Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms.

OBJECTIVE: The aim of this study was to evaluate the efficacy of a single night-time dose of a syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple cold symptoms. MATERIALS: A syrup containing 15 mg dextromethorphan hydrobromide, 7.5 mg doxylamine succinate, 600 mg paracetamol and 8 mg ephedrine sulfate (Wick MediNait produced by WICK Pharma, Germany, a subsidiary of Procter & Gamble GmbH; test syrup) or placebo (placebo syrup) for oral administration. METHODS: This was a randomized, double-blind, placebo-controlled, multi-center, parallel design study. At enrollment, eligible subjects had to have at least moderate nasal congestion and a runny nose, at least mild cough and at least mild pain with one or more of the following: sore throat, sore chest, headache or body pain/aches. Subjects were randomized into either Group T (test syrup) or Group P (placebo syrup). On the evening of enrollment, subjects rated baseline symptoms, ingested the assigned study product and completed symptom-relief assessments at 3 hours post-dosing. Within one hour of awakening the following morning, subjects completed night-time symptom relief and sleep satisfaction assessments. All symptoms were recorded using an Interactive Voice Response system. Treatment comparisons were made after adjusting for the severity of baseline symptom using analysis of covariance. RESULTS: Of 485 subjects who took the study product, 432 (224 in Group T; 208 in Group P) were evaluable for analysis. For the primary endpoint (composite of nasal congestion/runny nose/cough/pain relief scores 3 hours post-dosing), subjects in Group T had clinically and statistically significantly greater relief than Group P (p = 0.0002). Each individual symptom score also showed statistically significant improvement at this time point (p < or = 0.017). The next morning, Group T continued to show clinically and statistically significant benefits over Group P on the composite score and each of the individual symptoms (p < or = 0.003). Evidence of benefit with the test syrup was also seen in the higher score for overall night-time relief (p < 0.0001) and greater satisfaction on sleep (p = 0.002) compared to placebo syrup. Improvement in individual symptoms after 3 hours was obtained in 16-42% more subjects in Group T than in Group P, whereas the percentage of subjects in Group T having Good or Very Good relief the morning after dosing increased by 25-68% compared to subjects in Group P. 14 subjects (5 in Group T; 9 in Group P) reported AEs but none of these occurred with an incidence greater than 1%. There were no serious AEs. CONCLUSIONS: The results confirm the multisymptom benefit of a single dose of the test syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate and support its role as an effective and convenient therapy for symptoms of nasal congestion, runny nose, cough and pain/body aches associated with the common cold and for increasing sleep quality disturbed by the common cold.

Laparoscopic cholecystectomy in octogenarians.

Performance of laparoscopic cholecystectomy (LC) is increasing, and patients age 80 and over comprise an increasingly larger proportion of the LC population. This study documents that the increase is accompanied by safe outcome in this patient population. However, the evidence also suggests that cholelithiasis appears to have been a neglected condition in this age group. The prevalence of nonelective procedures, the conversion rate to an open operation, more intraoperative complications, and the percentage having evidence of common bile duct stone passage all support this assertion. With the technology of LC, we are now appropriately addressing the problem with a treatment that allows less surgical trauma to the patient and shorter recovery time. Same-day LC surgery for the octogenarian appears to be very safe and would justify a decision to perform earlier LC in these patients. Surgery done before the appearance of comorbid conditions that increase the surgical and anesthetic risks may result in improved outcomes for the elderly at lower cost. Even when necessary in the already hospitalized patient, LC can be accomplished with morbidity and mortality comparable to those of elective abdominal procedures in younger populations.

Cholecystectomy in patients aged 80 and older.

BACKGROUND: We assessed whether the increase in performance of laparoscopic cholecystectomy has affected patients aged 80 and older and if outcomes of a laparoscopic approach in this population would show improvement over those for open surgery. METHODS: We analyzed an 11-state discharge database obtained from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project. Release 1 contains a 20% sample of United States hospitals for the period 1988 to 1992. Diagnosis-related group (DRG) codes 197 and 198 were searched, and demographics, type of surgery, and outcome measures were analyzed. RESULTS: In 5 years, 350,451 patients underwent cholecystectomy with the DRG codes listed. Of those, 18,500 patients were aged 80 to 105. The total number of cholecystectomies increased each year. Performance of laparoscopic cholecystectomy rose rapidly and that of open cholecystectomy decreased. Overall mortality with laparoscopic cholecystectomy was 1.8%, was lower than that of open cholecystectomy, was lower in women, and decreased with time. CONCLUSIONS: Patients aged 80 and older have participated in the increased performance of cholecystectomy and the switch to laparoscopic cholecystectomy. This has a low mortality, low length of stay, and higher proportion of patients being discharged to home compared with patients having open cholecystectomy.