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Results for “Randomized controlled trials”

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At least 541 records · Page 30Linked to original sources
PubMed1994

Placebo-controlled randomized trial of infusional fluorouracil during standard radiotherapy in locally advanced head and neck cancer.

PURPOSE: To determine whether the addition of infusional fluorouracil (I-FU) to standard radiotherapy improves survival at acceptable toxicity in patients with locally advanced squamous cell head and neck cancer (SCHNC). PATIENTS AND METHODS: Consenting patients with an Eastern Cooperative Oncology Group (ECOG) performance status < or = 2; with stage III or IV SCHNC of the oral cavity, oropharynx, hypopharynx, or larynx; and who were recommended for radiotherapy with curative intent received 66 Gy of radiation therapy delivered in 2-Gy fractions once daily 5 days per week for 6 1/2 weeks. Those in the experimental arm received I-FU 1.2 g/m2/d, as a 72-hour infusion in the first and third weeks of radiation. Saline infusions were used in the placebo arm. RESULTS: One hundred seventy-five patients were randomized (88 to I-FU and 87 to placebo), and the treatment arms were well balanced. The complete response rate was 68% for I-FU and 56% for placebo (P = .04). The overall median survival duration was 33 months for I-FU and 25 months for placebo (P = .08). Progression-free survival also favored I-FU (P = .06). Toxicity was greater in I-FU patients, but did not interfere with the scheduled delivery or completion of radiation. CONCLUSION: The addition of I-FU to standard radiation in SCHNC improved the complete response rate and was associated with beneficial trends in progression-free and overall survival compared with radiation alone. I-FU patients also experienced greater morbidity, but this did not compromise delivery of radiotherapy.

Aged↗
PubMed2003

A role for anabolic steroids in the rehabilitation of patients with COPD? A double-blind, placebo-controlled, randomized trial.

STUDY OBJECTIVES: Skeletal muscle weakness commonly occurs in patients with COPD. Long-term use of systemic glucocorticosteroids further contributes to muscle weakness. Anabolic steroids could be an additional mode of intervention to improve outcome of pulmonary rehabilitation by increasing physiologic functioning, possibly mediated by increasing erythropoietic function. PATIENTS AND METHODS: We randomly assigned 63 male patients with COPD to receive on days 1, 15, 29, and 43 a deep IM injection of 50 mg of nandrolone decanoate (ND) [Deca-Durabolin; N.V. Organon; Oss, The Netherlands] in 1 mL of arachis oil, or 1 mL of arachis oil alone (placebo) in a double-blind design. All patients participated in a standardized pulmonary rehabilitation program. Outcome measures were body composition by deuterium and bromide dilution, respiratory and peripheral muscle function, incremental exercise testing, and health status by the St. George's Respiratory Questionnaire. RESULTS: Treatment with ND relative to placebo resulted in higher increases in fat-free mass (FFM; mean, 1.7 kg [SD, 2.5] vs 0.3 kg [SD, 1.9]; p = 0.015) owing to a rise in intracellular mass (mean, 1.8 kg [SD, 3.1] vs - 0.5 kg [SD, 3.1]; p = 0.002). Muscle function, exercise capacity, and health status improved in both groups to the same extent. Only after ND were increases in erythropoietic parameters seen (erythropoietin: mean, 2.08 U/L [SD, 5.56], p = 0.067; hemoglobin: mean, 0.29 mmol/L [SD, 0.73], p = 0.055). In the total group, the changes in maximal inspiratory mouth pressure (PImax) and peak workload were positively correlated with the change in hemoglobin (r = 0.30, p = 0.032, and r = 0.34, p = 0.016, respectively), whereas the change in isokinetic leg work was correlated with the change in erythropoietin (r = 0.38, p = 0.013). In the patients receiving maintenance treatment with low-dose oral glucocorticosteroids (31 of 63 patients; mean, 7.5 mg/24 h [SD, 2.4]), greater improvements in PImax (mean, 6.0 cm H(2)O [SD, 8.82] vs - 2.18 cm H(2)O [SD, 11.08], p = 0.046), and peak workload (mean, 20.47 W [SD, 19.82] vs 4.80 W [SD, 7.74], p = 0.023) were seen after 8 weeks of treatment with ND vs placebo. CONCLUSIONS: In conclusion, a short-term course of ND had an overall positive effect relative to placebo on FFM without expanding extracellular water in patients with COPD. In the total group, the improvements in muscle function and exercise capacity were associated with improvements in erythropoietic parameters. The use of low-dose oral glucocorticosteroids as maintenance medication significantly impaired the response to pulmonary rehabilitation with respect to respiratory muscle function and exercise capacity, which could be restored by ND treatment.

Aged↗
PubMed1985

Coeliac plexus block versus pancreaticogastrostomy for pain in chronic pancreatitis. A controlled randomized trial.

Seventeen patients with chronic pancreatitis and dilated pancreatic ducts were randomly allocated to coeliac plexus block or pancreaticogastrostomy. The number of patients with pain relief after coeliac plexus block and pancreaticogastrostomy did not differ at discharge. Pain score and use of analgesics before coeliac plexus block and 6 months later were unaffected but were significantly less after pancreaticogastrostomy. Operation decreased pancreatic tissue pressure significantly. This pressure decrease is believed to explain pain relief.

Adult↗
PubMed1987

A controlled randomized trial of budesonide versus prednisolone retention enemas in active distal ulcerative colitis.

Sixty-four patients with active distal ulcerative colitis participated in a multicentre, randomized, investigator-blind trial to compare the effect of budesonide enema, 2 mg/100 ml, with prednisolone disodium phosphate enema, 31.25 mg/100 ml. Budesonide is a new potent corticosteroid with a rapid first-pass elimination. The patients were treated for 4 weeks, and the efficacy of the drugs were evaluated by sigmoidoscopy, histology, and subjective symptoms after 2 and 4 weeks. After 4 weeks of treatment 16 of 31 patients (52%) receiving budesonide enema had healed endoscopically, compared with 8 of 33 (24%) (p = 0.045) receiving prednisolone enema. Budesonide was superior to prednisolone in terms of both significantly improved sigmoidoscopic and histologic scores and subjective symptoms evaluated by visual analogue scales. The patients receiving prednisolone had a significant depression of endogenous cortisol levels during the treatment period, but not the patients receiving budesonide. Budesonide enema seems to be a promising therapy for active distal ulcerative colitis and causes no adverse reactions.

Adolescent↗
PubMed1993

Cisapride in functional dyspepsia: a double-blind, placebo-controlled randomized trial in general practice patients.

This trial included patients from general practice with endoscopy-negative chronic dyspepsia and epigastric pain or discomfort. Eleven eligible patients with sufficiently severe dyspeptic symptoms after a 2-week placebo run-in period were entered into a 4-week, parallel group, double-blind randomized comparison of 10 mg cisapride three times daily and matched placebo, and were subsequently evaluable. Symptoms were comparable in the two treatment groups at the start of double-blind treatment. The cisapride group had a significantly greater reduction in the frequency of daytime epigastric pain/discomfort and the frequency and severity of nocturnal pain/discomfort after 2 weeks. After 2 weeks, all six cisapride recipients were free of nocturnal pain, compared with only one of five placebo recipients. After 4 weeks of double-blind therapy, improvements in the placebo group had reduced between-treatment differences, with five of six cisapride recipients and three of five placebo recipients being free of nocturnal pain. Cisapride was well tolerated.

Abdominal Pain↗
PubMed1995

Prospective double-blind placebo-controlled randomized trial on the use of ranitidine in preventing postoperative gastroduodenal complications in high-risk neurosurgical patients.

To determine the efficacy of ranitidine in preventing clinically acute overt gastroduodenal (GD) complications (bleeding and/or perforation) after neurosurgery, 101 patients with nontraumatic cerebral disease considered at high risk of developing postoperative GD complications were randomized in a standard double-blind manner to receive either ranitidine (50 mg every 6 hours) or placebo medication preoperatively. Postoperative serial GD endoscopy was used to document the occurrence of complications: an overt symptomatic complication was defined as bleeding requiring blood transfusion and/or surgery. Fifty-two patients received ranitidine and 49 received a placebo preoperatively; 30 developed overt GD bleeding; nine of these received ranitidine and 21 received a placebo. Ranitidine significantly reduced the incidence of bleeding (p < 0.05). Multivariate logistic regression analysis revealed three factors of independent significance in predicting overt GD bleeding: use of a placebo drug, a gastric pH of less than 4, and a high daily volume of gastric output. The authors conclude that ranitidine is useful in preventing postoperative GD complications in high-risk neurosurgical patients.

Adolescent↗
PubMed2001

Effects of the total triterpenic fraction of Centella asiatica in venous hypertensive microangiopathy: a prospective, placebo-controlled, randomized trial.

The aim of this study was to demonstrate whether total triterpenic fraction of Centella asiatica (TTFCA), was effective in improving the microcirculation in venous hypertension and microangiopathy. Forty patients with severe venous hypertension, ankle swelling, lipodermatosclerosis were included. After informed consent, patients were randomized into a treatment and a placebo group: those in the treatment group received TTFCA (tablets, 60 mg, twice daily for 8 weeks). The two groups of subjects were comparable for age and sex distribution. The mean age was 48 years (SD 9; M:F= 11:11) in the treatment group (22 patients) and 47.6 (SD 7; M:F= 10:8) in the placebo group (18 patients). There were no differences between placebo and treatment group at inclusion; there was no change between inclusion and measurements at 8 weeks in the placebo group. A decrease (p < 0.05) in RF (flux at rest) and RAS (rate of ankle swelling) were observed in the treatment group. The decrease in capillary filtration was associated with improvement in signs and symptoms (p < 0.05). The difference in flux, signs and symptoms, and filtration was clinically important at 8 weeks. No side effects were observed. In conclusion venous microangiopathy was improved by TTFCA treatment.

Administration, Oral↗
PubMedDate not supplied

Treatment of vascular inner ear disease with pentoxifylline: a 4-week, controlled, randomized trial.

The efficacy of pentoxifylline (PXF) in vascular inner ear disease (VIED) was studied comparing PXF and placebo in a 4-week study; 60 patients with unilateral loss of hearing, vertigo, dizziness, tinnitus (analyzed with an analogue scale line), and cochlear flow reduction were included. The aim of the study was to study the effect of PXF (1800 mg/day) in VIED considering clinical outcome and cochlear flow. All patients completed the study. Improvement in cochlear flow (p<0.05) and a decrease in score in both groups were observed. The cochlear flow increase was 287.5% in the PXF group vs 168% in the placebo group (119.5% difference; p<0.02). There was a difference in score decrease (44.1% larger) in the PXF group (p<0.05). PXF was more effective considering flow and symptoms.

Cochlea↗
PubMedDate not supplied

Treatment of vascular inner ear disease in vascular patients with pentoxifylline: a controlled, randomized trial.

The efficacy of Pentoxifylline in vascular inner ear disease (VIED) was studied comparing PXF and placebo in a 4-week study; 40 patients with vascular disease and monolateral loss of hearing, vertigo, dizziness, tinnitus (analyzed with an analogue scale line), and cochlear flow reduction were included. The aims of the study were to study the effects of PXF (1600 mg daily) in VIED considering clinical outcome and cochlear flow. Of the 20 included patients, 19 completed the study. One dropout in the placebo group was due to low compliance. Intention-to-treat analysis indicated an improvement in cochlear flow (p<0.05) and a decrease in score in both groups. The cochlear flow increase was 287.5% in the PXF group vs 168% in the placebo group (119.5% difference; p<0.02). There was a difference in score decrease (44.1% larger) in the PXF group (p<0.05).Between-group analysis favors PXF considering blood flow and symptoms. Results indicate good efficacy and tolerability of PXF in VIED.

Cochlea↗
PubMedDate not supplied

Treatment of vascular retinal disease with pentoxifylline: a controlled, randomized trial.

The aim of this study was to evaluate the effect of PXF (1800 mg daily) in patients with sudden loss of vision (SLV) in a 4-week trial, evaluating clinical outcome and retinal flow parameters. Inclusion criteria were SLV associated with thrombosis of the retinal artery; decrease in retinal blood flow (PSF: peak-systolic flow; EDF: end-diastolic flow velocity) and asymmetry between the two retinal arteries (>40%) documented by duplex scanning. All 10 included patients completed the study. The groups were comparable. No side effects were reported. A significant improvement in flow velocity (p<0.05) and a decrease in analogue score in both groups were observed. PSF increase was 550% in the PXF group vs 288% in the placebo group (262% difference). EDF increase was 400% in the PXF group vs 200% in the placebo group (200% difference). There was a significant difference in the analogue score decrease (33.3% difference larger in the PXF group; p<0.05). In conclusion, PXF treatment improved retinal flow after retinal artery occlusion better than placebo and should be considered as an important option in this condition.

Blood Flow Velocity↗
PubMedDate not supplied

Treatment of retinal vein thrombosis with pentoxifylline: a controlled, randomized trial.

The aim of this study was to evaluate PXF (pentoxifylline; 1600 mg daily vs placebo) in patients with retinal vein thrombosis (RVT) in a 4-week trial, evaluating clinical outcome and retinal flow. Inclusion criteria were sudden loss of vision (SLV); retinal vein thrombosis (RVT); decrease in retinal vein flow; asymmetry between retinal veins (>40%) documented by duplex scanning (retinal vein thrombosis flow = RVTF). All 18 included patients completed the study. The groups were comparable. No side effect was observed. An improvement in arterial flow (p<0.05) and a decrease in analogue score (p<0.05) were observed in both groups (due to the spontaneous evolution with partial thrombus lysis in 4 weeks). The increase in arterial flow (PSF and EDF) were greater (p<0.05) in the PXF group. The RVFV increase was better in the PXF group (350% increase vs 200% increase in the placebo group; p<0.05). There was a significant difference in the analogue score decrease (4 vs 7) in the PXF group (p<0.05). In conclusion, PXF improved retinal flow after RVT better than placebo. It should be considered as an important treatment option.

Adult↗
PubMedDate not supplied

Intermittent claudication in diabetics: treatment with exercise and pentoxifylline--a 6-month, controlled, randomized trial.

The aims of this study were to evaluate the effect of PXF (1600 mg daily) in diabetic patients with intermittent claudication. Of the 60 included patients, 53 completed the study (27 in the PXF group). There were seven dropouts. The groups were comparable for age, sex distribution, and total walking distance (TWD), and risk factors. There was an increase in TWD at 3 and 6 months in both groups (p<0.05) possibly due to exercise. However the increase (both absolute and percentage) in TWD was significantly larger in the PXF group. At 6 months, PXF produced a 292% increase in TWD (vs 180% produced by placebo) (p<0.02). The excess increase produced by PXF treatment was 112% at 6 months in comparison with placebo (p<0.02). Treatment was well tolerated. Between-group analysis favors PXF considering TWD, and results indicate good efficacy and tolerability.

Aged↗
PubMed1985

Acetylsalicylic acid and dipyridamole improve the early patency of aorta-coronary bypass grafts. A double-blind, placebo-controlled, randomized trial.

A total of 125 patients undergoing aorta-coronary bypass grafting for disabling angina were randomized to receive either 330 mg of acetylsalicylic acid (aspirin) plus 75 mg of dipyridamole three times daily or a placebo for 6 months postoperatively. In addition, all patients were given warfarin for 3 months. Repeat angiography was performed at 6 months in 103 patients. In the treatment group 95 grafts were implanted in 48 patients, of which 87 were patent (91.6% patency rate). This figure compares with 88 grafts patent out of 118 implanted in 55 patients in the placebo group (74.6% patency rate) (p less than 0.01). We conclude that antiplatelet therapy improves the early patency of saphenous vein aorta-coronary bypass grafts.

Adult↗
PubMed1978

Prevention of deep vein thrombosis in urological patients: a controlled, randomized trial of low-dose heparin and external pneumatic compression boots.

A prospective, randomized clinical trial in 83 patients undergoing open urological operations was performed to compare the relative prophylactic efficacy of low-dose heparin and external pneumatic compression (EPC) of the calves in comparison to no treatment in the prevention of deep vein thrombosis (DVT). The diagnosis of deep vein thrombosis was established by the I125 fibrinogen scan and contrast phlebography. The data indicate that EPC is more effective than no treatment (p less than 0.04) and more effective than low-dose heparin (p less than 0.04) in the prevention of DVT. There was one pulmonary embolus in each of the three groups, and in the treatment groups this occurred without evidence of DVT.

Adult↗
PubMed1984

S-adenosyl-L-methionine antagonizes oral contraceptive-induced bile cholesterol supersaturation in healthy women: preliminary report of a controlled randomized trial.

Recent experimental investigations have shown that S-adenosyl-L-methionine (SAMe) reverses estrogen-induced bile secretion impairment. The mechanism of this action seems to be related to the capability of SAMe both to inactivate catecholestrogens by methylation reaction and to methylate membrane phospholipids increasing the liver plasma membrane fluidity reduced by the estrogens. Aim of this investigation was to know whether SAMe also prevents oral contraceptive-induced cholesterol supersaturation of gallbladder bile in humans. To six healthy nonobese women whose bile cholesterol saturation index increased from a mean basal value of 0.77 (SD 0.22) to 1.20 (SD 0.38) (p less than 0.01) after two cycles of treatment with oral contraceptives containing 50 micrograms ethynylestradiol, plus 250 micrograms d-norgestrel, 200 mg SAMe per os tid was administered in addition to the oral contraceptive for other two cycles. The bile cholesterol saturation index decreased to 0.88 (SD 0.26) (p less than 0.05 versus oral contraceptive value). These results indicate that SAMe antagonizes biliary lipid changes induced by estrogen-progestin containing oral contraceptive and suggest its potential usefulness in women on oral contraceptive treatment to prevent lithogenic bile secretion.

Adult↗
PubMed2005

Lack of herbal supplement characterization in published randomized controlled trials.

PURPOSE: Herbal supplements in the United States and abroad have poor quality control and high content variability. We assessed the extent to which recently published randomized controlled trials of herbal supplements characterized and verified the content of the supplement under study. METHODS: We identified all MEDLINE-indexed English language randomized controlled trials evaluating single-herb preparations of echinacea, garlic, ginkgo, saw palmetto, or St. John's wort that were published between January 1, 2000, and February 9, 2004. From each article we extracted information characterizing the herbal supplement studied. RESULTS: Of 81 randomized controlled trials meeting inclusion criteria, 12 (15%) reported performing tests to quantify actual contents, and 3 (4%) provided adequate data to compare actual with expected content values of at least one chemical constituent. In those 3 studies, actual content varied between 80% and 113% of expected values. Studies of higher overall quality (Jadad score > or =3) performed testing somewhat less frequently (5/54; 9%) than those with lower Jadad scores (7/27; 26%) (P = .09). CONCLUSION: Documented characterization of herbal supplements in published randomized controlled trials is inadequate. Investigators may be unaware of the extent to which herbal quality-control issues may detract from the value of otherwise well-designed clinical trials. The scientific and clinical utility of future herbal randomized controlled trials would be enhanced if authors provided evidence that the herbal products studied were of high quality.

Drug Contamination↗
PubMed2004

Interactive video behavioral intervention to reduce adolescent females' STD risk: a randomized controlled trial.

A longitudinal randomized design was used to evaluate the impact of a theoretically based, stand-alone interactive video intervention on 300 urban adolescent girls' (a) knowledge about sexually transmitted diseases (STDs), (b) self-reported sexual risk behavior, and (c) STD acquisition. It was compared to two controls, representing high-quality informational interventions. One used the same content in book form; the other used commercially available brochures. Following randomization, the interventions were administered at baseline, with booster sessions at 1, 3, and 6 months. Self-reports revealed that those assigned to the interactive video were significantly more likely to be abstinent in the first 3 months following initial exposure to the intervention, and experienced fewer condom failures in the following 3 months, compared to controls. Six months after enrollment, participants in the video condition were significantly less likely to report having been diagnosed with an STD. A non-significant trend in data from a clinical PCR assay of Chlamydia trachomatis was consistent with that finding.

Adolescent↗