Boswellia serrata extract shows cognitive benefits in a double-blind, randomized, placebo-controlled pilot clinical trial in individuals who suffered traumatic brain injury

被引:5
作者
Meshkat, Shakila [1 ,2 ]
Mahmoodi Baram, Somayeh [3 ,4 ]
Rajaei, Shima [3 ,4 ]
Mohammadian, Fatemeh [2 ]
Kouhestani, Emad [1 ]
Amirzargar, Nasibeh [5 ]
Tafakhori, Abbas [5 ]
Shafiee, Sajad [6 ]
Meshkat, Melika [7 ]
Balenci, Laurent [8 ]
Kiss, Alex [9 ]
Riazi, Ali [8 ]
Salimi, Amir [10 ]
Aghamollaii, Vajiheh [2 ]
Salmani, Farzaneh [3 ]
Karima, Saeed [3 ]
机构
[1] Univ Tehran Med Sci, Sch Med, Tehran, Iran
[2] Univ Tehran Med Sci, Roozbeh Psychiat Hosp, Dept Neurol, Tehran, Iran
[3] Shahid Beheshti Univ Med Sci, Sch Med, Dept Clin Biochem, Tehran, Iran
[4] Shahid Beheshti Univ Med Sci, Behbalin Co Ltd, Incubat Ctr Pharmaceut Technol, Tehran, Iran
[5] Univ Tehran Med Sci, Neurosci Inst, Iranian Ctr Neurol Res, Tehran, Iran
[6] Mazandaran Univ Med Sci, Dept Neurosurg, Sari, Iran
[7] Azad Univ Pharmaceut Sci, Sch Pharm, Tehran, Iran
[8] Kondor Pharma Inc, 3403 Amer Dr, Toronto, ON, Canada
[9] Sunnybrook & Womens Coll Hlth Sci Ctr, Dept Res Design & Biostat, Toronto, ON, Canada
[10] Shahid Beheshti Univ Med Sci, Sch Med, Tehran, Iran
关键词
Traumatic brain injury; TBI; boswellia serrata; cognitive function; anti-inflammatory; cognition; Clinical trial; Boswellic acids; INTRACEREBRAL INFLAMMATORY RESPONSE; IMPAIRMENT; ACIDS; NEUROPROTECTION; EFFICACY; MEMORY;
D O I
10.1080/02699052.2022.2059816
中图分类号
Q189 [神经科学];
学科分类号
071006 ;
摘要
Background: Traumatic brain injury (TBI) is a major cause of death and disability. TBI can result in neuropsychiatric and cognitive problems as well as neurodegenerative pathologies that can appear right after or develop and persist years after injury. Method: We conducted a double-blind, randomized, placebo-controlled clinical trial on patients who suffered from TBI three months to three years ago. The patients were randomized to placebo (n = 34) or K-Vie (TM) group (n = 46) for a treatment period of 3 months. The main primary outcomes include cognitive assessment in the Rey Auditory Verbal Learning Test-Recognition Test (RAVLT), Wechsler adult intelligence Digit Symbol Substitution Test (DSST) and trail-making test part B (TMT-B). Assessments were performed at baseline and at the month 3 follow-up visit. Linear mixed models were carried out to evaluate cognitive changes from baseline across all cognitive assessment tests. Result: The current study showed significant (p < 0.05) improvement in cognitive function of patients who were given K-Vie (TM) compared with placebo across the RAVLT, DSST and TMT-B performance assessments. A larger cohort would be beneficial to further confirm the clinical utility of K-Vie (TM) and assess its effects in acute phases of TBI.
引用
收藏
页码:553 / 559
页数:7
相关论文
共 47 条
[1]   Boswellia serrata An Overall Assessment of In Vitro, Preclinical, Pharmacokinetic and Clinical Data [J].
Abdel-Tawab, Mona ;
Werz, Oliver ;
Schubert-Zsilavecz, Manfred .
CLINICAL PHARMACOKINETICS, 2011, 50 (06) :349-369
[2]   Boswellic acids in chronic inflammatory diseases [J].
Ammon, H. P. T. .
PLANTA MEDICA, 2006, 72 (12) :1100-1116
[3]   Boswellic Acids and Their Role in Chronic Inflammatory Diseases [J].
Ammon, H. P. T. .
ANTI-INFLAMMATORY NUTRACEUTICALS AND CHRONIC DISEASES, 2016, 928 :291-327
[4]   Modulation of the immune system by Boswellia serrata extracts and boswellic acids [J].
Ammon, H. P. T. .
PHYTOMEDICINE, 2010, 17 (11) :862-867
[5]   MILD TRAUMATIC BRAIN INJURIES: A 10-YEAR FOLLOW-UP [J].
Andersson, Elisabeth Elgmark ;
Bedics, Beate Karrdahl ;
Falkmer, Torbjorn .
JOURNAL OF REHABILITATION MEDICINE, 2011, 43 (04) :323-329
[6]  
Arbuthnott K, 2000, J CLIN EXP NEUROPSYC, V22, P518, DOI 10.1076/1380-3395(200008)22:4
[7]  
1-0
[8]  
FT518
[9]   Functional improvement and immune-inflammatory cytokines profile of ischaemic stroke patients after treatment with boswellic acids: a randomized, double-blind, placebo-controlled, pilot trial [J].
Baram, Somayeh Mahmoodi ;
Karima, Saeed ;
Shateri, Somayeh ;
Tafakhori, Abbas ;
Fotouhi, Akbar ;
Lima, Behnam Safarpour ;
Rajaei, Shima ;
Mahdavi, Meisam ;
Tehrani, Hessam Sepasi ;
Aghamollaii, Vajiheh ;
Aghamiri, Seyed Hossein ;
Mansouri, Behnam ;
Gharahje, Sina ;
Kabiri, Samaneh ;
Hosseinizadeh, Maryamosadat ;
Shahamati, Shima Zare ;
Alborzi, Amir Taher .
INFLAMMOPHARMACOLOGY, 2019, 27 (06) :1101-1112
[10]   Neurogenic inflammation after traumatic brain injury and its potentiation of classical inflammation [J].
Corrigan, Frances ;
Mander, Kimberley A. ;
Leonard, Anna V. ;
Vink, Robert .
JOURNAL OF NEUROINFLAMMATION, 2016, 13