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Biomedical subjects

N Gitlin

Publications and source records attributed to N Gitlin.

At least 37 records · Page 2Linked to original sources

Omeprazole versus placebo in duodenal ulcer healing. The United States experience.

The study objective was to study the ulcer healing effects and safety of the proton pump inhibitor, omeprazole, given in a dose of 20 mg once daily before breakfast. The study design was a randomized, double-blind, multicenter comparison of omeprazole and placebo using endoscopy to assess ulcer healing after two or four weeks of therapy. One hundred fifty-three patients with endoscopically documented active duodenal ulcer were studied. One hundred two patients received omeprazole and 51 received placebo. Patients in both groups were similar with regard to age, sex, duration of disease, initial ulcer size, smoking history, and alcohol use. A "per protocol" analysis of healing rates showed a significant advantage for omeprazole (P less than 0.01) at both week 2 (41% vs 13%) and week 4 (75% vs 27%). Concomitant factors (including smoking and ulcer size) did not alter the significance of the differences in healing rates between omeprazole and placebo. Complete relief of day and night pain was more often achieved (P less than 0.01) in the omeprazole group. "All-patients treated" analyses for healing and pain relief gave results similar to the respective "per protocol" analyses. Omeprazole was well tolerated; fewer patients had clinical and laboratory adverse experiences in the omeprazole group than in the placebo group. Fasting serum gastrin levels increased with omeprazole therapy (mean 34.9 to 73.5 pg/ml) but exceeded the normal range (greater than 150 pg/ml) in only 12.3% of patients. Two weeks after therapy was stopped, serum gastrin levels showed a decrease toward baseline but had not yet completely returned to pretreatment levels (mean 49.7 pg/ml).(ABSTRACT TRUNCATED AT 250 WORDS)

Double-Blind Method↗

The relationship between plasma cortisol and gastric mucosa prostaglandin levels in rats with stress ulcers.

A correlation between the levels of plasma cortisol, gastric mucosal prostaglandins and the degree of gastric ulceration produced by stress in rats was examined. Four groups of rats were evaluated. Group A, the cold stressed group; group B, their controls; group C, those receiving intraperitoneal indomethacin; and group D, those receiving intraperitoneal saline. Group A developed stress ulcers and their gastric mucosal prostaglandin levels (prostaglandin E2 (PGE2) and prostacyclin levels, as measured by its stable metabolite 6-keto-prostaglandin F1 alpha (6-keto-PGF-1 alpha, but not thromboxane) were significantly reduced when compared with their respective non-stressed controls. The plasma cortisol levels in both group A and B increased slightly in the first hour but there was no statistical difference between the two groups and there was no change at 2, 3 or 4 h of stress. Group C (indomethacin) also developed ulcers and had low gastric mucosal prostaglandin levels when compared with group D (saline). The plasma cortisol levels did not alter in either group C or D. It has been postulated that stress ulcers may involve the depletion of gastric mucosal prostaglandin levels which, in turn, may be a consequence of a higher plasma cortisol level. A decrease in gastric prostaglandins independent of any change of plasma cortisol levels was demonstrated in this study and the mechanism of production of stress gastric ulcers remains obscure.

Animals↗

Misoprostol in the treatment of duodenal ulcer refractory to H2-blocker therapy. A placebo-controlled, multicenter, double-blind, randomized trial.

A multicenter, double-blind, randomized study compared 200 micrograms of misoprostol and placebo four times daily for four weeks in the treatment of 225 patients with duodenal ulcer (0.7 cm to 2.0 cm in size) persisting after at least four weeks of adequate, conventional therapy with cimetidine or ranitidine. Misoprostol was significantly superior to placebo in healing duodenal ulcers (achieving a healing rate of 37 percent versus 22 percent in the placebo group [p = 0.02], and in relieving ulcer pain [p = 0.01]). Healing also occurred more frequently with misoprostol than with placebo in patients with subgroups of particularly resistant ulcers. In the treatment of ulcers refractory to at least eight weeks of histamine H2-blocker therapy, misoprostol achieved a healing rate of 42 percent versus 20 percent with placebo. In the treatment of pyloric channel ulcers, 28 percent of patients in the misoprostol group showed healing as compared with 20 percent in the placebo group. Diarrhea was reported by 15.4 percent and 3.4 percent of patients receiving misoprostol and placebo, respectively, and was usually mild and transient. Misoprostol is safe and effective therapy for duodenal ulcers that have not healed during the course of H2-blocker therapy.

Adolescent↗

A multicenter, double-blind, randomized, placebo-controlled comparison of nocturnal and twice-a-day famotidine in the treatment of active duodenal ulcer disease.

The efficacy and safety of famotidine, a potent new long-acting H2-receptor antagonist, was compared with placebo in a multicenter, double-blind, randomized, placebo-controlled study in the United States. A total of 384 patients with endoscopically proven acute duodenal ulcer disease were enrolled. Patients received either famotidine or a placebo. The patients receiving famotidine were treated with one of three dose regimens, 40 mg h.s., 40 mg b.i.d., or 20 mg b.i.d. Patients were reassessed by endoscopy at 2, 4, and 8 wk if ulcer healing had not occurred sooner. A diary was kept to record the duration and intensity of the day and night pain and the amount of Gelusil antacid (Parke-Davis, Morris Plains, N.J.) ingested. Three hundred sixty-three patients met the evaluation criteria. The results revealed a 4-wk healing rate of 70%, 75%, 67%, and 31% for the famotidine 40 mg h.s., 40 mg b.i.d., 20 mg b.i.d., and placebo groups, respectively. The 8-wk healing rates for the same respective groups were 83%, 82%, 82%, 45%. Ulcer pain and antacid consumption occurred less often in the famotidine groups. The clinical and laboratory safety profile of the famotidine groups was similar to that of the placebo group. Famotidine appears to be an effective and safe once-a-day therapy for the treatment of acute duodenal ulcer disease. The recommended dosage is 40 mg h.s.

Clinical Trials as Topic↗

The diagnosis and prevalence of subclinical hepatic encephalopathy in apparently healthy, ambulant, non-shunted patients with cirrhosis.

Thirty-seven patients, all with histologic evidence of cirrhosis and with a normal neurological examination and normal mental status were evaluated by psychometric testing for subclinical hepatic encephalopathy. They were all regarded as having well compensated cirrhosis, not requiring any treatment or dietary restrictions and they were working, and many of them driving. A group of 19 patients with a history of alcoholism, or medical disorders, but without clinical or biochemical evidence of cirrhosis, served as controls. They were matched by age, sex, education, and alcohol consumption. Investigations performed were an EEG, fasting arterial ammonia, liver biochemical tests and a series of verbal and performance psychometric tests. The EEG was abnormal in 3 (8.3%) of patients, the ammonia elevated in 17 (45.9%) of patients and 26 patients (70.3%) failed 2 or more psychometric tests, as compared to 2 (10.5%) of the control group. It is concluded that 2 out of 3 patients with stable, well compensated cirrhosis were suffering from subclinical hepatic encephalopathy and that impairment of performance rather than verbal skills occurred. The digital symbol test, trail test (number connection test) and block design tests readily identified the patients with subclinical hepatic encephalopathy. The implication of these observations in patients with cirrhosis, especially those working in mechanical or skilled occupations, needs consideration.

Ammonia↗

Cimetidine-induced hemolytic anemia: the fallacy of clinical associations.

Two patients developed hemolytic anemia while taking cimetidine. Neither patient was taking other drugs known to cause hemolytic anemia. In both, the hemolytic anemia resolved after the drug was stopped. In one patient, the direct antiglobulin (Coombs') test was strongly positive when the hemolytic anemia was recognized and became only weakly positive as the hemolysis subsided. However, serologic studies for antidrug antibodies yielded negative results in both patients; readministration of cimetidine for 55 days in patient 1 and for more than 24 months in patient 2 did not cause recurrence of hemolysis. We conclude that we cannot incriminate cimetidine as the cause of the hemolytic anemia in either of our patients. These findings emphasize that a temporal association of drug administration and hemolytic anemia is not proof of a cause-effect relationship and that reports of drug-related adverse hematologic effects must be interpreted with caution.

Adult↗

The serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase ratio as a prognostic index in severe acute viral hepatitis.

The SGOT/SGPT ratio was studied in 25 patients with severe acute viral hepatitis due to either B or non A-non B hepatitis. The transaminase levels were performed within 10 days of onset of the hepatitis or within 4 days of the diagnosis of fulminant hepatic failure. Twelve patients died of their acute illness. There was a significant difference between the SGOT/SGPT ratios of females who died mean = 2.05) and lived (mean 0.45) (p less than 0.001) and between the SGOT/SGPT ratios of males who died (mean - 1.01) and lived (mean 0.45) (p less than 0.02). Using 95% confidence intervals the expected ratios for combined sexes were calculated to be 0.31 to 0.63 for survivors and from 1.20 to 2.26 for nonsurvivors. Neither age not viral etiology affected the prognosis in this study.

Acute Disease↗