Walnut Shell Glasses Moxibustion To Improve Dry Eye Symptoms - Randomized Controlled Trials

ObjectiveTo observe the short-term curative effect and long-term curative effect of walnut shell glasses moxibustion for improving the symptoms of dry eyes,and to evaluate the safety and acceptability,compare the differences with sodium hyaluronate eye drops initially.MethodsA prospective,randomized,two-group,parallel-controlled study protocol was used.To assign dry eye patients who met the inclusion criteria into walnut shell glasses moxibustion group and sodium hyaluronate group with 1:1 ratio randomly.They were treated with walnut shell glasses moxibustion and sodium hyaluronate eye drops respectively.The study period was 29 weeks,the baseline period was 1 week,the treatment period was 4 weeks,and the follow-up period was 24 weeks.The walnut shell glasses moxibustion group was treated 3 times a week,and the sodium hyaluronate group was administered 4 times a day.The main outcome indicators was the change of the Ocular surface disease index(OSDI)score from the baseline at the end of the 4 weeks of treatment;the secondary outcome indicators included the Visual Analog Scale(VAS),Tear break-up time(BUT),cornea fluorescent pigmentation(FL),tear secretion test(Schirmer Ittest,SchI).ResultA total of 96 patients with dry eye were included in this study.In the walnut shell glasses moxibustion group,44 patients completed the trial,and 40 patients in the sodium hyaluronate group completed the trial.Main Outcome Measures:At the end of the 4 weeks of treatment,the OSDI scale scores change from baseline was-15.14±17.49 in walnut shell glasses moxibustion group,and-9.35±21.15 in sodium hyaluronate group.Within the group comparison,both groups had statistical differences before and after treatment(P<0.05).The difference between two groups was-5.79 and the confidence interval was-14.18 to 2.60.The difference between the groups has no statistically significant(P>0.05).Secondary Outcomes:?Effectiveness is defined as the proportion of people with a 50%or more reduction in OSDI scores.There were 15 cases in the walnut shell glasses moxibustion group and the effective rate was 34.09%,12 cases were in the sodium hyaluronate group and the efficiency was 30.00%.There was no statistical difference between two groups(P>0.05);?The average OSDI score change from baseline during treatment period was-10.96±14.95 in walnut shell glasses moxibustion group and-8.41±19.30 in sodium hyaluronate group.There was a statistical difference between the two groups and the baseline ratio(P<0.05).The difference between groups was-2.55(95%CI-10.00,4.91).There was no statistical difference between the two groups(P>0.05);?The eye symptoms VAS scores compared with baseline values was-27.78 ± 21.39 in walnut shell glasses moxibustion group and-16.58±21.16 in sodium hyaluronate group.There was a statistical difference both in two groups interior comparison(P<0.05).The difference between two groups was-11.20(95%CI-20.45,-1.95).There was a statistically significant difference between the two groups(P<0.05);?Daily average eye symptoms VAS scores during treatment period changes from baseline were-20.08±16.63 in the walnut shell glasses moxibustion group and-13.43±18.61 in the sodium hyaluronate group.There was a statistically significant difference between the two groups in daily VAS and baseline(P<0.05).The difference between groups was-6.65(95%CI-14.30,1.00).There was no statistical difference between the two groups(P>0.05);?After treatment BUT changes from baseline was 1.00(2.00)in walnut shell glasses moxibustion group and 0.00(2.00)in sodium hyaluronate group.within the group compared walnut shell glasses moxibustion group and the baseline ratio was statistically significant(P<0.05).There was no statistically significant difference in the interior group and inter group(P>0.05);?The change in FL from baseline after treatment was 0.00(2.00)in the walnut shell glasses moxibustion group and 0.00(3.00)in the sodium hyaluronate group.There was no statistically significant difference in the interior group and inter group(P>0.05);?Changs in Schl from baseline after treatment were-1.00(6.25)in the walnut shell glasses moxibustion group and-1.00(6.25)in the sodium hyaluronate group(P>0.05).There was no statistical difference in the interior group and inter group;?The long-term efficacy evaluation was OSDI scale score and eye symptoms VAS score.The OSDI scale scores of walnut shells and glasses moxibustion group were compared with those of the baseline.There were significant differences between the three visits(P<0.05).The OSDI scale scores and baseline scores of the 8th and 16th weeks of the sodium hyaluronate group were statistically significant.There was no statistical difference(P<0.05)between the 28th week(P>0.05).There was no significant difference in OSDI scale scores between the 3 visits(P>0.05);Comparing the two groups with baseline,there were significant differences in three visits(P<0.05).There was no statistical difference between the two groups(P>0.05).Safety and acceptability:There were no serious adverse events in the two groups.The incidence of adverse events in walnut shell glasses moxibustion group was 14.58%,and the sodium hyaluronate group was 6.25%.Basically there were no discomfort during the moxibustion process,and the it was easy to accept for most patients.ConclusionWalnut shell glasses moxibustion can reduce the severity of dry eye,improve the subjective symptoms of dry eye patients,and the efficacy may continue for 24 weeks.No serious adverse events occurred during the treatment and the safety was good.