ObjectiveThe aim of this multi‐centre, randomised, double‐blind, placebo‐controlled trial was to compare the efficacy and safety of the fixed combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine (study drug marketed as Dorithricin®) in repeat dosing for 3 days to match placebo lozenges in the treatment of acute pharyngitis in adults.MethodsPatients (pts, aged ≥18 years) with acute pharyngitis, ie, non‐streptococcal sore throat and moderate‐to‐severe pain (intensity NRS ≥ 7; VAS ≥ 50) were assigned to study drug (n = 160) or matching placebo (n = 161). Efficacy was assessed by investigator for 2 hours post initial dose (p.i.d.), and 3 days later (Visit 2). Primary efficacy endpoint was the complete resolution of throat pain and difficulty in swallowing at Visit 2 (3 days p.i.d.). Safety and local tolerability were also assessed.ResultsSeventy‐two hours (p.i.d.), complete resolution of throat pain and difficulty in swallowing were achieved by 44.6% patients on study drug compared with 27.2% patients on placebo (difference 17.4% (CI [5.8%; 29.7%]; 64% improvement [GEE, P = 0.0022]).Until 2 hours p.i.d., reduction in symptoms was better with study drug (P < 0.005). Treatment satisfaction was higher with study drug (patients′/investigators′ assessment (78.9%/78.9% vs 55.0%/55.6% for placebo) and was well tolerated, overall safety profile was comparable to placebo.ConclusionThe strength of this randomised controlled trial lies in the endpoint of complete remission after 3 days p.i.d., especially in the light of other trials addressing acute pharyngitis. The results of this study show a significant benefit of the study drug over placebo in the treatment of acute pharyngitis. Local treatment with the fixed combination (0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine) provides a rapid analgesic effect and is effective in relieving both severe throat pain as well as difficulty in swallowing associated with acute pharyngitis leading to a 64% improved complete remission within 72 hours. The triple active combination is a suitable treatment option for patients in the self‐management of acute pharyngitis and sore throat. Clinical trial registration: ClinicalTrials.gov, NCT03323528.
Background: Antibiotics are commonly used as first-line treatment for acute lower uncomplicated urinary tract infections (uUTIs). However, antimicrobial resistance is a growing global problem and efficacious nonantibiotic treatment options are urgently needed. Methods: A secondary analysis was conducted with data from a randomized, controlled, double-blind trial comparing a fixed combination of extracts of restharrow root, Java tea, and goldenrod herb (Aqualibra®) to placebo in 200 women with acute lower uUTI. Symptom scores reported in the original trial were reanalyzed and adjusted to the definitions of the Acute Cystitis Symptom Score (ACSS). Results: Based on a subgroup of patients with evaluable microbiologic data (n = 122), the decrease of the mean sum-score of three typical ACSS-adjusted symptoms showed significant superiority of the herbal preparation over placebo already after one day of treatment (p = 0.0086); on Day 7, the average difference was −1.9 score points (p < 0.0001). The superior efficacy of the herbal preparation on Day 1 was mainly driven by a difference in response rates of the symptom ‘dysuria’ (group difference: −29.4%, p = 0.0042). Furthermore, significantly fewer patients in the verum group required antibiotic therapy (15.3% vs. 49.2%, p = 0.0001). These results were confirmed in the intention-to-treat (ITT) population (n = 200). Conclusions: A fixed combination of extracts of restharrow root, Java tea, and goldenrod herb was superior to placebo regarding symptom relief and prevention of antibiotic use in women with lower uUTI. Trial registration: ClinicalTrials.gov: NCT04032574.
ZusammenfassungFür homöopathische Komplexmittel existiert, trotz fast 100-jähriger Verordnungspraxis, nur wenig allgemeingültige Lehrbuchliteratur. Ebenso wird kaum unabhängige Forschung betrieben. Um das Erkenntnismaterial zur Verordnungspraxis zu erweitern, wurde unter dem Dach der Arzneimittel-Hersteller eine Therapeutenbefragung zur Verordnungs- und Dosierungspraxis sowie zum Auftreten von homöopathischen Erstverschlimmerungen und Arzneimittelprüfsymptomen durchgeführt. Insgesamt konnten von 513 Fragebögen 504 ausgewertet werden. Als ein wichtiges Ergebnis zeigte sich, dass nur wenige Therapeuten den strikten Dosierungsempfehlungen der Packungsbeilage folgen, sondern nach individuellen Behandlungsschemata bzw. patientenspezifischen Kriterien verordnen. Wünschenswert wäre daher, die von den Zulassungsbehörden vorgegebenen Dosierungsangaben in der Packungsbeilage zu erweitern und die Patienten über die Möglichkeit der individuellen Dosierung zu informieren, um die Anwendung in der Praxis besser wiederzugeben.
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