Polyunsaturated Phosphatidylcholine (Essentiale) for Chronic Hepatitis: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

HU Guoping , LIU Kai , WANG Su , TANG Hong , ZHAO Liansan

Center of Infectious Disease; West China Hospital of Sichuan University; State Key Laboratory of Biotherapy; Chengdu 610041; China;

Corresponding author：

Keywords：

Essentiale; Polyunsaturated Phosphatidylcholine; Chronic hepatitis; Randomized controlled trials; Systematic review; Meta-analysis

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Objective 　To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for chronic hepatitis.
Methods 　We searched EMBASE (1980May,2003), MEDLINE(1966May,2003), CBM (1979May,2003), The Cochrane Library Issue 2, 2003 and handsearched 8 related Chinese journals. Randomized controlled trials(RCT) comparing PPC versus placebo/no treatment for chronic hepatitis were included with no restrictions of blinding, language and publication. Two reviewers independently performed data extraction and assessed the quality . Data were entered and analyzed by RevMan 4.2 software supplied by the Cochrane Collaboration .
Results 　Six high quality trials involving 568 patients were included. Four studies involving 451 patients showed the clinical effective rate of PPC for chronic hepatitis was 52.5% while the control group was 37.5% with statistical difference [RR1.81,95%CI(1.41,2.33),Z=4.69, P lt;0.00001].A meta-analysis involving three studies with 100 patients showed the PPC can statically improve histopathology of chronic hepatitis comparing with control group [RR 2.58,95%CI (1.61,4.15),Z=3.91,P lt;0.0001].No serious adverse events were reported.
Conclusions 　PPC is a safe medicine used for treating chronic viral hepatitis and may relieve clinical symptoms and signs.At the same time ,it has positive effect on hepatic histopathology for patients .However ,more high quality clinical trials are required.

Citation： HU Guoping,LIU Kai,WANG Su,TANG Hong,ZHAO Liansan. Polyunsaturated Phosphatidylcholine (Essentiale) for Chronic Hepatitis: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2005, 05(7): 543-548. doi: Copy

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19.	Niederau C, Strohmeyer G, Heintges T, Peter K, Gopfert E (Leich Study Group). Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double blind, placebo controlled trial[J]. Hepato-Gastroenterology, 1998; 45(21): 797-804.
20.	Llic V, Begic-Janev. The efficacy of "essential" phospholipids in the therapy of HBsAg+ chronic active hepatitis[J]. Med Welt, 1991; 41(47): 523-525.
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1. 王莉. 慢性肝炎的分类--诊断、分级、分期[J]. 国外医学: 消化系疾病分册, 1995; 15(2): 100～102.
2. 张孝秩, 贡德曼, 巫善明, 陈庆年. 复方多稀磷脂酰胆碱治疗慢性乙型活动性肝炎的随机对照双盲临床试验[J]. 药物流行病学杂志, 1995; 4(1): 4～6.
3. 中华医学会传染病与寄生虫病学分会肝病学分会. 联合修订病毒性肝炎防治方案[J]. 中华传染病杂志, 2001; 19(1): 56～62.
4. 中华肝病协会肝纤维化研究组. 肝纤维化诊断及疗效评估共识[J]. 中华肝脏病杂志, 2002; 10(5): 327.
5. 王家良, 刘鸣主编. 循证医学[M]. 北京: 人民卫生出版社, 2001; 34.
6. 王宝恩, 李俊红, 林三仁, 闵佳, 张玲霞, 李俊红. 易善复硬胶囊治疗慢性病毒性肝炎多中心、随机双盲、安慰剂对照临床试验[R].(总结报告,由安万特公司提供)2000.
7. Wang L. The classification of chronic hepatitis-diagnosis ,grade and stage[J]. Foreign Medical Sciences:(section of digestive disease), 1995; 15(2): 100-102.
8. Zhang XZ, Gunderman KJ, Wu SM, Chen QN. Therapeutic effect of polyenephosphatidylcholine compound in chronic active hepatitis B in a double-blind randomized controlled trials[J]. Chin J of Pharmacoepidemiology, 1995; 4(1): 4-6.
9. Chinese Infectious and Parasitic Diseases Association and Chinese Liver Diseases Association. The protocol of prevent and treatment of viral hepatitis[J]. Chin J of Infectious Diseases, 2001; 19(1): 56-62.
10. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis[J]. Hepatology, 1981; 1(3): 43.
11. Hepatic Fibrosis Study Group of Chinese Liver Diseases Association. Consensus on evaluation of the diagnosis and efficacy of hepatic fibrosis[J]. Chin J of hepatology, 2002; 10(5): 327.
12. Wang JL, Liu M, Chief Editor. Evidence-based medicine[M]. Peking: The people sanitary publishing company, 2001; 34.
13. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J]? Control Clin Trials, 1996; 17(34): 1-12.
14. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5): 408-412.
15. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M. Does quality of reports of randomized trials affect estimates of intervention efficacy reported in Meta-analyses[J]? Lancet,1998; 352(9128): 609-613.
16. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses[J]. Annals of Internal Medicine, 2001; 135(11) : 982-989.
17. Perter J, Jenkins BP, Portmann A.L, Eddleston W.F, Roger Williams. Use of polyunsaturated phosphatidyl choline in HBsAg negative chronic active hepatitis: results of prospective double blind controlled trial[J]. Liver, 1982; 2(3): 77-81.
18. Kordac V, Brodanova M, Marecek Z, Jirasek AP. Essentiale forte in the treatment of chronic active hepatitis[J]. Prakt Lek (Praha), 1985; 65(43): 834-837.
19. Niederau C, Strohmeyer G, Heintges T, Peter K, Gopfert E (Leich Study Group). Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double blind, placebo controlled trial[J]. Hepato-Gastroenterology, 1998; 45(21): 797-804.
20. Llic V, Begic-Janev. The efficacy of "essential" phospholipids in the therapy of HBsAg+ chronic active hepatitis[J]. Med Welt, 1991; 41(47): 523-525.
21. Wang BE, Li JH, Lin SR, Min J, Zhang LX, Li JH. The multi-central randomized double-blind controlled clinic trials of essentiale for chronic viral hepatitis[R]. (The end report ,supplied by avantis) 2000.
22. Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials[J]. N Engl J Med, 1983; 309(354): 1358-1361.

Chinese Journal of Evidence-Based Medicine

Polyunsaturated Phosphatidylcholine (Essentiale) for Chronic Hepatitis: A Systematic Review

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