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At least 55 records · Page 3Linked to original sources
PubMed2004

Identifying response to acid suppressive therapy in functional dyspepsia using a random starting day trial--is gastro-oesophageal reflux important?

BACKGROUND: Single subject trials offer an alternative approach to identify and characterize responders to a specific treatment. AIM: To test a new single subject trials design, called random starting day trial, to identify acid-related symptoms in dyspepsia. METHODS: A total of 119 patients with functional dyspepsia entered a 12-day, double-blind random starting day trial. All patients started on placebo and switched to omeprazole 80 mg/day at a randomized and blinded day between day 5 and day 9, with active treatment continuing for the rest of the trial. Based on changes of a daily symptom score, response was defined as a sustained > or =50% reduction of symptoms within 3 days of active treatment. RESULTS: Thirteen of 119 patients (11%) were classified as spontaneous responders because of complete symptom relief before switching to omeprazole. Of the remaining 106 patients, 15 (15.6%) were classified as responders. Five of six (83%) responders compared with 28 of 53 (53%) non-responders had pathological reflux. Multivariate testing identified symptoms suggestive of gastro-oesophageal reflux predictive of response. CONCLUSIONS: The random starting day trial design could identify a subset of dyspeptic patients with a uniform symptomatic response to acid-suppressive therapy. Response seems to be associated with gastro-oesophageal reflux. The random starting day trial needs to be further validated to be considered as a reliable instrument in clinical research.

Anti-Ulcer Agents↗
PubMed2005

Effects of lithium on saccadic eye movements in healthy subjects in a ten-day double-blind placebo-controlled cross-over pilot study.

INTRODUCTION: Although previous studies have shown that lithium modifies eye movements or psychomotor speed, no studies have ever explored the predictive saccades or memory guided saccades during lithium administration. We took the objective to determine the influence of lithium in pseudo-random, predictive or memory-guided saccades in healthy subjects with a view to detect reduced psychomotor speed, inability to anticipate incoming events, or working memory deficits. METHODS: A ten day lithium-placebo randomized double-blind cross-over pilot study was carried out with 12 healthy male volunteers. The cognitive assessment included pseudo-random, predictive and memory guided saccades before and after lithium and placebo periods. A biological assay substantiated the lithium effect on TSH and thyroid hormones. RESULTS: There was no change in pseudo-random or memory guided saccades when comparing lithium or placebo administration. However the ratio of anticipated saccades decreased under the lithium sequence while it remained stable under placebo. Also, subjects having lithium serum levels of > 0.5 meq/l had longer latencies in anticipated saccades. CONCLUSION: The findings do not support a major effect of lithium on alertness or on working memory, although the dosage and duration of lithium was sufficient to modify TSH blood level. Nevertheless, lithium treatment was associated with decreased anticipation in predictive saccades, suggesting this could reflect a reduced ability to anticipate quick motor movements and could be related to the well-known effect of lithium as an anti-impulsive medication.

Adult↗
PubMed1983

Importance of retinal photoreceptors to the photoperiodic control of seasonal breeding in the ewe.

Two experiments were performed to determine whether the eyes are necessary for photoperiodic control of reproduction in ewes. In the first, intact and estradiol-treated ovariectomized (OVX + E) ewes were housed in each of 2 photoperiod-controlled rooms with a vasectomized ram and subjected to 90-day alternations between long and short days. Prior to blinding, long days initiated anestrus in intact ewes and a suppression of serum luteinizing hormone (LH) levels in OVX + E ewes; short days caused onset of estrous cycles and an increase in LH levels in the intact and OVX + E ewes, respectively. After 1.5 years of such photoperiodic control, all ewes were blinded by bilateral orbital enucleation. Photoperiodic control was lost following blinding, but circannual alternations between cyclicity and anestrus or high and low LH levels, were maintained in most ewes for the remaining 2.5 years of the study. In one group of OVX + E ewes, serum LH levels remained synchronized to the 90-day shifts in photoperiod for about 1 year after blinding. Once the sighted ram was removed from the room, however, the 90-day rhythm in LH disappeared and a circannual pattern of LH became evident, suggesting that blind ewes may receive photoperiodic information from a sighted ram. This possibility was supported by the results of the second experiment in which 12 additional OVX + E ewes were blinded and exposed to 90 long days and 90 short days in the absence of a sighted ram. In these ewes, serum LH levels were not controlled by the changes in photoperiod. These results are consistent with the following conclusions: 1) the eyes are necessary for perception of photoperiod in the ewe and 2) ewes have an endogenous circannual rhythm of reproduction and/or they can be controlled by other environmental signals in the absence of photoperiodic input. Further, the results lead to the hypothesis that blind ewes can receive photoperiodic information indirectly from a sighted ram.

Animals↗
PubMed1983

A 21-day double-blind study of the effect of adding sustained-release theophylline (Nuelin SA) to inhaled salbutamol in patients with asthma.

The effect of adding sustained-release theophylline tablets (Nuelin SA) in a dose of 350 and 700 mg daily to regular treatment with inhaled salbutamol was assessed in a double-blind cross-over study in 19 patients with reversible airways obstruction. In this combination, oral theophylline, even in the relatively low dose of 350 mg a day, produced a significant additional improvement in lung function. Subjectively, patients showed a preference for the combination of theophylline and inhaled salbutamol compared with the beta-stimulant alone.

Adult↗
PubMedDate not supplied

[Evaluation of the tolerance and efficiency of quinfamide, a new intraluminal amebicide, in man (one day treatment). Double blind study].

A new intraluminal amebicide (Quinfamide) was tested to assess its effectivity and tolerance for treatment of non-dysenteric intestinal amebiasis. The drug was administered to three groups of ten patients each, whom received 300, 600 and 1 200 mg. on a 24 hours schedule. Another group of ten patients received Teclozan as control drug. Diagnosis and results were judged by rectosigmoidoscopy before, 15 and 30 days after treatment. In addition, microscopic investigation of ameba was performed in freshly passed stools, before, and after 8, 15 and 30 days of treatment. Success after treatment with the three doses of Quinfamide was obtained in 89.2% of the cases. Side reactions were clinically non-significant. More experience is needed before the effectivity of the drug is stablished.

Acetamides↗
PubMed2004

Reproducibility of a symptom response to omeprazole therapy in functional dyspepsia evaluated by a random-starting-day trial design.

BACKGROUND: Satisfactory treatment options for functional dyspepsia are lacking. Single subject trial designs may identify subgroups of patients with a uniform response to therapy. AIM: To test reproducibility of response in a new random-starting-day trial design developed to identify acid-related symptoms in functional dyspepsia. METHODS: One hundred and nineteen patients with functional dyspepsia completed a 12-day, double-blind random-starting-day trial with an initial placebo run-in followed by switch to omeprazole on a randomized and blinded day (between days 5 and 9) with active treatment continuing for the rest of the trial. Response was defined as a sustained > or =50% reduction of a daily symptom-score within 3 days of active treatment. Fifty-nine patients repeated the random-starting-day trial at relapse of symptoms. RESULTS: After exclusion of placebo responders, 14% (15 of 106) were classified as responders in the first and 20% (10 of 50) in the subsequent random-starting-day trial series. Sixty-eight per cent (40 of 59) of the patients reproduced their initial response with a chance-corrected agreement of 0.29. Comparing response patterns using different symptom rating-scales showed good correlation (kappa 0.60). CONCLUSION: Reproducibility of response in a random-starting-day trial was imperfect, mainly because of the low response rates and strict response criteria. Lack of symptom stability impairs the value of the random-starting-day trial and only patients with frequent and stable symptoms should be evaluated in this design.

Anti-Ulcer Agents↗
PubMed2000

Perioperative antibiotic use in high-risk penetrating hollow viscus injury: a prospective randomized, double-blind, placebo-control trial of 24 hours versus 5 days.

BACKGROUND: The purpose of this study was to compare the safety and therapeutic efficacy of a 24-hour versus 5-day course of ampicillin/sulbactam for the prevention of postoperative infections in high-risk patients sustaining hollow viscus injury from penetrating abdominal trauma. METHODS: A total of 317 patients from four Level I trauma centers with penetrating abdominal injuries and at least one hollow viscus perforation each received one preoperative and three postoperative doses of ampicillin/sulbactam 3 g intravenously. After receiving 24 hours of unblinded ampicillin/sulbactam, patients were then randomized into one of two groups. Group 1 received 4 additional days of blinded ampicillin/sulbactam (5 days total of antibiotic), and Group 2 received 4 days of placebo (24 hours of antibiotic). Patients were assessed postoperatively for occurrence of deep surgical-site infections (intra-abdominal abscess, fasciitis, and peritonitis) and superficial (wound) surgical-site infections. Development of nonsurgical-site infections (e.g., pneumonia, urinary tract infection, phlebitis, and cellulitis) was also recorded. Continuous variables were analyzed by analysis of variance and discrete variables by the Cochran-Mantel-Haenszel chi2 test. Multivariate logistic regression analyses were also performed to identify independent risk factors for postoperative infection. RESULTS: A total of 159 patients were randomized into Group 1, and 158 patients were randomized into Group 2. The Injury Severity Score and penetrating abdominal trauma index were 18+/-8 and 21+/-13, respectively, for Group 1 and 18+/-9 and 20+/-15, respectively, for Group 2. A total of 162 (51%) patients sustained one or more colon injuries (82 in Group 1 and 80 in Group 2). There were 16 (10%) surgical-site infections in Group 1 and 13 (8%) surgical-site infections in Group 2 (p = 0.74). Group 1 patients experienced 17 (11%) nonsurgical-site infections, whereas Group 2 had 32 (20%) nonsurgical-site infections. This difference, however, was not statistically significant (p = 0.16). Only the total number of blood units transfused and the presence of a PATI score greater than or equal to 25 were found to be independently associated with the development of a postoperative surgical- and nonsurgical-site infections (p = 0.001 and p = 0.003, respectively). Of note, the presence of a colon injury was not found to be an independent risk factor (p = 0.11) for either surgical or nonsurgical site postoperative infection in our study. CONCLUSION: High-risk patients with colon or other hollow viscus injuries from penetrating abdominal trauma are at no greater risk for surgical-site or nonsurgical-site infection when treated with only a 24-hour course of a broad-spectrum antibiotic.

Adult↗
PubMed1970

Harderian gland: influence on pineal hydroxyindole-O-methyltransferase activity in neonatal rats.

A circadian rhythm has been found in hydroxyindole-O-methyltransferase activity of the pineal gland of blinded 12-day-old rats. Five additional hours of lighting can partly prevent the nocturnal increase in pineal hydroxyindole-O-methyltransferase activity in such rats. Removal of the Harderian gland abolishes this response to light in 12-day-old blinded animals, giving further support to the suggestion that this gland may function as an extraretinal photosensitive organ influencing the pineal gland in blinded suckling rats.

Animals↗
PubMed1977

Cephalothin prophylaxis in cardiac valve surgery. A prospective, double-blind comparison of two-day and six-day regimens.

A prospective, double-blind study comparing a 6 day with a 2 day regimen of cephalothin prophylaxis was conducted among 200 patients undergoing prosthetic valve replacement. No cases of endocarditis occurred during the 2 month follow-up. Sternal wound infection developed in 2.8 per cent of the 6 day group and 2.1 per cent of the 2 day group. Pneumonia developed in 8.5 per cent of the 6 day and 5.3 per cent of the 2 day group; most of the bacteria isolated were susceptible to cephalothin. Urinary tract infection developed more frequently in the 2 day group (17.0 versus 8.5 per cent), particularly during the first 6 postoperative days. Three of 11 patients with no detectable cephalothin in their sera at the close of operation developed staphylococcal wound infections, compared with 2 of 175 patients whose sera contained cephalothin at the close of surgery (p = 0.002, Fisher's exact test). A short course of prophylactic antibiotics is prudent, but there is no justification for prolonging their administration.

Cephalothin↗
PubMed1988

Double-blind comparison of 3-day versus 7-day treatment with norfloxacin in symptomatic urinary tract infections. The Inter-Nordic Urinary Tract Infection Study Group.

The therapeutic efficacy and safety of norfloxacin 400 mg twice daily for 3 or 7 days was compared in a double-blind randomized multiclinic study including 485 female general practice patients with uncomplicated symptomatic lower urinary tract infections. 373 patients were considered valid for efficacy, 193 in the 3-day treatment group and 180 in the 7-day treatment group. The short-term efficacy (elimination of significant bacteriuria 3-13 days post-treatment) was 93.8% and 96.6% in the 3 and 7-day treatment groups, respectively, and the accumulated efficacy (elimination of significant bacteriuria 3 days post-treatment up until 45 days after the first dose) 81.3% and 91.7%, respectively (p less than 0.004). The median time to disappearance of symptoms was 3 days in both groups. Norfloxacin was well tolerated in both treatment groups.

Bacteriuria↗
PubMed2001

Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial.

OBJECTIVE: To examine whether long term consumption of a probiotic milk could reduce gastrointestinal and respiratory infections in children in day care centres. DESIGN: Randomised, double blind, placebo controlled study over seven months. SETTING: 18 day care centres in Helsinki, Finland. PARTICIPANTS: 571 healthy children aged 1-6 years: 282 (mean (SD) age 4.6 (1.5) years) in the intervention group and 289 (mean (SD) age 4.4 (1.5) years) in the control group. INTERVENTION: Milk with or without Lactobacillus GG. Average daily consumption of milk in both groups was 260 ml. MAIN OUTCOME MEASURES: Number of days with respiratory and gastrointestinal symptoms, absences from day care because of illness, respiratory tract infections diagnosed by a doctor, and course of antibiotics. RESULTS: Children in the Lactobacillus group had fewer days of absence from day care because of illness (4.9 (95% confidence interval 4.4 to 5.5) v 5.8 (5.3 to 6.4) days, 16% difference, P=0.03; age adjusted 5.1 (4.6 to 5.6) v 5.7 (5.2 to 6.3) days, 11% difference, P=0.09). There was also a relative reduction of 17% in the number of children suffering from respiratory infections with complications and lower respiratory tract infections (unadjusted absolute % reduction -8.6 (-17.2 to -0.1), P=0.05; age adjusted odds ratio 0.75 (0.52 to 1.09), P=0.13) and a 19% relative reduction in antibiotic treatments for respiratory infection (unadjusted absolute % reduction -9.6 (-18.2 to -1.0), P=0.03; adjusted odds ratio 0.72 (0.50 to 1.03), P=0.08) in the Lactobacillus group. CONCLUSIONS: Lactobacillus GG may reduce respiratory infections and their severity among children in day care. The effects of the probiotic Lactobacillus GG were modest but consistently in the same direction.

Absenteeism↗
PubMed1994

Double-blind study comparing 3-day regimens of cefixime and ofloxacin in treatment of uncomplicated urinary tract infections in women.

This double-blind randomized study compared 3-day regimens of cefixime (400 mg once daily) and ofloxacin (200 mg twice a day) in the treatment of urinary tract infections in women. The respective clinical cure rates for the two groups of women were 89 and 92% after 7 days and 81 and 84% after 4 weeks. The respective microbiological cure rates (free of bacteriuria) for the two groups of women were 83 and 86% after 7 days and 77 and 80% after 28 days. A 3-day cefixime regimen seems to be as efficient as a 3-day ofloxacin regimen in the treatment of uncomplicated cystitis in women.

Adolescent↗
PubMed2005

Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial.

BACKGROUND: In an earlier 21-day, placebo-controlled trial, ziprasidone was efficacious in improving symptoms of mania and was well tolerated. To confirm these results, a similarly designed 21-day trial was conducted. METHODS: Inpatients with bipolar I disorder, manic or mixed, were randomized to ziprasidone (40 to 80 mg BID) or placebo. Efficacy rating scales were derived from the Schedule for Affective Disorders and Schizophrenia-Change Bipolar Scale (SADS-CB). SADS-CB-derived Mania Rating Scale (MRS) total score was the primary efficacy parameter. Secondary SADS-CB-derived efficacy parameters included Manic Syndrome and Behavior and Ideation Subscales, Hamilton Depression Rating Scale (HAM-D), and the Montgomery Asberg Depression Rating Scale (MADRS). The Clinical Global Impression-Severity Scale (CGI-S), the Global Assessment of Functioning (GAF), and the Positive and Negative Syndrome Scale (PANSS) were also assessed. RESULTS: Sixty-five placebo and 137 ziprasidone patients were evaluable for efficacy. Baseline-to-endpoint mean changes in MRS scores were -11.1 for ziprasidone and -5.6 for placebo (all patients, last observation carried forward [LOCF]; P < 0.01). Ziprasidone produced significantly greater improvements in Manic Syndrome (P < or = 0.01) and Behavior and Ideation Subscales (P < or = 0.001), CGI-S score, (P < or = 0.001), PANSS Total (P < or = 0.01) and Positive Subscale (P < or = 0.001) scores, and GAF (P < or = 0.001). With ziprasidone, significant improvements were observed from Day 2 onward for MRS and CGI-S at all time points except Day 4 for MRS. Treatment-related discontinuations due to adverse events were 5.8% for ziprasidone and 1.5% for placebo (P = 0.20). CONCLUSIONS: Ziprasidone was well tolerated, rapidly efficacious, and superior to placebo in improving symptoms and global illness severity in these inpatients with acute bipolar mania, both manic and mixed episodes.

Acute Disease↗
PubMedDate not supplied

Action of oral methylprednisolone in terminal cancer patients: a prospective randomized double-blind study.

A 14-day, randomized, double-blind crossover trial was carried out comparing an oral glucocorticoid, methylprednisolone (MP), against placebo for the relief of pain and other symptoms in 40 terminally ill cancer patients. After the 14-day, double-blind phase was completed, all patients were given MP for 20 days. The daily dose of MP was 32 mg, and end points of the study were pain, psychiatric status, appetite, nutritional status, daily activity, and performance. Mean intensity of pain (visual analogue, 0-100 +/- SD) was 36.8 +/- 14 after MP treatment and 57.7 +/- 15 after placebo (P less than 0.01). Following the 14-day, double-blind phase, appetite and daily activity increased in 24 of 31 patients (77%) and in 21 of 31 patients (68%) with MP, respectively; depression and analgesic consumption decreased in 22 of 31 patients (71%) and in 16 of 28 patients (57%) with MP, respectively. MP was preferred over placebo by 23 of the 31 patients (74%), and, in 22 of the 31 cases (71%), the investigator chose MP over placebo. No serious toxicity was found at the dose of MP used. It is concluded that MP increases the comfort of terminally ill cancer patients.

Activities of Daily Living↗
PubMed1989

An early pineal-induced suppression of pituitary prolactin mRNA levels in light-deprived male hamsters.

Light deprivation by blinding or exposure to short photoperiod results in depressed prolactin (PRL) cell activity and gonadal regression in the male Syrian hamster after at least 42-56 days of treatment, and both of these events can be prevented if pineal removal accompanies light deprivation. In the present study, we investigated changes in PRL cell activity after 11, 21, or 42 days of blinding by measuring changes in: (1) pituitary PRL mRNA levels; (2) newly synthesized pituitary PRL, and (3) pituitary-RIA-PRL. The purpose of this study was to characterize the early (i.e. prior to gonadal regression and loss of reproductive function) effects of light deprivation on PRL production in the pituitary gland of the male hamster, and to determine whether a reduction in PRL mRNA levels precedes the inhibition of PRL synthesis and storage. After 11, 21, and 42 days of blinding, PRL mRNA levels in the male hamster pituitary (relative PRL mRNA/pituitary) were significantly depressed compared to intact controls by 33, 41, and 65%, respectively. Pituitary PRL synthesis (dpm of 3H-PRL/pituitary) and RIA-PRL (micrograms PRL/pituitary) were significantly depressed (by 49 and 53%, respectively) only after 42 days of blinding. All of these statistically significant depressions were prevented when the surgical blinding procedure was accompanied by pineal removal. There were no differences in testicle, pituitary, or body weight as a result of treatment. These results support the hypothesis that light deprivation by blinding causes a pineal-dependent decline in PRL mRNA levels, which leads to a decrease in PRL synthesis and pituitary RIA-PRL.

Animals↗