中药治疗干燥综合征随机对照试验的系统评价和meta分析

doi:10.3736/jcim20110306

Abstract

Background: Chinese herbal medicine (CHM) has been widely used in the treatment of Sjogren's syndrome. However, there remains no systematic review to assess the effectiveness and safety of CHM.
Objective: To assess the effectiveness and safety of CHM in the treatment of Sjogren's syndrome.
Search strategy: Literature was searched from PubMed, the Cochrane Library (Issue 3, 2010), the China National Knowledge Infrastructure Database, the Chongqing VIP Chinese Science and Technology Periodical Database, the Chinese Biomedical Literature Database (SinoMed), Wanfang Data and the Traditional Chinese Medical Periodical Literature Database. The time limitation ran from the commencement of each database to October 15, 2010.
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 data independently. The assessment of methodological quality was based on the Cochrane handbook and the data were analyzed by using RevMan 5.0.17 software. Heterogeneity of the included studies was tested and use of statistical model was based on the heterogeneity. The efficacy measure was relative risk (RR) or mean difference with a 95% confidence interval (CI).
Results: A total of 52 RCTs involving 3 886 patients were included. The included trials were all of low quality. CHM was superior in improving clinical symptoms to WM, with statistical significance between the groups (RR: 1.36; 95% CI: 1.24–1.49); CHM plus WM was better than WM used alone (RR: 1.38; 95% CI: 1.30–1.46). CHM improved lacrimal gland function more effectively than WM, with statistical significance between the groups (RR: 2.12; 95% CI: 1.06–3.18); CHM plus WM was better than WM used alone (RR: 1.90; 95% CI: 0.99–2.81). CHM was superior to WM in the improvement of erythrocyte sedimentation rate (RR: –9.63; 95% CI: –15.73––3.52), and CHM plus WM was also more effective than WM used alone (RR: –8.42; 95% CI: –14.71––2.13). However, there was no statistical difference between groups in other immune index (C-reactive protein, rheumatoid factor, IgG, IgA and IgM). The reported adverse effects of CHM were mainly gastrointestinal symptoms, such as diarrhea. The incidence of adverse effects of WM was higher than that of CHM.
Conclusion: CHM appears to improve the symptoms of Sjogren's syndrome. However, due to the low quality of included studies, further well-designed multicenter and large-scale RCTs are still needed to evaluate the beneficial effects of CHM.

Key words: drugs,Chinese herbal, Sjogren's syndrome, meta-analysis, randomized controlled trials

Hui Luo, Mei Han, Jian-ping Liu. Systematic review and meta-analysis of randomized controlled trials of Chinese herbal medicine in the treatment of Sjogren's syndrome. Journal of Chinese Integrative Medicine, 2011, 9(3): 257-274.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20110306

http://www.jcimjournal.com/EN/Y2011/V9/I3/257

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Figures/Tables 6

Figure 1

Table 1

Characteristics of included studies"

Study	Diagnosis	Sample size	Age (years)	Gender (male/female)	Interventions	Control	Duration (months)	Follow-up	Outcome measure
Zheng 2010^[10]	2002 International criteria^[62]	60	38.0	Female	Runzao formula and control intervention	Prednisone, methotrexate and symptomatic support	3	No	Effective rate, amount of tear secretion, salivary flow rate, GB, CRP, RF and adverse effect
Yin 2010^[11]	2002 International criteria^[62]	40	49.0	Female	Yangyin Qingre Jiedu decoction	Prednisone	1	No	Effective rate, symptom score, Amount of tear secretion, WBC, RF, ESR and adverse effect
Liu 2010^[12]	2002 International criteria^[62]	132	Median (male/ female): 42/40	57/75	Yuquan pill, Shengmai injection and control intervention	Muscarinic receptor agonist, prednisone, triptergium wilfordii polyglycosidum, cyclophosphamide and symptomatic support	1	No	Effective rate and adverse effect
Li 2010^[13]	Self-made criteria	240	41.0	86/154	Qingre Quyu decoction and control intervention	Symptomatic support	6	No	Effective rate
Huang 2010^[14]	2002 International criteria^[62]	61	59.1	7/54	Shenmai injection and control intervention	Anethol trithlone tablets	0.5	No	Effective rate, amount of tear secretion, salivary flow rate and adverse effect
Hu 2010^[15]	2002 International criteria^[62]	64	46.2	Female	Ziyin Yangxue Qingre formula and control intervention	Hydroxychloroquine sulfate tablets	3	No	Effective rate, symptom score, amount of tear secretion, salivary flow rate, sugar-melt test, CRP, ESR, IgG, IgA, IgM and adverse effect
Zhang 2009^[16]	2002 International criteria^[62]	100	40.6	6/89	Jinju Qingrun capsule, placebo of prednisone and symptomatic support	Prednisone, placebo of Jinju Qingrun capsule and symptomatic support	3	No	Effective rate, symptom score, amount of tear secretion, salivary flow rate, ESR, IgG, IgA, IgM, γ-globulin and adverse effect
Yang 2009^[17]	Unclear	168	53.7	33/135	Yangyin Shengjin Qingre Tongluo formula and prednisone	Prednisone and cyclophosphamide	3 to 6	No	Effective rate
Wang 2009^[18]	2002 International criteria^[62]	50	45 to 78	5/45	Xuefu Zhuyu oral liquid and control intervention	Transfer factor oral liquid	3	No	Effective rate
Wang WP 2009^[19]	1992 Europe^[63]	60	58.0	6/54	Yangyin Jianpi Huoxue decoction, methotrexatum and hydroxychloroquine	Methotrexatum, hydroxychloroquine and brombexine	3	No	Scores of symptoms and signs, ESR and CRP
Wan 2009^[20]	Dong 1996^[64]	60	28 to 73	7/53	Quzao decoction and control intervention	Brombexine and symptomatic support	2	No	Effective rate
Su 2009^[21]	1992 Europe^[63]	60	Median: 53.1	2/58	Yangyin Huoxue Shengjin formula and control intervention	Hydroprednisone and methotrexate	6	No	Effective rate, symptom score, amount of tear secretion, sugar-melt test, ESR, IgG, IgA, IgM and T lymphocyte subpopulation
Mao 2009^[22]	2002 International criteria^[62]	100	45 to 75	10/90	Xuefu Zhuyu oral liquid and control intervention	Transfer factor capsule and symptomatic support	3	No	Effective rate and adverse effect
Lu 2009^[23]	2002 International criteria^[62]and TCM diagnosis^[8]	58	42.6	4/54	Shengjin granules	Hydroxychloroquine	3	No	Effective rate, symptom score, salivary flow rate, amount of tear secretion, ESR, CRP, TNF-α, ICAM-1, IgG, IgA, IgM and adverse effect
Lian 2009^[24]	2002 International criteria^[62]and TCM diagnosis^[8]	40	52.1	Female	Shengjin Runzao granules	Placebo	1.5	No	Effective rate, improvement of symptoms and signs, ESR, IgG, RF and adverse effect
Huang 2009^[25]	2002 International criteria^[62]	58	29 to 68	5/53	Yiqi Yangyin Huoxue formula and control intervention	Anethol trithlone tablets	1	No	Effective rate and adverse effect
Gao 2009^[26]	2002 International criteria^[62]	126	30 to 78	11/115	Xuefu Zhuyu oral liquid and control intervention	Transfer factor capsule and symptomatic support	3	No	Effective rate
Zhong 2008^[27]	2002 International criteria^[62]	256	37.0	26/230	Chaihu Tongluo capsule, placebo of prednisone and methotrexate	Prednisone acetate, methotrex ate and placebo of Chaihu Tongluo capsule	3	No	Effective rate, salivary flow rate, amount of tear secretion, ESR, CRP, A/G, Tb, IgG, IgA, IgM and adverse effect
Feng 2008^[28]	2002 International criteria^[62]	78	47.4	Female	Total glycosides of paeony and control intervention	Methotrexate	9	Yes	Effective rate, amount of tear secretion, sugar-melt test, ESR, γ-globulin and adverse effect
Lü 2008^[29]	2002 International criteria^[62]	124	43.6	16/108	Jinyuan decoction	Brombexine and symptomatic support	3	No	Effective rate, T lymphocytes (NK cells, CD3, CD4, CD8), IgG, IgA, IgM and adverse effect
Jin 2008^[30]	2002 International criteria^[62]	47	45.0	5/42	Zengye Runzao decoction	Hydroxychloroquine, vitamin C, B and E, and symptomatic support	2	No	Effective rate and improvement of symptoms
Han 2008^[31]	2002 International criteria^[62]	58	32.6	5/53	Xuanfei Bujin particle	Brombexine	3	No	Effective rate, amount of tear secretion, corneal staining test, BUT test, β2-M, sICAM-1,sIL-2R, ESR, IgG, IgA, IgM and improvement of symptoms
Chen 2008^[32]	1992 Europe^[63]	52	57.5	6/46	Yiqi Shengjin powder	Mucosolvan and symptomatic support	Unclear	No	Effective rate, ESR, IgG, IgA, IgM and improvement of symptoms
Wu 2007^[33]	Guidelines of China^[1]	42	55.0	8/34	Maiwei Dihuang decoction and control intervention	Brombexine, thymopeptide and symptomatic support	2	No	Effective rate and improvement of symptoms
Yan 2007^[34]	Unclear	56	Median (male/ female): 55.2/53.6	6/50	Jiawei Shengmai drink and control intervention	symptomatic support	4	No	Effective rate
Sun 2007^[35]	2002 International criteria^[62]	124	44.9	16/108	Qingli Shutong formula and control intervention	Brombexine and symptomatic support	3	No	Effective rate and salivary flow rate
Shen 2007^[36]	Unclear	20	60 to 70	Female	Hydrocortisone injection and compound glycyrrhizin injection	Hydrocortisone injection and diammonium glycyrrhizinate injection	2 to 3	Yes	Effective rate and adverse effect
Mao 2007^[37]	1992 Europe^[63]	40	53.1	4/36	Yiqi Jianpi decoction	Prednisone	3	No	Effective rate, symptom score, amount of tear secretion, salivary flow rate, sugar-melt test, ESR, CRP and RF
Li 2007^[38]	2002 International criteria^[62]	68	47.3	7/61	Compound glycyrrhizin injection and control intervention	Hydroxychloroquine, brombexine and symptomatic support	1	No	Effective rate, amount of tear secretion, tear break-up time, salary flow rate, β2-M, ESR, RF, IgA, IgG, IgM and adverse effect
Zhou 2006^[39]	2002 International criteria^[62]	60	Median (male/ female): 50/46.25	5/55	Qingzao Jiedu Yangyin Runzao formula	Prednisone and symptomatic support	3	No	Effective rate, amount of tear secretion, salivary flow rate, sugar-melt test, IgG and adverse effect
Zhou DH 2006^[40]	2002 International criteria^[62]	45	55.0	11/34	Dandi Qiongyu granules and control intervention	Brombexine, anethol trithione, thymopeptide and symptomatic support	2	No	Effective rate and symptom score
Wu 2006^[41]	2002 International criteria^[62]	62	44.9	8/54	Yiqi Yangyin Quyu formula and control intervention	Prednisone, methotrexate and symptomatic support	3	No	Effective rate, IgG, IgA, IgM, NK cells, CD3, CD4 and CD8
Shen 2006^[42]	Zhang 1999^[65]	60	52.8	4/56	Runzao oral liquid and control intervention	Bromhexine and symptomatic support	3	Yes	Effective rate, amount of tear secretion, salivary flow rate, sugar-melt test, rose bengal staining test, foci lymphocyte infiltrates, ESR, RF, γ-globulin, anti-SSA antibody, anti-SSB antibody, antinuclear antibody and adverse effect
Niu 2006^[43]	1992 Europe^[63]	40	33.4	1/39	Jianpi Huashi Qingre formula and control intervention	Prednisone and symptomatic support	1	No	Effective rate, ESR, CRP, IgG, IgA, IgM and improvement of symptoms and adverse effect
Chen 2006^[44]	1992 Europe^[63]	60	52.8	5/55	Suangan Shengjin formula 1 and 2	Prednisone	6	No	Effective rate, RF and ESR
Yang 2005^[45]	Zhang 1999^[65]	84	41.5	3/81	Yangyin Shengjin formula and acupuncture	Methotrexate	3	No	Effective rate, amount of tear secretion, salivary flow rate, ESR, CRP and IgG
Si 2005^[46]	TCM diagnosis of SATCM^[66]	58	Unclear	Unclear	Runzao Tuiyi Mingmu decoction and auricular-plaster therapy	Prednisone and symptomatic support	1 to 3	No	Effective rate
Liu 2005^[47]	2002 International criteria^[62]	60	Median (male/ female): 48.5/48.0	5/55	Qingzao formula	Prednisone	3	No	Effective rate, improvement of symptoms, amount of tear secretion, salivary flow rate, ESR, CRP and adverse effect
Zhao 2003^[48]	Dong 1996^[64]	60	Median (male/ female): 48/44	2/58	Qiju Dihuang decoction	Hydroxychloroquine and symptomatic support	Unclear	No	Effective rate and adverse effect
Qian 2003^[49]	Unclear	72	Unclear	5/67	Jinxueyuan granules	Brombexine	3	No	Effective rate, improvement of symptoms, sugar-melt test, amount of tear secretion and ESR
Zhong 2003^[50]	Lu 1987^[67]	186	30.7	41/145	Ziyang Shengxue decoction	Prednisone and symptomatic support	3 to 6	No	Effective rate, salivary flow rate, amount of tear secretion, WBC, RBC, HB and PLT
Li 2002^[51]	Dong 1996^[64]	60	35 to 59	6/54	Shengmai injection and control intervention	Symptomatic support	0.5	No	Amount of tear secretion, salivary flow rate and adverse effect
Wu 2002^[52]	Dong 1996^[64]	40	Median: 56	4/36	Ziyin Huoxue formula and control intervention	Thymosin and symptomatic support	2	No	Effective rate, salivary flow rate and amount of tear secretion
Cui 2002^[53]	Unclear	50	25 to 56	6/44	Runfei Huatan Tongluo formula	Tripterygiitotorum tablets and symptomatic support	Unclear	No	Effective rate
Shen 2002^[54]	Zhang 1999^[65]	60	52.9	5/55	Liuwei Dihuang decoction, Zengye decoction and symptomatic support	Bromhexine and symptomatic support	6	Yes	Effective rate, salivary flow rate, amount of tear secretion, sugar-melt test, tear break-up time, rose bengal staining test, lymphocytes infiltration of alabial gland, RF, ESR, anti-SSA antibody, anti-SSB antibody, antinuclear antibody and adverse effect
Hu 2001^[55]	Manthorpe 1981^[68]	150	43.9	23/127	Zengye mixture formula	Brombexine and thymopeptide	6	No	Effective rate, symptom improvement, amount of tear secretion, sugar-melt test, FL, ESR, ANA, RF, IgG, IgA and IgM
Wang 2000^[56]	1992 Europe^[63]	40	50.4	5/35	Runzao mixture formula	Levamisole and symptomatic support	Unclear	No	Effective rate
Feng 2000^[57]	Dong 1996^[64]	44	34 to 65	1/43	Shengjin Runzao granules	Symptomatic support	1	No	Salivary flow rate
Chen 2000^[58]	Unclear	38	48.5	3/35	Qingzao Jiufei decoction and Dahuang Zhechong pill	Levamisole and symptomatic support	1	No	Effective rate
Liao 1999^[59]	1992 Europe^[63]	43	50.8	A:5/27; B: unclear	Mendong Qingfei drink	Brombexine and symptomatic support	1	No	Effective rate
Yang 1998^[60]	Unclear	22	25 to 50	5/17	Qingkailing injection and compound Danshen injection	Prednisone, thymopeptide and symptomatic support	3	No	Symptom improvement
Zhou 1997^[61]	Unclear	50	52.0	12/38	Qiju Dihuang pill or Huanglian Shangqing pill or Maiwei Dihuang pill or Shihu Yeguang pill, fresh decoction of phragmites, glycyrrhiza and acupuncture	Pilocarpine and symptomatic support	Unclear	No	Effective rate

Table 1

Figure 2

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Systematic review and meta-analysis of randomized controlled trials of Chinese herbal medicine in the treatment of Sjogren's syndrome

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