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

1. Four weeks of combination therapy with anti-inflammatory drug aceclofenac and vitamin B complex was superior to aceclofenac alone for pain control and functional improvement in patients with painful foot and ankle conditions. 

Evidence Rating Level: 1 (Excellent)

Analgesic anti-inflammatory drugs are commonly used to treat foot disorders, but their long-term use can result in adverse health outcomes such as gastrointestinal bleeding, peptic ulcers, and increased cardiovascular risk. Vitamin B complex has been suggested to enhance the effects of anti-inflammatory analgesics and reduce their side effects. However, research on the role of vitamin B complex in pain related to foot disorders is limited. This study thus examined the efficacy of combining anti-inflammatory drugs with vitamin B complex in alleviating pain and improving foot function in patients with chronic foot disorders. This multi-center, randomised clinical trial included 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. Patients were randomized 1:1 to receive either aceclofenac only at 100 mg twice daily (control group) or aceclofenac 100 mg plus vitamin B complex supplement twice daily (experimental group) for 4 weeks. The primary outcome was pain assessed using the 10-cm visual analog scale (VAS) (higher score indicates greater pain). In total, 156 patients were analyzed, of which 79 were in the experimental group (mean [SD] age = 55.53 [13.83] years, female [%] = 47 [59.4]) and 77 were in the control group (mean [SD] age = 56.97 [12.68] years, female [%] = 47 [61.0]). After 4 weeks, a greater reduction in VAS scores was found in the experimental group compared to the control group (−2.87 ± 1.86 vs. −0.91 ± 1.81, p < 0.001). The experimental group also had greater improvements in health-related quality of life (EuroQol 5 Dimension scores 0.079 ± 0.143 vs 0.008 ± 0.111, p = 0.001) and in function (Foot and Ankle Outcome Score 9.94 ± 14.38 vs 2.97 ± 11.79, p = 0.001). No serious adverse events were reported. Overall, this study found that the combination of the anti-inflammatory drug aceclofenac and vitamin B complex was superior to aceclofenac alone for pain control and functional improvement in patients with chronic foot disorders. These findings suggest that combination therapy is a promising strategy for alleviating pain and improving function in orthopaedic outpatient settings. Future studies should investigate the long-term benefits of this combination therapy.

Click here to read this study in PLOS One

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