Blood pressure of students the day before examination. A double-blind study of the effects of barbiturate and placebo.
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Adult↗
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Results for “DAY BLINDNESS”
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A double-blind comparison of once-a-day pimozide, trifluoperazine, and placebo in the maintenance care of chronic schizophrenic outpatients.
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Adult↗
Calcipotriene ointment applied once a day for psoriasis: a double-blind, multicenter, placebo-controlled study.
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Administration, Cutaneous↗
Analgesic effects of intraarticular bupivacaine after day-case arthroscopy.
A blind, prospective, randomized, controlled trial was conducted to assess the analgesic properties of intraarticular bupivacaine after day-case arthroscopy. Forty-eight patients undergoing routine arthroscopy were randomly allocated to receive 10 ml of 0.5% bupivacaine or 0.9% saline into the joint at the end of the procedure. The analgesic effects were assessed by visual analogue scales at discharge, on going to bed, and the following morning. Significant reduction in reported pain was found in the treatment groups on leaving the hospital and later the same evening, although no benefit was found the following day.
Ambulatory Care↗
The analgesic efficacy of tenoxicam versus placebo in day case laparoscopy: a randomised parallel double-blind trial.
The analgesic efficacy and duration of action of tenoxicam, an injectable non-steroidal analgesic with a long elimination half-life, were studied in day case laparoscopy in a double-blind randomised prospective parallel placebo-controlled trial. Tenoxicam 20 mg or saline was given intravenously at induction of anaesthesia in 67 women undergoing day case investigative laparoscopy for infertility or abdominal pain. Outcome measures were time to first analgesia, pain levels at 2, 4 and 24 h plus postoperative analgesic consumption in hospital and at home. The study showed no statistically significant difference in any of these measures between the two groups. Tenoxicam 20 mg intravenously immediately pre-operatively cannot be recommended for day case surgery on the basis of this study.
Adult↗
Multiclinic double-blind comparison of triazolam and flurazepam for seven nights in outpatients with insomnia.
In this two-clinic seven-day double-blind study, 0.5 mg triazolam (Halcion) was compared to flurazepam (Dalmane) in the treatment of insomnia. Two clinical investigators completed 118 outpatients, 61 on triazolam and 57 on flurazepam. Five patients, four on triazolam and one on flurazepam, discontinued because of side effects; and three patients, one on triazolam and two on flurazepam, discontinued because of ineffectiveness of the medication. Analysis of pooled data for the 110 evaluable patients showed that 0.5 mg triazolam was significantly better than 30 mg flurazepam on the following parameters: (1) how much the medication helped the patients sleep, (2) onset of sleep, (3) duration of sleep, (4) evaluation of duration of sleep, and (5) feeling of restfulness in the morning. The trend for all other parameters favored triazolam treatment, but the values did not reach statistical significance. Side effects were similar in both groups, with drowsiness being reported most frequently. No change in efficacy indicating tolerance development during the seven days of drug administration was observed in either group.
Adolescent↗
A case of cortical blindness due to carbon monoxide poisoning.
We report a case of cortical blindness occurring 7 days after acute CO poisoning with no other neurological or psychic deficits apart from denial of the blindness with visual confabulation and slight loss of retentive memory. There was scant correlation between the course of the clinical pattern, which cleared completely within 6 days, and the electroencephalographic pattern with marked and diffuse slowing, which did not recede completely during 3 months observation. CT scanning of the skull, initially within normal limits, displayed 2 weeks later a faint but diffuse hypodensity of the white substance, more marked in the occipital region, which was no longer present 80 days after the first scan.
Acute Disease↗
A comparative, randomised, double-blind study of trazodone prolonged-release and paroxetine in the treatment of patients with major depressive disorder.
OBJECTIVES: To evaluate the efficacy and safety of trazodone prolonged release compared with paroxetine in the treatment of patients with major depression. RESEARCH DESIGN AND METHODS: A total of 108 patients aged 20-68 years were enrolled in this multicentre, double-blind, double-dummy, randomised, paroxetine-controlled study. Each patient received 3 days single-blind placebo treatment followed by 6 weeks double-blind treatment with either trazodone prolonged release 150-450 mg/day (n = 55) or paroxetine 20-40 mg/day (n = 53). OUTCOME MEASURES: Efficacy was evaluated by the rate of patients responding to each treatment and considered to be in remission, and by mean changes from baseline in the Hamilton Depression Rating scale scores (HAM-D), Montgomery Asberg Depression Rating Scale scores (MADRS), and Clinical Global Impression (CGI)--Severity and Global Improvement scores. Time to onset of efficacy and safety were assessed. RESULTS: Trazodone and paroxetine were equally effective at reducing symptoms of depression and promoting remission. Onset of efficacy was slightly faster for patients treated with paroxetine. Overall, there were no significant differences between the groups at endpoint in efficacy measures, and in percentage of responders (> 85%) or patients in remission (> 65%). Sleep disorders (HAM-D subset) were significantly less evident for patients in the trazodone group at the end of the study (p < 0.05). Adverse drug reactions were reported by 35% of trazodone-treated patients (mainly of the nervous system) and 26% of paroxetine-treated patients (mainly gastrointestinal), although none was considered to be serious. CONCLUSIONS: This study showed that after a 6-week period trazodone and paroxetine are not different in reducing the symptoms of depression and, in many patients, in producing the remission of the illness. The known divergence in tolerability profile of the two medications, related to their differing pharmacological properties, was also confirmed. Trazodone may be of advantage in depressed patients with sleep difficulties.
Adult↗
A randomized double-blind trial of ondansetron alone versus in combination with dexamethasone versus in combination with dexamethasone and lorazepam in the prevention of emesis due to cisplatin-based chemotherapy.
OBJECTIVE: To compare the effectiveness and side effects of antiemetic regimens using ondansetron alone (O) versus ondansetron plus dexamethasone (OD) versus ondansetron plus dexamethasone plus lorazepam (ODA) in the prevention of emesis induced by cisplatin-based chemotherapy. DESIGN: Randomized, double-blind trial. PATIENTS AND METHODS: In this study, 75 patients who were receiving cisplatin (60 mg/m2) on day 1 and 5-fluorouracil (1,000 mg/m2) on day 2 to day 6 were enrolled. Patients were randomized to one of three treatment regimens: O, OD, or ODA. The patients assigned to O regimen received ondansetron 8 mg intravenously as a loading dose 15 minutes prior to cisplatin, then 1 mg/h continuous i.v. infusion (24 mg/day) for 48 hours. OD regimen consisted of ondansetron given as above plus dexamethasone administered at a dose of 10 mg i.v. injection every 12 hours for 3 days. ODA regimen was OD regimen plus lorazepam administered at a dose of 0.5 mg orally every 6 hours for 3 days. To ensure blinding, O group patients received 10 ml placebo-saline i.v. injection every 12 hours for 3 days, and O and OD group patients received placebo tablets orally every 6 hours for 3 days. RESULTS: One patient did not receive assigned antiemetic regimen and was excluded from the analysis. In the acute phase, complete control of emesis was seen in 85% of all patients, and there was no significant difference among the three groups (p = .442). Complete control of nausea during the acute phase was achieved in 10 patients (41.2%) treated with O regimen alone, in 23 patients (92.0%) treated with OD regimen, and in 16 patients (64.0%) treated with ODA regimen (p < .001). In the delayed phase, 68% of patients who received the three-drug combination (ODA) and 56% of patients who received the two-drug combination (OD) obtained complete control of emesis, as opposed to 29% who were given ondansetron alone (p < .021). The incidences of headache, flushing, dry mouth, hiccups, and constipation were mild and tolerable and did not differ among the three groups. DISCUSSION: Ondansetron was very effective in the prevention of nausea and vomiting during the acute phase after cisplatin administration. In treating delayed nausea and vomiting, although the results of three regimens were still disappointing, the combination of ondansetron plus dexamethasone or plus lorazepam provided superior results. Patients who received the lorazepam-containing regimen appeared more comfortable and less restless than those who were given other regimens.
Adult↗
Oxcarbazepine: double-blind, randomized, placebo-control, monotherapy trial for partial seizures.
OBJECTIVE: To evaluate the efficacy and safety of oxcarbazepine in a placebo-control trial. METHODS: A multicenter, double-blind, randomized, placebo-control, two-arm parallel group, monotherapy design was used to compare oxcarbazepine administered 1,200 mg twice daily to placebo in hospitalized patients with refractory partial seizures, including simple and complex partial seizures and partial seizures evolving to secondarily generalized seizures. Patients exited the trial after completing the 10-day double-blind treatment phase or after experiencing four partial seizures, two new-onset secondarily generalized seizures, serial seizures, or status epilepticus, whichever came first. RESULTS: Analysis of the primary efficacy variable--time to meeting one of the exit criteria--showed a statistically significant effect in favor of oxcarbazepine (p = 0.0001). The secondary efficacy variables--percentage of patients who met one of the exit criteria (p = 0.0001) and total partial seizure frequency per 9 days during the double-blind treatment (p = 0.0001)--were also statistically significant in favor of oxcarbazepine. CONCLUSION: These results demonstrate that oxcarbazepine given as monotherapy is effective and safe for the treatment of partial seizures in this paradigm.
Adolescent↗
Clinical effects of sleep deprivation and clomipramine in endogenous depression.
Three groups of ten hospitalized endogenously depressed patients were treated with clomipramine alone (CL), a combination of sleep deprivation and clomipramine (CL/SD), and a combination of sleep deprivation and placebo (PL/SD), respectively. The sleep deprivation (SD) regime consisted of two deprivations per week. Measurements by self, blind and nurse ratings were taken twice daily during the experimental period of 15 days. Self and blind ratings indicate that, on average, over the entire experimental period, CL/SD was the most effective treatment in alleviating depression. The results of the PL/SD treatment were not significantly different from those of CL. In contrast, the nurse ratings did not differentiate significantly between the CL/SD and CL groups. Hamilton depression ratings indicated significantly less depression after one week of treatment with CL/SD relative to the treatment with CL alone. After the second week, however, no such differential clinical gain was found for the CL/SD group. It is concluded that SD in combination with clomipramine as compared with CL alone induces a faster onset of improvement in depression.
Clomipramine↗
Double-blind comparison of piroxicam and indomethacin in the treatment of cervicobrachial syndrome and periarthritis scapulohumeralis (stiff shoulder).
In a 14-day double-blind multicenter trial the efficacy and safety of piroxicam was compared with that of indomethacin among patients with extra-articular rheumatic conditions marked by cervicobrachial pain. The drugs were found to have comparable overall efficacy, with over 75% of the patients in both drug groups experiencing some improvement. Piroxicam appeared to provide somewhat better results in the subpopulation with cervicobrachial syndrome, while indomethacin was marginally better among patients with periarthritis scapulohumeralis. There was a trend toward better relief of nighttime pain with piroxicam in the cervicobrachial syndrome group at week 2. Fewer adverse reactions were observed with piroxicam, and the number of patients discontinued for side effects was also lower for piroxicam (4.1%) than for indomethacin (9.5%).
Adolescent↗
Weekend holidays during methylphenidate use in ADHD children: a randomized clinical trial.
OBJECTIVE: The aim of this study was to assess whether weekend drug holidays during methylphenidate (MPH) administration would change the efficacy and tolerability to the medication in male children with Attention-Deficit Hyperactivity Disorder (ADHD). METHODS: In a 28-day, double-blind study, children with diagnoses of ADHD were randomized to receive BID MPH for 7 days a week (n = 21) or to receive BID MPH on weekdays and a placebo on weekends (n = 19). Parents completed the Conners' Abbreviated Rating Scale (ABRS) to assess ADHD symptoms and the Barkley's Side Effect Rating Scale (SERS) to assess side effects on weekends. Teachers completed the ABRS on each Monday after weekends. RESULTS: Both groups showed a significant reduction on the ABRS over time as the dose was increased. However, the group difference in the ABRS scores was not statistically significant, either on weekend parent ratings (at the endpoint, p = 0.41; effect size = 0.26) or on teachers' ratings (at the endpoint, p = 0.99; effect size = 0.002). The omission of MPH on weekends was associated with significantly less severity of insomnia (F = 3.96, d.f. = 1, p = 0.05) and a trend for less interference on appetite (F = 3.18, d. f. = 1, p = 0.08). CONCLUSION: Our findings suggest that weekend holidays during MPH administration reduce the side effects of insomnia and appetite suppression without a significant increase in symptoms, either on weekends or in the first school day after them. Possible explanations for these findings (rate-dependent response or impact of demands of the environment) are discussed in this paper.
Adolescent↗
[Postpartum amaurosis in patients with pre-eclampsia].
Cortical blindness without retinal changes is a rare complication in preeclampsia. We report two patients, both of whom developed cortical blindness one and two days post partum. In one of these patients, the blindness occurred following eclamptic seizure. In both patients the total blindness recovered fully after two and three days respectively following treatment for hypertension and cerebral edema. Spasm of small vessels in the occipital cortex is assumed to be the cause of this complication.
Adult↗
The effect of chromium picolinate on serum cholesterol and apolipoprotein fractions in human subjects.
Chromium has been implicated as a cofactor in the maintenance of normal lipid and carbohydrate metabolism. A deficiency of chromium results from diets low in biologically available chromium. Picolinic acid, a metabolite of tryptophan, forms stable complexes with transitional metal ions, which results in an improved bioavailability of the metal ion chromium. To determine whether or not chromium picolinate is effective in humans, 28 volunteer subjects were given either chromium tripicolinate (3.8 micromol [200 micrograms] chromium) or a placebo daily for 42 days in a double-blind crossover study. A 14-day period off capsules was used between treatments. Levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, and apolipoprotein B, the principal protein of the LDL fraction, decreased significantly while the subjects were ingesting chromium picolinate. The concentration of apolipoprotein A-I, the principal protein of the high-density lipoprotein (HDL) fraction, increased substantially during treatment with chromium picolinate. The HDL-cholesterol level was elevated slightly but not significantly during ingestion of chromium picolinate. Only apolipoprotein B, of the variables measured, was altered significantly during supplementation with the placebo. These observations show that chromium picolinate is efficacious in lowering blood lipids in humans.
Adult↗
Efficacy and safety of controlled-release versus immediate-release oxycodone: randomized, double-blind evaluation in patients with chronic back pain.
OBJECTIVE: To compare the efficacy and safety of controlled-release oxycodone given every 12 hours with immediate-release oxycodone given four times daily in patients with persistent back pain. DESIGN: Randomized, double-blind, active-controlled, two-period crossover trial. PATIENTS: Fifty-seven adult outpatients with stable, chronic, moderate-to-severe low back pain despite analgesic therapy were enrolled; 47 were randomized; 11 discontinued for side effects, most commonly nausea and vomiting. INTERVENTIONS: Controlled-release oxycodone tablets given every 12 hours; immediate-release oxycodone tablets given four times daily; dose titration with controlled-release or immediate-release for up to 10 days; double-blind treatment for 4-7 days each. OUTCOME MEASURES: Patients' pain scores (0 = none, 1 = slight, 2 = moderate, 3 = severe). RESULTS: Pain intensity decreased from moderate to severe at baseline to slight at the end of titration with both oxycodone formulations. The daily oxycodone dose was 40 mg or less in 68% of patients. During double-blind treatment, mean pain intensity was maintained at 1.2 (0.1 SE) with controlled-release and at 1.1 (0.1 SE) with immediate-release oxycodone. The most common adverse events were constipation, nausea, pruritus, somnolence, and dizziness. CONCLUSIONS: Controlled-release oxycodone given every 12 hours was comparable with immediate-release oxycodone given four times daily in efficacy and safety, and it provides convenient, twice-daily, around-the-clock treatment for selected patients with persistent back pain that is inadequately controlled by nonopioids or as-needed opioid therapy.
Analgesics, Opioid↗
Intravenous fluid load and recovery. A double-blind comparison in gynaecological patients who had day-case laparoscopy.
The effect of intra-operative fluid and dextrose administration upon recovery was tested in a randomised, double-blind trial. Three groups of 25 patients, each undergoing laparoscopic examination as day cases, were studied. The two groups who received fluid (20 ml/kg compound sodium lactate solution) showed significant improvement (p less than 0.05) in the variables that reflected hydration. The fluid group who also received dextrose (1 g/kg) exhibited further significant improvement. Intra-operative fluid and dextrose administration appears to confer some benefit upon recovery in patients who have minor surgery.
Adolescent↗
Double-blind clinical trial of anaesthetic premedication for use in major day surgery.
Three anaesthetic premedication regimens have been compared by double-blind controlled trial in 158 patients undergoing day-case surgery for varicose veins or hernia. Atropine plus droperidol was superior to atropine plus diazepam or atropine alone in lessening nausea and vomiting and in reducing the need for postoperative analgesia.
Adult↗