title: Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial.
abstract: BACKGROUND
  Patients irradiated for brain tumors often suffer from cerebral edema and are usually treated with dexamethasone, which has various side effects. To investigate the activity of Boswellia serrata (BS) in radiotherapy-related edema, we conducted a prospective, randomized, placebo-controlled, double-blind, pilot trial.
  
  
  METHODS
  Forty-four patients with primary or secondary malignant cerebral tumors were randomly assigned to radiotherapy plus either BS 4200 mg/day or placebo. The volume of cerebral edema in the T2-weighted magnetic resonance imaging (MRI) sequence was analyzed as a primary endpoint. Secondary endpoints were toxicity, cognitive function, quality of life, and the need for antiedematous (dexamethasone) medication. Blood samples were taken to analyze the serum concentration of boswellic acids (AKBA and KBA).
  
  
  RESULTS
  Compared with baseline and if measured immediately after the end of radiotherapy and BS/placebo treatment, a reduction of cerebral edema of >75% was found in 60% of patients receiving BS and in 26% of patients receiving placebo (P = .023). These findings may be based on an additional antitumor effect. There were no severe adverse events in either group. In the BS group, 6 patients reported minor gastrointestinal discomfort. BS did not have a significant impact on quality of life or cognitive function. The dexamethasone dose during radiotherapy in both groups was not statistically different. Boswellic acids could be detected in patients' serum.
  
  
  CONCLUSIONS
  BS significantly reduced cerebral edema measured by MRI in the study population. BS could potentially be steroid-sparing for patients receiving brain irradiation. Our findings will need to be further validated in larger studies.
authors.affiliation: Department of Radiation Oncology, University Hospital Freiburg, Freiburg, Germany.
authors.forename: Simon
authors.initials: S
authors.lastname: Kirste
authors.forename: Markus
authors.initials: M
authors.lastname: Treier
authors.forename: Sabine Jolie
authors.initials: SJ
authors.lastname: Wehrle
authors.forename: Gerhild
authors.initials: G
authors.lastname: Becker
authors.forename: Mona
authors.initials: M
authors.lastname: Abdel-Tawab
authors.forename: Kathleen
authors.initials: K
authors.lastname: Gerbeth
authors.forename: Martin Johannes
authors.initials: MJ
authors.lastname: Hug
authors.forename: Beate
authors.initials: B
authors.lastname: Lubrich
authors.forename: Anca-Ligia
authors.initials: AL
authors.lastname: Grosu
authors.forename: Felix
authors.initials: F
authors.lastname: Momm
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D029743:Boswellia; D001929:Brain Edema / Q000188:drug therapy* / Q000209:etiology; D001932:Brain Neoplasms / Q000150:complications / Q000532:radiotherapy*; D003071:Cognition / Q000187:drug effects; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects / Q000379:methods; D010865:Pilot Projects; D010919:Placebos; D011788:Quality of Life; D014315:Triterpenes / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D014315:Triterpenes; C054625:boswellic acid