New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study.

BACKGROUND: This study evaluated the safety and effectiveness of a new polyethylene glycol (PEG) laxative (MiraLax, Braintree Laboratories Inc, Braintree, Mass) in 23 patients reporting a history of constipation. METHODS: After a 7-day placebo control period, patients were randomized into a double crossover trial of placebo versus 17 g of PEG daily for 4 days. Patient maintained a stool diary. RESULTS: Daily ingestion of a 17 g dose of PEG increased mean daily bowel movement frequency to once per day by the last 7 days of the 14-day treatment period. This was a statistically significant improvement over placebo, which provided about 1 bowel movement every 2 days during the last week of therapy. Patient diary ratings of related subjective symptoms were improved with PEG treatment over placebo. Both investigator and patients rated PEG therapy superior to placebo. No clinically significant changes in blood chemistry, complete blood count (CBC), or urinalysis were observed. CONCLUSIONS: Daily therapy with 17 g of PEG laxative for 14 days resulted in a significant improvement in bowel movement frequency in constipated patients relative to placebo by the second week of treatment.

Clinical effectiveness of a dentifrice containing potassium chloride as a desensitizing agent.

Sensodyne F, a dentifrice currently marketed in the United Kingdom, containing potassium chloride (KCl) and sodium monofluorophosphate (MFP) was compared to a placebo dentifrice for effectiveness in alleviating dentinal hypersensitivity. This randomized, double-blind, parallel clinical study covered 12 weeks of product use by 41 subjects. Hypersensitivity levels of the affected teeth were assessed by tactile stimulation, cold air stimulation and overall subjective patient response. The results from these three methods of assessment demonstrated that the KCl/MFP dentifrice was significantly more effective than the placebo dentifrice in reducing dentinal hypersensitivity. The therapeutic response to the KCl/MFP dentifrice as measured by air sensitivity and overall subjective evaluation was statistically significant when compared to the placebo dentifrice within 4 weeks of use. Significant improvement was observed for all parameters at the conclusion of the 12-week clinical study period. Plaque reduction was significantly reduced at week 8 and continued to improve by week 12. The results indicate that KCl with sodium MFP significantly reduced dentinal hypersensitivity and improved overall patient comfort.

Designing hypersensitivity clinical studies.

A dentinal hypersensitivity study is really a clinical pain study. The fundamental difficulties in reproducibly and reliably measuring pain impact heavily on the study. Other critical issues include investigator and subject selection, study design, randomization strategy, study duration, sample size, and statistical analysis. This article discusses principles involved in establishing the efficacy of a desensitizing agent.

Effect of metabolites on epsilon-N-hydroxylysine formation in cell-free extracts of Aerobacter aerogenes 62-1.

The conversion of L-lysine to its corresponding epsilon-N-hydroxy derivative has been achieved for the first time by cell-free extracts of Aerobacter aerogenes 62-1. Partial fractionation by differential centrifugation (at 12 000 X g) revealed that both supernatant and pellet are essential for maximum enzymatic activity. The omega-N-hydroxylase (EC 1.14.99) was found to function optimally at pH 7-7.5 and exhibited an apparent Km of about 75 muM for L-lysine. L(+)-Lactate or DL-lactate and pyruvate greatly stimulate the omega-N-hydroxylase activity. The system is strongly inhibited by arsenite and sulfite.

Influence of secretory immunoglobulin A and purified secretory component on dextran-sucrase activity of Streptococcus mutans.

The net stimulation of dextransucrase EC 2.4.1.5) activity from Streptococcus mutans HS6 by dextran, secretory immunoglobulin A, or secretory component was investigated. Approximately equal stimulation resulted from treatment with these three components.

A ten-year assessment of methicillin-associated side effects.

The exact incidence and importance of side effects associated with methicillin therapy in children is unknown. During the ten-year period from 1964 to 1974 approximately 3,000 Houston children who received methicillin were observed for side effects. The great majority of these patients received the drug for less than ten days; however, side effects were more common in patients receiving long-term therapy. In order to assess these side effects, experiences with 124 children who received methicillin for ten days or longer were reviewed in depth. The average dose of methicillin was 200 mg/kg/day and the average duration was 22 days. In this highly selected group there were no adverse side effects in 54.8% and only eosinophilia in an additional 13%. Leukopenia occurred in 16%, microscopic hematuria in 8%, gross hematuria in 4%, skin rash in 6%, and "drug fever" in 6%. In many instances several of these side effects occurred within a single patient so that the total number of patients with definite side effects was 39 of 124 (31.5%). The true incidence figure of overall side effects is much lower than 31.5%. Corrected incidence rates based on a conservative figure of 3,000 methicillin-treated children are less than 1.5% for all side effects. In some patients the mechanism producing the adverse reactions seemed to be chemical irritation or toxicity and in others hypersensitivity. In nine of the 39 patients follow-up studies were not optimal. In the other 30 patients all side effects were reversible.