Efficacy of lubiprostone for functional constipation treatment in adolescents and children: Randomized controlled trial.

OBJECTIVES: Adolescent and pediatric functional constipation (FC) is a common clinical problem. Currently, data on lubiprostone for the treatment of pediatric FC are scarce. This study investigated the efficacy and safety of lubiprostone in the treatment of pediatric FC. METHODS: In a single-blinded, randomized controlled study, we included 280 patients aged 8-18 years with FC. Patients were randomized either to a weight-based lubiprostone dose (n = 140) or conventional laxatives (n = 140), including lactulose, bisacodyl, or sodium picosulfate, for 12 weeks, followed by 4 weeks posttreatment follow-up. RESULTS: Improvement in constipation was achieved in 128 (91.4%) patients in the lubiprostone group, and in 48 (34.3%) patients of the conventional therapy group (p < 0.001) and was sustained after treatment discontinuation. One quarter of the lubiprostone group experienced the first spontaneous bowel motion within 48 h after dose initiation. A total of 75.7% of the lubiprostone group could achieve and sustain Bristol stool form of 3 or 4 during the last 4 weeks of therapy and through the 4 weeks of follow-up versus 50 (35.7%) patients in the conventional therapy group (p < 0.001). No life-threatening adverse drug reactions were encountered, and no treatment-related discontinuation. Mild self-limited colicky abdominal pain and headache were the most prevalent side effects in the lubiprostone group. CONCLUSIONS: Lubiprostone is an effective and well-tolerated pharmacotherapy for youthful age and pediatric age groups, which may alter the paradigm of pediatric FC treatment.

Effect of neuromuscular electrical stimulation and early physical activity on ICU-acquired weakness in mechanically ventilated patients: A randomized controlled trial.

BACKGROUND: Intensive care unit-acquired weakness (ICU-AW) is common in critically ill patients and increases the duration of mechanical ventilation (MV) and weaning time. Early mobilization, range of motion (ROM) exercises, and neuromuscular electrical stimulation (NMES) can prevent ICU-AW by maintaining muscle mass. However, studies highlighting the effects of combining NMES with early physical activity in ICU patients are limited. AIM: To evaluate the effect of NMES and early physical activity on ICU-AW in mechanically ventilated patients. DESIGN: A single-blinded randomized controlled trial was conducted in Alexandria, Egypt. METHOD: Patients were randomly assigned to one of four groups: NMES, ROM, combined therapy (ROM + NMES), or conventional care (control group). The Medical Research Council (MRC) scale was used to assess the ICU-AW for the study patients over a 7-day period. The duration of the patient's MV and ICU stays were recorded. RESULTS: Of the 180 patients who were assessed for eligibility, 124 were randomly assigned to one of four groups: 32 patients in ROM exercises, 30 in NMES, 31 in combined therapy (ROM + NMES), and 31 in the control group. On day 7, ROM + NMES and NMES groups showed higher MRC scores than ROM and control groups (50.37 ± 2.34, 49.77 ± 2.19, 44.97 ± 3.61, and 41.10 ± 3.84, respectively). ANOVA test results indicated significant differences (p < .001) across the four groups. ICU-AW occurred in 0% of the ROM + NMES group, 60% of the ROM group, 13% of the NMES group, and 100% of the control group (p < .001). The MV duration (in days) in the ROM + NMES group was shorter (12.80 ± 3.800) than in the ROM, NMES, or control groups (21.80 ± 4.460, 18.73 ± 4.748, and 20.70 ± 3.932, respectively). ICU-LOS was shorter in the ROM + NMES group (17.43 ± 3.17 days) compared with the ROM group (22.53 ± 4.51 days), the NMES group (21.10 ± 5.0 days), and the control group (21.50 ± 4.42 days) with significant differences (p < .001) between the four groups. CONCLUSION: Daily sessions of NMES and early physical activity were well tolerated, preserved muscle strength, prevented ICU-AW, and decreased the duration of the MV and ICU stay. RELEVANCE TO CLINICAL PRACTICE: The findings of this study support the use of NMES and early physical exercises by critical care nurses as part of routine care for critically ill patients.