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Journal of Integrative Medicine ›› 2020, Vol. 18 ›› Issue (6): 478-491.doi: 10.1016/j.joim.2020.08.007

• Systematic Review • Previous Articles     Next Articles

Modified Zhibai Dihuang pill, a traditional Chinese medicine formula, on steroid withdrawal in systemic lupus erythematosus: A systematic review and meta-analysis

Liang Dai a, Ka Kei Chanb, Jian-chun Mao c, Yu Tian c, Jun-hua Gu c, Jun Zhou c, Linda L.D. Zhong b   

  1. a Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    b Hong Kong Chinese Medicine Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China
    c Rheumatology Department, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
  • Received:2020-04-30 Accepted:2020-08-26 Online:2020-11-10 Published:2020-08-26
  • Contact: Jun Zhou; E-mail address: dr_zhoujun@126.com. Linda L.D. Zhong; E-mail address: ldzhong@hkbu.edu.hk

Background
Zhibai Dihuang pill (ZBDH), a Chinese herbal formula, has been widely used as an adjunctive therapy to help reduce a patient's steroid dose while maintaining low disease activity in systemic lupus erythematosus (SLE).

Objective
This systematic review evaluates the therapeutic effect of modified ZBDH in reducing steroid use in patients with SLE.

Search strategy
A systematic literature search was carried out using seven databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Chinese VIP Information and Wanfang Database, from their inception to June 1st, 2019. The search terms included “systemic lupus erythematosus,” “Chinese medicine” and “clinical trial,” and their synonyms. Subject headings matching the above terms were also used.

Inclusion criteria
This meta-analysis included randomized controlled trials that evaluated the reduction of steroid dose in patients with SLE. Traditional Chinese medicine (TCM) formulas in experimental group should be prescribed based on ZBDH and used as adjunctive therapy and the comparator should contain steroids.

Data extraction and analysis
Two authors independently conducted database searches, study selection, data extraction and quality assessment. The extracted information contained study design, sample size, recruitment mode, diagnostic criteria, inclusion and exclusion criteria, participant characteristics, TCM patterns, TCM formulas and treatment outcomes. The primary outcome was the change of steroid dose. Secondary outcomes included SLE Disease Activity Index (SLEDAI), biomarkers of disease activity and clinical response rate. STATA 15.0 was used to analyze the pooled effects reported as weighted mean difference (WMD) or odds ratio, with a 95% confidence interval (CI).

Results
In total, 20 trials involving 1470 SLE patients were included. The pooled result showed that modified ZBDH taken in combination with standard care led to a larger reduction in steroid dose, compared to standard care alone (WMD: 3.79; 95% CI: 2.58–5.01; P < 0.001). Favorable outcomes were also seen in secondary outcome criteria, such as SLEDAI and complement 3. The modified ZBDH treatments were well tolerated without increasing adverse effects.

Conclusion
The systematic review provided preliminary evidence supporting the use of ZBDH as a co-therapy to aid steroid dose reduction in patients with SLE. However, more rigorous studies should be conducted to validate these findings, and explore the mechanisms of ZBDH’s relevant bioactive constituents.

Key words: Systemic lupus erythematosus, Steroid, Traditional Chinese medicine, Systematic review, Meta-analysis

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