Comparison of the Efficacy of Topical Arnebia euchroma Product with Topical Phenytoin on Pressure Ulcer in Patients with Spinal Cord Injury: A Triple-Blind, Randomized Clinical Trial.

Background: Arnebia euchroma (Ae) in traditional Persian medicine is used for wound treatment. This study assessed the efficacy of Ae liniment on pressure ulcer (PU) remedy in patients with Spinal Cord Injury.

Methods: In this triple-blind, randomized clinical trial, grade 2 and 3 wounds were randomly assigned to receive either Ae liniment or Phenytoin Cream 1% twice a day for 5 weeks. Recovery was measured by the wound size, exudate, and tissue type by the "Pressure Ulcer Scale for Healing" (PUSH) tool on days 0, 7, 14, 21, 28, and 35. PUSH score between groups was compared with the Mann-Whitney U test, and also within each group by Friedman test.

Results: 74 patients (37 in each group) participated and completed the study. Mean±SD of PUSH Scores at baseline, and 1,2,3,4,5 week after the treatment in Ae group were 9.73±2.65, 9.92±3.08, 8.24±3.86, 7±4.08, 5.22±4.3, 3.41±3.85 and in Phenytoin group were 10.05±1.85, 9.97±1.9, 9.59±2.08, 9.22±2.09, 8.54±2.72, 7.57±3.26. PUSH Score decrease in the Ae group was70.33 ± 32.25% , and in group 2 was 27.67± 26.8% (P < 0.001), which indicates that in comparison of the PUSH Score decrease between the two groups, this reduction was significantly higher in the Ae group. During the study, complete wound healing was observed in 16 patients (43.2%) in the Ae group and in the Phenytoin group in 3 wounds (8.1%) (P = 0.010). No side effects were reported in either group.

Conclusion: PU healing was significantly better in the Ae group than phenytoin cream. It may be considered as a potential option in the treatment of PU in patients with Spinal Cord Injury.