| ObjectivePsoriasis causes worldwide concern because of its high prevalence,high relapse risk and high impact of health-related quality of life.The pathogenesis of psoriasis is unclear.Chinese medicine has been commonly used in an integrative way for psoriasis patients for many years.However,explicit evidence has not yet been obtained.The purpose of the present trial is to examine the efficacy and safety of the PSORI-CM01 granule,a compound Chinese herbal medicine,with a combination of balneotherapy and coal tar therapy for psoriasis vulgaris patients.To explore if it can provide a new basis for the comprehensive natural therapy in the treatment of psoriasis vulgaris and explore the mechanism of comprehensive natural therapy for psoriasis based on perspective of cytokines.MethodsThe study design is a double-blind,parallel,randomized controlled trial.A total of 643 patients were screened,and 80 participants were randomly allocated into two groups,the treatment group and the control group.All patients accepted bathing with hot spring mineral water(The 195 Hospital of Chinese People’s Liberation Army,Xianning,Hubei)for 30 minutes a day and topical use of coal tar 3 times a day.The duration of treatment was 4 weeks.The primary outcomes are Psoriasis Area and Severity Index 50(PASI-50)rate and relapse incidence rate in the treatment period.Secondary outcomes include PASI-75 rate,PASI-90 rate,rebound rate in the treatment period and improvement of body surface area(BSA),Physician’s Global Assessment(PGA),visual analogue scale(VAS),self-administered psoriasis area and severity index(SAPASI),Skindex16 and Dermatology Life Quality Index(DLQI).There were40 cases of serum,including 10 cases of patients’serum in the treatment group before and after treatment and 10 cases of patients’serum in the control group before and after treatment.And 10 cases of healthy population serum samples are taken as a healthy control group.IL-17,IFN-γ,TNF-α,IL-10,IL-6,IL-4 and IL-2 were detected by CBA.Statistical analysis was performed by t test,t’test,two independent sample rank sum test,paired t test,paired rank sum test,Pearsonχ~2test,Fisher’s exact test,rank sum test and mixed linear model.ResultsBaseline ratio of all patients was equilibrium.72 cases were TCM Blood Stasis accounted for 90%.53 cases of patients had different type and disease,which was dampness syndromes of most patients,a total of 37 cases,accounting for 46.3%.During treatment,Drug compliance were no significant difference between the two groups(P>0.05).Rate of combined use of drugs were no significant difference between the two groups(P>0.05).After fourth weeks of treatment,the primary outcomes:firstly,to achieve PASI-50 rate,treatment group and control group was statistically significant(P<0.05)after two weeks;treatment group and control group was statistically significant(P<0.05)after four weeks,showed efficacy of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis is better than placebo combined with balneotherapy and coal tar,suggesting that the PSORI-CM01 granule can improve the effect of balneotherapy and coal tar.Secondly,the relapse incidence rate in the treatment period,after four weeks of treatment,only the treatment group had 1 patient with relapse,the control group had no relapse,the relapse incidence rate in the treatment period of the two groups had no significant difference(P>0.05),indicating the effect of two groups of patients after treatment and relapse rate were stable and very low.Secondary outcomes:firstly,to achieve PASI-75 rate,treatment group and control group was statistically significant(P<0.05)after four weeks,showed efficacy of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis is better than placebo combined with balneotherapy and coal tar,suggesting that the PSORI-CM01 granule can improve the effect of balneotherapy and coal tar.Secondly,to achieve PASI-90 rate,one patient of each group achieve PASI-90 after four weeks,the difference between the two groups was no statistically significant(P>0.05).Thirdly,the rebound rate in the treatment period,there was no rebound in patients after four weeks,indicating that the efficacy of the two groups of patients after treatment were stable and very low.Fourth,BSA,PSORI-CM01 granule to reduce the effect of BSA with time,BSA showed a significant downward trend over time.The decline rate of BSA in the treatment group and the control group were statistically significant(P<0.05),and the decline rate of BSA in the treatment group was faster.There was no significant difference(P>0.05)between the treatment group and the control group in the overall BSA.Considering the BSA indicator,PSORI-CM01 granule has not obvious synergistic effect in 4 weeks,but the trend of BSA with time extension,the curative effect of PSORI-CM01 granule may emerge.Fifth,PGA,PSORI-CM01 granule to reduce the effect of PGA with time,PGA showed a significant downward trend over time.The decline rate of PGA inthetreatmentgroupandthecontrolgroupwasstatistically significant(P<0.05),and the decline rate of PGA in the treatment group was faster.There was no significant difference(P>0.05)between the treatment group and the control group in the overall PGA.After fourth week,there was significant difference(P<0.05)between the two groups,the treatment group PGA was significantly lower than the control group showed efficacy of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis is better than placebo combined with balneotherapy and coal tar,suggesting that the PSORI-CM01 granule can improve the effect of balneotherapy and coal tar.The trend of PGA with time extension,the efficacy of PSORI-CM01the granule may be further enhanced.Sixth,VAS,PSORI-CM01 granule had no effect on the reduction of VAS with time,it can be considered that the decline rate of VAS in the treatment group and the control group were the same.VAS showed a significant downward trend with time.There was no significant difference(P>0.05)between the treatment group and the control group in the overall VAS.With VAS as the outcome measure,PSORI-CM01 granule combined with balneotherapy and coal tar were not superior to placebo in combination with balneotherapy and coal tar.However,from the perspective of the change trend of VAS,with time extension,the subjective feeling of patients was more obvious,andtheeffectofPSORI-CM01granulemaybefurther demonstrated.Seventh,SAPASI,PSORI-CM01 granule had no effect on the reduction of SAPASI with time,it can be considered that the treatment group and the control group SAPASI decreased the same speed.SAPASI showed a significant downward trend with time.There was no significant difference(P>0.05)between the treatment group and the control group in the overall SAPASI.After four weeks of treatment,the control group SAPASI was higher than that of the treatment group increased and there was a statistically significant difference(P<0.05)between the two groups.It can be considered that the treatment group SAPASI was lower than that of the control group,showed efficacy of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis is better than placebo combined with balneotherapy and coal tar,suggesting that the PSORI-CM01 granule can improve the effect of balneotherapy and coal tar,and change from the trend of SAPASI with time extension,the efficacy of PSORI-CM01 granule may be further enhanced.Eighth,SKINDEX-16,SKINDEX-16 scores after treatment decreased,and the treatment group decreased more than that of control group,but no statistical significance(P>0.05)between the treatment group and the control group after fourth weeks treatment,although the impact of psoriasis on the quality of life of patients decreased,but the influence could not be attributed to PSORI-CM01 granule.Ninth,DLQI,DLQI scores after treatment decreased,the treatment group decreased the same with the control group no statistical significance(P>0.05)between the treatment group and the control group DLQI after fourth weeks treatment,although the impact of psoriasis on the quality of life of patients decreased,but the influence could not be attributed to PSORI-CM01 granule.After 4 weeks of treatment,there was no significant difference(P>0.05)in the mean PASI value of the two groups.But the PSORI-CM01granule combined with balneotherapy and coal tar reducing effect to PASI associated with the time,PASI was decreased significantly with time,there was statistical significance(P<0.05)in treatment group and control group in PASI decrease speed difference,the treatment group PASI decreased faster.From the PASI score,the PSORI-CM01 granule combined with balneotherapy and coal tar in the second weeks showed a statistically significant(P<0.05)effect on psoriasis.PSORI-CM01 granule combined with balneotherapy and coal tar effect was more obvious after four weeks,so it could be concluded that PSORI-CM01 granule have clinical significance for the treatment of psoriasis.At the end of the four weeks treatment,the safety test was balanced,suggesting that PSORI-CM01 granule were safe for psoriasis.There was no significant difference(P>0.05)in the incidence of adverse events between the two groups.Therefore,it can be considered that the incidence of adverse events in the treatment group and the control group was the same,and the PSORI-CM01 granule does not increase the possibility of adverse events.The experiment results show that after 4 weeks of treatment,the serum level of IL-17 increased significantly in the treatment group and the serum level of IFN-γincreased significantly in the control group,the differences were statistically significant(P<0.05).Effect of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis vulgaris may be in the Th17 channel,Tlymphocytes in local skin,especially after treatment Th17 cells migrate to the peripheral blood circulation,caused IL-17 cytokines in peripheral blood circulation increased,the level of IL-17 tends to the level of health group.The action point of balneotherapy and coal tar in the treatment of psoriasis vulgaris may be in the Th1 channel,T lymphocytes in local skin,especially after treatment Th1 cells migrate to the peripheral blood circulation,cause IFN-γcytokine in peripheral blood circulation increased,the levels of IFN-γtends to the level of health group.ConclusionThe clinical results showed efficacy of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis is better than placebo combined with balneotherapy and coal tar,suggesting that the PSORI-CM01granule can improve the effect of balneotherapy and coal tar.The treatment is a good curative effect,little side effect comprehensive natural therapy,which provides a new basis for the selection of comprehensive natural therapy in the treatment of psoriasis.The experiment results show that the action point of PSORI-CM01 granule combined with balneotherapy and coal tar in the treatment of psoriasis vulgaris may be in the Th17 channel,and the action point of balneotherapy combined with coal tar in the treatment of psoriasis vulgaris may be in the Th1 channel. |
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