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Results for “Randomized controlled trials”

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PubMed2003

Efficacy of different therapy regimes of low-power laser in painful osteoarthritis of the knee: a double-blind and randomized-controlled trial.

BACKGROUND AND OBJECTIVES: A prospective, double-blind, randomized, and controlled trial was conducted in patients with knee osteoarthritis (OA) to evaluate the efficacy of infrared low-power Gallium-Arsenide (Ga-As) laser therapy (LPLT) and compared two different laser therapy regimes. STUDY DESIGN/MATERIALS AND METHODS: Ninety patients were randomly assigned to three treatment groups by one of the nontreating authors by drawing 1 of 90 envelopes labeled 'A' (Group I: actual LPLT consisted of 5 minutes, 3 J total dose + exercise; 30 patients), 'B' (Group II: actual LPLT consisted of 3 minutes, 2 J total dose + exercise; 30 patients), and 'C' (Group III: placebo laser group + exercise; 30 patients). All patients received a total of 10 treatments, and exercise therapy program was continued during study (14 weeks). Subjects, physician, and data analysts were unaware of the code for active or placebo laser until the data analysis was complete. All patients were evaluated with respect to pain, degree of active knee flexion, duration of morning stiffness, painless walking distance and duration, and the Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) at week 0, 6, 10, and 14. RESULTS: Statistically significant improvements were indicated in respect to all parameters such as pain, function, and quality of life (QoL) measures in the post-therapy period compared to pre-therapy in both active laser groups (P < 0.01). Improvements in all parameters of the Group I and in parameters, such as pain and WOMAC of the Group II, were more statistically significant when compared with placebo laser group (P < 0.05). CONCLUSIONS: Our study demonstrated that applications of LPLT in different dose and duration have not affected results and both therapy regimes were a safe and effective method in treatment of knee OA.

Aged↗
PubMed2006

Carotid intima-media thickness and antihypertensive treatment: a meta-analysis of randomized controlled trials.

BACKGROUND AND PURPOSE: Hypertension promotes carotid intima-media thickening. We reviewed the randomized controlled trials that evaluated the effects of an antihypertensive drug versus placebo or another antihypertensive agent of a different class on carotid intima-media thickness. METHODS: We searched the PubMed and the Web of Science databases for randomized clinical trials, published in English before 2005, and included 22 trials. RESULTS: In 8 trials including 3329 patients with diabetes or coronary heart disease, antihypertensive treatment initiated with an angiotensin-converting enzyme (ACE) inhibitor, a beta-blocker, or a calcium-channel blocker (CCB), compared with placebo or no-treatment, reduced the rate of intima-media thickening by 7 microm/year (P=0.01). In 9 trials including 4564 hypertensive patients, CCBs, ACE inhibitors, an angiotensin II receptor blocker or an alpha-blocker, compared with diuretics or beta-blockers, in the presence of similar blood pressure reductions, decreased intima-media thickening by 3 microm/year (P=0.03). The overall beneficial effect of the newer over older drugs was largely attributable to the decrease of intima-media thickening by 5 microm/year (P=0.007) in 4 trials of CCBs involving 3619 patients. In 5 trials including 287 patients with hypertension or diabetes, CCBs compared with ACE inhibitors did not differentially affect blood pressure, but attenuated intima-media thickening by 23 microm/year (P=0.02). The treatment induced changes in carotid intima-media thickness correlated with the changes in lumen diameter (P=0.02), but not with the differences in achieved blood pressure (P>0.53). CONCLUSIONS: CCBs reduce carotid intima-media thickening. This mechanism might contribute to their superior protection against stroke.

Adrenergic beta-Antagonists↗
PubMed1989

A randomized controlled trial of medroxyprogesterone acetate and psychotherapy for the treatment of pelvic congestion.

The value of medroxyprogesterone acetate (MPA) and of psychotherapy in the treatment of lower abdominal pain due to pelvic congestion was assessed in a randomized controlled trial. Eighty-four women with abnormal pelvic venography were assigned to one of four treatment groups: MPA alone, MPA plus psychotherapy, placebo alone, and placebo plus psychotherapy. Women were treated for 4 months and thereafter followed up regularly for 9 months with pain assessments, pelvic ultrasound scanning, and hormone measurements. During treatment, MPA showed a significant benefit in terms of a reduction in visual analogue scale pain score, with 73% of women reporting at least 50% improvement compared with 33% of those treated with placebo. At 9 months after the end of therapy there was no overall significant effect of MPA or psychotherapy, but there was an interaction between MPA and psychotherapy, with 71% of the women in this group showing a greater than or equal to 50% reduction in pain score. Therapy with MPA is a useful first-line therapy for women with pain associated with demonstrable pelvic congestion.

Adult↗
PubMed2004

Effect of homocysteine-lowering treatment with folic acid plus vitamin B on cerebrovascular atherosclerosis and white matter abnormalities as determined by MRA and MRI: a placebo-controlled, randomized trial.

BACKGROUND: A high plasma homocysteine concentration is an independent risk factor for large and possibly small vessel disease. We investigated the effects of homocysteine-lowering treatment with folic acid plus vitamin B(6) on markers of cerebrovascular atherosclerosis and cerebral microangiopathy. MATERIALS AND METHODS: Using 158 healthy siblings (mean age 46.0 +/- 7.6 years) of patients with premature atherosclerotic disease, we performed a randomized, placebo-controlled trial using 5 mg of folic acid plus 250 mg of vitamin B(6) daily (n = 78) or placebo medication (n = 80). Participants were followed for 2 years with magnetic resonance angiography (MRA) (carotid stenosis; carotid and/or vertebral elongation) and magnetic resonance imaging (MRI) (white matter abnormalities; cerebral atrophy). RESULTS: Seventeen (10.8%) subjects refused MRA/MRI owing to claustrophobia and were excluded. From the remaining 141 participants, 68 received vitamin and 73 received placebo medication [42 (61.8%) and 48 (65.8%) had postmethionine hyperhomocysteinaemia, respectively]. Twenty-four participants (15.2%; 10 in the treatment and 14 in the placebo group) did not complete both years of the trial. Vitamin treatment was associated with an increase in plasma folate (13-fold vs. placebo; P < 0.001) and vitamin B(6) (8.8-fold; P < 0.001). Fasting and postmethionine total homocysteine concentrations decreased 38.7% (95% CI, 27.4-50.0) and 29.1% (95% CI, 19.2-39.0) vs. placebo (all P < 0.001). During follow up six individuals in the vitamin-treated and 11 in the placebo-treated group deteriorated in their outcome measurements. Vitamin treatment, as compared with placebo, was associated with nonsignificantly improved outcomes on both MRA and MRI outcome measurements (odds ratio 0.48; 95% CI 0.17-1.41; P = 0.18 and 0.48; CI 0.14-1.60; P = 0.23, respectively). CONCLUSIONS: These results could indicate a possible favourable effect of homocysteine-lowering treatment on cerebrovascular atherosclerosis and cerebral microangiopathy among healthy siblings of patients with premature atherosclerotic disease, but larger trials are required to establish this with certainty.

Adult↗
PubMed2006

Early intervention with epoetin alfa during platinum-based chemotherapy: an analysis of the results of a multicenter, randomized, controlled trial based on initial hemoglobin level.

OBJECTIVE: This analysis of the results of a randomized, controlled trial evaluating the effects of epoetin alfa (EPO) therapy on transfusion requirements, hemoglobin (Hb), and quality of life (QOL) in patients with cancer receiving platinum-based chemotherapy was conducted to evaluate the effect of initial Hb level on study outcomes. METHODS: Patients with Hb levels < or =12.1 g/dl were randomized 2:1 to receive EPO, 10,000 U three times weekly s.c. or best supportive care (BSC) until 4 weeks after their last chemotherapy cycle. For this analysis, patients were stratified by baseline Hb level (< or =9.7 g/dl, >9.7 g/dl to < or =10.5 g/dl, >10.5 g/dl to < or =11.3 g/dl, and >11.3 g/dl to < or =12.1 g/dl), and study results were reanalyzed. RESULTS: Significantly fewer EPO patients than BSC patients with initial Hb levels >9.7 g/dl to < or =12.1 g/dl required transfusions. EPO maintained Hb levels throughout the study for patients with Hb levels >11.3 g/dl to < or =12.1 g/dl, compared with a decrease with BSC. For patients with baseline Hb levels >10.5 g/dl, for whom the mean changes from baseline to last assessment were measured by the Cancer Linear Analogue Scale assessments of energy and overall QOL as well as by the Functional Assessment of Cancer Therapy (FACT)-Fatigue and FACT-An Anemia subscale, QOL scores were significantly greater with EPO than with BSC. QOL declined in patients receiving BSC, and the mean decreases in QOL scores were greater for BSC patients with baseline Hb levels >10.5 g/dl, compared with the overall BSC group. CONCLUSION: In patients with cancer receiving platinum-based chemotherapy and with baseline Hb levels >10.5 g/dl, early intervention with EPO reduces transfusions, maintains Hb level, and maintains or improves QOL. This study supports the positive effects of early intervention when analyzed according to initial Hb value.

Adult↗
PubMed2002

Effect of student involvement on patient perceptions of ambulatory care visits: a randomized controlled trial.

OBJECTIVE: To determine if patient satisfaction with ambulatory care visits differs when medical students participate in the visit. DESIGN: Randomized controlled trial. SETTING: Academic general internal medicine practice. PARTICIPANTS: Outpatients randomly assigned to see an attending physician only (N = 66) or an attending physician plus medical student (N = 68). MEASUREMENTS AND MAIN RESULTS: Patient perceptions of the office visit were determined by telephone survey. Overall office visit satisfaction was higher for the "attending physician only" group (61% vs 48% excellent), although this was not statistically significant (P =.16). There was no difference between the study groups for patient ratings of their physician overall (80% vs 85% excellent; P =.44). In subsidiary analyses, patients who rated their attending physician as "excellent" rated the overall office visit significantly higher in the "attending physician only" group (74% vs 55%; P =.04). Among patients in the "attending physician plus medical student" group, 40% indicated that medical student involvement "probably" or "definitely" did not improve their care, and 30% responded that they "probably" or "definitely" did not want to see a student at subsequent office visits. CONCLUSIONS: Although our sample size was small, we found no significant decrement in patient ratings of office visit satisfaction from medical student involvement in a global satisfaction survey. However, a significant number of patients expressed discontent with student involvement in the visit when asked directly. Global assessment of patient satisfaction may lack sensitivity for detection of dissatisfaction. Future research in this area should employ more sensitive measures of patient satisfaction.

Adult↗
PubMed2005

Efficacy and tolerability of frovatriptan in acute migraine treatment: systematic review of randomized controlled trials.

OBJECTIVE: To evaluate the efficacy and tolerability of frovatriptan in acute migraine treatment. METHODS: Systematic review and meta-analysis of randomized controlled trials. Clinical trials of frovatriptan were systematically identified through electronic searches and historical searches up until February 2005. Studies were included if they were (i) double-blind, randomized, placebo controlled trials that evaluated frovatriptan 2.5 mg in acute migraine treatment and (ii) reporting the efficacy data in terms of pain-free, headache response, headache recurrence, or relief of migraine-associated symptoms. Two authors extracted data independently. Disagreements were resolved through discussion. The efficacy was estimated using risk ratio (RR), risk difference, and number needed to treat together with 95% confidence intervals. RESULTS: Five trials involving a total of 2,866 patients were included. Frovatriptan 2.5 mg was more effective than placebo in rendering patient pain-free (RR 3.70, 95% CI 2.59-5.29, P < 0.0001 at 2 h and 2.67, 95% CI 2.21-3.22, P < 0.0001 at 4 h post-dose). It was also superior to placebo in reducing headache severity. The pooled RR was 1.66 (95% CI 1.48-1.88, P < 0.0001) and 1.83 (95% CI 1.66-2.00, P < 0.0001), respectively, at 2 and 4 h after treatment. In those whose headache was relieved at 4 h, the risk of headache recurrence within 24 h was reduced by 26% with frovatriptan (RR 0.74, 95% CI 0.59-0.93, P = 0.009). Frovatriptan was also superior to placebo in improving symptoms associated with migraine. At 2 h after dosing, frovatriptan reduced the risk of nausea by 14% (95% CI 6-20%, P = 0.0005), photophobia 17% (95% CI 12-22%, P < 0.0001), and phonophobia 14% (95% CI 17-20%, P < 0.0001). The corresponding numbers at 4 h after dosing were 37% (95% CI 30-43%, P < 0.0001), 34% (95% CI 29-39%, P < 0.0001) and 30% (95% CI 23-36%, P < 0.0001), respectively. Frovatriptan caused more adverse events than did placebo (RR 1.31, 95% CI 1.07-1.62, P = 0.01). CONCLUSION: The available evidence suggests that frovatriptan is more effective but may cause more adverse events than placebo in the treatment of acute moderate to severe migraine. It is effective in providing pain relief and reducing the risk of recurrence. However, its effectiveness relative to other more established agents needs to be better defined by appropriate head to head trials.

Carbazoles↗
PubMedDate not supplied

Reaching out to promote physical activity in Australia: a statewide randomized controlled trial of a stage-targeted intervention.

PURPOSE: This study examined the broader use of a print-media intervention, which was previously shown to be effective at promoting physical activity to participants recruited from a regional Australian community, as a strategy suitable for a more diverse statewide population sample. METHODS: Participants were randomly selected adults who responded to a telephone interview conducted by the New South Wales Health Department and consented to participate in a randomized controlled trial. Consenters were allocated to either intervention (n = 361) or control (n = 358) conditions. The intervention, a personalized letter plus stage-targeted booklets, was sent 1 week postbaseline. Data were collected via telephone interview at baseline and 2 and 8 months and were analyzed using repeated measures analysis of variance (ANOVA) and chi2 statistics. RESULTS: The groups were similar at baseline (mean age 43 +/- 3 years; 64% women). Process evaluation showed high intervention recall (76% at 2 months) and high follow-up response rates (> 85% at 8 months) were achieved. Nonsignificant increases in physical activity were observed (F1,719 = 2.18, p = .14). DISCUSSION: A single mailing of stage-targeted print materials was not effective in promoting increases in physical activity among participants selected from the statewide population. Future research could examine how the effectiveness of print media might be enhanced, possibly by using supplementary media, community-based prompts, or other incentives.

Adult↗
PubMed2005

Randomized controlled trial to evaluate laparoscopic surgery for colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404.

A randomized controlled trial was started in Japan to evaluate whether laparoscopic surgery is the optimal treatment for colorectal cancer. Patients with T3 or deeper carcinoma in the colorectum without transverse and descending colons are pre-operatively randomized to either open or laparoscopic colorectal resection. Surgeons in 24 specialized institutions will recruit 818 patients. The primary end-point is overall survival. Secondary end-points are relapse-free survival, short-term clinical outcome, adverse events, the proportion of conversion from laparoscopic surgery to open surgery, and the proportion of completion of laparoscopic surgery.

Adult↗
PubMed2026

Ultrasound-guided high-voltage vs conventional pulsed radiofrequency in elderly cervical radiculopathy: A randomized controlled trial.

BACKGROUND: Elderly patients with cervical radiculopathy present therapeutic challenges owing to comorbidities and medication-related risks. Long-term pharmacotherapy and surgical interventions are often suboptimal, necessitating evaluation of optimized pulsed radiofrequency strategies under image guidance. OBJECTIVES: This superiority trial compared the efficacy and safety of ultrasound-guided cervical nerve root high-voltage pulsed radiofrequency (HVP-PRF) versus conventional pulsed radiofrequency (C-PRF) for pain management in elderly patients with cervical radiculopathy. METHODS: This single-center, parallel-group, assessor-blinded randomized controlled trial enrolled patients aged 60-85 years with cervical radiculopathy, randomly assigned (1:1) to HVP-PRF (70 V) or C-PRF (45 V). Procedures were performed under ultrasound guidance with sensory/motor stimulation confirmation and temperature &#x2264;42&#xb0;C. The primary outcome was change in upper-limb radiating pain on the Numeric Rating Scale (&#x394;NRS) from baseline to 3 months. Secondary outcomes included Neck Disability Index (NDI), neck pain NRS, Patient Global Impression of Change, responder rates, rescue analgesia use, and adverse events. Follow-up occurred at 1 week, 1, and 3 months. RESULTS: A total of 104 patients were randomized and 101 received treatment. At 3 months, HVP-PRF demonstrated significantly greater radiating pain improvement versus C-PRF (adjusted mean difference 1.24, 95% CI 0.46-2.02, P=0.002). Functional improvement (NDI) was superior in the HVP-PRF group at 3 months (AMD 6.47, 95% CI 2.11-10.83, P=0.004). Responder rates (&#x2265;50% pain reduction) were higher with HVP-PRF at 3 months (68.75% vs. 42.22%, OR 3.01, P=0.011) and 6 months (65.22% vs. 43.18%, OR 2.52, P=0.035). Rescue analgesic use was lower in the HVP-PRF group during 1-3 months intervals (both P<0.05). Adverse event rates were comparable (27.45% vs. 32.00%). CONCLUSION: Under ultrasound visualization and electrical stimulation-based target confirmation with temperature control &#x2264;42&#xb0;C, HVP-PRF provided greater and more durable relief of upper limb radiating pain compared with C-PRF in elderly patients with cervical radiculopathy, with a comparable safety profile.

Humans↗
PubMed1998

Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group.

CONTEXT: Nonpharmacologic interventions are frequently recommended for treatment of hypertension in the elderly, but there is a paucity of evidence from randomized controlled trials in support of this recommendation. OBJECTIVE: To determine whether weight loss or reduced sodium intake is effective in the treatment of older persons with hypertension. DESIGN: Randomized controlled trial. PARTICIPANTS: A total of 975 [corrected] men and women aged 60 to 80 years with systolic blood pressure lower than 145 mm Hg and diastolic blood pressure lower than 85 mm Hg while receiving treatment with a single antihypertensive medication. SETTING: Four academic health centers. INTERVENTION: The 585 obese participants were randomized to reduced sodium intake, weight loss, both, or usual care, and the 390 nonobese participants were randomized to reduced sodium intake or usual care. Withdrawal of antihypertensive medication was attempted after 3 months of intervention. MAIN OUTCOME MEASURE: Diagnosis of high blood pressure at 1 or more follow-up visits, or treatment with antihypertensive medication, or a cardiovascular event during follow-up (range, 15-36 months; median, 29 months). RESULTS: The combined outcome measure was less frequent among those assigned vs not assigned to reduced sodium intake (relative hazard ratio, 0.69; 95% confidence interval [CI], 0.59-0.81; P<.001) and, in obese participants, among those assigned vs not assigned to weight loss (relative hazard ratio, 0.70; 95% CI, 0.57-0.87; P<.001). Relative to usual care, hazard ratios among the obese participants were 0.60 (95% CI, 0.45-0.80; P<.001) for reduced sodium intake alone, 0.64 (95% CI, 0.49-0.85; P=.002) for weight loss alone, and 0.47 (95% CI, 0.35-0.64; P<.001) for reduced sodium intake and weight loss combined. The frequency of cardiovascular events during follow-up was similar in each of the 6 treatment groups. CONCLUSION: Reduced sodium intake and weight loss constitute a feasible, effective, and safe nonpharmacologic therapy of hypertension in older persons.

Aged↗
PubMed2004

Monitoring and educational feedback to improve the compliance of tattooists and body piercers with infection control standards: a randomized controlled trial.

OBJECTIVES: Blood-borne viruses, which present a grim health and economic burden for both developed and developing countries, can be transmitted through tattooing and piercing. Limited data exist concerning intervention strategies for increasing skin penetration operators' compliance with infection control standards. We evaluated the efficacy and acceptability of an educational feedback intervention for tattooists and piercers. METHODS: A randomized controlled trial was conducted in Sydney, NSW, Australia, among 37 tattooing and body-piercing premises in 2002. RESULTS: No effects were found in terms of improved knowledge. There was a significantly greater increase in the experimental group in the perceived risk of being detected and penalized for noncompliance. There was a significantly greater improvement in the demonstration of 2 of 3 infection control procedures and a nonsignificant trend toward greater improvement in inspection scores in the experimental group. The odds of compliance were significantly higher in the experimental group for 2 of the 3 demonstration practices and in 2 of 5 observed infection control practices. CONCLUSION: The findings contribute new information concerning alternative approaches to increasing tattooists and piercers' infection control compliance with regulations/guidelines.

Communicable Disease Control↗
PubMed2002

Prospective preference assessment: a method to enhance the ethics and efficiency of randomized controlled trials.

The concomitant problems of underenrollment and selective enrollment limit the efficiency of many randomized controlled trials (RCTs). In addition, the traditional informed consent process is often inadequate to respect research participants' autonomy. Past efforts to overcome these problems are not universally applicable. A new method, called prospective preference assessment (PPA), is suggested as a way to simultaneously enhance participant accrual, identify groups of patients to whom a trial's results may apply, and promote participants' interests. PPA is a method by which investigators would evaluate potential trial participants' motivations for and concerns about enrolling in a planned trial prior to formal recruitment. The information provided by PPA would then be used to (1) modify the final trial design and conduct to make enrollment more attractive, and (2) identify ways in which the patients who do enroll may differ from those who do not, thereby elucidating the trial's generalizability. The methodologic and ethical advantages of this method are described, and potential barriers to the method's implementation are addressed. The added costs of prospectively assessing the views of potential research participants prior to initiating RCTs are considered in relation to the method's ability to enhance the value of the information to be obtained. It is concluded that PPA is a feasible approach to a more democratic and efficient research process and that its adoption would be consistent with current trends in health care.

Human Experimentation↗
PubMed2005

Training community consultants to help family members improve dementia care: a randomized controlled trial.

PURPOSE: We investigated whether community consultants could be trained to teach family caregivers a systematic behavioral approach for reducing mood and behavior problems in persons with Alzheimer's disease. DESIGN AND METHODS: This study consisted of a randomized controlled trial; we randomly assigned 95 family caregivers and care recipients with Alzheimer's disease to STAR-caregivers (STAR-C) or control groups. Masked interviewers conducted assessments at baseline, after treatment, and after 6 months. Consultants were master's-level health care professionals who were currently practicing in community settings serving older adults. We assessed the extent to which consultants were able to learn and adhere to the treatment protocol, and the relationship between adherence and measures of caregiver mood, burden, and care recipient mood and behavior. RESULTS: Community consultants were able to learn and adhere to the behavioral treatment protocol. Caregivers receiving STAR-C training showed significant improvements in depression, burden, and reactivity to behavior problems in the care recipient. There were also significant reductions in the frequency and severity of care recipient behavior problems, and improved quality of life. Results were maintained at 6-month follow-up. IMPLICATIONS: Community-based consultants successfully implemented a behavioral intervention with family caregivers of persons with Alzheimer's disease. Consequently, STAR-C seems to be a practicable and reasonable evidenced-based approach to caregiver training in actual clinical settings.

Aged↗
PubMed2006

The Can-SAD study: a randomized controlled trial of the effectiveness of light therapy and fluoxetine in patients with winter seasonal affective disorder.

OBJECTIVE: Light therapy and antidepressants have shown comparable efficacy in separate studies of seasonal affective disorder treatment, but few studies have directly compared the two treatments. This study compared the effectiveness of light therapy and an antidepressant within a single trial. METHOD: This double-blind, randomized, controlled trial was conducted in four Canadian centers over three winter seasons. Patients met DSM-IV criteria for major depressive disorder with a seasonal (winter) pattern and had scores > or = 23 on the 24-item Hamilton Depression Rating Scale. After a baseline observation week, eligible patients were randomly assigned to 8 weeks of double-blind treatment with either 1) 10,000-lux light treatment and a placebo capsule, or 2) 100-lux light treatment (placebo light) and fluoxetine, 20 mg/day. Light treatment was applied for 30 minutes/day in the morning with a fluorescent white-light box; placebo light boxes used neutral density filters. RESULTS: A total of 96 patients were randomly assigned to a treatment condition. Intent-to-treat analysis showed overall improvement with time, with no differences between treatments. There were also no differences between the light and fluoxetine treatment groups in clinical response rates (67% for each group) or remission rates (50% and 54%, respectively). Post hoc testing found that light-treated patients had greater improvement at 1 week but not at other time points. Fluoxetine was associated with greater treatment-emergent adverse events (agitation, sleep disturbance, palpitations), but both treatments were generally well-tolerated with no differences in overall number of adverse effects. CONCLUSIONS: Light treatment showed earlier response onset and lower rate of some adverse events relative to fluoxetine, but there were no other significant differences in outcome between light therapy and antidepressant medication. Although limited by lack of a double-placebo condition, this study supports the effectiveness and tolerability of both treatments for seasonal affective disorder and suggests that other clinical factors, including patient preference, should guide selection of first-line treatment.

Adult↗
PubMed1998

Randomized, controlled trial of video self-instruction versus traditional CPR training.

STUDY OBJECTIVE: We conducted a prospective, randomized, controlled trial to test the hypothesis that a 34-minute video self-instruction (VSI) training program for adult CPR would yield comparable or better CPR performance than the current community standard, the American Heart Association Heartsaver course. METHODS: Incoming freshman medical students were randomly assigned to VSI or the Heartsaver CPR course. Two to 6 months after training, we tested subjects to determine their ability to perform CPR in a simulated cardiac arrest setting. Blinded observers used explicit criteria to assess our primary outcome, CPR performance skill. In addition, we assessed secondary outcomes including sequential performance of individual skills, ventilation and chest compression characteristics, and written tests of CPR-related knowledge and attitudes. RESULTS: VSI trainees displayed superior overall performance compared with traditional trainees. Twenty of 47 traditional trainees (43%) were judged not competent in their performance of CPR, compared with only 8 of 42 VSI trainees (19%; absolute difference, 24%; 95% confidence interval, 5% to 42%). CONCLUSION: In a group of incoming freshman medical students, we found that a half-hour of VSI resulted in superior overall CPR performance compared with that in traditional trainees. If validated by further research, VSI may provide a simple, quick, and inexpensive alternative to traditional CPR instruction for health care workers and, perhaps, the general population.

Adult↗
PubMed1997

Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial.

OBJECTIVE: Cognitive behavior therapy for chronic fatigue syndrome was compared with relaxation in a randomized controlled trial. METHODS: Sixty patients with chronic fatigue syndrome were randomly assigned to 13 sessions of either cognitive behavior therapy (graded activity and cognitive restructuring) or relaxation. Outcome was evaluated by using measures of functional impairment, fatigue, mood, and global improvement. RESULTS: Treatment was completed by 53 patients. Functional impairment and fatigue improved more in the group that received cognitive behavior therapy. At final follow-up, 70% of the completers in the cognitive behavior therapy group achieved good outcomes (substantial improvement in physical functioning) compared with 19% of those in the relaxation group who completed treatment. CONCLUSIONS: Cognitive behavior therapy was more effective than a relaxation control in the management of patients with chronic fatigue syndrome. Improvements were sustained over 6 months of follow-up.

Adult↗