Publishing negative findings and the challenge of avoiding type II errors in studies of suspect teratogens: Example of a recent ondansetron publication.

It is important that negative, as well as positive, studies be published to complete the available picture in areas of scientific inquiry. At the same time, it is critical that the implications of a negative study not be overstated and generalized when major issues of study design and data accuracy may be the reason that no relationship was discovered. The challenge of avoiding type II errors in interpreting negative findings has major public health implications, especially when the relationship of an exposure to birth defects is the concern.

Gastric pH and Therapeutic Responses to Exsomeprazole in Patients With Functional Dyspepsia: Potential Clinical Implications.

Background: Therapy for functional dyspepsia remains a challenge. This study aimed to evaluate esomeprazole (E) versus placebo (P) regarding (1) the effectiveness in providing relief of abdominal pain or discomfort during 16 weeks of therapy in patients with functional dyspepsia having moderate or severe symptoms; (2) the effects on gastric acid suppression and (3) the relationship between symptom relief and gastric pH.

Methods: Enrolled patients were randomized to E (n = 38) or P (n = 35) in a double-blind, placebo-controlled trial.

Stimulation of Mucin, Mucus, and Viscosity during Lubiprostone in Patients with Chronic Constipation may Potentially Lead to Increase of Lubrication.

Objectives: The purpose of this clinical trial was to explore whether lubiprostone increases the rate of mucus and mucin secretion and its viscosity in chronic constipation (CC) patients. The secretion of chloride (CS) into the gastrointestinal tract lumen is pivotal in the body's ability to process non-digestible food components. CS sets the optimal rate of hydration for non-digestible food components, their fluidity, and their adequate propulsion along the alimentary tract.

Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India.

Objective: To investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH).

Methods: One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum.

Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol.

Objective: The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss >or= 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study.

Factors associated with acute postpartum hemorrhage in low-risk women delivering in rural India.

Objective: Postpartum hemorrhage (PPH), a major cause of maternal mortality and morbidity in low-income countries, can occur unpredictably. This study examined the sociodemographic, clinical, and perinatal characteristics of low-risk women who experienced PPH.

Methods: This analysis was conducted using data on 1620 women from a randomized trial testing oral misoprostol for prevention of PPH in rural India.

Significant enhancement of esophageal pre-epithelial defense by tegaserod: implications for an esophagoprotective effect.

Background & Aims: Tegaserod, a serotonin 5-hydroxytryptamine (5-HT)4 receptor agonist, is thought to stimulate intestinal secretions. The aim of the current study was to assess the effect of tegaserod vs placebo on salivary and esophageal protective factors in patients with gastroesophageal reflux disease (GERD).

Methods: This study was a randomized, double-blind, placebo-controlled, cross-over trial in 38 GERD patients treated with tegaserod 6 mg twice a day vs placebo.

Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

Background: Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting.

The impact of a school entry law on adolescent immunization rates.

Purpose: Middle school entry laws increase coverage with recommended vaccines, but their effect on vaccines that are not required is unknown. We compared vaccination coverage for hepatitis B, tetanus and diphtheria (Td), and measles, mumps and rubella (MMR) in areas of states with discordant middle school, hepatitis B school entry laws, and evaluated the relationship between demographic characteristics and adolescent immunization rates.

Methods: Retrospective design with purposive school sampling, using location of residence to determine study group.

Initiating a novel therapy in preventing postpartum hemorrhage in rural India: a joint collaboration between the United States and India.

Background: Maternal mortality rates in India are estimated at 560/100,000 live births and postpartum hemorrhage (PPH) accounts for 35-56% of these deaths. Given that 50% of births in rural India occur at home, oral Misoprostol administered by minimally trained midwives may be an effective uterotonic agent for preventing PPH when the use of other uterotonics is not feasible. While the import for testing the effectiveness of this intervention may be readily obvious, the elements essential for the conduct of a scientific study in rural areas served by indigenous health workers may not be as evident.