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 EN

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.