Should immunoglobulin therapy be used in allogeneic stem-cell transplantation? A randomized, double-blind, dose effect, placebo-controlled, multicenter trial

Article Abstract:

Background: The universal use of prophylactic immunoglobulin in stem-cell transplantation has not been supported by strong evidence of benefit. Results of most trials were reported before effective drugs for cytomegalovirus infection and disease were available, and no trial was placebo controlled. Objective: To assess the role and the dose-effect relationship of immunoglobulin in the prophylaxis of complications after allogeneic stem-cell transplantation. Design: Multicenter randomized, double-blind, dose effect placebo-controlled study. Setting: 19 stem-cell transplantation centers in France. Patients: 200 patients who had allogeneic stem-cell transplantation from HLA-identical sibling donors between 1998 and 2000. Intervention: Immunoglobulin at doses of 50 mg/kg of body weight, 250 mg/kg, or 500 mg/kg weekly from day -7 to day 100 after transplantation or placebo. Measurements: Cumulative incidence of infection, graft-versus-host disease, veno-occlusive disease, interstitial pneumonia, and transplantation-related mortality at 6 months; overall survival at 2 years after transplantation. Results: Immunoglobulin had no benefit over placebo; 92% of patients in the pooled immunoglobulin group and 90% of patients in the placebo group had one or more infections (difference, 2 percentage points [95% CI, -8 to 12 percentage points]). Cumulative incidences of interstitial pneumonia, graft-versus-host disease, transplantation-related mortality, and overall survival ere similar in patients receiving placebo and those receiving immunoglobulin; no dose-effect relationships were evident. Grade 3 (severe) veno-occlusive disease occurred more frequently as the immunoglobulin dose increased (P=0.01). Conclusions: Use of prophylactic immunoglobulin in allogeneic recipients of stem-cell transplant from HLA-identical sibling donors is not recommended.

Infection, Prevention, Complications and side effects, Immunoglobulins, Immunosuppressive agents, Hematopoietic stem cell transplantation, Author Abstract

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Effectiveness and safety of intranasal ipratropium bromide in common colds: a randomized, double-blind, placebo-controlled trial

Article Abstract:

Nasal sprays containing ipratropium bromide may have moderate effects on nasal symptoms associated with the common cold. Researchers randomly assigned 411 patients with nasal symptoms of the common cold to take either ipratropium bromide nasal spray, placebo nasal spray, or no spray. Patients taking the ipratropium bromide spray reported 20%-30% fewer sneezing symptoms and had 26% less nasal discharge than patients using the placebo spray. Patients' perceptions of symptom improvement were also more favorable than either of the other groups. Nasal congestion symptoms were similar for both groups using spray treatments.

Evaluation, Drug therapy, Cold (Disease), Common cold, Ipratropium

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