Chitapanarux 2010

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

Chitapanarux 2010

Radiation Oncology

Monocenter

Prospective, randomized, double-blind, placebo-controlled study

Two arms

N= 63

Thailand

01/2007-04/2009

Advanced cervical cancer

47 vs. 52 yrs,

Female

RT (200 cGY per fraction, five fractions a week) plus weekly Cisplatin

N= 32

2x109 units of Lactobacillus acidophilus plus Bifidobacterium bifidum (equivalent to 2 capsules)

two times a day before meals (morning and evening), beginning 7 days before start of RTX, continuing every day of RTX

N= 31

Identical appearing placebo containing magnesium stearate, talc, purified water, 2 capsules two times a day before meals (morning and evening), beginning 7 days before start of RTX, continuing every day of RTX

Incidence and severity of diarrhea

Use of antidairrhoeal medication (Loperamide)

Diarrhea

Grade 1 (29/32 [91 %]) vs. 17/31 [55 %])

Grade 2 (3/32 [9 %] vs. 13/31 [42 %])

Grade 3 (0/32 [0 %] vs. 1/31 [3 %])

Prevalence of formed stool (1/32 [3 %] vs. 0/31 [0 %])

Prevalence of soft stool (25/32 [78 %] vs. 11/31 [35 %])

Prevalence of liquid stool (6/32 [19 %] vs. 20/31 [65 %])

Use of Loperamide (3/32 [9 %] vs. 10/31 [32 %])

No information

No information

1b/1+

“Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and has a significant benefit on stool consistency.”