Acupuncture BL1 Acupoint For 74 Patients With Dry Eye Disease:a Randomized Controlled Trial

Objective:To evaluate the effect and safety of the BL1 acupoint on the dry eye disease.Methods:A randomized and positive-controlled clinical trial design was used.Patients recruited will be initially screened according to the dry eye diagnostic criteria.The BL1 acupoint grouop was randomly divided into the acupuncture group of 37 cases(37 eyes)and the sodium hyaluronate group of 37 cases(37 eyes).The BL1 acupoint grouop was treated 3 times a week for 4 weeks,12 times in total.The sodium hyaluronate group was used,4 drops a day,1 drop each time,for 4 weeks.The BL1 acupoint grouop and sodium hyaluronate group were at baseline,after the end of treatment and 16th weeks evaluated by the Sch I,BUT,FL,VAS and OSDI.Acceptability evaluation was performed after the end of the 4th week of treatment.Safety evaluation was performed before and after each treatment.The main outcome index was Sch I changes after 4 weeks of treatment from baseline.The secondary indicator was the change in Sch I from baseline at the 16th week follow-up.BUT,FL,VAS,OSD1 from baseline after 4 weeks of treatment and at 16 weeks of follow-up,safety and acceptance evaluation.Results:This study included 74 patients with dry eye disease.In the BL1 acupoint 36 patients completed the study.In the sodium hyaluronate group 35 patients completed the test.Major outcome indicators:after 4 weeks,within the group comparison,the BL1 acupoint had statistical differences before and after treatment(p<0.05).The change values of the BL1 acupoint group from baseline of Sch I was 4.29±3.91 and 0.83±1.71 in the sodium hyaluronate group.The difference between the groups has no statistically significant(P>0.05).Secondary outcome indicators:?after 16 weeks,the BL1 acupoint group increased by 3.30±3.12 from the baseline of Sch I,and the sodium hyaluronate group was 0.33±1.47 P<0.05).?At the end of 4 weeks,the BL1 acupoint group increased by 2.67±2.45 from the baseline of BUT,and the sodium hyaluronate group was 1.54±2.73(P>0.05).In follow-up,the BL1 acupoint increased 2.52±2.53 compared with the baseline,and the sodium hyaluronate group was 0.70±2.45(P<0.05).?At the end of 4 weeks the change value of the BL1 acupoint from the baseline was-1.39±1.15,and sodium hyaluronate group was 0.17±1.90(P>0.05).In the follow-up,the change from baseline in the BL1 acupoint was-1.12±1.41,and sodium hyaluronate group was-0.20±1.90(P>0.05)?At the end of 4 weeks the change value of the BL1 acupoint from baseline was-2.10±1.43,and sodium hyaluronate group was 1.62±1.90(P>0.05).In the follow-up,the change value of the BL1 acupoint from baseline was-2.97±1.74,and sodium hyaluronate group was-0.65±2.71(P<0.05).?At the end of 4 weeks,the change from baseline of OSDI in the BL1 acupoint group was-18.16±19.00,and the sodium hyaluronate group was-11.01±21.69(P>0.05).In the follow-up,the change from baseline in the BL1 acupoint was-36.05±19.84,and the sodium hyaluronate group was-12.05±25.08(P<0.05).?Acupuncture acceptance evaluation:there was no significant difference in acceptance between the two groups(P=0.13).?Safety evaluation:acupuncture in the BL1 acupoint group and sodium hyaluronate group did not show any significant adverse reactions.Conclusions:Acupuncture the BL1 acupoint may increase Sch I,and stabilize the tear film,reduce corneal epithelial damage,and improve subjective symptoms,and the efficacy may continue for 12 weeks.In two groups the safety and conception were good.