Vitamin B supplementation enhances the efficacy of non-steroidal anti-inflammatory drugs in patients with painful foot and ankle conditions: A multicenter, prospective, randomized controlled trial

Abstract

Objective The management of foot disorders often involves anti-inflammatory drugs for chronic inflammation and pain. Combining anti-inflammatory drugs with vitamin B complex may have a synergistic effect, but its efficacy in foot disorders remains unclear. This study aimed to investigate the effects of combining vitamin B complex with anti-inflammatory drugs in patients with foot disorders. Methods This study enrolled 201 patients aged ≥ 19 years with foot disorders of Achilles tendinitis, foot or ankle arthritis, Civinini-Morton syndrome (Morton’s neuroma), or plantar fasciitis from four hospitals in Korea between October 2020 and December 2021. The patients were randomized in a 1:1 ratio to receive either aceclofenac 100 mg twice daily alone (control group, n = 77) or aceclofenac 100 mg and vitamin B complex twice daily (experimental group, n = 79) for 4 weeks. Among 201 randomized participants, 156 patients(79 in the experimental group and 77 in the control group) completed all scheduled follow-up visits and were included in the final analysis. The primary outcome measure was pain as assessed using the 10-cm visual analog scale (VAS). The secondary outcome measures were health-related quality of life and foot/ankle outcomes as assessed using the EuroQol 5 Dimension (EQ-5D) questionnaire and the Foot and Ankle Outcome Score (FAOS), respectively. Results VAS scores were more significantly reduced in the experimental group than in the control group, after 4 weeks (−2.87 ± 1.86 (from 6.95 ± 0.15 to 4.08 ± 0.17) vs. −0.91 ± 1.81 (from 5.99 ± 0.14 to 5.08 ± 0.21], p < 0.001). Similarly, improvements in the EQ-5D scores were significantly greater in the experimental group (0.079 ± 0.143 (from 0.69 ± 0.01 to 0.77 ± 0.01] vs 0.008 ± 0.111 (from 0.75 ± 0.01 to 0.76 ± 0.01], p = 0.001). Additionally, the increase in FAOS after treatment was significantly larger in the experimental group (9.94 ± 14.38 vs 2.97 ± 11.79, p = 0.001). Subgroup analysis revealed the combined therapy was particularly more effective in patients with chronic symptoms lasting over 3 months and in conditions like plantar fasciitis, foot or ankle arthritis, and Civinini-Morton syndrome. Conclusion Combining vitamin B complex with anti-inflammatory drugs effectively reduces pain and improves function in patients with chronic foot disorders. This combination therapy offers a promising strategy for improving pain control and functional outcomes in orthopaedic outpatient settings.