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.

/ / Recommend

Add to citation manager EndNote| Reference Manager|ProCite|BibTeX|RefWorks

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

http://www.jcimjournal.com/EN/Y2010/V8/I1/35

TrendMD

Figures/Tables 4

Table 1

Figure 1

Table 2

Table 3

References 6

[1]	Shen PA. Contemporary immunology in traditional Chinese medicine[M]. Beijing: People’s Medical Publishing House, 2003: 316-318
	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

Related Articles 15

[1]	Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2]	Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3]	Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4]	Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5]	Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6]	J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[7]	Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[8]	Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[9]	Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[10]	Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[11]	Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[12]	Susana Seca, Sebastian Kirch, António S.Cabrita, Henry J.Greten. Evaluation of the effect of acupuncture on hand pain, functional deficits and health-related quality of life in patients with rheumatoid arthritis—A study protocol for a multicenter, double-blind, randomized clinical trial. Journal of Integrative Medicine, 2016, 14(3): 219-227.
[13]	Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[14]	Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[15]	Maria Sousa Cláudia, Coimbra Daniela, Machado Jorge, J. Greten Henry. Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(5): 314-318.

Metrics

Viewed

Full text

Abstract

Cited

Shared

Discussed

Comments

Recommended 10

[1]	Wei-xiong Liang. Problems-solving strategies in clinical treatment guideline for traditional Chinese medicine and integrative medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 1-4
[2]	Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)". Journal of Chinese Integrative Medicine, 2008, 6(1): 15-21
[3]	Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[4]	Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[5]	Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[6]	Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[7]	SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[8]	Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[9]	Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[10]	A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H₂₂ cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82

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

RichHTML

PDF (PC)

Like