OBJECTIVES: This pilot trial was conducted to establish whether Boswellia Serrata (BS), a traditional herbal medicine, could improve the outcome of patients who have diffuse axonal injury (DAI). METHODS: In total, 38 patients with pure DAI were enrolled in this 12-week, double-blind, randomized, cross-over study. The patients were randomly assigned to receive either placebo (group A, n = 20) or BS capsules (group B, n = 18) for 6 weeks and then switched to the other intervention for another 6 weeks. The disability rating scale (DRS) was used to assess the outcome at 2-, 6- and 12-weeks post-trauma. RESULTS: A non-significant trend for improvement of DRS total scores was observed after the use of BS. Regarding the DRS sub-scores, however, there was significant improvement in 'cognitive ability to self-care' during the second 6 weeks in group A on BS compared to an insignificant spontaneous recovery in group B during the same period on placebo. Moreover, both groups experienced a close-to-significant increase in the cognitive function-related items of the DRS during the periods they were on BS. The reported adverse events were all of mild quality and had similar frequency between the groups. CONCLUSION: These results suggest that BS resin does not significantly affect general outcome, but may enhance the cognitive outcome of patients with DAI.
RCT Entities:
OBJECTIVES: This pilot trial was conducted to establish whether Boswellia Serrata (BS), a traditional herbal medicine, could improve the outcome of patients who have diffuse axonal injury (DAI). METHODS: In total, 38 patients with pure DAI were enrolled in this 12-week, double-blind, randomized, cross-over study. The patients were randomly assigned to receive either placebo (group A, n = 20) or BS capsules (group B, n = 18) for 6 weeks and then switched to the other intervention for another 6 weeks. The disability rating scale (DRS) was used to assess the outcome at 2-, 6- and 12-weeks post-trauma. RESULTS: A non-significant trend for improvement of DRS total scores was observed after the use of BS. Regarding the DRS sub-scores, however, there was significant improvement in 'cognitive ability to self-care' during the second 6 weeks in group A on BS compared to an insignificant spontaneous recovery in group B during the same period on placebo. Moreover, both groups experienced a close-to-significant increase in the cognitive function-related items of the DRS during the periods they were on BS. The reported adverse events were all of mild quality and had similar frequency between the groups. CONCLUSION: These results suggest that BS resin does not significantly affect general outcome, but may enhance the cognitive outcome of patients with DAI.