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Results for “Randomized trial”

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PubMed1989

Etoposide combined with cyclophosphamide plus vincristine compared with doxorubicin plus cyclophosphamide plus vincristine and with high-dose cyclophosphamide plus vincristine in the treatment of small-cell carcinoma of the lung: a randomized trial of the Bristol Lung Cancer Study Group.

A total of 353 patients with previously untreated small-cell lung cancer (SCLC) were accrued in this multicenter trial. Patients were randomly assigned to receive one of the following three regimens: cyclophosphamide 1,000 mg/m2 intravenously (IV) day 1, vincristine 1.4 mg/m2 IV day 1, and etoposide 50 mg/m2 IV day 1, followed by etoposide 100 mg/m2/day orally days 2 through 5 (CEV); cyclophosphamide 1,000 mg/m2 IV day 1, vincristine 1.4 mg/m2 IV day 1, and doxorubicin 50 mg/m2 IV day 1 (CAV); cyclophosphamide 2,000 mg/m2 day 1 and vincristine 1.4 mg/m2 IV day 1 (CV). Cycles were repeated every 3 weeks. Treatment groups were comparable with respect to extent of disease, age, sex, performance status, and metastatic sites. No significant differences in response rates, response duration, or survival could be detected in limited disease, although there appeared to be a trend favoring CEV. Among extensive-disease patients, response duration on the CEV regimen was longer than on the CV regimen or the CAV program (P less than .001). The superiority of the CEV regimen was also demonstrated in the survival analysis in which differences attained statistical significance (P = .01). In this group the median survival was increased from 29 weeks on CV to 31 weeks on CAV and 39 weeks on CEV. Myelosuppression was the most frequent toxicity. It was more severe with CV than CEV or CAV. Most nonhematologic side effects were comparable among the three treatment groups. However, the high doses of cyclophosphamide in the CV regimen produced a higher incidence of hemorrhagic cystitis than in the CEV or CAV programs (P less than .001). Cardiotoxicity only occurred in the CAV group (P = .05). The addition of etoposide to the CV regimen resulted in significantly longer response duration and survival without increased toxicity. Similarly, the substitution of etoposide for the doxorubicin in the CAV regimen was associated with prolonged survival and reduced cardiotoxicity.

Adult↗

PubMed2005

Results of two randomized trials evaluating adjuvant anthracycline-based chemotherapy in 1146 patients with early breast cancer.

Two randomized trials evaluated the effect of 6 courses of anthracycline-based chemotherapy in early breast cancer. A total of 1146 patients were included: 311 high-risk node-negative premenopausal patients and 835 high-risk node-negative or node-positive postmenopausal patients. Patients were randomized after surgery to receive either no chemotherapy (control group) or 6 courses of anthracycline-based chemotherapy (CT group). Postmenopausal patients received adjuvant tamoxifen for at least two years. Radiotherapy was delivered after completion of chemotherapy in the CT group. The 10-year disease-free survival (DFS) rates were 60% in the control group and 65% in the CT group (log-rank test, p = 0.01). The 10-year distant metastasis rates were 28% and 23% (p = 0.02), and the 10-year local recurrence rates were 12% and 10%, respectively (p = 0.24). Chemotherapy was significantly less effective in post-menopausal patients with estrogen receptor-positive tumors. Adjuvant anthracycline-based chemotherapy yielded a significant benefit for DFS by lowering the risk of distant metastases. After up to 10 years of follow-up, deferring radiotherapy after chemotherapy did not compromise local control.

Adult↗

PubMed2004

Homocysteine and cardiovascular disease: biological mechanisms, observational epidemiology, and the need for randomized trials.

Basic research indicates that homocysteine causes endothelial dysfunction and damage, accelerates thrombin formation, inhibits native thrombolysis, promotes lipid peroxidation through free radical formation, and induces vascular smooth muscle proliferation and monocyte chemotaxis. Most, but not all, observational epidemiological studies indicate that individuals with higher homocysteine levels have increased risks of cardiovascular disease. The magnitude ranges from approximately 20% in prospective studies to approximately 80% in retrospective case-control studies. In all observational epidemiological studies, however, the amount of uncontrolled and uncontrollable confounding is as large as the postulated small to moderate effect size. Thus, the totality of evidence should include randomized trials of sufficient sample size and duration with clinical end points. Folic acid reduces levels of homocysteine, but at present, despite several plausible biological mechanisms and a large body of observational epidemiological data, it is unclear whether supplementation will reduce risks of cardiovascular disease. It is also unclear whether any benefit of folic acid is attributable to lowering homocysteine levels. The current evidence is necessary, but not sufficient to judge causality. Such judgments await the availability of data from large-scale randomized trials. The availability of such data would permit rational clinical decision-making for individual patients and policy decisions for the health of the general public.

Cardiovascular Diseases↗

PubMed1983

Parenteral and oral antibiotics in elective colon and rectal surgery. A prospective, randomized trial.

Our evaluation consisted of a prospective, randomized clinical trial in a homogenous group of 241 patients undergoing elective colon and rectal resections. A significant decrease in wound infection was found in the patients who received intravenous cefoxitin in conjunction with standard bowel preparation. The infection rate correlated with the type of resection; rectal resections had the highest rate in each study group, but parenteral prophylaxis produced a significantly lower wound infection rate. E. coli and Staph. aureus were the most common bacterial isolates in both groups. B. fragilis was recovered in only two Group A patients, which most likely reflects the exceedingly low recovery rate of anaerobic bacteria in our laboratory. Urinary cultures were positive in a large number of patients and reflect the standard use of Foley catheterization in all patients who undergo resection of the colon or rectum. These data indicate that perioperative prophylactic administration of cefoxitin reduces the wound sepsis rate when combined with oral antibiotics and mechanical bowel preparation in patients undergoing resection of the colon or rectum.

Administration, Oral↗

PubMed2003

Radiotherapy does not compensate for positive resection margins in rectal cancer patients: report of a multicenter randomized trial.

PURPOSE: Circumferential resection margin (CRM) involvement is a prognostic factor for local recurrence in rectal cancer. In a randomized trial comparing preoperative radiotherapy (5 x 5 Gy), followed by total mesorectal excision (TME) with TME alone, we demonstrated the beneficial effect of short-term preoperative radiotherapy on local recurrences. Here we evaluate the effect of radiotherapy on local recurrence rates in patients with different CRM involvements. METHODS AND MATERIALS: Circumferential margins were defined as positive (< or =1 mm), narrow (1.1-2 mm), or wide (>2 mm). Postoperative radiotherapy was mandatory for surgery-only patients with a positive CRM, but was not always administered and enabled us to compare local recurrence rates for patients with or without postoperative radiotherapy. Furthermore, the effect of preoperative radiotherapy was assessed in the different margin groups. RESULTS: Of 120 patients in the surgery-only group with a positive CRM, 47% received postoperative radiotherapy. There was no difference in the local recurrence rate between the irradiated and nonirradiated patients (17.3% vs. 15.7%, p = 0.98). Preoperative radiotherapy was effective in patients with a narrow CRM (0% vs. 14.9%, p = 0.02) or wide CRM (0.9 vs. 5.8%, p < 0.0001), but not in patients with positive margins (9.3% vs. 16.4%, p = 0.08). CONCLUSION: Preoperative hypofractionated radiotherapy has a beneficial effect in patients with wide or narrow resection margins, but cannot compensate for microscopically irradical resections resulting in positive margins.

Adenocarcinoma↗

PubMed2004

Randomized trial of cefepime monotherapy or cefepime in combination with amikacin as empirical therapy for febrile neutropenia.

A multicenter open randomized trial was conducted to compare cefepime monotherapy with cefepime/amikacin combination (dual) therapy in treating febrile neutropenic patients with hematologic disorders. Among the 189 evaluable patients, 5.8% had microbiologically and 10.6% had clinically documented infections. Excellent response was seen in 32.6% and 45.7% of monotherapy and dual therapy recipients, respectively, at day 3 (P=.065). At day 3, patients with neutrophil counts of <500/ mu L receiving dual therapy had a better response than did those receiving monotherapy (45% vs. 27.6%; P=.024). The same was true for patients with leukemia. Adverse events were minimal, and early death was observed in 7 patients in the dual therapy group and 5 patients in the monotherapy group. Overall, cefepime monotherapy is as effective as dual therapy for the initial treatment of febrile neutropenic patients. Further study is warranted for patients with severe neutropenia and leukemia who may benefit from dual therapy.

Amikacin↗

PubMed1991

Effects of primary chemotherapy in conservative treatment of breast cancer patients with operable tumors larger than 3 cm. Results of a randomized trial in a single centre.

272 women with operable breast adenocarcinomas larger than 3 cm were included in a randomized trial. The patients in group A (n = 138) with histological nodal involvement (N+) or a lack of estrogen and progesterone receptors (EPR-) were treated by initial mastectomy and axillary node dissection + adjuvant chemotherapy. Those in group B (n = 134) were treated by initial chemotherapy (the same as in group A) followed by loco-regional treatment, adjusted according to their response to chemotherapy. Prognostic factors were identical in the two groups. In group A, 32 patients received no adjuvant treatment (N- and EPR+), while 104 were given adjuvant chemotherapy (N+ and/or EPR-). Two patients were lost to follow-up. In group B, all patients received initial chemotherapy; 44 were in complete clinical remission and were treated with radiotherapy only; 40 with residual tumor (less than 20 mm) were treated with tumorectomy + axillary node dissection + radiotherapy; 49 with residual tumors (greater than 20 mm) had mastectomies. Conservative treatment was administered to 84 patients in group B (62.6%). EPR-tumors responded better to chemotherapy than did EPR+ ones (p = .003). After a median follow-up of 34 months, isolated local recurrences were more frequent in the group with initial chemotherapy, which, however, experienced a better overall survival (p = 0.04).

Adenocarcinoma↗

PubMed1995

Interim results on a randomized trial of mitomycin C in combination with orchidectomy for newly diagnosed metastatic prostate cancer.

The interim results of a randomized trial comparing orchidectomy alone versus orchidectomy and mitomycin C in 178 newly diagnosed metastatic prostate cancer patients are presented. Of 148 evaluable patients 75 were treated with orchidectomy alone and 73 received adjuvant intravenous mitomycin C. Mean time to progression was 15 months in the orchidectomy group versus 14 months in the mitomycin C group. Interim analysis did not demonstrate a favorable effect of the combination with this chemotherapeutic agent compared to orchidectomy alone (P = .45).

Aged↗

PubMed1997

Prospective randomized trial comparing Shouldice and Bassini-Kirschner operation technique in primary inguinal hernia repair.

The authors conducted a prospective randomized trial to compare the Shouldice and the Bassini-Kirschner technique between April, 1994 and December, 1995. During this period 129 adult patients, mean age 54 (17-87) years underwent operation on primary inguinal hernias in their department. 63 Shouldice and 66 Bassini-Kirschner operations were performed by 17 surgeons. The duration of surgery, the technique of anesthesia, the perioperative complications, the duration of postoperative care, then one year after the operation the recurrence rate and the patient's subjective complains were investigated. 85 patients of 129 were examined one year after the operation in spite of that all the patients were invited for control. Both operations gave almost the same results in the perioperative period and nearly identical recurrence rate (4.44% in Shouldice and 5.0% in Bassini-Kirschner group). The patient's subjective complains were also very similar one year after the operation. The authors could not find significant difference in the results of the two types of surgery although they were well experienced with the Bassini-Kirschner operation and just starting to practice the Shouldice procedure. These facts suggest that having more experience with the Shouldice operation makes available the extreme low recurrence rate published by several authors.

Adolescent↗

PubMed2005

Prospective randomized trial comparing absorbable and non-absorbable sutures in open carpal tunnel release.

A prospective randomized trial was undertaken to compare the influence of absorbable and non-absorbable sutures on pillar pain, scar tenderness, extent of wound inflammation and overall outcome of the surgery following open carpal tunnel release. Forty hands in 33 patients (mean age, 51 years; range, 31-74 years) were randomized into group A (absorbable sutures) or group B (non-absorbable sutures). Clinical assessment was done at 2, 6 and 12 weeks follow-up. The outcome of surgery in terms of improvement of severity of symptoms and functional status of patients was assessed using a self-administered Boston Questionnaire. There was no significant difference between the two groups for any of our outcome measures at the final follow-up.

Adult↗

PubMed2001

How to reduce the number of patients needed for randomized trials: a basic introduction.

Complementary therapies are often used to treat patients with persisting conditions. In a typical randomized trial, patients are assessed for symptom severity at baseline, randomized to treatment or control and then reassessed after a suitable follow-up period. It can be shown that the number of patients required for such trials can be reduced by the use of two methods: repeat measurement and analysis of co-variance (ANCOVA). An example is given of a trial of acupuncture for back pain. Administering the pain questionnaire twice at baseline and four times at follow-up reduces the number of patients by approximately 20% compared to single questionnaire administration. Use of ANCOVA decreases the number of patients by approximately a further 10%. There are considerable economic and ethical advantages to reducing sample size by a third; however, ANCOVA is statistically complex and expert statistical help is required.

Acupuncture Therapy↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Con solidated S tandards o f R eporting T rials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Algorithms↗

PubMed1985

A randomized trial to evaluate the immunorestorative properties of synthetic thymosin-alpha 1 in patients with lung cancer.

A randomized trial was performed in 42 postradiotherapy patients with non-small cell lung cancer to determine whether the administration of synthetic thymosin-alpha 1 by either a loading dose or a twice-weekly schedule could accelerate the reconstitution of thymic dependent immunity. The radiotherapy-induced immunosuppression was characterized by an absolute T cell lymphopenia and by impaired T cell function in lymphoproliferative assays. Placebo-treated patients did not show any improvement in T cell numbers or function over 15 weeks of serial immune monitoring, and exhibited gradual depressions of helper T lymphocyte percentages. Patients treated with thymosin by the loading dose regimen exhibited a normalization of T cell function (p = 0.04), whereas patients treated with the twice-weekly schedule maintained normal helper T cell percentages (p = 0.04). Thymosin treatment was associated with significant improvements in relapse-free and overall survival, which was most pronounced for patients with nonbulky tumors. Thymosin-alpha 1 exhibits schedule-dependent immune restorative and homeostatic properties. Large scale Phase III trials are indicated to definitively establish the impact of thymosin therapy in lung cancer patients treated with radiotherapy.

Adjuvants, Immunologic↗

PubMed2001

Ten-year follow-up of three different initial treatments in de-novo PD: a randomized trial.

BACKGROUND: The long-term effectiveness of three different initial drug regimes in patients with early, mild PD was evaluated by the PD Research Group of the United Kingdom (PDRGUK). In 1995, the selegiline arm of the trial was terminated following an interim analysis. METHOD: This was an open, randomized trial. Between 1985 and 1990, 782 patients with de-novo PD were recruited and randomized to one of three treatment arms: levodopa plus dopa decarboxylase inhibitor; levodopa plus decarboxylase inhibitor and selegiline; or bromocriptine. The main endpoints were mortality, disability, and adverse events. Intention-to-treat analysis was used. RESULTS: There was no significant difference in mortality between the bromocriptine and the levodopa arms (hazard ratio 1.15 [95% CI 0.90, 1.47]). Patients initially randomized to bromocriptine had slightly worse disability scores throughout follow-up. This difference was significant during the first years. Patients in the bromocriptine arm returned to pretreatment disability levels one year earlier than those in the levodopa arm. Patients randomized to bromocriptine had a significantly lower incidence of dyskinesias than those randomized to levodopa (rate ratio 0.73 [95% CI 0.57, 0.93]). However, this difference was not significant when only moderate to severe dyskinesias were considered. Patients in the bromocriptine arm had slightly lower rates of dystonias and on-off fluctuations, but moderate and severe forms were equally frequent in both arms. CONCLUSION: Starting treatment with the dopamine agonist bromocriptine does not reduce mortality in PD. A slightly lower incidence of motor complications is achieved at the expense of significantly worse disability scores throughout the first years of therapy.

Antiparkinson Agents↗

PubMed2004

Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot double-blind randomized trial [ISRCTN45683816].

BACKGROUND: The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. METHODS: Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS) (Group 1) and capsule of imipramine 100 mg/day (TDS) (Group 2) for a 6-week study. RESULTS: Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09). In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. CONCLUSION: The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted.

Adult↗

PubMed2001

Reducing postnatal pain from perineal tears by using lignocaine gel: a double-blind randomized trial.

BACKGROUND: Perineal pain is one of the most common causes of maternal morbidity in the early puerperium. Several randomized trials have shown that topical application of local anesthetics is effective in reducing postepisiotomy pain, but no randomized study has assessed the efficacy of local anesthetics for other perineal trauma. This study investigated if topically applied 2 percent lignocaine gel was an effective treatment for this group of women. METHODS: A double-blind placebo controlled trial was conducted in a regional teaching hospital in the northwest of England. One hundred and forty-nine women who had sustained a first- or second-degree tear were allocated by sealed envelopes to the lignocaine gel or placebo group. The primary outcome was self-reported pain at 24 hours postdelivery as measured on a numerical rating scale (pain score). Secondary outcomes included pain scores at 48 hours, the need for oral analgesia, and maternal satisfaction. Based on a pilot study, we calculated that 128 women were required to detect a 25 percent difference in pain scores between the two groups with 80 percent power (alpha = 0.05). The pain scores of women in each trial arm were compared using the unpaired t test and 95 percent confidence intervals. RESULTS: Women using lignocaine gel had lower average pain scores, although this only reached statistical significance at 48 hours after delivery (p = 0.023). In general, women liked using the study gel. No difference was found in consumption of oral analgesia. CONCLUSIONS: This study suggested that lignocaine gel may be effective on the second postnatal day. Further research is required to assess the optimum timing of this intervention and the population that would most benefit from its use.

Administration, Topical↗

PubMed1993

Proactive screening mammography counseling within the Cancer Information Service: results from a randomized trial.

In 1987, the Division of Cancer Prevention and Control, National Cancer Institute (NCI), funded a randomized trial of a proactive counseling protocol to promote screening mammography among age-eligible female callers to the Cancer Information Service (CIS). This protocol included interactive counseling by CIS counselors to help callers overcome barriers to screening mammography; this counseling was an extension of usual service and was combined with a 2-week follow-up mailout to reinforce the brief (6-minute) proactive telephone-counseling protocol. The screening-mammography counseling intervention was tested in two regional CIS offices using a randomized two-group design. Callers were randomly assigned to the intervention or control group based on the week of their call to the CIS (n = 1831 eligible female callers). Self-reported adherence to NCI screening-mammography guidelines was assessed from telephone interviews conducted at 12 months' follow-up (87% response rate). Among all CIS callers enrolled in this study, self-reported adherence to screening-mammography guidelines at 12 months' follow-up was 63.5%. The most frequently cited barriers to screening mammography reported by CIS callers were inconvenience/being too busy (52%), cost (36%), lack of physician referral (34%), no symptoms (34%), and fear of radiation (29%). A significant intervention effect on adherence behavior was found but only in one of the two test sites and only among CIS callers reporting total family income of $30,000 or more (odds ratio = 1.38, P = .04). The vast majority (90%) of CIS callers (both intervention and control subjects) endorsed the concept of proactive counseling by the CIS. The implications of these findings for the CIS and future research are discussed.

Adult↗

PubMed2004

Effects of 2 prevention programs on high-risk behaviors among African American youth: a randomized trial.

OBJECTIVE: To test the efficacy of 2 programs designed to reduce high-risk behaviors among inner-city African American youth. DESIGN: Cluster randomized trial. SETTING: Twelve metropolitan Chicago, Ill, schools and the communities they serve, 1994 through 1998. PARTICIPANTS: Students in grades 5 through 8 and their parents and teachers. INTERVENTIONS: The social development curriculum (SDC) consisted of 16 to 21 lessons per year focusing on social competence skills necessary to manage situations in which high-risk behaviors occur. The school/community intervention (SCI) consisted of SDC and school-wide climate and parent and community components. The control group received an attention-placebo health enhancement curriculum (HEC) of equal intensity to the SDC focusing on nutrition, physical activity, and general health care. MAIN OUTCOME MEASURES: Student self-reports of violence, provocative behavior, school delinquency, substance use, and sexual behaviors (intercourse and condom use). RESULTS: For boys, the SDC and SCI significantly reduced the rate of increase in violent behavior (by 35% and 47% compared with HEC, respectively), provoking behavior (41% and 59%), school delinquency (31% and 66%), drug use (32% and 34%), and recent sexual intercourse (44% and 65%), and improved the rate of increase in condom use (95% and 165%). The SCI was significantly more effective than the SDC for a combined behavioral measure (79% improvement vs 51%). There were no significant effects for girls. CONCLUSIONS: Theoretically derived social-emotional programs that are culturally sensitive, developmentally appropriate, and offered in multiple grades can reduce multiple risk behaviors for inner-city African American boys in grades 5 through 8. The lack of effects for girls deserves further research.

Adolescent↗