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Results for “randomized controlled trials”

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PubMed1999

The ALBI trial: a randomized controlled trial comparing stavudine plus didanosine with zidovudine plus lamivudine and a regimen alternating both combinations in previously untreated patients infected with human immunodeficiency virus.

A total of 151 previously untreated patients infected with human immunodeficiency virus type 1 (HIV-1) with CD4 cell counts >/=200/microL and plasma HIV-1 RNA levels of 10,000-100,000 copies/mL were randomly assigned to 24 weeks of open-labeled stavudine plus didanosine (group 1), zidovudine plus lamivudine (group 2), or stavudine plus didanosine followed by zidovudine plus lamivudine (group 3). The mean decrease in HIV-1 RNA level was greater in group 1 (2.26 log10 copies/mL) than in groups 2 (1.26 log10 copies/mL) or 3 (1.58 log10 copies/mL; P<.0001). The mean increase in CD4 cell counts was greater in groups 1 (124 cells/microL) and 3 (118 cells/microL) than in group 2 (62 cells/microL; P=.02). All regimens were generally well tolerated. The combination of stavudine plus didanosine reduced plasma HIV-1 RNA concentrations and increased CD4 cell counts more effectively than did the combination of zidovudine plus lamivudine or the regimen alternating both combinations.

Adult↗
PubMedDate not supplied

Effect of reduced dietary sodium on blood pressure: a meta-analysis of randomized controlled trials.

OBJECTIVE: - To ascertain whether restriction of dietary sodium lowers blood pressure in hypertensive and normotensive individuals. DATA SOURCES: - An English-language computerized literature search, restricted to human studies with Medical Subject Heading terms, "hypertension," "blood pressure," "vascular resistance," "sodium and dietary," "diet and sodium restricted," "sodium chloride," "clinical trial," "randomized controlled trial," and "prospective studies," was conducted. Bibliographies of review articles and personal files were also searched. TRIAL SELECTION: - Trials that had randomized allocation to control and dietary sodium intervention groups, monitored by timed sodium excretion, with outcome measures of both systolic and diastolic blood pressure were selected by blinded review of the methods section. DATA EXTRACTION: - Two observers extracted data independently, using purpose-designed forms, and discrepancies were resolved by discussion. DATA SYNTHESIS: - The 56 trials that met our inclusion criteria showed significant heterogeneity. Publication bias was also evident. The mean reduction (95% confidence interval) in daily urinary sodium excretion, a proxy measure of dietary sodium intake, was 95 mmol/d (71-119 mmol/d) in 28 trials with 1131 hypertensive subjects and 125 mmol/d (95-156 mmol/d) in 28 trials with 2374 normotensive subjects. After adjustment for measurement error of urinary sodium excretion, the decrease in blood pressure for a 100-mmol/d reduction in daily sodium excretion was 3.7 mm Hg (2.35-5.05 mm Hg) for systolic (P<.001) and 0.9 mm Hg (-0.13 to 1.85 mm Hg) for diastolic (P=.09) in the hypertensive trials, and 1.0 mm Hg (0.51-1.56 mm Hg) for systolic (P<.001) and 0.1 mm Hg (-0.32 to 0.51 mm Hg) for diastolic (P=.64) in the normotensive trials. Decreases in blood pressure were larger in trials of older hypertensive individuals and small and nonsignificant in trials of normotensive individuals whose meals were prepared and who lived outside the institutional setting. CONCLUSION: - Dietary sodium restriction for older hypertensive individuals might be considered, but the evidence in the normotensive population does not support current recommendations for universal dietary sodium restriction.

Blood Pressure↗
PubMedDate not supplied

Sertraline for the prevention of relapse in detoxicated alcohol dependent patients with a comorbid depressive disorder: a randomized controlled trial.

AIMS: We performed a double-blind, placebo-controlled randomized trial of sertraline in recently detoxified alcohol-dependent patients with current depressive symptoms. The objectives of the study were to evaluate the efficacy of sertraline at achieving stable abstinence, at ameliorating depressive symptoms and at improving quality of life in these patients. METHODS: The study included 83 patients, who received either sertraline (50-150 mg/day) or placebo for 24 weeks. The primary outcome criteria were the rate of relapse into alcohol consumption and the rate of response on the Montgomery and Asberg Depression Rating Scale (MADRS). RESULTS: At the end of the treatment period, relapse rates were 23.1% in the placebo group and 31.8% in the sertraline group. Responder rates for depression were 38.5% for the placebo group and 44.2% for the sertraline group. There was no significant difference between treatment groups with either variable. However, when patients were stratified into severe (MADRS score >or=26) and moderate (MADRS score <26) depression at inclusion, a significant treatment benefit with sertraline was observed in the former group. Quality of life, determined by the SF-36, improved in both groups, with more benefit observed for the sertraline group on mental health items. Sertraline was well tolerated, and the incidence of adverse events was similar in the two treatment groups. CONCLUSIONS: The explanation for the overall good outcome in both treatment groups and for the inability to demonstrate a clear treatment effect may reside in the clinical features of the patients included.

Adult↗
PubMed2001

Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS Trial: a randomized controlled trial.

CONTEXT: It is not known whether intranasal corticosteroids are beneficial to treat acute rhinosinusitis in patients with a history of chronic or recurrent sinus symptoms. OBJECTIVE: To assess whether the addition of an intranasal corticosteroid to antibiotic therapy affects the speed and rate of recovery of such patients with acute rhinosinusitis. DESIGN, SETTING, AND PATIENTS: A double-blind, randomized, placebo-controlled multicenter trial of 95 patients (median age, 39 years) with a history of recurrent sinusitis or chronic rhinitis and evidence of acute infection by sinus radiograph or nasal endoscopy, which was conducted from October 1998 through April 2000 at 22 sites (12 primary care and 10 otolaryngology). INTERVENTION: Two puffs (total dose, 200 microgram) of fluticasone propionate (n = 47) or placebo nasal spray (n = 48) in each nostril once daily for 21 days; all received 2 puffs of xylometazoline hydrochloride in each nostril twice daily for 3 days and 250 mg of cefuroxime axetil twice daily for 10 days. MAIN OUTCOME MEASURE: Time to clinical success (patient reported cured or much improved) during telephone follow-up at 10, 21, and 56 days. RESULTS: A total of 88 patients (93%) completed follow-up. Patients recorded their symptoms, work assessment, and compliance during the 3-week treatment phase. Patients receiving fluticasone achieved a significantly higher rate of clinical success than patients receiving placebo (93.5% vs 73.9%; P =.009). Patients treated with fluticasone improved significantly more rapidly (median of 6.0 days to clinical success) vs patients in the placebo group (median of 9.5 days; P =.01). CONCLUSIONS: The addition of fluticasone to xylometazoline and antimicrobial therapy with cefuroxime improves clinical success rates and accelerates recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis.

Acute Disease↗
PubMed2006

Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial.

CONTEXT: Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. OBJECTIVE: To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. DESIGN: Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. SETTING: Ninety hospitals in Europe, Latin America, and Asia. PATIENTS: A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. INTERVENTION: Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685). MAIN OUTCOME MEASURES: The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. RESULTS: In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, -0.22 mm; 95% CI, -0.26 to -0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, -3.60%; 95% CI, -5.12% to -2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73). CONCLUSION: In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00235092.

Aged↗
PubMed2004

The number, quality, and coverage of randomized controlled trials in nephrology.

Randomized controlled trials (RCT) are the optimal study design to answer intervention questions. The authors evaluated the number, quality, and coverage of RCT in nephrology. MEDLINE was searched using the relevant medical subject headings for nephrology and 12 major specialties in internal medicine, limited by "randomized controlled trial" as a publication type. A random selection of 160 RCT in nephrology (40 for each decade) published since 1966 and an additional 270 RCT from ongoing or published Cochrane systematic reviews in various areas of nephrology, dialysis, and transplantation were evaluated for quality of reporting using standard criteria. The number of RCT published in nephrology from 1966 to 2002 (2779) is fewer than all other specialties of internal medicine (range: 5335 in hematology to 27109 in cardiology) with the proportion of all citations which are RCT being the third lowest (1.15%). There has been an increase in both indices from 1966 to 1996, but not at a greater rate than other specialties, and there has been no increase over the past 5 yr. Some areas of nephrology, in particular glomerulonephritis, are clear outliers with very low numbers of RCT to guide clinical decision-making. Overall the quality of RCT reporting in nephrology is low and has not improved over the past 30 yr with unclear allocation concealment (89%), lack of reported blinding of outcome assessors (92%), and failure to perform "intention-to-treat analysis" (50%) particularly frequent. The challenges of improving the quality and quantity of trials in nephrology are substantial, but they can be overcome by using standard guidelines and checklists for trial reporting, greater attention to the trial methods and not just the results, involving experts in trial design and reporting, multicenter collaboration, and larger and simpler trials.

Humans↗
PubMed2002

The addition of a tramadol infusion to morphine patient-controlled analgesia after abdominal surgery: a double-blinded, placebo-controlled randomized trial.

UNLABELLED: In this double-blinded, randomized controlled trial, we tested whether the addition of tramadol to morphine for patient-controlled analgesia (PCA) resulted in improved analgesia efficacy and smaller morphine requirements compared with morphine PCA alone after abdominal surgery in adults. Sixty-nine patients were randomly allocated into two groups, each receiving morphine 1 mg/mL via PCA after surgery. The tramadol group received an intraoperative initial loading dose of tramadol (1 mg/kg) and a postoperative infusion of tramadol at 0.2 mg. kg(-1). h(-1). The control group received an intraoperative equivalent volume of normal saline and a postoperative saline infusion. Postoperatively, tramadol was associated with improved subjective analgesic efficacy (P = 0.031) and there was significantly less PCA morphine use in the tramadol group (P = 0.023). No differences between the groups were found with regard to nausea, antiemetic use, sedation, or quality of recovery (all P > 0.05). We conclude that a tramadol infusion combined with PCA morphine improves analgesia and reduces morphine requirements after abdominal surgery compared with morphine PCA alone. IMPLICATIONS: In this study, we determined whether adding a second pain-killing drug, tramadol, could improve pain relief after major surgery in patients receiving morphine patient-controlled analgesia. We found that patients receiving tramadol had significantly better opinions of their pain relief and used significantly less morphine with no increase in side effects.

Abdomen↗
PubMed1998

Laparoscopic or open appendectomy? Critical review of randomized, controlled trials.

PURPOSE: A randomized, controlled trial is considered to be the "gold standard" to evaluate a new procedure. Thus, this critical review assessed whether the published randomized trials on laparoscopic appendectomy show that it is superior to the open approach. METHODS: Twelve original articles involving a randomized, controlled trial on laparoscopic appendectomy in adults published between January 1990 and December 1996 were selected. We studied first whether each trial was positive (a procedure is superior to the other) or negative (no difference). We reviewed for each trial the methodology used and the following outcomes: operating time, intraoperative and postoperative complications, time until resumption of diet, postoperative pain, hospital stay, cost, and quality of life analyses. Postoperative morbidity was considered as the major primary outcome. RESULTS: There were six positive and six negative trials. Postoperative complication rates were similar, but the two approaches had specific potential complications, wound infections following open appendectomy, and intra-abdominal abscesses following laparoscopic appendectomy. This review failed to show a superiority of the laparoscopy for the other outcomes, particularly postoperative pain. CONCLUSION: Differences in positive trials concerned subjective and controversial outcomes, and the flaw in negative trials was their lack of power. Thus, nothing is definitively well established, even after 12 randomized trials.

Appendectomy↗
PubMed2001

Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial.

CONTEXT: The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days. OBJECTIVE: To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment. DESIGN: Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000. SETTING: Ninety-two tertiary care centers in the United States and Canada. PARTICIPANTS: A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation. INTERVENTION: Patients were randomly assigned to receive placebo or eptifibatide (two 180-microg/kg boluses 10 minutes apart and continuous infusion of 2.0 microg/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo. MAIN OUTCOME MEASURES: Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups. RESULTS: By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P =.002). The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI, 0.60-0.93; P =.008). Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P =.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of the placebo group (HR, 0.91; 95% CI, 0.68-1.22; P =.51). CONCLUSION: Adjunctive eptifibatide therapy during coronary stent implantation provides benefit through 6-month follow-up.

Aged↗
PubMed2005

Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial.

BACKGROUND: A randomized, controlled trial of GH supplementation to adult height in girls with short stature due to Turner syndrome was conducted in Canada. We report results in subjects who completed the protocol and subjects who participated in follow-up. METHODS: One hundred fifty-four girls with Turner syndrome, aged 7-13 yr, were randomly assigned to one of two groups: 1) GH by sc injection six times per week (0.30 mg/kg.wk), and 2) control (C), no GH treatment. Both cohorts received standardized sex steroid replacement starting at a chronological age of 13 yr. Subjects were followed until protocol completion, defined as height velocity less than 2 cm/yr and bone age 14 yr or greater. A subsequent protocol addendum requested follow-up safety and efficacy assessment in all patients at least 1 yr after the last core protocol visit. RESULTS: One hundred four patients completed the study (61 GH, 43 C), and 50 withdrew (15 GH, 35 C). At protocol completion, mean heights were 147.5 +/- 6.1 (GH) and 141.0 +/- 5.4 cm (C), respectively (P < 0.001). Of those who completed the protocol, 59 (40 GH, 19 C) had height data at least 1 yr after protocol completion; in that group, mean heights were 149.0 +/- 6.4 (GH) and 142.2 +/- 6.6 cm (C), respectively (P < 0.001). At protocol completion and follow-up, the mean height gain due to GH, estimated by analysis of covariance, was +7.2 cm (confidence interval 6.0, 8.4) and +7.3 cm (confidence interval 5.4, 9.2), respectively (both P < 0.001). CONCLUSIONS: This is the first evidence from a randomized, controlled trial to adult height that GH supplementation with induction of puberty at a near physiological age increases the adult height of girls with Turner syndrome.

Adolescent↗
PubMed2003

Prevention of hip fractures by external hip protectors: a randomized controlled trial.

CONTEXT: Several randomized controlled trials have been performed to examine the effectiveness of external hip protectors in reducing the incidence of hip fractures, but the results are controversial. OBJECTIVE: To examine the effectiveness of hip protectors in reducing the incidence of hip fractures in an elderly high-risk population. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of elderly persons aged 70 years or older, who have low bone density, and are at high risk for falls. Participants lived in apartment houses for the elderly, homes for the elderly, and nursing homes in Amsterdam and surrounding areas in the Netherlands. They were enrolled in the study between March 1999 and March 2001; the mean follow-up was 69.6 weeks. Of the 830 persons who were screened, 561 persons were enrolled. INTERVENTION: External hip protector. Both groups received written information on bone health and risk factors for falls. MAIN OUTCOME MEASURE: Time to first hip fracture. Survival analysis was used to include all participants for the time they participated. RESULTS: In the intervention group, 18 hip fractures occurred vs 20 in the control group. Four hip fractures in the intervention group occurred while an individual was wearing a hip protector. At least 4 hip fractures in the intervention group occurred late at night or early in the morning. Both in univariate analysis (log-rank P =.86) and in multivariate analysis (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.55-2.03), no statistically significant difference between the intervention group and control group was found with regard to time to first hip fracture. In addition, the per protocol analysis in compliant participants did not show a statistically significant difference between the groups (HR, 0.77; 95% CI, 0.25-2.38). CONCLUSION: The hip protector studied was not effective in preventing hip fractures.

Accidental Falls↗
PubMed2003

Effects of exercise training on physical activity in older people: a randomized controlled trial.

BACKGROUND: Recent randomized controlled trials indicated that exercise training for elderly significantly increased their physical fitness. However, very few studies have examined changes in physical activity after exercise training. The purpose of this study was to investigate whether six-month exercise training for older adults can increase and maintain their physical activity in daily life. METHODS: Sixty-two men and women aged 60 to 81 years (mean age 67.1 years), living in communities, were randomly allocated into an exercise group (n = 32) or a control group (n = 33). The intervention started in April 1998 and lasted for 25 weeks. The exercise regimen consisted of endurance training and resistance exercises in a two-hour class conducted at least twice a week. The subjects completed a physical activity diary at each pre-intervention (March 1998), post-intervention (September 1998) and follow-up (April 1999) measurement of physical activity. Physical activity, expressed as total daily energy expenditure, was calculated by multiplying the amount of time spent in each activity and the corresponding METs. RESULTS: Total daily energy expenditure significantly increased from 40.8 kcal/kg/day to 43.5 kcal/kg/day in the exercise group (p = 0.03), but did not change in the control group. At the follow-up measurement, the mean total daily energy expenditure in the exercise group remained significantly higher, by 1.7 kcal/kg/day, than that at the pre-intervention (p = 0.05). CONCLUSIONS: This randomized controlled trial indicated that exercise training for elderly was effective in increasing physical activity in daily life.

Activities of Daily Living↗
PubMed2006

The effectiveness of high-intensity versus low-intensity back schools in an occupational setting: a pragmatic randomized controlled trial.

STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To compare high- and low-intensity back schools with usual care in occupational health care. SUMMARY OF BACKGROUND DATA: The content and intensity of back schools vary widely and the methodologic quality of randomized controlled trials is generally weak. Until now, no back school has proven to be superior for workers sick-listed because of subacute nonspecific low back pain. METHODS: Workers (n = 299) sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain were recruited by the occupational physician and randomly assigned to a high-intensity back school, a low-intensity back school, or care as usual. Outcome measures were days until return to work, total days of sick-leave, pain, functional status, kinesiophobia, and perceived recovery and were assessed at baseline and at 3 and 6 months of follow-up. Principal analyses were performed according to the intention-to-treat principle. RESULTS: We randomly allocated 299 workers. Workers in the low-intensity back school returned to work faster compared with usual care and the high-intensity back school, with hazard ratios of 1.4 (P = 0.06) and 1.3 (P = 0.09), respectively. The comparison between high-intensity back school and usual care resulted in a hazard ratio of 1.0 (P = 0.83). The median number of sick-leave days was 68, 75, and 85 in the low-intensity back school, usual care, and high-intensity back school, respectively. Beneficial effects on functional status and kinesiophobia were found at 3 months in favor of the low-intensity back school. No substantial differences on pain and perceived recovery were found between groups. CONCLUSIONS: The low-intensity back school was most effective in reducing work absence, functional disability, and kinesiophobia, and more workers in this group scored a higher perceived recovery during the 6-month follow-up.

Adult↗
PubMed2006

Limits to causal inference based on Mendelian randomization: a comparison with randomized controlled trials.

"Mendelian randomization" refers to the random assortment of genes transferred from parent to offspring at the time of gamete formation. This process has been compared to a randomized controlled trial of genetic variants. This could greatly aid observational epidemiology by potentially allowing an unbiased estimate of the effects of gene products on disease outcomes. However, studies utilizing Mendelian randomization to estimate effects of gene products on outcomes should be interpreted with caution. In this paper, the authors discuss some of the challenges facing epidemiologists in the analysis and interpretation of Mendelian randomization studies, particularly those that become apparent when the analogy with randomized controlled trials is closely examined. The authors conclude that Mendelian randomization is a powerful addition to etiologic research tools. However, care must be taken, because drawing valid causal inferences from its application depends upon more extensive assumptions than are required in randomized controlled trials.

Causality↗
PubMed1990

Role of pyloroplasty in the retrosternal stomach: results of a prospective, randomized, controlled trial.

A prospective, randomized, controlled trial comparing clinical outcome and emptying of a solid meal from the retrosternal stomach, with and without pyloroplasty is described. Forty consecutive patients with oesophageal cancer undergoing retrosternal gastric reconstruction of the oesophagus were studied. In 20 patients the pylorus was left intact (group 1) and 20 patients underwent an Aust pyloroplasty (group 2). Nine patients in group 1 suffered postoperative symptoms of gastric stasis compared with only one patient in group 2 (P = 0.0106). Three patients in group 1 died from aspiration pneumonia before discharge from hospital. A gastric emptying test was performed on 24 patients between 1 and 3 months after surgery. By this time, most survivors had recovered from symptoms attributed to gastric stasis and no significant difference in gastric emptying could be demonstrated between the two groups. Selection of patients, a wide range of emptying times and improvement in gastric emptying on follow-up may explain the lack of correlation between postoperative symptomatology and the gastric half-emptying times. A pyloroplasty is advised to prevent the potentially lethal effects of gastric stasis in the early postoperative period following retrosternal reconstruction of the oesophagus.

Adult↗
PubMed1995

Treatment of postmenopausal osteoporosis with slow-release sodium fluoride. Final report of a randomized controlled trial.

OBJECTIVE: To test whether slow-release sodium fluoride inhibits spinal fractures and is safe to use. DESIGN: Placebo-controlled randomized trial. INTERVENTIONS: Slow-release sodium fluoride, 25 mg twice daily, in four 14-month cycles (12 months receiving sodium fluoride followed by 2 months not receiving it) compared with placebo. Calcium citrate, 400 mg calcium twice daily, continuously in both groups. PATIENTS: 48 of 54 patients who received sodium fluoride and 51 of 56 patients who received placebo completed at least 1 year of the study. All patients had postmenopausal osteoporosis. RESULTS: Compared with the placebo group, the fluoride group had a lower individual vertebral fracture rate (0.064 +/- 0.182 per patient-year compared with 0.205 +/- 0.297 per patient-year; P = 0.002), a higher unadjusted fracture-free rate (85.4% compared with 56.9%; P = 0.001), and a greater survival estimate (relative risk, 0.3 [95% CI, 0.12 to 0.76]) for new fractures. The recurrent spinal fracture rate did not differ between the two groups. The fluoride group had a substantial increase in L2-L4 bone mass of 4% to 5% per year for 4 years, a mean increase in femoral neck bone density of 2.38% +/- 3.33% per year, and no change in radial shaft bone density. The frequency with which minor side effects and appendicular fractures occurred was similar in the two groups; no patients developed microfractures or gastric ulcers. CONCLUSION: Slow-release sodium fluoride and calcium citrate administered for 4 years inhibits new vertebral fractures (but not recurrent fractures), augments spinal and femoral neck bone mass, and is safe to use.

Aged↗
PubMed2004

Predictors of smoking cessation among African-Americans enrolled in a randomized controlled trial of bupropion.

OBJECTIVES: Identification of individual characteristics that predict successful smoking cessation treatment has been limited to studies with mostly white participants. This study identifies factors that predict successful quitting among African-Americans participating in a smoking cessation trial. METHODS: Twenty-one baseline variables were analyzed as potential predictors from a double-blind placebo-controlled, randomized trial that used bupropion SR for smoking cessation among 600 African-American smokers. Chi-square tests, two sample t tests, and multiple logistic regression procedures were employed to identify predictors of 7-day abstinence among the 535 participants who completed the 7-week medication phase. RESULTS: Univariate predictors of cessation were receiving bupropion (P < 0.0001), not smoking menthol cigarettes (P = 0.0062), smoking after 30 min of waking (P < 0.0001), older age (P = 0.0085), smoking fewer cigarettes per day (P = 0.0038), and lower cotinine levels (P = 0.0002). Logistic regression identified three significant independent predictors. Participants who received bupropion treatment were more than twice as likely to quit smoking at the end of treatment compared to participants who received placebo (OR = 2.62; 95% CI = 1.77-3.88, P < 0.0001), while smoking within 30 min of waking (OR = 0.40; 95% CI = 0.25-0.62, P < 0.0001) and higher salivary cotinine levels at baseline (OR = 0.799; 95% CI = 0.629-0.922, P < 0.0001) reduced the likelihood of quitting. CONCLUSIONS: This is the first report identifying predictors of smoking cessation among African-Americans participating in a clinical trial. Results indicate that, aside from bupropion treatment, various indicators of addiction were the strongest predictors. While this is similar to findings among white smokers, thresholds of addiction may need to be adjusted for African-American smoking patterns. Additional studies focused on diverse populations are needed to improve treatment approaches and to identify population-specific factors that are important for treatment-matching approaches.

Adult↗