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At least 649 records · Page 36Linked to original sources

PubMed1986

An open assessment study of the acceptability, tolerability and safety of nedocromil sodium in long-term clinical use in patients with perennial asthma.

Fifty-one patients (22 male, 29 female) aged 22-60 years (mean age 41.2 years), predominantly extrinsic asthmatics, took part in this study, a follow-up to a 28-day, double-blind trial (Lal et al., Thorax 1984: 39: 809). Forty-four patients completed 12 months of treatment after a 4-week baseline; seven withdrew. A number of symptoms (e.g. coughing, wheezing, sore throat) were reported but none appeared particularly frequently; most were attributable to the technique of inhalation. After 4 weeks of treatment with nedocromil sodium (Tilade 4 mg q.i.d.), patients were encouraged to reduce use of inhaled corticosteroids (48 patients) and sodium cromoglycate (16). Inhaled bronchodilators were to be used as required and other medication was to continue as before. At the end of the study, 28 patients had stopped using inhaled steroids and 10 had significantly reduced the dosage (p less than 0.001, week 5 to end). Ten patients had stopped using sodium cromoglycate. Inhaled bronchodilator use was significantly reduced (p less than 0.001, weeks 1-8; p less than 0.05, weeks 9-12) early in the study but returned to baseline as inhaled steroid usage was reduced. Diary card assessments of wheezing and shortness of breath showed significant improvement, particularly in the early part of the study. Diary card PEFRs showed no marked changes but significant decreases, though small, were found in FEV1, FVC and PEFR on clinic visits. Clinical assessment showed improvement in the first half of the study; the differences were less marked as inhaled steroid usage declined. Final opinions of treatment effectiveness significantly favoured nedocromil sodium. This study demonstrates the acceptability, tolerability and safety of nedocromil sodium.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenal Cortex Hormones↗

PubMedDate not supplied

[Ocular findings in leukemia in childhood].

A 6 1/2 years old boy got completely blind within 3 days. Ophthalmoscopically regular findings suggested a retrobulbar opticus infiltration in a pediatric-diagnosed acute myeloic leukemia FAB-M2. A quick diagnosis and prompt cytostatic therapy combined with irradiation of the retrobulbar space opened the way for complete remission with bilateral optic atrophy. The ophthalmoscopic examination of 12 other leukemic children showed once more the involvement of the central nervous system with bilateral papilloedema, 2 times retinal hemorrhages and one vitreous bleeding; 8 children had no ocular symptoms. Comparing these findings to those described in literature, the authors point out the value of ophthalmoscopy to exclude ophthalmologic damages and to avoid side-effects of cytostatic therapy, fortunately not observed till now.

Adolescent↗

PubMed1983

Effects of oral norephedrine on common cold symptoms.

The aim of the trial was to examine the effectiveness of an oral decongestant in common cold. Thirty subjects with naturally acquired colds got a 100 mg sustained release tablet containing norephedrine on one day and a placebo tablet on another day in double blind design. Changes in nasal patency were assessed by rhinomanometry, measurement of nasal expiratory peak flow, and a self-assessment test, and the number of sneezes and of nose blowings were recorded in a 10 hours period after medication. Rhinomanometry, but not peak flow measurements showed a significant difference (p less than 0.02) two hours after medication, and the self-assessment of nasal blockage showed that the effect lasted for the entire 10 hours observation period (p less than 0.01). Nasal respiration was reestablished in half of the blocked noses. There was no effect on number of sneezes and nose blowings. In conclusion, oral norephedrine has a moderate decongestant effect, which may justify its use in adults with common colds. This symptom amelioration must be balanced against cost of therapy and risk of side effects. A prevention of otitis media and of sinusitis has not been documented in the literature.

Administration, Oral↗

PubMed1984

Nimesulide and antibiotics in the treatment of acute urinary tract infections.

A double-blind parallel 20-day trial was carried out in 40 patients with acute infectious inflammation of the urogenital tract to compare the effectiveness of antibiotic treatments alone or with concomitant use of a new non-steroidal antiinflammatory drug, 4-nitro-2-phenoxymethane sulfonanilide (nimesulide) 200 mg/d. During the course of the treatment, nimesulide plus antibiotics induced a significantly greater and more rapid improvement of the treated patients in comparison with antibiotics plus placebo, in case of prostate swelling, redness, oedema, compulsion, pollakiuria, nycturia and body temperature. The assessment on efficacy expressed by the investigator and the patient was significantly better in the case of antibiotic plus nimesulide as compared to the antibiotic treatment alone (p less than 0.01). With the improvement of clinical complaints, there resulted a significant reduction of erythrocyte sedimentation rate and of white blood cell count. In the antibiotic plus nimesulide treatment group, the laboratory parameters used as a control for the tolerability of the drug did not show any significant variation. There were no side-effects reported.

Adult↗

PubMed1980

Alprazolam compared to diazepam and placebo in the treatment of anxiety.

Alprazolam was compared to diazepam and placebo in 235 outpatients suffering from manifest anxiety. In this 28-day double-blind study, alprazolam was more effective than placebo and essentially equivalent to diazepam in alleviating the symptoms of anxiety. However, alprazolam produced a markedly lower incidence of side effects than either diazepam or placebo. Of particular note, drowsiness was reported less than half as frequently by alprazolam patients than by diazepam patients. These results were achieved with an average daily dose of 1.5 mg alprazolam compared to 18.6 mg diazepam.

Adolescent↗

PubMed1994

[Comparison of the effectiveness of olicard 40 retard and cardonit 40 prolongatum preparations in treatment of stable coronary heart disease].

The purpose of the work was a comparison of the effectiveness of representatives of two subgroups of nitrates: Olicard 40 (isosorbide mononitrate) and Cardonit 40 (isosorbide dinitrate) in the treatment of ischaemic heart disease. The studied group consisted of 52 patients with stable coronary heart disease who were given for 30 days according to "blind trial" rules either Cardonit 40 or Olicard 40 in single daily dose. The effects of the treatment were monitored, assessing the parameters during three exercise tests and two 24-hour records by the Holter method. The advantage of Olicard 40 was demonstrated, expressed by higher effectiveness in the treatment of coronary heart disease (especially its "silent" form) without development of tachyphylaxis and with lower per cent of adverse reactions.

Adult↗

PubMedDate not supplied

[Comparative study, using a placebo, of the frequency of micturition after repeated administration of piretanide SR 6 mg/day (Eurelix) to healthy volunteers].

Thirty healthy volunteers received piretanide SR 6 mg/day (n = 15) or placebo (n = 15) in a 10-day double-blind parallel-group comparative trial. 24-h urine output was significantly greater with piretanide than with placebo on D1 (1919 +/- 434 ml and 1160 +/- 335 ml respectively, p = 0.001 one-sided) as on D10 (1563 +/- 538 ml and 1236 +/- 435 ml respectively, p = 0.04 one-sided). Nevertheless the evolution of urinary output from D1 to D10 was significantly different (p = 0.008): it remained stable with placebo but diminished with piretanide. The diuretic effect of piretanide was apparent with a supplementary miction between 8 a.m. and 4 p.m. both on D1 and D10. Between 4 p.m. and 8 a.m., the number of mictions was the same in both groups. Thus piretanide SR 6 mg has a mild effect on the number of mictions; it should not alter patients' well-being.

Adult↗

PubMed1993

Lipopolysaccharide induced monocyte thromboplastin synthesis and coagulation responses in patients undergoing coronary bypass surgery after preoperative supplementation with n-3 fatty acids.

Twenty patients with coronary heart disease (CHD) and elevated serum lipids were randomized into 2 groups of 10 to receive encapsulated preparations of either a concentrated ethylester form of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil in doses of 6 g per day, given double blindly for approximately two months prior to coronary bypass surgery. Lipopolysaccharide (LPS) induced monocyte thromboplastin synthesis was studied during the preoperative period and one week following surgery. The ability of n-3 fatty acids to modify tissue factor pathway inhibitor (TFPI) and tissue plasminogen activator inhibitor (PAI-1) was also evaluated along with fibrinogen and thrombin-antithrombin III (TAT) complexes. No significant changes were noted preoperatively. Monocyte reactivity, PAI-1, fibrinogen and TAT increased significantly after surgery. These changes were not modified by preoperative loading with n-3 fatty acids.

Acute-Phase Reaction↗

PubMed1996

Prostaglandin E2 content in residual gastric juice reflects endoscopic damage to the gastric mucosa after naproxen sodium administration.

OBJECTIVES: The diagnostic potential of residual gastric juice for development of naproxen sodium-induced mucosal damage has not been explored. We studied prostaglandin E2 (PGE2) content in residual gastric juice before and after naproxen sodium administration and assessed relationships with endoscopic mucosal damage. METHODS: Thirty volunteers received the recommended over-the-counter dose (660 mg/day) of naproxen sodium or placebo in this 7-day, double-blind, endoscopically controlled, cross-over study. RESULTS: PGE2 concentration in gastric juice did not increase after placebo; naproxen significantly reduced PGE2 concentration (p < 0.001). In three subjects in whom no endoscopic changes occurred after naproxen administration, PGE2 concentration increased by 14%. In seven subjects who developed hemorrhagic changes, PGE2 concentration declined by 50% (p = 0.08). In 20 subjects who developed numerous hemorrhagic and erosive changes within the antral mucosa, PGE2 concentration declined by 70% (p < 0.001). The starting PGE2 value in subjects with severe mucosal hemorrhagic and erosive changes after naproxen was almost eightfold higher than in subjects who did not develop mucosal damage (p = 0.007) and 67% higher than in subjects with hemorrhagic changes only (p = 0.25). CONCLUSION: PGE2 measurement in residual gastric juice, aspirated before and after nonsteroidal antiinflammatory drug treatment, may be useful in monitoring mucosal damage and may identify patients who are likely to develop endoscopic mucosal changes.

Adult↗

PubMed1996

[Voluntary changes of visual evoked potentials in cases with hysteria and/or simulation].

We report a 25-year-old woman with gradual loss of visual acuteness, during puerperium and blindness in fifteen days. Two months latter she remain steady. Visual evoked potentials using monocular checkerboard pattern-reversal, were abnormal. Clinical suspicion of voluntary alteration of VEP was considered. A second VEP exploration with binocular stimulation and maneuvers of distraction were carried out. Normal VEP were recorded. Deliberate alteration of the visual evoked potential should be considered in patients suspicious of hysteria or malingering.

Adult↗

PubMed1997

Clinical evaluation of the effect of a hydrogen peroxide mouth rinse, sodium bicarbonate dentifrice, and mouth moisturizer on oral health.

The objective of this 60-day single-blind, parallel trial, using 150 subjects, was to evaluate the effect of a 20% sodium bicarbonate dentifrice, a 1.5% hydrogen peroxide solution and a mouth moisturizer on oral tissues and microflora. Subjects were randomly assigned to one of five groups. The treatments were: 1) Sage dentifrice (sodium bicarbonate). Toothette Plus containing baking soda saturated with the hydrogen peroxide solution and use of a mouth moisturizer, 2) Crest dentifrice, Toothette Plus containing baking soda saturated with the hydrogen peroxide solution and use of a mouth moisturizer, 3) Crest dentifrice, Toothette Plus containing baking soda with a control solution and no mouth moisturizer, 4) Crest dentifrice, Toothette (without baking soda), saturated with a control solution and no mouth moisturizer, and 5) Crest dentifrice, Toothette saturated with 1.5% flavored H2O2 and no mouth moisturizer. From a subgroup of 35 patients (seven from each group) buccal smears for exfoliative cytology were taken as were supragingival microbiological samples from the mesial aspect of first molars (pooled). Buccal smears were evaluated for signs of histopathological changes. Microbiological samples from supra- and subgingival plaque for P. gingivalis, P. intermedia, A. actinomycetemcomitans. A viscosus, F. nucleatum, F. sanguis and C. albicans were evaluated. Clinical parameters measured were a stain index (SI), the modified gingival index (MGI), and a plaque index (PI). There were no adverse changes in the oral microflora and no anaplastic or other pathological changes in any subjects. Clinical parameters showed a statistically significant reduction in the MGI ranging from 26.7-29.9% with no significant differences among the groups (p > 0.05). The PI showed small reductions in all groups except group 2, but the differences were not statistically significant from each other or baseline (p > 0.05). The SI revealed slight increases in all groups and no differences among the groups. It can be concluded that use of Sage dentifrice, Toothette Plus saturated with Perox-A-Mint and Sage Mouth Moisturizer are safe to oral tissues. Using these components did not result in clinically noticeable stain formation, promote plaque formation, or produce any significant adverse changes in the oral microflora.

Adolescent↗

PubMed2004

Antibiotic prophylaxis for orthognathic surgery: a prospective, randomised clinical trial.

A prospective, randomised, placebo-controlled double-blind clinical trial, compared short-term (1 day) and long-term (5 days) antibiotic prophylaxis after orthognathic surgery. Thirty four patients had single jaw or bimaxillary osteotomies and were given two perioperative doses of amoxycillin. Patients were then randomised to receive either placebo or amoxycillin for 5 days in a double-blind manner. Postoperatively the patients were monitored for infection by scoring a series of validated measurements of infection. In the postoperative period four patients required additional antibiotics in the short-term group and two in the long-term group (P = 0.67). Morbidity scores were higher in the short-term group, at 406 to 264 (P = 0.04), and when individual variables were compared there was a significant difference in the degree of swelling (P = 0.04). Although a 5-day regimen of antibiotic prophylaxis in orthognathic surgery did not decrease the incidence of postoperative infection significantly, it may decrease the morbidity of the operation.

Adolescent↗

PubMed1976

[Clinical double-blind study with two different dosages of maprotiline (150 and 225 mg per day) (author's transl)].

Effects and side-effects of 150 mg and 225 mg maprotiline per day were compared by means of a double-blind trial in 20 depressed inpatients. The first 2 days patients received a high initial dosage of 300 mg per day. Patients were examined on days 0, 2, 5, 10, 15, 20, and 30. Symptoms were evaluated by the AMP system and the Hamilton scale for depressions. Laboratory examinations were carried out on days 0, 10, 20, and 30. Exanthemas developed in five patients, three of whom were on the higher dosage. Moreover, the lower dosage caused less fine hand tremor. Coinciding with the beginning of treatment a linear decrease of depressive symptoms was noted. This demonstrates the rapid onset of the antidepressant effect. Moreover, contrary to what has been stated for antidepressants generally, the onset of action was frequently noted well before 10-20 days of treatment. Some patients improved within a few days while others needed more time. The time lag until antidepressants influence depressive symptoms shows pronounced individual differences. No significant difference between the two dosages was found. The profiles show a better antidepressant effect for the higher dosage; however, because of a higher incidence of side-effects on the higher dosage of maprotiline, it cannot be recommended as routine. On the other hand, depressive inpatients should receive a daily dosage of at least 150 mg. Our findings suggest a dose-effect relationship for maprotiline.

Adult↗

PubMed2003

A combined analysis of two studies assessing the ocular comfort of antiallergy ophthalmic agents.

BACKGROUND: Many topical agents with similar efficacies are available for the treatment of ocular allergies. In addition to efficacy, comfort is an important criterion because it affects overall patient satisfaction, compliance, and in turn efficacy. OBJECTIVE: The goal of this study was to compare the comfort profiles of permirolast, ketorolac, cromolyn, and nedocromil ophthalmic solutions using combined results from 2 separate clinical trials. METHODS: Two clinical trials were conducted. Adults with asymptomatic eyes were included in the first study. In this single-center, 7-day, prospective, double-blind, single-dose, crossover, parallel-group study, subjects were randomized to be bilaterally dosed with pemirolast, cromolyn, or ketorolac at each of 3 visits. Study 2 was a single-center, 1-day, prospective, randomized, double-blind, single-dose, contralateral, active-control study in which subjects received pemirolast in 1 eye and nedocromil in the contralateral eye. In both studies, subjects completed a pre- and postinstillation ocular comfort questionnaire: the primary variable was overall ocular discomfort, measured on a 4-point scale original to these studies (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Half-increments were permitted. Secondary variables included burning/stinging, foreign-body sensation, tearing, and photophobia. RESULTS: Forty-five subjects (29 women, 16 men; mean [SD] age, 35.9 [12.6] years) were enrolled in study 1; 48 subjects (30 women, 18 men; mean [SD] age, 33.6 [10.2] years) were enrolled in study 2. In study 1, overall discomfort was significantly lower with pemirolast than with cromolyn (P = 0.001) or ketorolac (P < 0.001). In terms of overall discomfort, the number of subjects with a clinically significant increase (>/=1 unit) in score was significantly lower with pemirolast compared with ketorolac (P = 0.021). Burning/stinging and tearing were also significantly lower with pemirolast than with cromolyn (P < 0.001 and P = 0.014, respectively). Mean changes in score compared with preinstillation were consistently lower with pemirolast than with cromolyn for both burning/stinging (P < 0.001) and tearing (P = 0.014). In study 2, overall discomfort was significantly lower with pemirolast than with nedocromil (P < 0.001). The number of subjects with a clinically significant increase in overall discomfort score was significantly lower with pemirolast than with nedocromil (P = 0.007). No changes in ocular tolerability parameters were reported in either study. CONCLUSION: In these single-dose studies, pemirolast was found to be significantly more comfortable than cromolyn, ketorolac, or nedocromil.

Administration, Topical↗

PubMed1999

A placebo-controlled study of the effects of L-tryptophan in patients with premenstrual dysphoria.

In a randomized controlled clinical trial, 37 patients with premenstrual dysphoric disorder were treated with L-tryptophan 6 g per day and 34 were given placebo. The treatments were given under double-blind conditions for 17 days, from the time of ovulation to the third day of menstruation, during three consecutive cycles. Visual Analog Mood Scales revealed a significant (p = 0.004) therapeutic effect of L-tryptophan relative to placebo for the cluster of mood symptoms comprising the items dysphoria, mood swings, tension and irritability. These results suggest that increasing serotonin synthesis during the late luteal phase of the menstrual cycle is therapeutic in patients with premenstrual dysphoric disorder.

Adult↗

PubMed2001

Early neurohormonal effects of trandolapril in patients with left ventricular dysfunction and a recent acute myocardial infarction: a double-blind, randomized, placebo-controlled multicentre study.

Angiotensin-converting enzyme inhibitors improve long-term survival in patients with left ventricular dysfunction after a myocardial infarction, but their mechanism of action is not entirely clear. The neurohormonal effects may be important in this respect, as well as an early hemodynamic unloading induced by these drugs. The primary objective was to assess the effect of trandolapril on plasma levels of atrial natriuretic peptide. A secondary objective was to assess the effects of trandolapril on selected neurohormones, vasoactive peptides and enzymes, which may be important in the development of left ventricular remodeling and heart failure following an acute myocardial infarction. A total of 119 patients with an acute myocardial infarction and a wall motion index < or =1.2 (16-segment echocardiographic model) were randomized to double blind treatment with trandolapril or placebo within 3-7 days after the onset of infarction. Blind treatment was discontinued 21 days after the index infarction. Venous blood samples were collected at rest, before randomization and on the day after treatment was discontinued. At the end of the study, there were no differences in plasma levels of atrial natriuretic peptide between the two treatment groups. Angiotensin-converting enzyme activity was suppressed and plasma renin activity was higher in the trandolapril group. No differences in plasma levels of N-terminal pro-atrial natriuretic peptide, brain natriuretic peptide, aldosterone, noradrenaline, adrenaline, vasopressin, big endothelin-1 and neuropeptide Y were found between the two treatment groups. There were positive correlations between several markers of neurohormonal activation at baseline and variables expressing left ventricular dysfunction and clinical heart failure. Neurohormonal activation is related to left ventricular dysfunction. The effects of 2-3 weeks of angiotensin-converting enzyme inhibition on neurohormonal activation does not predict the already established beneficial long-term effects after myocardial infarction. Thus, early modulation of circulatory neurohormone levels may not be a major mechanism for the efficacy of angiotensin-converting enzyme inhibitors in these patients. Selected plasma hormone markers may still be used to identify patients who might get the greatest benefit from treatment.

Aged↗

PubMed1999

A placebo-controlled clinical trial of L-tryptophan in premenstrual dysphoria.

BACKGROUND: Antidepressant drugs, including specific serotonin reuptake inhibitors, have been shown to be beneficial in the treatment of premenstrual dysphoric disorders. The present study tests the efficacy of L-tryptophan, which acts specifically on serotonergic neurons, in this disorder. METHODS: In a randomized controlled clinical trial, 37 patients with premenstrual dysphoric disorder were treated with L-tryptophan 6 g per day, and 34 were given placebo. The treatments were administered under double-blind conditions for 17 days, from the time of ovulation to the third day of menstruation, during three consecutive menstrual cycles. RESULTS: The Visual Analogue Scales (VAS) revealed a significant (p = .004) therapeutic effect of L-tryptophan relative to placebo for the cluster of mood symptoms comprising the items of dysphoria, mood swings, tension, and irritability. The magnitude of the reduction from baseline in maximum luteal phase VAS-mood scores was 34.5% with L-tryptophan compared to 10.4% with placebo. CONCLUSIONS: These results suggest that increasing serotonin synthesis during the late luteal phase of the menstrual cycle has a beneficial effect in patients with premenstrual dysphoric disorder.

Adult↗

PubMed2001

Similar therapeutic serum levels attained with emulsified and oil-based preparations of coenzyme Q10.

Studies of the therapeutic efficacy of coenzyme Q10 (CoQ10) have been confounded by the variable bioavailability of numerous CoQ10 preparations. The aims of the present study were to determine the early serum levels attained by two different preparations of CoQ10, a soybean oil-based preparation and a complex micelle emulsion and to assess whether these preparations of oral CoQ10 influence plasma lipid profiles. Twelve healthy individuals received 300 mg CoQ10 daily of either preparation for 7 days in a double-blind cross-over design with a 21-day washout period. Blood samples to determine serum levels of CoQ10 and lipids were taken at baseline, after 24 h and 7 days. Both preparations induced significant increases in serum CoQ10 levels at 24 h and 7 days. These were for soy oil: baseline 0.27 +/- 0.03 mol/L, 24 h 0.50 +/- 0.04 mol/L (180%) and 7 days 0.80 +/- 0.05 mol/L (291%), mean +/- SEM: for emulsion: baseline 0.29 +/- 0.03 mol/L, 24 h 0.45 +/- 0.03 mol/L (150%) and 7 days 0.79 +/- 0.06 mol/L (270%). There were no significant differences between CoQ10 levels for the two preparations at either time point. There was no change in any of the serum lipids following the 7 days treatment. We conclude that administration of either a soy oil suspension or a complex emulsion of CoQ10 increases serum levels to the therapeutic range within 1 week.

Adult↗