Evidence-Based Complementary and Alternative Medicine / 2012 / Article / Tab 1

Review Article

Chinese Herbal Medicine in Treating Primary Sjögren’s Syndrome: A Systematic Review of Randomized Trials

Table 1

Characteristics of included randomized controlled trials.

Study IDDiagnostic criteria Sample sizeMean age (years)Gender (male/female)InterventionControlDuration (months)FollowupOutcome measures

Zhang 2011 [12]2002 international 5938.03/54Jinju Qingrun capsuleHydroxychloroquine sulfate3NoResponse rate, amount of tear secretion, salivary flow rate, improvement of symptoms and signs, ESR, IgG, IgA, IgM, 𝛾 -globulin, and adverse effect

Zheng 2010 [13]2002 international 6038.0FemaleRunzao formula and control interventionPrednisone, methotrexate, and symptomatic support3NoResponse rate, amount of tear secretion, salivary flow rate, GB, CRP, RF, and adverse effect

Yin 2010 [14]2002 international 4049.0 FemaleYangyin Qingre Jiedu decoctionPrednisone1NoResponse rate, symptom score, Amount of tear secretion, WBC, RF, ESR, and adverse effect

Liu 2010 [15]2002 international 13241.057/75Yuquan pill, Shengmai injection, and control interventionMuscarinic receptor agonist, prednisone, tripterygium wilfordii polyglycosidum, cyclophosphamide, and symptomatic support1NoResponse rate and adverse effect

Li 2010 [16]Self-made criteria24041.0 86/154Qingre Quyu decoction and control interventionSymptomatic support6NoResponse rate

Huang 2010 [17]2002 international 6159.1 7/54Shenmai injection and control interventionAnethol trithione tablets0.5NoResponse rate, amount of tear secretion, salivary flow rate, and adverse effect

Hu 2010 [18]2002 international 6446.2 FemaleZiyin Yangxue Qingre formula and control interventionHydroxychloroquine sulfate tablets3NoResponse rate, symptom score, amount of tear secretion, salivary flow rate, sugar-melt test, CRP, ESR, IgG, IgA, IgM, and adverse effect

Xuan 2010 [19]2002 international 6053.021/39Shenglu Runzao decoctionHydroxychloroquine sulfate tablets12No Response rate, symptom score, RF, ESR, SS-A, and SS-B

He 2010 [20]1992 Europe 4835.0Female Total Glucosides of Paeony and Hydroxychloroquine sulfate tabletsHydroxychloroquine sulfate tablets3No Response rate, ESR, IgA, IgM, γ-globulin, amount of tear secretion, salivary flow rate, and adverse effect

Xie 2010 [21] Dong 1996 [22]6055.2/52.611/49Yin-nourishing decoctionPrednisone, cyclophosphamide1No Response rate, symptom score

Li 2010 [23]2002 international 4054.1/48.61/39Yushu-Dihuang decoction Hydroxychloroquine sulfate tablets2No Response rate, symptom score, self-made quality of life, and adverse effect

Yu 2010 [24]2002 international 6152.1/55.45/56Zi Zao YinPlacebo 3No Response rate, symptom score, salivary flow rate, liver-kidney function, ESR, CRP, ANA, SSA, SSB, and IgG

Zhang 2009 [25]2002 international 10040.6 6/89Jinju Qingrun capsule, placebo of prednisone and symptomatic supportPrednisone, placebo of Jinju Qingrun capsule and symptomatic support3NoResponse rate, symptom score, amount of tear secretion, salivary flow rate, ESR, IgG, IgA, IgM, γ-globulin, and adverse effect

Yang 2009 [26]NA16853.7 33/135Yangyin Shengjin Qingre Tongluo formula and prednisonePrednisone and cyclophosphamide3 to 6NoResponse rate

Wang 2009 [27]2002 international 5045 to 785/45Xuefu Zhuyu oral liquid and control interventionTransfer factor oral liquid3NoResponse rate

Wang 2009 [28]1992 Europe 6058.0 6/54Yangyin Jianpi Huoxue decoction, methotrexatum and hydroxychloroquineMethotrexatum, hydroxychloroquine and brombexine3NoScores of symptoms and signs, ESR, and CRP

Wan 2009 [29] Dong 1996 [22] 6028 to 737/53Quzao decoction and control interventionBrombexine and symptomatic support2NoResponse rate

Su 2009 [30]1992 Europe 6053.12/58Yangyin Huoxue Shengjin formula and control interventionHydroprednisone and methotrexate6NoResponse rate, symptom score, amount of tear secretion, sugar-melt test, ESR, IgG, IgA, IgM, and T lymphocyte subpopulation

Mao 2009 [31]2002 international 10045 to 7510/90Xuefu Zhuyu oral liquid and control interventionTransfer factor capsule and symptomatic support3NoResponse rate and adverse effect

Lu 2009 [32]2002 international and TCM diagnosis [11]5842.6 4/54Shengjin granulesHydroxychloroquine3NoResponse rate, symptom score, salivary flow rate, amount of tear secretion, ESR, CRP, TNF-α, ICAM-1, IgG, IgA, IgM, and adverse effect

Lian 2009 [33]2002 international and TCM diagnosis [11]4052.1 FemaleShengjin Runzao granulesPlacebo1.5NoResponse rate, improvement of symptoms and signs, ESR, IgG, RF, and adverse effect

Huang 2009 [34]2002 international 5829 to 685/53Yiqi Yangyin Huoxue formula and control interventionAnethol trithlone tablets1NoResponse rate and adverse effect

Gao 2009 [35]2002 international 12630 to 7811/115Xuefu Zhuyu oral liquid and control interventionTransfer factor capsule and symptomatic support3NoResponse rate

Liu 2009 [36]1992 Europe 6041.33/39.954/56Maiwei Dihuang decoction Artificial tear, bromohexine hydrochloride3No Response rate, symptom score, ESR, ALT, AST, IgG, IgA, IgM, RF, anti-SSA, anti-SSB, SIL-2R, and amount of tear secretion

Zhong 2008 [37]2002 international 25637.0 26/230Chaihu Tongluo capsule, placebo of prednisone and methotrexatePrednisone acetate, methotrexate, and placebo of Chaihu Tongluo capsule3NoResponse rate, salivary flow rate, amount of tear secretion, ESR, CRP, A/G, Tb, IgG, IgA, IgM, and adverse effect

Feng 2008 [38]2002 international 7847.4 FemaleTotal glycosides of paeony and control interventionMethotrexate9YesResponse rate, amount of tear secretion, sugar-melt test, ESR, γ-globulin, and adverse effect

Lv 2008 [39]2002 international 12443.6 16/108Jinyuan decoctionBrombexine and symptomatic support3NoResponse rate, T lymphocytes (NK cells, CD3, CD4, CD8), IgG, IgA, IgM, and adverse effect

Han 2008 [40]2002 international 5832.6 5/53Xuanfei Bujin particleBrombexine3NoResponse rate, amount of tear secretion, corneal staining test, BUT test, β2-M, sICAM-1, sIL-2R, ESR, IgG, IgA, IgM, and improvement of symptoms

Wu 2007 [41]Guidelines of China [1]4255.0 8/34Maiwei Dihuang decoction and control interventionBrombexine, thymopeptide and symptomatic support2NoResponse rate and improvement of symptoms

Yan 2007 [42]NA56Median: 55.2/53.66/50Jiawei Shengmai drink and control interventionsymptomatic support4NoResponse rate

Sun 2007 [43]2002 international 12444.9 16/108Qingli Shutong formula and control interventionBrombexine and symptomatic support3NoResponse rate and salivary flow rate

Shen 2007 [44]NA2060 to 70FemaleHydrocortisone injection and compound glycyrrhizin injectionHydrocortisone injection and diammonium glycyrrhizinate injection 2 to 3YesResponse rate and adverse effect

Mao 2007 [45]1992 Europe 4053.1 4/36Yiqi Jianpi decoctionPrednisone3NoResponse rate, symptom score, amount of tear secretion, salivary flow rate, sugar-melt test, ESR, CRP, RF

Li 2007 [46]2002 international 6847.3 7/61Compound glycyrrhizin injection and control interventionHydroxychloroquine, brombexine, and symptomatic support1NoResponse rate, amount of tear secretion, tear break-up time, salary flow rate, β2-M, ESR, RF, IgA, IgG, IgM, and adverse effect

Zhou 2006 [47]2002 international 60Median: 50/46.255/55Qingzao Jiedu Yangyin Runzao formulaPrednisone and symptomatic support3NoResponse rate, amount of tear secretion, salivary flow rate, sugar-melt test, IgG, and adverse effect

Zhou 2006 [48]2002 international 4555.0 11/34Dandi Qiongyu granules and control intervention Brombexine, anethol trithione, thymopeptide, and symptomatic support2NoResponse rate and symptom score

Shen 2006 [49] Feng 1999 [50]6052.8 4/56Runzao oral liquid and control interventionBromhexine and symptomatic support3YesResponse 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 [51]1992 Europe 4033.4 1/39Jianpi Huashi Qingre formula and control interventionPrednisone and symptomatic support1NoResponse rate, ESR, CRP, IgG, IgA, IgM, and improvement of symptoms and adverse effect

Chen 2006 [52]1992 Europe 6052.8 5/55Suangan Shengjin formula Prednisone6NoResponse rate, RF, and ESR

Yang 2005 [53] Feng 1999 [50]8441.5 3/81Yangyin Shengjin formula and acupunctureMethotrexate3NoResponse rate, amount of tear secretion, salivary flow rate, ESR, CRP, and IgG

Si 2005 [54] TCM diagnosis of SATCM [55]5822 to 7026/32Runzao Tuiyi Mingmu decoction and auricular-plaster therapyPrednisone and symptomatic support1 to 3NoResponse rate

Liu 2005 [56]2002 international 60Median: 48.5/485/55Qingzao formulaPrednisone3NoResponse rate, improvement of symptoms, amount of tear secretion, salivary flow rate, ESR, CRP, and adverse effect

Zhao 2003 [57] Dong 1996 [22]60Median: 48/442/58Qiju Dihuang decoctionHydroxychloroquine and symptomatic supportNANoResponse rate and adverse effect

Qian 2003 [58]NA72NA5/67Jinxueyuan granulesBrombexine3NoResponse rate, improvement of symptoms, sugar-melt test, amount of tear secretion, and ESR

Li 2003 [59] Dong 1996 [22]6035 to 596/54Shengmai injection and control interventionSymptomatic support0.5NoAmount of tear secretion, salivary flow rate, and adverse effect

Wu 2002 [60] Dong 1996 [22]40Median: 564/36Ziyin Huoxue formula and control interventionThymosin and symptomatic support2NoResponse rate, salivary flow rate and amount of tear secretion

Shen 2002 [61]Feng et al. 1999 [50]6052.9 5/55Liuwei Dihuang decoction, Zengye decoction, and symptomatic supportBromhexine and symptomatic support6YesResponse rate, salivary flow rate, amount of tear secretion, sugar-melt test, tear break-up time, rose bengal staining test, lymphocytes Infiltration of a labial gland, RF, ESR, anti-SSA antibody, anti-SSB antibody, antinuclear antibody, and adverse effect

Hu 2001 [55] Manthorpe 1981 [62]15043.9 23/127Zengye mixture formulaBrombexine and thymopeptide 6NoResponse rate, symptom improvement, amount of tear secretion, sugar-melt test, FL, ESR, ANA, RF, IgG, IgA, and IgM

Wang 2000 [63]1992 Europe 4050.4 5/35Runzao mixture formulahydrochloride salt and symptomatic supportNANoResponse rate

Feng 2000 [50] Dong1996 [22]4434 to 651/43Shengjin Runzao granulesSymptomatic support1NoSalivary flow rate

Zhou 1997 [64]NA5052.0 12/38Qiju Dihuang pill or Huanglian Shangqing pill or Maiwei Dihuang pill or Shihu Yeguang pill, fresh decoction of phragmites, Glycyrrhiza, and acupunctureparasympathomimetic alkaloid and symptomatic supportNANoResponse rate

Wang 2010 [65]2002 international57UnclearUnclearYiqi Yangyin quyu formula and placebo of hydroxychloroquineHydroxychloroquine and placebo of yiqi yangyin quyu formula6NoSexual hormone, symptom improvement

Note. 2002 international : 2002 international classification of Sjögren’s syndrome proposed by the American-European Consensus Group [66]; 1992 Europe : Preliminary criteria for the classification of Sjögren’s syndrome by the European Community [67]; NA: not available.