Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “DAY BLINDNESS”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 415 records · Page 23Linked to original sources
PubMed1984

Reproductive performance in dairy cows following postpartum treatment with gonadotrophin releasing hormone and/or prostaglandin: a field trial.

Three hundred and five Holstein Friesian cows were given either 250 micrograms gonadotrophin releasing hormone (GnRH) or saline on day 15 postpartum followed by 500 micrograms cloprostenol or saline on day 24 postpartum. Four treatment groups were formed using random allocation: Group I -- placebo (Day 15)/placebo (Day 24), Group II -- GnRH (Day 15)/placebo (Day 24), Group III -- placebo (Day 15)/cloprostenol (Day 24), Group IV -- GnRH (Day 15)/cloprostenol (Day 24). Double blind techniques were used during the follow-up period. Rectal palpation, to assess uterine involution and ovarian activity was performed just prior to each treatment and again at 28 days postpartum. In addition blood samples were collected at 15, 24 and 28 days postpartum for measurement of plasma progesterone. There were no significant differences among treatment groups with respect to services per conception, number of heats detected before first service and culling for infertility. Cows treated only with GnRH had an increased calving to first estrus and calving to first breeding interval, and tended to have an increased calving to conception interval. Treatment with cloprostenol significantly decreased calving to conception and calving to first observed estrus intervals. Treatment with GnRH on day 15 postpartum resulted in a significant increase in the subsequent incidence of pyometra and prebreeding anestrus. On the other hand, cloprostenol treatment on day 24 postpartum resulted in a decreased incidence of pyometra, regardless of GnRH treatment and a decreased incidence of prebreeding anestrus in GnRH treated cows compared to cows receiving only GnRH at day 15 postpartum.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1991

Cocaine reduction in unmotivated crack users using carbamazepine versus placebo in a short-term, double-blind crossover design.

On the basis of cocaine-caused kindling in animals and the usefulness of carbamazepine in treating kindling-type seizures, carbamazepine has been tried in clinical settings with cocaine-dependent individuals. This report presents findings of a 20-day, double-blind, placebo-controlled crossover study in 32 nontreatment-motivated, paid, chronic crack cocaine users. Carbamazepine significantly lowered the mean number of positive urine specimens compared with placebo. Of clinical importance, serum carbamazepine levels of 4 micrograms/ml (17 mumol/L) or more were associated with greater improvement. A consistent, clinically important trend linked therapeutic levels with improvement for all subjective and objective outcome variables. Comparison of daily acknowledged cocaine use or professed cocaine abstinence, with cocaine use indicated by daily urinalysis in these chronic cocaine users, has suggested the possibility of cocaine saturation as an important methodologic limitation inherent in outpatient studies of cocaine use in humans.

Administration, Oral↗
PubMedDate not supplied

[Psychogenic blindness caused by a command to kill].

Corporal H.M. was detailed to shoot Jews as a member of a firing squad in 1941 during the German advance in White Russia. First at all, a shooting practice was to take place on the subsequent day. He became blind in his right eye overnight and as a right-handed marksman was no longer able to shoot properly. He was transferred to the front, where he was wounded. He spent 18 months in military and civil hospitals and a sanatorium until he was discharged from the army in the middle of the war because of his weak vision and "autonomic vasomotor neurosis". His psychogenic amblyopia lasted 52 years until he was afflicted with amaurotic blindness in his left eye owing to an attack of glaucoma which had not been treated in time. The vision of his right eye increased again for the first time to 0.1 (10%), but remained reduced owing to a brunescent cataract.

Adult↗
PubMed1984

Failure of once daily inhaled corticosteroid treatment to control chronic asthma.

Twelve patients with chronic asthma received either high dose beclomethasone once a day or standard doses of beclomethasone three times a day in a double blind crossover trial to determine whether inhalation once a day would be sufficient. With the once a day regimen peak expiratory flow rates fell significantly, symptoms of nocturnal asthma increased, and two patients withdrew from the study because of worsening asthma. Whether control can be achieved with steroids inhaled once a day by simply increasing the total daily dose remains to be seen.

Adult↗
PubMed2005

Long-term use of sedative hypnotics in older patients with insomnia.

BACKGROUND AND PURPOSE: Insomnia is a common problem that increases with age and can last months to years. While substantial data establish the efficacy and safety of short-acting hypnotic therapy for the management of short-term insomnia using benzodiazepines receptor agonists (BzRAs), there are few studies on the continued efficacy and safety of these drugs when used for sustained periods. This paper reports the results of a 1-year open-label extension phases of two randomized, double-blind trials of zaleplon. PATIENTS AND METHODS: In the open-label phase, older patients self-administered zaleplon nightly from 6 to 12 months and were then followed through a 7-day single-blind placebo-controlled run-out period. RESULTS: The safety profile in this population of older adults was similar to that observed in a short-term trial of an equivalent population. The data also suggested that long-term therapy produced and maintained statistically significant improvement in time to persistent sleep onset, duration of sleep and number of nocturnal awakenings (P<0.001 for each variable) for treatment durations of up to 12 months. Discontinuation was not associated with rebound insomnia. CONCLUSION: The open-label trial of long-term hypnotic therapy with zaleplon 5 and 10 mg suggests that they are safe and effective for the treatment of insomnia in older patients. Placebo-controlled, double-blind trials are needed in zaleplon and other BzRAs to confirm these results.

Acetamides↗
PubMed2002

Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring.

BACKGROUND: Cysteinyl leukotrienes are important proinflammatory mediators believed to have a role in allergic rhinitis. OBJECTIVE: This multicentre, randomized, double-blind, placebo- and active-controlled trial evaluated the effectiveness and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, for treating patients with seasonal allergic rhinitis. METHODS: After a 3- to 5-day, single-blind placebo run-in period, 1302 male and female patients (aged 15-81 years) with active allergic rhinitis symptoms were randomly assigned to receive montelukast 10 mg (n = 348), loratadine 10 mg (n = 602), or placebo (n = 352) administered once daily at bedtime for 2 weeks during the spring allergy season. RESULTS: Mean patient characteristics and symptom scores at baseline were similar for the three treatment groups. The primary end-point, daytime nasal symptoms score (mean of nasal congestion, rhinorrhea, nasal pruritus, and sneezing scores; 0-3 scale), improved from baseline during treatment by (least squares mean, 95% confidence interval) - 0.37 (- 0.43, - 0.31), - 0.47 (- 0.52, - 0.43), and - 0.24 (- 0.29, - 0.18) in the montelukast, loratadine, and placebo groups, respectively (P < or = 0.001 comparing each active treatment with placebo). Mean changes from baseline in all other diary-based scores, including night-time and eye symptom scores, were significantly greater for each active treatment than for placebo. The rhinoconjunctivitis quality of life overall score improved significantly with montelukast and with loratadine as compared with placebo. Montelukast and loratadine showed a safety profile comparable to that of placebo. CONCLUSION: Montelukast is well tolerated and provides improvements in daytime and night-time symptoms, as well as quality of life parameters, for patients with seasonal allergic rhinitis.

Acetates↗
PubMed1986

Pressor response of oral tyramine in healthy men given amiflamine and placebo.

During two baseline challenge tests, oral tyramine (50 to 400 mg) was given to 12 healthy men to find each individual's cardiovascular pressor response. All 12 subjects "tolerated" 200 mg oral tyramine, but three of the 12 developed an increment in systolic blood pressure greater than 30 mm Hg when given a dose of 400 mg. Thereafter, amiflamine, 5 mg bid (n = 8), or placebo, 1 capsule twice a day (n = 4), were given in a double-blind fashion for 7 days, and oral tyramine challenge tests (12.5 to 400 mg) were given on days 5 to 7. During dosing with amiflamine or placebo, no subject tolerated 400 mg oral tyramine and no difference between the two regimens was found with regard to tyramine response. Plasma concentrations of amiflamine and two of its metabolites were measured on days 4 to 7. Steady-state concentrations were reached within 4 to 5 days. Plasma concentrations of tyramine after 400 mg tyramine showed a positive correlation with the increase in systolic blood pressure (P less than 0.001).

Administration, Oral↗
PubMed1984

Effect of flutamide or cyproterone acetate on pituitary and testicular hormones in normal men.

To test the effects of antiandrogen treatment on the endocrine system 20 normal young men were treated with 750 mg/day flutamide [4-nitro 3'-trifluoromethylisobutyranilide (FLU)] or 100 mg/day cyproterone acetate (CPA) for 14 days followed or preceded by a placebo treatment of the same duration 4 weeks apart. Allocation of both drugs and sequence of active and placebo substance was by random number in a double blind design. On days 1 and 14 two basal blood samples were obtained 15 min apart followed by an iv injection of 25 micrograms GnRH and 10 mg metoclopramide (MTCL). Subsequently blood samples were taken after 25, 45, 60, and 90 min. On day 8 the GnRH/MTCL test was performed after 13 basal blood samples were obtained to establish a baseline for PRL concentrations unbiased by short term stress. After 14 days of FLU treatment, serum testosterone (T) increased significantly [17.4 +/- 1.4 (SE) vs. 26.9 +/- 1.5 nmol/liter, as well as estradiol (E2) concentrations (144 +/- 12 vs. 177 +/- 20 pmol/liter). Dihydrotestosterone increased slightly after 14 days of FLU administration (1.59 +/- 0.14 vs. 1.98 +/- 0.30 nmol/liter). At the same time basal LH concentrations were significantly elevated (5.9 +/- 0.5 vs. 8.6 +/- 0.6 ng/ml), whereas FSH levels were not affected (2.8 +/- 0.6 vs. 2.8 +/- 0.6 ng/ml). No changes in PRL values were detected throughout treatment with FLU. The effect of CPA was quite different. At the end of the treatment phase, serum T levels were reduced considerably (14.6 +/- 1.8 vs. 3.3 +/- 0.4 nmol/liter). Serum E2 decreased similarly (95 +/- 13 vs. 35 +/- 6 pmol/liter). Conversion of T to dihydrotestosterone was also diminished significantly (1.72 +/- 0.33 vs. 1.14 +/- 0.33 nmol/liter). Both gonadotropins were significantly depressed after 14 days of CPA administration (LH, 5.6 +/- 0.7 vs. 2.8 +/- 0.4 ng/ml; FSH, 2.4 +/- 0.3 vs. 1.4 +/- 0.2 ng/ml). Basal PRL levels were not affected, although the response of MTCL was reduced at the end of the treatment phase. Both drugs reduced the response of LH and FSH to GnRH administration.

Adult↗
PubMed1988

Reproductive performance of dairy cows following treatment with cloprostenol 26 and/or 40 days postpartum: a field trial.

One hundred and seventy Holstein Friesian cows were randomly assigned to receive either 500 ug cloprostenol or saline placebo on Day 26 postpartum followed by 500 ug cloprostenol or saline on Day 40 postpartum. Four treatment groups were formed: Group 1-saline (Day 26)/saline (Day 40); Group 2-cloprostenol/(Day 26) saline (Day 40); Group 3-saline (Day 26)/cloprostenol (Day 40); Group 4-cloprostenol (Day 26)/cloprostenol (Day 40). Double blind techniques were used in administering treatments and in assessing the response to treatment. Palpation of the reproductive tract per tectum and uterine biopsies were performed on 92 cows prior to each treatment at Day 26 and Day 40 postpartum. Progesterone concentrations were determined on milk samples collected prior to treatment. There were no significant differences among treatment groups with respect to services per conception, number of heats detected before first service and culling for infertility. Cloprostenol treatment at Day 26 appeared to delay the first estrus, but it reduced the number of days to conception after the first service. Cows receiving cloprostenol at Days 26 and/or 40 had a decreased calving-to-conception interval compared to controls (P=0.01). Sequential therapy with two doses of cloprostenol resulted in slightly better reproductive performance than either treatment on Day 26 or 40 alone. Treatment with cloprostenol resulted in a decrease in the subsequent incidence of pyometra (P<0.05). It is concluded that in the herd studied, cloprostenol therapy at Day 26 and/or 40 postpartum was beneficial to reproductive performance. Although it was anticipated that cloprostenol would be more effective in cows with elevated progesterone levels, the opposite was observed at the Day 26 cloprostenol treatment. Uterine biopsy at Days 26 and/or 40 had a detrimental effect on subsequent reproductive performance.

Journal Article↗
PubMed1998

Transdermal fentanyl for pain control in adults with chronic cancer pain.

The transdermal therapeutic system (TTS) for fentanyl is a drug-delivery system for use in patients with chronic pain who require an opioid analgesic. A multicentre, randomized, double-blind, placebo-controlled study was performed to evaluate the efficacy and safety of TTS-fentanyl as an analgesic for chronic cancer pain. One hundred and thirty-eight patients entered a 15-day dose-titration period, followed by a 9-day double-blind period (95 patients) with TTS-fentanyl or placebo. Fifty-five patients entered a follow-up period of indefinite duration. For the majority of patients, TTS-fentanyl 50-75 µg/h provided effective analgesia. Due to an unexpectedly high placebo response, it was not possible to show fentanyl to be statistically superior to placebo at the 5% significance level. Nine patients treated with fentanyl and 13 treated with placebo were withdrawn from the study during the double-blind therapy because of insufficient efficacy (not significant), while 66% of fentanyl-treated patients experienced effective pain control compared with 48% of placebo-treated patients (p=0.071). During the course of the double-blind therapy, the mean dose of rescue morphine increased slightly more in the placebo group than in the fentanyl group. At the end of the double-blind phase, the investigators rated trial medication as being 'good' or 'excellent' in 30 patients in the fentanyl group and 23 in the placebo group. TTS-fentanyl appeared to be well tolerated, with a low incidence of constipation, somnolence and nausea. Due to an unexpectedly high placebo response it was not possible to demonstrate fentanyl to be statistically superior to placebo. This may reflect the practical difficulties of performing clinical trials in cancer patients with great inter-individual variability. Copyright 1998 European Federation of Chapters of the International Association for the Study of Pain.

Journal Article↗
PubMed2001

Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial.

OBJECTIVE: To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder (OCD) with a double-blind, placebo-controlled, multicenter study. METHOD: Subjects, aged 8 to 17 years, meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994. After a 7- to 14-day single-blind, placebo washout/screening period, subjects were randomly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks. Subjects who had not responded after 6 weeks could discontinue the double-blind phase of the study and enter a long-term, open-label trial of fluvoxamine. Analyses used an intent-to-treat sample with a last-observation-carried-forward method. RESULTS: Mean Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores with fluvoxamine were significantly (p < .05) different from those with placebo at weeks 1, 2, 3, 4, 6, and 10. Significant (p < .05) differences between fluvoxamine and placebo were observed for all secondary outcome measures at all visits. Based on a 25% reduction of CY-BOCS scores, 42% of subjects taking fluvoxamine were responders compared with 26% taking placebo. Forty-six (19 fluvoxamine, 27 placebo) of 120 randomized subjects discontinued early. Adverse events with a placebo-adjusted rate greater than 10% were insomnia and asthenia. CONCLUSIONS: Fluvoxamine has a rapid onset of action and is well tolerated and efficacious for the short-term treatment of pediatric OCD.

Adolescent↗
PubMed2006

Traveler's diarrhea in Thailand: randomized, double-blind trial comparing single-dose and 3-day azithromycin-based regimens with a 3-day levofloxacin regimen.

BACKGROUND: Traveler's diarrhea in Thailand is frequently caused by Campylobacter jejuni. Rates of fluoroquinolone (FQ) resistance in Campylobacter organisms have exceeded 85% in recent years, and reduced fluoroquinolone efficacy has been observed. METHODS: Azithromycin regimens were evaluated in a randomized, double-blind trial of azithromycin, given as a single 1-g dose or a 3-day regimen (500 mg daily), versus a 3-day regimen of levofloxacin (500 mg daily) in military field clinics in Thailand. Outcomes included clinical end points (time to the last unformed stool [TLUS] and cure rates) and microbiological end points (pathogen eradication). RESULTS: A total of 156 patients with acute diarrhea were enrolled in the trial. Campylobacter organisms predominated (in 64% of patients), with levofloxacin resistance noted in 50% of Campylobacter organisms and with no azithromycin resistance noted. The cure rate at 72 h after treatment initiation was highest (96%) with single-dose azithromycin, compared with the cure rates of 85% noted with 3-day azithromycin and 71% noted with levofloxacin (P=.002). Single-dose azithromycin was also associated with the shortest median TLUS (35 h; P=.03, by log-rank test). Levofloxacin's efficacy was inferior to azithromycin's efficacy, except in patients with no pathogen identified during the first 24 h of treatment or in patients with levofloxacin-susceptible Campylobacter isolates, in whom it appeared to be equal to azithromycin. The rate of microbiological eradication was significantly better with azithromycin-based regimens (96%-100%), compared with levofloxacin (38%) (P=.001); however, this finding was poorly correlated with clinical outcome. A higher rate of posttreatment nausea in the 30 min after receipt of the first dose (14% vs. <6%; P=.06) was observed as a mild, self-limited complaint associated with single-dose azithromycin. CONCLUSIONS: Single-dose azithromycin is recommended for empirical therapy of traveler's diarrhea acquired in Thailand and is a reasonable first-line option for empirical management in general.

Adult↗
PubMed1999

Randomized, double-blind, comparative study of levofloxacin and ofloxacin in the treatment of complicated urinary tract infections.

Levofloxacin, the optical S-(-) isomer of ofloxacin, was compared with ofloxacin in the treatment of complicated urinary tract infections (UTIs). Patients eligible for the trial were randomly assigned to either a daily 300 mg of levofloxacin or 600 mg of ofloxacin for 10 consecutive days. The double blind design was achieved by a double-dummy technique utilizing placebo of both test drugs. Efficacy variables measured were: urine white blood cell counts for the effects on pyuria, urine cultures for effects on bacteriuria, subjective symptoms, and overall clinical efficacy which combined results from effects on bacteriuria, pyuria and subjective symptoms. Safety endpoints were the incidence of adverse events and laboratory test monitoring after a 10-day treatment. A total of 104 patients were enrolled into this trial and 46 patients were evaluable for efficacy endpoints. Most patients with culture-negative (48 cases), mixed flora (5 cases), and less than 10,000 colony forming units/mL of bacteria (3 cases) were excluded from analyses. None of the demographic and baseline characteristics were significantly different between treatments (p > 0.05). Therapeutic effects upon bacteriuria for both treatment groups were similar with a response rate of 90.0% for levofloacin and 88.5% for ofloxacin. Efficacy on the subjective symptoms revealed response rates of 90.0% in the levofloxacin group and 80.7% in the ofloxacin group, with the overall clinical efficacy of 90% in the levofloxacin and 84.6% in the ofloxacin groups. All the efficacy variables measured between treatments were not statistically different which indicated an equivalent efficacy in the treatment of complicated UTIs (p > 0.05). Of the 104 patients exposed to the test medications, only three having adverse effects. One developed epigastralgia in the levofloxacin group, and 2 developed a headache in the ofloxacin treatment. All events were moderate in severity and were resolved quickly after medication. Four laboratory data abnormalities were observed (defined by 25% as exceeding the normal range), and were considered to not be related to the test medications. Both antibiotics were efficacious in the treatment of complicated UTIs (response rates ranging from 80 to 90%) and were well tolerated. Levofloxacin demonstrated comparable antibacterial effects and safety profiles with double potency dosage, compared to the ofloxacin.

Adult↗
PubMed2004

[Influence of nutritional status on the effectiveness of a dietary supplement of live lactobacillus to prevent and cure diarrhoea in children].

The influence of undernutrition on the effectiveness of a dietary supplement of live lactobacillus regarding prevention and treatment of infantile diarrhoea was studied on 200 children 6 to 24m old. Children, undernourished (D) or controls (C), received for 90 days, in a blind experiment, a fermented milk providing L. Acidofilus y L. Casei (10(7)-10(8)/ml) (LB) or an equivalent amount of fluid milk (L). diarrhoea episodes were recorded and classified according duration: 1-4, 5-14 days, and protracted diarrhea (DP) those lasting beyond 14 days. Study requirements were fulfilled by 119 children: D-L: n=25; D-LB: n=32; C-L: n=27 y C-LB: n=35. Preventive aspects were evaluated through number of episodes and through their lasting the therapeutic ones. Episodes recorded were 134: 29 in D-L; 48 in D-LB; 37 in C-L and 20 in C-LB. In the D-LB group over 90% episodes were very short (1-4 days), percentage far higher to that observed in D-L and similar to C-LB. There were 12 episodes of DP, 9 D and 3 in C, all in the L groups. In conclusion, although the fermented milk prevent half episode in the controls but not in the undernourished, it was able to shorter episodes duration and prevent protracted diarrhoea irrespectively of nutritional status. Therefore, undernutrition impaired the ability of the lactobacillus supplement to prevent children diarrhoea, which implicates immune system, but not curative effects which are the result of local actions.

Analysis of Variance↗
PubMed1992

Double-blind randomized study comparing the efficacies and safeties of a short (3-day) course of azithromycin and a 5-day course of amoxicillin in patients with acute exacerbations of chronic bronchitis.

The efficacies and safeties of a three-dose regimen of azithromycin (500 mg once daily for 3 days) and a 15-dose regimen of amoxicillin (500 mg three times daily for 5 days) were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. A total of 92% of patients suffered a type 1 exacerbation. Treatment success, defined as cure or major improvement, was achieved in all patients in the azithromycin group by day 5, compared with 23 (92%) of 25 patients in the amoxicillin group. On day 12, these data were 24 of 25 (96%) in the azithromycin group and 20 of 25 (80%) in the amoxicillin group (results were not significantly different). Several pathogens were isolated (MIC ranges [micrograms per milliliter] in parentheses): Haemophilus influenzae or Haemophilus parainfluenzae was isolated 23 times (azithromycin, less than or equal to 0.06 to 32; amoxicillin, 0.12 to 2); Streptococcus pneumoniae was isolated from 11 patients (azithromcyin, less than or equal to 0.06 greater than 256; amoxicillin, less than or equal to 0.06 to 0.25); Moraxella (Branhamella) catarrhalis was isolated from eight patients (azithromycin, less than or equal to 0.06; amoxicillin, less than or equal to 0.06 to 16); and other members of the family Enterobacteriaceae were isolated from eight patients. One patient treated with azithromycin had Legionella pneumophila pneumonia, and another in that group had a significant rise in titer of antibody against influenza A virus. One patient treated with amoxicillin also had a significant rise in titer of antibody against influenza A virus. Microbiological response rates were comparable. One patient who received azithromycin developed abnormal liver function. Two patients treated with amoxicillin developed abnormal liver functions, one developed exanthema, and one treatment was stopped because of nausea. It is concluded that a three-dose (3-day) regimen of azithromycin is as effective clinically and microbiologically as a 15-dose (5-day) regimen of amoxicillin in the treatment of acute exacerbations of chronic bronchitis.

Aged↗
PubMed2001

Efficacy of azelastine nasal spray in the treatment of vasomotor (perennial nonallergic) rhinitis.

BACKGROUND: Azelastine hydrochloride is an antihistamine with anti-inflammatory properties that is available in the United States in a nasal spray formulation for the treatment of seasonal allergic rhinitis. Vasomotor (perennial nonallergic) rhinitis (VMR) is a noninfectious, chronic rhinitis usually not associated with inflammatory cell infiltration. OBJECTIVE: Two multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials were conducted to determine whether patients with symptoms of VMR (rhinorrhea, sneezing, postnasal drip, and nasal congestion) could be effectively treated with azelastine nasal spray. METHODS: All of the patients who participated in the trials had a diagnosis of VMR, symptoms for at least 1 year, negative skin tests for a mixed panel of seasonal and perennial allergens, and a nasal cytology examination negative for eosinophils. After a 1-week, single-blind, placebo lead-in period, patients who met the symptom severity qualification criteria were randomized to receive either azelastine nasal spray (two sprays per nostril twice daily, 1.1 mg/day) or placebo nasal spray for 21 days. Patients recorded the severity of their VMR symptoms on diary cards each morning and evening of the trial using a four-point symptom rating scale (0 = none to 3 = severe). The primary efficacy variable was the overall reduction from baseline in the total vasomotor rhinitis symptom score (TVRSS) over the 21-day, double-blind treatment period. RESULTS: In both studies, azelastine nasal spray significantly (study 1, P = .002; study 2, P = .005) reduced the TVRSS from baseline when compared with placebo. Significant improvement was observed within the first week and improvement in all symptoms favored treatment with azelastine nasal spray. No serious or unexpected adverse events were reported in either study. Bitter taste (19% vs 2%) was the only adverse experience that occurred with a statistically significantly greater incidence in the azelastine group than in the placebo group. CONCLUSIONS: This is the first demonstration of the efficacy of an antihistamine in the therapy of VMR in two double-blind, placebo-controlled clinical trials.

Administration, Intranasal↗
PubMed1983

Reduction in fever and symptoms in young adults with influenza A/Brazil/78 H1N1 infection after treatment with aspirin or amantadine.

During an outbreak of influenza A/Brazil/78 H1N1 infection, 47 volunteers with clinical and virological influenza of less than 2 days duration were treated in a randomized double-blind fashion for 5 days with 100 or 200 mg of amantadine daily or with 3.25 g of aspirin daily. The aspirin treatment group defervesced more rapidly (10.3 h versus 21.5 h and 23.6 h; P less than 0.01), but by the second daily follow-up visit, both groups of amantadine recipients exhibited greater symptomatic improvement. Bothersome side effects resulted in discontinuation of therapy by 35% of the aspirin treatment group but only 3% of the amantadine treatment group (P less than 0.05). Individuals who present to a physician during an influenza A epidemic with characteristic symptoms will experience symptomatic benefit from amantadine treatment, with negligible toxicity.

Adolescent↗
PubMed2001

Passionflower in the treatment of opiates withdrawal: a double-blind randomized controlled trial.

OBJECTIVE: Clonidine-based therapies have been utilized as the main protocol for opiate detoxification for several years. However, detoxification with clonidine has its limitations, including lack of efficacy for mental symptoms. Accumulating evidence shows the efficacy of Passiflora incarnata extract in the management of anxiety. In our continuing study of traditional medicines, which have neurotropic effects, this plant had an anxiolytic effect, which may be used as an adjuvant agent in the detoxification of opiates by clonidine. We present the results of a double-blind randomized controlled trial of clonidine plus passiflora extract vs. clonidine plus placebo in the outpatient detoxification of 65 opiates addicts. METHODS: A total of 65 opiates addicts were assigned randomly to treatment with passiflora extract plus clonidine tablet or clonidine tablet plus placebo drop during a 14-day double-blind clinical trial. All patients met the DSM IV criteria for opioid dependence. The fixed daily dose was 60 drops of passiflora extract and a maximum daily dose of 0.8 mg of clonidine administered in three divided doses. The severity of the opiate withdrawal syndrome was measured on days 0, 1, 2, 3, 4, 7 and 14 using the Short Opiate Withdrawal Scale (SOWS). CONCLUSION: Both protocols were equally effective in treating the physical symptoms of withdrawal syndromes. However, the passiflora plus clonidine group showed a significant superiority over clonidine alone in the management of mental symptoms. These results suggested that passiflora extract may be an effective adjuvant agent in the management of opiate withdrawal. However, a larger study to confirm our results is warranted.

Adult↗