Health Technology Assessment Of Terazosin,Tamsulosin And Finasteride For Benign Prostatic Hyperplasia

PartⅠEvaluation of the effectiveness of terazosin, tamsulosin and finasteride for benign prostatichyperplasiaObjectives: Benign prostatic hyperplasia (BPH) is a common condition among elderly men, which can result in bothersome lower urinary tract symptoms(LUTS). The treatment goal for BPH patients is to relieve these bothersome symptoms. Terazosin, tamsulosin and finasteride are most frequently used for the treatment of LUTS. This health technology assessment was designed to evaluate the effectiveness of terazosin, tamsulosin and finasteride for BPH, provide the best available choice for BPH patients, offer the best evidence for clinical decision-making, and formulate best references for decision-makers to improve the clinical quality of treatment of BPH.Methods: We searched the potentially related original studies all over the world, and only included randomized control trials (RCTs) and clinical control trials (CCTs). Medline, Embase, Cochrane Library and four Chinese databases were electronically searched, correlative websites, such as'google', and relative journals were searched by hand. The studies included in the references of eligible studies were additionally searched. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation of cross-check. Different opinions were consulted by the third party. Meta-analysis was done by Revman 4.2. If the data without heterogeneity( a >0.05) and they could be pooled using fixed effect model, and otherwise they could be solved by sensitivity analysis, subgroup analysis or randomized effect model. Results: Thirteen original studies involving 2,543 subjects met inclusioncriteria. Compared with terazosin, tamsulosin can improve international prostatic symptom score, with WMD of 0.75, 95% Confident interval(CI) 0.07 to 1.43, P=0.03. And there is no statistic difference between terazosin and tamsulosin in improving (WMD=0.1, 95% CK-0.52, 0.72), p=0.75), the average rate of urine flow(WMD=0.23, 95% CK-0.39, 0.85), P=0.46), the residual urine volume (WMD=0.70, 95% CI (-2.85, 4.26) ,P=0.70) and in diminishing the volume of prostate (WMD=0.00, 95% CI (-3.78, 3.78) ,P=1.00) . There is no statistic difference between finasteride and tamsulosin in improving the international prostatic symptom score (WMD=0.65, 95%CI(-0.45, 1.75 ),P=0.25) or the max rate of urine flow (WMD=0.39, 95% CK-0.72, 1.51) ,P=0.49). Only two studies compared finasteride with terazosin and had different conclusions. Only one study compared finasteride or terazosin with their combination and suggested that their combination had higher effective power than finasteride along but no difference with terazosin along. Conclusions: Although the effectiveness in some aspect was higher in thetamsulosin group, there was not enough evidence to show which is best among these three drugs. Combination of finasteride and terazosin did not show more effectiveness than terazosin along. This review suggests that tamsulosin along should be used for the treatment of BPH and combination need to be identified by better evidence. It was important to improve the quality of original studies.Part IISafety and Acceptability Assessment ofterazosin, tamsulosin and finasteride for benignprostatic hyperplasiaObjectives: To evaluate the safety and acceptability of terazosin, tamsulosin, finasteride and their combination for the treatment of benign prostatic hyperplasia.Methods: We searched MEDLINE, EMBASE, Cochrane Library, Chinese Biomed-database, correlative websites and relative medical journals. The references of eligible studies were additionally searched. We collected randomized control trials (RCTs), clinical control trials (CCTs), cohort studies, and case reports about serious adverse events all over the world. Two reviewers evaluated the quality of the literatures and extracted the data independently. After testing heterogeneity, data of the trials included were meta-analyzed if appropriate, or otherwise, would be described.Results: Nine completed RCTs, one CCTs and three other studies met the inclusion criteria. Of the ten RCTs or CCTs, terazosin and tamsulosin were compared in six trails. Our meta-analysis suggested that tamsulosin may have a better safty profile than terazosin in the occurrence of CNS symptoms ( OR = 4.66 , 95% CI ( 2.75 , 7.89 ), PO.00001 ) and discontinuations due to adverse reaction (OR=3.93, 95% CI( 1.40, 11.01), P=0.009). There is no statistic difference between terazosin and tamsulosin in the occurrence of other adverse events. Terazosin and finasteride were compared in three RCTs or CCTs. Our meta-analysis suggested that terazosin may cause more CNS symptoms(OR=0.33, 95% CK0.23, 0.46), PO.00001) and less sexual dysfunctions(OR= 1.86, 95% CI (1.16, 3.00), P=0.01) than finasteride do. Tamsulosin and finasteride were compared in only one trail, so a meta-analysis could not be done. But the results of this trail indicated that tamsulosin seemed to be safer than finasteride. Two studies compared terazosin and finasteride with their combination, but had disagree conclusions.Conclusion: According to our analysis, we concluded that tamsulosin may have a better safty and acceptability profile than terazosin. For terazosin and finasteride, their safty vary in different organs. The safty of tamsulosin and finasteride can not be concluded definitely because of the insufficiency of information. Our research conclusion is instructive for clinical medication. But more high-quality multicentre large sample clinical trials are required to confirm the conclusion.PartEconomical Assessment of terazosin, tamsulosin and finasteride for benign prostatic hyperplasiaObjective: To re-assess original studies about economic analysis of terazosin, tamsulosin and finasteride for the treatment of benign prostatic hyperplasia in the world, and analyze their cost and efficacy so as to help men with BPH choosing proper medicine and provid references for the government in decision making.Methods: Seven medical literature databases were searched, including MEDLINE, EMBASE, Cochrane Library, and Chinese Biomed-database. Related websites were also searched, and related journals were searched by hand. The studies included in the reference list were additionally searched. Eligibility and trial quality were assessed and the useful data were extracted independently by two reviewers with a confirmation of crosscheck. Different opinions were consulted by the third person to meet agreement. The data on outcomes of effectiveness were pooled if possible, otherwise, were described (qualitative systematic review).Results: Six original studies were included in this systematic review. Qualitative systematic review was conducted since the methods and interventions of the trials included were totally different. One study used the cost — minimization analysis method and others used the cost — effectiveness analysis method. There was no significant difference in cost— effectiveness between terazosin and finasteride. Tamsulosin had lowerincremental cost — effectiveness than terazosin and lower cost —effectiveness than fmasteride.Conclusion: The cost—effectiveness of tamsulosin was the lowest in thisthree drugs based on the current evidence. This would be very useful inclinical practice. The conclusion should be carefully considered due to thequality limitation of the eligible trials. The related original economic studiesneed to be done in China.