Efficacy Of Acupuncture In Improving The Symptoms And The Quality Of Patients With Moderate Or Severe Acne Vulgaris

ObjectiveEvaluate the effect and safety of acupuncture on symptoms and the quality of life of patients with moderate or severe acne vulgaris,compared with sham acupuncture.Methods70 eligible participants with acne vulgaris will be randomly assigned to acupuncture or sham acupuncture groups(1:1 allocation).The period of study was 29 weeks which inculding the baseline period of 1 week,the treatment period of 4 weeks,and the follow-up period of 24 weeks.All participants will receive 4-week treatment comprising of a total of 12 sessions(3 sessions per week).The baseline outcomes of this study included demographic,clinical characteristics of included participants with acne vug lairs,the patient expectations of acupuncture for particiapnts with acne vuglaris.The primary outcome will be the change from baseline in the Skindex-16 scale total score at treatment completion(at week 4).The secondary outcomes:the change from baseline in the Skindex-16 scale total score at treatment completion(at week 16 and week 28);the change from baseline in the Skindex-16 subscale(the symptoms of participants with acne vulgaris,the emotions of participants with acne vulgaris,and functioning of participants with acne vulgaris)scores(at week4,week 16 and week 28),the change from baseline in the inflammatory lesion count(at week4,week 16 and week 28),the change from baseline in the visual analogue scale scores for assessment of itch and pain(at week4,week 16 and week 28),patient expectations of acupuncture,the blinding of the effect of sham acupuncture and safety evaluation.All outcome analyses will be performed in the intention-to-treat analysis.ResultsA total of seventy patients with moderate and severe acne vulgaris were included in this study,and the participants of the acupuncture group and the sham acupuncture group completed a total of 12 times of treatment.There were no statistical differences in the demographic and clinical characteristics of included participants with acne vuglairs between acupuncture group and sham acupuncture group(There were a statistical differences in academic qualifications and working hours of included participants with acne vuglair between acupuncture group and sham acupuncture group,P=0.03 and P=<0.001).And there was no statistical difference in the patient expectations of acupuncture between acupuncture group and sham acupuncture group.Primary outcome is the change from baseline in the Skindex-16 scale total score at week 4.The change from baseline in the Skindex-16 scale total score at week 4 of acupuncture group is-15.03(31.19),and the change from baseline in the Skindex-16 scale total score at week 4 of acupuncture group is-10.49±24.22.And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05).The secondary outcomes:1.At week 16,the change from baseline in the Skindex-16 scale total score of acupuncture group is-10.42(17.91),and the change from baseline in the Skindex-16 scale total score of acupuncture group is-7.66±18.31.And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05);At week 28,the change from baseline in the Skindex-16 scale total score at of acupuncture group is-5.45±18.1,and the change from baseline in the Skindex-16 scale total score at of acupuncture group is-4.01±21.16.The acupcuncture group had no statistical differences compared with baseline(P>0.05),and the sham acupuncture group had statistical differences compared with baseline(P<0.05).There had no statistical differences of between-group;2.The change from baseline in the Skindex-16 scale total subscale total score(the symptoms of participants with acne.vulgaris)at week 4 of acupuncture group is-5.20±17.21,and the change from baseline in the Skindex-16 subscale total score(the symptoms of participants with acne vulgaris)at week4 of acupuncture group is-1.03±25.58.And the acupuncture group and sham acupuncture group had no statistical differences compared with baseline(P>0.05),but there had no statistical differences of between-group(P>0.05);At week 16,the change from baseline in the Skindex-16 subscale total score(the symptoms of participants with acne vulgaris)of acupuncture group is 0.45±24.04,and the change from baseline in the Skindex-16subscale total score(the symptoms of participants with acne vulgaris)of acupuncture group is 5.00±29.00.And the acupuncture group and sham acupuncture group had no statistical differences compared with baseline(P>0.05),but there had no statistical differences of between-group(P>0.05);At week 28,the change from baseline in the Skindex-16 subscale total score(the symptoms of participants with acne vulgaris)of acupuncture group is 7.03±20.66,and the change from baseline in the Skindex-16subscale total score(the symptoms of participants with acne vulgaris)of acupuncture group is 10.91±31.00.And the acupuncture group and sham acupuncture group had no statistical differences compared with baseline(P>0.05),but there had no statistical differences of between-group(P>0.05);3.The change from baseline in the Skindex-16 scale total subscale total score(the emotions of participants with acne vulgaris)at week 4 of acupuncture group is-29.32±25.22,and the change from baseline in the Skindex-16 subscale total score(the emotions of participants with acne vulgaris)at week 4 of acupuncture group is-4.76(19.05).And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P<0.05);At week 16,the change from baseline in the Skindex-16 subscale total score(the emotions of participants with acne vulgaris)of acupuncture group is-22.57±28.86,and the change from baseline in the Skindex-16subscale total score(the emotions of participants with acne vulgaris)of acupuncture group is-14.89±23.08.And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05);At week 28,the change from baseline in the Skindex-16 subscale total score(the emotions of participants.with acne vulgaris)of acupuncture group is-12.80±27.10,and the change from baseline in the Skindex-16subscale total score(the emotions of participants with acne vulgaris)of acupuncture group is-11.14±27.43.And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05);4.The change from baseline in the Skindex-16 scale total subscale total score(the functioning of participants with acne vulgaris)at week 4 of acupuncture group is-10.31±21.23,and the change from baseline in the Skindex-16 subscale total score(the functioning of participants with acne vulgaris)at week 4 of acupuncture group is-6.67±31.44.The acupcuncture group had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline((P>0.05).There had no statistical differences of between-group(P>0.05);At week 16,the change from baseline in the Skindex-16 subscale total score(the functioning of participants with acne vulgaris)of acupuncture group is 0(27.50),and the change from baseline in the Skindex-16 subscale total score(the functioning of participants with acne vulgaris)of acupuncture group is-0.97±22.84.The acupuncture group and sham acupuncture group had no statistical difference compared with baseline(P>0.05),but there was no statistical difference of between-group differences(P>0.05);At week 28,the change from baseline in the Skindex-16 subscale total score(the functioning of participants with acne vulgaris)of acupuncture group is 0(26.67),and the change from baseline in the Skindex-16subscale total score(the functioning of participants with acne vulgaris)of acupuncture group is 0(33.33).The acupuncture group and sham acupuncture group had no statistical difference compared with baseline(P>0.05),but there was no statistical difference of between-group differences(P>0.05);5.The change from baseline in the inflammatory lesion count at week 4 of acupuncture group is-2(3),and the change from baseline in the inflammatory lesion count at week4 of acupuncture group is-1(5).And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05);At week 16,the change from baseline in the inflammatory lesion count of acupuncture group is-2(5.25),and the change from baseline in the inflammatory lesion count of acupuncture group is-2(8).The acupcuncture group ’had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline((P>0.05).There had no statistical differences of between-group(P>0.05);At week 28,the change from baseline in the inflammatory lesion count of acupuncture group is-3(5),and the change from baseline in the inflammatory lesion count of acupuncture group is-3(7).The acupcuncture group had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline(P>0.05).There had no statistical differences of between-group(P>0.05);6.The change from baseline in the visual analogue scale scores for assessment of itch at week 4 of acupuncture group is-5(10),and the change from baseline in visual analogue scale scores for assessment of itch at week4 of acupuncture group is-1(23).And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05);At week 16,the change from baseline in the visual analogue scale scores for assessment of itch of acupuncture group is-9.97±25.27,and the change from baseline in the visual analogue scale scores for assessment of itch of acupuncture group is-7.21±26.87.The acupcuncture group had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline((P>0.05).There had no statistical differences of between-group(P>0.05);At week 28,the change from baseline in the visual analogue scale scores for assessment of itch of acupuncture group is-10(26.50),and the change from baseline in the visual analogue scale scores for assessment of itch of acupuncture group is-6.25±27.80.The acupcuncture group had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline(P>0.05).There had no statistical differences of between-group(P>0.05);7.The change from baseline in the visual analogue scale scores for assessment of pain at week 4 of acupuncture group is-5(18),and the change from baseline in visual analogue scale scores for assessment of pain at week 4 of acupuncture group is-5(25).And the acupuncture group and sham acupuncture group had statistical differences compared with baseline(P<0.05),but there had no statistical differences of between-group(P>0.05);At week16,the change from baseline in the visual analogue scale scores for assessment of pain of acupuncture group is-8(21.23),and the change from baseline in the visual analogue scale scores for assessment of pain of acupuncture group is-3.5(29.25).The acupcuncture group had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline(P>0.05).There had no statistical differences of between-group(P>0.05);At week 28,the change from baseline in the visual analogue scale scores for assessment of pain of acupuncture group is-5(19.50),and the change from baseline in the visual analogue scale scores for assessment of pain of acupuncture group is-8.78±29.57.The acupcuncture group had statistical differences compared with baseline(P<0.05),and the sham acupuncture group had no statistical differences compared with baseline((P>0.05).There had no statistical differences of between-group(P>0.05);8.For the blinding of the effect of sham acupuncture,there had no statistical differences of between-group(P>0.05);9.For safety evaluation,there were none of related adverse events and serious adverse events during the 4-week treatment in acupunctue group and sham acupuncture group.ConclusionAcupuncture and sham acupuncture can both improve the symptoms of patients with moderate or severe acne vulgaris,reduce the number and degree of inflammatory lesion counts,and improve the quality of life.There is a trend of acupuncture is better than sham acupuncture,but this trial not get a positive result due to the small sample size of this trial.Acupuncture is better than sham acupuncture in the emotional aspect of the quality of life of patients with acne vulgaris.Therefore,the safety of acupuncture for acne vulgaris is well,so the efficacy of acupuncture patients with acne vulgaris needs to be confirmed with a larger sample size study.