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PubMed2006

Serotonin regulation of the human stress response.

Acute tryptophan depletion (ATD) is a technique that has been used to evaluate the effects on humans of acutely reducing serotonin neurotransmission. We have developed a model using a single breath of 35% CO(2) that activates the hormonal axis and produces autonomic and behavioural arousal, thus modelling a stress response. This study combines ATD and single breath 35% CO(2) inhalation to study stress responses in volunteers. A randomised, double-blinded, placebo-controlled, cross-over trial involving 14 healthy adult volunteers aged between 18 and 65 years was undertaken. Subjects underwent double-blind tryptophan depletion over 2 days and were then crossed over 1 week later. During each study day, at the time of peak depletion, participants were single blinded to receive a single breath of 35% CO(2) or air. This was followed 40 min later by the other gas. Psychological outcomes were assessed with the Spielberger State Anxiety Inventory (SSAI), Visual Analogue Scales (VAS), Panic Inventory (PI), Panic and Agoraphobia Scale (PSI) and Beck Depression Inventory (BDI). Physiological outcome was measured by serial plasma cortisol, prolactin and tryptophan levels, pulse and blood pressure. Tryptophan depletion did not exacerbate 35% CO(2) inhalation effects on anxiety symptoms. Single breath CO(2) robustly increased plasma cortisol levels in comparison to an air inhalation; this was less certain for prolactin levels. ATD influenced the HPA axis (associated with higher cortisol levels), apparently independent of CO(2) or air inhalation stressors. ATD and 35% CO(2) inhalation both induced a pressor response and bradycardia in these normal volunteers. Thirty-five percent CO(2) inhalation and ATD independently activate the human stress response, but do not appear to produce synergistic effects when combined, at least for the conditions produced in this study.

Adult↗

PubMed1985

Effects of a large carbohydrate load on walking performance in chronic air-flow obstruction.

The purpose of this study was to determine whether a single large liquid carbohydrate (CHO) load (920 calories) affects walking performance in patients with chronic air-flow obstruction (CAO). Walking performance was measured using the 12-min walking test. Fifteen patients with stable CAO (FEV1, 1.30 +/- 0.41 L; FVC, 3.26 +/- 0.46 L) underwent 12-min walking tests 40 min after ingestion of either CHO or placebo on consecutive days in randomized double-blind fashion. Three practice walks were performed on a preliminary day in order to eliminate learning effects. Resting measurements of ventilation (VE) and carbon dioxide output (VCO2) were obtained prior to each walking test. Carbohydrate significantly increased both VCO2 (from 0.288 +/- 0.060 to 0.372 +/- 0.057 L/min, p less than 0.001) and VE (from 15.2 +/- 3.5 to 18.5 +/- 3.1 L/min, p less than 0.001) at rest. The total 12-minute walking distance decreased from 894 +/- 199 to 847 +/- 191 m following CHO (p less than 0.005). This distance decreased in 14 of the 15 study patients. The decrease in walking distance ranged from 1.5 to 168 m (0.2 to 15.2%). From this study we conclude that a large liquid carbohydrate load adversely affects walking performance in patients with CAO. This potential impairment of functional capacity should be considered when caloric intake is increased in attempts to improve nutritional status in this patient population.

Aged↗

PubMedDate not supplied

Impact of stocking density, breed, and feathering on the prevalence of abdominal skin scratches in broiler chickens.

Associations between abdominal skin scratches and stocking density, strain of birds, and degree of feathering were investigated in a clinical trial. Four hundred eighty 1-day-old male broiler chicks from two different strains (A and B) were assigned to four groups: 1) high density (0.07 m2/bird) and strain A, 2) high density and strain B, 3) normal density (0.14 m2/bird) and strain A, and 4) normal density and strain B. Birds were examined for scratches and feathering at 28, 35, and 42 days of age. Two outcomes were considered for scratches: presence (yes/no) and severity (severe [if a deep cut or at least three superficial cuts were present]/not severe). Only the examination at 35 days of age was blind. The outcome "scratches" was significantly associated with stocking density at all ages (P < or = 0.0001), strain A at 28 days of age (P = 0.0480), and poor feathering at 35 days of age (P < or = 0.0001). The outcome "severe scratches" was significantly associated with stocking density at 35 (P = 0.0003) and 42 days of age (P = 0.0021), strain A at 35 (P = 0.0089) and 42 days of age (P = 0.0306), and poor feathering at 35 days of age (P = 0.0018). Stocking density, strain of birds, and degree of feathering could be considered as potential risk factors for abdominal scratches in broiler chickens.

Abdomen↗

PubMed1975

[A double blind comparison of naproxen and indomethacin on the after-midnight-pain of patients with morbus bechterew].

27 patients with ascertained ankylosing spondylitis experiencing constant after-midnight-pain received, following three medication-free days, in a double blind, randomized, cross-over fashion indometacin (100 g/day) and d-2-(6'-methoxy-2'-naphthyl)-propionic acid (naproxen) (500 mg/day), as suppositories, for a period of six days each. The intensity of the night-pain was recorded daily. Naproxen was shown to be equally effective as indometacin in alleviating the after-midnight backache of ankylosing spondylitis. Side effects occurred under indometacin in 5 cases, under naproxen in 3 cases.

Adult↗

PubMed2002

Randomized, comparative, double-blind study of amlodipine vs. nicardipine as a treatment of isolated systolic hypertension in the elderly.

A 90-day, multicenter, randomized, double-blind, parallel-group study was conducted to compare the efficacy of amlodipine (once a day) with nicardipine (two to three times a day), in the treatment of isolated systolic hypertension (ISH) in the elderly. Patients (n = 133) aged > or = 60 years, with ISH were randomized to receive either amlodipine 5 mg/day, or nicardipine 60 mg/day (titrated if necessary to 10 mg/day and 100 mg/day, respectively) for 90 days. Efficacy was assessed by measuring office blood pressure (BP), and 24-h ambulatory blood pressure monitoring (ABPM). The two treatments substantially and comparably reduced office systolic blood pressure (SBP) and pulse pressure (PP), and also produced a slight decrease in diastolic blood pressure (DBP). Amlodipine reduced SBP, as assessed by ABPM, to a significantly greater extent than nicardipine. Both treatments were well-tolerated. The sustained effect of amlodipine, compared with nicardipine, was reflected in its significantly greater antihypertensive activity, particularly during the nocturnal period, as assessed by ABPM. The study demonstrates that once a day dose of amlodipine is an effective antihypertensive treatment for elderly ISH patients.

Aged↗

PubMed1982

Trial of three-day and ten-day courses of amoxycillin in otitis media.

A randomised double-blind controlled trial compared three-day and 10-day courses of amoxycillin (25 mg/kg daily) in children with otitis media. Seventeen doctors from five centres admitted 84 children between the ages of 2 and 10 years. Symptoms and signs were measured on admission to the trial, on day 3, and on day 15. Mother's observations were recorded daily for 10 days. Audiograms were performed at four and 12 weeks after the end of the trial. The treatment groups showed little difference in the speed of resolution of symptoms and signs, the numbers of primary treatment failures, or the frequency of recurrent ear infections. There were no complications in either group. Most children with otitis media can probably be successfully and safely treated with no more than a three-day course of amoxycillin providing their progress is reviewed about the fifth or sixth day after treatment started. This policy could save over 1 million pounds annually in antibiotic costs.

Amoxicillin↗

PubMed1988

A comparison of nalbuphine with fentanyl for postoperative pain relief following termination of pregnancy under day care anaesthesia.

A double-blind investigation was undertaken to compare the efficacy of nalbuphine and fentanyl in the prevention of pain after day case termination of pregnancy. Forty patients were allocated randomly to receive nalbuphine 0.25 mg/kg or fentanyl 1.5 micrograms/kg immediately before induction of anaesthesia. The patients completed scores for pain and nausea, and performed a reaction time test to assess recovery. An observer assessed patient appearance at 1, 2 and 4 hours postoperatively. Patients who received nalbuphine had significantly lower pain scores at 1 hour (p less than 0.01) and 2 hours (p less than 0.05) and required significantly (p less than 0.05) less postoperative analgesia. No significant differences were found between the groups for incidence of nausea or for observer assessment of appearance. There was some evidence of psychomotor impairment at 2 hours in the nalbuphine group. Freedom from Controlled Drug Act regulations and improved analgesia with nalbuphine, render it more satisfactory for day case surgery than the more commonly used fentanyl.

Abortion, Induced↗

PubMed1983

Three-day treatment of acute lower urinary tract infections in women. A double-blind study with amoxycillin and co-trimazine.

The aim of this study was to determine if a three-day treatment of lower urinary tract infection (UTI) is effective. 215 women with symptoms of lower UTI, seen in general practice, were randomly allocated to a double-blind study and given either amoxycillin 1000 mg twice a day for three days or trimethoprim 90 mg/sulphadiazine 410 mg (co-trimazine) 2 tablets initially, then one tablet twice daily for three days. 157 women (73%) had significant bacteriuria. Therapeutic efficacy was evaluated in 146 patients. One week after treatment had started, 88% of the women in the amoxycillin group and 100% in the co-trimazine group were cured (p less than 0.01). After a follow-up period of four weeks, the cumulative relapse frequencies were 19% and 9% respectively. Adverse reactions were mild in most cases. Two patients, both on co-trimazine, had to discontinue treatment because of nausea and vomiting. Vulvovaginal irritation was more often reported by women treated with amoxycillin (n = 8) than by those treated with co-trimazine (n = 1) (p less than 0.05). It is concluded that a three-day course of amoxycillin or co-trimazine in lower UTI is safe, causes few adverse reactions, is simple to administer and comfortable for the patient. Co-trimazine seems to be more effective than amoxycillin.

Adolescent↗

PubMed2002

Chronobiotic effects of the melatonin agonist LY 156735 following a simulated 9h time shift: results of a placebo-controlled trial.

INTRODUCTION: The melatonin agonist LY 156735 (LY) is a new investigational drug under development to treat circadian rhythm disorders. The present study assessed the efficacy of LY to alleviate the symptoms of shift lag and to enhance readaptation of desynchronized circadian rhythms to a new time zone. SUBJECTS AND METHODS: Eight healthy male volunteers of age 25-35 yr participated in three identical trials of 13d duration in a temporal isolation unit separated by washout intervals. A high dose (HD) of 5 mg and a low dose (LD) of 0.5 mg of LY and placebo (PL) were administered double-blinded in a three-period cross-over design. Each trial consisted of an adaptation period, a pre-shift period for baseline measurements, a simulated 9h phase-advance shift, and a post-shift period for follow-up. The time shift was performed at 23:00h of day 6 by advancing the laboratory time to 08:00h of day 7. Double-blind study medication was administered at 14:30h on day 6, and at 22:30h on days 7-10. Subjective ratings of jet lag, alertness, tenseness, and daytime fatigue were assessed using visual analog scales (VAS) and standardized questionnaires. The objective markers of readaptation included core body temperature, wrist actigraphy, cortisol and electrolyte excretion, and a battery of computerized performance tests. RESULTS: HD but not LD enhanced the readaptation speed of all physiological rhythms investigated, as demonstrated by a significantly faster movement of acrophases towards the post-shift target time. HD (p = 0.05) significantly blunted the post-shift deterioration of performance in those tests that were sensitive to shift lag. Parameters of subjective well-being were not significantly affected by either dose. CONCLUSION: This pilot study demonstrates the chronobiotic efficacy of LY when taken at a dose of 5 mg/d.

Adaptation, Physiological↗

PubMed1984

Diclofenac and piroxicam in a double-blind trial results and methodological problems. Working Party of the Society for Rheumatology of the GDR for the Testing of Anti-rheumatic Drugs.

Diclofenac (150 mg/d) and piroxicam (20 mg/d) were compared in a cross-over trial with 12-day periods of double-blind treatment and 3-day wash-out periods. The following open phase of the trial lasted for two months and served to assess the tolerance. For this the dosage of diclofenac was reduced to 100 mg/d. 134 volunteers from 5 departments of rheumatology participated in the study. Statistical analysis showed that the two groups were of homogenous composition and that--with certain limitations--the necessary assumptions for the evaluation as a cross-over experiment were fulfilled. All tests used to determine the efficacy showed approximately parallel improvement with both formulations and in the wash-out phase this was followed by marked deterioration. The sum of the parameters for individual improvement showed a tendency in favour of piroxicam. However, clear superiority of one trial formulation over the other with respect to efficacy or tolerance could not be demonstrated by the statistical analysis.

Adult↗

PubMed1996

Double-blind comparison of the side-effect profiles of daily versus alternate-day dosing schedules in lithium maintenance treatment of manic-depressive disorder.

The side-effect profiles of daily vs. alternate-day lithium carbonate dosing schedule were compared in a double-blind study of 50 manic-depressive patients. Following a 3-month period on daily lithium maintenance treatment the patients were randomly allocated to daily or alternate-day lithium dosing aiming at maintaining the same 12-h serum concentration as prior to allocation (median 0.7 mmol/l). The daily and alternate-day median lithium doses were 700 mg and 1200 mg, respectively. There was no significant correlation between changes in the side-effect scores on the UKU side-effect rating scale and lithium dosing schedule (ordinal logistic regression), although analysis revealed a trend in favour of alternate-day dosing with respect to polyuria/polydipsia and diarrhoea (loose stool). The study thus lends no support to the hypothesis that lithium-related side-effects can be diminished by extending the interval between lithium doses from 1 to 2 days.

Adult↗

PubMed1976

Increase in the power of human memory in normal man through the use of drugs.

Nootropyl (Piracetam) a drug reported to facilitate learning in animals was tested for its effect on man by administering it to normal volunteers. The subjects were given 3x4 capsules at 400 mg per day, in a double blind study. Each subject learned series of words presented as stimuli upon a memory drum. No effects were observed after 7 days but after 14 days verbal learning had significantly increased.

Female↗

PubMed1977

Effects of constant light exposure and blindness on the oxidative metabolism of selected brain areas in male rats.

Male rats were housed in continuous illumination or blinded when 21 day-old and killed 69 days later. The continuous illumination exposure increased the weights of testes and sex accessory organs and reduced the pineal gland weight. Blindness decreased weights of testes, sex accessory organs and anterior pituitary. The oxygen consumption rate of the hypothalamus was higher in the blinded animals than in the controls and lower in the continuously illuminated rats. No one of such groups showed significant changes in the oxygen consumption by either the amygdala or the hippocampus.

Animals↗

PubMed1988

Captopril at 50 mg as well as at 100 mg once a day reduces blood pressure for up to 24 h: a double-blind randomized crossover study in mild to moderate hypertensives.

The extent and the duration of the antihypertensive effect of captopril, given once a day at a dose of 50 mg, compared with placebo and with the 100 mg once daily dose was studied in 30 mild or moderate uncomplicated essential hypertensives (mean +/- s.e.m. age 52.0 +/- 1.5 years), who responded (mean blood pressure decrease greater than 10%) to a single oral dose (12.5 mg) of captopril. According to a randomized, double-blind, crossover design, they were given 50 mg captopril four times a day, 100 mg captopril four times a day or matched placebo for 1 month. At the end of each treatment period blood pressure and heart rate were measured every 30 min from 3 h before to 2 h after the last dose. Although the heart rate did not change, mean blood pressure after the 50- and 100-mg doses of captopril was consistently significantly (P less than or equal to 0.05) lower than after placebo. The hypotensive effect peaked at the second hour and was still significant 24 h after dosing without any significant differences between the 50- and the 100-mg doses. These findings indicate that captopril, given chronically once a day at a dose of 50 mg to mild to moderate hypertensive responders, exerts its hypotensive effect up to 24 h and that doubling the dose does not increase either the extent or the duration of its action.

Blood Pressure↗

PubMed1995

Haemodynamic and renal responses to oral losartan potassium during salt depletion or salt repletion in normal human volunteers.

We examined the haemodynamic and renal response to oral losartan potassium (100 mg) during activation of the renin system in humans. Eight healthy volunteers followed a low-salt (40 mmol sodium) diet for 4 days on four occasions 2 weeks apart. Double-blind salt depletion was achieved by 3-day administration of frusemide (40 mg twice daily, b.i.d.) with placebo salt replacement, salt repletion by placebo frusemide (b.i.d.), and active salt replacement (100 mmol/day). On day 4, subjects received randomised double-blind placebo or losartan. Prestudy salt depletion was associated with nonsignificant decreases in serum sodium (138 +/- 2 mM), potassium (3.5 +/- 0.2 mM) and increased urea (6.5 +/- 1.1 mM), and creatinine (91 +/- 6 microM) as compared with screening. Prestudy (day 3) 24-h urinary volume was similar during deplete preparation (placebo 1.707 +/- 0.81 L, losartan 1.509 +/- 0.626 L) or deplete preparation (placebo 1.726 +/- 0.5 L, losartan 1.764 +/- 0.52 L), but sodium excretion was greater during replete preparation. Salt replete supine blood pressure (BP) profiles showed little effect of losartan (mean maximal supine BP -9 +/- 6 mm Hg) as compared with placebo (-1 +/- 4 mm Hg), with a similar relative result for erect BP. After salt depletion, losartan caused a greater response in both supine (-24 +/- 9) and erect (-33 +/- 15) BP than did placebo (supine -12 +/- 5, erect -14 +/- 9). In this protocol after salt depletion, losartan caused a transient increase in urea and creatinine (143 +/- 40 microML) 8 h after dosing as compared with placebo (105 +/- 13 microM).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2001

Double-blind, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day versus a 21-day low-dose oral contraceptive regimen containing 20 microg ethinyl estradiol and 75 microg gestodene.

This prospective, double-blind, randomized study was conducted to compare the contraceptive reliability, cycle control, and tolerability of a 23-day versus a 21-day oral contraceptive regimen containing 20 microg ethinyl estradiol and 75 microg gestodene. Participants took trial medication daily for 28 days, either 23 tablets with active substances plus 5 placebo tablets or 21 tablets with active substances plus 7 placebo tablets. Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of seven cycles. Efficacy data gathered from 4,878 treatment cycles (23-day regimen: 2,362 cycles; 21-day regimen: 2,516 cycles) were obtained from 703 participants (23-day regimen, n = 342; 21-day regimen, n = 361). Both preparations proved to be effective contraceptives and provided good cycle control. One pregnancy because of method failure was recorded in each treatment group. This resulted in a study Pearl Index of 0.5 for each treatment. For the 23-day regimen, 36.0% of participants reported at least one intracyclic bleeding episode during Cycles 2-4 (primary target) compared to 37.1% in the 21-day regimen. In the 23-day regimen group, intracyclic bleeding episodes were reported by 42.4% of the participants in Cycle 1 but only in 14% in Cycle 7 and in the 21-day regimen group by 44.6% in Cycle 1 and only 17.3% in Cycle 7. Overall, intracyclic bleeding was reported in 21.9% of the 23-day regimen cycles and in 22.7% of the 21-day regimen cycles.A greater number of 23-day regimen participants had shorter withdrawal bleeding periods than with the 21-day regimen. In significantly (p <0.0001) more cycles in the 23-day regimen group, participants reported withdrawal bleeding periods that lasted only 1-4 days compared to the 21-day regimen group. For the majority of the treatment cycles, the median number of bleeding days in the 23-day regimen group was 4 days and in the 21-day regimen group 5 days. Both preparations were well tolerated and showed a similar adverse events pattern. The discontinuation rate because of adverse events was low (23-day regimen, 6%; 21-day regimen, 4%). No serious vascular adverse events were reported. More than 75% of the women in both groups either lost more than 2 kg of weight or did not gain weight during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study.

Contraceptives, Oral↗

PubMed2002

Comparison of single-dose azithromycin and 12-dose, 3-day erythromycin for childhood cholera: a randomised, double-blind trial.

BACKGROUND: Cholera is a major public-health problem, with children most affected. However, effective single-dose antimicrobial regimens have been identified only for adults. Our aim was to compare the efficacy of azithromycin and erythromycin regimens in the treatment of children. METHODS: We did a double-blind, randomised study of 128 severely dehydrated children (age 1-15 years) with cholera, treated at one of two treatment centres in Bangladesh in 1999. Children were assigned single-dose azithromycin (20 mg/kg bodyweight, maximum individual dose 1 g; n=65) or 12.5 mg/kg erythromycin (maximum dose 500 mg; n=63) every 6 h for 3 days. Patients stayed in hospital for 5 days. We measured fluid balance every 6 h, and obtained a rectal swab or stool sample for culture daily. Our primary outcome measures were clinical success of treatment-ie, cessation of watery diarrhoea within 48 h-and bacteriological success-ie, absence of Vibrio cholerae O1 or O139 from cultures of stool or rectal swab samples after study day 2. Analysis was per protocol. FINDINGS: Two children in both groups withdrew from the study, and we excluded one child in the erythromycin group. Treatment was clinically successful in 48 (76%) patients who received azithromycin and 39 (65%) who received erythromycin (difference 11%, 95% CI -5 to 27, p=0.244); and bacteriologically successful in 45 (71%) and 49 (82%) patients, respectively (10%, -5 to 25, p=0.261). Patients treated with azithromycin had a shorter duration of diarrhoea (median 24 h vs 42 h; difference 12 h, 0-18 h, p=0.019) and fewer episodes of vomiting (1 vs 4; difference 1 episode, 0-3 episodes, p=0.023). INTERPRETATION: Single-dose azithromycin is as effective for treatment of cholera in children as standard erythromycin therapy, but is associated with less vomiting.

Adolescent↗

PubMedDate not supplied

Status epilepticus amauroticus secondary to meningitis as a cause of postpartum cortical blindness.

BACKGROUND AND OBJECTIVES: A patient who underwent cesarean delivery with epidural anesthesia presented 6 days postpartum with acute cortical blindness. METHODS: Initial studies included an ophthalmology consultation as well as a full neurologic workup, including cranial computed tomography, diagnostic lumbar puncture, magnetic resonance imaging, body fluid cultures, and electroencephalography. Early broad-spectrum antibiotic coverage was initiated, and because of possible epileptic activity on electroencephalogram, phenytoin was added to the treatment regimen. RESULTS: Soon after beginning the initial phenytoin dose, the patient reported full return of her vision. She was eventually discharged from the hospital in good condition. CONCLUSIONS: This case report illustrates how blindness can be related to seizure activity.

Acute Disease↗