Mansouri‐Tehrani 2016.
| Methods | Study design: placebo‐controlled RCT with 3 parallel groups Duration of the study, recruitment: October 2012 to May 2013 Follow‐up: 5 weeks Country: Iran |
|
| Participants | 78 participants between 20 and 85 years of age with diagnosis of pelvic cancer (colorectal, prostate, endometrial, bladder, ovarian, cervical, bone sarcoma) who were about to receive radiotherapy (11 participants dropped out) Exclusion criteria: opioid usage, antimicrobial treatment, presence of any acute or chronic gastrointestinal condition associated with diarrhoea for ≥ 1 month before inclusion Mean age ± SD: 63.7 ± 15.1 versus 57.9 ± 17.5 versus 64.2 ± 11.7 years Male/female: 14/8 versus 8/13 versus 17/7 Cancer site, n:
|
|
| Interventions | Probiotics: ‘LactoCareOD’ (Zist Takhmir Company, Tehran, Iran) containing Lactobacillus casei 1.5 × 10⁹ CFU, Lactobacillus acidophilus 1.5 × 10¹º CFU, Lactobacillus rhamnosus 3.5 × 10⁹ CFU, Lactobacillus bulgaricus 2.5 × 10⁸ CFU, Bifidobacterium breve 1 × 10¹º CFU, Bifidobacterium longum 5 × 10⁸ CFU, and Streptococcus thermophilus 1.5 × 10⁸ CFU per 500 mg Intervention group 1 (n = 22): 2 probiotic capsules per day after consumption of 150 grams of low‐fat yogurt Intervention group 2 (n = 21): 2 probiotic capsules and 30 grams honey per day after consumption of 150 grams of low‐fat yogurt and 15 grams of honey at night Placebo group (n = 24): 2 placebo capsules per day after consumption of 150 grams of low‐fat yogurt All participants received conventional radiotherapy for 4 to 5 weeks (total dose from 4000 to 5000 cGy (1.8 Gy/d)) |
|
| Outcomes | Severity of diarrhoea according to the Common Toxicity Criteria of the National Cancer Institute, stool consistency according to an adapted Bristol Scale, daily number of bowel movements, need for antidiarrhoeal medication, bloating | |
| Notes | Trial registration: IRCT2015030421338N1 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "A randomized, placebo‐controlled study was performed"/"Simple randomization was used to allocate patients to three groups" |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No details provided, but group 1 received probiotics and group 3 (control group) received similar medication with placebo capsules |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | "The patients evaluated for the daily number of bowel movement (defecation), diarrhea grade, stool consistency score, the need for antidiarrheal medication and bloating weekly by one person" Not sure whether this person was unaware of the treatment group |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Double‐blind, placebo‐controlled trial: low risk for assessment of objective outcomes (mortality) |
| Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | "Among 78 patients involved in this study, 11 patients were excluded for failure to follow up" Reasons for dropout and intervention group of dropouts not presented |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | "Among 78 patients involved in this study, 11 patients were excluded for failure to follow up" Reasons for dropout and intervention group of dropouts not presented |
| Selective reporting (reporting bias) | Low risk | Outcomes presented according to trial registration form (IRCT2015030421338N1); laboratory outcomes reported in another paper |
| Other bias | Low risk | No indications of other bias |