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Int J Clin Exp Med 2018;11(3):1458-1466www.ijcem.com /ISSN:1940-5901/IJCEM0065223

Review ArticleTamsulosin versus nifedipine to facilitate urinary stone passage: a systematic review and meta-analysis

Yongqiang Zhang1,2*, Dongbo Yuan1,3,4,5*, Haofu Rao3,7, Tianfei Cheng3,8, Boshi Luan3, Wei Wang3, Jiaming Su6, Yuanlin Wang1,3, Zhaolin Sun1,3,4,5, Guiping Ouyang2, Jianguo Zhu1,3,4,5

1Guizhou Provincial People’s Hospital, The Affiliated Hospital of Guizhou University, Guizhou, 550002, China; 2School of Pharmaceutical Sciences, Guizhou University, Guizhou, 550002, China; 3Department of Urology, Guizhou Provincial People’s Hospital, The Affiliated Hospital of Guizhou Medical University, Guizhou, 550002, China; 4Medical College of Guizhou University, Guizhou, 550025, China; 5College of Life Science, Guizhou Univer-sity, Guizhou, 550025, China; 6Zunyi Medical University, Guizhou, 563000, China; 7The First People’s Hospital of Xiushui county, Jiujiang City, Jiangxi, 332400, China; 8The People’s Hospital of Liang Ping District in Chongqing, Chongqing, 405200, China. *Equal contributors.

Received September 8, 2017; Accepted January 8, 2018; Epub March 15, 2018; Published March 30, 2018

Abstract: Objectives: To assess the effectiveness of Tamsulosin versus Nifedipine, as an expulsive agent, for both intact ureteral stones and stones after shock wave lithotripsy. Methods: Relevant studies were searched for in MEDLINE, SCOPUS, and the Cochrane database libraries. All randomized controlled trials comparing Tamsulosin to Nifedipine for the treatment of ureteral stones (intact or after shock wave lithotripsy), were included in the study. The primary outcome was the proportion of the patients who passed the stones. Results: Ten randomized trials (RCT), with a total of 4816 patients that underwent medical therapy only, were included in this meta-analysis. Tamsulosin was associated with a higher risk of stone passage rate (SPR) (OR = 2.67, 95% CI 1.31-5.44, P<0.05), and with a shorter average stone-expulsion time, in tamsulosin groups (WMD: -1.95; 95% CI: -3.73-0.17; P = 0.03). There were no statistically significant differences in the side effects between these groups (OR = 0.78, 95% CI 0.60-1.02, P = 0.07). Three trials comprised of 199 patients who had the expulsive therapy after shock wave lithotripsy. No statisti-cally significant differences were detected in the SPR, between the two groups (OR = 1.56, 95% CI 0.82-2.96, P = 0.17). Conclusions: This meta-analysis suggested that Tamsulosin was more effective and quicker than Nifedipine as an expulsive agent for the intact ureteral stones.

Keywords: Tamsulosin, nifedipine, urinary stone, shock wave, meta-analysis

Introduction

It is estimated that urinary stone disease aff- ects approximately 5-12% of the world’s popu-lation. There is a male predominance of about 13%, versus 7% in women. In addition, the re- currence of renal colic in the urolithiasis patients is 50%, within five years of their first epi-sode. These data demonstrate the substantial economic consequences and the significant health care issues resulting from this high prev-alence of urolithiasis [1-4].

Several studies have demonstrated that small (≤ 5 mm) ureteral stones had a spontaneous passage rate of 71-98% [5-7]. However, pas-sage of stones can cause significant morbidity, namely renal or ureteral colic. The colic episode

can not only cause severe pain, but often results in hospitalization. Therefore, medical expulsive therapy has been advocated to facili-tate stone passage, and to reduce morbidities. This treatment has been used for both intact ureteral stones and for stones after shock wave lithotripsy.

Both, calcium-channel blockers and adrenergic α-antagonists, have been used as expulsive agents. Tamsulosin and Nifedipine were the most commonly used drugs [8, 9]. Several ran-domized trials have been published to com- pare the effectiveness of Tamsulosin versus Nifedipine, as expulsive agents. They were used for both intact stones and after shock wave lithotripsy. These studies produced substantial conflicting results. Therefore, we embarked on

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Tamsulosin versus nifedipine to urolithiasis

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this review and meta-analysis of the published literature, in an attempt to provide a more comprehensive assessment of the efficacy of Tamsulosin, as compared to Nifedipine, as an expulsive agent.

Methods

Search strategy, eligibility criteria, and exclu-sion criteria

Randomized controlled trials were identified from MEDLINE, SCOPUS, and the Cochrane database libraries. The search terms used for the retrieval of the relevant studies included both “Tamsulosin” and “Nifedipine”. There was no restriction by the year of publication, the lan-guage, or publication status applied. The refer-ence lists the identified publications, and rele-vant review articles, that were searched looking for additional studies. Trials that met the follow-

assessed by the Jadad score [10]. The primary endpoint in the studies was the overall stone expulsion rate (cumulative incidence). The se- condary endpoint was side-effects incidence and average stone-expulsion time. Randomized controlled trials, with scores greater than or equal to three points were defined as high-qual-ity studies. Whereas, the randomized controlled trials with scores less than three points were defined as lesser quality studies [11].

Statistical analysis

The data in the form of means and standard deviations were included in our meta-analysis. The continuous variables, such as the median and the range, were excluded. In this meta-analysis, weighted mean differences (WMDs) were used for the analysis of continuous vari-ables. The odds ratios (ORs) were used for the dichotomous variables. Random-effects mod-

Figure 1. Systematic search and selection strategy.

ing criteria were eligible for inclusion in this study: (1) ran-domized controlled trials; (2) studies comparing Tamsulosin with Nifedipine for the treat-ment of ureteral stones; (3) reporting data of the propor-tion of patients who passed stones. Exclusion criteria were (1) not containing the two medications; (2) reporting insuffi-cient data. When there was a duplicated publication or data, only the newest eligible data was included. The details of the systematic search and selection strategy are shown in Figure 1.

Data extraction and quality assessment

The data extraction included authors, year of publication, journal source, sample size, patient characteristics, overall stone expulsion rate, average stone-expulsion time, side-effects, incidence, mean analgesic consumption for renal colic, pain relief therapy, and its route of administra-tion. The quality of the ran-domized controlled trials included meta-analysis that was


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els were used to identify the heterogeneity among the studies [11]. Heterogeneity was assessed using the chi-square test. The ninety-five percent confidence intervals (CIs) were calculated. P values ≤ 0.05 were considered to be statistically significant. Statistical analyses were performed using Review Manager version 4.2 (Cochrane Collaboration, Copenhagen, De- nmark).

Results

Characteristics of included studies

The initial search yielded fifty-three citations, using the medication only. Ten randomized tri-

als [12-21] met the inclusion criteria, and con-stituted the base of the meta-analysis. It has a total of 4,816 patients (2,414 in the Tamsulosin group and 2,402 in the Nifedipine group). In addition, three RCTs [22-24] used the medica-tions after the shock wave lithotripsy (SWL), with a total of 199 patients (98 in the Tam- sulosin group and 101 in the Nifedipine group), that were also considered to be suitable for the meta-analysis. Tables 1 and 2 summarize the main characteristics of the studies included in this meta-analysis. All of the thirteen random-ized controlled trials were considered to be of high quality, with scores of no less than 3 points as assessed by the Jadad score (Table 3).

Table 1. Characteristics of the 10 selected clinical studies (use drug alone)

Study Location Study style Group No. of

Patients Age (years) Overall stone expulsion

Average stone-expulsion time

Ye et al. (2010) China RCT Tamsulosin 1596 30.7 1530 (95.9%) 78.35 hoursNifedipine 1593 34.5 1171 (73.5%) 137.93 hours

Porpiglia et al. (2004) U.S.A. RCT Tamsulosin 28 50.5 24 (85%) 7.9 daysNifedipine 30 45.6 24 (80%) 9.3 days

Dellabella et al. (2005) U.S.A. RCT Tamsulosin 70 43.8 68 (97.1%) 72 hoursNifedipine 70 43.8 54 (77.1%) 120 hours

Gandhi et al. (2013) India RCT Tamsulosin 64 34.0 51 (79.7%) 9 daysNifedipine 64 30.4 32 (50%) 23 days

Zhang et al. (2009) China RCT Tamsulosin 102 34.6 75 (73.5%) -Nifedipine 97 36.3 66 (68.0%) -

Lü et al. (2006) China RCT Tamsulosin 60 38 49 (81.7%) 4 daysNifedipine 60 34 44 (73.3%) 8 days

Balci et al. (2014) Turkey RCT Tamsulosin 25 39.5 19 (76.%) 9 daysNifedipine 25 36.4 16 (64.%) 9.1 days

Islam et al. (2010) Bangladesh RCT Tamsulosin 32 46.6 27 (84.4%) 7.9 daysNifedipine 31 47.7 22 (71.0%) 9.3days

Liao et al. (2011) China RCT Tamsulosin 59 34 (19-49) 49 (83.1%) 11 daysNifedipine 53 34 (19-49) 27 (51.0%) 14 days

Pickard et al. (2015) UK RCT Tamsulosin 378 43.1 307 (81.2%) 16.5 daysNifedipine 379 42.3 304 (80.2%) 16.2 days

RCT = randomized controlled trial.

Table 2. Characteristics of the 3 selected clinical studies (use drug after shock wave lithotripsy)

Study Location Study style Group

Gender Overall stone expulsion

Stone locationMale Female Up Mid Low

Micali et al. (2007) China. RCT Tamsulosin 16 12 23 (82.1%) - - 28Nifedipine 23 12 30 (85.7%) 18 17 -

FabioC. et al. (2011) U.S.A RCT Tamsulosin 16 22 23 (60.5%) 11 13 14Nifedipine 18 17 17 (48.6%) 7 14 14

Choi. et al. (2008) U.S.A RCT Tamsulosin 25 7 27 (84.4%) 15 - 17Nifedipine 26 5 21 (67.7%) 14 - 17

RCT = randomized controlled trial.


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Improvement of ureteral stone passage

Nifedipine versus tamsulosin for the manage-ment of ureteral stones: Eight RCTs [12-21] investigated the efficacy of medical expulsive therapy. All of them showed that the Tamsulosin was associated with a higher rate of stone pas-sage than Nifedipine. A random-effects model was used to combine the data, because the heterogeneity was evident (P<0.00001). In the pooled data, the incidence of successful stone passage in the Tamsulosin group was signifi-cantly higher than the Nifedipine group (OR = 2.67, 95% CI 1.31-5.44, P<0.05) (Figure 2).

Adjuvant tamsulosin versus nifedipine after SWL for renal stones: All of the studies [22-24] showed improved stone expulsion rate. There were, however, no significant differences between the Tamsulosin group and the Nifedipine group. The fixed effects model was used to combine the data, because the heterogeneity was not significant (P = 0.42). In the pooled data, the Tamsulosin group and the Nifedipine group had similar stone passage rate (OR = 1.56, 95% CI 0.82-2.96, P = 0.17) (Figure 3).

Side-effects profile

Nifedipine versus tamsulosin for the manage-ment of the in situ ureteral stones: There were eight trials [12-17, 20, 21] that included the adverse events. The other two trials [18, 19] did not. Both showed a lack of significant differ-

ed data, meta-analysis demonstrated less stone-expulsion time in the Tamsulosin group than in the Nifedipine group (WMD: -1.95; 95% CI: -3.73-0.17; P = 0.03) (Figure 5).

Mean analgesic consumption for renal colic

The presentation of these data was heteroge-neous. Since there was also the lack of mean and standard deviation data, a meta-analysis would not be appropriate. Of the included stud-ies, seven trials [12, 13, 15-19] showed that the mean consumption of diclofenac for recur-rent renal colic in the Tamsulosin group was less than the Nifedipine group. Whereas, in the other trial, [14] the conclusion was diametric. Therefore, the difference in the consumption of diclofenac between the groups was unclear. Three trials in the SWL did not record any anal-gesic data. No meta-analysis could be done.

Pain relief therapy

Only one study [13] provided data regarding pain relief therapy. It showed that the rate of pain relief therapy in the Tamsulosin group (1.53%) was significantly less than that that in the Nifedipine group (4.84%). Again, a meta-analysis would not be appropriate.

Assessment of publication bias

A funnel plot was performed to assess publica-tion bias in this meta-analysis. The shapes of

Table 3. Quality assessment of included RCTs

Investigator Randomization Double-blind

Withdrawals/drop outs Score

Use drug aloneYe et al. 2 0 1 3Porpiglia et al. 2 0 1 3Dellabella et al. 2 0 1 3Gandhi et al. 2 0 1 3Zhang et al. 2 0 1 3Lü et al. 2 0 1 3Melih et al. 2 0 1 3Islam et al. 2 0 1 3Liao et al. 2 0 1 3Pickard et al. 2 0 1 3Use drug after shock wave lithotripsyMicali et al. 2 0 1 3Fabio C. et al. 2 1 1 4Choi. et al. 2 0 1 3

ence between the Tamsulosin and the Nifedipine group. The fixed effect model was used to combine the data because the heterogeneity was not significant (P = 0.27). In the pooled data, there were no statistically sig-nificant differences in the side effect incidences between the groups (OR = 0.78, 95% CI 0.60-1.02, P = 0.07) (Figure 4).

Average stone-expulsion time

Five studies [16-18, 20, 21], includ-ing 498 patients, provided data on the average stone-expulsion time in both groups. The random-effects model was used to combine the data, because the heterogeneity test showed heterogeneity in the average stone-expulsion time of the five clinical studies (P = 0.04). In the pool-


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the funnel plots included the side-effects inci-dence and overall stone expulsion. The meta-analyses were symmetrical and did not show any obvious evidence of asymmetry (Figure 6). In addition, the P value of the Egger’s tests was more than 0.05, thus it provided statistical evi-dence of the funnel plot symmetry (Figure 6).

The result, therefore, suggested that publica-tion bias was not evident in this meta-analysis.

Discussion

Ureteral stones are a common form of urolithia-sis. Ureteral colic is extremely painful and is the

Figure 2. Forest plot showing stone passage between Nifedipine and Tamsulosin groups.

Figure 3. Forest plot showing stone passage between Nifedipine and Tamsulosin groups after SWL.

Figure 4. Forest plot showing side-effects between Nifedipine and Tamsulosin groups.


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most common cause of urolithiasis in patients seeking emergency medical care. Fortunately, most ureteral stones will pass spontaneously. Treatment that can facilitate the stone passage will, undoubtedly, relieve patient suffering and reduce the medical cost. In this context, medi-cal expulsive therapy has gained widespread interest in recent years [25, 26]. The adrenergic α-antagonists and the calcium-channel blockers were found to be the most effective classes of the expulsive agents. Tamsulosin and Nifedipine are two of the more frequently used medications for this purpose. Their effi-cacy and safety profile have been extensively studied. However, there was inconsistent data regarding which of the two medications is supe-rior in terms of efficacy and safety profile. SWL and ureteroscopy represent the current surgi-cal treatment options for the ureteral stones that have failed to pass spontaneously. SWL is a non-invasive procedure, but it has a lower success rate and a higher re-treatment rate [8, 9, 27-29]. URS, on the other hand, is an inva-sive procedure, but with the highest success rate. It is also more costly than SWL. Patients who have undergone SWL therapy are routinely placed on expulsive medication to facilitate the passage of stone fragments, and to reduce the risks of post-treatment colic.

There were thirteen clinical studies [12-21, 22-24] that compared Tamsulosin with Nifedi- pine (use alone or SWL) to investigate their value as medical expulsive therapy in the treat-ment of urinary stone disease. This meta-anal-ysis of ten clinical studies [12-21] showed that the stone passage rate in the Tamsulosin group was 91.1%, while the rate for the Nifedipine group was 73.3%. Therefore, Tamsulosin was a significantly more effective expulsive agent than Nifedipine. The meta-analysis of three clinical studies [22-24] with SWL showed no sig-

nificant differences between the Tamsulosin group (stone passage rate of 74.5%), and the Nifedipine group (stone passage rate of 67.3%).

There are eight trials [12-17, 20, 21] that have included an adverse event and two that did not. The incidence of side-effects in the Tamsulosin group was 4.4%, while the incidence in the Ni- fedipine group was 5.6%. Our meta-analysis revealed that the side-effect profile was not significantly different between the Tamsulosin group and the Nifedipine group. Whereas, the adverse event between the two groups, after shock wave lithotripsy [22-24] lacks data. Th- erefore, we can’t make a conclusion and we need to do further research in future studies.

Our meta-analysis of five clinical studies [16-18, 20, 21] revealed significantly less opera- tive time in the Tamsulosin group than in the Nifedipine group. This may lead to reduced average onset of pain and analgesia for patients. But Balci et al. [16], and Ye, et al. [13] data showed that the common analgesic con-sumption of the Tamsulosin group and the Nifedipine group was 544 mg/day and 602 mg (P = 0.98) and 0.98 mg and 109.33 mg, respec-tively (P<0.01). These biases can be caused by the pain tolerance and the severity of obstruc-tion among patients.

There were some limitations to this meta-anal-ysis. First, studies included data on the average stone expulsion time and the mean consump-tion of diclofenac. Neither included data in the form of mean and standard deviation, to all- ow proper meta-analysis. However, nine stud-ies [12-18, 20, 21] did show that Tamsulosin had a significantly shorter stone expulsion time than Nifedipine. Seven trials [12, 13, 15-19] showed that the mean consumption of diclofenac, needed for recurrent renal colic, in the

Figure 5. Forest plot showing average stone-expulsion time between Nifedipine and Tamsulosin groups.


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Tamsulosin group was less than that in the Nifedipine group. The conclusion of the other trial [14] was diametric. Yet, another study [13]

included data on pain relief therapy, demon-strating that Tamsulosin was actually signifi-cantly inferior than Nifedipine. These conflicting

Figure 6. Funnel plot for the results from all studies comparing stone passage, side-effects in patients between Nifedipine and Tamsulosin groups.


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and insufficient data affected the accuracy of this meta-analysis. Second, different studies might have differing defining criteria for the out-comes we were interested in, but might not be reported in the study methodology. Third, there was the limitation of nonpublication and selec-tive reporting bias, which could not be account-ed for.

This meta-analysis suggested that Tamsulosin was more effective and a more quickly expul-sive medication than Nifedipine for the patients with ureteral stones. The study showed that there was no significant difference in effi-cacy between these two medications when they were used after SWL. Further prospective, randomized, and double-blind RCTs, will be needed to reach a more definitive conclusion.

Acknowledgements

The study was supported by the Outstanding Youth Science and Technology Talent Cultivating Project of the Guizhou Province in 2013 (2013-18), The Young Talents Project of Guizhou Pro- vince in 2012 (2012-18), The Science and Te- chnology Project of Guiyang in 2015 (2015- 1001), and the National Natural Science Fou- ndation of China (81360119).

Disclosure of conflict of interest

None.

Address correspondence to: Dr. Guiping Ouyang, School of Pharmaceutical Sciences, Guizhou Uni- versity, Guizhou 550002, China. Tel: +86-851836- 20779; Fax: +86-85183620779; E-mail: oygp710- @163.com; Dr. Jianguo Zhu, Department of Urology, Guizhou Provincial People’s Hospital, The Affiliated Hospital of Guizhou Medicine University, Guiyang 550002, Guizhou Province, China. Tel: +86-8518- 5925503; Fax: +86-85185925503; E-mail: [email protected]

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