psoriasis is a chronic , recurrent , inflammatory disorder of the skin affecting approximately 2% of the world 's population .
psoriasis vulgaris ( psv ) is the most common type of psoriasis , which manifests as well - demarcated , scaly patches on the skin .
psoriasis is considered severe if more than 10% of a patient 's body surface is affected or if a patient scores more than 10 on the psoriasis area severity index ( pasi ) .
topical therapies are used for mild or localized disease while systemic therapies and phototherapy are used for patients with moderate to severe disease .
extracts of the chinese herb tripterygium wilfordii hook f ( twhf ) , also known as  lei gong teng ,  are used as one of the most common systemic treatments for inflammatory and immune disorders including psoriasis , rheumatoid arthritis ( ra ) , crohn 's disease , nephritis , and systemic lupus erythematosus .
recently , extracts of twhf have been tested in western countries , with good efficacy .
however , acitretin is a teratogen , causes dyslipidemia , the therapeutic effect is slow to onset , and it has other side effects that limit widespread use . although both therapies are effective , twhf has never been directly compared with systemic acitretin in a randomized clinical study .
we compared the efficacy and safety of twhf and acitretin for the treatment of moderate to severe psv in a randomized , double - blind , double - dummy , parallel - group clinical trial .
adults ( age > 18 years and < 75 years ) with moderate to severe psv were eligible to enroll in the study .
eligible patients had a pasi score greater than or equal to 10 or a psoriasis - affected body surface area 10% or higher .
exclusion criteria included : participation in other clinical studies during the past 30 days ; patients with psoriatic erythroderma , psoriasis pustulosa , psoriasis arthritis , or guttate psoriasis ; patients taking systemic corticoid , immunosuppressive agents , or biologicals therapy during the past 4 weeks ; patients taking local corticoid therapy or phototherapy during the past 2 weeks ; patients that are pregnant , breastfeeding , planning to become pregnant within 2 years ; patients with acute or chronic systemic infections , hepatitis b virus , hepatitis c virus , hiv , a history of malignancy , severe systemic disease , or elevation of aspartate transaminase , alanine transaminase , blood - lipoids reaching 1.5 times the normal range ; and patients with allergies to twhf or acitretin .
this randomized , double - blind , double - dummy , parallel - group clinical study was conducted at peking union medical college hospital in china .
the first patient was enrolled on september 27 , 2011 , and the last patient completed the study on june 14 , 2014 .
patients were randomly assigned in a 1:1 ratio to receive either a chloroform  methanol extract of twhf 20 mg 3 times a day plus a placebo matching acitretin 30 mg once a day or acitretin 30 mg once a day plus a placebo matching a chloroform  methanol extract of twhf 20 mg three times daily , both for 8 weeks . a permuted block randomization design using a block size of four
the random sequence was generated by an independent randomization group , principal investigators enrolled the study participants , and a third - party vendor assigned the interventions using the web response system .
patients were assessed at baseline and at weeks 2 , 4 , and 8 . at the screening visit ,
the laboratory tests consisted of urinalysis , hematology , and blood biochemistry ( urea nitrogen , creatinine , cholesterol , triglycerides , high - density lipoprotein , aspartate transaminase , alanine transaminase ) at baseline , week 4 , and week 8 .
differences from baseline to weeks 2 , 4 , and 8 were tested using paired samples t - test .
differences in the primary outcomes between the two groups at weeks 2 , 4 and 8 were performed by analysis of variance ( anova ) test .
all analyses were performed using spss software program version 15.0 for windows ( spss inc . ,
safety was evaluated by all adverse events ( aes ) , laboratory tests , and physical examinations . at each visit
, patients were queried for any aes , and an assessment was made as to whether there were any possible , probable or definite relationships between study drug and aes .
an ae was defined as any undesirable symptom or sign that occurred after the initiation of the treatment , regardless of its relation to the study drug .
a serious ae was defined as any untoward medical occurrence that , at any dose , resulted in death , was life - threatening , required hospitalization , or resulted in persistent or significant disability , incapacity , or a congenital malformation , or required medical intervention .
the endpoint of the study was the response of 75% improvement in pasi score ( pasi 75 ) at weeks 2 , 4 , and 8 .
efficacy assessments ( pasi ) were performed by doctors who were blinded to the treatment group assignments .
adults ( age > 18 years and < 75 years ) with moderate to severe psv were eligible to enroll in the study .
eligible patients had a pasi score greater than or equal to 10 or a psoriasis - affected body surface area 10% or higher .
exclusion criteria included : participation in other clinical studies during the past 30 days ; patients with psoriatic erythroderma , psoriasis pustulosa , psoriasis arthritis , or guttate psoriasis ; patients taking systemic corticoid , immunosuppressive agents , or biologicals therapy during the past 4 weeks ; patients taking local corticoid therapy or phototherapy during the past 2 weeks ; patients that are pregnant , breastfeeding , planning to become pregnant within 2 years ; patients with acute or chronic systemic infections , hepatitis b virus , hepatitis c virus , hiv , a history of malignancy , severe systemic disease , or elevation of aspartate transaminase , alanine transaminase , blood - lipoids reaching 1.5 times the normal range ; and patients with allergies to twhf or acitretin .
this randomized , double - blind , double - dummy , parallel - group clinical study was conducted at peking union medical college hospital in china .
the first patient was enrolled on september 27 , 2011 , and the last patient completed the study on june 14 , 2014 .
patients were randomly assigned in a 1:1 ratio to receive either a chloroform  methanol extract of twhf 20 mg 3 times a day plus a placebo matching acitretin 30 mg once a day or acitretin 30 mg once a day plus a placebo matching a chloroform  methanol extract of twhf 20 mg three times daily , both for 8 weeks . a permuted block randomization design using a block size of four
the random sequence was generated by an independent randomization group , principal investigators enrolled the study participants , and a third - party vendor assigned the interventions using the web response system .
patients were assessed at baseline and at weeks 2 , 4 , and 8 . at the screening visit ,
the laboratory tests consisted of urinalysis , hematology , and blood biochemistry ( urea nitrogen , creatinine , cholesterol , triglycerides , high - density lipoprotein , aspartate transaminase , alanine transaminase ) at baseline , week 4 , and week 8 .
differences from baseline to weeks 2 , 4 , and 8 were tested using paired samples t - test .
differences in the primary outcomes between the two groups at weeks 2 , 4 and 8 were performed by analysis of variance ( anova ) test .
all analyses were performed using spss software program version 15.0 for windows ( spss inc . ,
safety was evaluated by all adverse events ( aes ) , laboratory tests , and physical examinations . at each visit
, patients were queried for any aes , and an assessment was made as to whether there were any possible , probable or definite relationships between study drug and aes .
an ae was defined as any undesirable symptom or sign that occurred after the initiation of the treatment , regardless of its relation to the study drug .
a serious ae was defined as any untoward medical occurrence that , at any dose , resulted in death , was life - threatening , required hospitalization , or resulted in persistent or significant disability , incapacity , or a congenital malformation , or required medical intervention .
the endpoint of the study was the response of 75% improvement in pasi score ( pasi 75 ) at weeks 2 , 4 , and 8 .
efficacy assessments ( pasi ) were performed by doctors who were blinded to the treatment group assignments .
of the 115 patients enrolled , 58 were allocated to the twhf group and 57 were allocated to the acitretin group
most patients were men ( 70.4% ) , and the mean age  sd was 41.1  12.2 years .
there was a higher attrition rate in the acitretin group ( 5.2% in the twhf group and 7.0% in the acitretin group by week 2 , and 8.6% in the twhf group and 12.3% in the acitretin group by week 8) .
discontinuation occurred because of withdrawn consent ( n = 1 ) , loss to follow - up ( n = 8) , ae ( n = 1 ) , and disease progression ( n = 2 ) . reasons for discontinuing the study were similar between groups
. baseline demographics and clinical characteristics of the patients sd : standard deviation ; twhf : tripterygium wilfordii hook f ; bmi : body mass index ; pasi : psoriasis area severity index .
the pasi score decreased from a median of 23.8 ( range 7.559.5 ) to 11.1 ( range 0.346.9 ) in the twhf group ( n = 58 ; p < 0.0001 ) and from 23.2 ( range 7.256.7 ) to 13.0 ( range 0.446.4 ) ( n = 57 ; p < 0.0001 ) in the acitretin group within 8 weeks [ table 2 ] .
the median pasi score improved in the twhf group by 50.4  31.0% and in the acitretin group by 42.7  45.7%
. there was no significant difference in median pasi improvement between the two groups ( p = 0.317 ) .
there was also no statistically significant difference between two groups at week 8 for pasi 25 ( 70.7% vs. 64.9% in the twhf and acitretin groups , respectively ; adjusted p = 0.553 ) [ figure 1a ] , pasi 50 ( 51.7% vs. 43.9% ; nominal p = 0.457 ) [ figure 1b ] , pasi 75 ( 19.0% vs. 17.5% ; nominal p = 1 ) [ figure 1c ] , and pasi 90 ( 5.2% vs. 5.3% ; nominal p = 0.204 ) [ figure 2 , 3 ] . at week 2
, there was also no significant difference in median pasi score improvement ( 18.7  41.1% vs. 18.3  16.5% in the twhf and acitretin groups , respectively ; adjusted p = 0.985 ) [ figure 1d ] , pasi 25 ( 50.0% vs. 31.6% ; nominal p = 0.058 ) [ figure 1a ] , pasi 50 ( 12.1% vs. 3.5% ; nominal p = 0.162 ) [ figure 1b ] , and pasi 75 ( 1.7% vs. 0% ; nominal p = 1 ) [ figure 1c ] .
similarly , at week 4 , there was no significant difference in median pasi score improvement ( 34.4  34.9% vs. 31.6 
24.7% in the twhf and acitretin groups , respectively ; adjusted p = 0.635 ) [ figure 1d ] , pasi 25 ( 55.2% vs. 59.6% ; nominal p = 0.707 ) [ figure 1a ] , pasi 50 ( 37.9% vs. 24.6% ; nominal p = 0.160 ) [ figure 1b ] , and pasi 75 ( 1.7% vs. 1.8% ; nominal p = 1 ) [ figure 1c ] .
treatment efficacy of twhf and acitretin sd : standard deviation ; twhf : tripterygium wilfordii hook f ; pasi : psoriasis area severity index .
( a ) pasi 25 response ; ( b ) pasi 50 response ; ( c ) pasi 75 response ; ( d ) percentage pasi improvement . clinical appearance of a patient from tripterygium wilfordii hook f group at baseline , weeks 2 , 4 , and 8 .
clinical appearance of a patient from acitretin group at baseline , weeks 2 , 4 , and 8 . at week 2 , the median pasi score improvement rate of the head , upper limbs , trunk , and lower limbs in the twhf group was 14.9  33.7% , 10.6  49.2% , 25.5  22.9% , and 9.7  61.0% , respectively .
there was no significant difference in median pasi improvement between different parts of the body ( p = 0.222 ) [ tables 3 and 4 ] .
there was also no significant difference in median pasi improvement between different parts of the body at weeks 4 ( p = 0.462 ) and 8 ( p = 0.882 ) in the twhf group .
similarly , in the acitretin group , there was no significant difference in median pasi improvement between different parts of the body at weeks 2 , 4 , and 8 ( p = 0.339 , p = 0.144 , and p = 0.764 , respectively ) .
treatment efficacy of different parts of the body ( meansd ) twhf : tripterygium wilfordii hook f ; pasi : psoriasis area severity index .
median pasi improvement of different parts of the body ( % , meansd ) twhf : tripterygium wilfordii hook f ; pasi : psoriasis area severity index .
there was no statistically significant difference between two groups at week 2 for median pasi improvement rate of the head ( 14.9  33.7% vs. 22.9  33.3% in the twhf and acitretin groups , respectively ; adjusted p = 0.221 ) , upper limbs ( 10.6  49.2% vs. 7.2  78.9% ; nominal p = 0.787 ) , trunk ( 25.5  22.9% vs. 18.0  21.4% ; nominal p = 0.084 ) , and lower limbs ( 9.7  61.0% vs. 14.9  19.8% ; nominal p = 0.550 ) . at week 8 , there was also no statistically significant difference between the two groups for median pasi improvement rate of the head ( 49.9  40.3% vs. 49.6  45.0% in the twhf and acitretin groups , respectively ; adjusted p = 0.979 ) , upper limbs ( 42.6  71.3% vs. 33.9  115.2% ; nominal p = 0.649 ) , trunk ( 48.8  42.0% vs. 36.9  86.9% ; nominal p = 0.381 ) , or lower limbs ( 45.5  39.7% vs. 38.9  38.2% ; nominal p = 0.394 ) . at week 4 , there was a statistically significant difference between two groups for median pasi improvement rate of the trunk ( 39.5  30.8% vs. 23.8  40.3% in the twhf and acitretin groups , respectively ; adjusted p = 0.026 ) .
however , there was no statistically significant difference between the two groups at week 4 for median pasi improvement rate of the head ( 35.1  41.4% vs. 39.2  37.9% in the twhf and acitretin groups , respectively ; adjusted p = 0.597 ) , upper limbs ( 35.7  44.0% vs. 31.3  36.9% ; nominal p = 0.575 ) , and lower limbs ( 27.1  45.3% vs. 27.1  28.0% ; nominal p = 0.991 ) .
more aes were reported in the acitretin group ( 78.1% ) compared with the twhf group ( 43.6% ) .
the most frequent complaints in twhf group were menstrual disorders in females , dry mouth , gastrointestinal complaints , and swelling of the lower limbs .
the results of blood biochemistry ( alanine transaminase , aspartate transaminase , urea nitrogen , creatinine , cholesterol , triglyceride , and high - density lipoprotein ) are shown in table 5 .
compared with baseline , there was a significant increase in the level of aspartate transaminase and triglycerides at week 8 in the twhf group ( p = 0.026 and p = 0.011 , respectively ) .
in the acitretin group , there was a significant increase in the level of alanine transaminase , cholesterol , and high - density lipoprotein at week 8 ( p = 0.03 , p < 0.01 , and p < 0.01 , respectively ) .
laboratory tests of twhf and acitretin ( meansd ) twhf : tripterygium wilfordii hook f ; alt : alanine transaminase ; ast : aspartate transaminase ; hdl : high - density lipoprotein .
of the 115 patients enrolled , 58 were allocated to the twhf group and 57 were allocated to the acitretin group
most patients were men ( 70.4% ) , and the mean age  sd was 41.1  12.2 years .
there was a higher attrition rate in the acitretin group ( 5.2% in the twhf group and 7.0% in the acitretin group by week 2 , and 8.6% in the twhf group and 12.3% in the acitretin group by week 8) .
discontinuation occurred because of withdrawn consent ( n = 1 ) , loss to follow - up ( n = 8) , ae ( n = 1 ) , and disease progression ( n = 2 ) . reasons for discontinuing the study were similar between groups
. baseline demographics and clinical characteristics of the patients sd : standard deviation ; twhf : tripterygium wilfordii hook f ; bmi : body mass index ; pasi : psoriasis area severity index .
the pasi score decreased from a median of 23.8 ( range 7.559.5 ) to 11.1 ( range 0.346.9 ) in the twhf group ( n = 58 ; p < 0.0001 ) and from 23.2 ( range 7.256.7 ) to 13.0 ( range 0.446.4 ) ( n = 57 ; p < 0.0001 ) in the acitretin group within 8 weeks [ table 2 ] .
the median pasi score improved in the twhf group by 50.4  31.0% and in the acitretin group by 42.7  45.7% .
there was no significant difference in median pasi improvement between the two groups ( p = 0.317 ) .
there was also no statistically significant difference between two groups at week 8 for pasi 25 ( 70.7% vs. 64.9% in the twhf and acitretin groups , respectively ; adjusted p = 0.553 ) [ figure 1a ] , pasi 50 ( 51.7% vs. 43.9% ; nominal p = 0.457 ) [ figure 1b ] , pasi 75 ( 19.0% vs. 17.5% ; nominal p = 1 ) [ figure 1c ] , and pasi 90 ( 5.2% vs. 5.3% ; nominal p = 0.204 ) [ figure 2 , 3 ] . at week 2
, there was also no significant difference in median pasi score improvement ( 18.7  41.1% vs. 18.3  16.5% in the twhf and acitretin groups , respectively ; adjusted p = 0.985 ) [ figure 1d ] , pasi 25 ( 50.0% vs. 31.6% ; nominal p = 0.058 ) [ figure 1a ] , pasi 50 ( 12.1% vs. 3.5% ; nominal p = 0.162 ) [ figure 1b ] , and pasi 75 ( 1.7% vs. 0% ; nominal p = 1 ) [ figure 1c ] .
similarly , at week 4 , there was no significant difference in median pasi score improvement ( 34.4  34.9% vs. 31.6  24.7% in the twhf and acitretin groups , respectively ; adjusted p = 0.635 ) [ figure 1d ] , pasi 25 ( 55.2% vs. 59.6% ; nominal p = 0.707 ) [ figure 1a ] , pasi 50 ( 37.9% vs. 24.6% ; nominal p = 0.160 ) [ figure 1b ] , and pasi 75 ( 1.7% vs. 1.8% ; nominal p = 1 ) [ figure 1c ] .
treatment efficacy of twhf and acitretin sd : standard deviation ; twhf : tripterygium wilfordii hook f ; pasi : psoriasis area severity index .
( a ) pasi 25 response ; ( b ) pasi 50 response ; ( c ) pasi 75 response ; ( d ) percentage pasi improvement . clinical appearance of a patient from tripterygium wilfordii hook f group at baseline , weeks 2 , 4 , and 8 .
clinical appearance of a patient from acitretin group at baseline , weeks 2 , 4 , and 8 . at week 2 , the median pasi score improvement rate of the head , upper limbs , trunk , and lower limbs in the twhf group was 14.9  33.7% , 10.6  49.2% , 25.5  22.9% , and 9.7  61.0% , respectively .
there was no significant difference in median pasi improvement between different parts of the body ( p = 0.222 ) [ tables 3 and 4 ] .
there was also no significant difference in median pasi improvement between different parts of the body at weeks 4 ( p = 0.462 ) and 8 ( p = 0.882 ) in the twhf group .
similarly , in the acitretin group , there was no significant difference in median pasi improvement between different parts of the body at weeks 2 , 4 , and 8 ( p = 0.339 , p = 0.144 , and p = 0.764 , respectively ) .
treatment efficacy of different parts of the body ( meansd ) twhf : tripterygium wilfordii hook f ; pasi : psoriasis area severity index .
median pasi improvement of different parts of the body ( % , meansd ) twhf : tripterygium wilfordii hook f ; pasi : psoriasis area severity index .
there was no statistically significant difference between two groups at week 2 for median pasi improvement rate of the head ( 14.9  33.7% vs. 22.9  33.3% in the twhf and acitretin groups , respectively ; adjusted p = 0.221 ) , upper limbs ( 10.6  49.2% vs. 7.2  78.9% ; nominal p = 0.787 ) , trunk ( 25.5  22.9% vs. 18.0  21.4% ; nominal p = 0.084 ) , and lower limbs ( 9.7  61.0% vs. 14.9  19.8% ; nominal p = 0.550 ) . at week 8
, there was also no statistically significant difference between the two groups for median pasi improvement rate of the head ( 49.9  40.3% vs. 49.6  45.0% in the twhf and acitretin groups , respectively ; adjusted p = 0.979 ) , upper limbs ( 42.6  71.3% vs. 33.9  115.2% ; nominal p = 0.649 ) , trunk ( 48.8  42.0% vs. 36.9  86.9% ; nominal p = 0.381 ) , or lower limbs ( 45.5  39.7% vs. 38.9  38.2% ; nominal p = 0.394 ) . at week 4 , there was a statistically significant difference between two groups for median pasi improvement rate of the trunk ( 39.5  30.8% vs. 23.8  40.3% in the twhf and acitretin groups , respectively ; adjusted p = 0.026 ) .
however , there was no statistically significant difference between the two groups at week 4 for median pasi improvement rate of the head ( 35.1  41.4% vs. 39.2  37.9% in the twhf and acitretin groups , respectively ; adjusted p = 0.597 ) , upper limbs ( 35.7  44.0% vs. 31.3  36.9% ; nominal p = 0.575 ) , and lower limbs ( 27.1  45.3% vs. 27.1  28.0% ; nominal p = 0.991 ) .
more aes were reported in the acitretin group ( 78.1% ) compared with the twhf group ( 43.6% ) .
the most frequent complaints in twhf group were menstrual disorders in females , dry mouth , gastrointestinal complaints , and swelling of the lower limbs .
the results of blood biochemistry ( alanine transaminase , aspartate transaminase , urea nitrogen , creatinine , cholesterol , triglyceride , and high - density lipoprotein ) are shown in table 5 .
compared with baseline , there was a significant increase in the level of aspartate transaminase and triglycerides at week 8 in the twhf group ( p = 0.026 and p = 0.011 , respectively ) . in the acitretin group
, there was a significant increase in the level of alanine transaminase , cholesterol , and high - density lipoprotein at week 8 ( p = 0.03 , p < 0.01 , and p < 0.01 , respectively ) .
laboratory tests of twhf and acitretin ( meansd ) twhf : tripterygium wilfordii hook f ; alt : alanine transaminase ; ast : aspartate transaminase ; hdl : high - density lipoprotein .
to our knowledge , this trial is the first randomized , double - blind , double - dummy , parallel - group clinical comparison of twhf with acitretin in moderate to severe psv .
because twhf has several important advantages over acitretin ( e.g. , low risk for teratogenicity , dyslipidemia , or photosensitivity ) , it is important to analyze whether or not the two therapies have similar efficacy .
the data from this trial clearly indicate that twhf and acitretin significantly improved psv within 8 weeks , indicating that both medicines are highly efficient for the treatment for moderate to severe psv .
our results demonstrated no statistically significant difference in treatment efficacy between the two groups in patients with moderate to severe psv in 8 weeks . a decrease in safety signals
psoriasis vulgaris is a common chronic relapsing inflammatory cutaneous disease . for patients with moderate - to - severe psv ,
currently , four conventional systemic agents : cyclosporin a , methotrexate , fumaric acid esters ( germany only ) , and acitretin , and five biological agents : infliximab , etanercept , adalimumab , alefacept ( united states and switzerland only ) , and ustekinumab are approved for chronic plaque psoriasis .
twhf , is approved in china and often used to treat a variety of immune and inflammation - related diseases such as psoriasis and ra .
acitretin is currently approved by the us food and drug administration for the treatment of severe psoriasis in adults . because it is teratogenic and
should not be used in women who are pregnant , breast - feeding , or may become pregnant within 3 years of discontinuing acitretin , its use is substantially limited in female patients of childbearing potential .
dyslipidemia may also occur and require dose reduction or treatment with lipid - lowering agents .
the extracts of twhf contain more than 70 ingredients , but triptolide is the most potent bioactive substance . it has been shown to possess potent anti - inflammatory and immunosuppressive properties in vitro as well as in different animal models in numerous preclinical studies .
inflammatory myeloid dendritic cells release interleukin-23 ( il-23 ) and il-12 to activate il-17-producing t cells , th1 cells , and th22 cells to produce abundant psoriatic cytokines il-17 , interferon- , tumor necrosis factor ( tnf ) , and il-22 .
these inhibit the immunological response and maintain cutaneous immunological homeostasis , which prevents autoimmunity against autoantigens .
triptolide can suppress the activation of t - lymphocytes , promote the differentiation of cd4 + t cells to foxp3 + tregs , and downregulate the level of tnf-. in addition , a recent study showed that the triptolide inhibits il-2 expression in t cells , and can inhibit the maturation and allogenicity of dendritic cells .
these mechanisms might explain the pharmacological effects of twhf in psv treatment . in a literature search including the databases : medline , the cochrane library , china biomedical literature on disc , national science and technology library , vip , and all chinese medical journals , only ten randomized controlled trials ( rcts ) using twhf extracts to treat psoriasis patients were found .
nine of these studies were performed using a group of patients who received a comparator drug , and only one was designed with a placebo group .
the comparator drugs included erythromycin , azithromycin , glycyrrhizin , di yin pian , or ampepitidium et elementum , indigo naturalis ( a dark blue plant used to treat psoriasis in traditional chinese medicine ) , and bimolane .
all the rcts demonstrated a statistically significant improvement of the disease after treatment with twhf extracts .
however , most of these claims were derived from uncontrolled clinical trials or retrospective reports .
the design of the above studies does not meet the criteria required for rigorous clinical trials .
in addition , significant improvement of pasi in patients with only mild forms of psoriasis may bias a favorable efficacy outcome .
therefore , rcts in a defined patient population with moderate to severe psv are needed to gain further insight into the potential benefits and risks of the use of twhf extracts .
the major side effects of twhf extracts documented in the literature are gastrointestinal complaints , skin rash and pigmentation , decreases in white and red blood cells and platelets , and dysfunction of the male and female reproductive system such as dysmenorrhea , irregular menstruation , or reversible sterility .
an adverse effect on renal function such as a decrease in creatinine clearance in elderly patients was also documented .
the side effect - related withdrawal rate for the chloroform  methanol extract of twhf in a 3-month trial was only 2.9% .
dry mouth , gastrointestinal complaints , and swelling of the lower limbs were also common complaints .
no significant abnormalities in urinalysis or blood panels were seen during the 8 weeks . compared with baseline
, there was a significant increase in the level of aspartate transaminase and triglycerides within 8 weeks in the twhf group .
we prescribed oral lipid - lowering drugs and hepatinica to patients whose level of serum aspartate transaminase and triglycerides reached 1.5 times the normal value . with this intervention
, the blood biochemistry values returned to normal or were maintained . in conclusion , tripterygium wilfordii hook f might be an effective and safe treatment in patients with moderate to severe psv .
twhf could be considered a suitable treatment option for certain patient populations , specifically patients who have contraindications to other therapies .
increases in aspartate transaminase and triglyceride levels can be treated symptomatically . because there is a lack of long - term trials or reports of open studies running for more than 1 year , it is difficult to judge the full potential of twhf for use in psoriasis .
further multi - center , large - sample clinical trials are needed to evaluate the long - term effects of twhf , including efficacy , safety , and tolerability .
 background : few clinical trials have evaluated the efficacy and safety of tripterygium wilfordii hook f ( twhf ) compared with acitretin in psoriasis . 
 we aimed to compare the efficacy and safety of twhf compared with acitretin in the treatment of moderate to severe psoriasis vulgaris.methods:adults with psoriasis area severity index ( pasi ) score  10 and psoriasis - affected body surface area  10% were randomized into a twhf ( 20 mg , 3 times a day ) or acitretin group ( 30 mg , once a day ) . 
 the treatment course lasted for 8 weeks . 
 patients were assessed at baseline and at 2 , 4 , and 8 weeks . 
 laboratory tests were performed at baseline , week 4 , and week 8 . 
 the data were analyzed using paired samples t - test or analysis of variance ( anova).results : a total of 115 patients was enrolled ( 58 twhf ; 57 acitretin ) . 
 the median pasi score improved in the twhf group by 50.4% and in the acitretin group by 42.7% . 
 there was no significant difference in median pasi improvement between two groups at 2 , 4 , and 8 weeks . 
 there was also no significant difference in pasi 25 , pasi 50 , pasi 75 , and pasi 90 response between the two groups at 2 , 4 , and 8 weeks . 
 there was a significant increase in the level of aspartate transaminase and triglycerides in the twhf group ( p = 0.026 and p = 0.011 , respectively ) . in the acitretin group 
 , there was a significant increase in the level of alanine transaminase , cholesterol , and high - density lipoprotein ( p = 0.030 , p < 0.01 , and p < 0.01 , respectively).conclusions : there was no significant difference in treatment efficacy between the twhf and acitretin groups within 8 weeks , but there were fewer treatment - related adverse events in the twhf group . 
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Patients
Study design
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Statistical analysis
Safety assessments
Study end points
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Psoriasis area severity index responses
Safety
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