Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial

Objective: Efficacy of treatment of acute haemorrhoidal crisis by Daflon 500 mg (D500) in comparison to a placebo (Pl). Design: Prospective, double blind, placebo controlled trial with randomization into two parallel groups. Setting: In- and outpatients at a University Hospital. Patients: One hundred patients with a history of haemorrhoidal disease, suffering from an acute haemorrhoidal attack. Interventions: Administration of Daflon 500 mg or placebo at a dose of three tablets b.i.d. for the first 4 days and two tablets b.i.d. for the following 3 days. Main outcome measures: Improvement of symptoms and signs measured by a score and patient acceptability. Results: Overall improvements of symptoms was greater in the D500 group than in the Pl group, from day 2 up to day 7. The clinical severity of proctorrhagia, anal discomfort, pain and anal discharge diminished in both groups, but to a greater extent in the D500 group ( p <0.001). Inflammation, congestion, oedema and prolapse were more markedly improved in the D500 group than in the Pl group. Duration and severity of the current haemorrhoidal episode, as assessed by patient self-evaluation, were less important in the D500 group compared with previous episodes. Use of analgesics and topical medications diminished in both groups, with a major reduction in the D500 group from day 4 ( p <0.001). Acceptability was good in both groups: no patient experienced major side-effects. Conclusion: Treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute haemorrhoids than with the placebo.

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

Rhinology Journal ◽

10.4193/rhino09.144 ◽

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.

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