Group support for patients with metastatic cancer. A randomized outcome study

The effects of weekly supportive group meetings for women with metastatic carcinoma of the breast were systematically evaluated in a one-year, randomized, prospective outcome study. The groups focused on the problems of terminal illness, including improving relationships with family, friends, and physicians and living as fully as possible in the face of death. We hypothesized that this invention would lead to improved mood, coping strategies, and self-esteem among those in the treatment group. Eighty-six patients were tested at four-month intervals. The treatment group had significantly lower mood-disturbance scores on the Profile of Mood States scale, had fewer maladaptive coping responses, and were less phobic than the control group. This study provides objective evidence that a supportive group intervention for patients with metastatic cancer results in psychological benefit. Mechanisms underlying the effectiveness of this group intervention are explored.     

Effects of psychosocial interventions with adult cancer patients: A meta-analysis of randomized experiments.

Meta-analytic methods were used to synthesize the results of published randomized, controlled-outcome studies of psychosocial interventions with adult cancer patients. Forty-five studies reporting 62 treatment control comparisons were identified. Samples were predominantly White, female, and from the United States. Beneficial effect size ds were .24 for emotional adjustment measures, .19 for functional adjustment measures, .26 for measures of treatment- and disease-related symptoms, and .28 for compound and global measures. The effect size of .17 found for medical measures was not statistically significant for the few reporting studies. Effect sizes for treatment-control comparisons did not significantly differ among several categories of treatment: behavioral interventions, nonbehavioral counseling and therapy, informational and educational methods, organized social support provided by other patients, and other nonhospice interventions. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Neoadjuvant androgen ablation for localized prostatic cancer: pathology methods, surgical end points and meta-analysis of randomized trials

PURPOSE: At least 7 centers or collaborative groups have performed randomized clinical trials of neoadjuvant androgen ablation and radical prostatectomy versus radical prostatectomy alone for localized prostatic cancer. Our objectives were to analyze treatment results in terms of 2 standard outcome measures, to identify patient characteristics and other factors that explain outcome differences between trials, and to use pooled data to test the hypothesis that neoadjuvant treatment alters outcomes. MATERIALS AND METHODS: Trials were identified by MEDLINE search and review of published bibliographies, and examined for pathological techniques used to assign surgical end points. An attempt was made to contact trial group members for clarification and updated information. The resulting data were transformed as needed into standardized end points of pT stage and negative surgical margin. A series of contingency tables were used to study relationships between treatment outcomes and various risk factors. RESULTS: In addition to neoadjuvant treatment, numerous risk factors related to treatment regimen and patient characteristics apparently influenced treatment outcome, and should be reanalyzed when future followup trial data become available. CONCLUSIONS: In radical prostatectomy there is a need for uniform ways to process specimens, assign surgical stage and establish standardized surgical end points. Despite differences in risk factors, the trials were similar in overall design. Within these constraints neoadjuvant androgen ablation was significantly associated with low pT stage and negative surgical margin. Longer followup is needed to validate these measures as good surrogates for tumor specific survival.     

Perisurgical erythropoietin application in anemic patients with colorectal cancer: A double-blind randomized study

BACKGROUND: Blood transfusions are associated with higher postoperative morbidity and tumor recurrence rates in colorectal cancer surgery, To reduce the need for transfusions in patients with tumor-induced anemia who are not suitable for autologous blood donation, it was tested whether perisurgical erythropoietin application would be able to stimulate hematopoiesis adequately. METHODS: In a double-blind randomized study 150 IU/kg body weight erythropoietin was given subcutaneously every 2 days beginning 10 days before operation and continuing until postoperative day 2. Twenty patients were randomized into the erythropoietin group with three observed dropouts and 10 patients into the placebo group. RESULTS: In the erythropoietin group two episodes of hypertension and one deep venous thrombosis were observed. Preoperative hemoglobin response in the erythropoietin group (p = 0.069) was paralleled by a highly significant reticulocyte increase (p = 0.0004). However, frequency of blood transfusion was not different between both study groups (erythropoietin, 1.82 +/- 0.80 units/ patient; placebo, 1.80 +/- 0.97 units/patient). If iron availability was analyzed, a strong correlation between ferritin blood levels and transferrin iron saturation with hemoglobin response was observed in regression analysis (p < 0.001). CONCLUSIONS: These results indicate that hematopoiesis in anemic patients with colorectal cancer can be stimulated by erythropoietin; however, clinical efficacy is to be expected only in selected patients with high iron availability, which calls for further studies combining erythropoietin and parenteral iron application.     

A randomized, double-blind, placebo-controlled trial of buspirone in combination with an SSRI in patients with treatment-refractory depression

BACKGROUND: Case reports and open studies have reported beneficial therapeutic effects of adding buspirone to a selective serotonin reuptake inhibitor (SSRI) in the management of treatment-refractory depression. This is the first placebo-controlled study to evaluate the efficacy and safety of this combination. METHOD: One hundred nineteen patients (82 women, 37 men) who fulfilled criteria for a major depressive episode according to DSM-IV and who had failed to respond to a minimum of 4 weeks (mean = 211 days) of treatment with citalopram or paroxetine were randomly assigned to 4 weeks of treatment with an SSRI plus buspirone (N = 58) or an SSRI plus placebo (N = 61). In addition, 97 patients participated in an optional open-label poststudy treatment phase with the SSRI plus buspirone for 2 weeks. The primary outcome measure was the score on the Clinical Global Impressions-Improvement (CGI-I) scale. RESULTS: A total of 50.9% of patients in the buspirone group and 46.7% in the placebo group responded after 4 weeks of treatment. The difference in response rate was not statistically significant. No statistically significant differences were found in the frequency of adverse events. At the follow-up of the open SSRI plus buspirone treatment, 69.4% of patients had responded. CONCLUSION: Adding buspirone to an SSRI is a safe and well-tolerated drug regimen. This study failed to demonstrate any difference in efficacy between buspirone or placebo augmentation of an SSRI. It could be argued, however, that the study was inconclusive due to the unusually high placebo response.     

Reversal of left ventricular hypertrophy in essential hypertension. A meta-analysis of randomized double-blind studies

OBJECTIVE: To determine the ability of various antihypertensive agents to reduce left ventricular hypertrophy, a strong, blood pressure-independent cardiovascular risk factor, in persons with essential hypertension. DATA SOURCES: MEDLINE, DIMDI, RINGDOC, ADES, EMBASE, and review articles through July 1995 (English-language and full articles only). STUDY SELECTION: Meta-analysis of all published articles including only double-blind, randomized, controlled clinical studies with parallel-group design. DATA EXTRACTION: Intensive literature search and data extraction according to a prefixed scheme performed independently by 2 investigators. Reduction of left ventricular mass index after antihypertensive therapy with placebos, diuretics, beta-blockers, calcium channel blockers, or angiotensin-converting enzyme (ACE) inhibitors was the principal parameter. DATA SYNTHESIS: Of 471 identified references describing the effects of antihypertensive drugs on left ventricular hypertrophy, only 39 clinical trials fulfilled the inclusion criteria of our study. We found that the decrease in left ventricular mass index was more marked the greater was the decline in blood pressure (systolic r=0.46, P<.001; diastolic r=0.21, P=.08) and the longer was the duration of therapy (r=0.38, P<.01). After adjustment for different durations of treatment (mean duration of treatment, 25 weeks), left ventricular mass decreased 13% with ACE inhibitors, 9% with calcium channel blockers, 6% with beta-blockers, and 7% with diuretics. There was a significant difference between drug classes (P<.01): ACE inhibitors reduced left ventricular mass more than beta-blockers (significant, P<.05) and diuretics (tendency, P=.08). Similar differences between drug classes were found with regard to effect on left ventricular wall thickness (P<.05). CONCLUSIONS: The database of articles published through July 1995 is small and incomplete, and most of the articles are of poor scientific quality. In this first meta-analysis including only double-blind, randomized, controlled clinical studies, decline in blood pressure, duration of drug treatment, and drug class determined the reductions in left ventricular mass index. The ACE inhibitors seemed to be more potent than beta-blockers and diuretics in the reduction of left ventricular mass index; calcium channel blockers were somewhat in the intermediate range. The ACE inhibitors and, to a lesser extent, calcium channel blockers emerged as first-line candidates to reduce the risk associated with left ventricular hypertrophy.     

Does expressive writing reduce health care utilization? A meta-analysis of randomized trials.

This meta-analysis examined whether writing about stressful experiences affects health care utilization (HCU) compared with writing on neutral topics or no-writing control groups. Randomized controlled trials of 30 independent samples representing 2,294 participants were located that contained sufficient information to calculate effect sizes. After omitting one study as an outlier, the effects were combined within 3 homogeneous groups: healthy samples (13 studies), samples with preexisting medical conditions (6 studies), and samples prescreened for psychological criteria (10 studies). Combined effect sizes, Hedges's g (95% confidence interval), with random effects estimation were 0.16 (0.02, 0.31), 0.21 (-0.02, 0.43), and 0.06 (-0.12, 0.24), respectively. Writing about stressful experiences reduces HCU in healthy samples but not in samples defined by medical diagnoses or exposure to stress or other psychological factors. The significance of these effects for individuals' health is unknown. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Cholesterol reduction and the risk for stroke in men. A meta-analysis of randomized, controlled trials

OBJECTIVE: Reducing serum cholesterol lowers the risk for ischemic heart disease, but its effects on other vascular diseases are unknown. Published trials were reviewed to determine the effect of cholesterol-lowering interventions on fatal and nonfatal stroke. DESIGN: Meta-analysis of randomized, controlled trials. DATA IDENTIFICATION: A literature search of English-language studies examining the effect of modified diets or medications on cardiovascular end points from 1965 to 1992 using MEDLINE and a review of references of five quantitative overviews of cholesterol reduction and coronary disease. DATA ANALYSIS: Thirteen studies met three eligibility criteria: patients randomized to intervention or control; fatal or nonfatal stroke reported separately; and end points assessed without knowledge of treatment status. Heterogeneity among studies and overall effects of treatment on fatal and nonfatal stroke were estimated using the Mantel-Haenszel-Peto method to combine independent study results. The influence of various study designs and interventions was explored using subgroup comparisons. RESULTS: For fatal stroke, the overall odds ratio associated with cholesterol-lowering interventions in 13 trials was 1.32 (95% Cl, 0.94 to 1.86), and the odds ratio for the 10 single-intervention trials was 1.34 (Cl, 0.91 to 1.96). Among eight trials reporting nonfatal events, the summary odds ratio for nonfatal stroke for treated participants compared with controls was 0.88 (Cl, 0.70 to 1.11), and the odds ratio for total strokes was 0.98 (Cl, 0.80 to 1.19). Among three trials using clofibrate, treatment significantly increased the risk for fatal stroke (odds ratio, 2.64; Cl, 1.42 to 4.92) but not for nonfatal stroke (odds ratio, 0.87; Cl, 0.61 to 1.26). Regression analysis showed no statistical association between the magnitude of cholesterol reduction and the risk for fatal stroke. CONCLUSIONS: Lowering serum cholesterol through modified diets or medications does not reduce stroke mortality or morbidity in middle-aged men. Clofibrate appears to increase the risk for fatal strokes, but the mechanism for this effect is unknown.     

Eastern Cooperative Oncology Group randomized trials of observation versus maintenance therapy for patients with metastatic breast cancer in complete remission following induction treatment

PURPOSE: To investigate the value of maintenance treatment for patients with metastatic breast cancer whose disease is in complete remission (CR). PATIENTS AND METHODS: One hundred ninety-five women (141 eligible) whose disease was in CR or in CR except for bone metastases following six cycles (6 months) of doxorubicin-containing induction treatment were randomized to receive cyclophosphamide, methotrexate, fluorouracil, prednisone, tamoxifen, and halotestin [CMF(P)TH] or observation. In a previous pilot study, patients in CR after 24 months of induction treatment were randomized to continue chemotherapy for 4 more years or stop chemotherapy. RESULTS: Among patients randomized to CMF(P)TH, life-threatening toxicity included leukopenia in 3%, thrombocytopenia in 3%, cardiac in 2%, and diabetes in 1%. The median time to relapse from randomization was 18.7 months on CMF(P)TH and only 7.8 months on observation (P < .0001). The median time to death was 32.2 months on CMF(P)TH and 28.7 months on observation (P=.74). Similar results were seen in the pilot study (median time to relapse, 12.6 and 6.4 months; median survival, 37.7 and 24.2 months; study too small for statistical significance). Maintenance treatment was always the most significant covariate in time-to-relapse models. CONCLUSION: There is definite toxicity associated with CMF(P)TH maintenance treatment. When CR was obtained on induction, maintenance treatment with CMF(P)TH was never significant in survival models. However, maintenance treatment was always the most significant covariate in the time-to-relapse models, which motivates its consideration for appropriately informed patients.     

多西他赛联合塞替派与多西他赛联合卡培他滨治疗转移性乳腺癌的随机、对照临床研究

目的:比较多西他赛联合塞替派方案和多西他赛联合卡培他滨方案治疗转移性乳腺癌的临床疗效及其安全性.方法:选择北京大学临床肿瘤学院乳腺肿瘤内科2006年8月至2008年9月收治的女性乳腺癌患者共46例,采用多西他赛联合塞替派(A组)或卡培他滨(B组)方案进行随机、对照临床治疗试验,A组第1,8天多西他赛35 mg/衬静脉滴注,第1天塞替派60-65 m岁扩静脉滴注,B组第1,8天多西他赛35 mg/耐静脉滴注,第1~14天卡培他滨1000 mg/m2,口服,每日2次.21 d为1个周期,至少应用2个周期.结果:多西他赛联合塞替派组22例,多西他赛联合卡培他滨组24例,两组患者基线情况一致.可评价疗效多西他赛联合塞替派组21例,多西他赛联合卡培他滨组22例.两组疗效分别为部分缓解9.52%..27.27% (2/21例,6/22例),稳定52.38% vs31.82% (11/21例,7/22例),进展38.10%..40.91% (8/21例,9/22例),疾病控制率分别为61.90% vs.59.09%(13/21例,13/22例),中位无进展生存期分别为7.9个月(95% CI 0.77~15.03)vs.8.3个月(95% C14.01~12.59),1年生存率分别为88.2%..81%,P值均＞0.05,每两组间差异无统计学意义.无化疗相关死亡病例.多西他赛联合塞替派组和多西他赛联合卡培他滨组最常见的不良反应为骨髓抑制,主要不良反应Ⅲ~Ⅳ度发生率分别为白细胞减少45.45% vs..26.09%,中性粒细胞减少45.45%..21.74%,血小板减少9.09% vs.0%,手足综合征0% vs.13.04%.P值均＞0.05,每两组间差异无统计学意义.结论:多西他赛联合塞替派方案治疗转移性乳腺癌有一定近期疗效,不良反应可耐受,可以作为经济、有效的解救方案.     

A randomized controlled trial of emotionally expressive writing for women with metastatic breast cancer.

Objective: To test the effects of emotionally expressive writing in a randomized controlled trial of metastatic breast cancer patients and to determine whether effects of the intervention varied as a function of perceived social support or time since metastatic diagnosis. Design: Women (N = 62) living with Stage IV breast cancer were randomly assigned to write about cancer-related emotions (EMO; n = 31) or the facts of their diagnosis and treatment (CTL; n = 31). Participants wrote at home for four 20-min sessions within a 3-week interval. Main Outcome Measures: Depressive symptoms, cancer-related intrusive thoughts, somatic symptoms, and sleep quality at 3 months postintervention. Results: No significant main effects of experimental condition were observed. A significant condition × social support interaction emerged on intrusive thoughts; EMO writing was associated with reduced intrusive thoughts for women reporting low emotional support (η2 = .15). Significant condition × time since metastatic diagnosis interactions were also observed for somatic symptoms and sleep disturbances. Relative to CTL, EMO participants who were more recently diagnosed had fewer somatic symptoms (η2 = .10), whereas EMO participants with longer diagnosis duration exhibited increases in sleep disturbances (η2 = .09). Conclusion: Although there was no main effect of expressive writing on health among the current metastatic breast cancer sample, expressive writing may be beneficial for a subset of metastatic patients (including women with low levels of emotional support or who have been recently diagnosed) and contraindicated for others (i.e., those who have been living with the diagnosis for years). (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Does PTCA in acute myocardial infarction affect mortality and reinfarction rates? A quantitative overview (meta-analysis) of the randomized clinical trials

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA) is often performed after acute myocardial infarction (AMI) either as an adjuvant to thrombolytic therapy or instead of thrombolysis. The effect of PTCA in AMI on mortality and reinfarction has remained unclear, with the available randomized trials indicating inconsistent results. METHODS AND RESULTS: A systematic overview (meta-analysis) of the randomized trials was conducted to assess the effect of PTCA in AMI on mortality and reinfarction rates. Data from 7 trials in which primary PTCA was evaluated and 16 trials in which PTCA after thrombolysis was studied were included in this overview, comprising a total of 8496 patient. The trials represented different approaches to the timing of PTCA after AMI. The trials of PTCA after thrombolytic therapy were also categorized according to the different protocols with respect to the routine or elective character of PTCA in the invasive group. A reduction in short-term (6 week) mortality (odds ratio, 0.56; 95% CI, 0.33, 0.94) and in the combined outcome of short-term mortality and nonfatal reinfarction (odds ratio, 0.53; 95% CI, 0.35, 0.80) was observed in the trials comparing primary PTCA with thrombolytic therapy. In contrast, in trials in which an approach of thrombolysis and PTCA was compared with thrombolytic therapy alone, there was no important difference in early mortality, with an apparent reduction in mortality between 6 and 52 weeks. The lower mortality between 6 and 52 weeks among 6-week survivors seemed to be restricted to the subgroup of trials in which PTCA was used as a routine strategy (odds ratio, 0.58; 95% CI, 0.39, 0.87). CONCLUSIONS: Although the analyses of the various categories of trials suggest that primary PTCA may be more beneficial than thrombolytic therapy in AMI, these data should be interpreted cautiously unless confirmed by larger studies. In contrast, the addition of various other strategies of PTCA to thrombolytic therapy does not convincingly indicate a clinically different outcome than if a more conservative strategy is followed, in which PTCA is used only if clinically indicated. Some specific strategies, however, such as rescue PTCA in high-risk patients with occluded arteries, may be of benefit.     

A pilot double-blind, randomized, and placebo-controlled study of orally administered IFN-alpha-n1 (Ins) in pediatric patients with measles

OBJECTIVE: To describe the effect of infection control interventions on the incidence of vancomycin-resistant enterococci (VRE), the utility of pharyngeal cultures for surveillance for VRE colonization, and the cost of barrier precautions. DESIGN: Evaluation of the occurrence of VRE infection or colonization, rates of vancomycin use, results of surveillance cultures before and after interventions, and the cost of increased barrier precautions. SETTING: University of Massachusetts Medical Center, a 347-bed tertiary-care teaching hospital with eight intensive-care units, one burn unit, and one bone marrow transplant unit. PARTICIPANTS: Patients in the intensive-care units and staff who were involved with patients colonized or infected with VRE. METHODS: Infection control interventions included placement of patients with VRE in private rooms, strict contact isolation, cohorting of patient and nursing staff, prohibiting of equipment sharing, and monitoring of compliance with the vancomycin restriction policy, with hand washing, and of the adequacy of environmental cleaning. Both rectal and pharyngeal cultures were obtained from patients at the beginning of the outbreak, and the utility of pharyngeal cultures was evaluated. The cost of barrier precautions was estimated by comparing the cost of glove and gown use before and after the outbreak began. RESULTS: The interventions decreased the number of new cases of VRE, but total eradication of VRE was not achieved. Compliance with the room-cleaning protocol was 91% (141/155 observations). Hand washing following interaction with patients who were not in isolation was 51%, vs 100% for patients in isolation. Overall, handwashing compliance was 71% (319/449): 56% (130/231) for physicians and 86% (187/218) for nurses (P<.0001). The mean number of doses of vancomycin dispensed per 1,000 patient days decreased from 145 to 114 per 1,000 patient days (P<.001). Compliance with vancomycin-use guidelines was 85%. Forty-six (77%) of 60 surveillance rectal swabs yielded enterococci, as compared to only 4 (11%) of 36 pharyngeal cultures (P<.0001). Expenses on glove and gowns alone increased by over $11,000 per year since the epidemic began. CONCLUSIONS: Implementation of the various infection control measures did not eradicate VRE cases from the hospital. Rectal cultures were more useful than pharyngeal cultures for surveillance of VRE. Controlling VRE epidemics can be costly.     

Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study

OBJECTIVE: Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications. RESEARCH DESIGN AND METHODS: In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28-40 kg/m2, and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured. RESULTS: After 1 year of treatment, the orlistat group lost 6.2 +/- 0.45% (mean +/- SEM) of initial body weight vs. 4.3 +/- 0.49% in the placebo group (P < 0.001). Twice as many patients receiving orlistat (49 vs. 23%) lost > or = 5% of initial body weight (P < 0.001). Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control, as reflected in decreases in HbA1c (P < 0.001) and fasting plasma glucose (P < 0.001) and in dosage reductions of oral sulfonylurea medication (P < 0.01). Orlistat therapy also resulted in significantly greater improvements than placebo in several lipid parameters, namely, greater reductions in total cholesterol, (P < 0.001), LDL cholesterol (P < 0.001), triglycerides (P < 0.05), apolipoprotein B (P < 0.001), and the LDL-to-HDL cholesterol ratio (P < 0.001). Mild to moderate and transient gastrointestinal events were reported with orlistat therapy, although their association with study withdrawal was low. Fat-soluble vitamin levels generally remained within the reference range, and vitamin supplementation was required in only a few patients. CONCLUSIONS: Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.     

A randomized double-blind trial of ondansetron alone versus in combination with dexamethasone versus in combination with dexamethasone and lorazepam in the prevention of emesis due to cisplatin-based chemotherapy

Sixty-five cases of invasive breast cancer < or = 1 cm. in largest diameter (pT1a-b) were studied retrospectively using immunohistochemical staining with PC10, a monoclonal antibody to proliferating cell nuclear antigen (PCNA). The percentage of PC10 positive tumor cells was closely related to histological grading. No association was found between PC10 score and nodal status. ER-ICA was performed on 42 cases and showed no correlation with PC10 staining. The clinical behaviour of these tumors was excellent, with 5-year survival rates overall of 96% (90% disease free survival), and apparently unrelated to histological type and grade, nodal involvement and hormonal receptor status. The prognostic value of PCNA labeling rates remains nuclear in breast cancer of minimal size as well as in larger ones.     

Oral combination antiemetics in patients with small cell lung cancer receiving cisplatin or cyclophosphamide plus doxorubicin

BACKGROUND: Intravenous antiemetic combinations containing a 5-HT3 receptor antagonist (like metoclopramide, ondansetron, or granisetron) with dexamethasone have become the standard therapy for the treatment of acute chemotherapy-induced vomiting. Intravenous antiemetics, however, can be more costly and take more time to prepare and deliver, and therefore are not preferred for home, outpatient, or office use. The objective of this study was to determine the antiemetic activity and safety of the oral combination antiemetic regimen of metoclopramide, dexamethasone, and diphenhydramine in patients with small cell lung cancer receiving standard outpatient chemotherapy programs. METHODS: Fifty-two patients receiving initial cisplatin (60 mg/m2) or cyclophosphamide (600-1500 mg/m2) plus doxorubicin (30-45 mg/m2) received an oral regimen of metoclopramide (3 mg/kg x 2 then 2 mg/kg x 2 or 4 doses), dexamethasone (20 mg) and diphenhydramine (50 mg x 2 or 3 doses) (oral MDD), beginning 30 minutes before chemotherapy. RESULTS: Vomiting was prevented in 15 of 21 (76%) patients (95% confidence interval [CI], 53%-92%) receiving cisplatin and 21 of 31 (71%) individuals (95% CI, 52%-86%) given cyclophosphamide plus doxorubicin. Adverse effects were mild and transient and included sedation, loose stools, akathisia, and hiccoughs. CONCLUSIONS: The oral MDD antiemetic regimen prevented acute emesis in 73% of the patients entered and was well tolerated in this population of patients with small cell lung cancer.     

Efficacy of bronchodilator therapy in bronchiolitis. A meta-analysis

OBJECTIVE: To determine if bronchodilators are efficacious in treating bronchiolitis. DATA SOURCES: A search of bibliographic databases (MEDLINE, Excerpta Medica, and Reference Update) for bronchiolitis and albuterol or ipratropium bromide, or adrenergic agents or bronchodilator agents. Reference lists were also used. STUDY SELECTION: Randomized, placebo-controlled trials of bronchodilator treatment in bronchiolitis were selected by 2 investigators. Fifteen of 89 identified publications met the selection criteria. DATA EXTRACTION: Investigators independently abstracted data for 3 outcomes: clinical score, oxygen saturation, and hospitalization. Clinical score was measured as a dichotomous variable (score +/- improved) or continuous variable (average score). DATA SYNTHESIS: For primary analysis, data were pooled from 8 trials of children with first-time wheezing. The effect size for average score was -0.32 (95% confidence interval [CI], -0.54 to -0.11; P < .01), favoring treatment; the relative risk for score +/- improved was 0.76 (95% CI, 0.60 to 0.95; P = .02), favoring treatment. Bronchodilators had no effect on hospitalization (relative risk, 0.85; 95% CI, 0.47 to 1.53; P = .58), but co-interventions may have been administered prior to this outcome. The results for oxygen saturation were too varied to allow pooling of the results. Secondary analyses were performed on 4 outpatient trials of children with first-time wheezing, 7 trials in which only nebulized beta-agonists were used, and on all 15 trials identified. The results were similar, but the data varied more. CONCLUSION: Bronchodilators produce modest short-term improvement in clinical features of mild or moderately severe bronchiolitis.     

A randomized, double-blind clinical trial comparing cefepime plus metronidazole with imipenem-cilastatin in the treatment of complicated intra-abdominal infections. Cefepime Intra-abdominal Infection Study Group

OBJECTIVE: To evaluate the safety and efficacy of cefepime hydrochloride plus metronidazole vs the combination of imipenem and cilastatin sodium in the treatment of complicated intra-abdominal infections in adult patients. DESIGN: Prospective, randomized, double-blind multicenter study. SETTING: University-affiliated hospitals in the United States and Canada. PATIENTS: Three hundred twenty-three patients with complicated intra-abdominal infections in whom an operative procedure or percutaneous drainage was required for diagnosis and management. INTERVENTION: Cefepime, 2 g, was administered intravenously every 12 hours (n= 164) in addition to metronidazole, 500 mg (or 7.5 mg/kg) intravenously every 6 hours. Imipenen-cilastatin sodium, 500 mg, was administered intravenously every 6 hours (n= 159). Surgical infection management was determined by the patients' surgeons. MAIN OUTCOME ASSESSMENTS: Clinical cure, defined as elimination of all signs and symptoms relevant to the original infection; and treatment failure, defined as persistence, increase or worsening of signs and symptoms resulting in an antibiotic change, requirement of an additional surgical procedure to cure the infection, or a wound infection with fever. RESULTS: Of the initial isolates, 84% were susceptible to cefepime and 92% were susceptible to imipenem-cilastatin. Among the 217 protocol-valid patients, those treated with cefepime+metronidizole were deemed clinical cures (88%) more frequently than were imipenem-cilastatin-treated patients (76%) (P=.02). Using multivariate analysis to adjust for identified clinical risk factors for an adverse outcome (severity of presenting illness, isolation of enterococcus, type of infection, and duration of prestudy hospitalization), there was a trend (P=.06) toward a higher cure rate favoring cefepime+metronidazole. Pathogens were eradicated in significantly (P=.01) more patients treated with combined cefepime and metronidazole (89%) than with imipenem-cilastatin (76%). CONCLUSION: The combination of cefepime plus metronidazole is safe and effective therapy for patients with severe intra-abdominal infections.     

Efficacy of the oral antiparasitic mebendazole plus trichlorfon (telmin plus trichlorfon) against Gasterophilus in the horse

The combined drug Mebendazole plus Trichlorfon (Telmin plus Trichlorfon, Janssen Pharmaceutica, Beerse/Belgium) has been tested in a field trial against naturally acquired Gasterophilus spp. infestations in horses. 44 foals (1 to 1.5 years old, 350-450 kg body-weight) originating from different endemic areas of Switzerland, have been randomly allocated to two groups as follows: 28 foals were treated with Mebendazole plus Trichlorfon, 16 animals served as untreated controls. The drug (paste) was administered and dosed according to the user's instruction. Macroscopic examinations of the digestive tractus and the larval counting has been performed immediately after slaughtering, i.e. 30 and 33 days after treatment, resp.. The efficacy of the product against Gasterophilus spp. amounts to 97.04% which is considered as highly effective. A further proof for the high efficacy is the observation of a lot of larvae-carrying foals in the control group. Since the larvae of Gasterophilus spp.--according to their life cycle--are essentially found in their hosts between November and February, an appropriate treatment should be performed during that period of time.