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 ±…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 201 participants or records.
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