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Results for “Randomized controlled trials”

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At least 1,063 records · Page 59Linked to original sources

PubMed2001

Two-year, blinded, randomized, controlled trial of treatment of active rheumatoid arthritis with leflunomide compared with methotrexate. Utilization of Leflunomide in the Treatment of Rheumatoid Arthritis Trial Investigator Group.

OBJECTIVE: Three 6-12-month, double-blind, randomized, controlled trials have shown leflunomide (LEF; 20 mg/day, loading dose 100 mg x 3 days) to be effective and safe for the treatment of rheumatoid arthritis (RA). This analysis of the North American trial assessed whether the clinical benefit evident at month 12 was sustained over 24 months of treatment with LEF as compared with the efficacy and safety of methotrexate (MTX), an equivalent disease-modifying antirheumatic drug, at 24 months. METHODS: The year-2 cohort, comprising patients continuing into the second year of treatment with > or = 1 dose of study medication and > or = 1 followup visit after week 52, consisted of 235 patients (LEF n = 98; placebo n = 36; MTX n = 101). The mean (+/- SD) maintenance dose of LEF was 19.6 +/- 1.99 mg/day in year 2 and that of MTX was 12.6 +/- 4.69 mg/week. Statistical analyses used an intent-to-treat (ITT) approach. Statistical comparisons of the active treatments only were prospectively defined in the protocol. RESULTS: In total, 85% and 79% of LEF and MTX patients, respectively, who entered year 2 completed 24 months of treatment. From month 12 to month 24, the American College of Rheumatology improvement response rates of > or = 20% (LEF 79% versus MTX 67%; P = 0.049), > or = 50% (LEF 56% versus MTX 43%; P = 0.053), and > or = 70% (LEF 26% versus MTX 20%; P = 0.361) were sustained in both of the active treatment groups. The mean change in total Sharp radiologic damage scores at year 2 compared with year 1 and baseline (LEF 1.6 versus MTX 1.2) showed statistically equivalent sustained retardation of radiographic progression in the active treatment groups. Maximal improvements evident at 6 months in the Health Assessment Questionnaire (HAQ) disability index (HAQ DI) and the physical component score of the Medical Outcomes Survey 36-item short form were sustained over 12 months and 24 months; improvement in the HAQ DI with LEF4(-0.60) was statistically significantly superior to that with MTX (-0.37) at 24 months (P = 0.005). Over 24 months in the ITT cohort, serious treatment-related adverse events were reported in 1.6% of the LEF-treated patients and 3.7% of the MTX-treated patients. Frequently reported adverse events included upper respiratory tract infections, diarrhea, nausea and vomiting, rash, reversible alopecia, and transient liver enzyme elevations. CONCLUSION: The safety and efficacy of LEF and MTX were maintained over the second year of this 2-year trial. Both active treatments retarded radiographic progression over 24 months. LEF was statistically significantly superior to MTX in improving physical function as measured by the HAQ DI over 24 months of treatment. Results indicate that LEF is a safe and effective initial treatment for active RA, with clinical benefit sustained over 2 years of treatment without evidence of new or increased toxicity.

Adult↗

PubMed1995

Improving compliance with breast cancer screening in older women. Results of a randomized controlled trial.

BACKGROUND: To compare three approaches for improving compliance with breast cancer screening in older women. METHODS: Randomized controlled trial using three parallel group practices at a public hospital. Subjects included women aged 65 years and older (n = 803) who were seen by residents (n = 66) attending the ambulatory clinic from October 1, 1989, through March 31, 1990. All provider groups received intensive education in breast cancer screening. The control group received no further intervention. Staff in the second group offered education to patients at their visit. In addition, flowsheets were used in the "Prevention Team" group and staff had their tasks redefined to facilitate compliance. RESULTS: Medical records were reviewed to determine documented offering/receipt of clinical breast examination and mammography. A subgroup of women without previous clinical breast examination (n = 540) and without previous mammography (n = 471) were analyzed to determine the effect of the intervention. During the intervention period, women without a previous clinical breast examination were offered an examination significantly more often in the Prevention Team group than in the control group, adjusting for age, race, and comorbidity and for physicians' gender and training level. The patients in the Prevention Team group were offered clinical breast examination (31.5%) more frequently than those in the patient education or control groups, but this was not significant after adjusting for the above covariates. Likewise, mammography was offered more frequently to patients in the Prevention Team and in the patient education group than to patients in the control group, after adjusting for the factors above using logistic regression. CONCLUSIONS: The results provide support for patient education and organizational changes that involve nonphysician personnel to enhance breast cancer screening among older women, particularly those without previous screening.

Aged↗

PubMed2005

Steroid hormones for contraception in men: systematic review of randomized controlled trials.

Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so an "add-back" therapy is needed. We conducted a systematic review of all randomized controlled trials of male hormonal contraception and azoospermia. Few significant differences emerged from these trials. Levonorgestrel implants combined with injectable testosterone enanthate (100 mg im) were significantly more effective than was levonorgestrel 125 microg po daily combined with testosterone patches [10 mg/d; odds ratio (OR) for azoospermia with the oral levonorgestrel regimen, 0.03; 95% CI, 0.00-0.29]. The addition of levonorgestrel 500 microg po daily improved the effectiveness of testosterone enanthate 100 mg im weekly by itself (OR for azoospermia with the combined regimen, 4.0; 95% CI, 1.00-15.99). Several regimens, including testosterone alone and gonadotropin-releasing hormone agonists and antagonists, had disappointing results. In conclusion, no male hormonal contraceptive is ready for clinical use. All trials published to date have been small exploratory studies. As a result, their power to detect important differences has been limited and their results have been imprecise. In addition, the definition of oligospermia has been imprecise or inconsistent in many reports. To avoid bias, future trials need to pay more attention on the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful.

Adult↗

PubMed1997

A randomized controlled trial of prophylactic isolated cytotoxic perfusion for poor-prognosis primary melanoma of the lower limb.

A randomized controlled trial of prophylactic isolated hyperthermic limb perfusion (IHLP) using melphalan at 2 mg/kg body weight has been performed on a total of 30 patients with primary melanoma of the lower limb > or = 1.7 mm thick. Excision (control, n = 14) was compared to excision plus IHLP (n = 16). The two groups were well matched for sex, tumour thickness and duration of follow-up (control group median: 63 months (range: 16-108), perfusion group median: 80 months (range: 37-113)). Recurrent disease developed in nine of the control group, seven of whom have died. In the perfusion group only two patients have developed recurrent disease, both of whom have died (recurrence: P < 0.004, mortality: P < 0.03, using Fishers' exact probability test). Inguino-femoral nodal recurrence occurred in five of nine control patients, but in only one patient in the perfusion group. These data support the use of adjuvant IHLP in the management of poor-prognosis primary melanoma of the lower limb.

Actuarial Analysis↗

PubMed2005

Obstetric risk factors for urinary incontinence and preventative pelvic floor exercises: cohort study and nested randomized controlled trial.

We conducted a cohort study assessing risk factors for developing urinary incontinence following childbirth, and a pilot randomized controlled trial of a physiotherapist-led intervention to reduce incidence of incontinence. A total of 723 women were recruited to the cohort study, of which 234 entered the nested trial and were randomized to intensive training in pelvic floor exercises or standard information. At 6 months post-partum, 45% of women reported some incontinence problems. A pre-existing incontinence problem was the best predictor of future incontinence (odds ratio 4.49, 95% confidence interval (CI) 3.09-6.53). Chronic constipation (1.86, 1.03-3.34) and episiotomy in at least one delivery (1.96, 1.25-3.07) were also independent risk factors, while an epidural or spinal (0.62, 0.42-0.92) was protective. The intervention as designed did not help in preventing future incontinence (relative risk 1.28, 95% CI 0.98-1.67), but this may be due to the failure to persuade the women to return for the classes. Any intervention aimed at promoting postnatal pelvic floor exercises should be limited to women who have already been experiencing incontinence problems.

Chronic Disease↗

PubMed2001

Transurethral incision compared with transurethral resection of the prostate for bladder outlet obstruction: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Transurethral prostatic resection is the gold standard surgical treatment in men with lower urinary tract symptoms suggestive of bladder outlet obstruction but it has also been related to some risks, such as a relatively high rate of blood transfusion, sexual function problems and so forth. Transurethral prostatic incision is a simpler and less invasive procedure than transurethral prostatic resection. However, it is underused. We systematically reviewed all published randomized controlled trials comparing the effectiveness of transurethral prostatic incision with standard transurethral prostatic resection for bladder outlet obstruction and performed a meta-analysis of the available relevant data. MATERIALS AND METHODS: Nine randomized controlled trials comparing the treatment effectiveness of transurethral prostatic resection and transurethral prostatic incision were identified, evaluated and reviewed in a meta-analysis. The quality of these studies was also appraised. RESULTS: Each treatment achieved clear improvements in subjective and objective outcomes. The improvement in symptoms was equivalent 12 months postoperatively for transurethral prostatic incision and resection. For maximum flow rate transurethral prostatic resection resulted in greater improvement than transurethral prostatic incision. However, transurethral prostatic incision had several advantages over transurethral prostatic resection, such as lower incidence of complications, fewer blood transfusions, decreased risk of retrograde ejaculation, and shorter operative time and hospital stay. Also, the treatments had an equivalent incidence of postoperative catheterization duration and reoperation rate within the first 12 months. Furthermore, patients in each group had a similar subjective view of the treatments received. CONCLUSIONS: In the first 12 months after surgery transurethral prostatic incision has effectiveness that is equivalent to transurethral prostatic resection for treating patients with suspected benign prostatic obstruction who have a relatively small prostate. However, there is little evidence on the relative long-term effectiveness of the 2 treatments 2 to 5 or 10 years after surgery. There is no clear cutoff point for prostate size that leads to good results after transurethral prostatic incision. A large-scale, multicenter randomized controlled trial is now required to evaluate comprehensively the effectiveness, impact on quality of life and overall cost of transurethral prostatic incision compared with transurethral prostatic resection.

Humans↗

PubMed2004

A randomized controlled trial of a commercial internet weight loss program.

OBJECTIVE: To assess, in a 1-year randomized controlled trial, the efficacy of eDiets.com (a commercial Internet weight loss program) in improving weight, cardiovascular health, and quality of life. RESEARCH METHODS AND PROCEDURES: Participants were 47 women with a mean age of 43.7 +/- 10.2 (SD) years and a mean BMI of 33.5 +/- 3.1 kg/m2. They were randomly assigned to either: 1) eDiets.com, a commercial Internet-based program available to the public; or 2) a weight loss manual (i.e., LEARN Program for Weight Control 2000). At baseline, participants in both groups met briefly with a psychologist who instructed them to follow the components of their program as closely as possible. Additional brief visits were provided at weeks 8, 16, 26, and 52 to review their progress. Change in weight was the main outcome measure. RESULTS: At week 16, participants in eDiets.com lost 0.9 +/- 3.2% of initial weight compared with 3.6 +/- 4.0% for women assigned to the weight loss manual. At week 52, losses increased to 1.1 +/- 4.0% and 4.0 +/- 5.1%, respectively. Results of a last-observation-carried-forward analysis found that women in the manual group lost significantly (p < 0.05) more weight (at both times) than those treated by eDiets.com. (Results, however, of baseline-carried-forward and completers analyses did not reach statistical significance.) There were no significant differences between groups in changes in cardiovascular risk factors or quality of life. DISCUSSION: This study provides consumers with important information about the probable benefits they can expect from participating in a popular Internet-based weight loss program.

Adolescent↗

PubMed2005

Cranberry juice and bacterial colonization in children--a placebo-controlled randomized trial.

BACKGROUND: The cranberry produces antimicrobial compounds such as proanthocyanidines in response to microbial invasion. In vitro it is able to prevent growth, adhesion or biofilm formation of a large number of bacteria, while clinically, cranberry juice has been shown to prevent urinary tract infections (UTI) in women. However, the effect of cranberry on bacterial colonization more widely has not been evaluated. We were interested in studying cranberry juice in children since many children with recurrent UTI need long-term antimicrobial prophylaxis and would benefit from an alternative. OBJECTIVE: To evaluate the effect of cranberry juice on nasopharyngeal and colonic bacterial flora, to evaluate how well cranberry juice is accepted by children and to evaluate its effect on infectious diseases and related symptoms. DESIGN: Children (mean age 4.3 years) in day care centers were randomized to receive either cranberry juice (n=171) or a placebo (n=170) for 3 months. Bacterial samples were collected before and after the intervention and analyzed for both respiratory bacterial pathogens and enteric fatty acid composition, reflecting changes in the colonic bacterial flora. Infectious diseases and their symptoms were monitored using symptom diaries. Compliance was evaluated as the number of drop-outs during the trial and by counting the numbers of doses taken. RESULTS: The carriage of respiratory bacteria did not change significantly during the intervention, while fecal fatty acid composition changed significantly with time (P<0.001) but did not differ between the groups (P>0.05). Cranberry juice had no effect on common infectious diseases or their symptoms. The cranberry juice was well accepted: the number of drop-outs in 3 months was 18 (11%) in the cranberry group and 11 (7%) in the placebo group, and most of the doses were taken as instructed, 145 (88%) and 129 (77%) children, respectively, taking at least 90% of the doses. CONCLUSIONS: Cranberry juice was well accepted by the children, but led to no change in either the bacterial flora in the nasopharynx or the bacterial fatty acid composition of stools. Thus cranberries seem to have beneficial effect on urinary health only and this is not compromised by other unexpected antimicrobial effects.

Beverages↗

PubMed1994

Issues in the mortality analysis of randomized controlled trials of cancer screening.

This paper is concerned with the analysis and interpretation of randomized controlled trials (RCTs) of periodic screening programs for the early detection of cancer in which there is a lengthy follow-up period without screening being offered. That is, screening is offered for a limited time with a subsequent follow-up period during which the cancer mortality is observed. The paper focuses on tests for a mortality reduction due to screening. Two approaches are presented, one based on the experience of all those randomized to the test and control groups, and the other based on the experience of selected groups of cancer cases found during the trial. In the latter approach it is necessary that the two groups selected for analysis be comparable groups of cancers. The concept of comparability is discussed with emphasis on factors that determine comparability and on ways to assess it. Examples from completed cancer screening RCTs are used to illustrate the ideas and methods presented.

Adult↗

PubMed2005

Controlled, randomized trial of island flap anoplasty for treatment of trans-sphincteric fistula-in-ano: early results.

Treatment of trans-sphincteric fistula is usually a compromise between recurrence and incontinence. Dermal island flap anoplasty has been found to be useful in the treatment of these fistulas. We performed a randomized trial to compare dermal island flap anoplasty with conventional treatment for trans-sphincteric fistula-in-ano. Seventy nine patients with fistula-in-ano were recruited; twenty patients with trans-sphincteric fistula confirmed by endoanal ultrasound were prospectively randomized to receive either dermal island flap anoplasty (IFA) or conventional treatment (CVN) for trans-sphincteric fistula-inano. Conventional treatment consisted of lay open fistulotomy or seton insertion if deemed unsuitable for fistulotomy. Dermal island flap anoplasty involved a cutaneous advancement flap into the rectum. Pain scores, fecal incontinence scores, operative complications, wound healing and recurrence rates were charted. Two patients in the CVN group required seton insertions, which were still intact at the 9-month follow-up. Two patients with similar high trans-sphincteric fistula in the IFA group avoided having a long-term seton. There were no differences in the postoperative pain score, incontinence score, complications, wound healing and recurrence rates between the two groups. IFA is a safe and useful method for treating transsphincteric fistula. It can be considered when a suprasphincteric extension is suspected, thus avoiding risk of incontinence or the discomfort of a long-term seton.

Adult↗

PubMed2006

A comparison between integrating clinical practice setting and randomized controlled trial setting into economic evaluation models of therapeutics.

BACKGROUND: Cost-effectiveness analyses generated from randomized controlled trials (RCTs) represent results obtained under ideal experimental conditions (efficacy) and the applicability of these data to real-world settings (effectiveness) may be questionable. OBJECTIVE: To compare cost-effectiveness results obtained from a RCT setting with the results derived from community-based clinical practice. METHODS: Using data from a community-based cohort study and from a RCT, two cost-effectiveness analyses were performed and the incremental cost-effectiveness ratios (ICERs) were calculated for the use of etanercept in the treatment of patients with rheumatoid arthritis. RESULTS: Using an effectiveness-based analysis, the mean quality-adjusted life years (QALYs) gained during the 12-month monitoring period were 0.45 and 0.35 for the treatment and control groups respectively. The ICER for etanercept treatment was 174,200 dollars (CDN) per QALY (95% confidence limits between 119,500 dollars and 285,000 dollars). Incorporating efficacy data obtained from the RCT into the analysis, the mean QALYs gained were 0.56 and 0.35 for the treatment and control groups respectively. This resulted in a substantially lower ICER for etanercept treatment of 82,952 dollars per QALY (95% confidence limits between 66,500 dollars and 103,430 dollars). CONCLUSION: Depending on the type of clinical setting used for the analysis, the resulting ICER for etanercept treatment was very different. These results help to explain the difference in cost-effectiveness reported in previous modeling studies, some based on RCT assumptions and some based on effectiveness setting.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1998

Treatment of ventilator-associated pneumonia with piperacillin-tazobactam/amikacin versus ceftazidime/amikacin: a multicenter, randomized controlled trial. VAP Study Group.

In a randomized trial conducted in 27 intensive care units, we compared the clinical efficacy and safety of piperacillin-tazobactam (TAZ; 4 g/0.5 g q.i.d.) and of ceftazidime (CAZ; 1 g q.i.d.), both combined with amikacin (7.5 mg/kg b.i.d.), as therapy for ventilator-associated pneumonia (VAP; acquired after > or =48 hours of mechanical ventilation). VAP was diagnosed with use of protected samples and quantitative cultures, and outcome was assessed blindly from treatment. Of 204 patients suspected of having VAP and randomized to a treatment arm of the study, 127 (64%) had bacteriologically confirmed infections, of which 37% were polymicrobial and 32% involved Pseudomonas aeruginosa; 115 patients (51 TAZ and 64 CAZ recipients) remained evaluable as per protocol. Clinical/bacteriologic cure rates (TAZ vs. CAZ, 51% vs. 36%; 95% confidence interval of difference, -0.2% to 30.2%), and 28-day mortality rates (16% vs. 20%) were similar; however, fewer bacteriologic failures occurred with TAZ (33% vs. 51%; P = .05). We conclude that the two regimens were of equivalent clinical efficacy in therapy for confirmed VAP.

Amikacin↗

PubMed1990

Statistical aspects of controlled single subject trials.

Randomized controlled trials in groups and single subjects differ in several statistical aspects. In group trials the experimental unit is a randomly selected subject from a predefined population and this subject is randomly assigned to a treatment. Outcome is confined to average effects which can be generalized to the specific population, but which do not necessarily apply to individual persons. In single subject trials the experimental unit is a treatment period and each treatment period is randomly allocated in a multiple cross-over sequence of periods. The single subject is only representative of itself, but similar responses in corresponding single subject trials may justify careful extrapolation of the results. Single subject trials have a high risk of Type II errors. However, the randomization procedure chosen and the type of statistical test applied may enhance the statistical power of such trials. Internal validity depends on modeling the trial design to the clinical features, drug properties and statistical requirements, while reliability is determined by the reproducibility of the trial response.

Humans↗

PubMed2005

Effect of chitosan on weight loss in overweight and obese individuals: a systematic review of randomized controlled trials.

This article aims to determine whether chitosan, a popular, over-the-counter, weight loss supplement, is an effective treatment for overweight and obesity. It is designed as a systematic review of randomized controlled trials. The data sources include the electronic databases Medline, EMBASE, Biosis, CINAHL and Cochrane Central Register of Controlled Trials (CCTR); the specialized websites Controlled Trials, International Bibliographic Information on Dietary Supplements (IBIDS), System for Information on Grey Literature in Europe (SIGLE), Reuter's Health Service, Natural Alternatives International and Pharmanutrients; and bibliographies of relevant journal articles. Included were randomized controlled trials of chitosan with a minimum duration of 4 weeks in adults who were overweight or obese and/or had hypercholesterolaemia at baseline. Fourteen trials involving a total of 1071 participants were included in the review. Analyses involving all trials indicated that chitosan preparations result in a small but statistically significant greater reduction in body weight (weighted mean difference -1.7 kg; 95% confidence interval -2.1, -1.3 kg, P < 0.00001) compared with placebo. Analyses restricted to high-quality studies showed that reductions in weight [-0.6 (-1.2, 0.1) kg, P = 0.11] were less than in lower quality studies [-2.3 (-2.7, -1.8) kg, P < 0.00001]. Results obtained from high-quality trials indicate that the effect of chitosan on body weight is minimal and unlikely to be of clinical significance.

Anti-Obesity Agents↗

PubMed2005

Publication bias of randomized controlled trials in emergency medicine.

OBJECTIVES: To determine the publication status and time to publication of randomized controlled trials (RCTs) that were presented at the Society for Academic Emergency Medicine (SAEM) meetings from 1995 to 2003. The impact of positive-outcome bias, time-lag bias, and gray literature bias also was assessed. METHODS: Retrospective cohort study of RCT abstracts presented at nine SAEM scientific meetings. Electronic searches identified publications from the abstracts. RESULTS: Of 4,399 abstracts, 383 (8.7%; 95% confidence interval [CI] = 7.8% to 9.5%) were identified as RCTs. One hundred ninety-four (50.7%; 95% CI = 45.7% to 55.7%) were subsequently published up to May 2004. The median time to publication was 32 months (95% CI = 23 to 41), with 59% of RCT abstracts published within five years of presentation. No evidence of positive-outcome bias or time-lag bias was identified; however, changes from abstract to manuscript were found. Manuscripts were less likely to endorse the experimental intervention than were abstracts (OR, 0.2; 95% CI = 0.0 to 0.6). CONCLUSIONS: The proportion of emergency medicine RCT abstracts published is slightly lower than that for other biomedical specialties; however, biases reported by investigators in other biomedical areas do not appear to be as problematic in emergency medicine research. Differences between conclusions from abstracts and manuscripts must be considered when employing meeting abstracts as a source of evidence for future research or for systematic reviews in emergency medicine.

Abstracting and Indexing↗

PubMed2006

Effects of pentoxifylline on the urinary protein excretion profile of type 2 diabetic patients with microproteinuria: a double-blind, placebo-controlled randomized trial.

AIMS: The purpose of this study was to identify the effect of pentoxifylline on the urinary protein excretion profile in type 2 diabetic patients. METHODS: 40 type 2 nonhypertensive diabetic patients were randomly allocated to receive either pentoxifylline 400 mg t.i.d. or placebo daily for 16 weeks. Eligible subjects were those with urinary albumin excretion between 20 and 200 microg/min. Subjects receiving angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), calcium antagonists, and diuretics as well as those with reduced renal function, pregnancy, urinary tract infection, and smoking were not included. A 6-month pretreatment stabilization phase aimed to reduce and stabilize fasting serum glucose levels was carried out. Urinary proteins were identified by electrophoresis, and immunodetection was identified by Western blot. Electrophoretic analysis was performed using molecular weight markers of 150, 132, 77, and 66 kDa to identify high-weight proteins, and 54, 41, 36, 27, 21, 14.3, and 12 kDa to identify low-weight proteins. RESULTS: At baseline, subjects in both groups who showed a glomerular tubular pattern did not differ in their urinary excretion profile. The urinary proteins identified were immunoglobulin G, ceruloplasmin, transferrin, and albumin (glomerular pattern) as well as alpha1-antitrypsin, alpha1-acid glycoprotein, collagenase inhibitor, alpha1-microglobulin, trypsin inhibitor, lysozyme, and beta2-microglobulin (tubular pattern). Subjects who received pentoxifylline had reduced urinary excretion of high- and low-molecular weight proteins. CONCLUSIONS: Urinary protein excretion in type 2 diabetic subjects shows a mixed, glomerular and tubular, pattern. Pentoxifylline reduces the excretion of both high and low molecular-weight urinary proteins.

Adult↗

PubMed2006

Abciximab and angiographic restenosis after coronary stent placement. Analysis of the angiographic substudy of ISAR-REACT--a double-blind, placebo-controlled, randomized trial evaluating abciximab in patients undergoing elective percutaneous coronary interventions after pretreatment with a high loading dose of clopidogrel.

BACKGROUND: ISAR-REACT was a trial designed to evaluate whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention (PCI) with stent placement after pretreatment with a 600 mg loading dose of clopidogrel. Objective for the angiographic substudy was to determine the impact of abciximab on angiographic restenosis after coronary stent placement. Previous analyses have suggested a reduction in the incidence of restenosis after the administration of abciximab. METHODS: The angiographic substudy comprises 1885 of 2159 patients enrolled in ISAR-REACT: 994 patients were randomly assigned to abciximab and 941 patients to placebo. All patients were scheduled for a routine angiographic follow-up after 6 months (performed in 80% of eligible patients). End points for the angiographic substudy were the rates of angiographic restenosis (> or = 50% diameter stenosis) and target lesion revascularization. RESULTS: The incidence of angiographic restenosis was 27% in the abciximab group and 29% in the placebo group (relative risk 0.92, 95% CI 0.79-1.06, P = .27). Late angiographic lumen loss was 0.95 +/- 0.68 and 0.99 +/- 0.70 mm, respectively (P = .25). Similar results were obtained in a subgroup analysis focusing on high-risk subsets. The rate of target lesion revascularization procedures was 22% in the abciximab group and 23% in the placebo group (relative risk 0.94, 95% CI 0.79-1.12, P = .52). CONCLUSIONS: In low- to intermediate-risk patients who undergo elective PCI after pretreatment with a high loading dose of clopidogrel >2 hours before PCI, the additional administration of the glycoprotein IIb/IIIa inhibitor abciximab is not associated with a significant reduction in angiographic restenosis.

Abciximab↗

PubMed1996

Effectiveness of ampicillin and combination of penicillin and chloramphenicol in the treatment of pneumonias: randomized controlled trial.

OBJECTIVE: To assess the effectiveness of ampicillin and a combination of benzyl penicillin and chloramphenicol in the treatment of pneumonias. DESIGN: Randomized controlled trial. SETTING: Tertiary care hospital. SUBJECTS: Patients 5 months to 4 years old with pneumonias of < 2 weeks duration. Exclusion criteria included acute bronchiolitis, allergy to penicillin, postmeasles pneumonia or prior administration of trial antibiotics in full dose for more than 2 days. INTERVENTION: Patients were randomized to receive either ampicillin (100 mg/kg/day) or combination of benzyl penicillin (100,000 units/kg/day) and chloramphenicol (100 mg/kg/day). The outcome measure was cure rate. RESULTS: There were 52 and 49 patients in the ampicillin and the combination groups, respectively. There was no significant difference in the baseline characteristics between groups except, nasal flare and cyanosis which were less in benzyl penicillin plus chloramphenicol group. There was also no difference either in the primary outcome, cure rate or secondary outcomes (days for cure, duration of tachypnea, fever and grunt) in the two. CONCLUSION: Considering the potential toxicity of chloramphenicol and the number of injections and doses to be given for the combination, ampicillin as a single drug could be preferred for the treatment of pneumonias, in this part of the country.

Ampicillin↗