METHODS: We searched PubMed, Embase and the Cochrane Central systematically for the randomised control trials (RCTs) of interventions for preventing OM. Network meta-analysis (NMA) was performed to estimate risk ratios (RR) and 95% confidence intervals (CI) from both direct and indirect evidence. The primary outcome was any grade of OM. Secondary outcomes were mild-moderate OM, severe OM and adverse events, such as taste disturbance and gastrointestinal adverse events. This study was registered with PROSPERO, number CRD42016052489.
RESULTS: A total of 29 RCTs with 2348 patients (median age, 56.1 years; 57.5% male) were included. Cryotherapy was associated with a significantly lower risk of OM than control (RR 0.51, 95% CI 0.38 to 0.68), and zinc sulphate (RR 0.47, 95% CI 0.23 to 0.97), but not significantly lower than sucralfate and palifermin. No significant differences were observed between cryotherapy and control for taste disturbance and gastrointestinal adverse events. Palifermin was associated with the highest risk of taste disturbance.
CONCLUSIONS: This NMA suggests that cryotherapy was the most effective intervention for preventing chemotherapy-induced OM with a safety profile similar to control, but not significantly lower than sucralfate and palifermin. Large RCTs are needed to confirm these findings.
METHODS: Seven databases and four trial registries were searched. Eligible studies included randomised- and non-randomised-controlled-trials in patients diagnosed with OM. Studies on Individualised- and non-Individualised-Homeopathy (IH, non-IH) were included, and controls were inactive and/or active treatment. Primary outcomes were clinical-improvement and antibiotic-use. Data extraction, Risk of Bias and certainty of evidence (GRADE) were performed using established methodology.
RESULTS: Nine studies (IH = 4, non-IH = 5) comprising seven Randomised Clinical Trials (RCTs) and two non-RCTs (nRCTS) compared homeopathy with placebo (n = 2) or standard care (n = 7). 4/7 included RCTs reported statistically significant individual outcomes at relevant time points (symptom score, MEE, and antibiotic use) favouring homeopathy. However, heterogeneity of study designs, homeopathic interventions and outcome measures hindered the pooling of data for most outcomes, except for antibiotic use (non-IH). Add-on non-IH reduced filled antibiotic prescriptions by 46 % (RR = 0.54 [95%CI: 0.28, 1.06], P = 0.07, I2 = 12 %), but this did not reach statistical significance. Most studies demonstrated that the homeopathy group had less adverse events than the control group.
CONCLUSIONS: The evidence base for the effectiveness of homeopathy and OM treatment is modest in study number, size, and risk of bias assessment. Individual RCTs report positive effects on clinical improvement and/or antibiotic use at relevant time points with homeopathy with no safety issues. Due to heterogeneity, the current evidence is insufficient to satisfactorily answer whether homeopathy is effective for clinical improvement and reducing antibiotic use in patients with OM. A Core Outcome Set for OM for future research is warranted to improve the potential for meta-analyses and strengthen the evidence base.
OBJECTIVE: The objective of this study was to determine the effects of folic acid or l-5-MTHF supplementation on blood folate concentrations, methyl nutrient metabolites, and DNA methylation in women living in Malaysia, where there is no mandatory fortification policy.
METHODS: In a 12-wk, randomized, placebo-controlled intervention trial, healthy Malaysian women (n = 142, aged 20-45 y) were randomly assigned to receive 1 of the following supplements daily: 1 mg (2.27 μmol) folic acid, 1.13 mg (2.27 μmol) l-5-MTHF, or a placebo. The primary outcomes were plasma and RBC folate and vitamin B-12 concentrations. Secondary outcomes included plasma total homocysteine, total cysteine, methionine, betaine, and choline concentrations and monocyte long interspersed nuclear element-1 (LINE-1) methylation.
RESULTS: The folic acid and l-5-MTHF groups had higher (P