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Efficacy and safety of Tripterygium wilfordii hook F versus acitretin in moderate to severe psoriasis vulgaris: a randomized clinical trial.

Wu C, Jin HZ, Shu D, Li F, He CX, Qiao J, Yu XL, Zhang Y, He YB, Liu TJ - Chin. Med. J. (2015)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.

ABSTRACT

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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Related in: MedlinePlus

Efficacy of Tripterygium wilfordii Hook F and acitretin. (a) PASI 25 response; (b) PASI 50 response; (c) PASI 75 response; (d) Percentage PASI improvement.
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Figure 1: Efficacy of Tripterygium wilfordii Hook F and acitretin. (a) PASI 25 response; (b) PASI 50 response; (c) PASI 75 response; (d) Percentage PASI improvement.

Mentions: The PASI score decreased from a median of 23.8 (range 7.5–59.5) to 11.1 (range 0.3–46.9) in the TwHF group (n = 58; P < 0.0001) and from 23.2 (range 7.2–56.7) to 13.0 (range 0.4–46.4) (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].


Efficacy and safety of Tripterygium wilfordii hook F versus acitretin in moderate to severe psoriasis vulgaris: a randomized clinical trial.

Wu C, Jin HZ, Shu D, Li F, He CX, Qiao J, Yu XL, Zhang Y, He YB, Liu TJ - Chin. Med. J. (2015)

Efficacy of Tripterygium wilfordii Hook F and acitretin. (a) PASI 25 response; (b) PASI 50 response; (c) PASI 75 response; (d) Percentage PASI improvement.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4836244&req=5

Figure 1: Efficacy of Tripterygium wilfordii Hook F and acitretin. (a) PASI 25 response; (b) PASI 50 response; (c) PASI 75 response; (d) Percentage PASI improvement.
Mentions: The PASI score decreased from a median of 23.8 (range 7.5–59.5) to 11.1 (range 0.3–46.9) in the TwHF group (n = 58; P < 0.0001) and from 23.2 (range 7.2–56.7) to 13.0 (range 0.4–46.4) (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].

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus