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At least 19 recordsLinked to original sources
PubMed1992

A new topical treatment for acute herpetic neuralgia and post-herpetic neuralgia: the aspirin/diethyl ether mixture. An open-label study plus a double-blind controlled clinical trial.

Topical aspirin/diethyl ether (ADE) mixture was used to treat 45 consecutive patients with acute herpetic neuralgia (AHN) (n = 28) and with post-herpetic neuralgia (PHN) (n = 17) in an open-label study. Good-to-excellent results were achieved by 93% of AHN patients and by 65% of PHN patients. Earlier treatment yielded better results for the AHN but not the PHN group. The topical treatment seemed to accelerate the healing of acute herpetic skin lesions and possibly modulate the severity of the herpetic infection. Furthermore, a striking reduction in the percentage of AHN patients developing PHN was observed in the treated group, as compared with the disease natural history reported in the literature (4 vs. 50-70%). Treatment tolerance was excellent with no adverse effect observed. In addition to the open trial, a pilot double-blind crossover placebo-controlled study (n = 11) compared the analgesic efficacy of ADE with two other NSAID (indomethacin and diclofenac) drug/ether mixtures. Aspirin (but not indomethacin and diclofenac) was significantly superior to placebo as regards pain relief (P less than 0.05).

Acute Disease↗
PubMed1980

Chemotherapy of onchocerciasis: a controlled clinical trial of topical diethylcarbamazine (DEC) in Guatemala.

A double-masked, controlled clinical trial was conducted in Guatemala to assess the safety and efficacy of diethylcarbamazine (DEC) lotion as compared to placebo lotion in the treatment of onchocerciasis. One hundred eighty-seven people were enrolled in this study and were followed for two months. Lotion was applied daily for seven days, then weekly for seven weeks. The decrease in mean microfilarial counts per skin snip was significantly greater in those receiving DEC lotion than for those receiving placebo lotion. The proportionate reduction in microfilarial counts was similar for people with light, moderate, or heavy microfilarial loads. Side effects were mainly related to skin changes, fever, and malaise, and occurred in nearly one-third of the people receiving DEC lotion. These reactions occurred almost as commonly in those people who were lightly infected as in those who had moderate or heavy infections.

Administration, Topical↗
PubMed1975

Povidone-iodine for the control of surgical wound infection: a controlled clinical trial against topical cephaloridine.

One hundred and ninety-two operation wounds ina general surgical practice were randomly allocated to receive either topical cephaloridine or a providone-iodine spray, and the rate of wound sepsis was studied. In all types of operation cephaloridine proved superior to providone-iodine as a prophylactic, the difference reaching a significant level in potentially contaminated wounds.

Administration, Topical↗
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↗
PubMed1995

Effects of aerobic exercise in normotensive adults: a brief meta-analytic review of controlled clinical trials.

The purpose of this study was to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in normotensive adults. The results of nine studies published in journals (1963 to 1992) and representing a total of 438 subjects (289 exercise, 149 control) were statistically aggregated using the meta-analytic technique. Statistically significant reductions were found for both resting systolic and diastolic blood pressure (mean +/- SD, systolic, 3 +/- 3, 95% confidence interval, 1.30 to 5.11; diastolic, 3 +/- 4, 95% confidence interval, 0.05 to 4.82). None of the changes were significant for the control groups. Absolute reductions corresponded with decreases of approximately 2% in resting systolic pressure and 4% in diastolic blood pressure. Significant correlations were found between changes in resting blood pressure and duration of training (systolic, r = .66; diastolic, r = .80, both at P < .05). The results of this study suggest that aerobic exercise results in small reductions on resting systolic and diastolic blood pressure among normotensive adults. However, such small reductions may not be clinically important. In addition, more meticulous studies on this topic are needed.

Adult↗
PubMed1994

Antiretroviral therapy for children.

Advances in the development of antiviral drugs have been rapid and dramatic. Since the recognition of HIV-1 as the cause of AIDS in 1984, and improved understanding of retroviral replication and pathogenesis, three antiviral drugs, Zidovudine, Didanosine, and Zalcitabine, have been developed to the point of routine use in humans. There is substantial experience with the former two in children. Despite being unable to cure HIV-1 infection, the benefits of antiretroviral therapy, including extended survival and reductions in opportunistic infections in adults, and improved weight gain and well-being in children, are strong arguments for routine treatment of symptomatic disease. Because these agents may also interfere with human cellular processes and have toxicities including anemia, neutropenia, pancreatitis, and neuropathy, their routine use for the treatment of asymptomatic children requires further controlled study. There are multiple candidate agents being developed for entry into clinical trials. An additional potentially effective strategy is the use of combinations of drugs at the same time or in sequence to maximize the viral targets being attacked, while minimizing toxicity, and to prevent the emergence of a drug-resistant virus.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Risperidone: review and assessment of its role in the treatment of schizophrenia.

OBJECTIVE: To review pharmacologic, pharmacokinetic, therapeutic, and safety information for the antipsychotic agent risperidone and to evaluate its place in the treatment of schizophrenia. DATA SOURCES: MEDLINE and Exerpta Medica databases; Janssen Pharmaceuticals; Food and Drug Administration Psychopharmacology Advisory Committee; PJB Publications; published articles and abstracts; unpublished research reports and abstracts. STUDY SELECTION: In vivo animal studies (pharmacology); volunteer studies (pharmacokinetics); clinical case reports, open clinical studies, and controlled clinical studies (clinical efficacy and adverse effects; long-term studies; studies in special populations. DATA EXTRACTION: Relevant data were extracted from published and unpublished source documents, evaluated, and summarized in tables for comparative review. Abstracts were used in 6 of 8 pharmacokinetic studies, 4 of 8 open clinical studies, and 2 of 9 controlled clinical studies. Use of abstracts limits the extent of data extracted. DATA SYNTHESIS: Risperidone is an effective treatment for positive symptoms of schizophrenia and may be effective for negative symptoms. Efficacy in treatment-resistant patients is inconclusive. In patients in whom low-to-moderate dosage is effective, there should be fewer and less severe adverse effects with risperidone than with haloperidol. Optimal dosage for schizophrenia appears to be 6 mg/d. Although data are limited, risperidone may be toxic on overdose. CONCLUSIONS: Risperidone is a useful addition to the antipsychotic drug armamentarium, but it should be viewed as an atypical antipsychotic agent. It is reasonable to consider a trial of risperidone in treatment-resistant schizophrenic patients prior to the use of clozapine and as a first-line treatment for newly diagnosed patients with schizophrenia.

Antipsychotic Agents↗
PubMed1994

[Neurohumoral mechanisms in cardiocirculatory decompensation].

Congestive heart failure is characterized by profound alterations in systemic haemodynamics as well as in neurohumoral profile with activation of the sympathetic nervous system, reninangiotensin axis, plasma vasopressin and atrial natriuretic peptides, i.e. factors involved in homeostatic control of the cardiovascular system. The sympathetic stimulation, which has been documented by a variety of methodological approaches (plasma norepinephrine measurement, norepinephrine spillover technique, microneurographic recording of efferent post-ganglionic muscle sympathetic nerve traffic) is already evident in the initial stages of the disease (NYHA classes I-II) and more manifest in severe heart failure (NYHA classes III-IV). Although representing in mild heart failure a compensatory mechanism aimed at preserving cardiac output, the sympathetic and neurohumoral activation, which can be likely ascribed to arterial baroreceptor dysfunction, may represent, in the clinical course of the disease, a maladaptative phenomenon. Thus pharmacological treatment of heart failure should be aimed not only at improving systemic haemodynamics but also at reversing neurohumoral activation and baroreflex impairment. Recent experimental clinical evidence suggests that these therapeutical goals can be satisfactorily achieved by digitalis glycosides and ACE-inhibitors.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1994

Effects of surfactant therapy on outcome of extremely premature infants.

Limits of viability of extremely premature infants have recently been addressed both in Europe and the United States. These reports, which demonstrate frequent adverse outcome of infants born before 26 weeks of gestation, have not considered the impact of surfactant therapy. We reviewed records of 445 infants born between 23 and 36 weeks gestation who were admitted to our nursery following the availability of surfactant treatment in 1986 through 1992. Two hundred and eighty-five infants were treated with surfactant (Survanta, Ross Laboratories) as part of controlled, prospective trials or as routine treatment under Food and Drug Administration approval. One hundred and fifty-six infants were unable to be treated with surfactant, as either they received placebo therapy during prospective trials or were born prior to approval of routine surfactant use in the United States. Four additional infants born following the commercial availability of surfactant did not receive surfactant therapy. Survival of untreated infants was 56% compared to 75% in treated infants (P < 0.001). Infants born at all gestational ages between 23 and 26 weeks had an increased likelihood of survival as a result of surfactant treatment. No differences in neurologic outcome between surfactant treated and non-treated infants were demonstrated at subsequent follow-up. We conclude that survival of extremely premature infants is improved following surfactant therapy and that subsequent neurologic outcome is not compromised as a result of this therapy.

Biological Products↗
PubMed1994

The neglect of glucosamine as a treatment for osteoarthritis--a personal perspective.

Osteoarthritis results from progressive catabolic loss of cartilage proteoglycans, owing to an imbalance between synthesis and degradation. Standard drug therapy is only of palliative benefit and may exacerbate loss of cartilage. Glucosamine is an intermediate in mucopolysaccharide synthesis, and its availability in cartilage tissue culture can be rate-limiting for proteoglycan production. A number of double-blind studies dating from the early 1980s demonstrate that oral glucosamine decreases pain and improves mobility in osteoarthritis, without side effects. Nevertheless, medical researchers and physicians in the US have totally ignored this rational and safe therapeutic strategy. By mechanisms that are still unclear, the natural methyl donor S-adenosylmethionine also promotes production of cartilage proteoglycans, and is therapeutically beneficial in osteoarthritis in well-tolerated oral doses. These and other safe nutritional measures supporting proteoglycan synthesis, may offer a practical means of preventing or postponing the onset of osteoarthritis in older people or athletes.

Animals↗
PubMed1994

The natural history of disc herniation and the influence of intervention.

The natural history of lumbar disc herniation must be considered when evaluating the influence and outcome of intervention. The combination of clinical signs and symptoms and corresponding radiologic findings permits a more certain diagnostic conclusion compared with many other obscure back disorders. The relationship between low back pain and a herniated disc is unclear. Mechanical compression and chemical changes may be the source of nerve root symptoms. Studies have shown that the natural course of acute radiculopathy has a good prognosis. Bed rest, information, and analgesics usually are sufficient therapeutic measures. Prolongation of symptoms requires radiologic examination. The decision regarding continued conservative therapy versus surgical intervention must be evaluated. Chemonucleolysis and percutaneous nucleotomy are being used, but the indications are uncertain.

Adult↗
PubMed1995

The role of proton pump inhibitors in the treatment of gastro-oesophageal reflux disease.

Efficacy (healing, symptom relief) and cost-effectiveness are the principal reasons for the rapidly increasing use of proton pump inhibitors (PPIs) for the management of gastro-oesophageal reflux disease. EFFICACY: Mean healing rates pooled from clinical trials are as follows: on omeprazole (OME) 20 mg vs. H2-receptor antagonist. H2RA (cimetidine (CIM) 1.6 g or ranitidine (RAN) 300 mg) (eight studies) at 4 weeks, 67% vs. 37%: at 8 weeks, 81% vs. 49%: on lansoprazole (LAN) 30 mg vs. H2RA (three studies), 83% vs. 47% and 91% vs. 63% at 4 and 8 weeks, respectively. The benefit is greatest in severe disease because the H2RAs are disproportionately less effective. Heartburn is more rapidly relieved and in a higher proportion: at 4 weeks, on OME 20 mg vs. H2RA. 77% vs. 47% and on LAN 30 mg vs. H2RA, 81% vs. 46%. Both PPIs are effective in H2RA-refractory disease, approximately 80% healing occurring in 8 weeks. Relapse rates after healing vary from 25% to 85% at 6 months. Maintenance therapy sustains remissions: relapse at 1 year is, on OME 20 mg vs. RAN 300 mg (2 studies), 12% vs. 79%, and 28% vs. 55% (and 38% on OME 10 mg); on LAN 30 mg vs. 10 mg vs. RAN 600 mg, 20% vs. 31% vs. 68%. The effectiveness of the lower dose allows for dose titration. COST EFFECTIVENESS: The higher drug costs for the PPIs are offset by their higher efficacy, making their use cost effective, particularly in severe disease. Efficacy and cost effectiveness are likely to further expand the use of PPIs at the expense of H2RAs as increasing numbers of patients with milder disease are treated.

Anti-Ulcer Agents↗
PubMed1995

Design and analysis of group sequential logrank tests in maximum duration versus information trials.

When monitoring a clinical trial with failure time data using the logrank test and the type I error spending function approach, the information time has to be estimated as a fraction of the maximum number of failures. In maximum duration trials, the denominator of this fraction is a random quantity and has to be estimated; besides, there are two candidates for the denominator, one under the null hypothesis of no treatment difference and the other under the specified alternative hypothesis. Either way, some adjustments are necessary in determining group sequential boundaries in order to maintain type I error at a desired significance level. As a consequence, the type I error spending function will be altered from the one chosen for the design, thus affecting the operating characteristics of the subsequent group sequential logrank tests. In maximum information trials, however, the maximum amount of information is fixed, and thus the estimate of the information time is always unbiased. The net effect is that computation of group sequential boundaries becomes straightforward, with a potential saving in study durations as compared to maximum duration trials. We will illustrate how adjustments are made in maximum duration trials to maintain type I error when the information times are estimated with the information horizons under the null and alternative hypotheses and present numerical explorations to compare robustness of two different estimates of the information times. We then propose a design procedure for maximum information trials and investigate the properties of maximum information trials for different group sequential boundaries. We also compare maximum information trials and maximum duration trials based on an example.

Biometry↗
PubMed1995

Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures.

The prevention of caries, gingivitis and periodontal diseases has been, and still is, a major objective for the dental profession. A large number of products are available to the general public, either over the counter or on prescription, formulated to prevent these diseases. Formulations are also used by professionals for the prevention and treatment of dental diseases. In recommending or using agents for prevention or therapy it is necessary for the practitioner to appreciate whether proof of efficacy is established. Preventive or therapeutic roles of formulations are frequently confused and there is a need to define the often misleading terminology used to describe products. Guidelines are required to enable the dental professional to understand research data and what constitutes proof of efficacy for preventive and/or therapeutic formulations. The guidelines should describe the research methodologies used today, including study design and analysis, ethics, the format of research papers and the relevance of laboratory data to clinical efficacy.

Anti-Infective Agents, Local↗