Relationship between Helicobacter pylori eradication and reduced duodenal and gastric ulcer recurrence: a review.

BACKGROUND & AIMS: The aim of this study was to determine whether the current literature supports the use of Helicobacter pylori cure as the primary efficacy end point in peptic ulcer clinical trials. This could potentially reduce the complexity of future trials. METHODS: Published articles containing information on both H. pylori eradication and ulcer recurrence were searched with MEDLINE. Abstracts were found by reviewing references from both primary and review articles. RESULTS: Fourteen duodenal ulcer and five gastric ulcer studies satisfied requisite inclusion criteria. Ulcer recurrence was significantly less common among H. pylori-cured patients vs. noncured patients (6% vs. 67% for patients with duodenal ulcers; 4% vs. 59% for patients with gastric ulcers). For H. pylori-cured patients, duodenal ulcer recurrence was higher in studies using two endoscopic tests compared with three tests (9% vs. 3%) and higher in abstracts compared with published articles (14% vs. 4%). Timing of H. pylori eradication (4 weeks vs. < / = 12 weeks) and ulcer recurrence assessment (6 months vs. < / = 12 months) was not significantly related to duodenal ulcer recurrence. CONCLUSIONS: The current literature strongly suggests that H. pylori eradication 4 weeks after therapy should be used as the primary efficacy end point for reduced gastric and duodenal ulcer recurrence for the purpose of clinical trial design.

Systemic steroids with or without 2% topical minoxidil in the treatment of alopecia areata.

BACKGROUND AND DESIGN: Thirty-two patients with mild to extensive alopecia areata, including 16 patients with alopecia totalis or universalis, entered a randomized, controlled trial of a 6-week taper of prednisone followed by either 2% topical minoxidil or vehicle applied three times daily for an additional 14 weeks. The results of this study were compared with an open trial of 48 patients with alopecia areata treated with a similar taper of prednisone with concomitant 2% topical minoxidil applied twice daily. Only terminal hair growth was considered and was quantitated as 1% to 24%, 25% to 49%, 50% to 74%, and 75% to 100%: only those with more than 25% terminal hair regrowth were considered to have had an objective response. RESULTS: At the end of 6 weeks of prednisone, 47% (15/32) of patients had more than 25% regrowth, including nine of 20 patients who had had at least 75% hair loss at baseline. Side effects of prednisone were primarily weight gain and mood changes/emotional lability. At 3 months, six of seven minoxidil-treated patients vs one of six vehicle-treated patients who had an objective response to prednisone maintained or augmented this hair growth: at the 20-week visit, these numbers were three of seven and zero of four patients, respectively. In the open trial, objective hair growth with prednisone was 30%, related to the extent of hair loss at baseline, and this growth persisted in more than 50% of patients at 6 months with the use of 2% topical minoxidil. CONCLUSIONS: A 6-week taper of prednisone offers potential for more than 25% regrowth in 30% to 47% of patients with alopecia areata with predictable and transient side effects. Two percent topical minoxidil three times daily appears to help limit poststeroid hair loss.

Evaluation of alternative statistical methods for linear model analysis to compare two treatments for 24-hour blood pressure response.

This paper evaluates alternative statistical methods for the analysis of 24-hour blood pressure data from a clinical trial which compares two treatments for hypertension. The primary objective of the study discussed here was to determine the time course for the blood pressure lowering effects of a test drug given once daily in the treatment of mild to moderate hypertension when compared with placebo. Thirty-five patients (24 on drug and 11 on placebo) were monitored for 24 hours at baseline and at two weeks post treatment, with diastolic blood pressure (DBP) measurements recorded at 22 time points within each 24-hour visit. The changes in DBP from baseline across the 22 time points are the response variables of interest. Various statistical methods for the assessment of treatment effects over the entire 24-hour dosing interval in a setting with small sample size are discussed and illustrated. The results from a special application of weighted least squares analysis of covariance, which employs a smoothed covariance matrix, support the hypothesis that a once daily dose of the drug significantly reduces DBP over the entire 24-hour dosing interval when compared with placebo. This method has the distinct advantage of enabling evaluation of treatment differences for the change in DBP from baseline at the 22 time points with the corresponding 22 baseline DBP as covariates simultaneously in a situation where the treatment group sample sizes are small.