Loratadine (SCH29851) 40 mg Once Daily versus Terfenadine 60 mg Twice Daily in the Treatment of Seasonal Allergic Rhinitis

1987 ◽  
Vol 15 (2) ◽  
pp. 63-70 ◽  
Author(s):  
G. Bruttmann ◽  
P. Pedrali
Keyword(s):  
Allergic Rhinitis ◽  
Placebo Group ◽  
Randomized Study ◽  
Placebo Patient ◽  
Double Blind ◽  
Once Daily ◽  
Treatment Groups ◽  
Nasal Symptoms ◽  
Active Medication ◽  
Significant Difference

Seventy patients received loratadine 40 mg once daily, terfenadine 60 mg twice daily, or placebo in a 14-day, double-blind, randomized study. Four nasal and four non-nasal symptoms associated with allergic rhinitis were evaluated. At the endpoint (the last evaluable visit), the mean total scores of combined nasal and non-nasal symptoms decreased (improved) from the baseline by 51.8% and 55.7% with loratadine and terfenadine, respectively, but increased (worsened) by 6.1% with placebo. There was a significant difference between both the loratadine and terfenadine treatment groups and the placebo group ( P=0.001) but not between the active medication groups ( P=0.608). Overall therapeutic response was good or excellent in 14 of the 23 patients given loratadine, in 18 of the 24 given terfenadine and in none of the 23 given placebo. The difference between each active medication group and the placebo group was significant ( P≤0.01) but there was no significant difference between the two active treatment groups ( P>0.35). No loratadine patient had any adverse side-effects. Sedating effects occurred in one terfenadine patient, headache in one placebo patient and two terfenadine patients (one terfenadine patient with severe headache discontinued treatment), and dyspepsia in two placebo patients. No anti-cholinergic effects occurred in this study. Loratadine 40 mg once daily was effective and safe in the relief of symptoms of allergic rhinitis.

scholarly journals Efficacy comparison of cetirizine and loratadine for allergic rhinitis in children

2012 ◽  
Vol 52 (2) ◽  
pp. 61
Author(s):  
Juliana Juliana ◽  
Rita Evalina ◽  
Lily Irsa ◽  
M. Sjabaroeddin Loebis
Keyword(s):  
Allergic Rhinitis ◽  
High Schools ◽  
Side Effects ◽  
Global Health ◽  
Treatment Effectiveness ◽  
Junior High Schools ◽  
Double Blind ◽  
Once Daily ◽  
Significant Difference ◽  
Therapeutic Responses

Background Allergic rhinitis represents a global health problemaffecting 10% to more than 40% of the population worldwide.Several studies in recent years have described the efficacy ofsecond-generation antihistamines in younger children. It isnot well established whether cetirizine is more effective thanloratadine in reducing symptoms of allergic rhinitis.Objective The objective of this study was to compare the efficacyof loratadine with cetirizine for treatment of allergic rhinitis.Methods We conducted a randomized, double-blind, controlledtrial of 100 children, aged 13 to 16 years, from October toNovember 2009 at two junior high schools in Medan. GroupI received 10 mg of cetirizine and group II received 10 mg ofloratadine, each once daily in the morning for 14 days. Drugefficacy was assessed by changes from baseline symptom scoresand evaluation of therapeutic responses after 3 days, 7 days and14 days of treatment.Results The efficacy of cetirizine compared to that of loratadinewas not statistically significant in diminishing nasal symptomsafter 3 days, 7 days and 14 days of treatment (P=0.40, P=0.07,and P=0.057, respectively). Evaluation of side effects, however,revealed significantly fewer headaches in the cetirizine group after3 days and 7 days of treatment (P=0.01 and P=0.03, respectively)than in the loratidine group. In addition, the loratadine grouphad significantly more instances of palpitations after 7 days oftreatment (P=0.04) compared to the cetirizine group.Conclusion There was no significant difference in cetirizine andloratadine treatment effectiveness on allergic rhinitis. However,loratadine was found to cause more headaches and palpitationsthan cetirizine. [Paediatr lndones. 2012;52:61-6].

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

Naproxen Sodium in the Treatment of Migraine

Cephalalgia ◽  
1985 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
ES Johnson ◽  
DM Ratcliffe ◽  
M Wilkinson
Keyword(s):  
Placebo Group ◽  
Rescue Medication ◽  
Naproxen Sodium ◽  
Double Blind ◽  
Treatment Groups ◽  
Parallel Group ◽  
Significant Difference ◽  
Previous Visit ◽  
Premonitory Symptoms ◽  
Visual Disturbances

Seventy patients with classical or common migraine were treated during their attacks with either naproxen sodium or placebo in a randomised, double-blind parallel group study. The initial dose of naproxen sodium was 825 mg followed one hour later by a further 550 mg, if symptoms were the same or had improved. If the migraine symptoms had worsened, patients were offered an escape analgesic combination of 1000 mg paracetamol and 10 mg metoclopramide. Patients were assessed at monthly intervals for changes in the severity and duration of headache, premonitory symptoms (mainly visual disturbances) and photophobia, nausea and vomiting associated with migraine attacks that had occurred since the previous visit. Patients were studied for a maximum of ten attacks and significant improvement was observed in the severity and duration of headache when the patients were on naproxen sodium. Also the premonitory symptoms and photophobia improved significantly on naproxen sodium and significantly less rescue analgesics were required. Patients suffering from common migraine had less severe headaches and photophobia when taking naproxen sodium than when taking placebo and the headaches were shorter in duration and patients took less rescue analgesic. No significant difference was observed between the treatment groups in patients with classical migraine. Ten patients in the placebo group and six in the naproxen sodium group reported side-effects but these were possibly related to the use of rescue medication. Naproxen sodium proved safe and effective in common migraine attacks, but in this study efficacy was not established for classical migraine.

scholarly journals Efficacy of Oral Bilastine in Comparison with Levocetirizine in Allergic Rhinitis- A Randomised Clinical Study

2021 ◽  
Author(s):  
M Vanitha ◽  
K Sowmini ◽  
K Santha Sheela Kumari ◽  
Resu Neha Reddy
Keyword(s):  
Allergic Rhinitis ◽  
Immunoglobulin E ◽  
Statistical Significance ◽  
Post Treatment ◽  
Once Daily ◽  
Treatment Groups ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Antihistaminic Drugs

Introduction: Allergic rhinitis is a heterogeneous disorder characterised by major symptoms like sneezing, itching, nasal congestion and rhinorrhea. Because of bothersome side effects of first-generation antihistaminic drugs, second generation antihistaminic drugs have been used since few years. Recent studies have showed that novel drug Bilastine has been approved as an effective treatment in Allergic rhinitis. Aim: To evaluate Total Nasal Symptom Scores (TNSS), Serum Immunoglobulin E (IgE), Serum Absolute Eosinophil Count (AEC) in patients with allergic rhinitis, pre and post-treatment with Bilastine and Levocetirizine. Materials and Methods: A randomised, open-labelled, study was conducted between January 2020 to March 2020. Hundred patients with allergic rhinitis were enrolled into the study. They were randomised into two groups of which group A received tablet Bilastine 20 mg once daily for two weeks and group B received tablet Levocetirizine 5 mg once daily for two weeks. The results of TNSS, IgE, AEC and pre and post-treatment values were compared in both the treatment groups. Unpaired t-test was used as the test of significance between the two treatment groups. Results: The prevalence of allergic rhinitis in the study was 49% in males and 51% in females. The mean difference in pre and post-treatment in TNSS (group A=1.627, group B=1.143), serum IgE (A=33.118, B=49.653), serum AEC (A=28.00, B=27.245) showed no statistically significant difference between two groups (p-value >0.05). Conclusion: Bilastine and levocetirizine are equally efficacious. Though there is clinical significance in treatment of allergic rhinitis between the groups, there is no statistical significance which would prove Bilastine is clinically superior to Levocetirizine for the allergic rhinitis treatment.

scholarly journals Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis

Neurology ◽  
2018 ◽  
Vol 90 (16) ◽  
pp. e1425-e1434 ◽  
Author(s):  
Karen Hewett ◽  
Donald B. Sanders ◽  
Richard A. Grove ◽  
Christine L. Broderick ◽  
Todd J. Rudo ◽  
...  
Keyword(s):  
Myasthenia Gravis ◽  
Lupus Erythematosus ◽  
B Lymphocyte ◽  
Randomized Study ◽  
Treatment Phase ◽  
Standard Of Care ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference

ObjectiveTo investigate the efficacy and safety of belimumab, a fully human immunoglobulin G1λ monoclonal antibody against B-lymphocyte stimulator, in participants with generalized myasthenia gravis (MG) who remained symptomatic despite standard of care (SoC) therapy.MethodsEligible participants with MG were randomized 1:1 to receive IV belimumab 10 mg/kg or placebo in this phase II, placebo-controlled, multicenter, double-blind study (NCT01480596; BEL115123). Participants received SoC therapies throughout the 24-week treatment phase and 12-week follow-up period. The primary efficacy endpoint was mean change from baseline in the Quantitative Myasthenia Gravis (QMG) scale at week 24; safety assessments included the frequency and severity of adverse events (AEs) and serious AEs.ResultsForty participants were randomized (placebo n = 22; belimumab n = 18). The mean change in QMG score from baseline at week 24 was not significantly different for belimumab vs placebo (p = 0.256). There were no statistically significant differences between treatment groups for secondary endpoints, including the MG Composite and MG–Activity of Daily Living scores. Acetylcholine receptor antibody levels decreased over time in both treatment groups. No unexpected AEs were identified and occurrence was similar in the belimumab (78%) and placebo (91%) groups. One participant receiving placebo died (severe sepsis) during the treatment phase.ConclusionsThe primary endpoint was not met for belimumab in participants with generalized MG receiving SoC. There was no significant difference in mean change in the QMG score at week 24 for belimumab vs placebo. The safety profile of belimumab was consistent with previous systemic lupus erythematosus studies.Classification of evidenceThis study provides Class I evidence that for participants with generalized MG, belimumab did not significantly improve QMG score compared with placebo.

Citrus juice fermented with Lactobacillus plantarum YIT 0132 alleviates symptoms of perennial allergic rhinitis in a double-blind, placebo-controlled trial

2016 ◽  
Vol 7 (5) ◽  
pp. 649-658 ◽  
Author(s):  
N. Harima-Mizusawa ◽  
M. Kano ◽  
D. Nozaki ◽  
C. Nonaka ◽  
K. Miyazaki ◽  
...  
Keyword(s):  
T Cells ◽  
Allergic Rhinitis ◽  
Placebo Group ◽  
Helper T Cells ◽  
Th2 Cells ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Citrus Juice ◽  
Nasal Symptoms

This study aimed to examine whether citrus juice fermented with Lactobacillus plantarum YIT 0132 (LP0132), which was pasteurised after fermentation, could alleviate the symptoms of perennial allergic rhinitis in a double-blind, placebo-controlled, parallel-group trial. Subjects with perennial allergic rhinitis consumed LP0132-fermented juice (n=17) or unfermented citrus juice (placebo; n=16) once a day for 8 weeks. During the pre-intervention and intervention periods, the subjects recorded nasal symptoms (number of sneezing attacks, number of nose-blowing incidents, and stuffy nose score). The primary endpoint, nasal symptoms score (NSS), was scored from 0 to 4 according to the ‘Practical Guideline for the Management of Allergic Rhinitis in Japan 2009’ using a combination of the three nasal symptom items. Blood samples were collected at pre-intervention and at 8 weeks after commencing the intervention. There were several significant improvements not only in the LP0132 group but also in the placebo group because of potential anti-allergic effects of citrus. Compared with the placebo group, the LP0132 group showed a significant reduction in the NSS and stuffy nose score during the intervention period. Also, the LP0132 group, but not the placebo group, showed significant attenuation of type 2 helper T cells (Th2 cells)/helper T cells, serum total immunoglobulin E (IgE), and eosinophil cationic protein (ECP), and showed significant augmentation of type 1 helper T cells (Th1 cells)/Th2 cells at 8 weeks of intervention compared with baseline. It is suggested that daily intake of fermented citrus juice containing heat-killed LP0132 has beneficial effects on symptoms of perennial allergic rhinitis, and these benefits may be associated with the attenuation of Th2 cells, total IgE, and ECP via the immunomodulating activities of LP0132.

Fluticasone Propionate Aqueous Nasal Spray Is Safe and Effective for Children With Seasonal Allergic Rhinitis

PEDIATRICS ◽  
1993 ◽  
Vol 92 (4) ◽  
pp. 594-599
Author(s):  
Jay Grossman ◽  
Charles Banov ◽  
Edwin A. Bronsky ◽  
Robert A. Nathan ◽  
David Pearlman ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Fluticasone Propionate ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Test Reaction ◽  
Double Blind ◽  
Positive Skin ◽  
Study Objective ◽  
Once Daily ◽  
Nasal Symptoms

Introduction. Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 µg once daily in patients (> 12 years of age) with seasonal allergic rhinitis. Study objective. To evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis. Study design. Multicenter, randomized, double-blind, placebo-controlled, parallel-group. Patients. Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment. Interventions. Children were randomly assigned to receive fluticasone propionate, either 100 µg or 200 µg, or placebo, given by intranasal spray once daily in the morning for 14 days. Measurements and results. Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 µg/d and 200 µg/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigatorrated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups. Conclusion. In children as young as 4 years, 100 µg of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 µg given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

Adjuvant chemotherapy with vincristine, cyclophosphamide, and doxorubicin after radiotherapy in local-regional nasopharyngeal cancer: results of a 4-year multicenter randomized study.

1988 ◽  
Vol 6 (9) ◽  
pp. 1401-1410 ◽  
Author(s):  
A Rossi ◽  
R Molinari ◽  
P Boracchi ◽  
M Del Vecchio ◽  
E Marubini ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Randomized Study ◽  
Nasopharyngeal Cancer ◽  
Distant Metastases ◽  
Undifferentiated Carcinoma ◽  
Treatment Groups ◽  
Distant Failure ◽  
Curative Radiotherapy ◽  
Significant Difference ◽  
Base Of The Skull

To evaluate the effect of adjuvant chemotherapy in patients with local-regional nasopharyngeal carcinoma (NPC) (squamous or undifferentiated) in complete remission at the end of curative radiotherapy (RT) 229 patients were randomized from 1979 to 1983 in a multicenter study to no further therapy (116 patients) or a combination of vincristine, cyclophosphamide, and Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) (VCA) for six monthly cycles (113 patients). The RT and RT + VCA groups were well balanced for median age (50 v 49 years), histology (undifferentiated carcinoma, 73% v 70%), tumor extent (tumor limited to nasopharynx, 57% v 57%), and nodal extent (negative nodes 26% v 24%, nodes in the lower cervical levels, 17% v 16%). RT was delivered to the nasopharynx, the base of the skull, and bilateral cervical nodes using a split course technique over 10 weeks up to the dose of 60 to 70 Gy in involved sites and 50 Gy to negative nodes. Response to RT was evaluated within 65 days post-RT treatment. Analysis at 48 months did not show significant difference between the two treatment groups in terms of relapse-free survival (RT, 55.8%, RT + VCA, 57.7%, P = .45) and overall survival (RT, 67.3%, RT + VCA, 58.5%, P = .13). The pattern of relapse was similar in the two treatment arms. Distant metastases were the cause of treatment failure in about 50% of relapsing patients. Although the results of the present study did not show any benefit from VCA administered after curative RT, combined systemic chemotherapy should be further explored due to the high incidence of local and distant failure after intensive RT.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

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