OBJECTIVETo evaluate the clinical efficacy on primary varicose veins treated with He's fire needle therapy.

METHODSFifty patients of primary varicose veins were randomized into an observation group (25 cases) and a control group (25 cases). In the observation group, He's fire needle therapy was applied for 8 weeks. The fire needling was done on the sites of varicose veins till the bleeding stopped automatically. Additionally, acupuncture with filiform needle was applied to Heyang (BL 55), Chengjin (BL 56), Chengshan (BL 57) and Kunlun (BL 60) on the affected side. In the control group, no intervention was given. The follow-up visit was conducted regularly and since the 8th week, the same treatment as the observation group was provided in the control group. The revised venous clinical severity score (RVCSS) was used for the evaluation of the primary outcomes. The methods for the evaluation of the secondary efficacy outcomes included the venous insufficiency epidemiologic and economic study of quality of life questionnaire scale (VEINES-QOL/sym questionnaire), the venous insufficiency epidemiologic and economic study of symptom score (VEINES-Sym score), the venous insufficiency epidemiologic and economic study of quality of life scale (VEINES-QOL score) and the Homburg varicose vein severity score (HVVSS). The evaluation was conducted at the baseline, at the end of the 4th week and the 8th week separately. The follow-up evaluation was done at the end of the 16th week in the observation group.

RESULTSDuring the study, 5 cases were dropped out, accounting for 10%. RVCSS score in the observation group was lower than that in the control group at the end of the 4th and 8th weeks separately (both P < 0.05). VEINES-QOL score and HVVSS score in the observation group were higher than those in the control group at the end of the 4th and 8th weeks separately (P < 0.05, P < 0.01). VEINES-Sym score in the observation group was increased as compared with that of the control group at the end of the 4th and 8th weeks, but the difference was significant at the end of the 8th week (P < 0.01). HVVSS score at the end of the 8th and 16th weeks was reduced as compared with that at the end of the 4th week in the observation group (both P < 0.05).

CONCLUSIONHE's fire needle therapy is effective on primary varicose veins. It significantly reduces the severity of disease, the severity of symptoms and the attack frequency of symptoms so that the quality of life is improved in the patients. Additionally, the good long-term efficacy is maintained in 8 weeks after treatment. When the duration of treatment is increased from 4 weeks to 8 weeks, HE's fire needle therapy remarkably improves the efficacy for reducing the symptom severity.