Background/Purpose: Tripterygium Wilfordii (TPW), a
Chinese herbal medication, has been widely used in China for
various chronic inflammatory and autoimmune diseases, including systemic lupus
erythematosus (SLE). Although the immunologic mechanism is poorly understood,
studies have shown that TPW inhibits T cell activation, cytokine gene transcription
in T cells and T cell expression of interleukin-2. To better inform clinical practice,
we systematically analyze randomized controlled trials (RCTs) on
the use of TPW in the treatment of SLE.

Methods: We performed a comprehensive search of
three Chinese databases, two English academic database and reference lists of
published articles through April 2015. We included only RCTs, in which TPW was
used for the treatment of adult patients with SLE. The effect of TPW on clinical
signs, symptoms and laboratory tests of SLE was measured. The effectiveness
rate was determined as the percentage of number of patients with complete and
partial response divided by the total number of patients in the study. We also
performed random-effect meta-analysis using the number of patients who improved
with treatment in the experimental and control groups when
appropriate.

Results: We identified 31 potentially relevant
studies. Eight RCTs with a total of 431 subjects met eligibility
criteria. Table 1 summarizes the trials evaluating the effect of TPW on the
improvement of clinical signs, symptoms and laboratory tests in patients with
SLE. All studies were published in China between 1989 and 2014. Studied
subjects received TPW
(variable dose on different formulation) alone or with steroids
(mainly prednisone 0.5-1 mg/kg/day) in experimental group (Leflunamide 10mg bid
in one group), compared with prednisone alone in control group (MTX 10mg weekly
in one group). Duration of treatments ranged from 0.5 to 6 months. Comparing
with a variety of controls, six of the eight studies have shown a statistically
significant improvement in clinical signs and symptoms, including rash,
arthritis/arthralgia, photosensitivity, fever, pleuritis, cerebritis and hair
loss. Improvements of sedimentary rate, C-reactive protein, dsDNA, Complete
Blood Count, proteinuria, hematuria, anti-Smith Antibody, complements and renal
function were also noted. Meta-analysis showed an increase of clinical
effective rate of 33% in experimental patients compared with controls (Risk
Ratio (RR)=1.20; 95%CI: 1.06-1.37; p=0.006; Figure 1), suggesting that TPW improves
the clinical signs, symptoms, abnormal laboratories
associated with SLE. No serious
adverse events were reported.

Conclusion: Evidence suggests that TPW may be a safe and
effective treatment that provides a glimmer of hope in the treatment of SLE. However,
standard criteria of improvement were not used, making it difficult to compare
the results between different studies. Further rigorously designed and
well-controlled RCTs of efficacy of TPW in SLE are warranted.