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Results for “Randomized controlled trial”

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At least 199 records · Page 11Linked to original sources
PubMed2006

Progesterone for the prevention of preterm birth among women at increased risk: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: This study was undertaken to determine whether progestational agents, initiated in the second trimester of pregnancy, reduce the risk of delivery less than 37 weeks, among women at increased risk of spontaneous preterm birth. STUDY DESIGN: Medline, pre-Medline, EMBASE, and Cochrane Central Register of Controlled Trials were searched. Randomized controlled trials with less than 20% lost to follow-up were included. RESULTS: Three trials were eligible for inclusion. There was a significant reduction in risk of delivery less than 37 weeks with progestational agents (relative risk [95% CI] = 0.57 [0.36-0.90]). There was no significant effect on perinatal mortality or serious neonatal morbidity. CONCLUSION: Progestational agents, initiated in the second trimester of pregnancy, may reduce the risk of delivery less than 37 weeks' gestation, among women at increased risk of spontaneous preterm birth, but the effect on neonatal outcome is uncertain. Larger randomized controlled trials are required to determine whether this treatment reduces perinatal mortality or serious neonatal morbidity.

Drug Administration Schedule↗
PubMed2004

Effects of taping on pain and function in patellofemoral pain syndrome: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To investigate the effectiveness of daily patella taping and exercise on pain and function in individuals with patellofemoral pain syndrome. BACKGROUND: Patella taping and muscle-strengthening programs are commonly used to treat patellofemoral pain syndrome. There is, however, little evidence for the effectiveness of these approaches. METHODS AND MEASURES: Twenty-four men and 6 women aged 17 to 25 years (mean +/- SD, 18.7 +/- 1.2 years) participated in the study. Subjects were randomly and exclusively assigned to 1 of 3 treatment groups: patella taping combined with a standardized exercise program, placebo patella taping and exercise program, or exercise program alone (n = 10 in each group). Taping was applied and exercises performed on a daily basis for 4 weeks. Outcome measures were visual analog scales for pain and the functional index questionnaire, recorded at weekly intervals by a therapist who was blinded to group allocation. RESULTS: Separate mixed-model ANOVAs, with repeated measures on time, indicated statistically significant improvements in pain and function over time for all groups (P<.01) and also significant differences between groups for all measures (P<.01). Separate independent samples t tests showed that the group receiving taping and exercises had better pain and function scores following treatment than the placebo taping-and-exercise group and the exercise-alone group. There were no significant differences between the placebo taping-and-exercise group and exercise-alone group at any time point. CONCLUSIONS: These findings indicate that over a period of 4 weeks a combination of daily patella taping and exercises was successful in improving pain and function in individuals with patellofemoral pain syndrome. The combination of patella taping and exercise was superior to the use of exercise alone.

Adolescent↗
PubMed2003

The effects of exercise and social support on mothers reporting depressive symptoms: a pilot randomized controlled trial.

A 12-week randomized controlled trial was conducted (n = 20) investigating the effects of a multi-intervention programme of exercise and social support compared to a control group. Both groups had given birth in the past 12 months and were experiencing depressive symptomatology. Pretest data of physical fitness and structured questionnaires were compared to post-test data. The results from the study showed that mothers who were in the multi-intervention group improved their fitness levels and depressive symptomatology significantly more than the control group. However, there were no significant changes to either group's social support levels. These results are encouraging and suggest that a pram push walking intervention might be an effective treatment for mothers suffering postnatal distress.

Adult↗
PubMed2002

Treatment of chronic lower back pain with lumbar extension and whole-body vibration exercise: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial with a 6-month follow-up period was conducted. OBJECTIVE: To compare lumbar extension exercise and whole-body vibration exercise for chronic lower back pain. SUMMARY OF BACKGROUND DATA: Chronic lower back pain involves muscular as well as connective and neural systems. Different types of physiotherapy are applied for its treatment. Industrial vibration is regarded as a risk factor. Recently, vibration exercise has been developed as a new type of physiotherapy. It is thought to activate muscles via reflexes. METHODS: In this study, 60 patients with chronic lower back pain devoid of "specific" spine diseases, who had a mean age of 51.7 years and a pain history of 13.1 years, practiced either isodynamic lumbar extension or vibration exercise for 3 months. Outcome measures were lumbar extension torque, pain sensation (visual analog scale), and pain-related disability (pain disability index). RESULTS: A significant and comparable reduction in pain sensation and pain-related disability was observed in both groups. Lumbar extension torque increased significantly in the vibration exercise group (30.1 Nm/kg), but significantly more in the lumbar extension group (+59.2 Nm/kg; SEM 10.2; P < 0.05). No correlation was found between gain in lumbar torque and pain relief or pain-related disability (P > 0.2). CONCLUSIONS: The current data indicate that poor lumbar muscle force probably is not the exclusive cause of chronic lower back pain. Different types of exercise therapy tend to yield comparable results. Interestingly, well-controlled vibration may be the cure rather than the cause of lower back pain.

Chronic Disease↗
PubMed2001

Growth and development in preterm infants fed long-chain polyunsaturated fatty acids: a prospective, randomized controlled trial.

OBJECTIVES: A randomized, masked, controlled trial was conducted to assess effects of supplementing premature infant formulas with oils containing the long-chain polyunsaturated fatty acids, arachidonic acid (AA; 20:4 n6), and docosahexaenoic acid (DHA; 22:6 n3) on growth, visual acuity, and multiple indices of development. METHODS: Infants (N = 470) with birth weights 750 to 1800 g were assigned within 72 hours of the first enteral feeding to 1 of 3 formula groups with or without long-chain polyunsaturated fatty acids: 1) control (N = 144), 2) AA+DHA from fish/fungal oil (N = 140), and 3) AA+DHA from egg-derived triglyceride (egg-TG)/fish oil (N = 143). Infants were fed human milk and/or Similac Special Care with or without 0.42% AA and 0.26% DHA to term corrected age (CA), then fed human milk or NeoSure with or without 0.42% AA and 0.16% DHA to 12 months' CA. Infants fed exclusively human milk to term CA (EHM-T; N = 43) served as a reference. RESULTS: Visual acuity measured by acuity cards at 2, 4, and 6 months' CA was not different among groups. Visual acuity measured by swept-parameter visual-evoked potentials in a subgroup from 3 sites (45 control, 50 AA+DHA [fish/fungal]; 39 AA+DHA [egg-TG/fish]; and 23 EHM-T) was better in both the AA+DHA (fish/fungal; least square [LS] means [cycle/degree] +/- standard error [SE; octaves] 11.4 +/- 0.1) and AA+DHA (egg-TG/fish; 12.5 +/- 0.1) than control (8.4 +/- 0.1) and closer to that of the EHM-T group (16.0 +/- 0.2) at 6 months' CA. Visual acuity improved from 4 to 6 months' CA in all but the control group. Scores on the Fagan test of novelty preference were greater in AA+DHA (egg-TG/fish; LS means +/- SE, 59.4 +/- 7.7) than AA+DHA (fish/fungal; 57.0 +/- 7.5) and control (57.5 +/- 7.4) at 6 months' CA, but not at 9 months' CA. There were no differences in the Bayley Mental Development Index at 12 months' CA. However, the Bayley motor development index was higher for AA+DHA (fish/fungal; LS means +/- SE, 90.6 +/- 4.4) than control (81.8 +/- 4.3) for infants </=1250 g. When Spanish-speaking infants and twins were excluded from the analyses, the MacArthur Communicative Development Inventory revealed that control infants (LS means +/- SE, 94.1 +/- 2.9) had lower vocabulary comprehension at 14 months' CA than AA+DHA (fish/fungal) infants (100.6 +/- 2.9) or AA+DHA (egg-TG/fish) infants (102.2 +/- 2.8). There were no consistent differences in weight, length, head circumference, or anthropometric gains. CONCLUSION: These results showed a benefit of supplementing formulas for premature infants with AA and DHA from either a fish/fungal or an egg-TG/fish source from the time of first enteral feeding to 12 months' CA.

Apgar Score↗
PubMed2005

Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial.

OBJECTIVE: This was a randomized controlled trial to evaluate the safety of uterine artery embolization (UAE) compared with hysterectomy. STUDY DESIGN: Twenty-eight Dutch hospitals recruited 177 patients with symptomatic uterine fibroids and menorrhagia who were eligible for hysterectomy. Patients were randomized to UAE (n = 88) or hysterectomy (n = 89). In this paper we evaluate the peri- and postprocedural complications, length of hospital stay, unscheduled visits, and readmission rates up to 6 weeks' post-intervention. Analysis was by intention to treat. RESULTS: Bilateral UAE failure occurred in 4 patients (4.9%). Major complications occurred in 4.9% (UAE) and 2.7% (hysterectomy) of cases (P = .68). The minor complication rate from discharge until 6 weeks after was significantly higher in the UAE group than in the hysterectomy group (58.0% vs 40.0%; RR 1.45 [1.04-2.02]; P = .024). UAE patients were more often readmitted (11.1% vs 0%; P = .003). Total length of hospital stay was significantly shorter in UAE patients (mean [SD]: 2.5 [2.7] vs 5.1 [1.3], P < .001). CONCLUSION: UAE is a procedure similar to hysterectomy with a low major complication rate and with a reduced length of hospital stay. Higher readmission rates after UAE stress the need for careful postprocedural follow-up.

Adult↗
PubMed1999

Effects of mailed advice on stress reduction among employees in Japan: a randomized controlled trial.

We conducted a randomized controlled trial (RCT) to examine the effects of mailed advice on reducing psychological distress, blood pressure, serum lipids, and sick leave of workers employed in a manufacturing plant in Japan. Those who indicated higher psychological distress (defined as having GHQ scores of three or greater) in the baseline questionnaire survey (n = 226) were randomly assigned to an intervention group or a control group. Individualized letters were sent to the subjects of the intervention group, informing them of their stress levels and recommending an improvement in daily habits and other behaviors to reduce stress. Eighty-one and 77 subjects in the intervention and control groups, respectively, responded to the one-year follow-up survey. No significant intervention effect was observed for the GHQ scores, blood pressure, serum lipids, or sick leave (p > 0.05). The intervention effect was marginally significant for changes in regular breakfasts and daily alcohol consumption (p = 0.09). The intervention effect was marginally significant for the GHQ scores among those who initially did not eat breakfast regularly (p = 0.06). The study suggests that only sending mailed advice is not an effective measure for worksite stress reduction. Mailed advice which focuses on a particular subgroup (e.g., those who do not eat breakfast regularly) may be more effective.

Absenteeism↗
PubMed1998

Interferon-alpha for prophylaxis of recurrent viral hepatitis C in liver transplant recipients: a prospective, randomized, controlled trial.

BACKGROUND: In a randomized, controlled trial, we sought to determine whether prophylaxis with interferon-alpha for 6 months had an impact on rate, severity, and timing of onset of recurrent hepatitis C virus (HCV) hepatitis in liver transplant recipients and to assess whether interferon use was associated with rejection in liver transplant recipients. METHODS: Twenty-four consecutive liver transplant recipients with HCV were randomized after transplantation to receive either interferon-alpha (3 million U three times weekly) for 6 months or no prophylaxis; median follow-up was 874 days. RESULTS: Recurrent HCV hepatitis (histopathologically proven) developed in 50% (6 of 12) of the interferon-alpha patients versus 42% (5 of 12) of the control patients (P=NS). Severity of recurrence (as assessed by Knodell score on liver biopsies) also did not differ between the two groups (mean 4.0 for interferon-alpha patients versus 3.5 for control patients, P=NS). Interferon-alpha, however, significantly delayed the timing of occurrence of HCV hepatitis; recurrent HCV hepatitis developed a median of 408 days after transplant in the interferon-alpha group versus 193 days in the control group (P=0.05). No difference in graft or patient survival was demonstrated in the two groups. Rejection episodes, treated with corticosteroids, occurred in 50% (6 of 12) of patients in the interferon-alpha group versus 42% (5 of 12) in the control group (P=NS). Corticosteroid resistant rejection (requiring OKT3) occurred in only one study patient (in the control group). CONCLUSIONS: Interferon-alpha in liver transplant recipients for 6 months delayed the occurrence of HCV hepatitis, but did not decrease the incidence nor the severity of HCV hepatitis after transplantation. Interferon-alpha use was not associated with a higher incidence of rejection compared with the control patients.

Adult↗
PubMed2026

Effects of an internet-based combined exercise and cognitive-behavioral therapy intervention on endocannabinoid system biomarkers and physical fitness in adults with mild-to-moderate depression: a SONRIE randomized controlled trial.

BACKGROUND: This SONRIE randomized controlled trial (NCT05849792) examined the effects of a 12-week combined physical exercise and internet-based cognitive-behavioral therapy (iCBT) intervention on endocannabinoid system (ES) biomarkers and physical fitness in adults with mild-to-moderate depression. METHODS: Eighty adults were randomly assigned 1:1 to an intervention (IG) or control (CG) group. Outcomes included nine ES biomarkers (2-arachidonoylglycerol, 2-AG; anandamide, AEA; seven analogues) and physical fitness, including cardiorespiratory fitness (CRF; 6-minute walking test) and muscular strength. Measurements were taken at baseline, post-intervention and 8-week follow-up. Primary analysis performed 2&#x2009;&#xd7;&#x2009;3 repeated-measures ANOVA on completers; mixed-effects intention-to-treat model as sensitivity analysis. RESULTS: No significant time &#xd7; group interaction was detected for any ES biomarker, including 2-AG (F(2,88)&#x2009;=&#x2009;0.17, p&#x2009;=&#x2009;0.844) and AEA (F(2,88)&#x2009;=&#x2009;1.20, p&#x2009;=&#x2009;0.306); both groups showed comparable within-group decreases in 2-AG, 2-LG and 2-OG. The intervention significantly improved CRF [between-group difference&#x2009;+&#x2009;81.6&#xa0;m at 12 weeks (F(2,78)&#x2009;=&#x2009;7.88, p&#x2009;=&#x2009;0.001)], exceeding the established minimal clinically important difference. None of the exploratory muscular fitness outcomes reached statistical significance; the arm curl test showed a borderline non-significant interaction (F(2,78)&#x2009;=&#x2009;2.83, p&#x2009;=&#x2009;0.065). CONCLUSION: A 12-week internet-based combined exercise and iCBT intervention significantly improved CRF in adults with mild-to-moderate depression. We did not find evidence of an intervention-specific effect on plasma ES biomarkers. These findings support the inclusion of internet-delivered exercise and psychological interventions in comprehensive treatment strategies for depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT05849792 (registered 6 May 2023).

Humans↗
PubMed2001

Additional beneficial effects of alendronate in growth hormone (GH)-deficient adults with osteoporosis receiving long-term recombinant human GH replacement therapy: a randomized controlled trial.

We conducted a randomized controlled trial in osteoporotic adult GH-deficient (GHD) patients to assess whether additional treatment with a bisphosphonate would further favorably influence parameters of bone turnover and bone mineral density measurements (BMD). All patients were receiving stable recombinant human (rhGH) replacement therapy for 4 yr at the start of the study. Eighteen GHD patients with osteoporosis were randomized to continue their rhGH maintenance dose or to receive combination therapy with rhGH and alendronate for 12 months. All patients were calcium and vitamin replete, and there were no changes in calcium, vitamin D, or hormone replacement therapy for the duration of the study. At baseline there were no significant differences between the alendronate and the control group in parameters of bone turnover, BMD, or prevalence of vertebral fractures. Childhood-onset and adult-onset GHD were equally distributed between the groups, with no statistical differences in age and gender or other parameters between groups. Mean serum osteocalcin, serum bone-specific alkaline phosphatase, and urinary N-telopeptide/creatinine ratio were within the normal range at the start of the study. In the alendronate group all measured parameters of bone turnover, i.e. bone-specific alkaline phosphatase, osteocalcin, and urinary N-telopeptide/creatinine ratio, significantly decreased after 6 months, with no further decrease thereafter. No changes were observed in the control group. In the alendronate-treated patients serum bone-specific alkaline phosphatase decreased from 10.9 +/- 0.9 to 6.8 +/- 0.7 microg/L at 6 months (P < 0.001), serum osteocalcin decreased from 3.9 +/- 0.4 to 1.7 +/- 0.3 microg/L (P < 0.001), and the urinary N-telopeptide/creatinine ratio decreased from 27.3 +/- 7.0 to 6.4 +/- 0.8 nmol/mmol (P = 0.01). In this group, lumbar spine BMD significantly increased from baseline by 3.4% at 6 months (P = 0.001) and by 4.4% at 12 months (P < 0.001) of treatment, with no further significant increase between 6 and 12 months (P = 0.217). No changes in lumbar spine BMD were observed in the control group. There were no significant changes in femoral neck BMD in either group for the duration of the study. No incident vertebral or peripheral fractures were documented in either group at the end of the study. In summary, this is the first report indicating that treatment with alendronate was able to significantly increase BMD at the lumbar spine in GHD patients with osteoporosis receiving stable rhGH replacement for 4 yr. This increase was significantly greater in alendronate-treated patients than in patients maintained on rhGH. The increase in lumbar spine BMD in the alendronate-treated patients was associated with a decrease in the measured markers of bone turnover, whereas these markers did not change further in the patients maintained on rhGH. This controlled study suggests that additional treatment with alendronate in GHD patients with osteoporosis receiving stable rhGH replacement therapy is effective in increasing BMD at the lumbar spine. Further investigation is required to assess whether rhGH replacement alone or combined treatment with rhGH and alendronate is able to reduce the increased fracture risk associated with GHD.

Adult↗
PubMed2001

Comparison between closed reduction with percutaneous pinning and open reduction with pinning in children with closed totally displaced supracondylar humeral fractures: a randomized controlled trial.

This was a randomized controlled trial of 28 children 1 year to 12 years of age with closed totally displaced supracondylar humeral fracture. The purpose of the study was to compare closed reduction and pinning (group A) and open reduction and pinning (group B). Each group consisted of 14 children. The general characteristics of both groups (age, sex side, displacement, nerve injury preoperatively) were statistically the same (P > 0.05). All cases healed with good alignment without cubitus varus, without infection and with a good range of motion except for one. The mean +/- standard deviation of the Baumann's angle difference between the injured and uninjured side were 2.32 +/- 1.6 degrees in group A (range, 0-6.5 degrees) and 2.45 +/- 1.8 degrees in group B (range, 0-6.5 degrees). This difference was statistically not significant (P = 0.8). By Flynn criteria, group A had good to excellent results in 100%, and group B had good to excellent results in 93% and fair in 7%. This difference was not statistically significant (P = 1). The satisfaction score (0-10) was significantly higher in group A for both parents' and evaluator's (blinded to treatment) perspective (P = 0.017 and 0.019, respectively). The author concludes that both treatments gave good results. Closed reduction should be performed first and, if it fails, then open reduction can be performed. This will produce good results in the hands of an experienced surgeon.

Child↗
PubMedDate not supplied

Octreotide for arrest of peptic ulcer hemorrhage--a prospective, randomized controlled trial.

BACKGROUND/AIMS: A prospective, randomized controlled trial was performed over a 10-month period to evaluate the hemostatic effects of octreotide and ranitidine in 84 patients with active peptic ulcer bleeding or nonbleeding visible vessels at the ulcer bases. PATIENTS AND METHODS: Forty-two patients received octreotide 100 mcg bolus intravenously followed by 25 mcg/h intravenously for 1.4 +/- 0.6 days (mean +/- SD). The other 42 patients received ranitidine 100 mg intravenously every 12 h. The two groups were matched for sex, age, location of bleeders, endoscopic findings, shock, and initial hemoglobin. RESULTS: Hemostasis was obtained in 35 (83.3%) of the octreotide group, and 23 (54.8%) of the control group (p<0.01). Volume of blood transfused, numbers of patients receiving aggressive management (endoscopic hemostasis or operation), and hospital stay were significantly less in the octreotide group as compared with those of the controls (p<0.05, p<0.05 and p<0.001, respectively). No obvious side effect was found in the octreotide group. CONCLUSION: We suggest that octreotide is a safe and effective drug in arresting peptic ulcer hemorrhage. It may be used as the first-line therapy for a patient with massive peptic ulcer hemorrhage before he is transferred to a medical center.

Anti-Ulcer Agents↗
PubMed1993

Strontium-89 as an adjuvant to external beam radiation improves pain relief and delays disease progression in advanced prostate cancer: results of a randomized controlled trial.

In a multicenter, randomized controlled trial involving 126 patients with endocrine-resistant advanced prostate cancer, all of whom received external beam radiotherapy, additional treatment with a single injected dose of 400 MBq strontium-89 (Metastron) significantly improved overall pain control. Adjuvant therapy with strontium-89 also significantly reduced analgesia requirements compared with placebo and delayed disease progression, as indicated by the requirement for further external beam radiotherapy. On certain measures, patients receiving strontium-89 also showed enhanced quality of life. Accompanying these changes, levels of prostate tumor markers were significantly reduced by strontium-89 treatment. The benefits resulting from adjuvant strontium therapy were associated with tolerable hematologic toxicity. The addition of strontium-89 to external beam radiation had no effect on survival. However, it has clear implications for improved palliation in advanced prostate cancer and may also impact positively on treatment costs.

Aged↗
PubMed1996

Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology.

OBJECTIVES: Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references. STUDY DESIGN: We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria. RESULTS: Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.

Bibliographies as Topic↗
PubMed2004

Dipyridamole for preventing recurrent ischemic stroke and other vascular events: a meta-analysis of individual patient data from randomized controlled trials.

BACKGROUND AND PURPOSE: Results from randomized controlled trials of dipyridamole, given with or without aspirin, for secondary prevention after ischemic stroke or transient ischemic attack (TIA) have given conflicting results. We performed a meta-analysis using individual patient data from relevant randomized controlled trials. METHODS: Randomized controlled trials involving dipyridamole in patients with previous ischemic stroke or TIA were sought from searches of the Cochrane Library, other electronic databases, references lists, earlier reviews, and contact with the manufacturer of dipyridamole. Individual patient data were merged from 5 of 7 relevant trials involving 11 459 patients. Results were adjusted for age, gender, qualifying event, and history of previous hypertension. RESULTS: Recurrent stroke was reduced by dipyridamole as compared with control (OR, 0.82; 95% CI, 0.68 to 1.00), and by combined aspirin and dipyridamole versus aspirin alone (OR, 0.78; 95% CI, 0.65 to 0.93), dipyridamole alone (OR, 0.74; 95% CI, 0.60 to 0.90), or control (OR, 0.61; 95% CI, 0.51 to 0.71). The point estimates obtained for the comparisons of aspirin and dipyridamole versus control (OR, 0.63; significant) or versus aspirin (OR, 0.88; nonsignificant) were similar if the data from the largest trial, ESPS II (which provided 57% of data), were excluded. Similar findings were observed for nonfatal stroke. The combination of aspirin and dipyridamole also significantly reduced the composite outcome of nonfatal stroke, nonfatal myocardial infarction, and vascular death as compared with aspirin alone (OR, 0.84; 95% CI, 0.72 to 0.97), dipyridamole alone (OR, 0.76; 95% CI, 0.64 to 0.90), or control (OR, 0.66; 95% CI, 0.57 to 0.75). Vascular death was not altered in any group. CONCLUSIONS: Dipyridamole, given alone or with aspirin, reduces stroke recurrence in patients with previous ischemic cerebrovascular disease. The combination of aspirin and dipyridamole also reduces the composite of nonfatal stroke, nonfatal myocardial infarction, and vascular death as compared with aspirin alone.

Aspirin↗
PubMed2000

Coordination of primary health care for back pain. A randomized controlled trial.

STUDY DESIGN: A randomized controlled trial comparing usual care with a program for the coordination of primary health care (CORE) for the treatment of subacute low-back pain patients. OBJECTIVES: To measure the effectiveness of the CORE program as a mean for implementing clinical practice guidelines for low-back pain in an urban community. SUMMARY OF BACKGROUND DATA: Clinical practice guidelines have been developed for primary care physicians and patients on the clinical management of low-back pain. The implementation of the guidelines in a large community is difficult with the multiplicity of medical and nonmedical back care providers and products. The CORE program was designed to make the guidelines fit in this complex environment. METHODS: One hundred ten workers compensated for low-back pain for 4 to 8 weeks in metropolitan Montreal were randomized in two groups: usual care (N = 56) and the CORE program (N = 54). Coordination of primary health care was performed by two primary care physicians and a nurse in liaison with the treating physicians, and included a complete examination, recommendations for the clinical management, and support to carry out the recommendations. All workers were followed for 6 months. Back pain and functional status were assessed at baseline, 3 months, and 6 months. RESULTS: In the 6-month follow-up, the CORE group returned to work 6.6 days (standard error = 8.9) quicker than the control group, a difference that was not statistically significant. However, the CORE group showed a sustained improvement in pain and functional status with two-fold differences at the end of the 6 months of follow-up. This represented nine points on the Oswestry scale (P = 0.02) and 12 points on the Quebec Back Pain Disability Scale (P = 0.01). The CORE group also used three times less specialized imaging tests of the spine at 3 months (P < 0.01) and exercised twice as much at 6 months (P < 0.05) than the controls. CONCLUSIONS: The therapeutic results for workers with low-back pain could be improved by implementing the clinical practice guidelines with primary care physicians in a large community, without delaying the return to work. The CORE intervention for back pain patients is highly relevant to primary care practice. It is simple in its application, flexible to accommodate physicians' and- patients' preferences in health care, and it is effective on patients' clinical outcome.

Adult↗