Moein Payam, Abbasi Fard Salman, Asnaashari Ali, Baratian Hajar, Barekatain Majid, Tavakoli Naser, Moein Houshang
Behavioral Sciences Research Center, Noor Hospital, Isfahan University of Medical Sciences , Isfahan , Iran .
Brain Inj. 2013;27(12):1454-60. doi: 10.3109/02699052.2013.825009. Epub 2013 Oct 2.
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).
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.
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.
These results suggest that BS resin does not significantly affect general outcome, but may enhance the cognitive outcome of patients with DAI.
开展这项初步试验以确定传统草药乳香(Boswellia Serrata,BS)是否能改善弥漫性轴索损伤(DAI)患者的预后。
总共38例单纯DAI患者参与了这项为期12周的双盲、随机、交叉研究。患者被随机分配接受安慰剂(A组,n = 20)或BS胶囊(B组,n = 18)治疗6周,然后换用另一种干预措施再治疗6周。使用残疾评定量表(DRS)在创伤后2周、6周和12周评估预后。
使用BS后观察到DRS总分有改善的趋势,但无统计学意义。然而就DRS分项评分而言,A组在使用BS后的第二个6周“自我护理认知能力”有显著改善,而B组在同期使用安慰剂时自发恢复不显著。此外,两组在使用BS期间DRS中与认知功能相关的项目均有接近显著的增加。报告的不良事件均为轻度,且两组发生率相似。
这些结果表明,BS树脂对总体预后无显著影响,但可能改善DAI患者的认知预后。