title: FlexiQule (Boswellia extract) in the supplementary management of osteoarthritis: a supplement registry.
abstract: The aim of the present pilot, registry study was an assessment in a supplement study of FlexiQule (standardized Boswellia extract) capsules in the supplementary management of patients with symptomatic knee osteoarthritis (OA) also treated with the "standard management" (SM) in comparison with a group of patients only managed with SM.
  
  
  METHODS
  This 4-week study included patients with symptomatic knee arthrosis (X-ray). Registry subjects were able to perform a treadmill walking test and to understand questions from the WOMAC questionnaire. Exclusion criteria were conditions requiring drug treatment, Body Mass Index >25, metabolic disorders, surgery within three months prior to inclusion, oncological condition or inability to walk.
  
  
  RESULTS
  Twenty-seven registry subjects using the supplement+SM and 28 using only SM completed the registry; at inclusion, the two groups were comparable including Karnofsky scale, WOMAC Score and the Treadmill Test. Of the subjects completing the registry 24 preferred to use the combination SM and the supplement. Safety evaluation: no problems - indicating the suspension of the supplementation ‑ were observed. Routine blood tests were normal at inclusion and did not significantly vary at 4 weeks. The Karnofski Scale at 4 weeks was improved in both groups: from 74.3;3.1 to 88.9;5.3 (P<0.05) in the Boswellia group in comparison with a variation from 75.3;5.2 to 79.4;3.3 (P<0.05) in the SM. The effects of the supplement were significantly higher (P<0.05). The WOMAC Score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (P<0.05). Social/emotional functions improved better with the supplement (P<0.05). Both groups improved their walking distance at 4 weeks. The improvement was higher (P<0.05) in the Boswellia group. The need for other drugs or tests during the registry period was reduced more in the supplement group (P<0.05).
  
  
  CONCLUSIONS
  The difference between SM and the supplementation associated to SM was significant) in favor of the supplementation with Boswellia for all target measurements evaluated in the registry at 4 weeks.
authors.affiliation: Department of Biomedical Sciences Irvine3 Labs, Circulation Sciences and the International Irvine Network, Chieti‑Pescara University, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Belcaro
authors.forename: M
authors.initials: M
authors.lastname: Dugall
authors.forename: R
authors.initials: R
authors.lastname: Luzzi
authors.forename: A
authors.initials: A
authors.lastname: Ledda
authors.forename: L
authors.initials: L
authors.lastname: Pellegrini
authors.forename: M R
authors.initials: MR
authors.lastname: Cesarone
authors.forename: M
authors.initials: M
authors.lastname: Hosoi
authors.forename: M
authors.initials: M
authors.lastname: Errichi
authors.forename: S
authors.initials: S
authors.lastname: Francis
authors.forename: U
authors.initials: U
authors.lastname: Cornelli
mesh_terms: D029743:Boswellia / Q000737:chemistry*; D003131:Combined Modality Therapy; D017281:Cost of Illness; D019587:Dietary Supplements; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D012042:Registries; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts