scholarly journals A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis

2010 ◽  
Vol 48 (3) ◽  
pp. 318-324 ◽  
Author(s):  
J.M. Pinto ◽  
N. Mehta ◽  
M. DiTineo ◽  
J. Wang ◽  
F.M. Baroody ◽  
...  
Keyword(s):  
Chronic Rhinosinusitis ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis

2010 ◽  
Vol 48 (3) ◽  
pp. 318-324
Author(s):  
J.M. Pinto ◽  
N. Mehta ◽  
M. DiTineo ◽  
J. Wang ◽  
F.M. Baroody ◽  
...  
Keyword(s):  
Chronic Rhinosinusitis ◽  
Controlled Trial ◽  
Mucosal Inflammation ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cellular Inflammation ◽  
Olfactory Testing

Evidence suggests IgE may play a role in chronic rhinosinusitis (CRS). We sought to determine if treatment with a monoclonal antibody against IgE (omalizumab) is effective in reducing CRS inflammation. We performed a randomized, double blind, placebo controlled clinical trial in subjects with CRS despite treatment (including surgery). Subjects were randomized to receive omalizumab or placebo for 6 months. The primary outcome was quantitative measurement of sinus inflammation on imaging. Secondary outcome measures included quality of life, symptoms, and cellular inflammation, nasal airflow (NPIF) and olfactory testing (UPSIT). Subjects on omalizumab showed reduced inflammation on imaging after treatment, whereas those on placebo showed no change. The net difference, however, was not different between treatments. Treatment with omalizumab was associated with improvement in the Sino-Nasal Outcome Test (SNOT-20) at 3, 5, and 6 months compared to baseline with no significant changes in the control group. Remaining measures showed no significant differences across treatments. We conclude that IgE plays, at most, a small role in the mucosal inflammation of CRS and the symptoms. Placebo controlled, blinded studies with larger enrollment are needed to determine the clinical significance of any potential change.

Clinical efficacy of specific immunotherapy to cat dander: a double-blind placebo-controlled trial

1997 ◽  
Vol 27 (8) ◽  
pp. 860-867 ◽  
Author(s):  
V.A. VARNEY ◽  
J. EDWARDS ◽  
K. TABBAH ◽  
H. BREWSTER ◽  
G. MAVROLEON ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Specific Immunotherapy ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

A randomized double blind, placebo controlled trial of a Chinese herbal preparation (CH100) in chronic Hepatitis C

2001 ◽  
Vol 120 (5) ◽  
pp. A384-A384
Author(s):  
L MOLLISON ◽  
L TOTTEN ◽  
C HOVELL ◽  
K THAYNE ◽  
C CONNELLY ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Controlled Trial ◽  
Herbal Preparation ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Chinese Herbal

40: Oral Ketoconazole for Prevention of Postoperative Penile Erection, a Prospective, Randomized, Double Blind, Placebo Controlled Trial

2007 ◽  
Vol 177 (4S) ◽  
pp. 14-15
Author(s):  
Brian J. DeCastro ◽  
Jack R. Walter ◽  
Leah P. McMann ◽  
Andrew C. Peterson
Keyword(s):  
Penile Erection ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

Effects of Mixed Dietary Supplements on Total Plasma Homocysteine Concentrations (tHcy): A Randomized, Double-Blind, Placebo-Controlled Trial

2012 ◽  
Vol 82 (4) ◽  
pp. 260-266 ◽  
Author(s):  
Salah E. Gariballa ◽  
Sarah J. Forster ◽  
Hilary J. Powers
Keyword(s):  
Older Patients ◽  
Controlled Trial ◽  
Plasma Homocysteine ◽  
Acute Illness ◽  
Vitamin B ◽  
Total Plasma ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nutrient Supplement ◽  
Plasma Thcy

Background: Although a number of studies have reported raised total plasma homocysteine (tHcy) concentrations in free-living older people, there are no data on homocysteine response to a mixed nutrient supplement in older patients. A raised plasma homocysteine concentration in older patients is partly a reflection of their co-morbidity, including impaired renal function, and there is uncertainty about the extent to which dietary interventions can improve plasma tHcy. Aim: To determine the plasma tHcy response to dietary supplements during acute illness. Methods: Two-hundred and thirty-six hospitalized, acutely ill older patients, who were part of a randomized double-blind placebo-controlled trial, were assigned to receive a daily oral nutritional supplement drink containing 1.3 mg of vitamin B2, 1.4 mg of vitamin B6, 1.5 μg of B12, 200 μg of folic acid, or a placebo, for 6 weeks. Outcome measures were plasma tHcy concentration at baseline, 6 weeks, and 6 months. Results: The mean plasma tHcy concentration fell among patients given the supplements (mean difference 4.1 µmol/L [95 % C.I, 0.14 to 8.03), p = 0.043], but tHcy concentration increased between 6 weeks and 6 months, after patients stopped taking the supplements [mean difference -2.0 µmol/L (95 % C.I, -03.9 to -0.18), p = 0.033]. About 46 % of patients in the placebo group and 55 % of patients in the supplement group had hyperhomocysteinemia (>14 µmol/L) at baseline compared with 45 % and 29 % at the end of the treatment period. Conclusions: A mixed nutrient supplement containing physiological amounts of B vitamins significantly reduced plasma tHcy concentrations in older patients recovering from acute illness.

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