清热利湿类中药复方治疗慢性前列腺炎的系统评价

目的:评价清热利湿类中药复方治疗慢性前列腺炎的疗效和安全性。方法:制定高敏感检索策略,全面检索截止2006年6月清热利湿类中药复方治疗慢性前列腺炎的临床对照研究文献,运用改良后Jadad量表评价纳入文献的方法学质量并提取有效数据进行Meta分析,用RevMan4.2软件完成统计和系统评价。结果:共44篇文献包含5746例患者符合纳入标准。3篇被评为高质量,其余为低质量。Meta分析表明,清热利湿类中药复方优于男康片(RR1.22,95%CI1.10~1.35)、舍尼通(RR1.26,95%CI1.13~1.41);亚组分析显示,该类复方优于前列康(RR1.32,95%CI1.19~1.45)、喹诺酮类抗生素(RR1.34,95%CI1.15~1.57);清热利湿中药对照α受体阻滞剂、普乐安片,以及清热利湿中药与合用喹诺酮类抗生素对照单用该类抗生素比较差异无显著性(P<0.01)。18篇文献报道了不良事件的结局,未见严重不良反应的报道。结论:清热利湿类中药复方在改善慢性前列腺炎症状或体征、生活质量、前列腺液指标等可能优于男康片、舍尼通、前列康和喹诺酮类抗生素。然而,由于现有试验的方法学质量普遍较低且该类复方使用的变异性大,目前尚无足够证据支持其治疗应用,需更多高质量的随机对照试验。     

Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia

PURPOSE: We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo controlled trial. MATERIALS AND METHODS: We randomized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo. End points included routine clinical measures (symptom score, uroflowmetry and post-void residual urine volume), blood chemistry studies (prostate specific antigen, sex hormones and multiphasic analysis), prostate volumetrics by magnetic resonance imaging, and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies. RESULTS: Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group (not statistically significant). Neither prostate specific antigen nor prostate volume changed from baseline. Prostate epithelial contraction was noted, especially in the transition zone, where percent epithelium decreased from 17.8% at baseline to 10.7% after 6 months of saw palmetto herbal blend (p <0.01). Histological studies showed that the percent of atrophic glands increased from 25. 2% to 40.9% after treatment with saw palmetto herbal blend (p <0.01). The mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis, cellular proliferation, angiogenesis, growth factors or androgen receptor expression. We noted no adverse effects of saw palmetto herbal blend. When the study was no longer blinded, 41 men elected to continue therapy in an open label extension. CONCLUSIONS: Saw palmetto herbal blend appears to be a safe, highly desirable option for men with moderately symptomatic BPH. The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo (not statistically significant). However, saw palmetto herbal blend therapy was associated with epithelial contraction, especially in the transition zone (p <0.01), indicating a possible mechanism of action underlying the clinical significance detected in other studies.     

The placebo effect and randomized trials: analysis of conventional medicine

Randomized controlled trials are generally regarded as the gold standard of study designs to determine causality. The inclusion of a placebo group in these trials, when appropriate, is critical to access the efficacy of a drug or supplement. The placebo response itself has received some attention in the medical literature over the past fifty years. The recent increasing utilization of dietary supplements and herbal medications by patients makes it imperative to reevaluate the placebo response in conventional and alternative medicine. This article will review a whole series of unique conditions (allergies/asthma, alopecia, BPH, erectile dysfunction, osteoporosis, weight loss...) and the placebo response associated with them from conventional medical randomized trials.     

Benign prostatic hyperplasia treated with saw palmetto: a literature search and an experimental case study

European physicians treat benign prostatic hyperplasia (BPH) with saw palmetto extract (SPE), while American physicians generally disregard SPE because "research is lacking." The authors investigated this discrepancy with a literature search and a clinical trial. The literature search began with MEDLINE, then expanded to "alternative" databases, including AGRICOLA, EMBASE, IBIS, and Cochrane, plus a manual search of unindexed herbal journals. The clinical trial was an experimental case study in which a 67-year-old man with symptomatic BPH was randomly administered SPE (160 mg standardized extract twice daily) or placebo. Outcome measures included the American Urological Association Symptom Index (AUASI), serum prostate-specific antigen, and prostate volume. Our expanded literature search revealed 58 clinical trials, whereas MEDLINE yielded only 19 clinical trials, or 33% of the total. Our clinical trial measured a baseline AUASI score of 20, which improved to 7 after unblinded administration of SPE. Subsequent double-blinded placebo produced a score of 14, and final single-blinded allotment of SPE produced a score of 11. Prostate-specific antigen was 10.3 ng/mL at baseline and 10.7 ng/mL at trial's conclusion. Baseline prostatic volume was 92 mL, and end volume was 75 mL. In conclusion, MEDLINE proved inadequate as a stand-alone search engine for locating information about an herbal medicine. Our experimental case study, similar to N = 1 research methodology, proved suitable for clinical evaluation of an herbal medicine in a rural private practice. SPE improved the patient's BPH. Unstandardized look-alike herbs may act as nontherapeutic placebos and may undermine consumer confidence in herbal medicine.     

The relative efficacy of terazosin versus terazosin and flutamide for the treatment of symptomatic BPH.

Pharmacotherapy for the treatment of BPH is currently being targeted to relax prostate smooth muscle (alpha blockade) and decrease prostate volume (androgen suppression). The objective of the present study was to determine the relative efficacy of terazosin vs. terazosin and flutamide (combination therapy) for the treatment of symptomatic BPH. Twenty-nine males with symptomatic BPH were enrolled into this 6-month open label study. The entry criteria included peak urinary flow rate between 4-15 ml/sec, a total Boyarsky symptom score greater than 7, and postvoid residual less than 300 ml. The daily dosage of terazosin was titrated to 5 mg over a 2-week interval. A 750 mg daily dosage of flutamide was added following 1 month of terazosin monotherapy. The dosages were lowered if significant adverse events developed. Efficacy assessments were performed at 1 month (terazosin alone), 6 months (combination therapy), or at the time of early withdrawal from the study. The efficacy of combination therapy was evaluable in 24 patients receiving combination therapy. At one month, the mean peak urinary flow rate and mean total Boyarsky symptom score improved 38% and 56% relative to baseline, respectively. The present study confirmed the previously observed efficacy and safety of terazosin for BPH. The addition of flutamide did not result in statistically significant improvements in the peak urinary flow rate or total Boyarsky symptom score. The adverse events related to flutamide resulted in 16 dose reductions and 14 premature withdrawals. The role of combination therapy will require a randomized placebo controlled study sufficiently powerful to identify clinically and statistically significant improvements in objective outcome parameters relative to the monotherapies.     

Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis

We reviewed randomized controlled trials to determine the efficacy and safety of systemically administered local anesthetics compared with placebo or active drugs. Of 41 retrieved studies, 27 trials of diverse quality were included in the systematic review. Ten lidocaine and nine mexiletine trials had data suitable for meta-analysis (n = 706 patients total). Lidocaine (most commonly 5 mg/kg IV over 30-60 min) and mexiletine (median dose, 600 mg daily) were superior to placebo (weighted mean difference on a 0-100 mm pain intensity visual analog scale = -10.60; 95% confidence interval: -14.52 to -6.68; P < 0.00001) and equal to morphine, gabapentin, amitriptyline, and amantadine (weighted mean difference = -0.60; 95% confidence interval: -6.96 to 5.75) for neuropathic pain. The therapeutic benefit was more consistent for peripheral pain (trauma, diabetes) and central pain. The most common adverse effects of lidocaine and mexiletine were drowsiness, fatigue, nausea, and dizziness. The adverse event rate for systemically administered local anesthetics was more than for placebo but equivalent to morphine, amitriptyline, or gabapentin (odds ratio: 1.23; 95% confidence interval: 0.22 to 6.90). Lidocaine and mexiletine produced no major adverse events in controlled clinical trials, were superior to placebo to relieve neuropathic pain, and were as effective as other analgesics used for this condition.     

补肾清热类中药复方治疗免疫性男性不育的系统评价

目的评价补肾清热类中药复方治疗男性免疫性不育的疗效和安全性。方法制定高敏感检索策略，全面检索截止2006年7月23日补肾清热类中药复方治疗男性免疫性不育的临床研究文献，运用改良后Jadad量表评价纳入文献的方法学质量并提取有效数据进行Meta-分析，用RevMan4．2软件完成统计和系统评价。结果共10篇文献包含1625名患者符合纳入标准。均为低质量。Meta分析结果表明，在提高患者配偶妊娠率，中药复方优于强的松（RR2．47，95％CI1．45—4．21），中药复方联合强的松优于单用强的松（RR2．30，95％CI1．58—3．33）：在降低患者抗精子抗体滴度，中药优于强的松（滴度降低1／2，RR1．82，95％CI1．21-2．75）、（滴度降低1/3，RR1．29，95％CI1．05-1．59）。10篇试验中3篇报告了不良事件的结局，严重副作用有结核病和胃溃疡。结论在提高男性免疫性不育患者配偶妊娠率方面，补肾清热类中药复方可能优于强的松，中药合用强的松优于单用强的松；在降低患者抗精子抗体滴度，中药优于强的松。然而，由于现有试验的方法学质量普遍较低，且该类补肾清热类中药复方使用的变异性大，目前尚无足够证据支持其治疗应用，尚需更多高质量的临床随机对照试验。     

经尿道前列腺切除术对性功能影响的Meta分析

目的:探讨经尿道前列腺电切术(TURP)、前列腺电汽化术(TUEVP)和钬激光前列腺剜除术(Ho-LEP)治疗良性前列腺增生(BPH)对男性性功能的影响。方法:搜集比较TURP、TUEVP及HoLEP对性功能影响的随机对照研究(RCT),以Meta分析法系统比较不同术式治疗BPH对性功能的影响。结果:9个RCT研究1 050例患者纳入分析,研究基线具有可比性。TURP与TUEVP相比,对勃起功能影响较小(P=0.04),对射精功能的影响无显著差异。HoLEP和TURP在术后12个月和24个月对勃起和射精功能的影响均无显著差异。结论:TUEVP比TURP更易引起勃起功能障碍,但对射精功能的影响无明显差别;HoLEP与TURP对勃起和射精功能的影响无明显差别。     

中医药治疗慢性肾衰竭疗效的系统评价

目的：评价中医药治疗慢性肾衰竭是否有助于提高临床疗效。方法：随机对照试验系统评价;采用电子和手工检索中国生物医学文献数据库CBMdisc、中国期刊全文数据库CNKI、维普资讯中文科技期刊数据库、Pubmed数据库和国内相关中医期刊;搜集和比较中药结合西药与单纯西药治疗慢性肾衰竭的临床随机对照试验;采用Cochrance协作网Review Manager4.2进行统计分析。结果：共纳入RCTs16篇,共1305例病人,Meta-分析结果表明,中西医结合治疗对慢性肾衰竭的临床疗效比单纯西医治疗有提高作用。但是,这些研究存在许多方法学上的问题,导致分析结果可信性降低。结论：中医药治疗能提高慢性肾衰竭的临床疗效,但这需要严格设计的大样本、多中心的随机双盲对照实验和系统评价来进一步证实。     

Phytotherapy versus hormonal therapy for postmenopausal bone loss: a meta-analysis

This meta-analysis included 14 randomized controlled trials involving 780 patients to compare phytotherapy with hormonal therapy in the treatment of postmenopausal bone loss. Current evidence suggests that phytotherapy may possess a similar effect on bone mineral density (BMD) values but clinically is not associated with a high incidence of uterine bleeding and breast pain as is hormonal therapy. Clinical trials indicate that phytotherapy may be a potential treatment for postmenopausal osteoporosis. The objective of this meta-analysis was to compare the efficacy and safety of phytotherapy with that of hormonal therapy, to assess the quality of phytotherapy trials, and to identify herbs used commonly in the treatment of postmenopausal bone loss. A total of 43 electronic databases were searched. The quality of eligible trials was assessed using Jadad’s scale. Outcome measures were BMD values and adverse events. Revman 5.0 software was used for data syntheses and meta-analyses. The database search revealed 14 randomized controlled trials involving 780 patients that met the inclusion criteria, and four trials were graded as high quality (score 3–5). There was no significant difference in lumbar, femoral or forearm BMD values between subjects treated with phytotherapy and those treated with hormonal therapy (P>0.05), but the incidence of uterine bleeding and breast pain was significantly lower in those treated with phytotherapy than in those treated with hormonal therapy (P = 0.002 and P = 0.01). The six most commonly used herbs in the included trials were identified. Phytotherapy may not show effects beyond hormonal therapy, but may be safer than hormonal therapy in the treatment of postmenopausal bone loss. Further trials with high-quality study designs should be conducted in this field.     

福施乐治疗良性前列腺增生的临床研究

目的:观察福施乐治疗BPH的有效性和安全性。方法:采用多中心、开放性、自身前后对照的临床研究方法,对60例BPH患者采用福施乐治疗12周。以国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、膀胱残余尿(PVR)和前列腺体积为主要疗效指标,以生活质量评分(QOL)和平均尿流率(Qave)为次要疗效指标,来评价福施乐治疗BPH的效果。结果:治疗12周后,患者IPSS评分、Qmax、PVR、QOL评分、Qave均比治疗前明显改善(P<0.01),而前列腺体积治疗前后无显著性差异(P>0.05)。结论:福施乐可明显改善BPH患者的排尿症状,增加尿流率,减少残余尿,无明显不良反应,治疗BPH安全、有效。     

舍曲林治疗早泄的有效性和安全性系统评价

目的 应用Meta分析评价舍曲林治疗早泄的临床疗效和安全性.方法 检索国内外有关比较舍曲林和安慰剂用于治疗早泄的随机对照试验和随机交叉实验,由两名评价员独立按Cochrane系统评价方法对文献进行质量评价和提取资料后,采用RevMan 5.2统计软件进行Meta分析.结果 共纳入5个随机对照试验和随机交叉实验,共208例患者.结果显示,舍曲林治疗组可以明显延长患者的射精潜伏期[MD =2.00,95％ CI（1.38,2.61）,P＜0.00001],提高患者的性生活满意度[RR=1.90,95％ CI（1.38,2.62）,P＜0.0001],但舍曲林治疗组的药物不良反应发生率较安慰剂组高[RR =2.29,95％ CI（1.40,3.77）,P=0.001].结论 舍曲林治疗组可以明显延长患者的射精潜伏期,提高患者的性生活满意度.由于文献纳入较少,需要更多大样本的随机对照试验进一步证实.     

What do I tell patients about saw palmetto for benign prostatic hyperplasia?

Saw palmetto is widely used to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Although there is passionate support for herbal and complementary therapies for LUTS, clinical evidence is mixed. Because there is a well-recognized, profound placebo effect in tests of efficacy for agents treating LUTS, it is imperative that all therapies be tested in placebo-controlled trials. This article reviews evidence of the efficacy and safety of saw palmetto for men with LUTS caused by BPH, with particular emphasis on published randomized clinical trials and the upcoming Complementary and Alternative Medicine for Urologic Symptoms (CAMUS) trial.     

A systematic review of Cernilton for the treatment of benign prostatic hyperplasia

OBJECTIVE: To systematically review the evidence for the clinical effects and safety of the rye-grass pollen extract (Cernilton) in men with symptomatic benign prostatic hyperplasia (BPH). METHODS: Trials were identified by searching Medline, specialized databases (EMBASE, Cochrane Library, Phytodok), bibliographies, and contacting relevant trialists and manufacturers. Randomized or controlled clinical trials were included if: men with symptomatic BPH were treated with Cernilton; a control group received either placebo or pharmacological therapy; the treatment duration was >/= 30 days; and clinical outcomes were reported. RESULTS: In all, 444 men were enrolled in two placebo-controlled and two comparative trials lasting 12-24 weeks. Three studies used a double-blind method although the concealment of treatment allocation was unclear in all. Cernilton improved 'self-rated urinary symptoms' (the proportion reporting satisfactory or improving symptoms) vs placebo and another plant product, Tadenan. The weighted mean (95% confidence interval) risk ratio (RR) for self-rated improvement vs placebo was 2.40 (1. 21-4.75) and the weighted RR vs Tadenan was 1.42 (1.21-4.75). Cernilton reduced nocturia compared with placebo or Paraprost (a mixture of amino acids); against placebo, the weighted RR was 2.05 (1.41-3.00), and against Paraprost the weighted mean difference for nocturia was - 0.40 times per evening (- 0.73 to 0.07). Cernilton did not improve urinary flow rates, residual volume or prostate size compared with placebo or the comparative study agents. Adverse events were rare and mild; the withdrawal rate for Cernilton was 4. 8%, compared with 2.7% for placebo and 5.2% for Paraprost. CONCLUSIONS: The Cernilton trials analysed were limited by their short duration, limited number of enrolees, omissions in reported outcomes, and the unknown quality of the preparations used. The comparative trials had no confirmed active control. The available evidence suggests that Cernilton is well tolerated and modestly improves overall urological symptoms, including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.     

The emerging role of alpha antagonists in the therapy of benign prostatic hyperplasia.

The rationale for using alpha blockade to treat benign prostatic hyperplasia (BPH) is based on the physiology and pharmacology of prostate smooth muscle. Approximately 20% of the area density of the prostate adenoma is smooth muscle. In vitro isometric tension studies have demonstrated that the contractile properties of the human prostate adenoma are mediated primarily by alpha 1 adrenoceptors. Alpha blockers presumably decrease the resistance along the prostatic urethra by relaxing the smooth muscle component of the prostate. Over the past 14 years, at least 16 clinical trials have confirmed the efficacy of alpha blockade in the treatment of BPH. The primary advantage of terazosin over all other commercially available alpha blockers is that its longer half-life allows for a once-daily dosage regimen. Two Phase II studies conducted in the United States, a multicenter dose titration randomized withdrawal study and the author's personal experience with terazosin, are summarized in this report. Overall, the peak urinary flow rate increased 50% and the mean urinary flow rate increased 46% following terazosin therapy. The mean obstructive and irritative scores improved 67% and 35%, respectively. The adverse reactions occurring with an incidence greater than 5% included headache (10%), asthenia (7%), and dizziness (14%). All adverse events were reversible on termination of therapy. The preliminary experiences with alpha blockers for the treatment of BPH has been very encouraging. Yet, the definitive role of alpha blockade in BPH awaits the reporting of multicenter, randomized placebo-controlled studies.     

Reporting of acute urinary retention in BPH treatment trials: importance of patient follow-up after discontinuation and case definitions

Objectives. A growing number of reports of retrospective analyses of adverse events occurring during studies with alpha-blockers in men with benign prostatic hyperplasia (BPH) have compared acute urinary retention (AUR) event rates with placebo-controlled finasteride trials. Because of differences in study designs, the present analysis was undertaken to compare data on the rates of AUR across different BPH trials accurately.Methods. We report the incidence of spontaneous AUR for placebo, finasteride, and alpha-blockers based on published data in randomized clinical trials in men with BPH.Results. On the basis of the data from all published randomized finasteride and alpha-blocker studies reporting AUR, the overall incidence rate for spontaneous AUR during active treatment with placebo, alpha-blockers, and finasteride ranged from 0.9 to 5.2, 0 to 1.2, and 0.3 to 1.2, respectively. The only study to provide data on AUR occurring during post-treatment follow-up was the Proscar Long-Term Efficacy and Safety Study (PLESS), in which approximately 25% of events occurred in patients after they had discontinued the study. Several of the alpha-blocker studies had significantly shorter durations, relatively small patient populations with smaller prostate volumes, lower numbers of events reported, and higher discontinuation rates with no follow-up, all of which could tremendously affect the reporting of AUR. Additionally, only PLESS reported on both spontaneous and precipitated AUR.Conclusions. Simply comparing the reported rates of AUR from published studies without taking into consideration spontaneous versus precipitated AUR, discontinuation rates, total patient follow-up, and prostate volume does not adequately allow for comparison of the true event rate across different clinical trials.     

Doxazosin in the treatment of benign prostatic hyperplasia. A review of the safety profile in older patients

The objective of this paper is to review the safety of doxazosin in older patients (>/=65 y) with benign prostatic hyperplasia (BPH) as reported in seven international clinical trials. Data from seven double-blind, placebo-controlled, phase III trials, in both normotensive and hypertensive patients with BPH were collated and analysed. Data on doxazosin were available for 341 men 65 y and over. Even though older patients can be at particular risk of adverse drug reactions, there was no apparent evidence of poor tolerability with doxazosin in older patients with BPH. The percentages of younger normotensive BPH patients (<65 y) experiencing at least one adverse event were 47 and 44% for doxazosin and placebo groups, respectively; for older normotensive BPH patients (>/=65 y) the corresponding values were 42 and 38%. For the younger hypertensive BPH patients the incidence rates for adverse events were 55% (doxazosin) and 42% (placebo) and for older hypertensive BPH patients 43 and 30%, respectively. The most commonly reported adverse events for all groups were dizziness, headache and fatigue and few serious adverse effects were reported throughout these trials. It can be concluded that doxazosin is well tolerated in young and old, normotensive and hypertensive patients with BPH.     

A Review of Laser Treatment for Symptomatic BPH (Benign Prostatic Hyperplasia)

Benign prostatic hyperplasia (BPH) is the predominant cause of bladder outflow obstruction and is associated with significant morbidity. Surgical removal of adenoma has been a key treatment principle for alleviation of obstruction. Lasers have been used as an alternative to transurethral resection of the prostate (TURP), due to the higher complications of the latter procedure, since the early 1990s. Early generations of lasers utilized coagulative and ablative techniques to dis-obstruct the bladder. Ablative techniques have remained popular with the resurgence of 532-nm vaporization (commonly known as GreenLight). Enucleation techniques especially with the holmium laser have shown durable efficacy in randomized controlled trials whilst new modalities such as thulium still require long-term data. This review examines the most common types of laser technology used in BPH surgery, with a focus on efficacy and side effect profile.     

The placebo effect and randomized trials: analysis of alternative medicine

Randomized controlled trials are generally regarded as the gold standard of study designs to determine causality. The inclusion of a placebo group in these trials, when appropriate, is critical to access the efficacy of a drug or supplement. The placebo response itself has received some attention in the medical literature over the past fifty years. The recent increasing utilization of dietary supplements and herbal medications by patients makes it imperative to reevaluate the placebo response in conventional and alternative medicine. This article will review some of the negative and positive results from randomized trials utilizing dietary supplements (androstenedione, beta-carotene, CoQ10, garlic, soy, vitamin C and E...) for a number of non-urologic and urologic conditions, including cancer.     

一贯煎治疗干燥综合征临床疗效及安全性的系统评价

目的:系统评价一贯煎治疗干燥综合征临床疗效及安全性。方法:计算机检索PubMed、The Cochrane Library、EMbase、中国知网、维普和万方等数据库,检索时间截至2019年4月30日,收集一贯煎治疗干燥综合征的随机对照试验。由2位研究人员单独筛选文献、提取资料,分析纳入文献的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入6个研究,均为中文文献。Meta分析显示,一贯煎治疗组临床疗效明显优于对照组,差异有统计学意义(OR=4.11,95%CI=[2.30,7.34],P<0.00001)。共有2个研究提及不良反应,且治疗组不良反应例数少于对照组。结论:一贯煎治疗干燥综合征临床有效,且不易引起不良反应。因本研究纳入文献量少,西药种类繁多,受纳入文献方法学质量及干预措施不同等条件的局限,上述结论需要进一步实施更多高质量、样本量大的随机对照试验验证。