.

The purpose of the present study was to examine several competing hypotheses which have been utilized to explain the negative relationship between interparental conflict and child/adolescent problems. These mechanisms of operation have included modelling, genetic transmission, disrupted parenting, the role of perceptual/appraisal processes of the conflict, and an inhibition hypothesis. One hundred and forty-two young adolescents and their mothers served as subjects. Eighty were from intact families and 62 from recently divorced families. Data were collected from the perspective of the adolescent, mother, behavioral observer, and social studies teacher. The results indicated that intact and divorced samples had to be considered separately as different pathways contributed to adolescent behavior problems in the two samples. For externalizing problems, a direct path between interparental conflict and problem behavior existed for the divorced sample whereas an indirect path through the adolescent's perceptions of the conflict existed for the intact sample. The different context in which the interparental conflict occurred for the two samples was offered as an explanation of this difference. For internalizing problems a significant direct path existed between conflict and problem behavior for both samples; however, the indirect paths through the adolescent's perceptions and through poor parenting skills contributed only for the divorced sample. The results suggest that various mechanisms appear to operate in influencing how interparental conflict influences behavior problems of young adolescents. Both the type of problem examined and the marital status of the parents appear important in determining the relative impact of the mechanisms. Implications for the behavior therapist are noted.

Adolescent school performance following parental divorce: are there family factors that can enhance success?

Most research on the effects of divorce on children has focused on delineation of specific areas of child maladjustment. A more optimistic approach seeks to identify variables that may mediate negative effects of a stressor, such as parental divorce. The goal of this study was to examine the relationship between one area of child adjustment, school achievement, and family factors which may mediate the negative influence of divorce. The subjects were 71 early adolescents and their recently divorced mothers. The adolescents were divided into low, medium, and high grade achievement groups. Analyses of variance and subsequent Newman-Keuls tests revealed that adolescents with high grade point averages had mothers with a lower level of depression, a higher educational level, less conflict with their ex-spouse, and less intense levels of conflict between mother and adolescent than those in the low grade point average group. A discriminant analysis resulted in a two-variable equation which accounted for 33% of the variance between low and high grade achievers. The two variables were mother's report of conflict between her and her ex-spouse in front of the adolescent and the adolescent's report of the intensity of arguments between him/herself and mother. These results indicated that school performance following divorce is not uniform for all adolescents and that family factors may mediate scholastic achievement problems.

The relationship of early adolescent functioning to parent-reported and adolescent-perceived interparental conflict.

Is an adolescent's perception of interparental conflict important or is the parents' report of such conflict sufficient to predict adolescent functioning? To examine this question, a study was undertaken with 178 young adolescents and their mothers, fathers, and social studies teachers. Adolescents completed a measure of their perceptions of interparental conflict while mothers and fathers completed a self-report measure of their conflict. Teachers provided an assessment of each adolescent's cognitive and social functioning at two separate times, 1 year apart. Results indicated that both parental report, particularly maternal, and adolescent perception of interparental conflict were significantly related to adolescent cognitive and social functioning, and the magnitude of the correlations did not differ significantly. Hierarchical regression analyses were performed in which mother and father report of conflict was forced into the equation initially and adolescent perception of such conflict was allowed to enter freely. These analyses indicated that adolescents' perceptions accounted for unique variance in their functioning, beyond that accounted for by parental report. The results are discussed in terms of the specific roles that parental conflict and adolescent perceptions of such conflict play and the possible mechanisms by which each operates.

Parent-completed and adolescent-completed CDIs: relationship to adolescent social and cognitive functioning.

The purpose of this study was to examine the relationship of both young adolescents' scores on the Children's Depression Inventory (CDI) and their mothers' ratings of the adolescents' depression (parent-completed CDI) to indices of their social and cognitive functioning obtained from a source outside the home. Subjects consisted of a nonclinic sample of 85 young adolescents (11-15 years of age), their mothers, and their social studies teachers. Recent school grades and teacher-completed measures served as the indices of adolescent social and cognitive competence. The results indicated that both adolescents' and mothers' CDI scores were significantly and negatively correlated with measures of adolescent cognitive and social functioning. Multiple regression analyses, utilizing adolescent- and parent-completed CDI scores as predictors, indicated that both predictor variables entered into the equations for cognitive functioning while only the mother-completed CDI entered into those for social functioning. When maternal depression was also entered into the multiple regressions, the findings regarding mother- and adolescent-completed CDI scores were not altered. The relationship of these findings to other somewhat disparate findings concerning the utility of mother and child reports of child depression is discussed.

Patterns of gastroesophageal reflux in children following repair of esophageal atresia and distal tracheoesophageal fistula.

We studied gastroesophageal reflux (GER) in 25 children between 3 and 83 mo post-repair of esophageal atresia and distal tracheoesophageal fistula (EATEF). The incidence of GER was determined by 18-24 hr pH monitoring of the distal esophagus and gastroesophageal scintiscan following the ingestion of 99mTc sulfur colloid in apple juice. Gastric emptying was also assessed in 20 children. Only 17 of 25 (68%) children had significant GER by esophageal pH monitoring, and 13 of 20 (65%) had significant GER by gastroesophageal scintiscan. Significant GER was found in 10 of 12 (83%) patients wih recurrent vomiting, respiratory symptoms or severe esophagitis. Three of these 10 patients required an operation to control GER. Significant GER occurred in continuous, discontinuous and mixed patterns. The discontinuous pattern was seen in 11 of 17 (65%) children, and was associated with slow gastric emptying. The only factor during the repair of EATEF that subsequently was associated with a higher incidence of significant GER (88% vs. 59%) and slow gastric emptying (11.2 +/- 4.2% vs. 25.9 +/- 3.7% gastric emptying at 30 min, p less than 0.05) was excessive tension at the esophageal anastomosis. Many children with EATEF do not have significant GER, but in those with significant GER slow gastric emptying seems to be important.