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At least 145 records · Page 8Linked to original sources
PubMed1990

Randomized, controlled trial of a 10-day course of amifloxacin versus trimethoprim-sulfamethoxazole in the treatment of acute, uncomplicated urinary tract infection. Amifloxacin Multi-Center Trial Group.

We conducted a randomized controlled trial of orally administered amifloxacin versus trimethoprimsulfamethoxazole (TMP-SMX) as treatments of acute uncomplicated urinary tract infection in women. Amifloxacin at a dosage of 200 mg twice a day appeared as safe and effective as TMP-SMX, but amifloxacin at 400 mg twice a day tended to cause adverse events more frequently than did TMP-SMX.

Administration, Oral↗
PubMed1983

Randomized controlled trial of physiotherapy for postoperative pulmonary complications.

A prospective randomized controlled trial was conducted in patients undergoing elective cholecystectomy to assess the value of routine chest physiotherapy. One hundred and two patients entered the study: 47 patients developed no pulmonary complications, 29 had pulmonary atelectasis and a further 26 developed chest infection. The pattern of changes in arterial oxygen tension in the period after operation supported the clinical allocation of the patients. Of 51 patients not receiving physiotherapy, 11 developed atelectasis and 19 chest infection. Of 51 treated patients, 18 developed atelectasis and seven chest infection. Routine prophylactic postoperative chest physiotherapy decreased significantly the frequency of chest infection (P less than 0.02).

Adult↗
PubMed1995

The "optional cross-over design" for randomized controlled trials.

In order to facilitate the performance of randomized controlled trials (RCT) in situations where no "hard" endpoints can be identified and the patient's subjective impressions about success of failure of a given treatment are paramount, the "optional cross-over design" is suggested. In this design, patients are randomised to receive either active medication or placebo during phase I. At its end the patient may choose to change to the other treatment arm, if therapy was felt to be unsuccessful (= optional cross-over). In phase II, treatment continues as in phase I except for those patients who have chosen the "optional cross-over". Further cross-over points may ensue depending on the particularities of the situation, however, two such options may be adequate for most studies. At the end of the trial period, the numbers of patients in each treatment arm are counted and evaluated statistically. If an optimally successful remedy is being tested, close to 100% of the study population could finish up in the active treatment arm. If, as in most instances, the remedy is not optimally successful, this percentage will be proportionally less. If an ineffective remedy is being tested, the distribution of the total sample within the two treatment arms approaches 50:50%. The "optional cross-over design" seems suited for RCT in areas where the complex, unmeasurable and subjective experience of the patient are considered to represent adequate endpoints.

Cross-Over Studies↗
PubMed1979

Randomized controlled trial of cefuroxime for established postoperative respiratory infection.

A randomized controlled trial has investigated the value of cefuroxime (a new antibiotic resistant to beta-lactamase) in 80 patients with established postoperative respiratory infection. Although the majority of respiratory isolates were sensitive to cefuroxime, there was no significant advantage in the antibiotic group compared with the controls with respect to duration of fever, radiological abnormality or infected sputum. We conclude that antibiotics are rarely necessary for the majority of patients who develop postoperative respiratory infections.

Cephalosporins↗
PubMed1995

The effect of a 12-month exercise trial on balance, strength, and falls in older women: a randomized controlled trial.

OBJECTIVE: To determine whether a 12-month program of regular exercise can improve balance, reaction time, neuromuscular control, and muscle strength and reduce the rate of falling in older women. DESIGN: A randomized, controlled trial of 12 months duration. SETTING: Conducted as part of the Randwick Falls and Fractures Study in Sydney, Australia. PARTICIPANTS: One hundred ninety-seven women aged 60 to 85 years (mean age 71.6, SD = 5.4) who were randomly recruited from the community. OUTCOME MEASURES: Accidental falls, postural sway, reaction time, neuromuscular control, and lower limb muscle strength. MAIN RESULTS: Exercise and control subjects were tested before, midway through, and at the end of the trial. At initial testing, exercisers and controls performed similarly in all tests and were well matched in relevant health and lifestyle factors. The mean number of classes attended for the 75 exercise subjects who completed the program was 60.0 (range 26-82). At the end of the trial, the exercise subjects showed improved performance in all five strength measures, in reaction time, neuromuscular control, body sway on a firm surface with the eyes open, and body sway on a compliant surface with the eyes open and closed. In contrast, there were no significant improvements in any of the test measures in the controls. In one test measure, hip flexion strength, the exercisers showed continued improvement throughout the study year. There was no significant difference in the proportion of fallers between the exercise and control subjects. Interesting trends were evident, however, between falls frequency and adherence to the exercise program. CONCLUSIONS: These findings show that exercise can produce long-term benefits with regard to improving sensorimotor function in older persons. The findings also suggest that high compliance to an exercise program may reduce falls frequency, although further studies are required to conclusively demonstrate that exercise offers an effective means of preventing falls.

Accidental Falls↗
PubMed1985

The Dublin randomized controlled trial of intrapartum fetal heart rate monitoring.

In a randomized controlled trial involving 12,964 women, a policy of continuous electronic intrapartum fetal heart monitoring was compared with an alternative policy of intermittent auscultation, both policies including an option to measure fetal scalp blood pH. Women allocated to electronic fetal heart monitoring had shorter labors and received less analgesia. The caesarean delivery rates were 2.4% for electronic fetal heart monitoring and 2.2% for intermittent auscultation but this small difference arose from the identification of nearly twice as many fetuses with low scalp pH (less than 7.20) in the electronic fetal heart monitoring group. The forceps delivery rate was 8.2% in the electronic fetal heart monitoring group compared with 6.3% in the intermittent auscultation group, and this excess was explained by more instrumental deliveries prompted by fetal heart rate abnormalities. There were 14 stillbirths and neonatal deaths in each group, with a similar distribution of causes. There were no apparent differences in the rates of low Apgar scores, need for resuscitation, or transfer to the special care nursery. Cases of neonatal seizures and persistent abnormal neurological signs followed by survival were twice as frequent in the intermittent auscultation group, and this differential effect was related to duration of labor. Follow-up at 1 year of babies who survived neonatal seizures revealed three clearly abnormal infants in each group. The implications of these findings for both theory and practice are discussed.

Adult↗
PubMedDate not supplied

Short-term responsiveness of manual thoracic end-play assessment to spinal manipulation: a randomized controlled trial of construct validity.

OBJECTIVE: To evaluate the short-term responsiveness of rotatory thoracic end-play assessment to spinal manipulation and, thereby, motion palpation construct validity. DESIGN: Prospective, single-blind, randomized, controlled trial (randomized blocks design). SETTING: Laboratory, Center for Technique Research. PARTICIPANTS: Sixty first-year chiropractic college student volunteers; seventy-three possible candidates were screened. INTERVENTIONS: The treatment group received manual high-velocity, low-amplitude rotatory manipulation. The control group received no intervention to minimize nonspecific effects of sham treatment. MAIN OUTCOME MEASURES: End-play response, defined as the change from restricted to normal end play immediately after intervention. Responsiveness, defined as the percentage of the end-play response attributable to spinal manipulation: relative response attributable to the maneuver, RRAM = (treatment group response--control group response)/treatment group response. RESULTS: Ten percent of the tests were positive for restriction of end play in left or right rotation from T3-T4 to T12-L1; the average rate was 2.1 restrictions per subject (SD = 1.4). End-play response was 60% in the treatment group, in contrast to the 37% response in the control group (z = 1.86, p = .04). More than a third of the response in the treatment group was attributable to spinal manipulation (RRAM = 39%). For one examiner, RRAM = 51%. Mild symptomatology did not affect responsiveness. CONCLUSIONS: The data suggest a moderate short-term responsiveness of rotatory thoracic end-play restriction to spinal manipulation, hence it has utility as a posttreatment evaluative test. This study was the first to use an external standard (manipulation) to demonstrate that segmental end-play restriction changes, hence end-play restriction itself, are detectable in human subjects with manual palpation by chiropractors. Further research is required to determine the generalizability of the study findings.

Adult↗
PubMed1997

A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the knee, with an emphasis on trial methodology.

We systematically reviewed randomized controlled trials (RCTs) of pharmacological therapy in knee osteoarthritis (OA), published between 1966 and August 1994. RCTs were identified by MEDLINE, supplemented by a manual search of reference lists. Qualitative assessment of RCTs was performed using Gotzsche's method; design and analysis features were rated on a scale of 0 (worst) to 8 (best). Heller et al's method was used to compare efficacy of nonsteroidal antiinflammatory drugs (NSAIDs) in comparative trials. A total of 80 RCTs were analyzed (45 involved NSAIDs, 3 analgesics, 5 intraarticular [IA] steroids, 9 biological agents, including IA hyaluronic acid, and 18 mixed modalities, including topical capsaicin). The median design and analysis scores for all 80 RCTs were 2 and 5, respectively. NSAIDs were superior to placebo in all short-term trials, but in the 32 comparative NSAID trials, only five (16%) found significant differences in efficacy. Heller et al's method identified differences in 14 NSAID comparisons; etodolac (600 mg/day) was superior in five of its nine comparisons. Indomethacin and aspirin were the most toxic NSAIDs. IA steroids were superior to placebo in short-term efficacy (< 1 month). Biological agents were superior to placebo and generally well tolerated over a mean follow-up of 48 weeks. Acetaminophen was superior to placebo and was comparably efficacious to low-dose naproxen and ibuprofen (< 2,400 mg/day). The data support the use of acetaminophen, topical capsaicin, IA steroids, IA hyaluronic acid, and NSAIDs in the treatment of patients with knee OA.

Humans↗
PubMed1996

Oral type II collagen treatment in early rheumatoid arthritis. A double-blind, placebo-controlled, randomized trial.

OBJECTIVE: To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA). METHODS: Ninety patients with RA (disease duration < or = 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study. RESULTS: There were no significant difference between the 3 groups in terms of response to treatment. However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group. Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy. CONCLUSION: Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.

Administration, Oral↗
PubMed1978

Results of a controlled randomized trial of proximal gastric vagotomy with and without pyloroplasty.

The 1--5 year results of a prospective randomized trial of proximal gastric vagotomy (PGV) with and without pyloroplasty in 64 men operated upon electively for chronic duodenal ulcer are reported. The effects of the operation on gastric secretion, as tested at 6 months with pentagastrin and isulin, were the same in both groups. There was no statistically significant difference in the clinical results between the two groups. The authors conclude that the addition of pyloroplasty makes little, if any, difference to the results of PGV. Pyloroplasty is thus better omitted as it adds nothing of value and may increase the risk of the procedure.

Adult↗
PubMed1978

Adjuvant chemotherapy in large-bowel cancer: demonstration of effectiveness of single agent chemotherapy in a prospectively controlled,, randomized trial.

In a prospectively randomized study, the effect of adjuvant chemotherapy with 5-FU on survival and recurrence rates was analyzed in 299 evaluable patients with colorectal carcinoma who either underwent a curative or a palliative resection. In the treatment group, chemotherapy consisted of the intravenous administration of 12 mg/kg daily of 5-FU for 4 consecutive days, then 6 mg/kg on alternate days, to the point of toxicity, or to a maximum of five doses, followed by 12mg/kg weekly for 1 year. Some degree of drug toxicity was seen in the majority of patients, was rarely severe, and there have been no drug-related deaths. Analysis of the survival curves and disease-free interval curves reveal definite evidence of drug benefit in two unfavorable subgroups, namely patients with Dukes C tumors and in patients whose tumor was located in the rectum. In the chemotherapy groups, patients who were treated to toxicity (WBC less than 4000 mm3), the disease-free interval was significantly longer than the nonleukopenic patients. We conclude that the addition of 5-FU to the surgical treatment of colorectal carcinoma provides a small, but significant benefit in patients with colorectal cancer in certain unfavorable subgroups, namely patients with Dukes C lesions and patients with rectal carcinoma.

Clinical Trials as Topic↗
PubMed1996

High-dose interferon-alpha 2b for re-treatment of nonresponders or relapsing patients with chronic hepatitis C. A controlled randomized trial.

Relatively few patients with chronic hepatitis C treated with standard doses of interferon-alpha 2b (3 million units per week for 24 weeks) have a sustained response. Our aim was to evaluate whether higher doses of interferon would improve this rate of response. Twenty-four patients with chronic hepatitis C who had failed to respond to (N = 21) or had relapsed after (N = 3) an initial course of standard interferon therapy were randomized to 15 million units (N = 13) or 22.5-30 million units per week (N = 11) for 24 weeks. Five of 13 subjects given 15 million units per week and 3/11 of subjects given 22.5-30 million units per week had complete normalization of serum alanine aminotransferase levels during therapy. Five patients (24% who had not responded to standard interferon had a complete response to high-dose interferon during therapy. Only one patient had a sustained response, with normal serum alanine aminotransferase 24 weeks after stopping interferon. Six patients were withdrawn before completing treatment, five in the 22.5-30 million unit per week group. We conclude that higher doses of interferon ameliorate the severity of hepatitis in patients who failed to respond to or relapsed after standard interferon therapy, but are unlikely to produce a sustained response. High-dose therapy is associated with an increase in side effects.

Alanine Transaminase↗
PubMed1986

Percutaneous transluminal coronary angioplasty after thrombolytic therapy: a prospective controlled randomized trial.

In 162 patients with acute transmural myocardial infarction, combined intravenous and intracoronary thrombolytic therapy with streptokinase was initiated. In vessels that remained occluded, mechanical recanalization was performed with a 3F recanalization catheter (group I, n = 79) or a 4F Grüntzig balloon catheter (group II, n = 83). After reperfusion, intracoronary streptokinase was administered superselectively. After termination of streptokinase infusion, angioplasty was performed only in patients in group II. There was no difference between the groups in relation to sex, age, infarct location, creatine kinase levels and time between onset of symptoms and start of treatment. Initial coronary angiography showed an open vessel in 27 (34%) of 79 patients in group I and 21 (25%) of 83 patients in group II. The final reperfusion rate was 90% (71 of 79) in group I and 86% (71 of 83) in group II. Angioplasty was attempted in 69 of the 71 patients in group II with a success rate of 65% and an occlusion rate of 3%. During the hospital stay, reocclusion occurred in 14 (20%) of 71 patients in group I. After thrombolytic therapy, coronary luminal narrowing in group I was 75 +/- 17% in patients without and 87 +/- 6% in patients with reocclusion (p less than 0.05). In group II, reocclusion was found in 10 (14%) of 71 patients. After angioplasty, the degree of coronary stenosis in group II was reduced from 82 +/- 12 to 51 +/- 30% (p less than 0.001). Reocclusion was found in 3 (7%) of the 45 patients with successful angioplasty and in 7 (32%) of the 22 patients with unsuccessful angioplasty (p less than 0.01). Improvement in regional left ventricular function was observed only in patients from group II with anterior myocardial infarction. In conclusion, by combined medical and mechanical recanalization, the rate of coronary reperfusion can be increased and infarct time shortened, providing the possibility of full revascularization by angioplasty, with improvement of regional wall motion and reduction of the rate of reocclusion.

Adult↗
PubMed1975

Chemotherapy of advanced breast cancer: a controlled randomized trial of cyclophosphamide versus a four-drug combination.

Ninety-nine patients with advanced breast cancer were randomized to receive either cyclophosphamide continuously or a combination of cyclophosphamide, methotrexate, 5-fluorouracil and vinblastine given intermittently. The number and duration of objective responses were greater in patients receiving the combination but the differences between the two treatments did not achieve formal significance. The combination was logistically easier to manage and produced less toxicity.

Adult↗
PubMed1987

Psychological group counseling for the prevention of ulcer relapses. A controlled randomized trial in duodenal and prepyloric ulcer disease.

The effect of psychological counseling on 1-year ulcer relapse rate of recurrent duodenal and prepyloric ulcer disease was evaluated in 148 patients randomly allocated into three treatment groups; psychological counseling group, maintenance cimetidine (400 mg at bedtime), and placebo cimetidine at bedtime. Ulcer relapses were monitored by endoscopy at 6 and 12 months after inclusion and at symptomatic recurrence. The estimated proportion of relapse-free patients after 12 months follow-up in the psychological counseling group (0.43 +/- 0.08) did not differ significantly from the placebo group (0.47 +/- 0.07), whereas the corresponding value for the cimetidine group (0.70 +/- 0.07) was significantly higher (p less than 0.01). The effect of cimetidine on ulcer recurrence, however, was confined to smokers; relapse risk among nonsmokers did not differ significantly between the treatment groups. The negative outcome of psychological counseling raises doubts as to whether duodenal or prepyloric ulcer recurrences can be prevented by such a therapeutic approach.

Adolescent↗
PubMed2026

Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 &#xb1; 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.

Bias↗
PubMed1993

Treatment of acute cortical infarct with intravenous glycerol. A double-blind, placebo-controlled randomized trial.

BACKGROUND AND PURPOSE: This clinical trial investigates the effectiveness of intravenous glycerol therapy in patients with acute cortical infarction in whom intracerebral hemorrhage was rigorously excluded. METHODS: Within 48 hours of symptoms from their first ischemic stroke, 113 hospital inpatients were randomized into the trial, provided that hemorrhage was excluded by computed tomography and informed consent was obtained. Patients were stratified into alert, semicoma, and coma groups using the Glasgow Coma Scale. Treatment was allocated according to a double-blind, randomized protocol; 56 patients received 500 mL of 10% glycerol in saline over 4 hours on 6 consecutive days, and 57 patients received corresponding placebo treatment with saline. Using a variety of objective scoring systems, patient follow-up was up to 6 months. RESULTS: Corresponding measures of outcome in the glycerol and placebo groups were similar. At 6 months, respective mortality rates were 17 of 56 and 16 of 57, and mean +/- SD improvements in scores were 9.98 +/- 14.40 vs 10.51 +/- 12.68 (long-term), 1.12 +/- 7.20 vs 1.57 +/- 6.30 (prognostic), -1.94 +/- 5.53 vs -2.06 +/- 5.34 (Glasgow Coma Scale), and 21.72 +/- 23.40 vs 11.94 +/- 18.10 (Barthel Index rating in survivors). Hemolysis (generally subclinical) was the only adverse effect. CONCLUSIONS: There was no clinically or statistically significant difference in outcome between the groups; a trend toward greater functional recovery among survivors was evident after treatment with glycerol.

Acute Disease↗