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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (8): 866-870.doi: 10.3736/jcim20110808

• Original Clinical Research • Previous Articles     Next Articles

Efficacy of Chinese herbal medicine Mailuo Shutong Granule and Hirudoid cream for chronic venous disorder-induced pigmentation in lower extremities: A prospective, randomized controlled trial

Xiao-long Wei, Rui Feng(), Zhi-qing Zhao, Zai-ping Jing   

  1. Department of Vascular Surgery, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
  • Received:2011-05-10 Accepted:2011-05-31 Online:2011-08-20 Published:2011-08-15

Background: Chronic venous disorder (CVD) of the lower extremities generally induces dermatologic complications in lower extremity skin, such as hyperpigmentation. If not treated effectively, the lesions may develop into severe outcomes, including dermal ulcer or necrosis.
Objective: To evaluate the clinical efficacy of Mailuo Shutong Granule, a compound traditional Chinese herbal medicine, and Hirudoid cream (heparinoid), in treatment of patients with dermal hyperpigmentation of skin caused by CVD.
Design, setting, participants and interventions: A total of 108 CVD outpatients with pigmentation from Department of Vascular Surgery, Shanghai Changhai Hospital were randomly divided into Mailuo Shutong group, Hirudoid group and combined therapy group, with 36 patients in each group. Patients in the Mailuo Shutong group and the Hirudoid group were treated with Mailuo Shutong Granule or Hirudoid cream, respectively, while those in the combined therapy group were treated with Mailuo Shutong Granule plus Hirudoid cream. They were all treated for 28 d.
Main outcome measures: Before and after the 28-day treatment, area and average gray value of pigmentation lesions were measured and evaluated.
Results: Thirty-three cases in the Mailuo Shutong group, 34 cases in the Hirudoid group and 31 cases in the combined therapy group were included for analysis. After treatment, area of pigmentation decreased and average gray value of pigmentation declined in all the 3 groups (P<0.05). The reductions of area and average gray value in the combined therapy group were more significant than those in the Mailuo Shutong group and Hirudoid group (P<0.05). There were no differences in improvement of pigmentation between the Mailuo Shutong group and Hirudoid group (P>0.05).
Conclusion: These data suggest that both Mailuo Shutong Granule and Hirudoid cream can improve CVD-induced hyperpigmentation, and combined treatment of the two drugs results in better clinical efficacy.

Key words: venous insufficiency, skin pigmentation, hyperpigmentation, drugs, Chinese herbal, Hirudoid, prospective study, randomized controlled trial

Figure 1

Flow diagram of this randomized trial"

Table 1

Area and average gray value of pigmentation lesions before and after treatment in three groups ($\bar{x}$±s)"

Group n Area (cm2) Average gray value
Mailuo Shutong
Before treatment 33 14.9±4.1 47.1±4.2
After treatment 33 11.8±2.8*△ 37.1±6.1*△
Before treatment 34 15.1±5.1 47.8±5.1
After treatment 34 11.6±2.4*△ 38.9±5.2*△
Combined therapy
Before treatment 31 15.3±5.3 50.1±4.2
After treatment 31 8.9±2.7* 30.7±5.4*
[1] Eberhardt RT, Raffetto JD . Chronic venous insufficiency[J]. Circulation, 2005,111(18):2398-2409
doi: 10.1161/01.CIR.0000164199.72440.08
[2] Barron GS, Jacob SE, Kirsner RS . Dermatologic complications of chronic venous disease: medical management and beyond[J]. Ann Vasc Surg, 2007,21(5):652-662
doi: 10.1016/j.avsg.2007.07.002 pmid: 17823046
[3] Neglen P ; Writing Group Ⅱ of the Pacific Vascular Symposium 6, Ekl öf B, Kulwicki A, Davies A, Deschamps T, Garcia M, Gloviczki P, Labropoulos N, Nicolaides A, Partsch H, Perrin M, Rabe E, Wittens C.Prevention and treatment of venous ulcers in primary chronic venous insufficiency[J]. J Vasc Surg, 2010,52(5 Suppl):15S-20S
[4] Cesarone MR, Belcaro G, Rohdewald P, Pellegrini L, Ledda A, Vinciguerra G, Ricci A, Gizzi G, Ippolito E, Fano F, Dugall M, Acerbi G, Cacchio M, Di Renzo A, Hosoi M, Stuard S, Corsi M . Rapid relief of signs/symptoms in chronic venous microangiopathy with pycnogenol: a prospective, controlled study[J]. Angiology, 2006,57(5):569-576
doi: 10.1177/0003319706291392
[5] Ghauri AS, Nyamekye IK . Leg ulceration: the importance of treating the underlying pathophysiology[J]. Phlebology, 2010,25(Suppl 1):42-51
doi: 10.1258/phleb.2010.010s07 pmid: 20870819
[6] Allen L . Assessment and management of patients with varicose veins[J]. Nurs Stand, 2009,23(23):49-57
doi: 10.7748/ns2009. pmid: 19263906
[7] Finlayson K, Edwards H, Courtney M . The impact of psychosocial factors on adherence to compression therapy to prevent recurrence of venous leg ulcers[J]. J Clin Nurs, 2010,19(9-10):1289-1297
doi: 10.1111/jcn.2010.19.issue-9-10
[8] Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL . Venous severity scoring: An adjunct to venous outcome assessment[J]. J Vasc Surg, 2000,31(6):1307-1312
doi: 10.1016/S0741-5214(00)90143-5 pmid: 10842165
[9] Meissner MH, Natiello C, Nicholls SC . Performance characteristics of the venous clinical severity score[J]. J Vasc Surg, 2002,36(5):889-895
doi: 10.1067/mva.2002.128637 pmid: 12422097
[10] Bergan JJ, Pascarella L, Schmid-Schönbein GW . Pathogenesis of primary chronic venous disease: Insights from animal models of venous hypertension[J]. J Vasc Surg, 2008,47(1):183-192
doi: 10.1016/j.jvs.2007.09.028
[11] Jünger M, Steins A, Hahn M, Häfner HM . Microcirculatory dysfunction in chronic venous insufficiency(CVI)[J]. Microcirculation, 2000,7(6 Pt 2):S3-S12
doi: 10.1111/j.1549-8719.2000.tb00145.x pmid: 11151969
[12] Tian N, Li YZ, Liu YY . Research on the microcirculation of blood-stasis syndrome[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2001,21(4):248-251
田牛, 李玉珍, 刘育英 . 血瘀证的微循环研究[J]. 中国中西医结合杂志, 2001,21(4):248-251
[13] Wang YN, Dai X, Liu M, Zhang M . Distribution rules of syndrome essential in lower extremity deep venous thrombosis[J]. Zhongguo Zhong Xi Yi Jie He Wai Ke Za Zhi, 2010,16(4):409-411
王雁南, 戴霞, 刘明, 张明 . 下肢深静脉血栓形成的证候要素研究[J]. 中国中西医结合外科杂志, 2010,16(4):409-411
[14] Wang HZ . Clinical observation of Chinese medicine treatment of deep vein thrombosis[J]. Zhong Yi Xue Bao, 2010,25(5):979-980
王慧真 . 中医药治疗下肢深静脉血栓形成临床观察[J]. 中医学报, 2010,25(5):979-980
[15] Hou LC, Song W . Treatment with Mailuo Shutong for deep venous thrombosis in lower extremity: a report of 354 cases[J]. Liaoning Zhong Yi Za Zhi, 2004,31(8):674
doi: 10.3969/j.issn.1000-1719.2004.08.038
侯连成, 宋薇 . 脉络舒通治疗下肢深部静脉血栓354例[J]. 辽宁中医杂志, 2004,31(8):674
doi: 10.3969/j.issn.1000-1719.2004.08.038
[16] Kumokawa T, Hirata K, Sato K, Kano S . Dermal absorption of mucopolysaccharide polysulfate(heparinoid) in human and minipig[J]. Arzneimittelforschung, 2011,61(2):85-91
doi: 10.1055/s-0031-1296172 pmid: 21428242
[17] Elling H . Immunofluorescence demonstration of transdermal deposition of mucopolysaccharides into the skin[J]. Arzneimittelforschung, 1987,37(7):816-818
[18] Kuisma I, Tamelander G . Mucopolysaccharide polysulphate cream in the prevention of pressure sores — a double blind study[J]. Ann Clin Res, 1987,19(6):374-377
[19] Bergqvist D, Brunkwall J, Jensen N, Persson NH . Treatment of superficial thrombophlebitis. A comparative trial between placebo, Hirudoid cream and piroxicam gel[J]. Ann Chir Gynaecol, 1990,79(2):92-96
[20] Tang HL, Zhai SD . Hirudoid for microcirculation disorder: a systematic review[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2010,10(8):946-951
唐惠林, 翟所迪 . 喜辽妥软膏防治微血管循环障碍效果的系统评价[J]. 中国循证医学杂志, 2010,10(8):946-951
[21] Vecchio C, Frisinghelli A . Topically applied heparins for the treatment of vascular disorders: a comprehensive review[J]. Clin Drug Investig, 2008,28(10):603-614
doi: 10.2165/00044011-200828100-00001 pmid: 18783299
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