Comparison Of The Efficacy Of Different Frequency Needle Cans In The Treatment Of Moderate To Severe Acne Vulgaris - A Randomized Controlled Trial

Objective:This trial is designed to evaluate the efficacy and safety of different frequencies in treating the moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear point tapping.Methods/Design:This study is conducted using prospective,randomized,two-group parallel controls,and the investigator and outcome assessor are masked.48 patients with acne vulgaris were randomly assigned to the experimental group(3 times a week)and the control group(1 times a week).Acupoints:Acupuncture:GV20,LU5,LI11,LI4,GV14,BL13,ST2,BL2,ST7,ST6 and ashi point on the face.Moving Cupping:Du Meridian(from GV14 to GV3)as well as the first(from BL11 to BL28)and second(from BL41 to BL53)side lines of the Urinary Bladder Meridian of Foot-Taiyang.Ear-point Tapping:Lung(C014),Heart(C015),Stomach(C04),Neifenmi(C018),Pizhixia(AT4).Treating methods:1.Moving capping:The patient is prone position and is repeatedly pushed and pulled 5 times by the Du Meridian as well as the first and second side lines of the Urinary Bladder Meridian.2.Patient remains prone position,use 0.20 mm*25 mm acupuncture needle,stab in the da-zhui acupoint upward inclined 0.5 inches,on feishu point in the direction of the spine inclined 0.5 to 0.8 inch,twist respectively to the left and right,twist three times,each torsional amplitude is 180 °.The patient was then supine,with a 0.20mm*13mm acupuncture needle for facial acupoints and skin lesions.When the skin lesion was punctured locally,the needle was rapidly inserted into the center of the base of the lesion from about 8mm on the lower margin of the skin,and a skin lesion was only inserted into one needle,with a maximum of 15 lesions on the face for acupuncture.The main hole is applied to cover the method,the small size is evenly inserted twirling and twirling three times,and the gas is left for 30 minutes.3.Ear point tapping:Alternate ears alternate treatment.Both groups took off their ear patches 24 hours later.The experimental group receive 3 times per week therapeutic frequency for 6 weeks,and the active comparator receive 1 time per week therapeutic frequency for 6 weeks.At week 18 and week 30,patients will be followed-up.Primary Outcome Measures:IGA success rate at the end of 6 week's treatment.Secondary Outcome Measures:?The change of IGA(Investigator's Global Assessment)score from baseline.? The change of the Visual Analogue Scale(VAS)for facial pruritus from baseline.? The change of the Visual Analogue Scale(VAS)for facial lesion pain from baseline.?The change of the Total Lesion Count(TLC)on the face from baseline.? The change of the Inflammatory Lesions(IN)on the face from baseline.?The change of the Skindex-16 dermatologic survey score from baseline.?Evaluation of acupuncture expectations.?Safety.Results:There are 48 patients with acne vulgaris into groups,each group of 24 cases,3 dropped during the treatment in each group,a total of 42 cases of complete treatment,36 cases completed the first follow-up,and 16 cases completed the second follow-up.Primary outcome:IGA success rate at the end of 6 week's treatment:IGA success rate are 23.8%and 33.3%respectively in experimental group and the control group,compare no statistical difference between groups,P = 0.924.Secondary outcome:? Changes in IGA scores from baseline:During the treatment period,the average weekly IGA score of the experimental group and the control group compared with baseline were-0.83(95%CI-1.12,-0.56),-0.60(95%CI-0.82,-0.39)respectively,and the differences were statistically significant before and after treatment both in two groups(P<0.01).The mean IGA score of the two groups was-1(-2,-0.75),P=0.167;and there was no statistical difference between the groups.In the two follow-up visits,IGA scores in both groups were lower than the baseline,and was statistically significant(P<0.05).The differences between the two groups were-1(-1,-1)(P=0.413),-1(-2,-1)(P=0.521),and there was no statistically significant difference between the groups.?Itchy VAS changes:During the treatment period,the average weekly skin pruritus VAS in the experimental group decreased by 12.44(95%CI-18.17,-6.71)and was statistically significant(P<0.01).The control group was reduced by 1.37(95%CI-9.34,6.60),no statistical significance(P>0.05).The difference between the groups was-11.07(95%CI-20.58,-1.56),P = 0.024,which was statistically significant.Experimental group in two follow-up visits,the itchy skin VAS compared with baseline had the decline of 12(28)and 20(30)respectively,and are all with statistical significance(P<0.01);the control group had the decline of 8.5(-27.25,0.75),13.17(-26.73,0.39)in the two follow-up visits respectively,all of which without statistical significance(P>0.05).The differences between the two follow-up groups were-8.5(-27.25,0.75)(P=0.089),-19(-26.75,-0.5)(P=0.511),which were not statistically significant.?VAS changes in facial skin pain:During the treatment period,the average weekly facial lesions in the experimental group decreased by 14.91(95%CI-31.49,-8.93),which was statistically significant(P<0.01).The control group was increased by 0.83(23.5),and was not statistically significant(P>0.05).The difference between the groups was-3.83(95%CI-23.17,5.71),P = 0.016,and the comparison between groups was statistically significant.In two follow-up visits,the experimental group of facial skin pain VAS compared with baseline change values within the group,and are all with statistical significance(P<0.05);The comparison in the control group was withno statistical significance(P>0.05).The differences between the two follow-up groups were-7.5(-34,0)(P=0.167),-12.5(95%CI-34.5,0)(P=0.090),which were not statistically significant.?Total lesion count:During the treatment period,the total facial skin loss count of the experimental group decreased by 16(24)and the control group was 31.05(95%CI-44.45,-17.65),which were both statistically significant(P<0.01).The difference between groups was-20.5(-41.5,-9)(P=0.421),without statistical significance.In two follow-up visits,experimental group's facial total lesion count compared with baseline were statistical significance(P<0.01);the comparison in the control group was statistically significant(P<0.05).The differences between groups were-36(-66,-18)(P=0.670),-7.73(95%CI-34.17,18.70)(P=0.540),without statistically significant..?Inflammatory lesions count:During the treatment period,the number of facial inflammatory skin lesions in the experimental group decreased by 6.62(95%CI-13.80,0.56)(P=0.092),which was not statistically significant.The control group decreased by 15.10(95%CI-24.26,-5.93)(P=0.002),which was statistically significant.The difference between the groups was 8.48(95%CI-2.80,19.76)(P=0.137),without statistical significance.In two follow-up visits,the experimental group facial inflammatory lesion count and the baseline change value contrast group,with statistical significance(P<0.01);Compared with the control group,at the 18th week was statistically significant(P<0.05),and in the 30th week there was no statistically significant(P>0.05).The differences between groups were-16(-32.50,-9)(P=0.168),-4.5(-15,4.75)(P=0.664),and there were no statistical difference.?Skindex-16 Quality of Life Scale:In the treatment period,the total score of Skindex-16 in the experimental group compared to the baseline decreased 27.48(95%CI-35.92,-9.68),the control group decreased 19.10(95%CI-28.52,-5.93),which were both statistically significant(P<0.01).The difference between the groups was-8.38(95%CI-20.64,3.87)(P=0.174),without statistical significance.?Evaluation of acupuncture expectations:There is no significant difference between the two groups of patients on the expected value of acupuncture,which can be used to exclude the effect of the expected effect of acupuncture on the main outcome indexes.?Safety:One patient in the experimental group was allergic to adhesive,the incidence of adverse reactions was 4.17%,control group without adverse reactions,comparing the two groups have no statistical difference,P = 0.235,no serious adverse events occurred in both groups.Conclusion:Three times per week of acupuncture,moving cupping combined with ear point tapping is not better than 1 time per week in improving the symptoms of acne vulgaris,which may be related to the insufficient sample size of the study.The improvement of the degree of itchy skin and the degree of pain of facial skin lesions could be better than once a week.The effect of different frequency of acupuncture,moving cupping combined with ear point tapping to treat acne vulgaris needs to be confirmed by the study of more rigorous design.