Introduction: DPN affects approximately 50% of diabetic individuals worldwide1. B Vits are used in DPN management although evidence supporting treatment outcomes vary.
Objective: Evaluate the evidence supporting B Vits usage in DPN.
Methods: Literature search: Medical Subject Headings and text words in Pubmed/EMBASE identified 226 clinical trials published between 1978 - Nov 2018. Using PRISMA guidelines, data was extracted from eligible studies and risk of bias assessed was assessed by 2 authors.
Main Results: Fifty-one studies involving 4621 patients were selected [40 RCTs (Placebo-controlled: 7; Active-control: 34) and 10 single-arm study]. Results from placebo-control studies involving daily B vitamin(vit) monotherapy [benfotiamine 300- 600mg OR methylcobalamin 1500μg (MC)] OR Superoxide Dismutase (SOD), Alpha Lipoic Acid (ALA), Acetyl L-Carnitine (AC) and Vit B12 combination showed significant improvement in neuropathy-related scores/symptoms vs. control. One study (150mg pyridoxine daily) showed no improvement in nerve conduction was noted vs. placebo. Vit B6 80mg + 800mg ALA/day showed no inflammatory marker improvement.
When Mono- or combination B Vits was compared to active controls[e.g.: micronutrients/herbs(ALA; ALC; Traditional Chinese Medicine), drugs (pregabalin; nortriptyline; venlafaxine) and lifestyle interventions (moxibustion; low-fat plant-based diet)], 29 studies showed improvements in DPN symptoms relative to control. Two studies showed less effectiveness compared to venlafaxine and cytidinie triphosphate. All single arm B Vit studies (IM MC 500μg 1/day OR 3/week OR benfotiamine/Vit B1/B12) showed improvement in nerve function.
Conclusion: B Vits had positive effect on neurophysiological symptoms and/or functions compared to baseline in 38 studies. RCTs evaluating the efficacy of B Vits in standardized combination/doses are limited. Further studies are required to elucidate optimum treatment combination/doses and duration.
J. Liew: None. A. Barlow: None. L. Lim: Research Support; Self; AstraZeneca. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. K. Suastika: None. Y. Yasahardja: None. S. Chan: None. A. Soh: None. L.S. Li: None. A.T. Tan: None.