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PubMed1997

Effects of 3-days' intake of a sustained-release preparation of the nitric oxide donor, isosorbide dinitrate, on oesophageal motility.

BACKGROUND: Nitric oxide plays an important role in gastrointestinal motility. We evaluated the effects of a sustained-release preparation of the nitric oxide donor isosorbide dinitrate on swallow-initiated oesophageal contractions and the lower oesophageal sphincter. METHODS: Twelve healthy men, aged 23-32 years, received, at 1-week intervals and under random double-blind conditions, for 3 days either 20 mg isosorbide dinitrate, 40 mg isosorbide dinitrate or placebo twice daily (b.d.). One hour after a further dose on day 4, oesophageal motility was recorded for 30 min using a multilumen catheter with a Dent sleeve straddling the lower oesophageal sphincter and side-hole openings 0, 3, 6 and 9 cm proximal to the sleeve. Contractile responses to twelve 5-mL water swallows were evaluated. RESULTS: Amplitude, duration, propagation velocity and onset latency of oesophageal contractions were not affected by either dosage of isosorbide dinitrate. Lower oesophageal sphincter resting pressure was significantly lower after 40 mg (15.1 mmHg +/- 1.2 S.E.M.) and 20 mg isosorbide dinitrate b.d. (15.0 +/- 1.0 mmHg) than after placebo (17.9 +/- 1.7 mmHg; P < 0.025). Headache was reported by all subjects on 40 mg isosorbide dinitrate, seven subjects on 20 mg and by one on placebo. CONCLUSIONS: Twenty and 40 mg sustained-release isosorbide dinitrate twice daily had no effect on swallow-initiated oesophageal contractions but decreased lower oesophageal sphincter resting pressure.

Adult↗

PubMed1983

[Double-blind comparative study of Bi-Profenid tablets and Profenid capsules in inflammatory rheumatism].

The effectiveness of Bi-Profenid tablets and Profenid capsules was studied comparatively in patients with inflammatory joint disease. 43 patients with rheumatoid arthritis or various chronic inflammatory joint diseases were given 300 mg of Bi-Profenid in 2 daily oral doses and 300 mg of Profenid in 3 daily oral doses, for two consecutive 7 day periods. This double blind cross-over study was carried out in two rheumatology centers. Effectiveness of the two forms of ketoprofen on morning stiffness and pain scale was found to be comparable. However, patients more often preferred Bi-Profenid (15 cases) to Profenid (10 cases); 12 patients reported no difference. Tolerance was excellent in 92.7% of cases under Profenid capsules and in 94.8% of cases under Bi-Profenid tablets.

Adolescent↗

PubMed1993

Double-blind, placebo-controlled study of a once-a-day, sustained-release preparation of alprazolam for the treatment of panic disorder.

OBJECTIVE: The goals of this study were to assess the antipanic efficacy of a new, sustained-release formulation of alprazolam and to assess the safety and tolerability of once-a-day administration of 1-10 mg of sustained-release alprazolam. METHOD: One hundred ninety-four patients with diagnosis of agoraphobia with panic attacks or panic disorder with limited phobic avoidance underwent a 1-week placebo washout before being randomly assigned to groups receiving 8 weeks of double-blind treatment with either sustained-release alprazolam or placebo. RESULTS: There was a significant treatment effect favoring sustained-release alprazolam (highest mean dose = 4.7 mg/day) across almost all measures of anxiety, panic, and phobic avoidance, despite a significantly higher dropout rate in patients receiving placebo. Eighty-five percent of the patients treated with sustained-release alprazolam, compared with 61% of the patients given placebo, reported complete blockade of panic attacks by the end of 6 weeks of treatment. Sedation was the most commonly reported adverse effect. Discontinuation of sustained-release alprazolam was associated with moderate but transient levels of distress in 48% of the patients; discontinuation of placebo led to distress in only 10% of the patients. Nonetheless, there was no difference in the proportion of patients who were able to remain off the study drug for at least 2 weeks. CONCLUSIONS: These results suggest that sustained-release alprazolam is highly effective in the acute treatment of panic disorder at doses comparable to those in the originally marketed compressed tablet of alprazolam. The medication was well tolerated but showed rebound effects during a rapid drug taper after 6 weeks of treatment.

Administration, Oral↗

PubMedDate not supplied

Psychopharmacological effects of pyritinol in normal volunteers.

Twelve healthy male volunteers received pyritinol 600 or 1,200 mg or placebo for 3 days according to a randomised, double-blind crossover design. On the 1st and 3rd days of each of the three treatment periods subjects completed a battery of psychological tests including Critical Flicker Fusion (CFFT), Choice Reaction Time (CRT), tests of memory and subjective drug effects at 1, 2, 4 and 6 h after dosing. Significant improvements in CFFT and CRT were found after pyritinol. There were no significant differences on the other tests, however, the observed enhancement in performance could be attributed to the effect of the drug.

Adult↗

PubMed1994

Study of the antiischemic action of EGb 761 in the treatment of peripheral arterial occlusive disease by TcPo2 determination.

In a randomized, placebo-controlled, double-blind, parallel study of 20 patients, the antiischemic effect of EGb 761 (Ginkgo biloba Extract) was studied by measuring the transcutaneous partial pressure of oxygen (TcPo2) during exercise. Transcutaneous oximetry during exercise provides a good, noninvasive estimation of local arterial perfusion and constitutes a real index of local and regional capillary perfusion. Twenty patients between the ages of forty-four and seventy-three years suffering from claudicating atherosclerotic arterial occlusive disease in stage II according to the Leriche and Fontaine classification, diagnosed for more than a year and stable for three months, were included. The eligible patients received placebo for fifteen days under single-blind conditions. At the end of this preinclusion period, the eligibility criteria were checked and the patients were randomized to two treatment groups. The first group received 320 mg per day of EGb 761 for four weeks and the second group received placebo. The treadmill walking test was performed under standardized conditions at the same time of day and by the same investigator. In a comparison of the differences before and after treatment, the areas of ischemia decreased by 38% in the EGb 761 group but remained essentially stable (+5%) in the placebo group. This difference between groups is significant (F [1.18] = 4.91; P = 0.04) and the 95% confidence interval for the difference ranges from 0.89 to 3.87. This study confirmed significantly the rapid antiischemic action of EGb 761 and its value in the management of peripheral arterial occlusive disease at the stage of intermittent claudication.

Adult↗

PubMed1995

Randomized, double-blind comparison of a prochlorperazine-based versus a metoclopramide-based antiemetic regimen in patients undergoing autologous bone marrow transplantation.

BACKGROUND: Highly emetogenic combination alkylator therapy is routinely used in autologous bone marrow transplantation for treatment of eligible patients with solid tumors. Antiemetic therapy remains less than optimal in this setting. METHODS: One hundred twenty-six patients with cancer receiving high dose cisplatin, cyclophosphamide, and carmustine with autologous bone marrow support were randomized to receive one of four double-blinded antiemetic regimens: 4-day continuous infusion prochlorperazine (6 mg/m2 intravenous [i.v.] loading dose followed by 1.5 mg/m2/hour) or metoclopramide (80 mg/m2 iv loading dose followed by 20 mg/m2/hr) each with either dronabinol 5 mg/m2 or placebo capsules for two doses before carmustine on the last day of chemotherapy. All subjects received scheduled lorazepam and diphenhydramine throughout the 4-day study period. Efficacy was measured by the Emetic Process Rating Scale and the Rhodes Index of Nausea and Vomiting (INV) Form 2. RESULTS: One hundred six patients completed the study and were fully evaluable. The median number of emetic episodes on the metoclopramide study arm were: 1 (0-7, day -6), 1 (0-6, day -5), 2 (0-9, day -4), and 2 (0-10, with dronabinol day -3) or 2 (0-7, no dronabinol day -3) and on the prochlorperazine study arm were: 4 (0-12, day -6), 0 (0-8, day -5), 0 (0-12, day -4) and 2.5 (0-9, with dronabinol day -3) or 2 (0-12, no dronabinol day -3). Metoclopramide was significantly better on the first day of therapy (day -6, P < .002) and prochlorperazine was significantly better on the third day of therapy (day -4, P < 0.002). There was no significant difference among any of the four arms on the last day of chemotherapy (day -3), or when the median number of emetic episodes over the total study period were compared. The patients' assessment of nausea, vomiting, and retching on the INV Form 2 was consistent with the observer ratings. Toxicities requiring dose reduction or discontinuation of antiemetic drugs included diarrhea, cardiac arrhythmias, sedation, anxiety, and akathisia. CONCLUSIONS: Both metoclopramide and prochlorperazine in combination with lorazepam and diphenhydramine offer good control of nausea and vomiting although the sedation and low risk for cardiac toxicity limit the regimen to an inpatient setting with close monitoring. No regimen was clearly superior during the entire treatment period but prochlorperazine offered more consistent control after the first day.

Adult↗

PubMed1989

Acute and chronic effects of oral enprostil, a synthetic dehydroprostaglandin E2, on uterine contractility.

In acute experiments eleven nonpregnant women received a single oral dose of enprostil (prostaglandin E2 analogue) 35-140 mcg. Uterine activity was measured by a microtransducer-tipped Millar catheter. A single, oral dose of enprostil caused a long-lasting contracture response of the uterus. 3 h after enprostil, uterine resting pressure (RP) was still high. In chronic experiments, eleven women with regular menstrual cycles received 35 mcg or 70 mcg BID enprostil and placebo in a crossover, double-blind fashion from cycle day 10 +/- 3 for four weeks, then had a washout period of four weeks followed by another four-week treatment period. An increase of uterine RP after enprostil was dose-dependent. After two weeks of twice-daily administration of enprostil, the baseline RP was lower than after placebo (p less than 0.01) and the increase in RP after the morning enprostil less than that seen on the first day. In eight patients studied, the mean values of plasma progesterone were normal, both during placebo--and enprostil--treated cycles.

Administration, Oral↗

PubMed2004

Human loiasis in a Cameroonian village: a double-blind, placebo-controlled, crossover clinical trial of a three-day albendazole regimen.

Because of the life-threatening, post-treatment reactions that have occurred in patients with loiasis treated with ivermectin, evaluation of a short-course albendazole regimen was undertaken in a Loa-endemic region of Cameroon. In a placebo-controlled, double-blinded, crossover study, 99 subjects with microfilaremia (100-3,3837/mL) were assigned to receive albendazole (400 mg; n = 48) or placebo (n = 51) for three days and were followed for 180 days; at day 180, the groups were crossed over and followed for an additional six months. In those initially receiving albendazole (ALB/PLAC), microfilarial levels decreased significantly by day 90 (P < 0.043), but returned to baseline by day 180. In those receiving albendazole at day 180 (PLAC/ALB), microfilarial levels also decreased following albendazole (P = 0.005). Blood eosinophil and antifilarial IgG levels did not change significantly for either group, although antifilarial IgG4 levels did in the ALB/PLAC group at day 180. Most subjects continued to have elevations in microfilaremia, suggesting that more intensive regimens of albendazole will be necessary to reduce Loa microfilaremia to levels safe enough to allow for ivermectin use.

Adolescent↗

PubMed1998

The temporal efficacy of early second-look lysis of adhesions in reducing postoperative adhesions in a murine model.

OBJECTIVE: Our aim was to determine whether early second-look lysis of adhesions reduces postoperative adhesions. STUDY DESIGN: With the murine uterine horn model, early second-look lysis of adhesions was performed 5, 7, 14, and 21 days after an electrocautery injury. Sites with adhesions (between 36 and 46/time point) underwent lysis of adhesions. Fourteen days later, a reviewer blinded to the treatment assessed adhesion formation, including adhesions not present at early second-look lysis of adhesions (eg, de novo adhesions). RESULTS: The rate of adhesion formation was 49% of control sites, unchanged when the early second-look lysis of adhesions was performed at 5 (44.4%) and 7 (39.5%) days, reduced at 14 days (28.6%), and increased at 21 days (74%). The pattern of de novo adhesions was similar, 17.6% when the early second-look lysis of adhesions was performed at 5 days, 10% at 7 days, 0% at 14 days, and 28.6% at 21 days. The only histologic difference between the groups was neovascularity at day 21. CONCLUSIONS: Early second-look lysis of adhesions was effective in reducing postoperative adhesions only when performed at 14 days in this model, suggesting that the specific cellular events occurring at the time of the early second-look lysis of adhesions are critical to efficacy.

Animals↗

PubMed1992

Treatment of postoperative pain with diclofenac in uvulopalatopharyngoplasty.

Diclofenac sodium suppositories 150-200 mg day-1 were compared with placebo in a double-blind study during the first 3 days after uvulopalatopharyngoplasty in 40 patients with habitual snoring or obstructive sleep apnoea syndrome. Consumption of rescue analgesics (paracetamol suppositories) and pain assessed by a visual analogue scale were significantly less in the diclofenac group. Bleeding time (modified Ivy's test) and reported side effects did not differ between the two groups.

Acetaminophen↗

PubMed1995

Efficacy and Safety of Evening Administration of Controlled-Delivery Diltiazem Capsules in Chronic Stable Angina Patients.

The safety and efficacy of controlled-delivery (CD) once-a-day formulation of diltiazem administered in the evening, at a dose of 240 mg, was assessed in 37 patients with stable angina pectoris. A double-blind, placebo-controlled, randomized, crossover protocol was used. Following a 4-day washout period, patients entered a 5--7-day single-blind placebo run-in period during which qualification and reproducibility exercise treadmill tests (ETTs) were performed 24 h postdose. Eligible patients were randomized in a double-blind fashion, to either CD diltiazem or to placebo for a 7--10-day treatment period. They then entered a 5--7-day single-blind washout period, after which they received the alternate treatment for another 7 to 10 days. ETTs were performed at the end of each treatment period. Compared to placebo, evening administration of CD diltiazem produced a marked improvement of the time to ETT termination, time to onset of angina, and time to 1 mm ST depression. In addition, the number of angina attacks recorded in patient diaries was reduced compared to placebo. Incidence of adverse events was comparable with CD diltiazem and placebo. We conclude that evening administration of controlled-delivery diltiazem is highly effective and safe in the treatment of stable angina pectoris.

Journal Article↗

PubMed1986

Treatment of childhood hyperactivity with desipramine: plasma drug concentration, cardiovascular effects, plasma and urinary catecholamine levels, and clinical response.

Twenty-nine boys with attention deficit disorder/hyperactivity were randomly assigned to receive desipramine (DMI; n = 17) or placebo (n = 12) for 14 days in a noncrossover, double-blind study. There was immediate behavioral improvement with DMI at day 3 that was sustained for 2 weeks; behavioral improvement did not correlate with plasma concentrations of DMI, hydroxy-DMI, or their sum at either days 3 or 14. There were no untoward side effects; there was a drug-induced increase in pulse and diastolic blood pressure. During drug therapy, the urinary excretion of norepinephrine, vanillymandelic acid, and 3-methoxy-4-hydroxyphenylglycol (MHPG) was decreased at both days 3 and 14. The plasma MHPG level was decreased at days 3 and 14 and (standing) plasma NE levels increased at day 14. The decreases in both urinary and plasma MHPG levels showed significant correlations with behavioral improvement during the second week. These data corroborate previous findings on sympathomimetic effects of tricyclic antidepressants in children and support a noradrenergic mechanism in the mediation of drug effects on attention deficit disorder/hyperactivity.

Administration, Oral↗

PubMed2002

14 day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status.

OBJECTIVE: Bisphosphonates are effective treatment for osteoporosis but have been associated with gastrointestinal (GI) mucosal injury. This study compared the incidence of gastric ulcers after treatment with risedronate, a pyridinyl bisphosphonate, or alendronate, a primary amino bisphosphonate, in healthy postmenopausal women stratified by Helicobacter pylori status. METHODS: Subjects were randomized to receive risedronate 5 mg (n = 318) or alendronate 10 mg (n = 317) daily for 14 days. Endoscopy and evaluator-blind assessments of the esophageal, gastric, and duodenal mucosa were performed at baseline and on Days 8 and 15. RESULTS: Overall, gastric ulcers > or = 3 mm were observed in 18 (6.0%) of 300 evaluable subjects in the risedronate group and 36 (12.1%) of 297 in the alendronate group during treatment (p = 0.013). On Day 8, the incidences of gastric ulcers in the risedronate and alendronate groups were 3.6% and 6.6%, respectively (p = 0.133), and on Day 15, they were 3.3% and 8.7% (p = 0.008). The incidence of gastric ulcers was not affected by H. pylori status. Mean gastric endoscopy scores at Days 8 and 15 were significantly lower in the risedronate group than in the alendronate group (p < 0.001). Mean esophageal and duodenal endoscopy scores were similar in the 2 groups at Days 8 and 15. When the treatment groups were combined, gastric endoscopy scores were significantly higher among H. pylori negative than H. pylori positive subjects at Days 8 and 15 (p < 0.05). Upper GI adverse events were reported by 18 (5.7%) subjects in the risedronate group (19 events) and 28 (8.8%) subjects in the alendronate group (32 events). Symptoms did not predict the presence of mucosal damage. CONCLUSION: Risedronate was associated with a significantly lower incidence of gastric ulcers than alendronate. H. pylori infection did not increase the incidence of bisphosphonate related gastric ulcers. The findings from this 14 day study in healthy volunteers support the hypothesis that bisphosphonates may differ from one another in their potential to produce upper GI mucosal damage.

Aged↗

PubMed2002

Therapeutic efficacy and clinical acceptability of fusafungine in follicular pharyngitis.

Eighty-one patients suffering from follicular pharyngitis were treated for 7 days in a double-blind, multicentre controlled study of fusafungine versus placebo. Evaluations were performed at inclusion, after 7 days of treatment, and 3 weeks after the end of the treatment. The effects of the pharyngitis on day-to-day life, changes in symptoms, morphological changes of lesions, and general changes observed by the investigator and expressed by the patient were the parameters evaluated at each visit. Results confirmed the efficacy of fusafungine in the treatment of local and symptomatic manifestations of follicular pharyngitis. Effects of follicular pharyngitis on day-to-day life decreased after 7 days of treatment and the differences between the treatment group and the placebo group was close to significance in favour of fusafungine. For the majority of symptoms, the percentage of patients who did not display the symptoms at D7 was greater in the fusafungine group. Postnasal drip decreased significantly in the fusafungine group. The investigators' and patients' judgement was also in favour of the fusafungine treatment. These improvements were confirmed at least 3 weeks after the end of the treatment.

Administration, Inhalation↗

PubMed1994

Glucose given after hypoxic ischemia does not affect brain injury in piglets.

BACKGROUND AND PURPOSE: Giving glucose before hypoxic ischemia worsens brain injury in piglets. Does giving glucose after hypoxic ischemia affect severity of injury? METHODS: Forty-three 0- to 3-day-old pigs were used. All piglets received 2 U/kg insulin before injury to prevent stress-induced hyperglycemia. Hypoxic ischemic brain damage was induced by clamping both carotid arteries and reducing arterial blood pressure to two thirds of normal by hemorrhage at time 0. At 15 minutes the fraction of inspired oxygen (FIO2) was reduced to 6%. At 30 minutes FIO2 was increased to 100%, the carotids were released, and the withdrawn blood was reinfused. The piglets were then randomized to receive either 2 mL/kg of 50% dextrose followed by 2 mL/kg per hour for 2 hours or an equal volume of saline. RESULTS: Neurological examination scores (20 is normal, 5 is brain dead, by blinded observer) at 1 day postinjury were similar in the two groups: glucose, median 15.5 (25th percentile, 12.2; 75th percentile, 18); controls, 15.6 (9.3, 18). Piglets were killed at 3 days with brain preservation at death. Pathological examination scores (sum of scores from cortex, hippocampus, and basal ganglia: 30 is normal, 3 is total necrosis) by blinded observer were similar in the two groups: glucose, 26 (18, 28); controls, 25 (16.5, 28); NS. CONCLUSIONS: Although elevated glucose levels during hypoxic ischemic injury worsen brain injury in the piglet, elevated glucose levels after injury do not affect the severity of the injury.

Animals↗

PubMed1986

Dose response studies of bevantolol in hypertensive patients.

This multicenter study, conducted to determine the antihypertensive efficacy of bevantolol at different fixed doses compared with placebo was carried out at four separate institutions using a common protocol. One hundred thirty-nine patients with mild to moderate essential hypertension were enrolled. At doses of 200 to 400 mg/day bevantolol was clearly effective in lowering diastolic blood pressure and in maintaining this effect over the eight weeks of this double-blind study. Twice a day dosing is indicated since efficacy was evident 12 hours post-dosing. Bevantolol was well tolerated.

Adrenergic beta-Antagonists↗

PubMed1999

Comparison of 7 versus 10 days of antibiotic therapy for hospitalized patients with uncomplicated community-acquired pneumonia: a prospective, randomized, double-blind study.

The objective of this study was to compare the outcome of 7 versus 10 days of antibiotic therapy for inpatients with moderately severe community-acquired pneumonia (CAP). A prospective, randomized, double-blind study with a follow-up period of 42 days was conducted. Fifty-two veterans were treated with 2 days of cefuroxime at 750 mg intravenously every 8 hours followed by group 1, 8 days oral therapy, and group 2, 5 days oral therapy followed by 3 days of placebo. Oral therapy consisted of cefuroxime axetil at 500 mg every 12 hours. No difference was seen in cure rates: 20 of 22 (90.9%) patients in group 1 and 21 of 24 (87.5%) patients in group 2. There were no late recurrences. Potential US cost-savings is $27.2 million. Inpatients with moderately severe CAP can be treated with 2 days of intravenous antibiotics followed by 5 additional days of oral antibiotics. Longer treatment duration prolongs the cost of care, without increasing the cure rate or decreasing the pneumonia recurrence rate.

Adult↗

PubMed1990

Bacterial vaginosis and the effect of intermittent prophylactic treatment with an acid lactate gel.

Intermittent treatment with an acid lactate gel (Lactal, ACO, Sweden) reduced symptoms of bacterial vaginosis (BV) and promoted the reestablishment of the normal vaginal flora of lactobacilli. Forty-two women seriously affected by recurrent BV were initially given acid gel (lactate gel, pH 3.8, 5 ml) to be inserted into the vagina daily for 7 consecutive days. Thereafter they entered into a double blind clinical trial and were treated prophylactically 3 days monthly for 6 months with either lactate gel or a placebo gel. Women treated with the lactate gel were clinically improved, i.e. no signs of BV in 88% compared to 10% in the placebo group (p less than 0.001). The vaginal lactobacilli flora was reestablished in 83% of the lactate group and in 16% of the placebo group. Local intermittent application of lactate gel was found to be free of side effects and is a preferable alternative to repeated treatments with antibiotics in patients with recurrent BV.

Adult↗