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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (1): 35-39.doi: 10.3736/jcim20100107

• Original Clinical Research • Previous Articles     Next Articles

Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: A randomized controlled trial

 Zhao-wei Chen, Jian Sun, Yu-mei Li, Yong-qiang Chen   

  1. Department of Orthopaedics and Traumatology, Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai 200071, China
  • Received:2009-07-27 Accepted:2009-10-15 Online:2010-01-20 Published:2010-01-15
  • Contact: Yong-qiang Chen E-mail:chenyongqiang@medmail.com.cn

Background

In China, patients with rheumatoid arthritis (RA) are often treated with traditional Chinese herbal medicine. There are certain advantages of traditional Chinese medicine therapy in treatment of RA.
Objective

To assess the efficacy and adverse reaction of Shenshi Qianghuo Dihuang Decoction (SQDD), a compound traditional Chinese herbal medicine, in treatment of RA.
Design, setting, participants and interventions

This was a 24-week prospective, randomized, controlled trial. Ninety RA patients meeting inclusion criteria from Shanghai Municipal Hospital of Traditional Chinese Medicine were randomly assigned to receive SQDD or methotrexate (MTX) with 45 cases in each group. The patients in SQDD group were orally administered with SQDD twice daily, and the patients in MTX control group were treated by oral administration of 15 mg MTX once a week. All the RA patients were treated for 24 weeks.
Main outcome measures

The primary outcome was the number of patients achieving the American College of Rheumatology 20% response. Clinical and laboratory parameters including tender joint count and swollen joint count, patient’s global assessment and physician’s global assessment (using a 0– 10 cm visual analogue scale), duration of morning stiffness, plasma C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR) and value of anti-cyclic citrullinated peptide (CCP) antibody were assessed.
Results

After 24-week treatment, the response rates in SQDD group and MTX group were 62.53% (24/41) and 67.5% (28/40) respectively, and there was no statistical difference between the two groups (P>0.05). The patient’s global assessment and physician’s global assessment, morning stiffness, grip strength, tender joint count, swollen joint count and the levels of ESR, CRP and anti-CCP antibody in SQDD and MTX groups were improved significantly as compared with those before treatment, and there were no significant differences between the two groups. The efficacy of MTX in improving rest pain and joint tenderness was better than that of SQDD (P<0.05). The incidence rate of adverse reactions in SQDD group was 9.75% (4/41), significantly lower than 32.5% (13/40) in MTX group (P<0.05).
Conclusion

SQDD has a therapeutic effect on RA, and the adverse reactions are less than MTX.

Key words: Rheumatoid arthritis, Shenshi Qianghuo Dihuang Decoction, Methotrexate, Randomized controlled trial

Table 1

The general data of two groups"

Characteristics MTX group (n=40) SQDD group (n=41)
Cases (Male/Female) 21/19 22/19
Mean age ($\bar{x}s$, years) 46.23±12.21 45.76±10.21
Duration of illness (?$\bar{x}s$, months) 52.21±41.31 47.32±48.32
Function of joint (Ⅰ/Ⅱ/Ⅲ/Ⅳ) 0/29/10/1 0/31/10/0
X-ray stage (Ⅰ/Ⅱ/Ⅲ/Ⅳ) 16/20/4/0 11/25/5/0

Figure 1

Flow diagram of this randomized trial"

Table 2

Changes of clinical parameters before and after treatment in two groups ($\bar{x}s$)"

Variable Baseline Twelve-week treatment Twenty-four-week treatment
MTX group
(n=40)
SQDD group
(n=41)
MTX group
(n=40)
SQDD group
(n=41)
MTX group
(n=40)
SQDD group
(n=41)
Pain (VAS 0 – 10) 6.61±1.31 6.92±1.22 4.32±0.21** 5.91±0.51** 3.13±1.23** 5.51±1.53**
Morning stiffness (min) 120.12±13.11 115.21±11.32 59.22±11.31* 65.36±14.22* 45.78±10.31** 46.32±14.52**
Grip strength (kPa) 12.32±9.21 12.25±3.11 14.45±4.12* 14.32±3.24* 15.67±4.22* 15.54±3.14*
Tender joint count 10.51±0.81 11.23±0.54 7.33±2.67* 8.93±1.35* 6.22±0.67* 7.51±1.15*
Swollen joint count 3.52±0.12 4.01±0.12 2.55±0.13** 2.95±0.23** 1.55±0.13** 1.72±0.32**
Patient's global assessment (VAS 0 – 10) 6.19±0.28 7.01±0.38 3.55±0.82* 3.92 ±0.38* 3.14±0.20* 3.44 ±0.18*
Physician's global assessment (VAS 0 – 10) 6.02±0.15 6.12±0.12 4.51±0.44* 4.74±0.27* 3.51±0.44* 3.14±0.76*

Table 3

Changes of laboratory parameters before and after treatment in two groups (?$\bar{x}s$)"

Variable Baseline Twelve-week treatment Twenty-four-week treatment
MTX group
(n=40)
SQDD group
(n=41)
MTX group
(n=40)
SQDD group
(n=41)
MTX group
(n=40)
SQDD group
(n=41)
ESR (mm/h) 82.21±15.01 84.55±13.03 70.66±17.01* 74.43±16.01* 14.32±7.11** 15.55±5.24**
CRP (mg/L) 10.21±1.84 11.33±0.82 8.21±1.82* 9.43±1.81* 6.22±1.21** 6.22±1.51**
RF (×103 U/L) 155.01±12.21 47.02±21.91 109.11±32.10* 98.02±29.97* 97.01±13.12* 99.12±10.13*
Anti-CCP Ab (RU/L) 0.23±0.56 0.25±0.45 0.22±0.46** 0.21±0.35** 0.21±0.35* 0.22±0.45*
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