Short ribosomal prophylaxis in the prevention of clinical recurrences of chronic otitis media in children

Abstract

SummaryThe aim of this study was to compare the efficacy and the safety of a short oral ribosomal immunotherapy (Immucytal) in the prevention of chronic otitis media in children. Seventy-two patients were enrolled in this study, 41 males and 31 females, aged between 6 and 14 years, with an history of recurrent otitis media. Patients were randomised to receive Immucytal (group A) or placebo (group B) according to the following protocol: one tablet daily in the morning 8 days per month for three consecutive months. Immucytal and placebo were identical in shape and size, in order to maintain double-blind conditions. The efficacy parameters were (evaluated before, at the end and 6 months after the beginning of the therapy): clinical score; changes in immunological parameters; patient's parents assessment of symptoms on a scale from 0 (much worse) to 4 (much improved) and hearing tests. Patients of group A, had an improvement of clinical items measured, serum concentrations of immunoglobulins, subjective patient's parents assessment of symptoms and hearing tests. For all evaluations, a significant difference between treatment groups was found. Using this dosage and posology (shorter than others) the beneficial effects of Immucytal were maintained until the end of the 6-month study period.

Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence

“…Proliferation of T cells is evident in patients with otitis media treated with ribomunyl (Table 1 ; Fig. 1 ) [ 44 ]. Furthermore, oral administration causes expansion of constituent-specific B cells and sIgA production [ 45 , 46 , 61 ], and increased serum IgA and IgG in children with RRTI [ 44 , 47 , 48 ].…”

“…1 ) [ 44 ]. Furthermore, oral administration causes expansion of constituent-specific B cells and sIgA production [ 45 , 46 , 61 ], and increased serum IgA and IgG in children with RRTI [ 44 , 47 , 48 ]. Increased sIgA concentrations in healthy volunteers were associated with reduced adhesion of a constituent strain, Streptococcus pneumoniae (Table 1 ; Fig.…”

“…In a number of trials on children with RRTI, including those with adenoiditis, pharyngotonsillitis and otitis media, ribomunyl reduced the incidence, prevalence and/or duration of infections [ 44 , 47 , 48 , 78 , 79 ]. The use of antibiotics/ancillary therapy [ 44 , 47 , 48 , 79 ], school absenteeism [ 44 , 47 , 79 ] and medical visits [ 48 ] was also reduced. In a comparison of ribomunyl prophylaxis for patients with more or less than five RTIs in the past year, only those with five or less showed a decrease in incidence of infection, and physicians did not rate a significant improvement in either group.…”

Immunostimulants in the prevention of respiratory infections

“…IS have been also used to prevent sinusitis (Gomez Barreto et al, 1998;Heintz et al, 1989;Zagar and Lofler-Badzek, 1988), otitis (Giovannini et al, 2000;Mora et al, 2002;Renzo et al, 2004) and occupational respiratory disease in factory workers (Carmona-Ramirez et al, 2002;De Marco et al, 1984). Although provocative, theses uses must have further randomised placebo controlled trials to establish the clinical benefit.…”