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PubMed1990

Gabapentin in partial epilepsy. UK Gabapentin Study Group.

Gabapentin is an analogue of gamma aminobutyric acid (GABA) which has anticonvulsant properties in animals. In a multicentre, double-blind, placebo-controlled, parallel-group study of 1200 mg/day gabapentin as additional therapy in 127 patients with drug-resistant partial epilepsy, 25% of patients who received gabapentin had the number of partial seizures at least halved, compared with 9.8% of patients given placebo. The median reduction in partial seizure frequency during 12 weeks' treatment was 29.2% with gabapentin compared with 12.5% with placebo. The mean adjusted response ratio for gabapentin (-0.192) was significantly better than the ratio of -0.060 for placebo by analysis of variance. 62% of patients who received gabapentin reported mostly mild or moderate adverse effects compared with 41% on placebo; no interactions were observed between gabapentin and other standard anticonvulsants. Gabapentin is an effective additional treatment for patients with partial epilepsy refractory to standard therapy, is fairly well tolerated, and appears to have a favourable efficacy-to-toxicity ratio.

Acetates↗
PubMedDate not supplied

[Treatment using immucytal in children with recurrent respiratory infections: an Italian multicenter experience].

120 children, 71 male and 49 female, aged between 2 years and 15 years (mean 6.15 +/- 3.52 years) with recurrent respiratory infections, were treated with Immucytal, an immunomodulator of bacterial origin, based on membrane proteoglycan fractions plus bacterial ribosomes. The children, selected on the basis of the previous year's clinical score, were treated according to a random design with either Immucytal or placebo, using the same dosage of one puff per nostril plus one puff in the oropharyngeal cavity three times a day, as follows: 1st month: two weeks' treatment, one week wash out, one week's treatment. 2nd, 3rd, 4th months: two weeks' treatment, two week's wash out. Monthly throughout the treatment period the frequency and severity of airway infections episodes were assessed using the same score as for admission. Blood chemistry test, immunological assays (circulating Ig, lymphocyte subpopulations, Merieux Multitest in vivo blastization test) and respiratory tests (spirometry using a pneumotachigraph) were done before and after the treatment. 118/120 children completed treatment; the two dropouts were in the placebo group, one for compliance and the other because of headaches. Respiratory symptoms improved significantly in the actively treated children already from the first month, but not in the placebo group. This improvement consisted of reduction of the respiratory infectious episodes in both the upper and lower airways. No changes were noted in respiratory function parameters. From the immunological viewpoint, there were significant rises in serum IgA and IgM and enhanced skin response tot he Multitest; there was no change in the percentages of different circulating lymphocyte subpopulations.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1994

Initiation of antiretroviral therapy in HIV infection: a review of interstudy consistencies.

A number of clinical trials have explored the optimal dosage for antiretroviral therapy and, in various ways, the optimal time, in terms of stage of human immunodeficiency virus (HIV) disease, at which treatment should begin. Some studies have shown that treatment with zidovudine results in a delay in progression to more advanced stages of HIV disease, and that the benefits are more durable among persons who started zidovudine with higher CD4+ cell counts. Efficacy is preserved and toxicity is reduced when zidovudine is used at dosages lower than those originally recommended. The Concorde study found that administration of zidovudine to asymptomatic persons was associated with increases in CD4+ cell counts and improvement in delaying disease progression at 55 weeks, but found no correlation between time of initiation of therapy and either longer-term delay in onset of symptomatic disease or ultimate survival. The analysis of these results, however, is complicated because of premature crossover of study participants from deferred treatment to immediate treatment. The consensus of the discussants of these studies is that antiretroviral treatment should be initiated by the time the CD4+ cell count has fallen to 200-500 cells/mm3. Although recognizing that, in general, viral infections call for treatment, the panelists were divided in their opinions about treatment of asymptomatic patients with CD4+ cell counts > 500/mm3.

Cohort Studies↗
PubMed1995

Clinical trials of extended spectrum penicillin/beta-lactamase inhibitors in the treatment of intra-abdominal infections. European and North American experience.

The clinical results with the beta-lactam/beta-lactamase inhibitor class of antimicrobials in the treatment of intra-abdominal infections are reviewed. The three agents now in clinical use--ampicillin/sulbactam, ticarcillin/clavulanate, and piperacillin/tazobactam--are effective against a broad variety of gram-positive and gram-negative organisms. The beta-lactamase inhibitor is an irreversible inactivator of beta-lactamase enzymes, which are produced by many gram-negative and gram-positive organisms. Randomized, prospective, clinical trials of each agent indicate clinical cure rates > 85% that are not significantly different from those obtained with second-generation cephalosporin or aminoglycoside plus antianaerobic comparators, with the exception of one study. Piperacillin/tazobactam has also been compared with imipenem, with equivalent or superior outcomes, depending on the dose of the imipenem comparator. Side effects in the non-penicillin-allergic patient are few. The incidence of abnormal renal function tests are generally lower than that obtained with aminoglycoside plus antianaerobic therapy. Introduction of this new beta-lactam antimicrobial group provides another important strategy for the adjunctive management of surgically treated, community-acquired, intra-abdominal infection.

Abdomen↗
PubMed1990

Spironolactone and altizide versus converting enzyme inhibitor (enalapril).

The safety and antihypertensive effectiveness of a fixed-dose combination form of spironolactone + altizide (S/A) were compared with those of enalapril, an angiotensin-converting enzyme inhibitor in a randomized, double-blind, parallel-group study of 186 patients with moderate essential hypertension. The 2 treatment groups were comparable in terms of age, gender, duration and severity of hypertension, diastolic blood pressure (BP), serum potassium and creatinine, and 24-hour urinary sodium excretion after a 4-week washout phase. After 8 weeks of treatment, both S/A and enalapril decreased BP significantly and to about the same extent. Enalapril, however, was more effective in decreasing supine diastolic BP in patients younger than age 50, whereas S/A yielded better results in those older than 50. Laboratory values were similar after both drugs were administered, and there were no clinically significant changes. The study demonstrated that S/A safely reduces elevated BP, particularly in older patients.

Adult↗
PubMedDate not supplied

[Controlled clinical study on the effect of quazepam versus triazolam in patients with sleep disorders].

Quazepam (QZP), a new long half-life benzodiazepine, seems to have a more specific hypnotic activity and a "physiological" mechanism of action. This study assessed its clinical efficacy and any withdrawal symptoms occurring after the treatment with QZP and triazolam (TRZ). Sixty-five patients (mean age 41.4 yrs +/- 12.43 SD) with sleep disorders were included in the study. The patients were treated with placebo for 4 days (run-in period) and if no amelioration of insomnia was observed, were then randomly allocated to 15 mg QZP (33 patients) or TRZ (32 patients) for 8 weeks and finally placebo for another week. Sleep quality, efficiency, side-effects and withdrawal effects were assessed by specific rating scales. In comparing data obtained from the two treatments, the following conclusions were drawn: 1) both drugs showed a hypnoinductive efficacy but patients treated with QZP had significantly fewer night awakenings; 2) at the end of treatment only patients treated with TRZ had longer awakenings and rebound symptoms; 3) a lower withdrawal symptom incidence was observed in patients treated with QZP. Therefore, QZP seems to have a good hypnotic effect without inducing withdrawal symptoms. In contrast TRZ turned out to be a merely hypno-inducing drug presenting higher risks of rebound effects after withdrawal.

Adolescent↗
PubMed1995

Calcium channel blockers for heart rate control in atrial fibrillation complicated by congestive heart failure.

OBJECTIVES: To review the safety and efficacy of verapamil and diltiazem with respect to ventricular response in atrial fibrillation (AF) in the setting of left ventricular (LV) systolic dysfunction. DATA SOURCES: Pertinent articles were identified through a MEDLINE search of the English language literature from 1984 to 1993, followed by a manual search of the bibliographies of pertinent articles. STUDY SELECTION: Studies selected were case reports, controlled trials, review articles and editorials. DATA EXTRACTION: Effects of verapamil and diltiazem on hemodynamics, ventricular response in AF, clinical parameters and mortality were reviewed. DATA SYNTHESIS: There are limited data about the effects of verapamil and diltiazem on ventricular function in patients with congestive heart failure. In vitro diltiazem has fewer negative inotropic effects than verapamil. Clinically there are some reports of hemodynamic and clinical deterioration in patients with significant LV dysfunction given verapamil although most patients improve with verapamil. There are more data concerning diltiazem in the setting of AF complicated by congestive heart failure. The drug does not appear to exacerbate heart failure, although hypotension can result. In chronic AF complicated by heart failure, there is concern that diltiazem may increase mortality. Options for therapy are digoxin, beta-blockers and atrioventricular node ablation. CONCLUSIONS: Calcium channel blockers may have a role in the acute reduction of ventricular response in patients with AF complicated by congestive heart failure; however, their safety in chronic heart rate control remains to be proven.

Atrial Fibrillation↗
PubMed1995

Changes in study design, gender issues, and other characteristics of clinical research published in three major medical journals from 1971 to 1991.

OBJECTIVE: To examine trends in study design and other characteristics of original research published in JAMA, Lancet, and the New England Journal of Medicine (NEJM) between 1971 and 1991. DESIGN: A retrospective cross-sectional study of original clinical research published in JAMA, Lancet, and NEJM during 1971, 1981, and 1991. MEASUREMENTS: Four hundred forty-four articles were independently reviewed by at least two investigators and classified according to study design and other preselected study characteristics. Changes over time were analyzed by chi-square tests for categorical variables and analysis of variance for continuous variables. MAIN RESULTS: Clinical results doubled, from 17% of all articles in 1971 to 35% in 1991 (p < 0.004), while case series decreased from 30% to 4% (p < 0.0001). Of 118 clinical trials, randomized controlled trials increased from 31% to 76% (p < 0.003) and nonrandomized controlled trials decreased from 42% to 8% (p < 0.002). Multicenter studies increased from 10% to 39% (p < 0.0001) and the prevalence of health services research increased from none in 1971 to 12% in 1991 (p < 0.001). The proportion of the studies explicitly excluding women from the subject population decreased from 11% in 1971 to 3% in 1991 (p < 0.03). In 1991 7% of the studies were composed entirely of men subjects, while only 0.7% of the studies were specific to men's health. Twelve percent of the studies in 1991 were specific to women's health. Between 1971 and 1991 there was no change in the prevalence of women first authors or studies addressing women's or minorities' health issues. CONCLUSIONS: Several important changes in clinical research studies published in JAMA, Lancet, and NEJM have taken place between 1971 and 1991. Clinical trials have increased in frequency, largely replacing studies containing ten or fewer subjects. Health services research has increased in prevalence, reflecting growing interest in studies addressing the delivery of health care. Our data support the hypothesis that exclusion of women from clinical research studies is an important contributor to the paucity of data concerning women's health.

Clinical Trials as Topic↗
PubMedDate not supplied

Data-proof practice.

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Clinical Trials as Topic↗
PubMed1993

Therapy of left ventricular dysfunction: implications of recent therapeutic trials and future directions for therapy.

The natural history of patients with heart failure has changed relatively little until recently. Several large randomized trials have however recently changed our approach to the patient with symptomatic as well as asymptomatic left ventricular dysfunction. Although the effect of digoxin on survival is still uncertain there is still good evidence from the Radiance study in which patients were randomly withdrawn from digoxin that patients who remain on digoxin have a significant improvement in exercise tolerance and well being. The Consensus trial in patients with class IV heart failure suggested that ACE inhibitors were effective in improving survival. This therapy has not however been widely adapted in patients with mild to moderate heart failure. The recent randomized SOLVD treatment trial in conjunction with the VHEFT II study clearly shows that ACE inhibitors should be the basis for therapy along with a diuretic and digoxin if necessary in all patients with symptomatic left ventricular dysfunction unless contraindicated or not tolerated. There is also evidence from the SOLVD prevention trial that ACE inhibitors can prevent the development of manifest heart failure and hospitalization for heart failure in patients with asymptomatic left ventricular dysfunction. The importance of ACE inhibitors in patients with asymptomatic left ventricular dysfunction is confirmed by data from the SAVE trial which examine both symptomatic and asymptomatic patients with left ventricular dysfunction 3-16 days post infarction. Of interest in both the SOLVD treatment and prevention trials as well as the SAVE trial was the finding that ACE inhibitors reduced the incidence of recurrent ischemic events.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Agonists↗