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.

A Parallel-Group Comparison of Budesonide and Beclomethasone Dipropionate for the Treatment of Perennial Allergic Rhinitis in Adults

1993 ◽  
Vol 21 (2) ◽  
pp. 67-73 ◽  
Author(s):  
H Al-Mohaimeid
Keyword(s):  
Allergic Rhinitis ◽  
Beclomethasone Dipropionate ◽  
Statistical Significance ◽  
Perennial Allergic Rhinitis ◽  
Diary Card ◽  
Runny Nose ◽  
Parallel Group ◽  
Symptom Scores ◽  
To Receive ◽  
Single Blind

The efficacy and safety of the two intranasal glucocorticosteroids, budesonide and beclomethasone dipropionate (BDP), were compared in a single-blind study of 120 patients with perennial allergic rhinitis. Patients were randomized to receive either budesonide 200 μg twice daily or BDP 200 μg twice daily from pressurized nasal inhalers for 3 weeks. No other anti-rhinitis medication was allowed during the study. Patients recorded symptoms (blocked nose, runny nose, itchy nose, sneezing, runny eyes and sore eyes) daily on a diary card and were asked to make a global assessment of their treatment at the end of the study. Mean daily symptom scores were lower in patients receiving budesonide than in those receiving BDP for all symptoms, although treatment differences only reached statistical significance for runny nose and sneezing. After 3 weeks, 38% of patients on budesonide and 27% on BDP were totally symptom-free, and 72% of patients on budesonide described the treatment as noticeably, very or totally effective compared with 58% on BDP. In conclusion, the present study showed budesonide to be more effective in controlling symptoms of perennial allergic rhinitis than BDP.

The Effectiveness of Oral Azelastine in the Management of Perennial Allergic Rhinitis

1994 ◽  
Vol 8 (6) ◽  
pp. 323-328 ◽  
Author(s):  
Eli O. Meltzer ◽  
Philip C. Halverson ◽  
Charles H. Banov ◽  
John M. Weiler ◽  
Thomas R. Woehler ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Inflammatory Responses ◽  
Lower Airway ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Runny Nose ◽  
Severity Scores ◽  
Symptom Complex ◽  
To Receive

Azelastine, a phthalazinone derivative, is a chemically novel antiallergy compound that inhibits inflammatory responses in the upper and lower airway. Previous clinical trials demonstrated the effectiveness of azelastine in the treatment of allergic rhinitis. The objective of this double-blind trial was to further evaluate the efficacy and safety of oral azelastine compared with placebo in patients with perennial allergic rhinitis. A total of 192 patients (between 13 and 60 years of age) who satisfied a minimum symptom score during a single-blind placebo evaluation period were randomized to receive one of three treatments: 2 mg of azelastine b.i.d., 1.34 mg of clemastine fumarate b.i.d., or placebo b.i.d. for a 4-week double-blind treatment period. In the primary efficacy analysis, rhinitis symptoms were analyzed as a Total Symptom Complex severity score (nose blows, runny nose, sneezes, stuffy nose, itchy nose, and itchy eyes/ears/throat). After 2 and 4 weeks of therapy, the azelastine group had greater mean percent improvements than the placebo group in the Total Symptom Complex severity scores. The overall and endpoint improvements for the azelastine group were statistically significant (P ≤ .026) versus placebo. Improvements in individual rhinitis symptoms for the azelastine group were superior to placebo for nose blows, runny nose, sneezes, itchy nose, and itchy eyes/ears/throat. Azelastine was well tolerated. Clemastine was also significantly more effective than placebo and was well tolerated. The results support oral azelastine's safety and effectiveness in the treatment of perennial allergic rhinitis.

Comparative Efficacy of Once Daily Loratadine versus Terfenadine in the Treatment of Allergic Rhinitis

1989 ◽  
Vol 17 (2) ◽  
pp. 150-156 ◽  
Author(s):  
C. H. Banov
Keyword(s):  
Allergic Rhinitis ◽  
Initial Dose ◽  
Small Sample Size ◽  
Small Sample ◽  
Double Blind ◽  
Once Daily ◽  
Excellent Response ◽  
Parallel Group ◽  
Parallel Group Trial ◽  
Group Trial

This 1 week study compared the efficacy of once daily administration of 10 mg loratadine with 120 mg terfenadine in out-patients with seasonal allergic rhinitis. It focussed on the efficacy of treatment at the end of the 24 h period following a daily dose. The study was designed as a double-blind, randomized, parallel-group trial, and 41 patients were enrolled and evaluated for efficacy. Patients took an initial dose at the study site and returned on days 2 and 8. At day 2 (24 h after the initial dose), according to the physician's evaluation 57% of loratadine-treated patients had a good or excellent response, compared to 50% of those given terfenadine. At day 8, 24 h after the final dose, 71% of the loratadine-treated patients and 35% of the terfenadine-treated patients had a good or excellent response ( P = 0.03). At days 2 and 8, reductions in mean symptom scores measured 22, 23 and 24 h after the initial and final doses showed an indication of being greater with loratadine than with terfenadine (non-significant due to small sample size). The incidence of sedation was similar in both groups. It is concluded that 10 mg loratadine, administered once daily, controls the symptoms of rhinitis more effectively than 120 mg terfenadine given once daily in the last few hours of the 24 h dosing period.

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.

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.

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.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

A Comparison of Loratadine, a New Nonsedating Antihistamine, with Clemastine and Placebo in Patients with Fall Seasonal Allergic Rhinitis

1987 ◽  
Vol 1 (3) ◽  
pp. 151-154 ◽  
Author(s):  
James P. Kemp ◽  
Sami L. Bahna ◽  
Paul Chervinsky ◽  
Gary S. Rachelefsky ◽  
James M. Seltzer ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Parallel Study ◽  
Double Blind ◽  
Daily Diaries ◽  
Ocular Symptoms ◽  
Symptom Scores ◽  
The Mean ◽  
Long Acting ◽  
To Receive

Loratadine is a new nonsedating long-acting H1-antagonist which has been shown to be effective at various doses in controlling symptoms of spring seasonal allergic rhinitis. In this multicenter, double-blind, parallel study, 313 adolescent and adult patients with moderate to severe, skin-test positive, fall seasonal rhinitis were randomized to receive either loratadine, 10 mg, in the morning and placebo in the evening, clemastine 1 mg. b.i.d., or placebo b.i.d. for 2 weeks. Patients maintained daily diaries of nasal and ocular symptoms and of adverse effects. They were evaluated before and 7 and 14 days after starting treatment. The mean symptom scores on days 7 and 14 showed greater improvement with both loratadine and clemastine treatments than with placebo. The incidence of somnolence in the loratadine group by comparison with the placebo group was not statistically different, whereas clemastine caused significantly more drowsiness than did placebo. We conclude that loratadine, 10 mg, once a day is as effective as clemastine b.i.d. in decreasing the symptoms of fall seasonal rhinitis and the incidence of somnolence with loratadine is not statistically different from that with placebo.

scholarly journals A Randomized, Placebo-controlled, Double-blind Study on the Effects of SZL on Patients With Mild to Moderate Depressive Disorder With Comparison to Fluoxetine

2020 ◽  
Author(s):  
yuan hu ◽  
yichen wang ◽  
chao chen ◽  
wenshan yang ◽  
weiyu zhu ◽  
...  
Keyword(s):  
Depressive Disorder ◽  
Depression Scale ◽  
Double Blind Study ◽  
Double Blind ◽  
Moderate Depression ◽  
Parallel Group ◽  
Clinical Presentations ◽  
Significant Difference ◽  
To Receive ◽  
Target Effects

Abstract Objective: Kaixinsan (KXS) decoction, as an ancient’s herbal formula, has been demonstrated to be active in various animal models resembling human depression with multi-target effects. This very first study evaluated the efficacy and tolerability of Shen Zhi Ling (SZL) tables (KXS preparation), compared with fluoxetine (FLX, positive comparator), in patients with mild to moderate depressive disorder.Methods: In this randomized double-blind parallel-group study, 156 patients with mild to moderate depression without taken any antidepressants in the past 6 months or 4 straight weeks were randomized to receive either 3.2g/d SZL plus 20mg/d FLX placebo (SZL group) or 20mg/d FLX plus 3.2g/d SZL placebo (FLX group), for 8 weeks. Their clinical presentations and some metabolic indexes were assessed during the 8 weeks visiting period.Results: Patients in SZL group showed a statistically significant improvement after 8 weeks of treatment in HAMD-17 score (18.79±2.09 to 4.43±4.71, p<0.001) and self-rating depression scale (SDS) score (58.49±8.89 to 39.84±12.09, p<0.001), but not in N-back total respond time (1145.55±608.26 to 1128.47±387.49, p>0.05). In addition, no significant difference at 8 weeks of treatment was found between SZL and FLX groups in SDS score (39.84±12.09 vs. 36.63±12.44) and N-back respond time (1128.47±387.49 vs. 1089.43±352.08) as well as reduction of HAMD-17 score (14.79±4.88 vs. 15.24±4.29) (p>0.05 for all). However, the serum APOB, APOC3 and ALB levels and HDL-C/LDL-C ratio decreased significantly in patients after SZL treatment, while only APOB/APOA1 ratio decreased significantly in FLX group. Other metabolic indexes did not alter significantly after treated with SZL or FLX.Conclusion: The efficacy and safety profile of SZL are comparable to that of fluoxetine in patients with mild to moderate depression. The beneficial effect of SZL is probably associated with improvement of lipid metabolic balance.

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