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Probiotic Supplements on Oncology Patients' Treatment-Related Side Effects: A Systematic Review of Randomized Controlled Trials.

ABSTRACT: Cancer affects more than 19.3 million people and has become the second leading cause of death worldwide. Chemo- and radiotherapy, the most common procedures in these patients, often produce unpleasant treatment-related side effects that have a direct impact on the quality of life of these patients. However, innovative therapeutic strategies such as probiotics are being implemented to manage these complications. Thus, this study aimed to evaluate the efficacy of probiotics supplements as a therapeutic strategy in adult oncology treatment-related side effects. A systematic review of randomized controlled trials was conducted in PubMed, Scielo, ProQuest and OVID databases up to and including January 2021, following the PRISMA guidelines. The quality of the included studies was assessed by the Jadad Scale. Twenty clinical trials published between 1988 and 2020 were included in this review. Seventeen studies (85%) revealed predominantly positive results when using probiotics to reduce the incidence of treatment-related side effects in oncology patients, while three studies (15%) reported no impact in their findings. This study sheds some light on the significance of chemotherapy and radiotherapy in altering the composition of gut microbiota, where probiotic strains may play an important role in preventing or mitigating treatment-related side effects.

SUBMITTER: Rodriguez-Arrastia M

PROVIDER: S-EPMC8074215 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Probiotic Supplements on Oncology Patients' Treatment-Related Side Effects: A Systematic Review of Randomized Controlled Trials.

Rodriguez-Arrastia Miguel M Martinez-Ortigosa Adrian A Rueda-Ruzafa Lola L Folch Ayora Ana A Ropero-Padilla Carmen C

International journal of environmental research and public health 20210417 8

Cancer affects more than 19.3 million people and has become the second leading cause of death worldwide. Chemo- and radiotherapy, the most common procedures in these patients, often produce unpleasant treatment-related side effects that have a direct impact on the quality of life of these patients. However, innovative therapeutic strategies such as probiotics are being implemented to manage these complications. Thus, this study aimed to evaluate the efficacy of probiotics supplements as a therap ...[more]

PMID: 33920572

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Project description:IntroductionAnemia is a common global health problem, particularly in impoverished regions, with a high incidence rate. The condition is multifactorial, with iron deficiency being one of the most prevalent causes. Current treatment for anemia often relies on iron supplements or erythropoiesis-stimulating agents, although these therapies may show limited efficacy for some patients. Recent evidence suggests that probiotics, prebiotics, and synbiotics, as microbiome modulators, hold significant potential in the treatment of anemia. These interventions may enhance iron absorption and improve overall blood health through their impact on gut microbiota, thus providing an alternative or complementary approach to conventional treatments.MethodsSix databases, including the Cochrane Central Register of Controlled Trials, Embase, PubMed, Web of Science (WOS), China National Knowledge Infrastructure (CNKI), and WangFang data library, were searched up to November 20, 2024. Studies published in English and Chinese were included. We included randomized controlled trials (RCTs) evaluating the effects of probiotics, prebiotics, or synbiotics in treating anemia. The experimental groups received probiotics, prebiotics, or synbiotics, while the control groups received placebo, alternative treatments, or no treatment. The primary outcome was hemoglobin (Hb) levels. Secondary outcomes included serum iron (SI) and serum ferritin (SF). A descriptive analysis was conducted for studies where meta-analysis was not feasible. The GRADE tool was used to assess the quality of evidence, and the Cochrane guidelines were employed to evaluate the risk of bias in each study.ResultsSeven studies were included comprising a total of eight RCTs, with the main types of anemia being iron deficiency anemia (IDA) and anemia of chronic kidney disease (CKD), involving 632 patients. The analysis revealed that probiotics, prebiotics, or synbiotics significantly improved Hb levels in patients with anemia (WMD = 10.760, 95% CI: 4.593 to 16.747, p = 0.001), though heterogeneity was high (I² = 96.5%). Two RCTs (n = 120 participants) reported significant increases in serum iron levels in the probiotic group (WMD = 3.835, 95% CI: 3.271 to 4.400), with moderate heterogeneity (I² = 38.7%). Two RCTs (n = 192 participants) reported no significant differences were observed between the groups in serum ferritin levels (WMD = 8.048, p = 0.115), and heterogeneity remained high (I² = 62.6%). Subgroup analyses revealed that probiotics improved Hb levels in renal and iron-deficiency anemia, as well as across different doses. The synbiotic group showed consistent efficacy (I² = 0%), while the prebiotic group did not exhibit significant effects, with extremely high heterogeneity (I² = 99.3%). This indicates that heterogeneity may stem from variations in intervention types, and the results should be interpreted with caution.ConclusionThere is moderate-quality evidence suggesting that probiotics, prebiotics, and synbiotics may improve anemia management, particularly by enhancing Hb levels. Further high-quality RCTs are required to explore the specific role of synbiotics in anemia management, including their comparative efficacy against probiotics and prebiotics alone, and their impact on gastrointestinal factors such as gut microbiota modulation and inflammation reduction.Systematic review registrationPROSPERO CRD42024590073.

Project description:BackgroundClinical significance in a randomized controlled trial (RCT) can be determined using the minimal clinically important difference (MCID), which should inform the delta value used to determine sample size. The primary objective was to assess clinical significance in the pediatric oncology randomized controlled trial (RCT) treatment literature by evaluating: (1) the relationship between the treatment effect and the delta value as reported in the sample size calculation, and (2) the concordance between statistical and clinical significance. The secondary objective was to evaluate the reporting of methodological attributes related to clinical significance.MethodsRCTs of pediatric cancer treatments, where a sample size calculation with a delta value was reported or could be calculated, were systematically reviewed. MEDLINE, EMBASE, and the Cochrane Childhood Cancer Group Specialized Register through CENTRAL were searched from inception to July 2016.ResultsRCTs (77 overall; 11 and 66), representing 95 (13 and 82) randomized questions were included for non-inferiority and superiority RCTs (herein, respectively). The minority (22.1% overall; 76.9 and 13.4%) of randomized questions reported conclusions based on clinical significance, and only 4.2% (15.4 and 2.4%) explicitly based the delta value on the MCID. Over half (67.4% overall; 92.3 and 63.4%) reported a confidence interval or standard error for the primary outcome experimental and control values and 12.6% (46.2 and 7.3%) reported the treatment effect, respectively. Of the 47 randomized questions in superiority trials that reported statistically non-significant findings, 25.5% were possibly clinically significant. Of the 24 randomized questions in superiority trials that were statistically significant, only 8.3% were definitely clinically significant.ConclusionsA minority of RCTs in the pediatric oncology literature reported methodological attributes related to clinical significance and a notable portion of statistically insignificant studies were possibly clinically significance.

Dataset Information

Probiotic Supplements on Oncology Patients' Treatment-Related Side Effects: A Systematic Review of Randomized Controlled Trials.

Publications

Probiotic Supplements on Oncology Patients' Treatment-Related Side Effects: A Systematic Review of Randomized Controlled Trials.

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