Hydroxocobalamin 15mg/5ml oral solution

BackgroundVitamin B12 deficiency is a widespread condition, particularly among elderly individuals, patients with malabsorption syndromes, and those following plant-based diets. This systematic review and meta-analysis aimed to evaluate and compare the effectiveness of sublingual and oral vitamin B12 administration in comparison with intramuscular (IM) injections, both for improving serum cobalamin and reducing homocysteine levels.MethodsA comprehensive search was conducted across PubMed, Scopus, and Embase up to July 2024. Eligible studies included randomised controlled trials, cohort, and case-control studies assessing B12 supplementation efficacy via oral, sublingual, or IM administration routes. Meta-analyses were performed using random-effects models. Subgroup analyses evaluated four key factors: administration route efficacy, daily dosage, age group and clinical conditions that may affect vitamin B12 metabolism (e.g., underlying pathology). Sixteen studies were included in the quantitative synthesis, comprising a total of 6,098 participants.ResultsVitamin B12 supplementation was associated with a significant increase in serum cobalamin levels across all routes of administration (pooled mean difference = +402.6 pg/mL; 95% CI: 293.6 to 511.5; p 2 > 80% in most comparisons), and Egger's test indicated potential publication bias. Given the high heterogeneity, further studies are needed to confirm the results.ConclusionSublingual and oral B12 supplementation appear to be as effective as intramuscular (IM) injections in improving cobalamin status and reducing homocysteine levels. Given their non-invasive nature, accessibility, and cost-effectiveness of sublingual formulations, they may represent a promising approach for long-term B12 management, particularly in patients with impaired absorption or in resource-limited settings. Further high-quality RCTs are warranted to refine dosing strategies and confirm long-term outcomes.Systematic review registrationCRD42024554513.

Abstract licence: CC BY

Background and objectiveChronic low back pain is one of the leading causes of disability. Current therapies offer limited efficacy and carry potential adverse risks. Vitamins B1, B6, and B12 have shown promise in the amelioration of musculoskeletal pain. The aim of this study was to evaluate the efficacy and safety of a combined injectable formulation of hydroxocobalamin (B12), thiamine hydrochloride (B1), and pyridoxine hydrochloride (B6) (TPH) as an adjunct treatment for chronic low back pain.Methodsa randomized, double-blind, phase 3 clinical trial was conducted across six centers in Peru. A total of 163 patients with chronic mechanical lower back pain were included and assigned to receive TPH plus NSAIDs (n=81) or placebo plus NSAIDs (n=82). The primary outcome was the proportion of patients achieving ≥30% reduction in the NRS-11 score by day 28. Analyses were performed using an intention-to-treat approach and models adjusted for covariates.ResultsIn the treatment group, 84% of participants achieved ≥30% reduction in the NRS-11 score compared to 64% in the control group (RR=1,31; 95% CI: 1,08-1,59; p=0,007). This effect remained significant after adjusting for BMI and albumin. Improvements were also observed in the Patient Global Assessment (PGA) and a favorable trend in the Oswestry Disability Index. The incidence of adverse events was higher in the treatment group, but no significant differences in serious events were found.ConclusionTPH as an adjunct to standard treatment was effective in reducing chronic low back pain and demonstrated an acceptable safety profile.

Abstract licence: CC BY