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At least 73 records · Page 4Linked to original sources
PubMed1992

Treatment of shigellosis: III. Comparison of one- or two-dose ciprofloxacin with standard 5-day therapy. A randomized, blinded trial.

OBJECTIVE: To determine whether a single dose, or 2 doses, of ciprofloxacin are as effective as 5-day, 10-dose therapy for the treatment of shigellosis in adult men who are moderately to severely ill. DESIGN: Randomized, double-blind clinical trial. SETTING: A diarrhea treatment center in the capital city of a developing country, Bangladesh. PATIENTS: A total of 128 adult men with dysentery of less than 96 hours duration. All had Shigella organisms isolated from a culture of stool. INTERVENTIONS: Patients were randomly assigned to receive either a single 1-gram dose of ciprofloxacin at admission to the study (single-dose group; n = 40), a 1-gram dose of ciprofloxacin at admission and 24 hours later (2-dose group; n = 43), or 500 mg of ciprofloxacin every 12 hours for 5 days (10 dose group; n = 35). All patients were hospitalized for 6 days. MEASUREMENTS: Stools were collected individually; their character and consistency were recorded and cultured daily. A physical examination and recording of symptoms were done daily, and the temperature was measured every 4 hours. Therapy was considered to have failed in patients who did not have improvement in the signs and symptoms of dysentery after 72 hours of therapy or in patients who on study day 5 had more than nine stools, or more than two watery stools, or were febrile. RESULTS: There were no treatment failures in the 78 patients infected with species of Shigella other than Shigella dysenteriae type 1. Among the 40 patients infected with S. dysenteriae type 1, treatment failed in 4 of the 10 patients who received single-dose therapy, 2 of the 15 patients who received 2-dose therapy, and none of the 15 patients who received 10-dose therapy (P = 0.017, single-dose therapy group compared with 10-dose group; P = 0.15 for the single-dose group compared with the 2-dose group; P > 0.2 for the 2-dose group compared with the 10-dose group). CONCLUSIONS: A single 1-gram dose of ciprofloxacin is effective therapy for patients infected with species of Shigella other than S. dysenteriae type 1. Single-dose therapy is inferior to 10-dose therapy for treating patients infected with S. dysenteriae type 1.

Adult↗
PubMed2001

Combined pre-incisional oral dextromethorphan and epidural lidocaine for postoperative pain reduction and morphine sparing: a randomised double-blind study on day-surgery patients.

The reduction in acute pain perception following dextromethorphan has previously been investigated in patients undergoing general anaesthesia. This random and double-blind study examined the effects of pre-incisional oral dextromethorphan on postoperative pain and intravenous patient-controlled morphine demand in 60 day-surgery patients undergoing lower body surgery under lidocaine (1.6%-16 ml) epidural anaesthesia after receiving placebo, 60 or 90 mg dextromethorphan, 90 min pre-operatively. Postoperative pain was scored on a visual analogue scale from 1 to 10. In-hospital observation continued for 6 h and for 3 days at home; diclofenac was available throughout. Dextromethorphan-treated patients reported significantly (p < 0.05) less pain and sedation, and felt better. Patients who received dextromethorphan 90 mg had significantly (p < 0.05) lower heart and respiratory rates than those who received 60 mg. Medicated patients required half the morphine and diclofenac of placebo patients: 38% of patients who received 90 mg and 21% who received dextromethorphan 60 mg used no morphine or diclofenac whatsoever, a previously unreported finding.

Aged↗
PubMed2004

A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis.

OBJECTIVE: To demonstrate that 5 days of treatment with a new fluoroquinolone, gemifloxacin, is at least as effective as 7 days of treatment with levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB). DESIGN: Randomized, double-blind, double dummy, multicentre, parallel group study SETTING: Sixty different medical centers in US, UK and Germany. MATERIAL AND METHODS: A total of 360 adults (>40 years of age) with AECB were randomly assigned to receive gemifloxacin 320 mg once daily for 5 days or levofloxacin 500mg once daily for 7 days. The primary efficacy parameter was a clinical response at follow-up (Days 14-21). RESULTS: In total, 335/360 patients completed the study (93.1%). Seven patients receiving gemifloxacin withdrew from the study compared to 18 patients receiving levofloxacin; this difference was statistically significant (Fisher's exact test: p=0.02). In the intent-to-treat (ITT) population, the clinical success rate at follow-up (Days 14-21) was 85.2% (155/182) with gemifloxacin and 78.1% (139/178) with levofloxacin. Clinical success rate in the per-protocol (PP) population was 88.2% (134/152) with gemifloxacin and 85.1% (126/148) with levofloxacin. At long-term follow-up (Days 28-35), the clinical success rates in the PP population were 83.7% (123/147) with gemifloxacin and 78.4% (109/139) with levofloxacin. The difference in success rates was 5.26% (95% CI: -3.83, 14.34). CONCLUSION: The clinical efficacy of gemifloxacin 320 mg once daily for 5 days in AECB was at least as good as levofloxacin 500 mg once daily for 7 days. Fewer withdrawals and superior clinical efficacy at long-term follow-up were also seen with gemifloxacin.

Administration, Oral↗
PubMed2000

Penicillin for acute sore throat: randomised double blind trial of seven days versus three days treatment or placebo in adults.

OBJECTIVE: To assess whether treatment with penicillin for three days and the traditional treatment for seven days were equally as effective at accelerating resolution of symptoms in patients with sore throat compared with placebo. DESIGN: Randomised double blind placebo controlled trial. SETTING: 43 family practices in the Netherlands. PARTICIPANTS: 561 patients, aged 15-60 years, with sore throat for less than seven days and at least three of the four Centor criteria-that is, history of fever, absence of cough, swollen tender anterior cervical lymph nodes, and tonsillar exudate. 142 patients were excluded for medical reasons and 73 needed penicillin. INTERVENTIONS: Patients were randomly assigned to penicillin V for seven days, penicillin V for three days followed by placebo for four days, or placebo for seven days. MAIN OUTCOME MEASURES: Resolution of symptoms in the first week, eradication of bacteria after two weeks, and recurrences of sore throat after two, four, and six months. RESULTS: Symptoms resolved 1.9 and 1.7 days earlier in patients taking penicillin for seven days than in those taking penicillin for three days or placebo respectively. Symptoms resolved 2.5 days earlier in patients with group A streptococci and 1.3 days earlier in patients with high colony counts of non-group A streptococci. 23 (13%) of the placebo group had to be given antibiotics later in the week because of clinical deterioration; three developed a peritonsillar abscess. The eradication rate for group A streptococci was 72% in the seven day penicillin group, 41% in the three day penicillin group, and 7% in the placebo group. Sore throat recurred more often in the three day penicillin group than in the seven day penicillin or placebo groups. CONCLUSION: Penicillin treatment for seven days was superior to treatment for three days or placebo in resolving symptoms of sore throat in patients with group A streptococcal pharyngitis and, possibly, in those with non-group A streptococcal pharyngitis.

Adolescent↗
PubMed1981

Antihypertensive effect of atenolol (100 mg once a day) and methyldopa (250 mg thrice a day). A double-blind cross-over multicentre study.

In a double-blind cross-over multicentre study lasting for 16 weeks, the antihypertensive effect of atenolol (100 mg once a day) was compared with that of methyldopa (250 mg thrice a day) in 48 patients with mild to moderately severe hypertension. At the end of the trial, atenolol was superior to methyldopa in achieving clinically relevant BP levels, less than 150/95 mmHg (p less than 0.001), and in respect to patients' drug preference (p less than 0.04). The BP levels after the first 2 weeks of treatment with either drug were identical but, in contrast to methyldopa, atenolol caused further significant reduction in BP during the following 4 weeks. This finding implies that one should hesitate to start additional therapy until after at least six weeks of atenolol treatment, whereas no further reduction in BP can be expected after the first 2 weeks of treatment with methyldopa. Two patients had to be withdrawn from the study during treatment with atenolol, as they developed severe bradycardia and dyspnoea, respectively. Other side-effects were few and of minor clinical importance.

Adult↗
PubMed1985

Premedication before day surgery. A double-blind comparison of diazepam and placebo.

Premedication with diazepam 0.25 mg kg-1 by mouth was compared with placebo in a double-blind trial in patients undergoing day-case surgery under general anaesthesia. Diazepam decreased significantly preoperative discomfort and apprehension. The patients were discharged on time regardless of the type of premedication, and complaints at the time of discharge and on the following day could be related only to the length of anaesthesia and not to the type of premedication. Premedication given early in the morning remained effective for up to 6 h.

Adolescent↗
PubMed1992

Effect of fluoxetine on alcohol consumption in male alcoholics.

To test the effect of inhibiting serotonin uptake on voluntary alcohol intake, 20 alcohol-dependent males were housed on a locked hospital ward with 60-ml drinks of 97.5 proof alcohol available in a fixed interval drinking decision paradigm 13 times each day. After a 3-day, single-blind placebo baseline period, 10 subjects each received the serotonin uptake blocker fluoxetine (up to 80 mg po daily) or placebo double-blind for 28 days. The fluoxetine group had a 14% lower alcohol intake during the 1st week only, associated with a lower proportion of requests for alcohol and less craving for alcohol (as rated by research staff). There were no significant effects in later weeks, nor any differences in scores on the Hamilton Depression and Anxiety Scales or the Hopkins Symptom Checklist.

Adult↗
PubMed2007

[Secondary amaurosis after infraorbital injury with a wooden foreign body].

We report a 68-year-old male who had orbital trauma from a bicycle accident. His vision was initially normal but deteriorated over 8 days to complete blindness. After 13 days, when he first consulted a physician, clinical investigation revealed total ophthalmoplegia, ptosis, and chemosis. Computed tomographic scan showed fractures of the medial orbital wall, orbital floor, and posterior ethmoid with dislocation into the orbital apex near the optic nerve. The patient was sent to our department for optic nerve decompression. Clinical examination showed induration and an already healed infraorbital entry wound suggesting an orbital foreign body, which was confirmed by ultrasound. Renewed analysis of CT scans in different window settings could clearly demonstrate a wooden foreign body in the lower eyelid. Additionally, a diffuse inflammation in the orbital apex was diagnosed. The foreign body was removed and decompression of the orbita and optic nerve was performed. Antibiotics and corticosteroids were administered i.v. Unfortunately, no visual improvement could be achieved.

Aged↗
PubMed1981

Clinical pharmacology and antiarrhythmic efficacy of encainide in patients with chronic ventricular arrhythmias.

We determined the pharmacokinetics, efficacy and therapeutic plasma concentration of encainide, a new antiarrhythmic drug that affects His-Purkinje conduction but not ventricular refractoriness. Nine patients with frequent and complex premature ventricular complexes were studied in a 3-day double-blind protocol. Each day, each patient received 75 mg of i.v. or oral encainide or placebo. Frequent blood samples for encainide plasma concentration determination and continuous ambulatory ECGs were obtained. There was a marked intersubject variation in bioavailability (mean 42 +/- 24%, range 7.4-82%), clearance (13.2 +/- 5.6 ml/min/kg, range 3.75-22.1 ml/min/kg) and half-life (3.4 +/- 1.7 hours i.v., 2.5 +/- 0.8 hours oral). Eight of nine patients had more than 90% suppression of premature ventricular complexes for 3-36 hours. Minimal antiarrhythmic plasma concentration was higher (39 +/- 54 ng/ml, range 3.5-170 ng/ml) after i.v. dosing than after oral dosing (14 +/- 16 ng/ml, range 1.5-48 ng/ml), suggesting an active metabolite after oral dosing in many patients. Minimal side effects were seen despite high peak plasma concentrations (range 794-1556 ng/ml i.v., 36-495 ng/ml oral). The minimal ratio of toxic to therapeutic plasma concentration ranged from 4.3-326 (median 23) after oral dosing. Antiarrhythmic action was associated with an 11-44% widening of the QRS complex that was not associated with other adverse effects. We conclude that encainide effectively suppresses ventricular arrhythmias. Despite a variable bioavailability, high clearance and short half-life, its wide ratio of toxic to therapeutic concentration and probable active metabolite permit a long duration of action, which should allow a reasonable dose schedule in most patients during chronic oral dosing.

Aged↗
PubMed1999

Target-controlled propofol vs. sevoflurane: a double-blind, randomised comparison in day-case anaesthesia.

We compared target-controlled propofol with sevoflurane in a randomised, double-blind study in 61 day-case patients. Anaesthesia was induced with a propofol target of 8 microgram.ml-1 or 8% sevoflurane, reduced to 4 microgram.ml-1 and 3%, respectively, after laryngeal mask insertion and subsequently titrated to clinical signs. Mean (SD) times to unconsciousness and laryngeal mask insertion were significantly shorter with propofol [50 (9) s and 116 (33) s, respectively] than with sevoflurane [73 (14) s and 146 (29) s; p < 0.0001 and p = 0.0003, respectively]; however, these differences were not apparent to the blinded observer. Propofol was associated with a higher incidence of intra-operative movement (55 vs. 10%; p = 0.0003), necessitating more adjustments to the delivered anaesthetic. Emergence was faster after sevoflurane [5.3 (2.2) min vs. 7.1 (3.7) min; p = 0.027], but the inhaled anaesthetic was associated with more nausea and vomiting (30 vs. 3%; p = 0.006), which delayed discharge [258 (102) min vs. 193 (68) min; p = 0.005]. Direct costs were lower with sevoflurane but nausea would have increased indirect costs. Patient satisfaction was high (>/= 90%) with both techniques. In conclusion, both techniques had advantages and disadvantages for day-case anaesthesia.

Adolescent↗
PubMed1988

Trimethoprim-sulfamethoxazole for acute dysuria in women: a single-dose or 10-day course. A double-blind, randomized trial.

STUDY OBJECTIVE: To compare single-dose and 10-day treatment regimens of trimethoprim-sulfamethoxazole in women with acute dysuria, urgency, or urinary frequency. DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: Student health center at a major university. PATIENTS: Consecutive sample of 255 young women including 216 with a bacteriologically documented urinary tract infection. INTERVENTION: Single-dose treatment (trimethoprim, 320 mg and sulfamethoxazole, 1600 mg) given to 116 women and 10-day treatment (trimethoprim, 160 mg and sulfamethoxazole, 800 mg, twice daily) given to 125 women. Women with a history of sulfonamide allergy were given trimethoprim alone: 10 received single-dose treatment (200 mg) and 5 received 10-day treatment (100 mg, twice daily). MEASUREMENTS AND MAIN RESULTS: The rates for resolution of symptoms at 3 days, 13 days, and 6 weeks after entry into the study were not significantly different between treatment groups. Among women with urinary tract infections, cumulative crude rates of recurrence in the single-dose and 10-day treatment groups, respectively, were 24% compared with 5% at 13 days after entry (P = 0.0002; 95% confidence interval [CI] for difference in proportions, 10%, 28%) and 32% compared with 21% at 6 weeks after entry (P = 0.07; 95% Cl, -2%, 24%). Factors independently associated with lower cure rates were a history of a urinary tract infection within the previous 6 weeks (adjusted odds ratio [OR], 3.8; 95% Cl, 1.4 to 10.6) and presence of 10(5) bacteria/mL or greater in an initial midstream culture (adjusted OR, 2.9; 95% Cl, 1.2 to 7.0). After controlling for these factors, the risk of failure after single-dose treatment was not statistically significantly different from 10-day treatment at 6 weeks (adjusted OR, 1.6; 95% Cl, 0.8 to 3.2; P = 0.21). Compared to 10-day treatment, single-dose treatment less effectively eradicated Escherichia coli from the vaginal flora (P less than 0.001) and led more often to early same-strain recurrences (P = 0.003). Meaningful adverse effects occurred in 12% of women given single-dose treatment compared with 25% of women receiving 10-day treatment (P = 0.009). CONCLUSIONS: Compared with single-dose treatment, 10-day treatment yields a superior cure rate at 2 weeks after the start of treatment, but by 6 weeks the advantage of longer treatment no longer exists. This effect may be explained by the lesser effectiveness of single-dose treatment in eradicating vaginal E. coli, resulting in more frequent same-strain recurrences within 2 weeks of treatment.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed2001

Randomized, controlled trial of oros methylphenidate once a day in children with attention-deficit/hyperactivity disorder.

OBJECTIVE: A new once-a-day methylphenidate (MPH) formulation, Concerta (methylphenidate HCl) extended-release tablets (OROS MPH), has been developed. This study was conducted to determine the safety and efficacy of OROS MPH in a multicenter, randomized, clinical trial. METHODS: Children with attention-deficit/hyperactivity disorder (ADHD; n = 282), all subtypes, ages 6 to 12 years, were randomized to placebo (n = 90), immediate-release methylphenidate (IR MPH) 3 times a day (tid; dosed every 4 hours; n = 97), or OROS MPH once a day (qd; n = 95) in a double-blind, 28-day trial. Outcomes in multiple domains were assessed, and data were analyzed using analysis of variance and Kaplan Meier product limit estimates for time to study cessation. The primary time point for analysis was the last available patient visit using last observation carried forward. RESULTS: Children in the OROS and IR MPH groups showed significantly greater reductions in core ADHD symptoms than did children on placebo. This was true both at the end of week 1 and at the end of treatment on the basis of mean teacher and parent IOWA Conners ratings. IR MPH tid and OROS MPH qd did not differ significantly on any direct comparisons. Forty-eight percent of the placebo group discontinued early compared with 14% and 16% in the IR MPH and OROS MPH groups, respectively. CONCLUSIONS: For the treatment of core ADHD symptoms, OROS MPH dosed qd and IR MPH dosed tid were superior to placebo and were not significantly different from each other.attention-deficit/hyperactivity disorder, methylphenidate, OROS, Concerta.

Appetite↗
PubMed1981

Effect of theophylline on cortisol secretion.

Theophylline is thought to improve asthma by increasing intracellular cyclic adenosine 3'-5'-monophosphate (cAMP) levels. It has been demonstrated in experimental animals that elevation of intracellular cAMP in the adrenal cortex causes an increased secretion of cortisol. We studied whether therapeutic doses of theophylline given intravenously and orally to human subjects over 3 days would increase cortisol secretion. A single-blind, 6-day protocol was employed in five normal and five asthmatic volunteers. Adrenal function was monitored by 8 A.M. and 4 P.M. serum cortisol and adrenocorticotropic hormone (ACTH) levels; daily 24-hr urine for urinary-free cortisol (UFF), 17-hydroxysteroids (17-OH), and 17-ketosteroids (17-KS); and alternate-day cortisol secretory rates (FSR) measured by isotope dilution after intravenous 14C-cortisol. Serum theophylline concentration also was monitored. Results in normal and asthmatic subjects were similar. Theophylline caused a significant but transient increase in UFF and 17-OH excretion. Urine volumes also increased significantly, suggesting that the renal effect of theophylline accounted for the increased UFF and 17-OH excretion. FSR increased during the first 24 hr after theophylline in eight of nine cases (p < 0.05 by sign test), mean values increasing from 14.2 to 19.3 mg, but this effect had dissipated by day 3 of theophylline administration. In contrast to these findings, theophylline had no effect on serum cortisol or ACTH or urinary 17-KS. It is likely that serum cortisol and ACTH remained unchanged because the increase in cortisol secretion was offset by a concomitant increase in cortisol clearance. It is concluded that theophylline produces a small, transient increase in cortisol secretion and clearance, and this effect is similar in asthmatic and normal subjects.

17-Ketosteroids↗