A double-blind, placebo-controlled study of the effectiveness and safety of nizatidine in the prevention of postprandial heartburn.

BACKGROUND: Heartburn is frequently associated with overindulgence in food and drink, meal-stimulated gastric acid secretion, and a gastroesophageal reflux with a pH of 4 or lower. Nizatidine is a selective histamine2 receptor antagonist that effectively suppresses gastric acid secretion at lower than prescription doses and has been approved for nonprescription use in the prevention of postprandial heartburn. OBJECTIVE: To examine the relative effectiveness of 3 dose levels of nizatidine (225 mg, 75 mg, and 25 mg) in preventing postprandial heartburn. METHODS: Four hundred thirteen subjects with documented moderate to severe heartburn following a standard meal that provoked heartburn were randomized to receive a single dose of nizatidine at 225 mg (n = 104), 75 mg (n = 101), or 25 mg (n = 105), or placebo (n = 103) 30 minutes before the meal, at 30 minutes (immediately after completing the meal), and at 60, 90, 120, 150, 180, and 210 minutes (from beginning the meal), subjects assessed the presence or absence of heartburn (yes or no) and the severity of heartburn (100-mm visual analog scale). RESULTS: The use of both 225 mg and 75 mg of nizatidine were significantly better than placebo in preventing heartburn in the proportion of subjects with complete prevention of heartburn (15 [14.4%] and 15 [14.9%], respectively, vs 3 [2.9%]; P < .001); the effects of nizatidine, 25 mg, in 7 subjects (7%) were not distinguishable from placebo. Similar results for nizatidine, 225 mg and 75 mg, were seen for longest duration of no heartburn, total duration of no heartburn, the average severity of heartburn, and the peak heartburn severity. All 3 doses of nizatidine were superior to placebo (P < .001) in reducing average and peak heartburn severity and were well tolerated. CONCLUSIONS: Single doses of 225 mg and 75 mg of nizatidine administered 30 minutes before a standard meal intended to provoke heartburn are significantly more effective than placebo for the prevention and/or reduction of postprandial heartburn.

Assessing the efficacy of three dentifrices in the treatment of dentinal hypersensitivity.

A multicenter clinical trial conducted by the authors compared the desensitizing efficacy of a new 5 percent potassium nitrate: 0.243 percent sodium fluoride dentifrice along with two clinically proven, commercially available desensitizing dentifrices to a placebo dentifrice. Sensitivity to cold air and tactile stimulation, along with patients' subjective assessments, were evaluated to assess the dentinal desensitizing efficacy of the test dentifrices. Results demonstrated that after four weeks, participants who used the new dentifrice formulation experienced significant decreases in dentinal sensitivity compared to the placebo group for all measured indexes.

Comparative analysis of three PMS assessment instruments--the identification of premenstrual syndrome with core symptoms.

Premenstrual syndrome (PMS) is a commonly encountered complaint among women. This study compared the PMS Diary (PMSD), which measures core menstrual symptoms (negative affect, water retention, and pain symptoms), with two commonly used self-rating forms, the Menstrual Distress Questionnaire (MDQ) and the Daily Rating Form (DRF). Thirty-seven premenopausal women with documented PMS completed the forms. A multitrait-multimethod analysis was performed to determine overall agreement and reliability. The three instruments and their component scale scores had strong internal consistency. Correlations between overall scores and between scales measuring similar constructs were strong. Correlations were 0.77 between PMSD and MDQ; 0.67 between PMSD and DRF; and 0.81 between MDQ and DRF. The PMSD performs as effectively as more extensive questionnaires in measuring symptoms in women with PMS. The PMS Diary is a concise yet reliable and valid instrument that can be easily administered in ambulatory care and longitudinal research.

Denture cleansing: a comparison of two methods.

A paste brushing method (Complete) and soaking in either of two denture cleanser tablet solutions (Efferdent or Polident) were compared for denture cleansing effectiveness as measured by plaque level. The 12-week product use period with weekly evaluations allowed an assessment of plaque reaccumulation on the denture surface as well as the effect of a single cleansing event and the contribution of bleaching to the total plaque-cleansing activity. The paste/brushing method was consistently the more effective procedure for removal of denture plaque. However, the bleaching effects of the effervescent tablets could be useful in an overall denture hygiene program.

Clinical evaluation of a new treatment for dentinal hypersensitivity.

The effectiveness of potassium nitrate (5%, delivered in a low abrasive toothpaste vehicle) as a daily home treatment of dentinal hypersensitivity was evaluated in a 4-week, double-blind, parallel, comparative study of 27 subjects with the condition. Hypersensitivity levels in affected teeth were assessed by two quantifying methods--electrical stimulus and cold air stimulus--and by a subjective recall procedure. The results from these three methods of assessment indicate that potassium nitrate desensitizes hypersensitive teeth to a significant degree. The therapeutic response (decline in dentinal hypersensitivity) to potassium nitrate was evident within 1 week and increased continuously for the length of the study period. Sensitivity threshold of teeth adjudged to be normally sensitive were not altered by treatment with potassium nitrate, nor did the agent exert any discernable effects on oral tissues.

An evaluation of two methods for the quantitation of dentinal hypersensitivity.

In a well-controlled, double-blind, parallel study design using burnishing with 33% sodium fluoride paste and "sham" burnishing with a placebo paste, both a cold air stimulus method and an electrical stimulus method can discriminate between levels of dentinal hypersensitivity. Correlation between the scores obtained by the methods was significant. The electrical stimulus method discriminated between the sodium fluoride and placebo effects to a greater degree than did the cold air method. Use of these methods should broaden the scientific foundation and rationale for evaluating the condition of dentinal hypersensitivity and the agents designed for treatment of persons with this condition.