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Table 2 Summary of clinical study on bromhexine

From: A reappraisal of the mucoactive activity and clinical efficacy of bromhexine

Author Study design Subjects BHC dosage Outcome Adverse events (n)
Gieseking 1968 [9] Observational Biopsy from 9 adult patients with cavitated tubercolosis or carcinoma 4 mg 3 times/24 h Increased secretion activity in the seromucus glands of the bronchial mucosa -
Lorenz 1974 [13] Observational 36 pregnant women 1 mg/kg/24 h Increase > 50% in total phospholipid concentration in fetal surfactant -
Crimi 1986 [15] Observational 13 adult patients with chronic bronchitis 48 mg/24 h Increase concentration of total phospholipids in bronchoalveolar fluid -
Flavell Matts 1973 [18] Observational 53 adult patients with asthmatic bronchitis and acute or chronic bronchitis 8-32 mg/3 times/24 h Reduced mucopolysaccharide fiber systems in sputum -
Bürgi 1974 [19] Single-blind crossover 22 adult patients with chronic bronchitis 8 mg/3 times/24 h Reduction in sputum glycoprotein fiber content and decreased viscosity -
Shimura 1983 [20] Observational 40 adults with chronic pulmonary diseases (excluding asthma) 24 mg/24 h BHC does not influence the molecular structure of the mucus -
Langlands 1970 [21] Double blind randomized controlled trial 27 adult patients with exacerbations of chronic bronchitis 8 mg/3 times/24 h No significant difference in respiratory function or mucus properties Nausea (n = 1)
Stark 1973 [22] Randomized controlled trial 42 adult patients with chronic bronchitis 48 mg/24 h No significant difference in mucus characteristics -
Götz 1970 [23] Observational 20 adult patients with allergic asthma 16-24 mg/24 h Increased gamma globulins in sputum -
Kado 1976 [24] Observational 13 adult patients with chronic bronchial infections - Increased concentrations of IgA and IgG in bronchial washings -
Thomson 1974 [25] Observational 9 adult subjects with chronic bronchitis 48 mg/24 h Increased mucociliary clearence -
Pavia 1979 [26] Observational 43 adult patients with chronic bronchitis - Increased mucociliary clearence -
Bergogne-Berezin 1979 [28] Double blind placebo controlled stud 22 adult patients undergone bronchoscopy and received erythromycin 4-12 mg/24 h Increased erythromycin concentration in bronchial fluid -
Roa 1995 [29] Double blind multicenter randomized controlled trial 392 adult patients hospitalized for uncomplicated bacterial lower respiratory tract infections receiving amoxicillin 32 mg/24 h Better overall resolution of symptoms and cough; increased expectoration Undefined (n = 6)
Lal 1975 [30] Randomized crossover placebo-controlled trial 41 adult patients with stable chronic obstructive bronchitis receiving oxytetracycline 48 mg/24 h Better subjective evaluation of sputum stickiness and physician assessment of outcome Headache (n = 2) Stomacache (n = 2)
Nesswetha 1967 [32] Double blind randomized controlled trial 242 adult patients with mixed respiratory conditions 15 mg/24 h Reduced cough No adverse events reported
Gent 1969 [33] Cross sectional, double blind, placebo controlled study 48 adult patients with chronic bronchitis, asthma, emphysema or diffuse parenchymal lung disease 24 mg/24 h Overall clinical and functional improvement Diarrhea (n = 1) Headache (n = 1)
Hamilton 1970 [34] Double blind randomized controlled trial 22 adult patients recovering from an exacerbation of chronic obstructive bronchitis 48 mg/24 h increased sputum production and reduced sputum viscosity No adverse events reported
Christensen 1970 [35] Double blind randomized controlled trial 61 adult patients with chronic bronchitis 24 mg/24 h Better overall clinical improvement and increased FEV1 -
Condie 1971 [36] Single blind randomized controlled trial 31 adult patients with chronic bronchitis 24 mg/24 h Reduced symptoms, increased sputum volume and PEFR Nausea and abdominal distension (n = 3)
Matts 1974 [37] Double blind randomized controlled trial 102 hospitalized adult patients with lower respiratory tract infections treated with oxytetracycline 32 mg/24 h Higher rate of favorable response to treatment, faster recovery and shorter hospitalization stay Nausea and anorexia (n = 22)
Armstrong 1975 [38] Randomized crossover placebo-controlled trial 12 adult patients with chronic bronchitis 72 mg/24 h Increased expectoration, improved auscultatory findings and PEFR Headache and nausea (n = 1) Dizziness (n = 1)
Valenti 1989 [39] Double blind multicenter randomized controlled trial 237 adult patients with chronic obstructive lung disease 60 mg/24 h decrease in cough, dyspnea and sputum volume; easier expectoration; improved auscultatory findings and improved FEV1 and PEFR; higher rates of treatment efficacy Vomiting and gastralgia (n = 1)
Bienvenido 1990 [40] Randomized controlled trial 28 adult patients with acute bronchitis or exacerbation of chronic bronchitis receiving amoxycillin 24 mg/24 h Reduced symptom severity and higher bacterial elimination -
Olivieri 1991 [41] Double blind multicenter randomized controlled trial 88 adult patients with exacerbation of bronchiectasis 90 mg/24 h Improved cough, auscultatory findings, expectoration difficulty and FEV1 -
Aylward 1973 [42] Double blind multicenter randomized controlled trial 38 adult patients with chronic obstructive bronchitis 48 mg/24 h Reduced sputum viscosity and increased expectoration volume Gastrointestinal (n = 1)
Barth 2015 [43] Randomized double blind controlled parallel trial 177 adult patients with cough due to uncomplicated upper respiratory tract infections 24 mg/24 h Better cough relief Mixed (pruritus, diarrhea, abdominal pain, skin rash) (n = 6)
Tarantino 1988 [44] Double blind randomized controlled trial 30 children with acute sinus inflammation receiving amoxycillin 48 mg/24 h Reduced nasal secretions, improvement in rhinitis; less school days lost No adverse events reported
Molina 1970 [45] Observational 48 infants with pharyngo-bronchitis, bronchopneumonia, bronchopneumonia with tubercolosis and asthmatic bronchitis 4-24 mg/24 h Better overall clinical improvement -
Fernandes 1973 [46] Observational 30 children with clinical symptom of mucus retention (asthma, common cold and bronchiolitis) 0.5 mg/kg Overall clinical improvement in patients with asthma and common cold No adverse events reported
Brezina 1973 [47] Observational 45 children with bronchitis - Overall clinical improvement No adverse events reported
Okamoto 1981 [48] Observational 37 children with bronchitis, common cold, asthmatic bronchitis, asthma and bronchiectasis 0.4-0.6 mg/kg Overall clinical improvement No adverse events reported
Koga 1981 [49] Observational 32 children with upper respiratory tract inflammation, acute bronchitis, bronchopneumonia and asthma 0.4 mg/kg/3 times/24 h Improved expectoration No adverse events reported
Camurri 1990 [50] Open randomized comparative study 32 children hospitalized for acute bronchitis 24 mg/24 h Improved expectoration and clinical outcom No adverse events reported
Azzolini 1984 [51] Open randomized comparative study 40 children with hypersecretory bronchopulmonary diseases (acute, asthmatic or recurrent bronchitis) 6-12 mg/24 h Improved general clinical conditions, dyspnea and sputum viscosity Nausea and regurgitation (n = 2)
Diarrhea (n = 1)
Boner 1984 [52] Observational 100 children with respiratory tract infections 0.6-0-8 mg/kg/24 h Overall clinical improvement and better resolution in patients with acute episodes Gastric intolerance (n = 3)
  1. IgA immunoglobulin A, IgG immunoglobulin G, FEV 1 forced expiratory flow 1st second, PEFR peak expiratory flow rate, BHC bromhexine hydrochloride, − = not available