沈氏羌活地黄汤治疗类风湿性关节炎随机对照临床试验

doi:10.3736/jcim20100107

Abstract

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

Zhao-wei Chen , Jian Sun, Yu-mei Li, Yong-qiang Chen. Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2010, 8(1): 35-39.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20100107

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References 6

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	沈丕安 . 现代中医免疫病学[M]. 北京: 人民卫生出版社, 2003: 316-318
[2]	American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 Update[J]. Arthritis Rheum, 2002,46(2):328-346 doi: 10.1007/BF03278953
[3]	Koh ET, Seow A, Pong LY, Koh WH, Chan L, Howe HS, Lim TH, Low CK . Cross cultural adaptation and validation of the Chinese Health Assessment Questionnaire for use in rheumatoid arthritis[J]. J Rheumatol, 1998,25(9):1705-1708
[4]	Albert DA, Huang G, Dubrow G, Brensinger CM, Berlin JA, Williams HJ . Criteria for improvement in rheumatoid arthritis: alternatives to the American College of Rheumatology 20[J]. J Rheumatol, 2004,31(5):856-866
[5]	Li YM . Professor Shen Pi’an’s experience in herbal administration to treat rheumatoid arthritis[J]. Shanghai Zhong Yi Yao Za Zhi, 2009,43(1):21-22
	李玉梅 . 沈丕安治疗类风湿性关节炎用药经验[J]. 上海中医药杂志, 2009,43(1):21-22
[6]	Shen PA. Pharmacology and clinical use of traditional Chinese herbal medicine[M]. Beijing: People’s Medical Publishing House, 2006: 101
	沈丕安 . 中药药理与临床运用[M]. 北京: 人民卫生出版社, 2006: 101

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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

Variable	Baseline		Twelve-week treatment		Twenty-four-week treatment
Variable	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*

Variable	Baseline		Twelve-week treatment		Twenty-four-week treatment
Variable	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*

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

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