Use of orally administered anhydrous crystalline maltose for relief of dry mouth.

OBJECTIVES: To examine the safety and efficacy of anhydrous crystalline maltose (ACM) for treatment of dry mouth. DESIGN: ACM was delivered orally as a 200-mg lozenge given three times daily over a 12-week (study Alpha) or 24-week (study Omega) period to a total of 22 and 97 subjects, respectively. All participants had prominent complaints of persistent dry mouth associated with primary Sjögren's syndrome. Patients were examined every 4 weeks in study Alpha and every 6 weeks in study Omega. SETTINGS: Patients were seen in outpatient clinics at a total of 33 sites within the United States. OUTCOME MEASURES: Unstimulated whole saliva output, a measure of basal salivary gland function, was determined at each visit. Symptoms associated with oral and ocular dryness were assessed at the same time with the use of 100-mm visual analog scales. Safety was assessed by physical examination and laboratory studies. RESULTS: During these clinical trials, a majority of subjects demonstrated an increase in unstimulated whole saliva output and the treatment exhibited an excellent safety profile. The ACM treatment in study Omega led to significant improvement in several subjective measures of oral and ocular comfort. CONCLUSIONS: In these two studies, ACM lozenges administered three times daily for 12 or 24 weeks improved salivary output and decreased complaints of dry mouth and eyes. Side effects were minimal, and treatment was without significant adverse events. This safe and simple intervention may provide clinical benefit to individuals with distressing dry mouth symptoms.

Low-dose oral use of human interferon-alpha in cancer patients.

In a double-blind placebo-controlled trial, 57 adult subjects with disseminated malignancies were given orally low doses of recombinant human interferon-alpha (rHuIFN-alpha) at 0.05 IU, 0.5 IU, or 5.0 IU/kg body weight. The objective was to determine the efficacy of orally administered rHuIFN-alpha on appetite stimulation and/or weight loss prevention in anorectic cancer patients. Almost two-thirds (64%) of the subjects given 5.0 IU/kg reported an increase in appetite or body weight after 5 weeks in contrast to only 29% of the placebo-treated subjects. However, at the end of the 91-day trial, no significant differences in appetite enhancement or weight gain were noted between these two groups. Additionally, the 5.0 IU/kg treated group experienced half as many deaths as the control group by the conclusion of this 91-day trial.

Treatment of primary Sjögren's syndrome with low-dose natural human interferon-alpha administered by the oral mucosal route: a phase II clinical trial. IFN Protocol Study Group.

The purpose of this investigation was to examine the safety and efficacy of four dosages of natural human interferon-alpha (nHuIFN-alpha) delivered over a 12-week period orally in lozenges (150 IU and 450 IU, once [QD] or three times [TID] daily) compared to placebo in subjects with primary Sjögren's syndrome. This randomized, double-blinded clinical trial demonstrated that nHuIFN-alpha at a dose of 150 IU administered TID by oral lozenge significantly improved stimulated whole saliva output compared to placebo after 12 weeks of treatment. The 150 IU TID dose also was suggestive of benefit for 5 of 7 subjective measures of oral and ocular comfort. IFN lozenges demonstrated a good safety profile, with no serious adverse events found in any treatment group. There were no significant differences between the placebo and the four doses of IFN for adverse events by total number, organ system, severity, dropouts, and number judged to be related to treatment. In conclusion, these results demonstrated that the use of 150 IU IFN lozenges TID for 12 weeks in subjects with primary Sjögren's syndrome improved salivary output and decreased complaints of xerostomia without causing significant adverse medical events.

Oral therapy with human interferon alpha in calves experimentally injected with infectious bovine rhinotracheitis virus.

Fifty-six calves, seronegative for infectious bovine rhinotracheitis (IBR) virus, were randomly divided into 7 equal groups (n = 8) and given 0.0, 0.05, 0.50, or 5.00 international units (IU) of natural or recombinant human interferon alpha per kg body weight (nHuIFN-alpha or rHuIFN-alpha, respectively) orally once daily for 4 consecutive days, starting 2 days before intranasal inoculation with virulent IBR virus. Calves given 0.05 IU nHuIFN-alpha/kg bwt had significantly greater weight gain at days 15 (P < 0.10) and 25 (P < 0.05) than the placebo-treated (0.0 IU) control group. The treatment groups given 0.05 and 0.5 IU nHuIFN-alpha/kg bwt nHuIFN-alpha had fewer days with temperature > 40 degrees C (P < 0.05 and P = 0.10, respectively), and lower mean rectal temperatures on days 8 and 11 (0.05 IU/kg bwt; P < 0.10) or on day 11 (0.5 IU/kg bwt; P < 0.10). None of the calves given 0.05 IU nHuIFN-alpha/kg bwt required antibiotic therapy. Calves given 0.50 IU/kg bwt of nHuIFN-alpha, or 0.05 IU/kg bwt of rHuIFN-alpha had fewer (P < 0.05) total days of antibiotic therapy compared to controls. These data indicate that low dose oral IFN-alpha treatment significantly reduced the clinical effects of IBR virus infection in feedlot cattle in an interferon dose-dependent fashion.

The effect of low dose oral human interferon alpha therapy on diarrhea in veal calves.

Low doses of recombinant human interferon alfa 2a (rHuIFN-alpha 2a), were given orally in milk replacer formula to veal calves to determine the efficacy of rHuIFN-alpha 2a for protection against diarrhea, ear and/or respiratory tract infections common in vealing operations. Calves given rHuIFN-alpha 2a had fewer days and a lower incidence of diarrhea, compared to placebo-treated calves. Calves treated with rHuIFN-alpha 2a had significantly (P < 0.05) fewer ear infections and fewer total days of ear infection than did placebo-treated calves. The mortality rate was lower in the rHuIFN-alpha 2a treatment group (1.6%) than in the placebo treatment group (2.9%) and calves given rHuIFN-alpha 2a had a greater average weight gain (13.1 lbs. more per calf) than calves given placebo. These data demonstrate that orally administered rHuIFN-alpha 2a exhibited a protective effect against clinically significant signs of disease in veal calves, reduced the mortality rate in this population, and enhanced average weight gain.

Voluntary reduction of cannabis use among graduate students.

Conceptualizing drug use within stages of drug career, this study explored differences between former and current regular marijuana users and the factors associated with reduction of their marijuana use. A total population of 2,983 graduate students were surveyed with a purposive sampling technique resulting in interviews with 186 study subjects. While no attribute variables were predictive of reduction or discontinuance, the frequency of substitution of other activities significantly differed among groups. The implications of these results are discussed within the context of alternative life-style changes in the marijuana careers of study subjects.

Reassessing the goal of drug education: diversity of preference among teachers and students.

Most of the proponents of drug education assume that the primary objective of such programs is to deter student drug use. To test this assumption, administrators, students and teachers from six public school districts were surveyed about what they thought the primary role of the school should be. While most administrators and teachers thought that the school's role should be limited to developing responsible attitudes or providing drug information, students selected a more diverse set of objectives for the schools. The policy implications of these findings are discussed.

The effect of high cervical cordotomy on portal vein plasma serotonin and 5-hydroxyindoleacetic acid levels in dogs with and without superior mesenteric artery occlusion.

In ten dogs undergoing high cervical cardotomy, there was a statistically significant fall in plasma serotonin (5-HT) levels in portal vein blood; no further change in plasma 5-HT occurred after superior mesenteric artery (SMA) occlusion, which is an effective stimulus for 5-HT release. In five dogs undergoing high cervical corotomy with no SMA occlusion, there was a comparable fall in portal vein plasma 5-HT levels. The 5-hydroxyindoleacetic acid (5-HIAA) values in portal vein blood in the two groups of dogs above fell to comparable levels. These findings indicate (1) that maintenance of the normal plasma 5-HT level in portal vein blood in this experimental model is dependent on the integrity of the spinal cord and (2) that SMA occlusion in animals with a high cervical cordotomy does not result in further changes in the plasma 5-HT level in portal vein blood.