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.

A randomized controlled trial of acupressure for the treatment of Raynaud's phenomenon: the difficulty of conducting a trial in Raynaud's phenomenon

“…The serum markers ICAM-1, VCAM-1, soluble E-selectin, VEGF, t-PA and endothelin-1 have been shown to be associated with RP (28–29–30–31) and were chosen based on an on-going systemic review and previous published data (28, 32), which revealed that these markers did change in longitudinal studies. Few small studies have shown a decrease in these parameters in association with treatment, but larger studies are needed to evaluate their sensitivity to change (28).…”

Drug Treatment of Raynaud’s Phenomenon

“…Ascorbic acid did not help RP and fi sh oil may have some modest benefi t [ 92 , 93 ]. Subsequent to publication of the metaanalysis, a negative trial was published using St. John's wort which was postulated to be benefi cial due to potential properties of the plant that could alter serotonin [ 94 ]. Interestingly RP improved with St. John's wort, but the improvement was even more with placebo.…”