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E B Nelson

Publications and source records attributed to E B Nelson.

61 records · Page 4Linked to original sources

Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial.

CONTEXT: Acute diarrhea with gas-related abdominal discomfort is a common, usually self-limited disorder with substantial social and economic impact. OBJECTIVE: To compare the efficacy and safety of a loperamide hydrochloride-simethicone combination product with those of loperamide alone, simethicone alone, and placebo in treating acute diarrhea with gas-related abdominal discomfort. DESIGN: Randomized, placebo-controlled, double-blind trial of 48 hours' duration. SETTING: A primary care, ambulatory practice in Acapulco, Mexico. PATIENTS: A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort. INTERVENTIONS: Each patient was randomly assigned to receive 2 chewable tablets containing loperamide hydrochloride, 2 mg, and simethicone, 125 mg (n = 124); loperamide hydrochloride, 2 mg (n = 123); simethicone, 125 mg (n = 123); or placebo (n = 123). This was followed by 1 tablet after each unformed stool, up to 4 tablets in any 24-hour period. MAIN OUTCOME MEASURES: Time to last unformed stool and time to complete relief of gas-related abdominal discomfort were the protocol-specified primary outcomes. Secondary outcomes included time to complete relief of diarrhea, number of unformed stools, and patient-assessed variables at the end of the study (overall illness relief, diarrhea relief, and abdominal discomfort relief). RESULTS: Patients who received loperamide-simethicone had significantly (P < .001) shorter time to last unformed stool and faster relief of gas-related abdominal discomfort than patients who received loperamide, simethicone, or placebo alone. Loperamide-simethicone was significantly (P < or = .01) more effective than the other 3 treatments for all end-of-study patient-assessed outcomes and all clinically important secondary outcomes. No significant differences in adverse events were found among treatment groups. CONCLUSIONS: The loperamide-simethicone combination chewable product provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort (gas pain, cramps, gas pressure, and bloating) than either of its components or placebo. The combination is well tolerated.

Abdominal Pain↗

Once- and twice-daily nitrendipine in patients with hypertension and noninsulin-dependent diabetes.

One hundred and six patients with uncomplicated mild to moderate essential hypertension received nitrendipine 10 mg twice a day or 20 mg once a day in a double-blind, randomized design. At the end of the dosing interval, supine and standing blood pressures were lowered 6/4 and 6/3 mm Hg respectively with the former regimen, and 2/3 mm Hg with the latter. In 10 patients, blood pressure variability through the dosing interval was not increased by nitrendipine 10 mg twice daily, but in another 10, 20 mg daily increased the variability by 28% compared to placebo. Significantly more patients had adverse effects with 20 mg daily than 10 mg twice daily; and both regimens caused more side effects than placebo. In 20 patients, serum glucose levels did not change significantly during treatment with nitrendipine, but in 10 of those with noninsulin-dependent diabetes, the range of maximum plasma insulin in response to a high-carbohydrate meal was 7 times as great during treatment with nitrendipine as it was during treatment with placebo. Nitrendipine lowers blood pressure when given once or twice daily, but twice-daily administration appears to be better tolerated.

Adult↗

Efficacy of nonprescription doses of ibuprofen for treating migraine headache. a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migraine headache. BACKGROUND: Migraine headache is a common illness with significant social and economic impact. DESIGN: Randomized, placebo-controlled, double-blind trial of 6 hours' treatment duration. METHODS: Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults aged 18 to 84 years with migraine headache of moderate to severe intensity. Each patient was randomly assigned to a single dose of study medication: ibuprofen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The percentage of patients with a reduction in baseline headache intensity from severe or moderate to mild or none 2 hours after treatment and the headache pain intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severity differences from baseline for migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability, and percentage of patients with migraine-associated symptoms reduced to none. RESULTS: Significantly (P < or = .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours (41.7% and 40.8%, respectively), compared with those treated with placebo (28.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P < or = .001) greater for patients treated with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differences in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with severe baseline pain intensity, ibuprofen, 400 mg, was significantly (P < or = .048) superior to placebo for the primary efficacy end points, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were statistically significantly more effective than placebo for all clinically important secondary pain relief outcomes. Mean severity changes of migraine-associated symptoms of nausea, photophobia, phonophobia, and functional disability at 2 and 6 hours were significantly (P < or = .03) in favor of both doses of ibuprofen over placebo, and results for the percentage of patients with symptoms reduced to none consistently, although less often statistically significant, favored ibuprofen. No statistically significant differences in adverse events were found among treatment groups. CONCLUSIONS: Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cost-effective, well-tolerated, single-ingredient nonprescription treatment for pain of migraine headache. In addition, while not always statistically significant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disability.

Adult↗

Propylbutyldopamine. Mechanism of blood pressure lowering in hypertensive patients.

The effects of propylbutyldopamine ( PBDA ), an analog of dopamine lacking significant vasoconstrictor effects, were examined in seven patients with essential hypertension. Cardiovascular hemodynamics, renal plasma flow, urinary sodium excretion, and the renin-angiotensin-aldosterone system were examined during PBDA infusion both before and after administration of low (8 micrograms/kg) and high (40 micrograms/kg) doses of the dopamine receptor antagonist metoclopramide. Infusion of PBDA at a rate of 20 micrograms/kg/min lowered mean arterial pressure from an average control value of 112 +/- 4 to 94 +/- 3 mm Hg during the last 5 minutes of infusion (p less than 0.01), and increased effective renal plasma flow from 330 +/- 22 ml/min to 591 +/- 46 ml/min (p less than 0.01). Changes in heart rate (+ 16% +/- 5% increase from control values of 77 +/- 3 bpm), urinary sodium excretion (+ 13% +/- 5% increase from control value of 121 +/- 11 muEq/min), plasma renin activity (+ 23% +/- 15% increase over control value of 1.3 +/- 0.3 ng angiotensin I/ml/hr), and plasma aldosterone (+ 26% +/- 12% increase over control value of 17 +/- 6 ng/dl) accompanied PBDA infusion. Pretreatment with metoclopramide at a dose of 8 micrograms/kg prior to PBDA infusion partially blunted the blood pressure reduction produced by PBDA alone (-10% +/- 8% vs -20% +/- 4% compared to control values, p less than 0.1) but had no effect on PBDA -induced increases in renal plasma flow (+ 179% +/- 15% vs + 179% +/- 9% compared to control).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗