Yavuz 2002

Referenz

(Autor, Jahr, Journal)

Studientyp

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

Patientenmerkmale

Indikation, Alter, Geschlecht (m/w), CTX

Intervention

Kontrolle

Zielgröße

Primary Endpoint

Secondary Endpoint

Finanzierung

Evidenzstufe (CEBM levels/ SIGN)

Bei Abwertung: Angabe von Gründen

Yavuz 2002

Int. J. of Radiation Oncology

Int

Monocenter, open randomized study

Two arms,

N=61

Turkey

Cancer in the pelvis without metastases beyond the regional lymph nodes

24-90 yrs.

m/f

(≥45 Gy, >4.5 weeks, daily dose 1.8-2.0 Gy

N= 33 Octreotide s.c., 100 µg three times daily

N= 29 Diphenoxylate and atropine orally, 2,5 mg four times daily

Primary Endpoints: Resolution of diarrhea, interruption of pelvic radiotherapy

Complete resolution of diarrhea within 3 days (20/33 vs. 4/28; p=0.002)

Discontinuation of radiotherapy (6/33 vs. 15/28 average (0.45±0.2 days vs. 1.89 ±0.5 days; p= 0.003)

Duration of diarrhea days (3.30±0.3 vs. 5.36±0.4)

No side effects were observed in either arm

No information given

2b-/1-

No blinding

“Octreotide seems to be more effective than conventional therapy with diphenoxylate and atropine in controlling acute radiation induced diarrhea and eliminating the need for raditotherapy interruptions.”