A randomized double blind crossover trial of diethylstilbestrol (DES) and estramustine phosphate (Emcyt) for stage D prostatic carcinoma.
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Capsules↗
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Results for “randomized crossover trial”
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Short- and long-term effects of molsidomine retard and molsidomine nonretard on exercise capacity and clinical status in patients with stable angina: a multicenter randomized double-blind crossover placebo-controlled trial.
A multicenter, randomized, double-blind, crossover, placebo-controlled study was conducted in 90 isosorbide dinitrate responders showing stable angina to compare the efficacy of molsidomine retard, 8 mg b.i.d., with that of molsidomine, 4 mg t.i.d., for 6 weeks. Total work performance (workload x min) was significantly improved, compared with baseline and placebo until 8 and 12 h after molsidomine and molsidomine retard administration, respectively. ST-segment depression decreased significantly under the two treatments at 60 W as well as at maximal exercise. The rate-pressure product (heart rate x systolic blood pressure) decreased and increased significantly at submaximal and maximal exercise level, respectively. All these effects remained significant after 6-week treatment, with only the ST segment showing a nonsignificant tendency to improvement at maximal work. The frequency of anginal attacks and of sublingual nitroderivative-tablets consumption decreased significantly with molsidomine, 4 mg, and molsidomine retard, 8 mg. However, overall results showed that the latter form reduces myocardial ischemia more efficiently at submaximal exercise level, has a more prolonged effect on exercise tolerance, and maintains it at a somewhat higher level after 6-week treatment.
Adult↗
A randomized double-blind crossover trial of intravenous lidocaine in the treatment of neuropathic cancer pain.
In a randomized, double-blind, crossover study, we evaluated the effect of intravenous lidocaine (5 mg/kg body weight over 30 min) on the neuropathic pain of advanced cancer patients. Pain intensity, assessed by a visual analogue scale, did not show any significant difference between lidocaine and placebo infusion. The blinded choice of patients and investigators also suggested no significant improvement from lidocaine when given by this regimen. Intravenous lidocaine does not appear to have a significant analgesic effect on neuropathic cancer pain.
Anesthetics, Local↗
The effect of small doses of botulinum toxin a on neck-shoulder myofascial pain syndrome: a double-blind, randomized, and controlled crossover trial.
OBJECTIVES: Myofascial pain syndrome is a common cause of muscular pain in the shoulder-neck region. Injections of large amounts of botulinum toxin A have been found to be beneficial for the alleviation of myofascial pain, but large doses of this toxin may cause paresis of the muscle and other adverse events. The aim of this work was to determine the effect of small doses (5 U) of botulinum toxin A (BTA) injected directly into the painful trigger points of the muscles, using a double-blind crossover technique. METHODS: On the basis of the empirical criteria proposed for diagnosis of myofascial pain syndrome, 31 patients suffering from myofascial pain in the neck-shoulder region were studied. The patients received either botulinum toxin A or physiological saline injections on 2 occasions 4 weeks apart. The total dose varied from 15 to 35 U of botulinum toxin A [28+/- 6 U (mean+/- SD)]. The follow-up measurements were carried out at 4 weeks after each treatment. Neck pain and result of treatment were assessed with questionnaires. The pressure pain threshold was determined using a dolorimeter. RESULTS: Neck pain values decreased from 4.3+/- 2.4 to 3.3+/- 2.0 after saline injections and from 4.1+/- 2.1 to 3.3+/- 2.2 after botulinum toxin A. The pressure pain threshold values increased from 5.2+/-1.6 to 5.9+/-1.5 and from 5.7+/-1.6 to 5.9+/-1.6 after injections with saline and botulinum toxin A, respectively. No statistically significant changes in the neck pain and pressure pain threshold values occurred between the botulinum toxin A and saline groups. After the first injections, the subjective result of treatment was significantly (P=0.008) in favor of botulinum toxin A, and after the second injections, the subjective result was better for saline, but the difference was not statistically significant (P=0.098). There was no significant difference in the prevalence of side effects between saline and botulinum toxin A. CONCLUSIONS: Our study shows that there was no difference between the effect of small doses of botulinum toxin A and those of physiological saline in the treatment of myofascial pain syndrome.
Adult↗
Randomized double-blind crossover trial of fampridine-SR (sustained release 4-aminopyridine) in patients with incomplete spinal cord injury.
A randomized double-blind dose-titration crossover trial of the safety and efficacy of oral fampridine-SR (sustained release 4-aminopyridine) was conducted on spinal cord injured (SCI) patients at two centers. Twenty-six patients (n = 26) with incomplete lesions completed the trial. These patients all had chronic (>2 years) and stable neurological deficits. They received fampridine-SR 12.5 and 17.5 mg b.i.d. over a 2-week treatment period, followed by a 1-week washout and 2 weeks of placebo, or vice versa. Patients reported significant benefit of fampridine-SR over placebo on patient satisfaction (McNemar's test, p2 < 0.05) and quality of life scores (p2 < 0.01). Sensory scores (p1 < 0.01), including both pin prick (p1 = 0.059) and light touch (p1 = 0.058), and motor scores (adjusted to reflect only paretic segments) (p1 < 0.01) all yielded evidence of benefit of fampridine-SR over placebo. The Ashworth scale of spasticity was significantly (p2 < 0.05) reduced when patients received fampridine-SR. There were no statistically significant benefits of the drug on measures of pain or bowel, bladder and sexual function, or functional independence. Side effects of lightheadedness and nausea were transient and trivial relative to efficacy, and approximately 30% of patients reported a wish to continue to use fampridine-SR. The clinical benefits most likely derive from the K+ channel blocking action of the drug. Potassium channel blockade enhances axonal conduction across demyelinated internodes and enhances neuroneuronal and neuromuscular transmission in preserved axons. These results provide the first evidence of therapeutic benefit of fampridine-SR in SCI patients.
4-Aminopyridine↗
Randomized clinical trials in single patients during a 2-year period.
OBJECTIVE: To describe the feasibility of a single patient trial (SPT) service and study the influence of formal SPTs on therapeutic precision. DESIGN: Descriptive and evaluate study of SPTs. All planned trials were double-blind, randomized, multiple crossover trials. Other key features of individual trials were random assignment of order and assessment of predetermined explicit outcomes. Patients and physicians rated level of confidence in treatment before and after the SPT on visual analog scales. SETTING: Two-year experience (September 1988 to September 1990) of an SPT trial referral service available to physicians in an academic medical center. OUTCOME MEASURES: The number of planned and completed SPTs; proportion of completed trials yielding definitive answers; patient- and physician-rated levels of confidence in treatment pre- and post-SPT; time-motion studies to estimate resource consumption (costs) for selected SPTs. RESULTS: Of 34 completed trials, 17 were judged to give definitive results whereas 17 showed trends only. Results favored active treatment in 16 trials that led to treatment being continued (nine patients) or started (seven patients). Treatment was discontinued (seven patients) or not started (11 patients) based on 18 trial results that demonstrated active treatment was ineffective (seven), harmful (two), or apparently equivalent (nine). Most patients (65%) reported no change in their already high level of confidence in therapy as a result of trials, whereas physicians' confidence levels in therapy either increased or decreased post-SPT depending on the direction of trial results. Patients consistently rated the SPT service as extremely useful. Time-motion estimates indicate that 16.75 staff hours were spent per trial leading to a direct cost estimate of approximately $450 to $500 per trial. CONCLUSION: We conclude that an SPT service is feasible, trial costs compare favorably with other conventional services, and clinicians appear to gain confidence and precision from SPTs. When patients or clinicians are uncertain about the value (including the possibility of side effects) of treatment for symptomatic chronic diseases, we believe an SPT can be offered to a patient and will likely yield results that will effect subsequent treatment.
Academic Medical Centers↗
A randomized, double-blind, crossover trial of modafinil on mood.
Modafinil, a medication for the excessive sleepiness associated with narcolepsy, has been hypothesized to improve not just alertness but mood as well. The purpose of this study was to determine how treatment with modafinil affects mood in healthy volunteers. Normal healthy volunteers (n = 12, 10 men and 2 women; 30-44 years) underwent a 3-day, counterbalanced, randomized, crossover, inpatient trial of modafinil (400 mg daily) versus placebo with 4-day washout period between 2 treatments. Mood was assessed daily using both the Positive and Negative Affect Schedule and a general mood scale, which consisted of 10 bipolar adjective ratings based on a severity scale ranging from 1 to 10. Modafinil increased general mood and Negative Affect scales relative to placebo and had a significant effect on Positive Affect scales. These results suggest that modafinil may have general mood-elevating effects accompanied by increased negative affect (anxiety). The findings may have implications for clinical practice, in particular for the adjunctive use of modafinil in treatment-resistant depression.
Administration, Oral↗
The effect of dairy product ingestion on human immunodeficiency virus-related diarrhea in a sample of predominantly gay men: a randomized, controlled, double-blind, crossover trial.
BACKGROUND: In the highly active antiretroviral therapy (HAART) era, chronic diarrhea remains common in human immunodeficiency virus (HIV) illness. Empirical lactose avoidance is often advised despite lack of evidence of benefit in a population at risk for osteopenia and malnutrition. METHODS: The a priori hypothesis was that moderate lactose ingestion would not worsen diarrhea in this population. We used a double-blind, noninferiority, randomized crossover trial in a community setting of primary and tertiary care HIV clinics. The participants all had chronic diarrhea and were a volunteer sample of 49 predominantly white HIV-infected men who have sex with men. They ingested 240 mL of low-fat milk (12 g of lactose) and lactose-free milk during 2 separate study periods. The primary outcome was mean difference in stool weight between the 2 study periods in the 8 hours after milk ingestion. Lactose was judged not to worsen diarrhea if this difference did not exceed 167 g in 8 hours with 95% certainty. RESULTS: Forty-eight (98%) of 49 participants were male. Median age, CD4 cell count, and viral load were 42 years (range, 20-62 years), 390 cells/mL (range, 20-1100 cells/mL), and 112 copies/mL (range, <50 to >500,000 copies/mL), respectively. Thirty-nine participants (80%) were taking HAART medication. Ten participants (20%) were lactase deficient. The mean difference in stool weight between the 2 study periods was -41.3 g/8 h (upper 95% confidence limit, -13.5 g) for the entire group and +11.3 g/8 h (upper 95% confidence limit, +47.4 g) for the lactase-deficient group. CONCLUSIONS: Moderate lactose ingestion does not worsen diarrhea in HIV-infected persons with chronic diarrhea, regardless of lactase status. Therefore, avoidance of modest quantities of milk may not be justified in this population.
Adult↗
The acute effect of phenylpropanolamine and brompheniramine on blood pressure in controlled hypertension: a randomized double-blind crossover trial.
STUDY OBJECTIVE: To determine the acute effect of phenylpropanolamine, 75 mg, and brompheniramine, 12 mg, in combination (PPA/B) on blood pressure in patients with controlled hypertension, using ambulatory blood pressure monitoring (ABPM). DESIGN: Randomized double-blind crossover trial. SETTING: Outpatient clinic at one medical center. PARTICIPANTS: 13 healthy volunteers aged 36 to 64 years, receiving medication for hypertension. INTERVENTIONS: Following 24-hour baseline ABPM, participants were randomized to receive either placebo or PPA/B every 12 hours for three doses, while ABPM continued. After a 24-hour washout period, all participants received the crossover regimen. MEASUREMENTS AND MAIN RESULTS: No clinically important or statistically significant difference was noted for mean systolic and diastolic blood pressures during the baseline (125/75), PPA/B (127/72), and placebo (126/73) phases of the study. Within the first four hours of treatment, the mean change in systolic blood pressure from baseline between PPA/B and placebo phases was 1.7 mm Hg (95% CI -5.3 to 8.7), and mean change in diastolic blood pressure was 0.9 mm Hg (95% CI -1.6 to 3.5), excluding a first-dose pressor effect. CONCLUSION: When used as recommended, PPA/B, a commonly used over-the-counter cold medication, has no significant acute effect on blood pressure in patients with controlled hypertension.
Blood Pressure↗
Comparison of lorazepam and zopiclone for insomnia in patients with stroke and brain injury: a randomized, crossover, double-blinded trial.
OBJECTIVES: To determine if lorazepam or zopiclone is more effective in providing a restful night of sleep and to assess the effects of these medications on cognition. DESIGN: A randomized, double-blinded, crossover trial was performed at a tertiary care rehabilitation inpatient unit in a teaching hospital. A total of 18 brain-injured and stroke patients, aged 20-78 yrs, were administered lorazepam, 0.5-1.0 mg, orally at bedtime as needed for 7 days and zopiclone, 3.75-7.5 mg, orally at bedtime as needed for 7 days. Total sleep time and characteristics of sleep were measured. Effects on cognition were also measured using the Folstein Mini Mental Status Exam. RESULTS: There was no difference in average sleep duration or in subjective measures of sleep. Cognition as assessed by the Mini Mental Status Exam revealed no difference in the zopiclone arm compared with the lorazepam arm. CONCLUSION: Zopiclone is equally effective as lorazepam in the treatment of insomnia in stroke and brain-injured patients.
Administration, Oral↗
Treatment of premenstrual dysphoric disorder with sertraline during the luteal phase: a randomized, double-blind, placebo-controlled crossover trial.
BACKGROUND: The authors designed a randomized, double-blind, crossover study to assess the efficacy of sertraline in the treatment of premenstrual dysphoric disorder (PMDD) when given only during the luteal phase of the menstrual cycle. METHOD: Thirty-one subjects were selected for a 7-month study period that included an initial 2 months of screening, 2 months of treatment with placebo or sertraline, 1 washout month, and 2 months of crossover treatment with either placebo or sertraline. Eleven subjects completed the study. Symptoms were monitored with daily reports using the Calendar of Premenstrual Experience (COPE). For each study phase, premenstrual COPE scores (7 days prior to menses) were examined using repeated measures analysis of variance. Scores were logarithmically transformed. Comparison of baseline scores between the luteal and follicular phases was examined using the paired t test. RESULTS: Analysis of COPE results during the treatment periods of the luteal phase showed a significant treatment effect, with higher scores during the placebo cycles compared with the sertraline-treated cycles (p = .0052 behavioral, p = .014 physical). CONCLUSION: This study is the first to demonstrate a significant response to a serotonin selective reuptake inhibitor used only during the luteal phase. The authors point out the importance of this finding both in terms of economic cost of patients as well as how it may add to the growing understanding of the etiology of PMDD.
1-Naphthylamine↗
Red hot chili pepper and hemorrhoids: the explosion of a myth: results of a prospective, randomized, placebo-controlled, crossover trial.
PURPOSE: Spicy foods are appreciated by a large part of the world population but have been blamed for causing hemorrhoids or exacerbating their symptoms, although no epidemiologic studies have been performed supporting this hypothesis. In this double-blind, randomized, placebo-controlled, crossover trial, we have studied the effects of a single dose of red hot chili pepper on the hemorrhoidal symptoms. METHODS: Fifty patients with second-degree and third-degree symptomatic hemorrhoids were randomly assigned to take a capsule containing red hot chili powder or placebo during lunch, scoring five hemorrhoidal symptoms (bleeding, swelling, pain, itching, and burning) on a visual analog scale. After one week, crossover treatment was administered according to the same methodology. Other treatments and foods potentially related with anorectal symptoms were discontinued during the study periods. RESULTS: Patients assigned low scores to their hemorrhoidal symptoms before the study and the scores remained unchanged during the 48 hours after both placebo and chili pepper treatment, the latter showing no statistically significant effects. CONCLUSIONS: There is no scientific evidence that a spicy meal based on red hot chili pepper may worsen hemorrhoidal symptoms and, therefore, there is no reason to prevent these patients from occasionally enjoying a spicy dish if they so wish.
Adult↗
Effect of short-term transdermal estrogen replacement therapy on sleep: a randomized, double-blind crossover trial in postmenopausal women.
OBJECTIVE: To evaluate the effect of estrogen replacement therapy on sleep architecture, arousals, and body movements. DESIGN: A 7-month, prospective, randomized, double-blind, placebo-controlled crossover trial. SETTING: Departments of obstetrics and gynecology and a university sleep center in Turku, Finland. PATIENT(S): Seventy-one postmenopausal women, 4 of whom were excluded and 5 of whom withdrew from the study; the final study group consisted of 62 women. INTERVENTION(S): Two periods of treatment with either estrogen or placebo. MAIN OUTCOME MEASURE(S): Polysomnography for measurement of sleep and arousals and a static charge-sensitive bed for monitoring of movements and breathing. Self-reports of climacteric symptoms for 14 days. RESULT(S): Estrogen effectively alleviated hot flashes, sweating, sleep complaints, and headaches. Estrogen decreased the total frequency of movement arousals but increased alpha-arousals, especially during light non-rapid eye movement sleep (stage 1). Sleep latency, distribution of sleep stages, sleep efficiency, and total sleep time were similar during treatment with estrogen and placebo. Changes in serum E2 concentrations correlated with neither subjective nor objective sleep quality. CONCLUSION(S): Estrogen replacement therapy improves objective sleep quality by alleviating the frequency of nocturnal movement arousals. It also reduces climacteric symptoms, especially vasomotor symptoms. Estrogen replacement therapy does not seem to have any effect on sleep architecture.
Aged↗
Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial.
CONTEXT: This multicenter, randomized, controlled, crossover trial of prepubertal children with cystic fibrosis (CF) tests the hypotheses that recombinant human GH (rhGH) treatment 1) improves height, weight, lean mass, and bone content irrespective of baseline measures; 2) improves clinical status and quality of life; and 3) has continued effect after cessation after 1 yr of treatment. METHODS: Sixty-one prepubertal subjects (<or=25th percentile for height and weight) were randomized into two groups: daily rhGH treatment or no treatment groups for 1 yr. In yr 2, treatments were crossed over. Outcome measures included serial standardized height and weight, number of hospitalizations and antibiotic courses, random blood glucose levels, lean mass, bone mineral content, pulmonary function, nutritional intake, and CF quality of life questionnaires. RESULTS: Groups were similar at baseline and prepubertal during the entire study. After 1 yr, GH showed significantly greater gain in height, weight, lean mass, and bone mineral content. Gain in height was similar regardless of baseline. There were fewer hospitalizations in the rhGH-treated group and improvement in CF quality of life questionnaires measures of weight and body image. There was no difference in pulmonary function between groups. Results were similar in those treated with rhGH the second year. After cessation of rhGH treatment, there was sustained effect for increased height and weight velocity, as well as accrual of bone mineral. CONCLUSION: rhGH therapy improves height and weight, decreases the number of hospitalizations, and improves quality of life in prepubertal children with CF. These effects are sustained after rhGH is discontinued.
Body Height↗
A randomized, double-blind, crossover trial of the effect of oxygen on dyspnea in patients with advanced cancer.
Dyspnea is a common symptom in palliative care. Despite this, there is uncertainty regarding the role of oxygen to treat the symptom in patients with advanced illness. This randomized, double-blind, crossover trial examined the effect of oxygen versus air on the relief of dyspnea in patients with advanced cancer. Following the blinded administration of air and oxygen via nasal prongs, 51 patients rated dyspnea and indicated preferences for the blinded treatments. On average, patients improved symptomatically with both air and oxygen, and there were no significant differences between the treatments. The subgroup of 17 hypoxic patients overall did not demonstrate a significant difference between air and oxygen, despite having improved oxygen saturations when administered oxygen. Hypoxia was corrected in 13 of 17 patients using the treatment dose of 4 L/min of oxygen. The experience of dyspnea is a complex, multifactorial phenomenon, with oxygen tension not correlating with the subjective experience. The administration of either air or oxygen via nasal prongs on average confers improvement of the symptom.
Administration, Inhalation↗
Gabapentin in the treatment of neuropathic pain after spinal cord injury: a prospective, randomized, double-blind, crossover trial.
BACKGROUND: Neuropathic pain is a common complaint after traumatic spinal cord injury (SCI). Gabapentin, a synthetic structural analogue of GABA, has been shown to have beneficial effects in the treatment of neuropathic pain in other diagnostic groups; however, no standardized clinical trial has been performed to evaluate its efficacy after SCI. DESIGN: A 10-week, prospective, randomized, double-blind, crossover, and placebo-controlled clinical trial. OBJECTIVE: To determine the efficacy of gabapentin in the treatment of SCI-related neuropathic pain. METHODS: Seven subjects with neuropathic pain, who were more than 30 days post-SCI, completed the study. Two groups received a 4-week course of gabapentin and placebo in a randomized crossover design with a 2-week washout period. The Neuropathic Pain Scale was used to record daily pain levels. Data were analyzed using the Wilcoxon signed rank test. RESULTS: Gabapentin has some beneficial effects on certain types of neuropathic pain. There was a significant decrease of "unpleasant feeling" and a trend toward a decrease in both the "pain intensity" and "burning sensation" at the fourth week of gabapentin treatment compared with those on the placebo. No significant difference was found among other pain descriptors during the gabapentin and placebo treatment, although this may have been limited by the small sample size and low maximum dosage of gabapentin. CONCLUSIONS: Gabapentin reduces certain types of neuropathic pain in the SCI population. Future studies with larger sample sizes, higher dosages, and quicker titration will help further determine the efficacy of gabapentin in the treatment of SCI-related neuropathic pain.
Acetates↗
A double-blind, randomized, placebo-controlled, crossover trial of pentoxifylline for the prevention of chemotherapy-induced oral mucositis.
Oral mucositis is a frequent side effect of cancer therapy. No effective method of prophylaxis is currently available. We conducted a randomized, double-blind, placebo-controlled, crossover trial of pentoxifylline to evaluate its potential in preventing mucositis in cancer patients receiving chemotherapy. Ten cancer patients were randomized for treatment with a 15-day course of 400 mg of pentoxifylline given orally four times daily. Concurrent chemotherapy consisted of bolus cisplatin and infusional 5-fluorouracil. Mucositis was evaluated with the use of the Oral Assessment Guide developed at the University of Nebraska. Patients completing two cycles of chemotherapy--one with pentoxifylline and one with placebo--were evaluated for prophylaxis efficacy. Comparison of the oral assessment scores of the two cycles with a two-sided Student's t test failed to demonstrate a cytoprotective effect for pentoxifylline over placebo. We conclude that pentoxifylline as given in this study is ineffective for preventing mucositis in patients receiving cisplatin and 5-FU.
Administration, Oral↗
Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study.
Enhanced airway clearance is thought to result in better-maintained pulmonary function in cystic fibrosis (CF). Postural drainage, percussion, and vibration (PDPV) have been the primary airway clearance technique (ACT) employed in CF for over 40 years. Two new airway clearance modalities are high-frequency chest wall oscillation (HFCWO) and oscillating positive expiratory pressure (OPEP). This pilot study was undertaken to evaluate the efficacy of these techniques during home use, assess patient satisfaction with them as compared to PDPV, and assess the feasibility of performing a definitive comparative trial. The prospective, randomized, multicenter crossover trial was conducted at three urban academic CF Care Centers. Twenty-nine CF patients, 9-39 years of age, participated. Subjects performed 4 weeks each of HFCWO and OPEP following 2-week lead-in/washout periods. Spirometry, lung volumes, National Institutes of Health and Petty Scores, and a satisfaction survey were performed at baseline and after each treatment period. An ACT preference survey was completed at the conclusion of the study. Twenty-four subjects completed both therapies. There were no statistically significant differences between therapies for spirometry, lung volumes, or clinical scores. No significant safety issues arose during the study period. Compliance between therapies was similar. Significant differences among therapies existed in patient satisfaction. Given a choice of therapy, 50% of subjects chose HFCWO, 37% OPEP, and 13% PDPV. This study suggests that HFCWO and OPEP are safe and as effective as patients' routine therapies when used for airway clearance in a home setting. Patient satisfaction and preference differ among ACTs and should be considered when prescribing home therapy. A definitive, multi-center, comparative study evaluating long-term efficacy of these techniques is feasible.
Adolescent↗