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The drug buprenorphine alone or in combination with naloxone appears to be effective for treating heroin addiction in a primary care setting, according to two studies of 326 and 461 heroin addicts. The drugs were more effective than a placebo, or inactive substance. Over a one-year period, up to 67% of the addicts' urine samples tested negative for heroin. They also said the drug reduced their craving for heroin.

Finasteride does not appear to be effective in the treatment of enlarged prostate. Researchers evaluated the effectiveness of finasteride and terazosin in 1,229 men with enlarged prostate who were randomly assigned to take finasteride, terazosin, both drugs or a placebo. Terazosin and the combination of terazosin and finasteride significantly reduced symptoms but finasteride alone was no more effective than the placebo. Terazosin belongs to a class of drugs that relax the smooth muscle of the prostate while finasteride is a drug that lowers blood levels of male hormones.

Objective: To assess the perceptions and attitudes of pharmacists and pharmacy technicians involved in an office-based opioid dependence treatment program using buprenorphine/naloxone.Design: Cross-sectional attitudinal assessment.Setting: Community, outpatient hospital, and clinic pharmacies.Participants: Pharmacists and technicians participating in a clinical trial of opioid dependence treatment using buprenorphine/naloxone.Intervention: Written and telephone surveys followed by interviews with open-ended items.Main Outcome Measures: Attitudes and perceptions regarding opioid-dependent patients and use of buprenorphine/naloxone for treatment of opioid dependence.Results: Pharmacies in seven states (New York, Virginia, Illinois, Florida, Texas, California, and Washington) participated in the clinical trial. A total of 40 pharmacists and pharmacy technicians responded to the initial written survey, representing 27 of the 32 pharmacies (84%). Follow-up interviews were obtained from one individual at 30 of those pharmacies (93.8%). Most pharmacy personnel (77.5%) involved with this study were not more concerned about theft or break-ins and would be willing to participate in opioid dependence treatment as the medication became available commercially (70%). The majority of respondents (85%) indicated that patients did not cause problems at their pharmacies. Compared with their experiences in administering other narcotic medications, most respondents did not express increased concern regarding prescription forgery (75%) or diversion (80%) of buprenorphine/naloxone.Conclusion: The majority of respondents expressed positive attitudes and perceptions regarding patients treated for opioid dependence with buprenorphine/naloxone. [ABSTRACT FROM AUTHOR]

Data from a study evaluating the efficacy of disulfiram for the treatment of alcoholism were analyzed by life-table methods. Previous analysis by more commonly used statistical tests showed a trend favoring disulfiram treatment, but the results were not statistically significant. Life-table methods are the appropriate techniques for analyzing longitudinal studies because they evaluate response to treatment over time rather than at one point in time. Analysis of our data using these methods revealed that disulfiram, combined with medical care and counseling, was superior to medical care and counseling alone in 128 men followed for 1 yr. This report demonstrates: (A) the advantage of life-table methods for evaluating treatment outcome data in alcoholism studies; and (B) the importance of disulfiram treatment in alcoholic patients similar to those we studied. [ABSTRACT FROM AUTHOR]

Describes the expanded role of statisticians in the area of medical clinical trials in private industry, academic centers and the US federal government. Planning, implementation and final analysis of the multicenter randomized clinical trial (MRCT); Complexity of the MRCT; Circumstances presenting the need for a coordinating center.

CSP #221 is a randomized multiinstitutional clinical trial to assess the efficacy of 10 d of perioperative total parenteral nutrition (TPN) in reducing morbidity and mortality in malnourished patients undergoing intraperitoneal and/or intrathoracic operations. In this paper a detailed protocol for the clinical efficacy trial is presented primarily as a reference document for use in interpretation of the results of the clinical trial. It is also anticipated, however, that review of this protocol may be useful to other investigators planning future clinical nutrition intervention trials. [ABSTRACT FROM AUTHOR]

The rationale for a large-scale clinical trial of preoperative total parenteral nutrition (TPN) is described in the context of previous clinical trials that have attempted to demonstrate reduction of operative morbidity with preoperative TPN. Defects in study design or execution potentially compromising the validity of these studies are analyzed. Results of a single-institution pilot study performed during the planning phase of the multiinstitutional preoperative TPN trial are presented. This literature review and pilot study provided the data necessary to permit appropriate design of many critical elements in the protocol for the clinical trial including sample size, eligibility criteria, duration and intensity of treatment regimens, and end-point criteria. The rationale underlying critical decisions in protocol design are presented in detail to allow more meaningful interpretation of the results of the clinical trial. [ABSTRACT FROM AUTHOR]

Interrelationships among circulating levels of cholesterol, vitamin A, and selected transport proteins, as well as other nutritional variables were examined in a large population of hospitalized cancer (CA, n = 94) and noncancer (NONCA, n = 432) patients in order to help clarify a relationship between serum cholesterol and vitamin A. Serum cholesterol and vitamin A levels were positively correlated (r = 0.39; p < 0.001) in both CA and NONCA groups. One hypothesis that might explain such a relationship was investigated. Results suggest that serum-transport protein levels and nutritional status are important factors that lead to a correlation between serum cholesterol and vitamin A by virtue of their mutual associations with both substances. Results suggest also that NONCA patients may have a more complex relationship of variates to serum-vitamin A levels than CA patients and that low levels of both cholesterol and vitamin A in CA patients may be related more to nutritional status than to the presence of cancer. [ABSTRACT FROM AUTHOR]

Objectives: Gastroesophageal reflux can induce bronchospasm, and antireflux therapy has been shown to improve pulmonary function in patients who have gastroesophageal reflux disease (GERD) associated with asthma. Our objective was to study the pulmonary effects of antireflux therapy in patients who had severe GERD without clinically apparent lung disease. Methods: In a Department of Veterans Affairs Cooperative Study, patients who had complicated GERD without important lung disease were randomly assigned to receive one of three types of antireflux treatment, including two kinds of medical therapy and a surgical therapy. Patients had pulmonary function tests (PFTs), including total lung capacity, residual volume, forced vital capacity, forced expiratory volume in 1 s, maximal midexpiratory flow, and diffusing capacity for carbon monoxide. Results: Two hundred forty-seven patients (243 men, four women; mean age 58 yr) entered the randomized trial, and 151 returned for PETs at 1 yr. For the entire study group and for all three treatment groups, mean values for PFTs at 1 yr did not differ significantly from those at baseline. Even in subgroups of patients whose baseline PFTs were abnormal and whose esophagitis had healed completely, there were no significant changes in results of PFTs. Conclusions: For veteran patients with severe GERD and no obvious lung disease, 1 yr of antireflux therapy had no important effect on pulmonary function. These findings suggest that GERD is not commonly associated with inapparent, reversible pulmonary dysfunction. [ABSTRACT FROM AUTHOR]