Evidence map›Paper›PMID 30329199›Full record

Trial reportInternational journal of clinical practice2018

Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha).

Jürgen Palm, Katharina Fuchs, Holger Stammer, Anne Schumacher-Stimpfl, Jens Milde, DoriPha investigators

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of clinical practice, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03323528 (A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03323528 phase4completednot on this map

A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis

TypeinterventionalSponsorMedice Arzneimittel Pütter GmbH & Co KGRan2017 to 2017Enrolled321ConditionsPharyngitisArmsBenzalkonium Chloride-Benzocaine Topical, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
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  4. Observational
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  6. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Jürgen Palmdoc-hno, Röthenbach, Germany.
Katharina FuchsPharmalog Institut für klinische Forschung GmbH, Munich, Germany.
Holger StammerPharmalog Institut für klinische Forschung GmbH, Munich, Germany.
Anne Schumacher-StimpflMedice Arzneimittel Pütter GmbH & Co.KG, Iserlohn, Germany.
Jens MildePharmalog Institut für klinische Forschung GmbH, Munich, Germany.
DoriPha investigators
Pharmalog (Germany) · DEMedice (Germany) · DE

Funding

Medice Arzneimittel Pütter GmbH & Co.KG
6 · The paper itself

Abstract

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

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 registrationClinicalTrials.gov, NCT03323528.

Indexed as

Acute DiseaseAdministration, OralAdultBenzalkonium CompoundsBenzocaineDeglutitionDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedPainPain MeasurementPatient SatisfactionPharyngitisBenzalkonium CompoundsBenzocaineDrug CombinationsTyrothricintyrothricin, benzalkonium chloride, benzocaine drug combination

Identifiers

PMID30329199
PMCPMC6282512
OpenAlexW2897893331

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.