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[Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: a randomized controlled trial].

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.

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Authors+Show Affiliations

,

Department of Orthopaedics and Traumatology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai 200071, China.

, ,

Source

MeSH

Adult
Arthritis, Rheumatoid
Drugs, Chinese Herbal
Female
Humans
Male
Methotrexate
Middle Aged
Phytotherapy
Treatment Outcome

Pub Type(s)

English Abstract
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

chi

PubMed ID

20082756

Citation

Chen, Zhao-wei, et al. "[Efficacy of Shenshi Qianghuo Dihuang Decoction in Rheumatoid Arthritis: a Randomized Controlled Trial]." Zhong Xi Yi Jie He Xue Bao = Journal of Chinese Integrative Medicine, vol. 8, no. 1, 2010, pp. 35-9.
Chen ZW, Sun J, Li YM, et al. [Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: a randomized controlled trial]. Zhong Xi Yi Jie He Xue Bao. 2010;8(1):35-9.
Chen, Z. W., Sun, J., Li, Y. M., & Chen, Y. Q. (2010). [Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: a randomized controlled trial]. Zhong Xi Yi Jie He Xue Bao = Journal of Chinese Integrative Medicine, 8(1), pp. 35-9.
Chen ZW, et al. [Efficacy of Shenshi Qianghuo Dihuang Decoction in Rheumatoid Arthritis: a Randomized Controlled Trial]. Zhong Xi Yi Jie He Xue Bao. 2010;8(1):35-9. PubMed PMID: 20082756.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: a randomized controlled trial]. AU - Chen,Zhao-wei, AU - Sun,Jian, AU - Li,Yu-mei, AU - Chen,Yong-qiang, PY - 2010/1/20/entrez PY - 2010/1/20/pubmed PY - 2012/3/7/medline SP - 35 EP - 9 JF - Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine JO - Zhong Xi Yi Jie He Xue Bao VL - 8 IS - 1 N2 - 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. SN - 1672-1977 UR - https://www.unboundmedicine.com/medline/citation/20082756/[Efficacy_of_Shenshi_Qianghuo_Dihuang_Decoction_in_rheumatoid_arthritis:_a_randomized_controlled_trial]_ L2 - http://www.diseaseinfosearch.org/result/592 DB - PRIME DP - Unbound Medicine ER -