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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (2): 141-153.doi: 10.3736/jcim20120204

• Systematic Review • Previous Articles     Next Articles

Systematic review and meta-analysis of randomized controlled trials of Chinese herbal medicine in treatment of multiple sclerosis

Liu Jian,Gao Ying(),Kan Bao-hong,Zhou Li   

  1. Department of Encephalopathy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2011-09-15 Accepted:2011-10-17 Online:2012-02-20 Published:2018-10-09

BACKGROUND: Chinese herbal medicine (CHM) has been widely used in the treatment of multiple sclerosis (MS). However, there is no systematic review to assess the efficacy and safety of CHM.
OBJECTIVE: To systematically evaluate the efficacy and safety of CHM in the treatment of MS.
SEARCH STRATEGY: Literature was searched from the China National Knowledge Infrastructure Database, the Chinese Biomedical Database (SinoMed), the Chongqing VIP Chinese Science and Technology Periodical Database, Wanfang Data, PubMed and the Cochrane Library. The time limitation ran from the commencement of each database to March 15, 2011.
INCLUSION CRITERIA: Randomized controlled trials (RCTs) testing CHM alone or in combination with Western medicine (WM) against WM or placebo used alone were included.
DATA EXTRACTION AND ANALYSIS: Two authors collected the data respectively. The assessment of methodological quality was based on the Cochrane Handbook and the data were analyzed by using RevMan 5.1.0 software. The efficacy measure was mean difference (MD) with a 95% confidence interval (CI).
RESULTS: After screening of the search results, 16 eligible RCTs with 913 cases were included. The included trials were all of low quality. Thirteen studies adopted Kurtzke Extended Disability Status Scale (EDSS) and two of them showed that EDSS in the treatment group was lower than that in the control group, and the MD and 95% CI were –0.88 (–1.26, –0.50). We performed descriptive analysis on the other eight studies which showed that EDSS of the treatment group was lower than that of the control group. Five studies adopted recurrent frequency and two of them showed that recurrent frequency in the treatment group was lower than that in the control group, and the MD and 95% CI were –0.34 (–0.52, –0.16). We performed descriptive analysis on the other three studies which showed that EDSS in the treatment group was lower than that in the control group. Analyses of secondary outcomes such as clinical symptom score, neurological sign score and immune indexes showed that integrated TCM and WM was more effective than WM treatment alone. The studies displayed that the number or range of magnetic resonance imaging lesion of the treatment group was lower than that of the control group, but there was no statistical significance. The reported adverse events in the CHM group were less than those in the control group.
CONCLUSION: CHM could improve neurological signs, clinical symptoms and immune indexes, and reduce recurrent frequency. The reported adverse events in the CHM group were less than those in the control group. However, further well-designed research is needed to evaluate the beneficial effects of CHM.

Key words: drugs, Chinese herbal, multiple sclerosis, meta-analysis, randomized controlled trials

Figure 1

Flow diagram of literature searching and screening of Chinese herbal medicine in treatment of multiple sclerosis CNKI: China National Knowledge Infrastructure Database; CBM: Chinese Biomedical Literature Database (SinoMed); VIP: Chongqing VIP Chinese Science and Technology Periodical Database; non-RCTs: non-randomized controlled trials."

Table 1

Characteristics of included studies"

Study Diagnosis criteria Sample size Gender(male/female)
Intervention Control Treatment duration Follow-up period Outcome measures
Liu XY 2002[13] Poser[6] 80 Not report Bushen Shengsui formula and control intervention Prednisone acetate tablet 3 months 2.5 years EDSS, changes of clinical symptoms, clinical symptom score, neurological signs score, efficiency rate and recurrent frequency
Shi LH 2004[14] Poser[6] 38 15/23 Jiannao Gusui decoction and control intervention Methylprednisolone, prednisone acetate tablet and functional exercise 3 months 1 to 2.5 years EDSS, efficiency rate, clinical symptom score, neurological signs score, recurrent frequency and somatosensory evoked potential
Li YL 2005[15] Poser[6] 60 21/39 Jiweiling Capsule and prednisone Placebo and prednisone 3 months Not reported EDSS, clinical symptom score, EDSS, clinical symptom score, evoked potential before and after therapy, changes of number of lesions on MRI
Liu GH 2006[16] Poser[6] 60 25/35 Bushen Tongluo formula and control intervention Methylprednisolone, prednisone acetate tablet and functional exercise 2 months Not reported EDSS and efficiency rate
Wang YH2006[17] Poser[6] 68 34/34 Jiweiling decoction and control intervention Methylprednisolone and prednisone acetate tablet 10 to 14 weeks Not reported Efficiency rate
Zhang GZ 2006[18,19] Poser[6] 60 25/35 Gusui Tongluo formula and control intervention Methylprednisolone, prednisone acetate tablet and functional exercise 2 months Not reported EDSS, efficiency rate, clinical symptom score and neurological signs score
Fan YP 2007[20,21] Poser[6] 65 17/48 Erhuang formula and control intervention Methylprednisolone, prednisone acetate tablet, immunosuppressant and functional exercise 3 to 4 weeks 1 year EDSS, recurrent frequency, MCP-1, IL-2, TGF-β1, IFN-α and clinical symptom score
Gao C 2008[22] McDonald[5] 40 13/27 Dihuang Heji tablet and control intervention Prednisone 12 months 3 years GFAP and S100B
Gao M 2008[23] Poser[6] 78 45/33 Dihuang Heji capsule and control intervention Methylprednisolone and prednisone acetate tablet 3 weeks 1 year EDSS and recurrent frequency
Guo MM 2008[24] Poser[6] 53 16/37 Jiannao Tongluo method Blank control 1.5 years Not reported EDSS, recurrent frequency and changes of number of lesions on MRI
Liang H 2009[25] Poser[6] 22 10/12 Yiguan decoction and control intervention Methylprednisolone, Prednisone 12 weeks 6 months EDSS and FA
Lin MC 2009[26] McDonald[5] 60 24/36 Dihuangheji capsule and control intervention Placebo, methylprednisolone, and prednisone acetate tablet 6 weeks 1 year EDSS and recurrent frequency
Qian BC 2009[27] McDonald[5] 60 22/38 Ziyin Guben decoction and control intervention Methylprednisolone, citicoline, vitamin C, potassium chloride and osteoform 28 d Not reported Efficiency rate, clinical symptom score, neurological signs score, EDSS and uric acid
Song LJ 2009[28,29] McDonald[5] 64 29/35 Medication based on syndrome differentiation and control intervention Methylprednisolone and prednisone 3 to 4 weeks Not reported EDSS, ISS, TNF-α, IL-12p40 and IFN-γ
Zeng HM 2009[30] Poser[6] 65 26/39 Buyang Huanwu decoction and control intervention Methylprednisolone and prednisone acetate tablet 4 to 6 weeks Not reported Efficiency rate
Chen L 2010[31] McDonald[5] 40 0/40 Tripterygium glycosides tabletand control intervention Glucocorticoid and functional exercise 3 months 6 months EDSS, MISI and FIM

Table 2

Quality assessment of included studies"

Study Random sequence
generation
Allocation
concealment
Blinding of
participants
and personnel
Blinding
of outcome
assessment
Incomplete
outcome data
Selective
reporting
Other
bias
Liu XY 2002[13] Unclear No No No No Yes Unclear
Shi LH 2004[14] Unclear No No No Yes Yes Unclear
Li YL 2005[15] Random number table No Double-blind
method
No Yes Yes Unclear
Liu GH 2006[16] Unclear No No No Yes Yes Unclear
Wang YH 2006[17] Random number table No No No Yes Yes Unclear
Zhang GZ 2006[18,19] Unclear No No No Yes Yes Unclear
Fan YP 2007[20,21] Random code No No No No Yes Unclear
Gao C 2008[22] Random number table No No No Yes Yes Unclear
Gao M[23] Unclear No No No Yes Yes Unclear
Guo MM 2008[24] Unclear No No No Yes Yes Unclear
Liang H 2009[25] Unclear No No No Yes Yes Unclear
Lin MC 2009[26] Unclear No Double-blind
method
No Yes Yes Unclear
Qian BC 2009[27] Computer randomization No No No Yes Yes Unclear
Song LJ 2009[28,29] Coin flipping or coin tossing No No No Yes Yes Unclear
Zeng HM 2009[30] Unclear No No No Yes Yes Unclear
Chen L 2010[31] Unclear No No No Yes Yes Unclear

Figure 2

Meta-analysis of EDSS score comparison in Chinese herbal medicine group and control group EDSS: Kurtzke Expanded Disability Status Scale; SD: standard deviation; IV: inverse variance; CI: confidence interval; df: degrees of freedom."

Table 3

Descriptive analysis of EDSS score in Chinese herbal medicine group and control group"

Study Experimental Control MD (95% CI) P value
Mean SD Total Mean SD Total
Liu XY 2002[13] 2.16 1.59 40 3.02 1.51 21 –0.86 (–1.67, –0.05) 0.04
Shi LH 2004[14] 2.33 1.67 19 4.40 1.58 19 –2.07 (–3.10, –1.04) <0.000 1
Li YL 2005[15] 2.75 0.97 30 3.58 1.11 30 –0.83 (–1.36, –0.30) 0.002
Zhang GZ 2006[18,19] 2.48 1.55 30 4.43 1.49 30 –1.95 (–2.72, –1.18) <0.000 01
Guo MM 2008[24] 2.65 1.99 27 3.67 1.63 26 –1.02 (–2.00, –0.04) 0.04
Liang H 2009[25] 3.00 0.65 12 3.20 0.84 10 –0.20 (–0.84, 0.44) 0.54
Qian BC 2009[27] 2.10 0.59 30 4.18 0.98 30 –2.08 (–2.49, –1.67) <0.000 01
Chen L 2010[31] 0.50 0.30 20 0.80 0.20 20 –0.30 (–0.46, –0.14) 0.000 2

Figure 3

Meta-analysis of recurrent frequency comparison in Chinese herbal medicine group and control group SD: standard deviation; IV: inverse variance; CI: confidence interval; df: degrees of freedom."

Table 4

Descriptive analysis of recurrent frequency in Chinese herbal medicine group and control group"

Study Experimental Control MD (95% CI) P value
Mean SD Total Mean SD Total
Liu XY 2002[13] 0.25 0.36 26 0.47 0.55 18 –0.22 (–0.51, 0.07) 0.14
Fan YP 2007[20,21] 0.09 0.30 14 0.44 0.63 16 –0.35 (–0.70, –0.00) 0.05
Guo MM 2008[24] 0.15 0.28 27 0.36 0.43 26 –0.21 (–0.41, –0.01) 0.04

Figure 4

Meta-analysis of inefficiency rate in Chinese herbal medicine group and control group M-H: Mantel-Haenszel; CI: confidence interval."

Table 5

Descriptive analysis of inefficiency rate in Chinese herbal medicine group and control group"

Study Experimental Control RR (95% CI) P value
Event Total Event Total
Liu XY 2002[13] 4 40 8 21 0.26 (0.09, 0.77) 0.02
Shi LH 2004[14] 1 19 7 19 0.14 (0.02, 1.05) 0.06
Wang YH 2006[17] 2 36 7 32 0.25 (0.06, 1.14) 0.07
Qian BC 2009[27] 1 30 6 30 0.17 (0.02, 1.30) 0.09
Ceng HM 2009[30] 3 35 10 30 0.26 (0.08, 0.85) 0.03

Table 6

Descriptive analysis of clinical symptom score in Chinese herbal medicine group and control group"

Study Experimental Control MD (95% CI) P value
Mean SD Total Mean SD Total
Liu XY 2002[13] 6.88 3.09 40 11.19 3.96 21 –4.31 (–6.26, –2.36) <0.000 1
Shi LH 2004[14] 5.5 3.13 19 7.78 3.13 19 –2.28 (–4.27, –0.29) 0.02
Li YL 2005[15] 7.43 2.57 30 10.37 3.55 30 –2.94 (–4.51, –1.37) 0.002
Zhang GZ 2006[18,19] 5.56 1.65 30 7.93 3.17 30 –2.37 (–3.65, –1.09) 0.003
Qian BC 2009[27] 4.87 1.45 30 7.70 2.95 30 –2.83 (–4.01, –1.65) <0.000 01

Table 7

Descriptive analysis of neurological sign score in Chinese herbal medicine group and control group"

Study ID Experimental Control MD (95% CI) P value
Mean SD Total Mean SD Total
Liu XY 2002[13] 6.2 4.51 40 7.43 3.56 21 –1.23 (–3.30, 0.84) 0.24
Shi LH 2004[14] 7.08 3.14 19 11.25 3.2 19 –4.17 (–6.19, –2.15) <0.000 1
Zhang GZ 2006[18,19] 7.32 2.98 30 12.06 3.16 30 –4.74 (–6.29, –3.19) <0.000 01
Qian BC 2009[27] 6 1.5 30 6.97 1.97 30 –0.97 (–1.86, –0.08) 0.03

Table 8

Descriptive analysis of the improvement rate in the number or range of MRI lesion in Chinese herbal medicine group and control group"

Study ID Experimental Control RR (95% CI) P value
Event Total Event Total
Li YL 2005[15] 16 21 8 18 1.71 (0.97, 3.03) 0.06
Guo MM 2008[24] 12 27 6 26 1.93 (0.85, 4.37) 0.12
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