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Effect of Traditional Chinese Medicine on Chronic

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    REVIEW

    Effect of Traditional Chinese Medicine on Chronic Prostatitis:

    a Systematic Review of Randomized Controlled Trials*

    Jiaxu Chen??, Lisheng Hu

    Abstract: To systematically evaluate the effectiveness of Chinese herbal drugs on CPT, We searched electronic medical database from China National Knowledge Infrastructure (CNKI), language restriction is Chinese, and date is from 1994-01-01 to 2002-12-31. A total of 108 trials were found. All studies with words like "randomization or quasi-randomization" in their abstracts were included, whether they used blind or not. 19 of these met the entry criteria were downloaded and fully printed. Because All 19 articles were the clinical trials with low quality (Jadad Score<3) in which all the four groups of clinical trials could not provide evidences of EBM A class (including 1a, 1b, 1c level), they could not be used to prove that the treating group is superior to the control group. But the result indicates that Chinese herbal drugs with special efficacy might have a bright medicinal prospect in treating CPT, which deserves a good design of multi-centered, randomized, parallel-controlled and double blinding trials to provide the best EBM evidences (A class A level).

    Key words: randomized controlled trials; prostatitis; Chinese herbal drugs

    Chronic prostatitis (CPT) is a commonly encountered disease with high mobility, which holds 20-30% of the incidence of urinary system and is frequently seen in man of 20~40 years old. It is also a disease with frequent recurrence and a cause of male sterility. Western therapies are not ideal to CPT, while Chinese herbal drugs perform well in treating and relieving this disease.

    1. Oral Chinese herbal therapy

    1.1 Treatment based on Syndrome differentiation

    Seven Syndromes: blood stasis caused by obstruction of dampness, blood stasis due to Qi-stagnation, downward flow of damp-heat, blood stasis caused by Qi-deficiency accompanied by toxins, obstruction of blood stasis due to damp-heat, lingering of evil due to insufficient vital-Qi and the kidney deficiency.

    1.2 Therapy of add-subtract of basic traditional prescriptions (organized by the authors)

    Medicines in treating groups: Daoshihuoxue decoction, Taohechengqi decoction, Sheshecheling decoction, Jingzhuo decoction, Shuangze decoction, method of relieving swelling by treating stranguria; Yishenqingyu decoction, methods like soothing liver to resolve dampness and promoting the blood circulation to resolve blood stasis. Medicines in control groups: only some groups had control medicines like Qianliekang tablet and cinrofloxacin.

    1.3 Special prescription and Herbs (organized by the authors)

    Medicines in treating groups: Zhiqian decoction, Qianlieqing granule, Qianliexiankangfu capsule, Qianliehuichun capsule, Qianliexianyan 3 capsule, Jinpu decoction, Qianliexian pill, Xiansheqianlieshu, Fukeqianjin tablet, Zijin capsule, Qianlie pill, Tonglieshu capsule, Qianlieqing granule compound Zonglvgen powder, Niaodaoqing granule, Feilinqing decoction, Qianlie 1 capsule, Lingyilianqiao decoction and Shireqing oral liquid. Medicines in control groups: Only part of the groups had control medicines, like non-Qianliekang tablet, cinrofloxacin, Nanbikang granule, Nankang tablet, erythromycin, Qianliekang capsule, cephalexin, norfloxacin and minocycline.

    2. Therapy of external Chinese medicine (organized by the authors)

    Drugs in treating groups: Qianliening 2 liquor, Ye'ai suppository, Radix Astragali (Huangqi), Radix Aconiti praeparata (Fuzi), Rhizoma Chuanxiong (Chuanxiong), Radix et Rhizoma Rhei (Dahuang), Cortex Phellodendri (Huangbai), Semen Strychni (Maqianzi), Borneolum Syntheticum (Bingpian), mixed with 75% alcohol; Radix Gentianae (Longdancao), Semen Plantaginis (Cheqianzi), Cortex Cinnamoni (Rougui), Cortex Phellodendri (Huangbai), Rhizoma Zingiberis Repens (Shengjiang), Rhizoma Zedoariae (Ezhu), Rhizoma Sparganii (Sanleng), Radix Bupleuri (Chaihu), Radix Sophorae Flavescentis(Kushen), Radix Linderae (Wuyao), Radix Angelicae Sinensis (Danggui), Fructus Evodiae (Wuzhuyu), Fructus Foeniculi (Xiaohuixiang), Fructus Kochiae (Difuzi), bran(Fupi), with vinegar; Raw Radix et Rhizoma Rhei (Dahuang), Flos Carthami (Honghua), Rhizoma Atractylodis (Cangzhu), Cortex Phellodendri (Huangbai), Fructus Gardeniae (Zhizi), Radix Sophorae Flavescentis (Kushen), Radix Scutellariae (Huangqin), Herba Taraxaci (Pugongying), Radix Paeoniae Rubra (Chishao), Fructus Cnidii (Shechuangzi), Folium et Caulis Perillae liquor (Zisu liquor), Indigo Naturalis (Qingdai), Borneolum Syntheticum (Bingpian), Ginger juice (Jiangzhi); Radix Arnebiae seu Lithospermi (Zicao), Cortex Phellodendri (Huangbai), Herba Houttuyniae (Yuxingcao), Rhizoma Coptidis (Huanglian), Caulis Lonicerae (Rendongteng), Semen Persicae (Taoren), Radix Angelicae Sinensis (Danggui); Rhizoma Coptidis (Huanglian), Cortex Phellodendri (Huangbai), Radix et Rhizoma Rhei (Dahuang), Caulis Sargentodoxae (Hongteng), Herba Patriniae (Baijiangcao), Squama Manitis (Chuanshanjia), Resina Olibani (Ruxiang), Myrrha (Moyao), Herba Asari (Xixin), Fructus Foeniculi (Xiaohuixiang), Galla Chinese (Wupeizi). Drugs in Control Groups: only a few groups used control medicines like rifadin and norfloxacin.

    3. Therapy of using oral and external Chinese herbal drugs together (organized by the authors)

    In treating groups: Longzhuhuayulishi decoction: take the decoction orally, and then decoct the gruffs to provide a hip bath. Qianlie decoction: take the decoction orally£¬then the gruffs were decocted to provide a hip bath. Qingjian decoction: take the decoction orally£¬then use the third time decoction for pudendal fumigation. Wucaoliuwei decoction: take the decoction orally; use the fourth time decoction for a hip bath each night. In control groups: only a few control groups had contrast medicines, for example Huqian tablet.

    4. Integrated therapy of western medicine and Chinese herbal medicine (prescriptions were all organized by the authors)

    Add-subtract of the basic traditional prescriptions, rifadin, hibitane, norfloxacin, metronidazole, minocycline or gluconic zinc. Manqianlie decoctionm, Sparfloxacin, Bazheng powder, Zengxiaolianhuang tablet. Types of syndrome differentiation (accumulation of damp-heat, blood stasis due to Qi stagnation, fire flaming up due to Yin deficiency and deficiency and damage of kidney Yang) were treated with Chinese herbal drugs and norfloxacin.

    What kind of therapeutic efficacy do all the above Chinese herbal drugs have in treating CPT? How forceful are the efficacies? These clinical problems are to be resolved urgently. Our objective is to assess the therapeutic effect of Chinese herbal drugs on CPT.

    METHODS

    1. Search strategy for identification of study

    Electronic search: database is China National Knowledge Infrastructure (CNKI); language restriction is Chinese; date is from 1994-01-01 to 2002-12-31.

    Key words combination: chronic prostatitis and Chinese herbal drugs.

    A total of 108 trials were found.

    2. Criteria for considering studies of this review

    All studies with words like "randomization or quasi-randomization" in their abstracts were included, whether they used blinding or not. 19 of theses met the entry criteria were downloaded and fully printed.

    3. Collection and analysis of data

    All the reports included were screened by the reviewers' critical appraisal: the study qualities like random-allocation and allocation concealment, conducting of double blind, handling of lost cases and follow-up were assessed by Jadad score. RevMan4.1 conducted the heterogeneity test, Meta-analysis and the funnel plot analysis.

    RESULTS

    1. Design characteristics and quality assessment of randomized control trial or quasi-randomized control trial of Chinese herbal therapy in CPT (Table 1)

    All 19 articles that met the entry criteria were clinical trial studies with low quality (Jadad score<3). 10 of the 19 studies divided the patients into two groups according to the sequential number (this method is called quasi-randomization, Jadad score=0). 9 just contained words like "randomly divided into two groups" (Jadad score=1). Only 1 article contained words "double blind" (Jadad score=1), while other 18 were single blind or non-blind trials (Jadad score=0). In all 19 trials, the number of lost cases (e.g.: dropouts, withdrawals or protocol deviations) and the reasons were not reported (Jadad score=0), and none of the above studies applied intention-to-treat (ITT) analysis. And among the studies, only 1 reported the time of follow-up. All the articles with "randomly divided into two groups" in their abstracts didn't report the concealment measures of randomized allocation, and none reported the calculating basis of sample size.

    Table 1. Design characteristics of randomized control trials or quasi-randomized control trials

    of Chinese herbal drugs therapy in CPT

    NameNumberAgeSexJadad MedicineMedicinesTreatmentFollow-up

    of Trialof Cases(Y)Scorein treatingin controldurationafter

    (D)treatment (D)

    Zhang,12534.51?3.31M0Chinese herbal drugsCinrofloxacin300

    199936.34?4.36taken orally

    Li, et al.7721~65M0Chinese herbal drugsNorfloxacin 300

    1999taken orally

    Cai, et al.8022~67M0Chinese herbal drugsCinrofloxacin300

    2000taken orally

    Gao, et al.15521~54M1Chinese herbal drugsRifadin,270

    199920~51applied externallyNorfloxacin

    Jiang,8821~58M1Chinese herbal drugsMinocycline,33 0

    et al. 200219~53applied externallyQianliekang

    Sun, et al.24020~54M0Chinese herbal drugsOfloxacin200

    200219~48applied externally

    Wu, et al.18621~56M0Chinese herbal drugsNorfloxacin40~800

    200123~62applied externallyor Ofloxacin51

    Jiang,7321~62M1Chinese herbal drugs both Qianliekang300

    2001orally and externallyor Ofloxacin

    Wu, et al.9618~53M1Chinese herbal drugs both Levofloxacin30 0

    200219~55orally and externally

    Xiao, et al.9121~65M1Chinese herbal drugs both Cinrofloxacin560

    200121~51orally and externally

    Yuan, et al. 12020~71M2Chinese herbal drugs both Quinolone 90 0

    2000 orally and externally Cephaloridine,Macrolides,Aminoglycoside,Sulfanilamide,Dexamethason,Shiyanda

    Chen, et al.50022~46M1Chinese herbal drugs both Antibiotics300

    2002 orally and externally (the name not

    reported)

    Wang, et al.10016~52M1Integrated WM: Microwave therapy 30 0

    1999 Chinese herbal drugs and

    microwave therapy

    Su, 19996822~48M1Integrated WM:Minocycline140

    Chinese herbal drugs and

    Minocycline

    Zhou,12437.5M0Integrated WM:Prostatic massage 21 0

    2000 ion-introduction therapy by machine, plus

    of Chinese herbal drugs Norfloxacin, Bactrim

    into rectum, plus

    Norfloxacin, Bactrim

    Wang, et al.7025~58M0Integrated WM: Roxithromycin, 90~100 365

    200124~60Chinese herbal drugs and plus ultrashort wave

    ultrashort wave massage to prostate

    massage to prostate

    Han, 200111519~50M0Integrated WM:Bactrim, Metronidazole45 0

    Chinese herbal drugs and radio

    frequency therapy

    He, et al.9018~40M0Integrated WM:Microwave radiation20 0

    2001 Clysis with Chinese herbal drugs,and microwave radiation

    Zheng, et al.8218~60M1Integrated WM: Minocycline300

    200217~43Chinese herbal drugs taken orally,and microwave radiation

    WM: western medicine

    2. Therapeutic efficacy of Chinese herbal drugs on CPT (Table 2)

    In the groups of taking Chinese herbal drugs orally (based on typing of syndrome differentiation), 2 of the 3 articles, whose 95% CI of OR included 1, which is not an evidence to show that the former one was superior to the latter one. The only one article's 95% CI of OR between 3.36 and 40.12 was too wide, which indicated sampling error of each sample to its ejusdem generic population was too large (for standard error is too large).

    As to the groups dealt with Chinese herbal drugs externally, in 3 of the 4 trials' 95%CI of OR were too wide, which indicated a greater sampling error.

    As to the groups applied integrated therapy of using Chinese herbal drugs both orally and externally, 1 of the 5 trials' 95% CI of OR included 1, which couldn't show that the former one was superior to the latter one. Other 4 trials' 95% CI of OR was too wide, which demonstrated a greater sampling error.

    In the groups of using integrated therapy of Chinese herbal medicine and western medicine, 2 of 7 studies' 95% CI of OR included 1, which couldn't show that the former one was superior to the latter one. 4 of the other 5 trials' 95% CI of OR were too wide, which demonstrated a greater sampling error.

    Table 2. Therapeutic efficacy of Chinese herbal drugs on CPT

    Chinese medicinesWM,Relative Benefits:P valueReference

    (Including Integrated WM)Control Group OR (95%CI)of test ofincluded

    treating group, n / Nn / N(Recalculated By Reviewers)hypothesis

    Chinese herbal drugs 142 / 180 54 / 102 3.27(1.92, 5.57) Z=4.36

    Taken orally (WQSFEM) P=0.00001

    Chinese herbal drugs

    Taken orally (BOSD) 68 / 87 24 / 38 2.09 (0.91, 4.80) <0.05£¬But Zhang,95% CI included 1 1999

    Chinese herbal drugs 41 / 45 15 / 32 11.62 (3.36, 40.12) No P value£¬ Li, et al.

    Taken orally (BOSD) no cross of Ridit 95% CI 1999

    Chinese herbal drugs 33 / 48 15 / 32 2.49 (0.99, 6.28) <0.05£¬but Cai, et al.

    Taken orally (BOSD) 95% CI included 1 2000

    Chinese herbal drugs 409 / 442 156 / 224 5.63 (3.50, 9.06) Z=7.12

    Applied externally (WQSFEM) P<0.00001

    Chinese herbal drugs 76 / 81 43 / 74 10.96 (3.97, 30.27) <0.01 Gao, et al.

    Applied externally (UC) 1999

    Chinese herbal drugs 54 / 58 23 / 30 4.11 (1.10, 15.41) <0.05 Jiang, et al.

    Applied externally (RE) 2002

    Chinese herbal drugs 160 / 180 42 / 60 3.43 (1.67, 7.06) <0.01 Sun, et al.

    Applied externally (RE) 2002

    Chinese herbal drugs 119 / 123 48 / 60 7.44 (2.28, 24.21) <0.01 Wu, et al.

    Applied externally (Pr) 2001

    Chinese herbal drugs 470 / 494 295 / 387 5.88 (3.67, 9.42) Z=7.37

    both orally and externally (WQSFEM) P<0.0001

    Chinese herbal drugs 46 / 48 17 / 25 10.82 (2.09, 56.15) <0.01 Jiang,both orally and externally 2001

    Chinese herbal drugs 58/ 60 31 / 36 4.68 (0.86, 25.52) <0.05, but Wu, et al.

    both orally and externally 95% CI included 1 2002

    Chinese herbal drugs 45 / 46 26 / 45 32.88 (4.16, 260.10) <0.01 Xiao, et al.

    both orally and externally 2001

    Chinese herbal drugs 55 / 60 44 / 61 4.25 (1.45, 12.43) <0.05 Yuan, et al.

    both orally and externally 2000

    Chinese herbal drugs 266 / 280 177 / 220 4.62 (2.45, 8.69) <0.01 Chen, et al.

    both orally and externally 2002

    Integrated WM: 347 / 377 195 / 272 4.57 (2.88, 7.26) Z=6.45

    (WQSFEM) P<0.00001

    Chinese herbal drugs 42 / 50 36 / 50 2.04 (0.77, 5.42) <0.01, but Wang, et al.

    and microwave therapy 95% CI included 1 1999

    Chinese herbal drugs 29 / 34 20 / 34 4.06 (1.26, 13.07) <0.05 Su,and Minocycline 1999

    Ion-introduction 61 / 64 54 / 60 2.26 (0.54, 9.47) <0.01, but Zhou,therapy of Chinese herbal drugs into rectum, plus WM 95% CI included 1 2000

    Chinese herbal drugs 34 / 35 26 / 35 11.77 (1.40, 98.86) <0.01 Wang, et al.

    and ultrashort wave 2001

    massage to prostate

    Chinese herbal drugs 82 / 85 17 / 30 20.90 (5.37, 81.42) <0.01 Han,and radio frequency therapy 2001

    Clysis with Chinese 54 / 60 19 / 30 5.21 (1.69, 16.03) <0.05 He, et al.

    herbal drugs, and microwave radiation 2002

    Chinese herbal drugs 45 / 49 23 / 33 4.89 (1.38, 17.31) <0.01 Zheng, et al.

    taken orally, and microwave radiation 2002

    WM: western medicine; WQSFEM: weighted quantitative synthesization of fixed effective model; BOSD: Based on syndrome differentiation; UC: Umbilicus compress; RE: Retention enema; Pr: Proctoclysis

    3. Meta analysis

    3.1 Weighted quantitative synthesization of groups taking Chinese herbal drugs orally in comparison with groups of western medicine

    Because of the heterogeneity Chi-square=5.47, df =2, p=0.065>0.05; it could be deduced that at the test level of ¦Á=0.05, the homogeneity hypothesis would not be refused. So the fixed effective model should be selected to perform weighted quantitative synthesization. Peto OR=3.27 (i.e., the effective ratio of the treating group is 3.27 times higher than that of the control group) (95% CI, 1.92~5.57, 1 was not included), since the trials met the inclusion criteria were evaluated as with low study qualities, it couldn't prove powerfully that the efficacy of the treating groups was superior to that of the control groups.

    3.2 Weighted quantitative synthesization of groups using Chinese herbal drugs externally in comparison with that of western medicine

    Because of the heterogeneity Chi-square=3.90, df =3, p=0.27>0.05; it could be deduced that at the test level of ¦Á=0.05, the homogeneity hypothesis would not be refused. So the fixed effective model should be selected to perform weighted quantitative synthesization. Peto OR=5.63 (i.e., the effective ratio of the treating group is 5.63 times higher than that of the control group) (95% CI, 3.50~9.06, 1 was not included), since the trials met the inclusion criteria were evaluated as with low study qualities, it couldn't prove convincingly that the efficacy of the treating group was superior to that of the control group.

    3.3 Weighted quantitative synthesization of groups using Chinese herbal drugs orally and externally in comparison with that of western medicine

    Because of the heterogeneity Chi-square=4.17, df =4, p=0.38>0.05; it could be deduced that at the test level of ¦Á=0.05, the homogeneity hypothesis would not be refused. So the fixed effective model should be selected to perform weighted quantitative synthesization. Peto OR=5.88 (i.e., the effective ratio of the treating group is 5.88 times higher than that of the control group) (95% CI, 3.67~9.42, 1 was not included), since the trials met the inclusion criteria were evaluated as with low study qualities, it couldn't prove effectively that the efficacy of treating group was superior to that of control group.

    3.4 Weighted quantitative synthesization of groups using Chinese herbal drugs and western medicine in comparison with that of western medicine

    Because of the heterogeneity Chi-square=9.21, df =6, p=0.16>0.05; it could be deduced that at the test level of ¦Á=0.05, the homogeneity hypothesis would not be refused. So the fixed effective model should be selected to perform weighted quantitative synthesization. Peto OR=4.57 (i.e., the effective ratio of the treating group is 4.57 times higher than that of the control group) (95% CI, 2.88~7.26, 1 was not included), since the trials met the inclusion criteria were evaluated as with low study qualities, it couldn't prove effectively that the efficacy of treating group was superior to that of control group.

    4. Funnel plot analysis

    Results of the funnel plots analysis of oral Chinese herbal drugs group, external Chinese herbal drugs group, a combination of oral Chinese herbal drugs and external Chinese herbal drugs group and a combination of Chinese herbal drugs and western medicine group: abscissa was OR, while y-axis was Se (log OR) of each sample, to express sampling error (finite population is the sample size of congeneric study that was brought into combination analysis). If the publication bias was negative, then the distribution of all points had a symmetrical shape like a funnel. All the four groups of clinical trials that met the inclusion criteria in this systematic review were distant asymmetrical and irregular plots (be omitted), which indicated a positive publication bias might exist. Now, it is said that an asymmetrical funnel plot is not a necessary requirement in telling the publication bias.

    DISCUSSION

    All the four groups of clinical trials met the inclusion criteria in this systematic review (19 trials totally) were low quality in all the trials evaluated by reviewers, for they couldn't provide evidences of EBM A class (including 1a, 1b and 1c level), which could be used to prove that the treating groups is superior to the control groups. But it indicates that Chinese herbal drugs might have a bright medicinal prospect with special efficacy in treating CPT. That deserves good design of multi-centered, randomized, parallel-controlled and double blind trials to make further retest, which aims to provide best EBM evidences (A class A level). So the authors (Chen, et al., 2001) suggested that the efficacy of TCM should be seriously evaluated according to the principle of evidence-based medicine, although its abundant clinical experiences especially case report have been repeated and lasted for thousands of years.

    ACKNOWLEDGEMENT

    We wish to thank Hong Mei for her kindly help and Els Van den Hewvel for her revising the English grammar and words.

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    (Edited by Yanling Xiao, Lian Hu, Xiaoman Ling and Yingqi Zhao)

    * Supported by the Teaching and Research Award Program for Outstanding Young Teachers in Higher Education Institutions of MOE, P. R.China, and Fok Ying Tong Education Foundation (No. 81037)

    ?? Corresponding to Jiaxu Chen, male, MD, PhD, research scholar at Harbor-UCLA, USA; Address: Box 83, School of Pre-clinical Medicine, Beijing University of Traditional Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, Beijing, Postcode: 100029; Tel: 010-64287074; Fax: 010-64286871; E-mail: chenjiaxu@hotmail.com

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