Ciprofloxacin plus fluocinolone acetonide versus ciprofloxacin alone in the treatment of diffuse otitis externa

2014 ◽  
Vol 128 (7) ◽  
pp. 591-598 ◽  
Author(s):  
J Lorente ◽  
F Sabater ◽  
M P Rivas ◽  
J Fuste ◽  
J Risco ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Cure ◽  
Otitis Externa ◽  
Fluocinolone Acetonide ◽  
Double Blind Study ◽  
Double Blind ◽  
Parallel Group ◽  
Excellent Safety Profile ◽  
The Mean ◽  
Ear Drops

AbstractObjective:We aimed to evaluate the clinical efficacy of ciprofloxacin plus fluocinolone acetonide (antibiotic plus corticosteroid) ear drops compared to ciprofloxacin (antibiotic) ear drops in diffuse otitis externa.Methods:This was a multicentre, randomised, parallel-group, double-blind study involving 590 patients of both sexes aged 7 years or older.Results:The rate of clinical cure was higher (p = 0.01) with ciprofloxacin plus fluocinolone acetonide than with ciprofloxacin alone. The mean total symptom score was lower with ciprofloxacin plus fluocinolone acetonide (p = 0.005). No differences were found in the percentage of patients reporting resolution of otalgia between patients receiving ciprofloxacin plus fluocinolone acetonide and patients receiving only ciprofloxacin. Resolution of oedema and otorrhoea (p = 0.003 and p = 0.002, respectively) was higher with ciprofloxacin plus fluocinolone acetonide, as was eradication or presumed eradication (p = 0.003). There were eight mild adverse events, three with the ciprofloxacin plus fluocinolone acetonide combination (not related to the treatment) and five when ciprofloxacin was administered alone (directly related to the treatment).Conclusions:Ciprofloxacin plus fluocinolone acetonide is a more effective treatment for diffuse otitis externa than ciprofloxacin alone. The ciprofloxacin plus fluocinolone acetonide combination also has an excellent safety profile.

A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed
Keyword(s):  
Allergic Rhinitis ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Once Daily ◽  
Runny Nose ◽  
Parallel Group ◽  
The Mean ◽  
To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

Amphetamine Withdrawal: II. A Placebo-Controlled, Randomised, Double-Blind Study of Amineptine Treatment

1999 ◽  
Vol 33 (1) ◽  
pp. 94-98 ◽  
Author(s):  
Manit Srisurapanont ◽  
Ngamwong Jarusuraisin ◽  
Jaroon Jittiwutikan
Keyword(s):  
Placebo Group ◽  
Therapeutic Effects ◽  
Double Blind Study ◽  
Double Blind ◽  
Intention To Treat ◽  
Parallel Group ◽  
Amphetamine Withdrawal ◽  
The Mean ◽  
Group 2 ◽  
Treat Analysis

Objective: The aim of this study was to examine the benefits of amineptine, a dopamine agonist antidepressant, in treating amphetamine withdrawal. Method: Inpatients with amphetamine withdrawal were recruited to participate in this placebo-controlled, randomised, double-blind, parallel group, 2-week comparison of amineptine and placebo treatments. The treatment effects were evaluated by means of the self-administered Amphetamine Withdrawal Questionnaire (AWQ) and the interviewer-administered Clinical Global Impression (CGI) scale. An intention-to-treat analysis was applied to evaluate the therapeutic effects at the end of week 1 and week 2. Results: Twenty-two patients took part in each treatment group. The week-1 and week-2 intention-to-treat analyses showed that the mean AWQ reversed vegetative scores (combined scores of decreased energy, increased appetite and craving for sleep items) of the amineptine group were significantly lower than those of the placebo group. The general condition of the amineptine group assessed by CGI also significantly improved at the end of week 2. Although the discontinuation rate due to dissatisfaction with treatment of amineptine group (1/21) was much lower than that of placebo group (6/22), those rates were not significantly different (p = 0.09). Conclusions: Amineptine is specifically effective for treating a major component of amphetamine withdrawal: a reversed vegetative syndrome. Although more than 2 weeks of amineptine treatment may contribute further benefits, both risks and benefits should be taken into account in doing so.

Evaluation of the Efficacy of ST2 and NT-proBNP in the Diagnosis and Prediction of Short- Term Prognosis in Heart Failure with Reduced Ejection Fraction

2017 ◽  
Vol 9 (04) ◽  
Author(s):  
Shivananda B Nayak ◽  
Dharindra Sawh ◽  
Brandon Scott ◽  
Vestra Sears ◽  
Kareshma Seebalack ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Cardiac Biomarkers ◽  
Double Blind Study ◽  
Short Term ◽  
Double Blind ◽  
Reduced Ejection Fraction ◽  
The Mean ◽  
Design And Methods ◽  
The Relationship

Purpose: i) To determine the relationship between the cardiac biomarkers ST2 and NT-proBNP with ejection fraction (EF) in heart failure (HF) patients. ii) Assess whether a superiority existed between the aforementioned cardiac markers in diagnosing the HF with reduced EF. iii) Determine the efficacy of both biomarkers in predicting a 30-day cardiovascular event and rehospitalization in patients with HF with reduced EF iv) To assess the influence of age, gender, BMI, anaemia and renal failure on the ST2 and NT-proBNP levels. Design and Methods: A prospective double-blind study was conducted to obtain data from a sample of 64 cardiology patients. A blood sample was collected to test for ST2 and NT-proBNP. An echocardiogram (to obtain EF value), electrocardiogram and questionnaire were also obtained. Results: Of the 64 patients enrolled, 59.4% of the population had an EF less than 40%. At the end of the 30- day period, 7 patients were warded, 37 were not warded, one died and 17 were non respondent. Both biomarkers were efficacious at diagnosing HF with a reduced EF. However, neither of them were efficacious in predicting 30-day rehospitalization. The mean NT-proBNP values being: not rehospitalized (2114.7486) and 30 day rehospitalization (1008.42860) and the mean ST2 values being: not rehospitalized (336.1975), and 30-day rehospitalization. (281.9657). Conclusion: Neither ST2 or NT-proBNP was efficacious in predicting the short- term prognosis in HF with reduced EF. Both however were successful at confirming the diagnosis of HF in HF patients with reduced EF.

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

The Effectiveness of Group Acceptance and Commitment Therapy and Cognitive Therapy on Alexithymia and Marital Boredom, Case study: Women Affected by Marital Infidelity in Mashhad, Iran

2022 ◽  
Author(s):  
Maryam Sadeghi ◽  
Naeimeh Moheb ◽  
Marziyeh Alivandi Vafa
Keyword(s):  
Cognitive Therapy ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Double Blind Study ◽  
University Counseling Center ◽  
Double Blind ◽  
University Counseling ◽  
Acceptance And Commitment ◽  
Marital Infidelity ◽  
The Mean

Introduction: The aim of current paper was to compare the effectiveness of acceptance and commitment group therapy (ACT) and group cognitive therapy (GCT) on Alexithymia and marital boredom (MB) among women affected by marital infidelity in Mashhad. Method: This clinical trial was a double- blind study with a pretest-posttest design in which two intervention groups and one control group were investigated. The study performed on women who realized their spouse infidelity and referred to Azad University Counseling Center in Mashhad in 2018. The sample consisted of 30 women who were selected by purposive sampling and were randomly assigned to two intervention groups and a control group (n=10 per group). The intervention groups were put under ACT training (twelve 90-minute sessions) and GCT training (twelve 90-minute sessions), but the control group did not receive any intervention. Data was obtained by the Toronto Alexithymia Scale-20 and Pines Marital Boredom Scale and was analyzed by multivariate analysis of covariance with SPSS (version 22) software. Results: The results showed a significant reduction in the mean score of MB in the ACT group, also there was a significant reduction in the mean score of Alexithymia in the GCT group (P <0.05). So comparing both therapies, ACT was more influential on reducing marital boredom whereas GCT was more effective on reducing alexithymia. Conclusion: Although both intervention methods were effective on Alexithymia and Marital Boredom in women affected by marital infidelity, it was demonstrated that ACT and GCT have more effect on Marital Boredom and Alexithymia, respectively.

scholarly journals Effects of ondansetron on respiratory pattern and sensation of experimentally induced dyspnea

2002 ◽  
Vol 120 (5) ◽  
pp. 141-145 ◽  
Author(s):  
José Antônio Baddini Martinez ◽  
Fábio Senra Rocha ◽  
Elizabet Sobrani ◽  
Fabíola Paula Lovreto Galhardo ◽  
João Terra Filho
Keyword(s):  
Respiratory Diseases ◽  
Insular Cortex ◽  
Respiratory Pattern ◽  
Double Blind Study ◽  
Double Blind ◽  
Respiratory Discomfort ◽  
The Mean ◽  
Respiratory Conditions ◽  
Voluntary Apnea ◽  
Study Setting

CONTEXT: Dyspnea remains a therapeutic challenge, especially in chronic respiratory conditions. Recent studies have shown that the induction of unpleasant dyspnea sensations activates areas in the insular cortex. OBJECTIVE: This study was designed to investigate the potential effects of ondansetron, a potent anti-serotonin agent, on induced dyspnea sensation. TYPE OF STUDY: A randomized double blind study. SETTING: Pulmonary Function Laboratory of Hospital das Clínicas de Ribeirão Preto. PARTICIPANTS: Ten healthy male volunteers (mean age ± standard error = 23.1 ± 0.41 years) without respiratory diseases and showing normal spirometric tests. INTERVENTIONS: Uncomfortable breathing was induced in the volunteers on two different days, via the use of inspiratory resistors (loads of 0, 7, 14 and 21 cm H2O/l/sec) and breathholding, two hours after taking 8 mg of ondansetron (Ond) or placebo (Plac). MAIN MEASUREMENTS: Respiratory discomfort during breathing under loading was evaluated on a 100-mm visual analog scale. The maximum length of time of voluntary apnea was measured in seconds. RESULTS: The mean maximum voluntary apnea time did not differ between the ondansetron and placebo days (Plac = 96 ± 6.6 sec vs. Ond = 100 ± 7.9 sec). Ondansetron did not influence the dyspnea sensation induced by different inspiratory loads (0 cm H2O/l/sec: Ond = 1.4 mm ± 0.44 vs. Plac = 2.1 ± 0.85 mm; 7 cm H2O/l/sec: Ond = 16.6 ± 2.74 mm vs. Plac = 13.7 ± 2.06 mm; 14 cm H2O/l/sec; Ond = 30.5 ± 4.50 mm vs. Plac = 27.1 ± 3.44 mm; 21 cm H2O/l/sec: Ond = 50.3 ± 6.72 mm vs. Plac = 49.4 ± 6.72 mm). Ondansetron led to significant decreases in tidal volume under basal conditions and when breathing under the highest inspiratory loading (0 cm H2O/l/sec: Ond = 0.83 ± 0.26 l vs. Plac = 1.0 ± 0.28 l; 21 cm H2O/l/sec: Ond = 0.86 ± 0.23 l vs. Plac = 1.1 ± 0.22 l) CONCLUSION: The present results suggest that 5-HT3 receptors do not play an important role in the mediation of dyspnea sensations.

Comparison of a New Hypnotic (Finorgal) with Placebo in a Double-Blind Trial

1979 ◽  
Vol 7 (5) ◽  
pp. 387-390
Author(s):  
Gianni Baiotti
Keyword(s):  
Placebo Treatment ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
The Mean ◽  
Mean Time

The hypnotic effects of Finorgal (ethchlorvynol with diphenhydramine) were compared with those of placebo in a double-blind study with crossover of treatments in thirty-five hospital in-patients. During the four-week period of Finorgal treatment there was a significant reduction in the mean time elapsing between the administration of the hypnotic and the onset of sleep, and a significant increase in the duration of sleep, compared with the four weeks of placebo treatment. There was also a significant increase in the proportion of nights when the patients felt they had slept well, and in the incidence of morning ‘hangover’ and nocturnal confusion during the Finorgal treatment periods. Patients had to be actively woken in the morning significantly more often following Finorgal administration. In patients experiencing pain in the night there was a significant reduction in the occurrence of pain during the nights when Finorgal had been given.

A Comparative Study of a New Food Supplement, ViviScal®, with Fish Extract for the Treatment of Hereditary Androgenic Alopecia in Young Males

1992 ◽  
Vol 20 (6) ◽  
pp. 445-453 ◽  
Author(s):  
A Lassus ◽  
E Eskelinen
Keyword(s):  
Treatment Group ◽  
Food Supplement ◽  
Androgenic Alopecia ◽  
Double Blind ◽  
Once Daily ◽  
Young Males ◽  
Highly Active ◽  
Parallel Group ◽  
The Mean

A controlled, randomized, double-blind, parallel-group study compared the effects of ViviScal® (a new food supplement incorporating special marine extracts and a silica compound) with those of a fish extract in the treatment of young males with hereditary androgenic alopecia. The pretreatment histological diagnosis was alopecia with a mild to moderate perifollicular inflammation zone. The study consisted of 20 subjects who received two tablets of ViviScal® once daily and 20 who received two tablets of fish extract once daily for 6 months. The mean patient age and mean duration and severity of baldness compared well between the two groups. Most patients had been treated with long-term topical 2% minoxidil for 1 year or more prior to the study. At baseline and after 6 months' treatment, a biopsy was taken for histological examination. A non-vellus hair count was performed at baseline and after 2, 4 and 6 months. In the fish extract treatment group three patients withdrew from the study before the fourth month due to lack of therapeutic effect. After 6 months' treatment, patients receiving ViviScal® showed a mean increase in non-vellus hair of 38% compared with a 2% increase in the fish extract treatment group (P < 0.0001). In the ViviScal® group, 19 (95%) subjects showed both clinical and histological cure, whereas none treated with fish extract showed any clinical or histological difference after 6 months' treatment ( P < 0.0001). In both groups, a minimal decrease in the erythemal index was observed. In conclusion, ViviScal® appears to be the first highly active treatment for androgenic alopecia in young males.

The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

2021 ◽  
Vol 8 (2) ◽  
pp. 321-325
Author(s):  
Dinesh Kumar Singh ◽  
B B Baj ◽  
Vipin Goyal
Keyword(s):  
Transurethral Resection ◽  
Blind Study ◽  
Transurethral Resection Of Prostate ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

scholarly journals A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

1995 ◽  
Vol 23 (4) ◽  
pp. 438-443 ◽  
Author(s):  
A. Davis ◽  
S. Krige ◽  
D. Moyes
Keyword(s):  
Recovery Time ◽  
Strabismus Surgery ◽  
Double Blind Study ◽  
Double Blind ◽  
Oral Fluids ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
To Receive ◽  
Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

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