title: Results of a Pilot Randomized Placebo-Controlled Trial in Primary and Secondary Raynaud's Phenomenon with St. John's Wort: Detecting Changes in Angiogenic Cytokines When RP Improves.
abstract: Objectives.To perform a 6-week double-blind RCT in Raynaud's phenomenon (RP) comparing the plant extract St. John's Wort (SJW) to placebo. Methods. RP patients having at least 7 attacks per week were stratified by primary and secondary RP and within secondary by systemic sclerosis or other connective tissue disease. Subjects completed a daily standardized diary recording all RP attacks (frequency, duration and severity). Serum levels of 18 inflammatory and angiogenic cytokines were measured pre- and post-treatment. Results. Eighteen patients completed the study; 8 received SJW and 10 placebo. The decrease in mean number of attacks per day was 0.75 with SJW and 1.01 with placebo, P = 0.06. Attack duration and severity were not different between groups. Cytokine analyses demonstrated no between-groups differences. Combining treatment groups, those with >50% improvement in frequency of attacks yielded a significant increase in E-selectin (P = 0.049), MMP-9 (P = 0.011), G-CSF (P = 0.02), and VEGF (P = 0.012) pre- versus post-treatment. A ≥50% improvement in severity of attacks corresponded to a significant increase in levels of sVCAM-1 (P = 0.003), sICAM-1 (P = 0.007), and MCP-1 (P = 0.004). Conclusions. There were no clinical or biomarker benefit of SJW versus placebo in RP. However, combining all patients, there were changes in some cytokines that may be further investigated.
authors.affiliation: Department of Medicine, University of Western Ontario, London, ON, Canada N6A 5C1.
authors.forename: Déanne
authors.initials: D
authors.lastname: Malenfant
authors.forename: Kelly
authors.initials: K
authors.lastname: Summers
authors.forename: Shannon
authors.initials: S
authors.lastname: Seney
authors.forename: Donna
authors.initials: D
authors.lastname: McBain
authors.forename: Lisa
authors.initials: L
authors.lastname: Petrlich
authors.forename: Sharon
authors.initials: S
authors.lastname: Watson
authors.forename: Louise
authors.initials: L
authors.lastname: Vanderhoek
authors.forename: Nooshin
authors.initials: N
authors.lastname: Samadi
authors.forename: Ashley
authors.initials: A
authors.lastname: Bonner
authors.forename: Janet
authors.initials: J
authors.lastname: Pope