Anxiolytic effect of rescue remedy for psychiatric patients: a double-blind, placebo-controlled, randomized trial.
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Anxiety↗
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Results for “Randomized controlled trials”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Adjuvant chemotherapy for breast cancer. A pooled estimate based on published randomized control trials.
The use of adjuvant chemotherapy for treating patients with operable breast cancer remains a worldwide controversy. Using the data from published randomized control trials with a minimum two-year follow-up, pooled estimates of relapse-free survival rates and overall survival rates were calculated. Relapse-free survival rates were improved by 12.5% (95% confidence interval [CI] +/- 4.5%) at three years and by 8% (CI +/- 6%) at five years, with studies using multiple agents showing a greater effect. A significant advantage was also present in overall survival rates at three years, but only for studies involving multiple agents (4% +/- 3.5%). Results from combining data for other types of trials were inconclusive. The use of this method is presented to illustrate its value as an explicit and systematic one for combining data from several randomized control trials in assessing a therapeutic controversy.
Antineoplastic Agents↗
Long-term lithium therapy for bipolar disorder: systematic review and meta-analysis of randomized controlled trials.
OBJECTIVE: The authors sought to determine the efficacy and acceptability of lithium for relapse prevention in bipolar disorder. METHOD: A systematic review and meta-analysis of randomized controlled trials comparing lithium with placebo in the long-term treatment of bipolar disorders was conducted. Data were obtained from searching the registers of the Cochrane Collaboration; reviewing reference lists, journals, and conference abstracts; and contacting authors, experts, and pharmaceutical companies. Outcomes investigated included risk of relapse (manic, depressive, and total) as well as risk of specific adverse effects and total withdrawal rates. RESULTS: Five randomized controlled trials (770 participants) were included. Lithium was more effective than placebo in preventing all relapses (random effects relative risk=0.65, 95% CI=0.50 to 0.84) and manic relapses (relative risk=0.62, 95% CI=0.40 to 0.95). The protective effect of lithium on depressive relapses was smaller and was less robust (relative risk=0.72, 95% CI=0.49 to 1.07). CONCLUSIONS: Lithium treatment reduces the risk of relapse in bipolar disorder. The preventive effect is clear for manic episodes, although it is equivocal for depressive episodes.
Antimanic Agents↗
Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial.
OBJECTIVE: To determine whether Pro-Active Call Center Treatment Support (PACCTS), using trained nonmedical telephonists supported by specially designed software and a diabetes nurse, can effectively improve glycemic control in type 2 diabetes. RESEARCH DESIGN AND METHODS: A randomized controlled implementation trial of 1-year duration was conducted in Salford, U.K. The trial comprised 591 randomly selected individuals with type 2 diabetes. By random allocation, 197 individuals were assigned to the usual care (control) group and 394 to the PACCTS (intervention) group. Lifestyle advice and drug treatment in both groups followed local guidelines. PACCTS patients were telephoned according to a protocol with the frequency of calls proportional to the last HbA(1c) level. The primary outcome was absolute reduction in HbA(1c), and the secondary outcome was the proportion of patients reducing HbA(1c) by at least 1%. RESULTS: A total of 332 patients (84%) in the PACCTS group and 176 patients (89%) in the control group completed the study. Final HbA(1c) values were available in 374 patients (95%) in the PACCTS group and 180 patients (92%) in the usual care group. Compared with usual care, HbA(1c) improved by 0.31% (95% CI 0.11-0.52, P = 0.003) overall in the PACCTS patients. For patients with baseline HbA(1c) >7%, the improvement increased to 0.49% (0.21-0.77, P < 0.001), whereas in patients with baseline HbA(1c) <7% there was no change. The difference in the proportions of patients achieving a >/=1% reduction in HbA(1c) significantly favored the PACCTS intervention: 10% (4-16, P < 0.001) overall and 15% (7-24, P < 0.001) for patients with baseline HbA(1c) >7%. CONCLUSIONS: In an urban Caucasian trial population with blood glucose HbA(1c) >7%, PACCTS facilitated significant improvement in glycemic control. Further research should extend the validity of findings to rural communities and other ethnic groups, as well as to smoking and lipid and blood pressure control.
Adult↗
Quality assessment of randomized controlled trials of oral implants.
The aim of this study was to assess the quality of randomized controlled trials (RCTs) concerned with the effectiveness of oral implants and to create a trial register. A multilayered search strategy was used to identify all RCTs published by the end of 1999 in any language. The Cochrane Oral Health Group specialist register, PubMed, and personal libraries were searched. Seventy-four RCTs were identified. Forty-three articles, not presenting the same patient material, were independently assessed by 3 researchers using a specially designed form. A statistician assessed all trials for the appropriateness of statistics. The quality of each study was assessed on 7 items, including 3 key domains. Randomization and concealment allocation procedures were not described in 30 articles (70%). Reasons for withdrawals were not given in 10 reports (23%). No attempt at blinding was reported in 31 studies (72%). The quality of RCTs of oral implants is generally poor and needs to be improved.
Databases, Bibliographic↗
Time to tracheal extubation after coronary artery surgery with isoflurane, sevoflurane, or target-controlled propofol anesthesia: a prospective, randomized, controlled trial.
OBJECTIVES: To determine if anesthesia with sevoflurane or target-controlled propofol reduced the time to tracheal extubation after coronary artery bypass graft surgery compared with isoflurane anesthesia. DESIGN: A 3-arm (isoflurane, sevoflurane, or propofol), randomized, controlled trial with patients and intensive care staff blinded to the drug allocation. SETTING: A single, tertiary referral hospital affiliated with the University of Melbourne. PARTICIPANTS: Three hundred sixty elective coronary artery surgery patients. INTERVENTIONS: Patients received either isoflurane (control group, 0.5%-2% end-tidal concentration), sevoflurane (1%-4% end-tidal concentration), or target-controlled infusion of propofol (1-8 microg/mL plasma target concentration) as part of a balanced, standardized anesthetic technique including 15 microg/kg of fentanyl. MEASUREMENTS AND MAIN RESULTS: The primary outcome was time to tracheal extubation. The median time to tracheal extubation for the propofol group was 10.25 hours (interquartile range [IQR] 8.08-12.75), the sevoflurane group 9.17 hours (IQR 6.25-11.25), and the isoflurane group 7.67 hours (IQR 6.25-9.42). Intraoperatively, the propofol group required less vasopressor (p = 0.002) and more vasodilator therapy (nitroglycerin p = 0.01, nitroprusside p = 0.002). There was no difference among the groups in time to intensive care unit discharge. CONCLUSIONS: The median time to tracheal extubation was significantly longer for the target-controlled propofol group. A significantly greater number in this group required the use of a vasodilator to control intraoperative hypertension.
Aged↗
Groningen Manipulation Study. The effect of manipulation of the structures of the shoulder girdle as additional treatment for symptom relief and for prevention of chronicity or recurrence of shoulder symptoms. Design of a randomized controlled trial within a comprehensive prognostic cohort study.
BACKGROUND: We present the design of the Groningen Manipulation Study. This randomized controlled trial is part of the Dutch Shoulder Disability Study, a comprehensive prognostic cohort study on shoulder disorders, with randomized controlled interventions in subcohorts. OBJECTIVE: To evaluate the effectiveness of manipulative treatment of the structures of the shoulder girdle, in addition to standard treatment by the general practitioner for relief of shoulder symptoms and prevention of persistent or recurrent shoulder symptoms. METHODS: A total of 250 patients with shoulder symptoms and a functional limitation of the shoulder girdle will be included from 30 general practices in Groningen, The Netherlands. All participating patients receive standard treatment by the general practitioner and will be randomly allocated to additional manipulative treatment. Evaluation measurements take place 6, 12, 26, and 52 weeks after randomization. CONCLUSION: The short-term primary outcome measure is the proportion of patients with relief of shoulder complaints and the long-term primary outcome is the proportion of patients without persistent or recurrent shoulder symptoms. Dependent and independent variables include a structured medical history, a physical examination of the shoulder and shoulder girdle, and a measure of the mobility of the cervico-thoracic spine with a 6-degree-of-freedom electromagnetic tracking device.
Adult↗
Transcranial Magnetic Stimulation for Patients with Exposure Therapy Resistant Obsessive-Compulsive Disorder (TETRO): Study Protocol for a Multicenter Randomized Controlled Trial.
BACKGROUND: Obsessive-compulsive disorder (OCD) is a disabling mental disorder, characterized by obsessions, compulsions, and substantial morbidity. Approximately 50% of adults with OCD fail to achieve satisfactory outcomes from first-line treatments, such as exposure therapy with response prevention (ERP), with or without medication. This leads to chronic social, educational, and occupational impairment. While invasive procedures such as deep brain stimulation are available for severe, treatment-refractory cases, a need remains for less invasive alternatives. Repetitive transcranial magnetic stimulation (rTMS), a noninvasive intervention, shows promise in reducing OCD symptoms. Unlike in depression, rTMS is not yet reimbursed for OCD in the Dutch healthcare system. OBJECTIVE: This study examines the efficacy and cost-effectiveness of low-frequency (1Hz) rTMS targeting the presupplementary motor area (pre-SMA) compared to sham rTMS as an adjuvant treatment to ERP in adults with OCD with inadequate response to first-line treatment. METHODS: A total of 250 adults with OCD will be enrolled in this multicenter randomized controlled trial. Participants will be randomly assigned to ERP combined with either active or sham 1Hz rTMS over the pre-SMA. Treatment is administered 4 times weekly for at least 5 weeks (20 rTMS-ERP sessions), with optional extension of 1 to 2 weeks, up to 28 rTMS-ERP sessions. Clinical assessments occur at baseline, weekly during treatment, posttreatment, and at 3, 6, and 12 months follow-up. Participants undergo pre- and posttreatment (functional) (MRI) scans, including a symptom provocation task. Blood sampling takes place pre- and posttreatment and at 3-month follow-up. The primary outcome is OCD severity at posttreatment, as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Secondary outcomes include functional improvement, quality of life, and societal costs. Pretreatment symptom profiles, genotype, and brain network topology will be analyzed as predictors of response and relapse risk. Pre-to-post treatment change in blood-based and magnetic resonance (MR)-based neuroplasticity markers will help explore differential mechanisms between ERP alone and combined rTMS-ERP. We expect that the verum rTMS protocol will be cost-effective compared to sham-rTMS. RESULTS: Recruitment started in April 2022, and as of February 2026, 201 participants have been enrolled. Posttreatment assessments are projected to be completed in December 2026, with final one-year follow-up evaluations anticipated by the end of 2027. CONCLUSIONS: To our knowledge, this study is the first adequately powered randomized controlled trial examining efficacy, cost-effectiveness, and mechanism of action of rTMS for OCD as adjuvant therapy to ERP. In case of efficacy and/or cost-effectiveness, it will pave the way for rTMS as insured health care for adults with OCD in the Netherlands, and possibly other European countries. Furthermore, this trial will provide insight into the mechanisms of treatment response to intensive ERP, with and without adjunctive rTMS, as well as potential side effects, individual variability, and long-term outcomes in adults with OCD.
Humans↗
Selective depletion of CD8+ cells for prevention of graft-versus-host disease after bone marrow transplantation. A randomized controlled trial.
We performed a prospective randomized, double-blind study to assess the efficacy of selective depletion of CD8+ bone marrow cells in preventing acute graft-versus-host disease (GVHD) in 38 patients undergoing HLA-identical sibling donor bone marrow transplantation for leukemia. All patients received CsA for GVHD prophylaxis. Nineteen patients received marrow depleted of CD8+ cells by ex vivo treatment with anti-leu2, an anti-CD8 mAb and complement; four patients had moderate (grade 1 or 2 acute GVHD) and the only patient who experienced grade 3 manifestations was a technical failure. The control group consisted of 19 patients who received unmodified bone marrow; one patient had grade 1, 4 patients had grade 2, and 10 had grade 3 or 4 acute GVHD. The actuarial incidence of grade > or = 2 acute GVHD was 20 +/- 20% in the CD8-depleted group compared with 80 +/- 18% in the controls (P = 0.004). Death in 5 of the control patients and the single patient in whom CD8 depletion was a technical failure was related to acute GVHD. Graft failure occurred in 2 patients in the CD8-depleted group and in none of the controls. Leukemic relapse occurred in 2 patients receiving CD8-depleted bone marrow and 2 patients in the control group. Seven patients receiving marrow depleted of CD8+ cells are alive and free of leukemia and 9 patients in the control group are alive, 7 of whom remain leukemia-free (P = 0.88). The 3-year actuarial leukemia-free survival is 37 +/- 22% of the CD8-depleted group and 36 +/- 22% for the control group. These results indicate that selective depletion of CD8+ cells from the bone marrow significantly reduces the incidence and severity of acute GVHD.
Adolescent↗
Can clinical trials requiring frequent participant contact be conducted over the Internet? Results from an online randomized controlled trial evaluating a topical ointment for herpes labialis.
BACKGROUND: The Internet has tremendous appeal for conducting randomized clinical trials and may be especially applicable to trials requiring frequent participant contact. Trials of cold sore remedies, for example, often require daily clinic visits during outbreaks, imposing substantial burden on participants. An Internet-based randomized clinical trial design may reduce this burden, permitting frequent symptom reports with considerably less effort. OBJECTIVE: To evaluate the feasibility of a Web-based randomized clinical trial requiring frequent participant interaction, using a 6-month, double-blind, randomized, placebo-controlled pilot trial of a topical ointment containing dioctyl sodium sulfosuccinate (DSS) (Zilex; Meditech Pharmaceuticals, Inc, Scottsdale, Arizona, USA) intended for treatment of recurrent herpes labialis. A secondary objective was to obtain preliminary data on effectiveness outcomes, to assist in planning a fully-powered trial of DSS. METHODS: Adults with physician-confirmed herpes labialis were recruited to apply to the trial. Eligible applicants were randomized to DSS or placebo, mailed to them upon enrolment with instructions to apply topically every 2 hours for the duration of every cold sore outbreak. Participants were instructed to complete online questionnaires at 2-week intervals and, at the initiation of a cold sore, daily "outbreak questionnaires" until outbreak termination. Feasibility outcome measures included trial participant characteristics, frequency of cold sores, participant retention and adherence (to study medication), and data completeness. Treatment effectiveness outcome measures included outbreak duration, days to crust formation, and pain. RESULTS: Of the 292 individuals applying, 182 screened eligible; 32 participants with confirmed herpes labialis enrolled in the trial. 16 were randomized into the verum group and 16 into the placebo group. 29 (91%) participants completed the trial. During the trial, 34 outbreaks were reported among 23 (72%) participants, resulting in a cold sore incidence rate of 19.8 per 100 person-months of observation. Online data were available for 32 outbreaks; the absence of a resolution date made it impossible to accurately calculate the duration of 12 (38%) outbreaks. Although the DSS treatment group had a shorter mean outbreak duration (6.6 vs 7.7 days, P =.2) and fewer mean days to crust formation (3.5 vs 4.9, P =.1), these differences did not reach statistical significance. The DSS group has statistically significant lower mean pain scores (3.1 vs 7.6, P =.04), but participants in this group also consumed more acetaminophen tablets than the placebo group (1.1 versus 0.5, P=.55). Adherence to medication was similar in both groups: 7 (50%) of the verum group reported using the cream as directed compared to 6 (46.2%) in the placebo group; (P =.8). CONCLUSIONS: We efficiently recruited participants and achieved high overall retention rates. However, participant adherence to the daily outbreak visit schedules was low and only 7 (50%) participants used the cream as directed. These limitations could be addressed in future Internet-based studies by using Personal Digital Assistants (PDAs), using reminder devices, and providing incentives. By enhancing participant adherence, clinical trials requiring frequent participant contact may be feasible over the Internet.
Administration, Topical↗
Gabapentin and postoperative pain--a systematic review of randomized controlled trials.
The objective of this systematic review was to evaluate the efficacy and tolerability of perioperative gabapentin administration for the control of acute postoperative pain. We searched Medline (1966-2006), the Cochrane Library (2006), Scopus, CINAHL and bibliographies from clinical trials and review articles. We included randomized controlled trials (RCTs) comparing gabapentin with inactive controls in surgical patients. Sixteen valid RCTs were included. Weighted mean difference (WMD) for postoperative pain intensity (0-100 mm visual analogue scale) was -16.55 mm at 6 h and -10.87 mm at 24 h for treatment with a single preoperative dose of gabapentin 1200 mg. Cumulative opioid consumption at 24 h was also significantly decreased with gabapentin (WMD, -27.90 mg). When gabapentin was administered at doses less than 1200 mg, pain intensity was also lower at 6 h (WMD, -22.43 mm) and 24 h (WMD, -13.18 mm). Cumulative 24 h opioid consumption was also lower (WMD, -7.25 mg). Gabapentin was associated with an increased risk of sedation (Peto OR 3.86; 95% CI 2.50-5.94) but less opioid-related side effects such as vomiting (Peto OR 0.58; 95% CI 0.39-0.86) and pruritus (Peto OR 0.27; 95% CI 0.10-0.74). In conclusion, gabapentin has an analgesic and opioid-sparing effect in acute postoperative pain management when used in conjunction with opioids.
Acute Disease↗
A randomized controlled trial for inguinal hernia repair to compare the Shouldice and the Bassini-Kirschner operation.
A randomized controlled trial was conducted on 142 adult male and female patients for primary inguinal hernias by the Shouldice or the Bassini-Kirschner surgical technique. Follow-up after one year revealed 7 recurrences out of 72 patients having had Bassini-Kirschner's operation and three recurrences out of 70 patients having had Shouldice's operation (p = 0.326, NS). Six patients died during the follow-up period and two were lost to the study. At two years follow-up examination nine recurrences out of 63 patients having had Bassini-Kirschner's operation and seven recurrences out of 65 patients having had Shouldice's operation were found (p = 0.792, NS). Both operations gave the same results when performed by either a consultant surgeon or a surgeon in training. The complication rate was high but similar for both techniques (18%). Although surgical literature abounds with excellent low recurrence rates using the Shouldice surgical technique, we were unable to reproduce these results. This might be due to lack of experience.
Adolescent↗
Asthma in adolescents: a randomized, controlled trial of an asthma program for adolescents and young adults with severe asthma.
BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects. OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma. METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study. RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06). CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.
Adolescent↗
A randomized controlled trial of acetyl salicylic acid in the secondary prevention of mortality from myocardial infarction.
The results of a randomized controlled trial of a single daily dose of acetyl salicylic acid (aspirin) in the prevention of reinfarction in 1,239 men who had had a recent myocardial infarct were statistically inconclusive. Nevertheless, they showed a reduction in total mortality of 12% at six months and 25% at twelve months after admission to the trial. Further trials are urgently required to establish whether or not this effect is real.
Age Factors↗
Oral erythromycin improves gastrointestinal motility and transit after subtotal but not total gastrectomy for cancer.
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Administration, Oral↗
Nurse case management to improve glycemic control in diabetic patients in a health maintenance organization. A randomized, controlled trial.
BACKGROUND: Control of hyperglycemia delays or prevents complications of diabetes, but many persons with diabetes do not achieve optimal control. OBJECTIVE: To compare diabetes control in patients receiving nurse case management and patients receiving usual care. DESIGN: Randomized, controlled trial. SETTING: Primary care clinics in a group-model health maintenance organization (HMO). PATIENTS: 17 patients with type 1 diabetes mellitus and 121 patients with type 2 diabetes mellitus. INTERVENTION: The nurse case manager followed written management algorithms under the direction of a family physician and an endocrinologist. Changes in therapy were communicated to primary care physicians. All patients received ongoing care through their primary care physicians. MEASUREMENTS: The primary outcome, hemoglobin A1c (HbA1c) value, was measured at baseline and at 12 months. Fasting blood glucose levels, medication type and dose, body weight, blood pressure, lipid levels, patient-perceived health status, episodes of severe hypoglycemia, and emergency department and hospital admissions were also assessed. RESULTS: 72% of patients completed follow-up. Patients in the nurse case management group had mean decreases of 1.7 percentage points in HbA1c values and 43 mg/dL (2.38 mmol/L) in fasting glucose levels; patients in the usual care group had decreases of 0.6 percentage points in HbA1c values and 15 mg/dL (0.83 mmol/L) in fasting glucose levels (P < 0.01). Self-reported health status improved in the nurse case management group (P = 0.02). The nurse case management intervention was not associated with statistically significant changes in medication type or dose, body weight, blood pressure, or lipids or with adverse events. CONCLUSIONS: A nurse case manager with considerable management responsibility can, in association with primary care physicians and an endocrinologist, help improve glycemic control in diabetic patients in a group-model HMO.
Algorithms↗
Are prophylactic antibiotics necessary with clean intermittent catheterization? A randomized controlled trial.
BACKGROUND/PURPOSE: Clean intermittent catheterization has been an established practice for more than 3 decades. The validity of antibiotic prophylaxis has been questioned although not tested. METHODS: Eighty-five patients were recruited into a randomized controlled trial. The randomization involved the placement into 1 of 2 groups: (A) continuing antibiotics or (B) discontinuing antibiotics. The trial would last 4 months with the outcome being a confirmed urinary tract infection. All groups were matched for age, sex, and pathology. RESULTS: The incidence of urinary tract infections was significantly increased in the group who continued to use antibiotics (n = 20) when compared with the group who discontinued prophylaxis (n = 3). The common infecting organism was Escherichia coli. CONCLUSIONS: The use of prophylactic antibiotics for children who intermittently catheterize may not be necessary. The use of prophylactic antibiotics may result in increased rates of infection because of the development of resistant organisms.
Adolescent↗
Occlusal treatments in temporomandibular disorders: a qualitative systematic review of randomized controlled trials.
Occlusal treatments (occlusal splints and occlusal adjustment) are controversial but widely used treatment methods for temporomandibular disorders (TMD). To investigate whether studies are in agreement with current clinical practices, a systematic review of randomized controlled trials (RCTs) of occlusal treatment studies from the period 1966 to March 1999 was undertaken. Eighteen studies met the inclusion criteria, 14 on splint therapy, and 4 on occlusal adjustment. The trials were scored using the quality scale presented by Antczak et al., 1986a (A.A. Antczak, J. Tang, T.C. Chalmers, Quality assessment of randomized control trials in dental research. I. Methods, J. Periodontal Res. 1986a;21:305-314). The overall quality of the trials was fairly low, the mean quality score was 0.43/1.00 (range 0.12-0.78). The most obvious methodological shortcomings were inadequate blinding, small sample sizes, short follow-up times, great diversity of outcome measures and numerous control treatments, some of unknown effectiveness. Splint therapy was found superior to 3, and comparable to 12 control treatments, and superior or comparable to 4 passive controls, respectively. Occlusal adjustment was found comparable to 2 and inferior to one control treatment and comparable to passive control in one study. Because of the methodological problems, only suggestive conclusions can be drawn. The use of occlusal splints may be of some benefit in the treatment of TMD. Evidence for the use of occlusal adjustment is lacking. There is an obvious need for well designed controlled studies to analyse the current clinical practices.
Humans↗