human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Acute bronchitis is a major source of morbidity in elderly patients . The purpose of this study was to assess the preventive effects of oral immunisation with a bacterial extract .  Three hundred and fifty four patients with chronic bronchitis , living in institutions for the elderly ( aged > 65 yrs ) , were included in a r and omized , placebo-controlled , double-blind study . The purpose of the study was to assess preventive effects of OM-85 BV ( an immunostimulating agent consisting of lyophilized fractions of eight of the most common pathogens isolated in respiratory tract infections ) against acute lower respiratory tract infections . Two hundred and ninety patients completed the study ( 143 taking placebo and 147 taking OM-85 BV ) . There was a 28 % reduction in the number of lower respiratory tract infections in the patients treated with OM-85 BV ; this was entirely due to 40 % reduction in the number of episodes of acute bronchitis ( p < 0.01 ) , with no difference in the number of episodes of pneumonia and bronchopneumonia . A larger number of patients in the OM-85 BV group were free of acute bronchitis throughout the 6 month study period ( 96 vs 69 ) and there was a 28 % reduction in the number of antibiotic prescriptions in the OM-85 BV treated group . These results suggest that OM-85 BV has a protective effect against acute bronchitis in elderly patients living in institutions RATIONALE OM-85 BV , an immunostimulant made from bacterial extracts , has been shown to reduce the risk of hospitalization for acute exacerbation in patients with chronic obstructive pulmonary disease , as well as to reduce the length of stay for all hospitalizations . METHODS In conjunction with a placebo controlled , r and omized clinical trial , a cost effectiveness analysis was carried out to assess the economic impact of using OM-85 BV . In the analysis , effectiveness was defined as the difference in the number of severe acute exacerbations , assessed by the number of hospitalizations for a respiratory problem , between the  placebo and OM-85 BV-treated groups . RESULTS The median cost to prevent one day of hospitalization for a respiratory condition was CDN$45 , with a 95 % CI of CDN$18 to CDN$210 . Bootstrap of the study population and sensitivity analyses showed that the results were robust and not likely due to r and om fluctuation ; 98.8 % of the cost effectiveness and 96.8 % of the cost-benefit ratios favoured the use of OM-85 BV .  Indirect costs , defined as a need for help , were reduced by 36 % in the group treated with OM-85 BV : 779 h of help compared with 1212 h in the placebo group . This trend , while not significant , is consistent with other results and suggests a decrease in the severity of exacerbations in the OM-85 BV-treated group . CONCLUSION Given the high prevalence of chronic obstructive pulmonary disease worldwide and the high cost of acute exacerbations , immunostimulants may become a key element in the improved control of this condition The efficacy of Broncho-Vaxom/Imocur ( OM-85 BV ) , an orally administered lyophilized bacterial extract , for recurrent respiratory and ear , nose and throat ( ENT ) infections was evaluated in 116 children aged 6 months to 19 years by comparing its activity in 61 children with that of a placebo in 55 children . The study was r and omized , double-blind , and comprised a 90-day treatment period followed by a 90-day follow-up period without test drugs . Over the 180 days , 39.5 % of patients taking OM-85 BV  remained free from infection compared with 16.5 % on placebo ( p less than 0.01 ) . 44 % on OM-85 BV did not need antibiotics  compared with 23.5 % on placebo ( p less than 0.05 ) . These differences were even greater in the subgroup of children aged 6 years and less ( 34 vs. 3.5 % for the absence of infections , p less than 0.01 and 37 vs. 10 % for the need of antibiotics , p less than 0.05 ) . Tolerance to OM-85 BV was excellent , and laboratory investigations showed no abnormalities attributable to this product . This work confirms that the immunomodulator OM-85 BV is an effective immunotherapy for recurrent respiratory and ENT infections in children In a 6-month placebo-controlled double-blind multicenter study in 230 patients with recurrent respiratory tract infections , the therapeutic efficacy of Broncho-Vaxom was demonstrated by comparing infection incidence and severity as well as antibacterial medication . Investigators and patients agreed that Broncho-Vaxom exerts a significantly greater protective effect than placebo . Reports of side effects were more frequent with placebo as compared to Broncho-Vaxom The efficacy of Broncho-Vaxom has been evaluated by a multicentric working group of physicians in 75 patients with chronic bronchitis using a r and omized double-blind trial . Initial data of the selected patients showed no significant differences in history , previous medication , individual state and spirometric lung function values between the control group ( n = 39 ) and the cases treated with the test medication ( n = 36 ) . After 30-day initial treatment both physician and patient favoured the active substance ( p less than 0.01 ) although there was statistically no evidence of a curative effect measured by objective criteria . Longterm follow-up over a period of six months again revealed a more effective course in the Broncho-Vaxom group according to individual observations ( p less than 0.05 ) . In fact there was an impressive trend towards reduction of clinical symptoms with Broncho-Vaxom medication . However , statistical analysis of individual symptoms ' scores and lung function tests did not show significant alterations within the two groups . Taking in account the complexity of bronchitic disease , statistical demonstration of a beneficial effect of Broncho-Vaxom with respect to clinical symptoms and lung function tests probably needs a longer observation period , a larger population and a choice of more sensitive methods BACKGROUND Hemodialysis ( HD ) patients suffer from several immune defects that make them prone to develop bacterial infections , in particular respiratory tract infections ( RTIs ) . PATIENTS AND METHODS As previous studies have shown that oral immunotherapy with an immunomodulating bacterial extract ( IBE ) is effective against RTIs , we decided to test its efficacy and safety in HD patients during a double-blind placebo-controlled prospect i ve study . 40 HD patients with a documented history of RTIs in the previous year were treated for 24 weeks of the endemic season with one capsule daily of IBE ( n = 21 ) or placebo ( PL , n = 19 ) . Clinical examinations , measurements of Mac-1 and gp150.95 on circulating phagocytes and routine laboratory evaluations were performed at week 0 , 4 , 12 and 24 . Patients were also examined at each dialysis session allowing an accurate recording of any infectious episode , its treatment and of any untoward effect . RESULTS During the last period of the study ( weeks 13 - 24 ) , IBE significantly reduced the number of patients with RTIs and consequently of antibiotic treatment courses as compared to PL ( p = 0.018 ) , whereas no difference was detected between IBE and PL during periods I ( weeks 0 - 4 ) and II ( weeks 5 - 12 ) . There was no difference between IBE and PL for other , non respiratory infections . IBE was associated at several time points with an increased expression on phagocytes of adhesion molecules involved in phagocytosis ( Mac-1 and gp150.95 ) . However , the expression of these molecules was not predictive for the occurrence of RTI . IBE was on the whole as well tolerated as PL , 7 patients presented side effects ( 5 IBE , 2 PL , NS ) which led to drop-out in 4 cases ( 3 IBE , 1 PL ) . No serious side effect was recorded , gastrointestinal upset being the most prevalent type . CONCLUSION The results of this study indicate that immunomodulation with selected bacterial extracts constitutes a promising approach for the prevention of bacterial airway infections in groups at risk , such as HD patients BACKGROUND Acute respiratory tract infections ( ARTIs ) are among the main causes of morbidity and mortality in children . The bacterial extract OM-85 BV has shown some protective effect for ARTIs in preschool children and a reduction in exacerbations of chronic bronchitis in adults . OBJECTIVES This trial reports results of a double-masked , placebo-controlled , parallel-group clinical study that assessed the efficacy and tolerability of OM-85 BV in the prevention of ARTIs in school girls living in an orphanage . METHODS Two hundred girls ( age range , 6 to 13 years ) living in an orphanage entered the trial . Participants were r and omly allocated to receive either OM-85 BV or placebo for 10 consecutive days a month for 3 consecutive months . Patients were followed up for 6 months , including the administration period . The trial began in September 1996 and finished in March 1997 . Primary end points were the type and number of infections . Secondary end points included when an infection occurred , time to clinical cure , severity of infection , absenteeism from school due to an ARTI , number of antibiotics or other drugs prescribed , and duration of concomitant drug treatment . RESULTS During the trial , patients in the OM-85 BV group experienced 143 ARTIs ( 135 upper ARTIs and 8 otitis episodes ) and patients in the placebo group experienced 299 ARTIs ( 273 upper ARTIs , 1 lower ARTI , and 25 otitis episodes ) . The median number of ARTIs was 1.0 ( 0.0 , 3.0 ; 5th percentile , 95th percentile ) in the OM-85 BV group compared with 3.0 ( 2.0 , 4.0 ; 5th percentile , 95th percentile ) in the placebo group . This difference was statistically significant ( P < 0.001 ) . Participants who received OM-85 BV also showed significantly better results ( P < 0.001 ) than participants who received placebo in terms of median duration of illness , median number of missed school days due to an ARTI , median number of antibiotic and drug courses , and median duration of concomitant treatment . There were significant differences ( P < 0.05 ) in severity of ARTIs during month 4 of the trial , with patients receiving OM-85 BV showing less severe ARTIs than patients receiving placebo and shorter mean time to clinical cure from the second month to the fourth month . No adverse events related to the trial medications were reported . CONCLUSIONS OM-85 BV had a preventive effect on ARTIs in the school girls , with a reduction in the antibiotic requirements and the duration of ARTIs . Future studies are needed to further explore the role of OM-85 BV in the prevention of ARTIs Immunomodulators have been evaluated mainly for their efficacy as a secondary preventive treatment to protect sick children from the recurrence of infections . We investigated the efficacy of one such product , IMOCURR , as a primary preventive treatment in children attending daycare , who face a very high risk of recurrent infections . EPICUR is a double-blind trial which was design ed to study the efficacy of IMOCURR versus placebo . In order to have sufficient statistical power , data collection was based on a daily follow-up procedure and all important concomitant risk factors , such as age , environment and season , were controlled at the study design stage . The sample size required was calculated to be at least 400 children and a total of 423 were actually included . The results obtained for the total follow-up period and those obtained for the treatment period only were very different . This finding raises important questions which have method ological implication s. This paper discusses these implication A 6-month double-blind , prospect i ve , r and omized , placebo-controlled trial was conducted to establish the safety and efficacy of OM-85-BV in the treatment of  subacute sinusitis  and in the following prevention of the respiratory tract infections in 56 children from 18 months to 9 years of age . In the subacute phase of the sinusitis the patients were given one OM-85-BV capsule ( 3.5 mg of bacterial extracts ) ( n = 26 ) or placebo ( n = 30 ) , daily for ten days ; additionally both groups took amoxicillin/clavulanate 40/10 mg/kg daily in three divided doses for 21 days . For the following two months the patients took one OM-85-BV capsule or placebo , ten days a month . In the subacute phase the OM-85-BV group of patients improved sooner ( 5.56 + /- 4.98 vs 10 + /- 8.49 days ) and had a shorter convalescence ( 15.38 + /- 8.91 vs 20.28 + /- 7.17 days ) . During the six month follow-up the patients in the OM-85-BV group had a lower number of infections ( 1.56 + /- 0.3 vs 2.22 + /- 0.43 ) and required a lower number of drug treatments ( 1.47 + /- 0.32 vs 1.94 + /- 0.42 ) 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Acute bronchitis is a major source of morbidity in elderly patients . The purpose of this study was to assess the preventive effects of oral immunisation with a bacterial extract .  Three hundred and fifty four patients with chronic bronchitis , living in institutions for the elderly ( aged > 65 yrs ) , were included in a r and omized , placebo-controlled , double-blind study . The purpose of the study was to assess preventive effects of OM-85 BV ( an immunostimulating agent consisting of lyophilized fractions of eight of the most common pathogens isolated in respiratory tract infections ) against acute lower respiratory tract infections . Two hundred and ninety patients completed the study ( 143 taking placebo and 147 taking OM-85 BV ) . There was a 28 % reduction in the number of lower respiratory tract infections in the patients treated with OM-85 BV ; this was entirely due to 40 % reduction in the number of episodes of acute bronchitis ( p < 0.01 ) , with no difference in the number of episodes of pneumonia and bronchopneumonia . A larger number of patients in the OM-85 BV group were free of acute bronchitis throughout the 6 month study period ( 96 vs 69 ) and there was a 28 % reduction in the number of antibiotic prescriptions in the OM-85 BV treated group . These results suggest that OM-85 BV has a protective effect against acute bronchitis in elderly patients living in institutions RATIONALE OM-85 BV , an immunostimulant made from bacterial extracts , has been shown to reduce the risk of hospitalization for acute exacerbation in patients with chronic obstructive pulmonary disease , as well as to reduce the length of stay for all hospitalizations . METHODS In conjunction with a placebo controlled , r and omized clinical trial , a cost effectiveness analysis was carried out to assess the economic impact of using OM-85 BV . In the analysis , effectiveness was defined as the difference in the number of severe acute exacerbations , assessed by the number of hospitalizations for a respiratory problem , between the  placebo and OM-85 BV-treated groups . RESULTS The median cost to prevent one day of hospitalization for a respiratory condition was CDN$45 , with a 95 % CI of CDN$18 to CDN$210 . Bootstrap of the study population and sensitivity analyses showed that the results were robust and not likely due to r and om fluctuation ; 98.8 % of the cost effectiveness and 96.8 % of the cost-benefit ratios favoured the use of OM-85 BV .  Indirect costs , defined as a need for help , were reduced by 36 % in the group treated with OM-85 BV : 779 h of help compared with 1212 h in the placebo group . This trend , while not significant , is consistent with other results and suggests a decrease in the severity of exacerbations in the OM-85 BV-treated group . CONCLUSION Given the high prevalence of chronic obstructive pulmonary disease worldwide and the high cost of acute exacerbations , immunostimulants may become a key element in the improved control of this condition The efficacy of Broncho-Vaxom/Imocur ( OM-85 BV ) , an orally administered lyophilized bacterial extract , for recurrent respiratory and ear , nose and throat ( ENT ) infections was evaluated in 116 children aged 6 months to 19 years by comparing its activity in 61 children with that of a placebo in 55 children . The study was r and omized , double-blind , and comprised a 90-day treatment period followed by a 90-day follow-up period without test drugs . Over the 180 days , 39.5 % of patients taking OM-85 BV  remained free from infection compared with 16.5 % on placebo ( p less than 0.01 ) . 44 % on OM-85 BV did not need antibiotics  compared with 23.5 % on placebo ( p less than 0.05 ) . These differences were even greater in the subgroup of children aged 6 years and less ( 34 vs. 3.5 % for the absence of infections , p less than 0.01 and 37 vs. 10 % for the need of antibiotics , p less than 0.05 ) . Tolerance to OM-85 BV was excellent , and laboratory investigations showed no abnormalities attributable to this product . This work confirms that the immunomodulator OM-85 BV is an effective immunotherapy for recurrent respiratory and ENT infections in children In a 6-month placebo-controlled double-blind multicenter study in 230 patients with recurrent respiratory tract infections , the therapeutic efficacy of Broncho-Vaxom was demonstrated by comparing infection incidence and severity as well as antibacterial medication . Investigators and patients agreed that Broncho-Vaxom exerts a significantly greater protective effect than placebo . Reports of side effects were more frequent with placebo as compared to Broncho-Vaxom The efficacy of Broncho-Vaxom has been evaluated by a multicentric working group of physicians in 75 patients with chronic bronchitis using a r and omized double-blind trial . Initial data of the selected patients showed no significant differences in history , previous medication , individual state and spirometric lung function values between the control group ( n = 39 ) and the cases treated with the test medication ( n = 36 ) . After 30-day initial treatment both physician and patient favoured the active substance ( p less than 0.01 ) although there was statistically no evidence of a curative effect measured by objective criteria . Longterm follow-up over a period of six months again revealed a more effective course in the Broncho-Vaxom group according to individual observations ( p less than 0.05 ) . In fact there was an impressive trend towards reduction of clinical symptoms with Broncho-Vaxom medication . However , statistical analysis of individual symptoms ' scores and lung function tests did not show significant alterations within the two groups . Taking in account the complexity of bronchitic disease , statistical demonstration of a beneficial effect of Broncho-Vaxom with respect to clinical symptoms and lung function tests probably needs a longer observation period , a larger population and a choice of more sensitive methods BACKGROUND Hemodialysis ( HD ) patients suffer from several immune defects that make them prone to develop bacterial infections , in particular respiratory tract infections ( RTIs ) . PATIENTS AND METHODS As previous studies have shown that oral immunotherapy with an immunomodulating bacterial extract ( IBE ) is effective against RTIs , we decided to test its efficacy and safety in HD patients during a double-blind placebo-controlled prospect i ve study . 40 HD patients with a documented history of RTIs in the previous year were treated for 24 weeks of the endemic season with one capsule daily of IBE ( n = 21 ) or placebo ( PL , n = 19 ) . Clinical examinations , measurements of Mac-1 and gp150.95 on circulating phagocytes and routine laboratory evaluations were performed at week 0 , 4 , 12 and 24 . Patients were also examined at each dialysis session allowing an accurate recording of any infectious episode , its treatment and of any untoward effect . RESULTS During the last period of the study ( weeks 13 - 24 ) , IBE significantly reduced the number of patients with RTIs and consequently of antibiotic treatment courses as compared to PL ( p = 0.018 ) , whereas no difference was detected between IBE and PL during periods I ( weeks 0 - 4 ) and II ( weeks 5 - 12 ) . There was no difference between IBE and PL for other , non respiratory infections . IBE was associated at several time points with an increased expression on phagocytes of adhesion molecules involved in phagocytosis ( Mac-1 and gp150.95 ) . However , the expression of these molecules was not predictive for the occurrence of RTI . IBE was on the whole as well tolerated as PL , 7 patients presented side effects ( 5 IBE , 2 PL , NS ) which led to drop-out in 4 cases ( 3 IBE , 1 PL ) . No serious side effect was recorded , gastrointestinal upset being the most prevalent type . CONCLUSION The results of this study indicate that immunomodulation with selected bacterial extracts constitutes a promising approach for the prevention of bacterial airway infections in groups at risk , such as HD patients BACKGROUND Acute respiratory tract infections ( ARTIs ) are among the main causes of morbidity and mortality in children . The bacterial extract OM-85 BV has shown some protective effect for ARTIs in preschool children and a reduction in exacerbations of chronic bronchitis in adults . OBJECTIVES This trial reports results of a double-masked , placebo-controlled , parallel-group clinical study that assessed the efficacy and tolerability of OM-85 BV in the prevention of ARTIs in school girls living in an orphanage . METHODS Two hundred girls ( age range , 6 to 13 years ) living in an orphanage entered the trial . Participants were r and omly allocated to receive either OM-85 BV or placebo for 10 consecutive days a month for 3 consecutive months . Patients were followed up for 6 months , including the administration period . The trial began in September 1996 and finished in March 1997 . Primary end points were the type and number of infections . Secondary end points included when an infection occurred , time to clinical cure , severity of infection , absenteeism from school due to an ARTI , number of antibiotics or other drugs prescribed , and duration of concomitant drug treatment . RESULTS During the trial , patients in the OM-85 BV group experienced 143 ARTIs ( 135 upper ARTIs and 8 otitis episodes ) and patients in the placebo group experienced 299 ARTIs ( 273 upper ARTIs , 1 lower ARTI , and 25 otitis episodes ) . The median number of ARTIs was 1.0 ( 0.0 , 3.0 ; 5th percentile , 95th percentile ) in the OM-85 BV group compared with 3.0 ( 2.0 , 4.0 ; 5th percentile , 95th percentile ) in the placebo group . This difference was statistically significant ( P < 0.001 ) . Participants who received OM-85 BV also showed significantly better results ( P < 0.001 ) than participants who received placebo in terms of median duration of illness , median number of missed school days due to an ARTI , median number of antibiotic and drug courses , and median duration of concomitant treatment . There were significant differences ( P < 0.05 ) in severity of ARTIs during month 4 of the trial , with patients receiving OM-85 BV showing less severe ARTIs than patients receiving placebo and shorter mean time to clinical cure from the second month to the fourth month . No adverse events related to the trial medications were reported . CONCLUSIONS OM-85 BV had a preventive effect on ARTIs in the school girls , with a reduction in the antibiotic requirements and the duration of ARTIs . Future studies are needed to further explore the role of OM-85 BV in the prevention of ARTIs Immunomodulators have been evaluated mainly for their efficacy as a secondary preventive treatment to protect sick children from the recurrence of infections . We investigated the efficacy of one such product , IMOCURR , as a primary preventive treatment in children attending daycare , who face a very high risk of recurrent infections . EPICUR is a double-blind trial which was design ed to study the efficacy of IMOCURR versus placebo . In order to have sufficient statistical power , data collection was based on a daily follow-up procedure and all important concomitant risk factors , such as age , environment and season , were controlled at the study design stage . The sample size required was calculated to be at least 400 children and a total of 423 were actually included . The results obtained for the total follow-up period and those obtained for the treatment period only were very different . This finding raises important questions which have method ological implication s. This paper discusses these implication A 6-month double-blind , prospect i ve , r and omized , placebo-controlled trial was conducted to establish the safety and efficacy of OM-85-BV in the treatment of  subacute sinusitis  and in the following prevention of the respiratory tract infections in 56 children from 18 months to 9 years of age . In the subacute phase of the sinusitis the patients were given one OM-85-BV capsule ( 3.5 mg of bacterial extracts ) ( n = 26 ) or placebo ( n = 30 ) , daily for ten days ; additionally both groups took amoxicillin/clavulanate 40/10 mg/kg daily in three divided doses for 21 days . For the following two months the patients took one OM-85-BV capsule or placebo , ten days a month . In the subacute phase the OM-85-BV group of patients improved sooner ( 5.56 + /- 4.98 vs 10 + /- 8.49 days ) and had a shorter convalescence ( 15.38 + /- 8.91 vs 20.28 + /- 7.17 days ) . During the six month follow-up the patients in the OM-85-BV group had a lower number of infections ( 1.56 + /- 0.3 vs 2.22 + /- 0.43 ) and required a lower number of drug treatments ( 1.47 + /- 0.32 vs 1.94 + /- 0.42 ) 
    Output:
    