Carthami-Semen acupuncture point injection for chronic daily headache: A pilot, randomised, double-blind, controlled trial

Abstract

This study was conducted to examine the possibility of Carthami-Semen (CS, Safflower seed) acupuncture point injection as a new promising treatment for chronic daily headache (CDH). A total of 40 subjects with CDH were recruited and randomised to a CS acupuncture point injection group or a normal saline (NS) acupuncture point injection group. Acupuncture point injections were applied twice a week during 4 weeks to the bilateral Fengchi (GB20), Jianjing (GB21) and Taiyang (EX-HN5) acupoints with CS extract or NS. The primary outcome measure was headache-related quality of life (QoL), assessed using the Headache Impact Test (HIT). Secondary outcome measures were the changes in the number of headache-free days and health status as assessed with the Short Form (36) Health Survey (SF-36). HIT scores decreased by 14.9 points in the CS acupuncture point injection group compared with 7.9 points in the NS acupuncture point injection group (p=0.013). Headache-free days increased by 32.6% in the CS acupuncture point injection group compared with 17.4% in the NS acupuncture point injection group (p=0.045). There were significant increases in SF-36 scores compared with baseline in both groups, but the mean improvement was greater in the CS acupuncture point injection group. No serious adverse events (AEs) were reported. We suggest that the CS acupuncture point injection could be a new safe and promising treatment for CDH. A larger and long-term follow-up trial is needed to determine more definitely the efficacy of CS acupuncture point injection and to elucidate how long the effect lasts.