Sarvizadeh 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

Sarvizadeh

2015

Advanced Biomedical Research

unicenter, double‑blinded, randomized, controlled

study

April - July 2011

Iran

head and neck cancer patients

Morphine

n=15

Control

n=13

Age, years

Morphin:47.5±14.6

Control: 52.1±11.0

Gender, male/female Morphin: 5/10

Controll: 5/8

Treatment

Radiotherapy

Morphin:5 pts

Control: 3 pts

Chemotherapy Morphin: 8 pts

Control: 5 pts

Chemoradiotherapy

Morphin: 2 pts

Control: 5 pts

Mucositis grade III/VI

Morphin: 11/4

Control: 9/4

morphine sulfate 2% or magic solution (contained magnesium aluminum hydroxide, viscous lidocaine, and diphenhydramine), 10 ml for every 3 h, six times a day, for 6 days

effectiveness of topical morphine compared with a routine mouthwash

Morphine vs. Control

3rd day score 2.00±0.70 vs. 2.46±1.05, p = 0.161

6th day score 1.71±0.60 vs. 2.46±1.26, p = 0.045*

Drug effect maintenance

< 1 h 8 vs. 8, p = 0.479**

1-2 h 7 vs. 5

Satisfaction

Satisfied 8 vs. 7, p =0.008

Tolerable 6 vs. 4

Intolerable 1 vs. 2

Serum therapy 0 vs. 1 (7.6%), p = 0.433

This study was supported by Vice Chancellor for Research of Isfahan University of Medical Sciences

2b
very small sample size, to small to provide appropriate randomization,
heterogenous patient population regarding tumor-therapy
follow-up was too short

"Topical morphine is more effective and more satisfactory to patients than the magic mouthwash in reducing severity of cancer treatment-induced oral mucositis. More studies with larger sample size and longer follow-up are required in this regard."