| ObjectiveComparing with the western medication,the research is to study the clinical effect of the fire needle therapy on acute gouty arthritis by a randomized controlled clinical test.It try to find out the mechanism of the fire needle therapy,and to provide clinical evidence for its efficacy.MethodsThe prospective randomized controlled study chose 70 cases from Guangdong Second Hospital of traditional Chinese Medicine during November 2018 to December 2019,which were met the diagnostic and inclusion criteria,to be the subjects of the study.They were randomly divided into a treatment group with 35 cases,and a control group with 35 cases.The treatment group was given fire needle therapy once a day.The control group was given Etoricoxib Tablets(120mg qd)for oral use.Both groups received 7 days treatment as one course in total.During the test,pain intensity,joint range of motion,joint swelling,pain duration,laboratory index(WBC,hs-CRP,ESR,UA)were recorded.Beside,the analgesic effects including the onset time and the duration of the treatment group were recorded.After one course,patients were evaluated for their tolerance to the treatment they received.And if the arthritis relapse or not in the follow-up visits in the 90th were recorded.Results70 cases were actually completed,There were no significant differences between the two groups in the age,gender composition,general conditions(temperature,respiration and heart rate before treatment),as well as basic conditions at first diagnosis(time from onset to treatment,joint distribution,pain degree,joint range of motion,joint swelling degree,and laboratory indicators)were not statistically different(P>0.05).1.Evaluation of painThe VAS scores of both groups were significantly decreased after treatment(P<0.01),but there were no significant difference between the two group(P>0.05).The VAS scores of the two groups were obviously decreased since the 1st treatment day(P<0.01).The VAS scores of the test group were significantly lower than the control group in the 1st,2nd,3rd treatment day(P<0.05),while there no significant difference in the 4th,5th,6th,7th treatment day(P>0.05).It indicates the fire needle therapy analgesic effect was better than western medication in the early stage,although in the middle and later stage were similar.The same conclusion was arrived by comparing the every day analgesic effect and cumulative analgesic effect.There were no significant difference between the two groups in the pain disappearance time and the pain disappearance rate(P>0.05).The time of the pain releasing over 30%of the test group were significantly shorter than the control group(P<0.05).In the test group,87.35%person-time had immediate analgesia effect after treatments,with 7.76±4.57min response time and 8.32±2.54h duration average.2.Joint range of motionThe range of motion of the test group were obviously improve since the 1st treatment day(P<0.01),comparing the 2nd day in the control group.The range of motion of the test group were significantly better than the control group in the 1st,2nd,3rd,4thtreatment day(P<0.05),while there no significant difference in the 5th,6th,7th day(P>0.05).3.Joint swelling degreeThe 1st treatment day,the joint swelling degree of test group were significant improve(P<0.01),comparing the 2nd day in the control group.The joint swelling degree of the both groups were similar after treatment(P>0.05),while there significant difference in 1st,2nd treatment days(P<0.05).4.Laboratory indexThe laboratory index(WBC,hs-CRP,ESR,UA)of both groups were significant dropped after treatment(P<0.05),but the uric acid in the test group were lower than the control group(P<0.05).5.Comprehensive scoreThe comprehensive score of both groups were obviously drooped in the 1st treatment day(P<0.05).The significant difference were show in the 1st,2nd,3rd,4thdays(P<0.05),but not in the following days(P>0.05).6.EfficacyThe total effective rate in the test group was 85.71%,and the control group was 74.29%,it is no significant difference between the two groups(P>0.05).7.Recurrence rate within 3 monthsThe Recurrence rate within 3 months of the test group was 11.43%,obviously lower than 37.14%of the control group(P<0.05).8.Safety evaluation and assessment of toleranceThere were no adverse events occurred in both groups.The assessment of tolerance of the test group was 84.06±7.25 points,obviously exceed than 78.20±11.25 points of the control group(P<0.05).ConclusionThe total effective rate of the fire needle therapy on gouty arthritis is similar to western medication,both are safety and well tolerance.However,the fire needle therapy achieved better effect in the matter of analgesia,improve joint function and detumescence in the early stage,comparing with western medication.Besides,the fire needle therapy can effectively protected from relapse within 3 months,worthy to be clinically popularized and applied. |
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