Sheibani 2015

Referenz

(Autor, Jahr, Journal)

Studientyp

Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum

Patienten-merkmale

Indikation, Alter, Geschlecht (m/w)

Intervention

Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme

Kontrolle

Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme

Zielgrößen

Primärer Endpunkt

Sekundäre(r) Endpunkt(e)

Primärer Endpunkt

Angaben für Intervention vs. Kontrolle

Sekundäre(r) Endpunkt(e)

Angaben für Intervention vs. Kontrolle

Finanzierung

Evidenzstufe

Bei Abwertung: Angabe von Gründen

Bewertung des Autors

Sheibani

2015

Asia-Pacific Journal of Clinical Oncology

double-blind placebo-controlled randomized clinical trial

N = 51

2009 to 2012

head and neck carcinoma

external beam radiotherapy for 5 d/week to total planned cumulative radiotherapy doses of at least 5000 cGy

Treatment group (TG)

N = 26 (51%)

Placebo group (PG)

N =  25 (49%)

Mean age (years)

TG 53.2 ± 11.2

PG 52.1 ± 12.0

Male/female

TG 17/9

PG 14/11

Drug addiction

TG 3 (11.5%)

PG 2 (8%)

Smoker

TG 10 (38.5%)

PG 6 (24%) 0.266

Study medications: 0.15% benzydamine oral rinse or oral rinsing with study treatments was initiated the day before RT and continued for 2 weeks after the end of RT. All patients were advised to rinse 15 mL of the solution (benzydamine or placebo) for 2 min, four to eight times daily before and during, and for 2 weeks after completion of RT.

efficacy of this medication in

reducing the signs and symptoms of oral mucositis

Mean mucositis score

treatment week 1:

TG 0.63 vs. PT 0.81 not sig.

treatment week 2:

TG 0.83 vs. PT 1.05 not sig.

treatment week 3:

TG 1.02 vs. PT 1.35 not sig.

treatment week 4:

TG 1.27 vs. PT 1.81 p = 0.01

treatment week 5:

TG 1.58 vs. PT 2.10 p = 0.01

treatment week 6:

TG 1.60 vs. PT 2.12 p = 0.01

treatment week 7:

TG 1.43 vs. PT 1.98 p = 0.01

Week 1 post RT:

TG 1.20 vs. PT 1.55 not sig.

Week 2 post RT:

TG 0.64 vs. PT 0.91 not sig.

1b

no information about funding
no information about the concealment method

"Benzydamine oral rinse can be considered as an effective, safe and well-tolerated medication for prevention of radiation-induced oral mucositis and alleviating its symptoms."