Efficacy and safety of ambroxol lozenges in the treatment of acute uncomplicated sore throat. EBM-based clinical documentation.

Sore throat is the hallmark of acute pharyngitis. Although usually caused by viral infections, it is frequently treated with antibiotics. Such inappropriate use of antibiotics might best be challenged by offering efficacious and safe symptomatic pain relief instead. However, there is need for robust evidence to support such alternatives. Presently, the evidence from randomised, placebo-controlled, double-blind clinical trials (RCT) with the local anaesthetic ambroxol (CAS 23828-92-4) in the treatment of sore throat is being reviewed. This relates to five RCT in 1,772 patients; 1,713 were evaluable with regard to efficacy. Treatment with ambroxol lozenges was statistically significantly superior to placebo in reducing sore throat pain intensity with a high level of consistency of the estimated effect across the different studies. The effect had an early onset and lasted up to at least 3 h after a single first lozenge. The pain relief was associated with a statistically superior regression of pharyngeal redness and inflammation; with ambroxol, the overall efficacy was more frequently rated as at least "good". Treatment with the ambroxol lozenges was well tolerated. There was heterogeneity in reporting adverse events: in one later study with less severe baseline pain intensity there was more frequent reporting of hypoaesthesia of the oral cavity and tongue as an untoward phenomenon. In patients with more severe baseline pain this reflection of the medication's pharmacological action was only rarely reported as untoward. It is concluded that lozenges containing 20 mg ambroxol are a safe and efficacious treatment for acute uncomplicated sore throat of recent onset in adult patients.

Comparison of bisacodyl and sodium picosulphate in the treatment of chronic constipation.

BACKGROUND: Chronic constipation is a widespread condition. Although laxatives are generally accepted as being effective treatments, few studies have made formal comparisons of their efficacy and safety in chronic use. OBJECTIVE: To compare the safety and efficacy of bisacodyl and sodium picosulphate in the treatment of chronic constipation over a 4-week period. METHODS: Patients with chronic constipation (N = 144), recruited from out-patient clinics, were analysed for safety and efficacy in this open-label, randomised, parallel-group study. Patients were treated daily for 4 weeks (bisacodyl, 5-10 mg daily: 70 patients; sodium picosulphate, 5-10 mg daily: 74 patients). Primary efficacy criteria consisted of the number of bowel movements and stool consistency. Secondary efficacy criteria were straining at stool and physicians' global efficacy assessment. Safety assessments included adverse event monitoring, tolerability and changes in laboratory parameters. RESULTS: Both treatments were equally effective in treating chronic constipation, providing sustained improvement in symptoms. Compared to baseline, there were significant (p < 0.001) improvements in stool frequency and consistency and in the occurrence of straining at 14 and 28 days for both treatment groups. Based on the physicians' global assessment, a significant improvement was observed in 74.6% (bisacodyl) and 79.2% (sodium picosulphate) of patients. Neither treatment had significant effects on serum electrolytes. There was a trend for better tolerability in patients receiving bisacodyl treatment based on the number of drug-related adverse events (bisacodyl: 7; sodium picosulphate: 14, two patients withdrawn). CONCLUSIONS: Bisacodyl and sodium picosulphate are equally well tolerated and effective in the treatment of chronic constipation over a 4-week period.

Efficacy and tolerability of ambroxol hydrochloride lozenges in sore throat. Randomised, double-blind, placebo-controlled trials regarding the local anaesthetic properties.

UNLABELLED: Two confirmatory clinical trials were performed to investigate the efficacy and tolerability of ambroxol lozenges at doses of 20 mg and 30 mg relative to placebo in relieving the symptoms of sore throat of at least moderately severe intensity in patients suffering from oro-pharyngeal catarrh accompanied by pain on swallowing, feeling of scratchiness, burning and urge to cough. OBJECTIVE: Description and comparison of the efficacy and tolerability of lozenges containing 20 mg or 30 mg ambroxol hydrochloride (trans-4-[(2-amino-3,5-dibrom-benzyl)amino]cyclohexano hydrochloride, CAS 18683-91-5) in relieving acute sore throat, in comparison to placebo. DESIGN: Two similar, multi-centre, prospective, placebo-controlled, randomised, double-blind trials involving three days of treatment with up to 6 lozenges containing 20 or 30 mg ambroxol hydrochloride per day. SUBJECTS: There were enrolled three-hundred-thirty-one (331, study I) and three-hundred-eighty-three (383, study II) outpatients with acute uncomplicated sore throat of at least moderately severe intensity which is not suspected to be due to bacterial pharyngitis. TREATMENTS: Double-blind treatment with up to six lozenges per day containing either 20 mg or 30 mg ambroxol hydrochloride or placebo (a lozenge with a distinct minty flavour). MAIN OUTCOME MEASURES: The time-weighted average pain relief over the first 3 h after the first lozenge as a ratio of the baseline pain intensity of sore throat (SPIDnorm) and the patients' evaluation of efficacy and tolerability at the end of each day of the three days treatment. RESULTS: All treatments led to a reduction of pain intensity; the means (+/- SD) SPIDnorm after the 1st lozenge were 0.53 +/- 0.28 or 0.50 +/- 0.30 or 0.38 +/- 0.28 with 20 mg or 30 mg ambroxol hydrochloride or placebo respectively in study I, and 0.53 +/- 0.30 or 0.60 +/- 0.28 or 0.39 +/- 0.31 in study II; the effect of treatment was statistically significant (p: 0.0002 or p: 0.0033 in study I and p: 0.0005 or p: 0.0001 in study II, respectively, for the comparison of 20 mg or 30 mg ambroxol hydrochloride vs. placebo). The improvement with the active treatments was greater than with placebo (95% confidence interval (CI) estimates of the mean treatment differences vs. placebo were 0.08 to 0.23 or 0.05 to 0.20 for lozenges with 20 mg or 30 mg ambroxol hydrochloride, respectively, in study I, and 0.06 to 0.21 or 0.13 to 0.28 in study II). At the end of each subsequent ambulatory treatment day with up to six lozenges per day, a statistically significantly higher proportion of patients scored a higher level of efficacy for the active treatments with ambroxol hydrochloride compared to placebo. The treatments investigated were equally well tolerated. CONCLUSIONS: Sucking lozenges containing 20 mg or 30 mg ambroxol hydrochloride has a beneficial pain-relieving effect in patients with acute sore throat, superior to that achieved by sucking a placebo lozenge. While both strengths were equally well tolerated, the higher strength of 30 mg ambroxol hydrochloride did not prove more effective. The findings confirm that the previously discovered local anaesthetic properties of ambroxol hydrochloride do have beneficial clinical implications.