title: Prevention of venous thrombosis and thrombophlebitis in long-haul flights with pycnogenol.
abstract: The aim of this study was to evaluate the occurrence of deep venous thrombosis (DVT) and superficial vein thrombosis (SVT) and its prophylaxis with an oral anti-edema and antithrombotic agent (Pycnogenol, Horphag, Research Management SA, Geneva, Switzerland) in long-haul flights, in subjects at moderate to high-risk of DVT and SVT. The study pre-included 244 pre-selected subjects; 211 were included (33 were excluded for several reasons due to logistic problems) and 198 completed the study; 13 subjects were lost for follow-up at the end of the flight, all for non-medical problems (i.e., for difficult connections). All subjects were scanned within 90 minutes before the flight and within 2 hours after disembarking. Subjects were supplemented with 100 mg Pycnogenol per capsule. Treatment subjects received two capsules between 2 and 3 hours before flights with 250 mL of water; two capsules were taken 6 hours later with 250 mL of water and one capsule the next day. The control group received comparable placebo at the same intervals. The flight duration was on average 8 hours and 15 minutes (SD 55 min) (range, 7.45-12.33). In the control group there were five thrombotic events (one DVT and four superficial thromboses) while only nonthrombotic, localized phlebitis was observed in the Pycnogenol group (5.15% vs. no events; p<0.025). The ITT (intention to treat) analysis detects 13 failures in the control group (eight lost to follow up + five thrombotic events) of 105 subjects (12.4%) vs. five failures (4.7%; all lost, no thrombotic events) in the treatment group (p<0.025). No unwanted effects were observed. In conclusion, this study indicates that Pycnogenol treatment was effective in decreasing the number of thrombotic events (DVT and SVT) in moderate-to-high risk subjects, during long-haul flights.
authors.affiliation: Department of Biomedical Sciences, Irvine2 Vascular Lab, G D'Annunzio University and San Valentino Vascular Screening Project (Pe), Faculty of Motory Sciences, L'Aquila University, Italy. cardres@pe.abol.it
authors.forename: G
authors.initials: G
authors.lastname: Belcaro
authors.forename: M R
authors.initials: MR
authors.lastname: Cesarone
authors.forename: P
authors.initials: P
authors.lastname: Rohdewald
authors.forename: A
authors.initials: A
authors.lastname: Ricci
authors.forename: E
authors.initials: E
authors.lastname: Ippolito
authors.forename: M
authors.initials: M
authors.lastname: Dugall
authors.forename: M
authors.initials: M
authors.lastname: Griffin
authors.forename: I
authors.initials: I
authors.lastname: Ruffini
authors.forename: G
authors.initials: G
authors.lastname: Acerbi
authors.forename: M G
authors.initials: MG
authors.lastname: Vinciguerra
authors.forename: P
authors.initials: P
authors.lastname: Bavera
authors.forename: A
authors.initials: A
authors.lastname: Di Renzo
authors.forename: B M
authors.initials: BM
authors.lastname: Errichi
authors.forename: F
authors.initials: F
authors.lastname: Cerritelli
mesh_terms: D001359:Aviation; D015444:Exercise; D005268:Femoral Vein / Q000000981:diagnostic imaging; D005419:Flavonoids / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D010936:Plant Extracts; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011152:Popliteal Vein / Q000000981:diagnostic imaging; D011292:Premedication; D013924:Thrombophlebitis / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D013977:Tibia / Q000098:blood supply / Q000000981:diagnostic imaging; D014195:Travel; D016896:Treatment Outcome; D014463:Ultrasonography; D020246:Venous Thrombosis / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*
chemical_list: D005419:Flavonoids; D010936:Plant Extracts; D010975:Platelet Aggregation Inhibitors; C024070:pycnogenols