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At least 487 records · Page 27Linked to original sources
PubMed1990

Effects of pill-giving on maintenance of placebo response in patients with chronic mild depression.

Fifty outpatients with mild, chronic, mood-reactive depression whose mood improved markedly after a 10-day single-blind placebo trial were randomly assigned in a double-blind design either to have their placebo medication discontinued or to have it maintained for an additional 6 weeks. Half of the patients in each condition relapsed within 6 weeks, indicating that pill-taking itself does not influence maintenance of placebo response. Placebo response was more likely to be maintained in patients who were currently married. At the end of 3 months, the overall relapse rate was 58%. The authors raise questions about the utility of the initial 10-day placebo washout in antidepressant clinical trials, and they discuss limits on the generalizability of their findings.

Adult↗
PubMed2001

Rapid reversal of psychotic depression using mifepristone.

The rationale for treating psychotic major depression with glucocorticoid receptor (GR) antagonists is reviewed. Five patients with psychotic major depression were given 600 mg of mifepristone in a 4-day, double-blind, placebo-controlled crossover study. All the patients completed the protocol and adverse effects were not observed or reported. All of the five patients showed substantial improvements in their Hamilton Rating Scale for Depression scores while they were receiving mifepristone, and four of the five patients showed substantial improvement in their Brief Psychiatric Rating Scale scores. Little, if any, improvement was seen with placebo. These preliminary results suggest that short-term use of GR antagonists may be effective in the treatment of psychotic major depression and that additional study, perhaps using higher doses or more treatment days, seems warranted.

Adolescent↗
PubMed2001

A randomized double-blind trial of intravenous trimetazidine as adjunctive therapy to primary angioplasty for acute myocardial infarction.

BACKGROUND: Despite high patency rates, primary angioplasty for myocardial infarction does not necessarily result in optimal myocardial reperfusion and limitation of infarct size. Experimentally, trimetazidine limits infarct size, decreases platelet aggregation, and reduces leukocyte influx into the infarct zone. To assess trimetazidine as adjunctive therapy to primary angioplasty for acute myocardial infarction a prospective, double-blind, placebo-controlled pilot trial was performed. METHODS: 94 patients with acute myocardial infarction were randomized to receive trimetazidine (40 mg bolus followed by 60 mg/day intravenously for 48 h) (n=44) or placebo (n=50), starting before recanalization of the infarct vessel by primary angioplasty. Patients underwent continuous ST-segment monitoring to assess return of ST-segment deviation to baseline and presence of ST-segment exacerbation at the time of vessel recanalization. Infarct size was measured enzymatically from serial myoglobin measurements. Left ventricular angiography was performed before treatment and repeated at day 14. RESULTS: Blinded ST segment analysis showed that despite higher initial ST deviation from baseline in the trimetazidine group (355 (32) vs. 278 (29) microV, P=0.07), there was an earlier and more marked return towards baseline within the first 6 h than in the placebo group (P=0.014) (change: 245 (30) vs. 156 (31) microV respectively, P=0.044). There was a trend towards less frequent exacerbation of ST deviation at the time of recanalization in the trimetazidine group (23.3 vs. 42.2%, P=0.11). There was no difference in left ventricular wall motion at day 14, or in enzymatic infarct size. There was no side effect from treatment. Clinical outcomes were similar between groups. CONCLUSION: Trimetazidine was safe and led to earlier resolution of ST-segment elevation in patients treated by primary angioplasty for acute myocardial infarction.

Adolescent↗
PubMedDate not supplied

Neuro-ophthalmological sequelae of sickle cell disease. A case report and review of the literature.

A case of homozygous sickle cell anaemia male patient, aged 16 years is reported. The initial symptom following a sickle cell crisis was impairment of vision, progressing rapidly to complete blindness within three days. Within 4 days of admission in the hospital, he lapsed into coma and died four weeks later. Autopsy findings revealed multiple cerebral, pontine and cerebellar infarcts. The literature on neuro-ophthalmological sequelae is reviewed.

Adolescent↗
PubMed2001

Aromatization mediates testosterone's short-term feedback restraint of 24-hour endogenously driven and acute exogenous gonadotropin-releasing hormone-stimulated luteinizing hormone and follicle-stimulating hormone secretion in young men.

The present clinical study examines the neuroregulatory hypothesis that feedback restraint of LH and FSH secretion by testosterone requires in vivo aromatization. To test this postulate, we prospectively and randomly assigned 47 healthy young men to 1 of 5 parallel short-term (5-day) double-blind interventions with: 1) placebo; 2) high-dose ketoconazole (KTCZ, 400 mg orally 4 times daily) to block both Leydig-cell and adrenal steroidogenesis; 3) KTCZ and transdermal testosterone delivery (7.5 mg daily); 4) KTCZ and transdermal estradiol (0.05 mg daily); or 5) KTCZ, testosterone, and the selective and potent aromatase inhibitor, anastrazole (5 mg orally twice daily). Blood was sampled every 10 min for 27 h on the last day of intervention to quantitate 24-h mean spontaneous and 3-h post-GnRH-stimulated (100 ng/kg iv bolus) LH and FSH release. KTCZ administration lowered the serum total testosterone concentration markedly from (mean +/- SEM) 423 +/- 57 ng/dL (15 +/- 2.0 nmo/L) during placebo ingestion to 58 +/- 8.6 ng/dL (2.0 +/- 0.3 nmol/L) (P < 10(-3)). Transdermal androgen addback along with KTCZ blockade increased testosterone levels to 607 +/- 57 ng/dL (21 +/- 2.0 nmol/L). KTCZ exposure alone drove a 3-fold increase in serum LH concentrations (P < 10(-3)) and a 2.5-fold rise in FSH secretion (P = 0.015), as assessed by high-specificity immunoradiometric assays. Concomitant transdermal testosterone (or estradiol) delivery repressed the elevated secretion of both LH and FSH to mid-normal baseline values. A 3-fold administration of anastrazole, KTCZ, and testosterone completely opposed exogenous testosterone's suppression of 24-h LH and FSH secretion. Anastrazole coadministration likewise abolished testosterone-dependent inhibition of 3-h GnRH-stimulated LH and FSH release. In summary, assuming the specificity of anastrazole's inhibition of aromatase activity, we conclude that circulating testosterone in healthy men curtails endogenously driven as well as exogenous GnRH-stimulated LH and FSH secretion conditional on its in vivo aromatization.

Administration, Cutaneous↗
PubMed2006

Effects of twenty-eight days of beta-alanine and creatine monohydrate supplementation on the physical working capacity at neuromuscular fatigue threshold.

The purpose of this study was to examine the effects of 28 days of beta-alanine (b-Ala) and creatine monohydrate (CrM) supplementation on the onset of neuromuscular fatigue by using the physical working capacity at neuromuscular fatigue threshold (PWC(FT)) test in untrained men. Fifty-one men (mean age +/- SD = 24.5 +/- 5.3 years) volunteered to participate in this 28-day, double-blind, placebo-controlled study and were randomly assigned to 1 of 4 groups: placebo (PLA; 34 g dextrose; n = 13), CrM (5.25 g CrM plus 34 g dextrose; n = 12), b-Ala (1.6 g b-Ala plus 34 g of dextrose; n = 12), or b-Ala plus CrM (CrBA; 5.25 g CrM plus 1.6 g b-Ala plus 34 g dextrose; n = 14). The supplement was ingested 4 times per day for 6 consecutive days, then twice per day for 22 days before posttesting. Before and after the supplementation, subjects performed a continuous incremental cycle ergometry test while a surface electromyographic signal was recorded from the vastus lateralis muscle to determine PWC(FT). The adjusted mean posttest PWC(FT) values (covaried for pretest PWC(FT) values) for the b-Ala and CrBA groups were greater than those for the PLA group (p < or = 0.05). However, there were no differences between the CrM vs. PLA, CrBA vs. b-Ala, CrM vs. b-Ala, or CrM vs. CrBA groups (p > 0.05). These findings suggested that b-Ala supplementation may delay the onset of neuromuscular fatigue. Furthermore, there appeared to be no additive or unique effects of CrM vs. b-Ala alone on PWC(FT).

Adult↗
PubMed1986

Ranitidine, 150 mg three times a day, in the treatment of reflux oesophagitis. A placebo-controlled, double-blind study.

The effect of ranitidine, 150 mg three times a day, in the treatment of reflux oesophagitis was studied. A double-blind method was used, and 41 patients with endoscopically verified symptomatic oesophagitis were randomly allocated to ranitidine or placebo. In addition, antacid tablets could be taken as needed. Eighteen patients in both the ranitidine and the placebo groups completed the study. Endoscopically, the healing rate was significantly higher in the ranitidine group after both 6 weeks' (p less than 0.05) and 12 weeks' (p less than 0.01) treatment. The proportion of patients whose oesophagitis healed or improved was also higher in the ranitidine group (p less than 0.05). The patients receiving ranitidine used significantly (p less than 0.002) less antacids than the controls, suggesting a favourable effect of ranitidine on the symptoms of oesophagitis. The histological study did not show significant differences between the ranitidine and the placebo groups. No serious side effects were noted. Ranitidine in a dose of 150 mg three times a day is effective and safe in the treatment of reflux oesophagitis.

Clinical Trials as Topic↗
PubMed2001

Optic neuritis with transient total blindness during lactation(1).

BACKGROUND: Lactation-induced blindness is a rare but devastating puerperal complication. There are few reported cases and no consistent associated disease processes historically identified. This case illustrates lactation-associated optic neuritis as an early identifier of multiple sclerosis. CASE: A nulliparous woman underwent a term vaginal delivery complicated only by chorioamnionitis. She was treated with intravenous antibiotics, which included spontaneous bacterial endocarditis prophylaxis. Her postpartum course was uncomplicated, and she was discharged on postpartum day 2 with her infant. She was readmitted on postpartum day 16 completely blind. Evaluation revealed bilateral optic neuritis. Symptoms were initiated and exacerbated during nursing. Transitory waxing and waning of her visual deficits were noted after aggressive steroid therapy and discontinuing nursing. The patient was subsequently diagnosed with multiple sclerosis of relapsing-remitting type. CONCLUSION: Multiple sclerosis must be considered as an etiology for acute puerperal lactation-associated blindness when there is no clear anatomic or infectious cause.

Blindness↗
PubMed2004

Atorvastatin decreases the coenzyme Q10 level in the blood of patients at risk for cardiovascular disease and stroke.

BACKGROUND: Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are widely used for the treatment of hypercholesterolemia and coronary heart disease and for the prevention of stroke. There have been various adverse effects, most commonly affecting muscle and ranging from myalgia to rhabdomyolysis. These adverse effects may be due to a coenzyme Q(10) (CoQ(10)) deficiency because inhibition of cholesterol biosynthesis also inhibits the synthesis of CoQ(10). OBJECTIVE: To measure CoQ(10) levels in blood from hypercholesterolemic subjects before and after exposure to atorvastatin calcium, 80 mg/d, for 14 and 30 days. DESIGN: Prospective blinded study of the effects of short-term exposure to atorvastatin on blood levels of CoQ(10). SETTING: Stroke center at an academic tertiary care hospital. Patients We examined a cohort of 34 subjects eligible for statin treatment according to National Cholesterol Education Program: Adult Treatment Panel III criteria. RESULTS: The mean +/- SD blood concentration of CoQ(10) was 1.26 +/- 0.47 micro g/mL at baseline, and decreased to 0.62 +/- 0.39 micro g/mL after 30 days of atorvastatin therapy (P<.001). A significant decrease was already detectable after 14 days of treatment (P<.001). CONCLUSIONS: Even brief exposure to atorvastatin causes a marked decrease in blood CoQ(10) concentration. Widespread inhibition of CoQ(10) synthesis could explain the most commonly reported adverse effects of statins, especially exercise intolerance, myalgia, and myoglobinuria.

Aged↗
PubMed2001

Effect of dofetilide on the pharmacokinetics of digoxin.

The effect of dofetilide on the steady-state pharmacokinetics of digoxin was evaluated in a randomized, double-blind study. Five days of dofetilide treatment did not significantly affect steady-state pharmacokinetic variables of digoxin compared with placebo; therefore, the use of dofetilide does not necessitate an adjustment in digoxin dose to maintain therapeutic digoxin levels.

Adult↗
PubMed2001

Reemergence of sexual dysfunction in patients with major depressive disorder: double-blind comparison of nefazodone and sertraline.

BACKGROUND: Several different classes of antidepressants have been associated with sexual adverse effects. This double-blind, randomized trial compared the effects of nefazodone and sertraline on reemergence of sexual dysfunction in depressed patients who had experienced sexual dysfunction as a result of sertraline treatment. Depressive symptoms were also monitored. METHOD: One hundred five patients with DSM-III-R major depressive episode who were experiencing sexual dysfunction attributable to sertraline (100 mg/day) were screened for entry. Eligible patients entered a 1-week washout period that was followed by a 7- to 10-day single-blind placebo phase. Patients without symptoms of sexual dysfunction at the end of the single-blind placebo phase were randomly assigned to receive double-blind treatment with either nefazodone (400 mg/day) or sertraline (100 mg/day) for 8 weeks. RESULTS: Nearly 3 times more sertraline-treated patients (76%; 25/33) experienced reemergence of sexual dysfunction (ejaculatory and/or orgasmic difficulty) than did nefazodone-treated patients (26%; 10/39) (p < .001). In addition, patients treated with nefazodone were more satisfied with their sexual functioning than were patients treated with sertraline. Both treatment groups demonstrated a similar and sustained improvement in depressive symptoms. Both drugs were well tolerated, and the overall incidence of adverse reactions was similar for both treatment groups; however, 9 sertraline-treated patients (26%) discontinued because of adverse events compared with 5 nefazodone-treated patients (12%). Of the patients discontinuing therapy for adverse events, 5 of the sertraline-treated patients did so because of sexual dysfunction reported as an adverse event, whereas only 1 of the nefazodone-treated patients discontinued therapy secondary to sexual dysfunction. CONCLUSION: In this sample of patients with major depression who had recovered from sexual dysfunction induced by treatment with sertraline, nefazodone treatment resulted in significantly less reemergence of sexual dysfunction than did renewed treatment with sertraline and provided continued antidepressant activity.

Adolescent↗
PubMed2000

Adjunctive therapy with oxcarbazepine in children with partial seizures. The Oxcarbazepine Pediatric Study Group.

OBJECTIVE: To evaluate the safety and efficacy of oxcarbazepine (OXC) as adjunctive therapy in children with inadequately controlled partial seizures on one or two concomitant antiepileptic drugs (AEDs). BACKGROUND: OXC has shown antiepileptic activity in several comparative monotherapy trials in newly diagnosed patients with epilepsy, and in a placebo-controlled monotherapy trial in hospitalized patients evaluated for epilepsy surgery. DESIGN: A total of 267 patients were evaluated in a multicenter, randomized, placebo-controlled trial consisting of three phases: 1) a 56-day baseline phase (patients maintained on their current AEDs); 2) a 112-day double-blind treatment phase (patients received either OXC 30-46 mg/kg/day orally or placebo); and 3) an open-label extension phase. Data are reported only from the double-blind treatment phase; the open-label extension phase is ongoing. METHODS: Children (3 to 17 years old) with inadequately controlled partial seizures (simple, complex, and partial seizures evolving to secondarily generalized seizures) were enrolled. RESULTS: Patients treated with OXC experienced a significantly greater median percent reduction from baseline in partial seizure frequency than patients treated with placebo (p = 0.0001; 35% versus 9%, respectively). Forty-one percent of patients treated with OXC experienced a > or =50% reduction from baseline in partial seizure frequency per 28 days compared with 22% of patients treated with placebo (p = 0.0005). Ninety-one percent of the group treated with OXC and 82% of the group treated with placebo reported > or =1 adverse event; vomiting, somnolence, dizziness, and nausea occurred more frequently (twofold or greater) in the group treated with OXC. CONCLUSION: OXC adjunctive therapy administered in a dose range of 6 to 51 mg/kg/day (median 31.4 mg/kg/day) is safe, effective, and well tolerated in children with partial seizures.

Adolescent↗
PubMed2003

Analgesic efficacy of low-dose diclofenac versus paracetamol and placebo in postoperative dental pain.

AIMS: To compare the efficacy and safety of diclofenac-K (12.5 mg) vs paracetamol (500 mg) and placebo given in a flexible dosage regimen to treat pain resulting from extraction of impacted third molar teeth. METHODS: This was a 2-day, double-blind, double-dummy, randomized, parallel-group, placebo-controlled study of diclofenac-K (12.5 mg) tablets vs paracetamol (500 mg) tablets and placebo in patients with moderate or severe pain within 8 hours of extraction of impacted third molars. RESULTS: After the first 2-tablet dose, patients took on average 2.5 additional tablets of diclofenac-K or 2.4 tablets of paracetamol, almost all as 1-tablet doses. Most placebo patients discontinued by taking rescue medication (ibuprofen 200 mg) on the first day. Pain relief after the initial dose of diclofenac-K (2 x 12.5 mg) was superior to placebo (P < .01 for all efficacy outcomes) and comparable to paracetamol (2 x 500 mg). About 30% of patients in each active treatment group took rescue medication during the study, compared to 78% on placebo. About 70% in each active treatment group considered the overall pain relief to be "some," "a lot," or "complete" compared to only 15% on placebo. The incidence of adverse events in each active treatment group was low and comparable between the treatments. CONCLUSION: An initial double-dose of diclofenac-K (2 x 12.5 mg) or paracetamol (2 x 500 mg) adequately relieved the most intense postoperative pain, and the flexible multiple dose regimen (1 or 2 tablets) maintained adequate pain relief thereafter. Most patients needed only 1-tablet doses following the initial 2-tablet dose.

Acetaminophen↗
PubMed1978

The blindness of Saint Paul.

The Book of Acts in the Bible relates the story of St Paul's sudden blindness and subsequent recovery of vision. St Paul was walking along when he saw a bright light; he fell down and awoke blind. He remained blind for three days, at which time his vision returned from a "laying on of hands." Numerous theories have been proposed to account for this event. A review of the available evidence suggests that there are six additional previously unreported possible causes, which are enumerated in detail.

Arterial Occlusive Diseases↗
PubMed2005

Oral nystatin prophylaxis of Candida spp. colonization in ventilated critically ill patients.

OBJECTIVE: Colonization of multiple body sites is a leading risk factor for Candida spp. infection in intensive care unit (ICU) patients. We evaluated whether oral nystatin prophylaxis reduces Candida spp. colonization in ventilated ICU patients. DESIGN AND SETTING: Prospective, randomized, open-label study with blinded assessment of the objective primary evaluation criterion in the medical-surgical ICU of a teaching hospital. PATIENTS: The study included 98 consecutive patients mechanically ventilated for at least 48 h (mean age 58+/-19 years; mean SAPS II 40+/-11), assigned to either treatment group (n=51) or control group (n=47). Study groups were comparable for age, SAPS II, reason for admission, and immune status. INTERVENTIONS: Patients were randomized to receive oral nystatin (treatment group; 3x10(6) U per day) or no nystatin (control group). Multiple body sites (trachea, stomach, rectum, urine, groin, and blood) were tested for Candida spp. on admission and then every 3 days by mycologists blinded to group assignment, and the colonization index was determined. RESULTS: Colonization by Candida spp. developed in 25% of controls but in none of the treated patients. In multivariate analysis, the absence of nystatin prophylaxis and ICU length of stay were independently associated with Candida spp. colonization. No invasive candidiasis was diagnosed in either study group. CONCLUSIONS: Oral nystatin prophylaxis efficiently prevented Candida spp. colonization in ICU patients at low risk of developing invasive candidiasis. Further studies are needed to determine whether this strategy remains efficient in reducing Candida spp. infections in higher risk ICU patients.

Administration, Oral↗
PubMed2006

Sleep hygiene and melatonin treatment for children and adolescents with ADHD and initial insomnia.

OBJECTIVE: To evaluate the efficacy of sleep hygiene and melatonin treatment for initial insomnia in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: Twenty-seven stimulant-treated children (6-14 years of age) with ADHD and initial insomnia (>60 minutes) received sleep hygiene intervention. Nonresponders were randomized to a 30-day double-blind, placebo-controlled, crossover trial of 5-mg pharmaceutical-grade melatonin provided by the study's sponsor. RESULTS: Sleep hygiene reduced initial insomnia to <60 minutes in 5 cases, with an overall effect size in the group as a whole of 0.67. Analysis of the trial data able to be evaluated showed a significant reduction in initial insomnia of 16 minutes with melatonin relative to placebo, with an effect size of 0.6. Adverse events were generally mild and not different from those recorded with placebo treatment. The effect size of the combined sleep hygiene and melatonin intervention from baseline to 90 days' posttrial was 1.7, with a mean decrease in initial insomnia of 60 minutes. Improved sleep had no demonstrable effect on ADHD symptoms. CONCLUSION: Combined sleep hygiene and melatonin was a safe and effective treatment for initial insomnia in children with ADHD taking stimulant medication.

Adolescent↗
PubMedDate not supplied

Low molecular weight heparin in the symptomatic treatment of chronic venous insufficiency. Controlled double blind study vs calcium heparin.

Ninety patients suffering from chronic venous insufficiency were submitted to subcutaneous treatment with calcium heparin in fixed doses (5000 I.U. t.i.d.) or with different doses of a low molecular weight heparin fraction 7,500 AXaU/day or 15,000 AXaU/day) for thirty days with a double blind random design. On days 0, 15 and 30, clinical parameters were assessed (edema, painfulness, cutaneous trophic lesions, paresthesia) and laboratory tests carried out (fibrinogenemia, plasma viscosity, euglobin lysis time, general tolerance parameters); at the beginning and at the end of the study the plethysmographic indexes of maximum venous flow and venous capacitance were evaluated. Treatment with 15,000 AXaU, of low molecular weight heparin caused modifications of the clinical and instrumental parameters which were on the whole better than those caused by heparin calcium t.i.d. throughout the study. The administration of 7,500 AXaU of low molecular weight heparin was practically equivalent to the control treatment at the end of the study, although at the intermediate assessment it was slightly less effective despite the fact that it had produced significant modifications with respect to the basal values. Treatment with low molecular weight heparin, with both doses used, produced fewer side effects than the reference drug.

Adult↗