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Results for “randomized crossover trial”

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PubMed1985

Effect of bepridil in patients with chronic stable angina: results of a multicenter trial.

The effects of bepridil, a calcium antagonist with a half-life of approximately 42 hr, were assessed in a double-blind, randomized, placebo-controlled crossover trial. Forty-four patients (39 men, five women) with exercise-induced angina pectoris and ST segment depression with exercise testing (modified Bruce protocol) were studied. Compared with placebo bepridil (400 mg daily) increased total exercise time, time to onset of angina, time to 1 mm of ST segment depression, time to 2 mm of ST segment depression, and total work achieved (all p less than or equal to .001). Both frequency of angina and nitroglycerin consumption decreased during the bepridil compared with the placebo period (p = .02 and .03, respectively). Minor side effects were noted during both the bepridil and placebo phases. Four patients experienced side effects that limited therapy (dizziness in three and abnormal results of liver function tests in one) and one patient died during the bepridil phase. This study suggests that bepridil, 400 mg daily, is effective for the treatment of exercise-induced myocardial ischemia and angina pectoris.

Angina Pectoris↗

PubMed1992

Effect of fenfluramine on mood: a double-blind placebo-controlled trial.

Depressed patients (n = 10), schizophrenics (n = 6), and normal control subjects was (n = 9) were administered fenfluramine hydrochloride (FF) (60 mg/os) or placebo in the context of a randomized, double-blind crossover trial. No effect of FF on mood or activation was detected over a 6-hr period. A previous report claiming acute antidepressant effects of FF in depressed subjects was not confirmed.

Adult↗

PubMed2001

Atrioventricular interval optimization and exercise tolerance.

Modern pacemakers offer many programming options regarding the AV interval including the ability to vary AV intervals depending on whether atrial activity is paced or spontaneous and to shorten AV intervals with increasing rates. To determine if optimization of these features improves exercise tolerance, 14 patients with intact sinus node function and AV block treated with dual chamber pacemakers were enrolled in a randomized double-blind crossover trial. Doppler echocardiographic measurements of cardiac index and mitral flow were assessed over a range of programmable AV intervals at rest to determine each patient's optimal AV interval. Eleven patients completed serial graded exercise tests with spiroergometry after randomly programming the AV interval three ways in a crossover manner: fixed AV interval = 150 ms without rate adaptation (150/Fixed), fixed AVinterval = 150 ms with rate adaptation (150/R), or optimized AV interval with rate adaptive AV interval shortening (optimized/R). Exercise capacity was determined by maximum oxygen uptake. Ten men and four women, age 64 +/- 8 years, were enrolled. At rest, optimization of the AVintervalimproved the cardiac index by 21% (P < 0.001) and mitral flow by 13.4% (P < 0.001) when compared to least-favorable AV intervals. During exercise, no differences in maximum heart rates were noted. Maximum oxygen uptake was increased in both groups with rate adaptive AVinterval shortening when compared tofixed AVinterval without rate adaptation: 13.9% (adjusted P < 0.04) and 14.6% (adjusted P < 0.02) in optimized/R and 150/R, respectively. No differences were noted between optimized/R and 150/R. In conclusion, rate adaptive AV interval shortening improved exercise tolerance independent of changes in heart rate. However, optimization of the AV interval with Doppler echocardiography at rest did not further improve exercise capacity.

Atrial Function↗

PubMed1993

Intradialytic granulocyte reactive oxygen species production: a prospective, crossover trial.

By the use of flow cytometric techniques, this prospective, randomized crossover study was designed to analyze intradialytic granulocyte reactive oxygen species (ROS) formation in whole blood with complement-activating and noncomplement-activating hollow fiber membranes. Dialysis with a complement-activating membrane resulted in a 6.5-fold increase in granulocyte hydrogen peroxide production 15 min after dialysis initiation and remained significantly elevated (P < 0.01) through the first 30 min with this membrane in comparison to both predialysis values and simultaneous values with a noncomplement-activating membrane. Further studies demonstrated that blood obtained at 15 min with a complement-activating membrane generated significantly less granulocyte ROS production in response to Staphylococcus aureus incubation than blood obtained either predialysis or at the same time in dialysis with a noncomplement-activating membrane. Both complement-activating and noncomplement-activating dialysis membranes caused slightly decreased granulocyte responsiveness to phorbol myristate acetate. It was concluded that hemodialysis with complement-activating membranes results in increased granulocyte ROS production and decreased responsiveness to S. aureus challenge during the dialysis procedure. These results document the potential role of ROS in hemodialysis-associated pathology and susceptibility to infection.

Adult↗

PubMed1999

Twice-daily versus once-daily morphine sulphate controlled-release suppositories for the treatment of cancer pain. A randomized controlled trial.

We evaluated the safety and efficacy of controlled-release morphine sulphate suppositories administered 12-hourly and once daily in patients with chronic cancer in a randomized double-blind crossover trial. Pain was assessed using a 100-mm VAS pain scale and a five-point ordinal pain scale. The VAS pain intensity score was 17.5+/-17.2 after suppositories every 12 h, versus 16.2+/-13.4 after suppositories every 24 h (difference not significant). The difference between the mean VAS pain scores with 12-hourly and once-daily dosing was 1.3 mm (not significant). The mean ordinal pain scores were 1.0+/-0.7 versus 1.0+/-0.6 for 12-hourly and once-a-day dosing, respectively (not significant). A retrospective power analysis indicated that a difference of 5.9 mm was detectable, even with only 6 patients. Adverse events noted were constipation, nausea, anorexia, and dry mouth. The use of once-a-day controlled-release morphine suppository is a more convenient and equally effective alternative to twice a day dosing.

Aged↗

PubMed1989

Comparative clinical trial of the tolerability, patient acceptability and efficacy of two transdermal glyceryl trinitrate patches ('Deponit' 5 and 'Transiderm-Nitro' 5) in patients with angina pectoris.

A randomized two-period crossover trial was carried out to compare the efficacy, tolerability and patient acceptability of two transdermal ('patch') formulations of glyceryl trinitrate. 'Deponit' 5 and 'Transiderm-Nitro' 5, both designed to deliver 5 mg glyceryl trinitrate in 24 hours. All patients were treated for 4 weeks with each of the formulations, changed once per day. Forty-seven patients entered the trial and all completed both phases of treatment. Both drugs resulted in highly significant mean reductions in angina attack frequency, the reduction being significantly greater with 'Deponit'. Similarly, mean sublingual glyceryl trinitrate consumption was also reduced; again, the greater reduction with 'Deponit' was significant. In terms of effectiveness, 'Deponit' was preferred to 'Transiderm-Nitro' by 19 patients, whilst only 5 patients preferred 'Transiderm-Nitro' (p less than 0.01). In terms of ease of application, comfort, appearance and adhesion (assessed in relation to daytime, night-time, washing, bathing and exercising), there were no appreciable or significant differences between patients' assessments of the two forms. Neither treatment had any appreciable effect on heart rate or blood pressure. Both formulations were very well tolerated, with very few reported side-effects.

Administration, Cutaneous↗

PubMed1993

Ondansetron plus metopimazine compared with ondansetron alone in patients receiving moderately emetogenic chemotherapy.

BACKGROUND AND METHODS: The serotonin (5-hydroxytryptamine3) antagonists have improved the treatment of acute chemotherapy-induced nausea and vomiting, but their ability to prevent delayed nausea and vomiting seems less pronounced. The results of a preliminary open trial suggested that the addition of a selective dopamine D2 antagonist could improve the antiemetic efficacy of the serotonin antagonists. In a randomized, double-blind, crossover trial, we compared oral treatment with ondansetron (8 mg twice a day) and the dopamine D2 antagonist metopimazine (30 mg four times a day) with treatment with ondansetron alone for three days in 30 patients who had vomited during the previous cycle of chemotherapy. All the patients received moderately emetogenic chemotherapy. RESULTS: Combination treatment with ondansetron and metopimazine significantly reduced the incidence of acute (P = 0.006) and delayed (P = 0.02) nausea and acute (P = 0.02) and delayed (P = 0.006) vomiting, as compared with treatment with ondansetron alone. Patients had significantly fewer days of nausea (P = 0.03) and vomiting (P = 0.003) if they received combination therapy. Sixty-seven percent of the patients preferred ondansetron and metopimazine, and 33 percent favored ondansetron alone (P = 0.10). Adverse reactions were mild with both regimens. With the exception of constipation, which was reported more frequently with combination therapy (P = 0.03), there were no significant differences in adverse reactions. CONCLUSIONS: Ondansetron plus metopimazine is a highly effective and safe antiemetic regimen that is markedly superior to treatment with ondansetron alone in patients receiving moderately emetogenic chemotherapy.

Adult↗

PubMed1992

Symptomatic benefit of supplemental oxygen in hypoxemic patients with terminal cancer: the use of the N of 1 randomized controlled trial.

The symptomatic effects of oxygen on the dyspnea of terminally ill cancer patients have not been clearly established. Therefore, the decision to administer oxygen is frequently made on an individual basis. We report on the use of N of 1 randomized clinical trial to compare the symptomatic benefit of respiratory failure due to terminal ovarian cancer. A 53-yr-old female patient underwent 6 randomized double-blind crossover trials between oxygen 5 L/min delivered by mask and air 5 L/min delivered by mask. Each treatment period lasted 5 min. The mean saturation of oxygen during the baseline period was 84% +/- 3%, versus 84% +/- 4% on air (P,NS) and 94% +/- 4% on oxygen (P less than 0.001). The mean visual analogue scale (VAS) for dyspnea was 77 +/- 4 during the baseline period as compared to 51 +/- 7 after air (P less than 0.001), and 40 +/- 5 after oxygen (P less than 0.001). The patient and the investigator chose oxygen blindly in 5 of 5 cases, air in 0 and 1 case, and no choice was made in 1 and 0 case, respectively. In 4 cases the patient considered the difference between oxygen and air to be of "much importance," and in one case to be of "moderate importance." No significant treatment, period, or interaction between period and treatment was detected for the difference in the VAS. We conclude that oxygen was significantly better than air for symptomatic improvement in this patient. The N of 1 technique is a simple and reliable method for the assessment of individual patients' response to oxygen.

Blood Gas Analysis↗

PubMed2004

In vitro testing to diagnose venom allergy and monitor immunotherapy: a placebo-controlled, crossover trial.

BACKGROUND: In people with a history of sting allergy, only prior reaction severity and older age are known to predict subsequent reaction risk. Furthermore, no diagnostic test other than a deliberate sting challenge has been found to identify people in whom venom immunotherapy (VIT) has been unsuccessful. OBJECTIVE: We aimed to assess the utility of a number of in vitro tests to diagnose venom allergy and to monitor immunotherapy. METHODS: During a double-blind randomized placebo-controlled crossover trial of Myrmecia pilosula ant VIT the following venom-specific tests were performed at enrolment, and at completion of treatment prior to a diagnostic sting challenge; leucocyte stimulation index (SI), IL-4 production, IgE RAST, histamine release test (HRT), leukotriene release test (LRT) and basophil activation test (BAT). Intradermal venom skin testing (VST) was also performed at trial entry. RESULTS: Only VST and HRT identified those at risk of sting anaphylaxis in the placebo group. Although IgE RAST, leucocyte SI and IL-4 production, LRT and BAT all correlated well with intradermal VSTs, they did not predict sting challenge outcome. After successful VIT, venom-induced leucocyte IL-4 production tended to fall, whereas IgE RAST increased and a natural decline in HRT reactivity was reversed. A confounding seasonal affect on laboratory results was suspected. CONCLUSION: The HRT warrants further assessment for diagnosis of venom allergy. Uninformative performance of the commercially available LRT and BAT tests may be due to pre-incubation with IL-3. None of the tests evaluated appear to be reliable markers of successful VIT.

Animals↗

PubMed1998

Nortriptyline versus amitriptyline in postherpetic neuralgia: a randomized trial.

UNLABELLED: OBJECTIVE (BACKGROUND): Amitriptyline (AT) is a standard therapy for postherpetic neuralgia (PHN). Our hypothesis was that nortriptyline (NT), a noradrenergic metabolite of AT, may be more effective. METHODS: A randomized, double-blind, crossover trial of AT versus NT was conducted in 33 patients. RESULTS: Thirty-one patients completed the trial. Twenty-one of 31 (67.7%) had at least a good response to AT or NT, or both. We found no difference with regard to relief of steady, brief, or skin pain by visual analog scales for pain and pain relief; mood; disability; satisfaction; or preference between the two drugs. Intolerable side effects were more common with AT. Most patients (26/33) were not depressed, and most responding showed no change in rating scales for depression despite the occurrence of pain relief. CONCLUSIONS: We concluded that this study provides a scientific basis for an analgesic action of NT in PHN because pain relief occurred without an antidepressant effect, and that although there were fewer side effects with NT, AT and NT appear to have a similar analgesic action for most individuals.

Aged↗

PubMed1993

Essential fatty acids in the treatment of premenstrual syndrome.

OBJECTIVE: To determine whether essential fatty acids are effective in the treatment of premenstrual syndrome (PMS). METHODS: In a randomized, double-blind, crossover trial, we studied 27 women diagnosed with PMS over ten menstrual cycles and 22 symptom-free controls over one cycle. The first cycle was used for diagnostic assessment. For the women with PMS, placebos were administered during the second cycle. This was followed by randomization to four cycles of active treatment with essential fatty acids and four cycles of placebo, with a crossover after completion of the fourth cycle. Assessment of symptoms and diagnosis of PMS were based on daily self-ratings made by the women throughout the study. RESULTS: Treatment with essential fatty acids did not reduce premenstrual symptoms or symptom cyclicity. However, time had a significant effect on a number of symptoms, indicating either a placebo effect or an effect from participation in the study. Women with PMS had a significantly higher frequency of dysmenorrhea and familial PMS than did the symptom-free controls. CONCLUSION: Treatment with essential fatty acids is ineffective therapy for PMS. The improvement we observed over time can be ascribed to either a placebo effect or participation in the study.

Adult↗

PubMed1999

Comparisons of the effects of different long-acting delivery systems on the pharmacokinetics and pharmacodynamics of diltiazem.

The benzothiazepine calcium channel antagonist diltiazem is a short-acting drug. To achieve effective 24-h blood pressure control with once-daily dosing, it relies on various extended drug-delivery systems that have grown in importance as a result of the recent reports relating the use of short-acting calcium channel antagonists to increased cardiovascular morbidity. This study examines the pharmacokinetics and resulting pharmacodynamics of two different delivery systems, each loaded with 240 mg of diltiazem and administered to 40 moderately hypertensive patients in a randomized, double-blind crossover trial. After a 4-week, single-blind placebo lead-in, patients with a clinical diastolic blood pressure of > or =100 mm Hg were randomized to either the single or dual microbead diltiazem delivery system for a 4-week period. At the end of this period, each subject was evaluated with 24-h ambulatory blood pressure monitoring and subjected to 24-h inpatient pharmacokinetic analysis on separate days. This was followed by a similar 4-week period in which each subject was treated with the alternative delivery system. For diltiazem, the area under the curve for plasma concentration versus time and the maximum plasma concentration attained by the single microbead system exceeded the values achieved by the dual bead system by 15% and 25%, respectively. These differences were greatest from the 3rd through the 13th h after dosing. During this period, both systolic and diastolic ambulatory blood pressure was significantly lower when the single microbead system was used. When compared with baseline blood pressure, blood pressure reductions achieved with the single microbead system exceeded reductions achieved with the dual microbead system by at least 2 mm Hg for 10 of the 24 postdose hours. Heart rates were slightly reduced but not significantly different. This improved blood pressure control at higher plasma levels of diltiazem suggests that a more efficient delivery system could provide better blood pressure control for identical doses of diltiazem.

Adult↗

PubMed2000

[Inhibition of nitric oxide synthase has an analgesic effect in chronic pain].

The efficacy of the inhibitor of nitric oxide synthase, NG-monomethyl-L-arginine hydrochloride (L-NMMA), was tested in 16 patients with chronic tension-type chronic headache. The study was designed as a randomized double-blind, crossover trial. Patients were assigned intravenous infusion of 6 mg/kg L-NMMA or placebo on two days separated by at least one week in a randomized order. Headache intensity was measured on a 100 mm visual analogue scale at baseline and at 30 min, 60 min, and 120 min after start of treatment. L-NMMA reduced pain intensity significantly more than placebo: 120 min after start of treatment, the mean pain score was decreased from 49 to 33 with L-NMMA and from 44 to 40 with placebo (p = 0.01). The present study demonstrates that inhibition of NOS has an analgesic effect in chronic tension-type headache.

Adult↗

PubMed1995

Double-blind, placebo-controlled trial of methylphenidate in older, depressed, medically ill patients.

OBJECTIVE: The authors examined the efficacy of methylphenidate in the treatment of depression in a group of older, medically ill patients. METHOD: Sixteen patients underwent an 8-day double-blind, randomized, placebo-controlled crossover trial; 13 completed the trial. RESULTS: Statistically and clinically significant treatment responses were found. CONCLUSIONS: These results support the use of methylphenidate in older, medically ill patients in whom rapid resolution of depressive symptoms is crucial.

Age Factors↗

PubMedDate not supplied

Diltiazem in the treatment of mild or moderate essential hypertension. Comparison with metoprolol in a crossover double-blind trial.

The antihypertensive efficacy and tolerability of a calcium antagonist drug, diltiazem (60 mg q.i.d. per os), was compared with that of metoprolol (100 mg b.i.d. pr os) in a crossover, double-blind randomized trial in 20 patients with mild or moderate essential hypertension. Blood pressure and heart rate were assessed at rest and during bicycle exercise before and after four-week periods of treatment. Both metoprolol and diltiazem reduced significantly systolic and diastolic blood pressure, while heart rate decreased only after metoprolol therapy. The reduction in blood pressure and the percentage of patients who responded favorably were similar with the two drugs. Furthermore, the overall levels of blood pressure during exercise were significantly reduced by both treatments, while only metoprolol was able to reduce the maximum increase in systolic blood pressure and heart rate induced by exercise. These results suggest that the use of diltiazem may be appropriate to the treatment of patients with mild or moderate essential hypertension.

Adult↗

PubMed1990

Topical anaesthesia of the normal tympanic membrane: a controlled clinical trial of different suspensions of lidocaine.

The purpose of this investigation was to find an effective method for topical lidocaine anaesthesia of the tympanic membrane for minor therapeutical procedures. Twelve subjects with healthy ears were tested in a randomized double-blind crossover trial. Xylocaine (lidocaine) aerosol 10%, lidocaine 4%, and lidocaine hydrochloride 5% were tested against placebo. Xylocaine aerosol was sprayed into a small container, shaken, and tempered. This made the application painless. The eardrum was stimulated by a point of a needle effective 25 min after application (p = 0.008 and p less than 0.05, respectively). Lidocaine hydrochloride showed no effect. No side effects were observed. The effectiveness seems to be dependent on the ionization of the drug, since the two effective drugs lidocaine and Xylocaine are un-ionized, whereas the ineffective lidocaine hydrochloride is ionized.

Adult↗

PubMed2006

Influence of nebivolol and enalapril on metabolic parameters and arterial stiffness in hypertensive type 2 diabetic patients.

OBJECTIVE: To compare the effects of a cardioselective beta-blocker (nebivolol) with those of an angiotensin-converting enzyme inhibitor (enalapril) on parameters of insulin sensitivity, peripheral blood flow and arterial stiffness during one extended glucose clamp experiment. DESIGN: A randomized, double-blind crossover trial, consisting of two 12-week treatment phases separated by a 4-week wash-out phase. METHODS: Patients with type 2 diabetes and arterial hypertension were randomly assigned to one of two treatment sequences (nebivolol-enalapril, enalapril-nebivolol). Haemodynamic, metabolic and other laboratory measurements were carried out on the first and last day of each treatment period by means of a glucose clamp experiment that also involved the measurement of blood flow and arterial stiffness. RESULTS: Twelve patients were included in this study, of which two dropped out early. Efficacy parameters were therefore available for 10 patients. There was no significant difference in any of the primary efficacy parameters. Moreover, the effects on blood pressure did not significantly differ between both treatments. Six adverse events happened during treatment with nebivolol compared with two during treatment with enalapril, but only one was regarded as possibly related to the treatment. CONCLUSIONS: This pilot study shows that the combined measurement of insulin sensitivity, blood flow and arterial stiffness is feasible. Nebivolol and enalapril did not show different effects with regard to these parameters in hypertensive diabetic patients. If these results are confirmed in larger clinical trials, this would argue against the reservations against beta-blockers as drugs of first choice in patients with diabetes because of potential metabolic side-effects.

Adrenergic beta-Antagonists↗

PubMed2006

Conventional and sustained-release valproate in children with newly diagnosed epilepsy: a randomized and crossover study comparing clinical effects, patient preference and pharmacokinetics.

OBJECTIVE: It has been suggested that sustained-release valproate (VPA) formulations may be more effective and better tolerated than conventional VPA due to better compliance and lower fluctuations in VPA serum concentrations, but comparative trials with conventional VPA in children are scarce. This randomized and crossover trial compared the efficacy (complete control of seizures), the tolerability, and the patient (or parents) preference of conventional VPA twice daily (CVbid) with those of sustained-release chrono VPA twice daily (ChVbid), once daily in the morning (ChVom) or once daily in the evening (ChVoe) in monotherapy. METHODS: The study was carried out in 48 children (29 girls), aged 5-14 years, with newly diagnosed partial epilepsy (n=26), or idiopathic generalized epilepsy (n=22). The study duration was 16 months (four phases of 4 months each). VPA pharmacokinetics data were also compared in the different regimens. Mean VPA dosage was of approximately 870 mg/day (approximately 22 mg/kg/day) and mean VPA concentration was of approximately 89 mg/l at 12 h post-dose and of 54 mg/l at 24 h post-dose. RESULTS: By intention in treatment there were no significant differences in efficacy (73%, 83%, 77% and 75%, respectively) or in adverse reaction frequency (56%, 58%, 67% and 46%, respectively). There were significant differences, however, in patient (or parents) preference, the order being ChVoe (31%) > ChVom (25%) > CVbid (17%) > ChVbid (8%). The mean VPA serum concentration fluctuation between 4 h and 0 h post-morning-dose was nonsignificantly lower after CVbid than after ChVbid. Fluctuation was significantly higher after ChVom than after CVbid or ChVbid. The mean VPA serum concentration difference between 12 h and 24 h post-dose was approximately 40 mg/l. CONCLUSION: Although our results should be confirmed by a larger study, they suggest that the efficacy and tolerability of chrono valproate is similar to that of conventional valproate, and that the main advantage is the once-daily administration.

Adolescent↗