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Results for “Randomized controlled trials”

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PubMed1997

Understanding and enhancing compliance with the second dose of hepatitis B vaccine: a cohort analysis and a randomized controlled trial.

OBJECTIVE: To determine the predictors and extent of noncompliance with a second dose of hepatitis B vaccine and the effectiveness of a compliance enhancement strategy. DESIGN: Cohort analysis and randomized clinical trial. SUBJECTS: A total of 256 consecutive adults attending a sexually transmitted diseases clinic from October 1992 to July 1993 who were seronegative for hepatitis B virus and agreed to receive hepatitis B vaccination. SETTING: Hamilton, Ont. INTERVENTION: Subjects were followed up for 4 months. Those who did not return for the second dose of vaccine by 6 weeks after the first (2 weeks overdue) were randomly assigned to the enhanced intervention group (telephone and mail reminders) or the regular intervention group (mail reminder only). Subjects were considered noncompliant if they did not return for the second dose by 4 months after the first. RESULTS: The risk of not returning for the second dose of vaccine within 4 months after the first was strongly and linearly associated with level of education (p = 0.004). The noncompliance rate among those with less than a grade 10 education was 50%, grade 10-13 education 34%, some college education 15% and some university education 9%. In the randomized controlled trial the enhanced intervention group had twice the compliance rate of the regular intervention group (48% v. 25%; p = 0.008). Subjects with no postsecondary education were highly responsive to the enhanced intervention (relative risk 2.1; p = 0.02) compared with those with a higher level of education (relative risk 1.0; p = 1.0). CONCLUSION: Hepatitis B vaccine recipients with lower educational levels are at increased risk of noncompliance with the second dose of vaccine but are highly responsive to telephone reminders.

Adult↗
PubMed2000

A randomized controlled trial of cognitive-behavioral therapy for persistent symptoms in schizophrenia resistant to medication.

BACKGROUND: Research evidence supports the efficacy of cognitive-behavioral therapy in the treatment of drug-refractory positive symptoms of schizophrenia. Although the cumulative evidence is strong, early controlled trials showed methodological limitations. METHODS: A randomized controlled design was used to compare the efficacy of manualized cognitive-behavioral therapy developed particularly for schizophrenia with that of a nonspecific befriending control intervention. Both interventions were delivered by 2 experienced nurses who received regular supervision. Patients were assessed by blind raters at baseline, after treatment (lasting up to 9 months), and at a 9-month follow-up evaluation. Patients continued to receive routine care throughout the study. An assessor blind to the patients' treatment groups rated the technical quality of audiotaped sessions chosen at random. Analysis was by intention to treat. RESULTS: Ninety patients received a mean of 19 individual treatment sessions over 9 months, with no significant between-group differences in treatment duration. Both interventions resulted in significant reductions in positive and negative symptoms and depression. At the 9-month follow-up evaluation, patients who had received cognitive therapy continued to improve, while those in the befriending group did not. These results were not attributable to changes in prescribed medication. CONCLUSION: Cognitive-behavioral therapy is effective in treating negative as well as positive symptoms in schizophrenia resistant to standard antipsychotic drugs, with its efficacy sustained over 9 months of follow-up.

Adult↗
PubMed2005

Use of multisystemic therapy to improve regimen adherence among adolescents with type 1 diabetes in chronic poor metabolic control: a randomized controlled trial.

OBJECTIVE: The aim of this study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, could improve adherence and metabolic control and decrease rates of hospital utilization among adolescents with chronically poorly controlled type 1 diabetes. RESEARCH DESIGN AND METHODS: A randomized controlled trial was conducted with 127 adolescents with type 1 diabetes and chronically poor metabolic control (HbA(1c) [A1C] > or =8% for the past year) who received their diabetes care in a children's hospital located in a major Midwestern city. Participants randomly assigned to MST received treatment for approximately 6 months. Data were collected at baseline and at 7 months posttest (i.e., treatment termination). Changes in A1C adherence, as measured by semistructured interviews and blood glucose meters and hospital admissions and emergency department visits, were assessed. RESULTS: In intent-to-treat analyses, participation in MST was associated with significant improvements in the frequency of blood glucose testing as assessed by blood glucose meter readings (F[1,125] = 16.75, P = 0.001) and 24-h recall interviews (F[1,125] = 6.70, P = 0.011). Participants in MST also had a decreasing number of inpatient admissions, whereas the number of inpatient admissions increased for control subjects (F[1,125] = 6.25, P = 0.014). Per protocol analyses replicated intent-to-treat analyses but also showed a significant improvement in metabolic control for adolescents receiving MST compared with control subjects (F[1,114] = 4.03, P = 0.047). CONCLUSIONS: Intensive, home-based psychotherapy improves the frequency of blood glucose testing and metabolic control and decreases inpatient admissions among adolescents with chronically poorly controlled type 1 diabetes.

Adolescent↗
PubMed2002

Pediatricians' attitudes toward randomized controlled trials involving children.

OBJECTIVE: To examine pediatricians' attitudes toward children's participation in randomized controlled trials (RCTs) and identify possible barriers to participation. STUDY DESIGN: Qualitative analysis of focus group discussions involving 16 pediatricians and 5 trainees from a pediatric teaching hospital in Australia. Doctors varied in occupation, experience, research activity, age, sex, ethnicity, and parenthood experience. A professional facilitator conducted the semistructured group discussions. The transcribed audiotapes were analyzed by theme linkage by using the constant comparative method. RESULTS: Pediatricians believed parents balanced perceived gains and risks when deciding about trial participation. They thought the child's condition, parents' health beliefs and personal attributes, and the doctors' beliefs and relationship with the investigators influenced parents' attitudes. Perceived gains included professional benefits for pediatricians, improved patient care, convenience for the families and themselves, and scientific advancement. Perceived risks included inconvenience, inadequate resources, and potential harms to the patient and doctor-patient relationship. Pediatricians with previous research experience were most knowledgeable about RCTs and perceived greatest gains from trial participation. Pediatricians' personal treatment preferences hindered trial support. CONCLUSIONS: This study suggests that children's participation in trials will be enhanced by increasing pediatricians' awareness of RCTs through education and involvement in trials and by improving the gains-risk balance.

Adult↗
PubMed1999

A randomized controlled trial assessing the benefit of humidified insufflation gas during laparoscopic surgery.

BACKGROUND: We conducted a randomized controlled trial during laparoscopic cholecystectomy to determine the extent of heat preservation and postoperative pain reduction using humidified carbon dioxide (CO2) gas insufflation instead of standard dry insufflation gas. METHODS: Forty consecutive patients were randomized. Twenty patients received humidified CO2, and 20 control patients received standard CO2 insufflation. A sample of 16 patients from each group was evaluated for postoperative pain levels. RESULTS: No adverse effects from the humidification of insufflated gas were observed. There was no significant difference in core body temperature between the two groups for this brief operation. Pain, as assessed by the Analogue Pain Score (APS) was significantly less for the group with humidified gas insufflation than for the control group at 6 h postoperatively as well as on the 1st, 2nd, and 3rd postoperative day and at follow-up 10 days after the operation. In the humidified group, the mean time to return to normal activities was significantly less-5.9 days, as compared to 10.9 days in the control group. CONCLUSIONS: The use of humidified insufflation gas reduces postoperative pain following laparoscopic cholecystectomy, but except for these relatively brief procedures, the heat-preserving effect of humidified gas insufflation is not significant.

Adult↗
PubMed1993

Cost-effectiveness of increased telephone contact for patients with osteoarthritis. A randomized, controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of telephone intervention for patients with osteoarthritis. METHODS: Randomized, controlled trial. RESULTS: The intervention did not significantly increase health care costs. The annual costs for a 1-unit improvement in physical functioning and in pain, as measured by the Arthritis Impact Measurement Scales, were $70.86 and $31.00, respectively. CONCLUSION: Telephone contact is a potentially cost-effective intervention in osteoarthritis.

Aged↗
PubMed2004

Efficacy of 904 nm gallium arsenide low level laser therapy in the management of chronic myofascial pain in the neck: a double-blind and randomize-controlled trial.

BACKGROUND AND OBJECTIVES: A prospective, double-blind, randomized, and controlled trial was conducted in patients with chronic myofascial pain syndrome (MPS) in the neck to evaluate the effects of infrared low level 904 nm Gallium-Arsenide (Ga-As) laser therapy (LLLT) on clinical and quality of life (QoL). STUDY DESIGN/PATIENTS AND METHODS: The study group consisted of 60 MPS patients. Patients were randomly assigned to two treatment groups: Group I (actual laser; 30 patients) and Group II (placebo laser; 30 patients). LLLT continued daily for 2 weeks except weekends. Follow-up measures were evaluated at baseline, 2, 3, and 12 weeks. All patients were evaluated with respect to pain at rest, pain at movement, number of trigger points (TP), the Neck Pain and Disability Visual Analog Scale (NPAD), Beck depression Inventory (BDI), and the Nottingham Health Profile (NHP). RESULTS: In active laser group, statistically significant improvements were detected in all outcome measures compared with baseline (P < 0.01) while in the placebo laser group, significant improvements were detected in only pain score at rest at the 1 week later of the end of treatment. The score for self-assessed improvement of pain was significantly different between the active and placebo laser groups (63 vs. 19%) (P < 0.01). CONCLUSION: This study revealed that short-period application of LLLT is effective in pain relief and in the improvement of functional ability and QoL in patients with MPS.

Adult↗
PubMed1990

Prospective randomized controlled trial of hepatic arterial embolization or infusion chemotherapy with 5-fluorouracil and degradable starch microspheres for colorectal liver metastases.

Survival benefit from hepatic artery embolization (HAE) or hepatic arterial infusion chemotherapy (HAI) in patients with unresectable colorectal liver metastases has not previously been assessed in a randomized controlled trial. Sixty-one patients were randomized, 20 to receive no treatment, 22 to receive HAE, and 19 to receive HAI with 5-fluorouracil and degradable starch microspheres. Both treatments were acceptable to the patients in terms of low treatment morbidity rate. Median survival from diagnosis of metastases was 9.6 months for controls, 8.7 months for the HAE group and 13.0 months in the HAI group. There was no apparent survival benefit for the HAE group. The increased survival in the HAI group was observed in all the subgroups analysed but failed to reach statistical significance. The greatest observed benefit was achieved in the subgroup with less than 50 per cent hepatic replacement with tumour at presentation (median survival from diagnosis 10.0 months for controls, 10.2 months for HAE and 23.6 months for HAI); 36 per cent of patients developed extrahepatic disease recurrence. No significant benefit has been shown from either HAE or HAI, but a more carefully selected group of patients with only low volume hepatic disease may benefit from HAI therapy.

Adolescent↗
PubMed1997

Pyloroplasty and pyloromyotomy in gastric replacement of the esophagus after esophagectomy: a randomized controlled trial.

BACKGROUND: Drainage methods for the gastric conduit after esophagectomy for carcinoma have been controversial. STUDY DESIGN: In a randomized controlled trial, 92 patients with esophageal carcinoma were randomized to have pyloroplasty or pyloromyotomy as a drainage procedure for the gastric conduit used for esophageal replacement. Only patients who underwent Lewis- Tanner operation or esophagogastrectomy and who had normal pyloroduodenal regions were included. RESULTS: The mean postoperative daily nasogastric output (SEM) were 164 mL (17 mL) in the pyloroplasty group and 179 mL (21 mL) in the pyloromyotomy group (p = not significant). No leakage occurred at the pyloroduodenal region in either group. In both groups, the anastomotic leakage rate was 2 percent, and the in-hospital mortality rate was 7 percent. No significant difference was found in postoperative morbidity and mortality. Gastric outlet obstruction developed in only two patients who underwent pyloromyotomy, and both required reexploration. One died of malignant obstruction of the gastric outlet and aspiration pneumonia. Scintigraphy performed 6 months after operation showed that the median half-life (interquartile range) for gastric emptying was 19 minutes (10 to 24 minutes) in the pyloromyotomy group and 8 minutes (5 to 19 minutes) in the pyloromyotomy group (p = 0.04). Long-term follow-up up to 5 years, however, did not reveal significant differences between the two groups in the type and quantity of food consumed. The incidence of other symptoms such as regurgitation, diarrhea, bile reflux, and dumping, also was no different. CONCLUSIONS: Pyloroplasty and pyloromyotomy were effective and safe drainage procedures for the gastric conduit used for esophageal replacement. The choice depends on the preference and experience of the surgeon. Most patients adapted to their new conduit with time.

Anastomosis, Surgical↗
PubMed1992

Effects of the multiple risk factor intervention trial smoking cessation program on pulmonary function. A randomized controlled trial.

To determine whether the decline in pulmonary function in smokers is modified by stop-smoking intervention, a randomized controlled study (the Multiple Risk Factor Intervention Trial) was done comparing participants in a special intervention group that included an intensive smoking cessation program with those assigned to usual care. The subjects were 6,347 middle-aged male smokers who had serial measurements of pulmonary function--principally the forced expiratory volume in 1 second (FEV1)--during 6 to 7 years of follow-up. No overall differences were detected in the rate of loss of FEV1 in the two groups. The use of beta-blockers, which had detrimental effects on FEV1, was significantly more common in the intervention group. Among nonusers of beta-blockers, heavy smokers lost FEV1 at a rate about 11 ml per year slower in the intervention group than in the control group (2P = .09) and ended the trial with an FEV1 about 90 ml higher (2P = .05). These results support the inference from observational studies that smoking cessation has a beneficial effect on pulmonary function in heavy smokers.

Adult↗
PubMed2005

Treatment of atopic dermatitis with herbal combination of Eleutherococcus, Achillea millefolium, and Lamium album has no advantage over placebo: a double blind, placebo-controlled, randomized trial.

OBJECTIVE: To test the efficacy of tri-herbal combination on atopic dermatitis in a randomized, placebo-controlled trial. METHODS: Forty-nine patients were included for 2 weeks of treatment. Patients were followed until week 8. RESULTS: The response to the real medication was significant in objective and subjective parameters. Patients maintained partial remission until the end of follow-up. The placebo-treated group had a similar response without a significant difference. CONCLUSIONS: Treatment with tri-herbal combination for atopic dermatitis does not differ from treatment with placebo.

Achillea↗
PubMed2002

Psychological treatments in schizophrenia: II. Meta-analyses of randomized controlled trials of social skills training and cognitive remediation.

BACKGROUND: Social skills training and cognitive remediation are psychological techniques with considerable face validity for the treatment of negative symptoms of schizophrenia and their consequences. This paper provides a meta-analytical review of these treatments. It includes an appreciable number of randomized controlled trials, using comparisons against both standard care and other active interventions. However, the assessment of particular outcomes sometimes had to be based on single studies. METHOD: A detailed search strategy was used to identify randomized controlled trials of social skills training and cognitive remediation, primarily employing electronic databases. Randomized controlled trials (RCTs) that met predefined criteria were then subjected to meta-analysis on a variety of outcome measures. RESULTS: There was no clear evidence for any benefits of social skills training on relapse rate, global adjustment, social functioning, quality of life or treatment compliance. Cognitive remediation had no benefit on attention, verbal memory, visual memory, planning, cognitive flexibility or mental state. CONCLUSIONS: Social skills training and cognitive remediation do not appear to confer reliable benefits for patients with schizophrenia and cannot be recommended for clinical practice.

Adolescent↗
PubMed2005

Efficacy of lifestyle education to prevent type 2 diabetes: a meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the efficacy of lifestyle education for preventing type 2 diabetes in individuals at high risk by meta-analysis of randomized controlled trials, as assessed by incidence and a reduced level of plasma glucose 2 h after a 75-g oral glucose load (2-h plasma glucose). RESEARCH DESIGN AND METHODS: Through an electronic search, 123 studies were identified. A literature search identified eight studies that met strict inclusion criterion of meta-analysis for 2-h plasma glucose and five studies for the incidence of diabetes. All were randomized controlled trials of > or =6 months with lifestyle education that included a dietary intervention. Subjects were adults diagnosed as being at high risk for type 2 diabetes. The difference in mean reduction of 2-h plasma glucose from baseline to the 1-year follow-up and relative risk (RR) of the incidence of diabetes in the lifestyle education group versus the control group were assessed. Overall estimates were calculated using a random-effects model. Those estimates were confirmed by several models, and the possibility of selection bias was examined using a funnel plot. RESULTS: Lifestyle education intervention reduced 2-h plasma glucose by 0.84 mmol/l (95% CI 0.39-1.29) compared with the control group. The 1-year incidence of diabetes was reduced by approximately 50% (RR 0.55, 95% CI 0.44-0.69) compared with the control group. Results were stable and little changed if data were analyzed by subgroups or other statistical models. Funnel plots revealed no selection bias. CONCLUSIONS: Lifestyle education was effective for reducing both 2-h plasma glucose and RR in high-risk individuals and may be a useful tool in preventing diabetes.

Adult↗
PubMedDate not supplied

Randomized controlled trials: do they have external validity for patients with multiple comorbidities?

PURPOSE: Many randomized controlled trials (RCTs) exclude patients who have multiple comorbidities. The aim of this study was to illustrate the prevalence of comorbidities among patients followed up in primary care who would have met the inclusion criteria of selected RCTs focusing on treatment of a particular condition. We used hypertension as an example of a particular chronic condition. METHODS: We used an existing database of 980 patients (660 women) that was representative of a population consulting primary care family doctors and that contained information about all chronic conditions. We randomly selected 5 RCTs that focused on patients with hypertension. The inclusion and exclusion criteria used in each of the 5 RCTs were applied (1 study at a time) to the patients in our database. The patients from our data set who met the inclusion criteria of a given RCT were considered eligible for that RCT. RESULTS: Of the patients from our data set who were eligible for each of the RCTs, 89% to 100% had multiple chronic conditions. The mean number of chronic conditions of patients eligible for each RCT ranged from 5.5 +/- 3.3 to 11.7 +/- 5.3. CONCLUSIONS: Results from this study suggest that RCTs targeting a chronic medical condition such as hypertension could find that, in a sample taken from family practice, most eligible patients have comorbid conditions. Whether these patients are sampled or excluded should be reported. Research results intended to be applied in medical practice should take the complex reality of effective treatment of these patients into consideration.

Adult↗
PubMed2005

[Randomized controlled trial on haiguiyuyang capsule in the treatment of duodenal ulcer].

OBJECTIVE: To assess the efficacy and safety of haiguiyuyang capsule in the treatment of duodenal ulcer (also diagnosed as weiwan pain and hanrecuoza syndrome according to the theory of TCM). METHODS: This is a multi-center clinical trial cooperatively conducted from May 2003 to March 2004 in accordance to the principle of informed consent, to the criteria for subject inclusion, exclusion, discontinuation, and to the relevant guidelines for evaluating the therapeutic effects of new TCM drugs. The design of double-blind, double-dummy and randomized controlled trial was adopted. 438 patients were randomized to the Test group (n = 330, treated with haiguiyuyang capsule) and to the Control group (n = 108, treated with ranitidine). The therapeutic course for both groups was 6 weeks. RESULTS: Regarding the efficacy in treating duodenal ulcer, in the Test group, the Marked Efficacy Rate was 66.37% and the Total Efficacy Rate was 82.13%; in the Control group, the Marked Efficacy Rate was 68.61% and the Total Efficacy Rate was 93.34%; there was no significant difference between the two groups (P>0.05). Regarding the efficacy in treating the syndrome diagnosed by TCM, in the Test group, the Marked Efficacy Rate was 70.31% and the Total Efficacy Rate was 93.34%; in the control group, the rates were 71.29% and 91.66% respectively; there was no significant difference between the two groups (P>0.05). Besides, regarding the abatement of distention and fullness of stomach after treatment, the haiguiyuyang capsule was better than ranitidine (P<0.05). No adverse side-effect was observed. CONCLUSION: The efficacy of haiguiyuyang capsule in treating duodenal ulcer is similar to that of ranitidine. No obvious adverse effect of it was observed in this trial.

Adolescent↗
PubMed1990

Aggressive or expectant management for patients with severe preeclampsia between 28-34 weeks' gestation: a randomized controlled trial.

Fifty-eight women with severe preeclampsia between 28-34 weeks' gestation qualified for a randomized controlled trial to establish whether elective delivery 48 hours after administration of betamethasone (aggressive-management group) or delivery later as indicated by maternal or fetal condition (expectant-management group) was more beneficial to maternal and fetal outcome. Twenty women who qualified were not randomized because they developed maternal or fetal indications necessitating delivery within 48 hours; these newborns developed most of the complications. Expectant management was not associated with an increase in maternal complications, but it significantly prolonged the gestational age (mean 7.1 days; P less than .05), reduced the number of neonates requiring ventilation (P less than .05), and reduced the number of neonatal complications (P less than .05).

Betamethasone↗
PubMed2006

A randomized controlled trial of implant-retained mandibular overdentures.

Evidence from randomized clinical trials of implant-retained overdentures is very limited at the present time. The aim of this study was to compare implant-retained mandibular overdentures and conventional complete dentures in a randomized controlled trial (RCT). Our a priori hypothesis was that implant-retained mandibular overdentures would be significantly better than conventional complete dentures. Edentulous patients (n = 118) were randomly allocated to either an Implant Group (n = 62) or a Denture Group (n = 56). Patients completed the Oral Health Impact Profile (OHIP) and a denture satisfaction scale pre-treatment and three months post-treatment. Upon completion of treatment, both groups reported improvement (p < 0.001, Wilcoxon Ranks Sum test) in oral-health-related quality of life and denture satisfaction. There were no significant post-treatment differences between the groups, but a treatment effect may be masked by application of "intention to treat" analysis. The OHIP change scores were significantly greater for patients receiving implants than for those who refused them.

Age Factors↗