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Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients.

Chitapanarux I, Chitapanarux T, Traisathit P, Kudumpee S, Tharavichitkul E, Lorvidhaya V - Radiat Oncol (2010)

Bottom Line: Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03).The patients in the study drug group had a significantly improved stool consistency (p < 0.001).Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com

ABSTRACT

Background: Radiation-induced diarrhea is frequently observed during pelvic radiotherapy. This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients.

Methods: Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin were randomly assigned to a study drug or placebo, in a double-blind study. Diarrhea was graded weekly according the Common Toxicity Criteria (CTC) system. Stool consistency and white and red blood cell count in stool were also assessed. The primary endpoint was to reduce the incidence of diarrhea, defined by a CTC grade 2 or more, and the need for anti-diarrheal medication.

Results: A total of 63 patients were enrolled. Grade 2 -3 diarrhea was observed in 45% of the placebo group (n = 31) and 9% of the study drug group (n = 32) (p = 0.002). Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03). The patients in the study drug group had a significantly improved stool consistency (p < 0.001).

Conclusions: Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency.

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Related in: MedlinePlus

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Figure 1: Trial profile.

Mentions: Between January 2007 and April 2009, sixty-three patients were randomly allocated to receive lactobacillus acidophilus plus bifidobacterium bifidum (InfloranĀ®) in 32 patients or a placebo in 31 patients (Fig 1). All 63 patients were eligible and assessable. All patients had undergone concurrent chemoradiotherapy. Age, stage of disease, performance status, and whole pelvis radiotherapy technique did not show any difference between the two groups. Baseline characteristics are shown in Table 1. During irradiation, diarrhea occurred in all patients. In the 31 eligible patients who received pelvic radiotherapy and placebo, rates of Grades 1, 2, and 3 diarrhea during treatment were 55, 42, and 3%, respectively. For the 32 eligible patients who received radiotherapy and lactobacillus acidophilus plus bifidobacterium bifidum, the overall rates of grades 1, 2, and 3 diarrhea were 91, 9, and 0%, respectively. The difference in the severity of diarrhea was significant p = 0.002 (Table 2). The patients who received lactobacillus acidophilus plus bifidobacterium bifidum also had a significantly improved stool consistency (p < 0.001) (Table 2). The prevalence of formed, soft, and liquid stool was 0%, 35% and 65%, respectively in placebo group. In contrast, in the study drug group the prevalence of formed, soft, and liquid stool was 3%, 78% and 19%, respectively. However white and red blood cell counts in patients' stool did not differ between the two groups. The severity of radiation-induced diarrhea is illustrated by 32% of patients in the placebo group needing anti-diarrheal medication, as against 9% of patients in the study drug group (p = 0.03). The median overall treatment time and median weight change from the beginning to the last treatment did not differ between groups (Table 2). There were no adverse events attributable to the study drug.


Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients.

Chitapanarux I, Chitapanarux T, Traisathit P, Kudumpee S, Tharavichitkul E, Lorvidhaya V - Radiat Oncol (2010)

Trial profile.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2874795&req=5

Figure 1: Trial profile.
Mentions: Between January 2007 and April 2009, sixty-three patients were randomly allocated to receive lactobacillus acidophilus plus bifidobacterium bifidum (InfloranĀ®) in 32 patients or a placebo in 31 patients (Fig 1). All 63 patients were eligible and assessable. All patients had undergone concurrent chemoradiotherapy. Age, stage of disease, performance status, and whole pelvis radiotherapy technique did not show any difference between the two groups. Baseline characteristics are shown in Table 1. During irradiation, diarrhea occurred in all patients. In the 31 eligible patients who received pelvic radiotherapy and placebo, rates of Grades 1, 2, and 3 diarrhea during treatment were 55, 42, and 3%, respectively. For the 32 eligible patients who received radiotherapy and lactobacillus acidophilus plus bifidobacterium bifidum, the overall rates of grades 1, 2, and 3 diarrhea were 91, 9, and 0%, respectively. The difference in the severity of diarrhea was significant p = 0.002 (Table 2). The patients who received lactobacillus acidophilus plus bifidobacterium bifidum also had a significantly improved stool consistency (p < 0.001) (Table 2). The prevalence of formed, soft, and liquid stool was 0%, 35% and 65%, respectively in placebo group. In contrast, in the study drug group the prevalence of formed, soft, and liquid stool was 3%, 78% and 19%, respectively. However white and red blood cell counts in patients' stool did not differ between the two groups. The severity of radiation-induced diarrhea is illustrated by 32% of patients in the placebo group needing anti-diarrheal medication, as against 9% of patients in the study drug group (p = 0.03). The median overall treatment time and median weight change from the beginning to the last treatment did not differ between groups (Table 2). There were no adverse events attributable to the study drug.

Bottom Line: Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03).The patients in the study drug group had a significantly improved stool consistency (p < 0.001).Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com

ABSTRACT

Background: Radiation-induced diarrhea is frequently observed during pelvic radiotherapy. This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients.

Methods: Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin were randomly assigned to a study drug or placebo, in a double-blind study. Diarrhea was graded weekly according the Common Toxicity Criteria (CTC) system. Stool consistency and white and red blood cell count in stool were also assessed. The primary endpoint was to reduce the incidence of diarrhea, defined by a CTC grade 2 or more, and the need for anti-diarrheal medication.

Results: A total of 63 patients were enrolled. Grade 2 -3 diarrhea was observed in 45% of the placebo group (n = 31) and 9% of the study drug group (n = 32) (p = 0.002). Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03). The patients in the study drug group had a significantly improved stool consistency (p < 0.001).

Conclusions: Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency.

Show MeSH
Related in: MedlinePlus