Therapy of nephrolithiasis: where is the evidence from clinical trials?

Pachaly, Maria Aparecida; Baena, Cristina Pellegrino; Carvalho, Mauricio de

doi:10.5935/0101-2800.20160015

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Brazilian Journal of Nephrology

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Review Article • J. Bras. Nefrol. 38 (1) • Jan-Mar 2016 • https://doi.org/10.5935/0101-2800.20160015 copy

Therapy of nephrolithiasis: where is the evidence from clinical trials?

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

The prevalence of kidney stone disease is increasing worldwide with significant health and economic burden. Newer research is finding that stones are associated with several serious morbidities. Yet, few randomized clinical trials or high quality observational studies have assessed whether clinical interventions decrease the recurrence of kidney stones. Therefore, in this review we analyze the available evidence on medical expulsive therapy for ureteral stones; describe the evidence about non-pharmacological stone therapy including dietary modifications and citrus juice-based therapy; and discuss the efficacy of thiazide diuretics for the treatment of hypercalciuria in recurrent nephrolithiasis.

Keywords:
citric acid; hypercalciuria; kidney calculi; nephrolithiasis; potassium citrate

TITLE	Exposure	Outcomes	Conclusion
Medical therapy to facilitate urinary stone passage: a meta-analysis¹⁰10 Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT, et al. Medical therapy to facilitate urinary stone passage: a meta-analysis. Lancet 2006;368:1171-9. PMID: 17011944 DOI:http://dx.doi.org/10.1016/S0140-6736(06)69474-9 http://dx.doi.org/10.1016/S0140-6736(06)...	The authors identified and summarized all randomized controlled trials in which calcium-channel blockers or α blockers was used. Only 9 (n = 693) of over 400 studies fit the inclusion criteria.	The main outcome was the proportion of patients who passed stones <= 6 or >= 6 mm	Findings suggest that MET is an option for facilitation of urinary-stone passage (ARR = 0.31, 95% CI-0.25-0.38). High-quality, randomized trial is necessary to confirm its efficacy
META-ANALYSIS REVIEW CRITERIA
Question	Answer	Question	Answer
1. Was the clinical question sensible and answerable?	Yes	6. Were the outcomes clinically relevant?	Yes
2. Were studies selected and data extracted by 2 or more individuals?	Yes	7. Was there low statistical heterogeneity for the primary outcome?	Yes, 28%; not significant
3. Was the search for studies detailed and exhaustive?	No, the authors did not state how the papers were selected for the review	8. Was the treatment effect large enough and precise enough to be clinically significant?	Yes
4. Were primary studies of high methodological quality?	No, eight of which were not blinded and six of which did not describe the randomization procedures	9. Was there any conflict of interest?	No
5. Were the assessments of studies reproducible?	Yes	10. General comments	Sample sizes were small and methodologies varied

Title	Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial¹¹11 Pickard R, Starr K, MacLennan G, Lam T, Thomas R, Burr J, et al. Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial. Lancet 2015;386:341-9. DOI: http://dx.doi.org/10.1016/S0140-6736(15)60933-3 http://dx.doi.org/10.1016/S0140-6736(15)...	Distal Ureteric Stones and Tamsulosin: a Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial¹²12 Furyk JS, Chu K, Banks C, Greenslade J, Keijzers G, Thom O, et al. Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial. Ann Emerg Med 2015 Jul 13. [Epub ahead of print] PMID: 26194935
Exposures	Tamsulosin 0.4 mg, nifedipine 30 mg, or placebo; expectant management for a single ureteral stone identified by CT at 24 UK hospitals	0.4 mg of tamsulosin or placebo daily for 28 days identified by CT at 5 EDs in Australia
Outcomes	Proportion of participants who did not need further intervention for stone within 4 weeks of randomization	Stone expulsion on CT at 28 days and time to stone expulsion
Conclusion	Tamsulosin 0.4 mg and nifedipine 30 mg are not effective	The rate of stone passage (primary outcome) was similar between tamsulosin and placebo. In the subgroup with 5- to 10-mm stones, tamsulosin increased clearance.
Randomization	Yes	Yes
Allocation concealment	Yes	No
Blinding participants	Yes	Yes
Blinding outcome assessor	Yes	Yes
Loss-to-FUP	Not important to the results	17%; Sensitivity analysis were conducted and they didn't change the results materially
Selective reporting	No	No
Intention-to-treat	Yes	Yes
Other bias	No	No

Abridged title	Unprocessed bran and intermittent thiazide in prevention of recurrent stones¹⁶16 Levy FL, Adams-Huet B, Pak CY. Ambulatory evaluation of nephrolithiasis: an update of a 1980 protocol. Am J Med 1995;98:50-9. DOI: http://dx.doi.org/10.1016/S0002-9343(99)80080-1 http://dx.doi.org/10.1016/S0002-9343(99)...	Thiazide for calcium urolithiasis in patients with hypercalciuria¹⁷17 Curhan GC, Willett WC, Knight EL, Stampfer MJ. Dietary factors and the risk of incident kidney stones in younger women: Nurses' Health Study II. Arch Intern Med 2004;164:885-91. PMID: 15111375 DOI: http://dx.doi.org/10.1001/archinte.164.8.885 http://dx.doi.org/10.1001/archinte.164.8...	Randomized prospective study of indapamide in preventing calcium stone recurrences¹⁸18 Carvalho M, Ferrari AC, Renner LO, Vieira MA, Riella MC. Quantification of the stone clinic effect in patients with nephrolithiasis. Rev Assoc Med Bras 2004;50:79-82. PMID: 15253032 DOI: http://dx.doi.org/10.1590/S0104-42302004000100040 http://dx.doi.org/10.1590/S0104-42302004...	The role of thiazides in the prophylaxis of recurrent calcium lithiasis¹⁹19 Pachaly MA, Baena CP, Buiar AC, de Fraga FS, Carvalho M. Effects of non-pharmacological interventions on urinary citrate levels: a systematic review and meta-analysis. Nephrol Dial Transplant 2015 Aug 26. [Epub ahead of print] DOI: http://dx.doi.org/10.1093/ndt/gfv303 http://dx.doi.org/10.1093/ndt/gfv303...
Year	1987	1992	1993	2006
Exposures	Group A: n: 18; Bran (40 g/d).	Group A: n: 93 No specific therapy	Group A: n:25; diet and fluid.	Group A: n: 17; no specific therapy
	Group B n: 14; Bran (40 g/d) + thiazide (50 mg twice a day)	Group B: 82 Trichlormethiazide (4 mg/d)	Group B: n:25; diet and fluid + indapamide (2.5 mg/d).	Group B: n: 21; hydrochlorothiazide (50 mg/d)
			Group C: n:25; diet and fluid + indapamide (2.5 mg/d) + allopurinol (300 mg/d)	Group C: n: 14; Hydrochlorothiazide (50 mg/d) + potassium citrate (20 mL Eq/d)
Outcomes	Stone/year per patient; stone-free patients (%) mean urinary excretion of lithogenic factors	Stone formation rate (stones/patient/y) Stone-free patients (%) Reduction in stone formation Remission rate Total number of newly formed stones	Stone formation rate (stones/patient/y); stone-free patients (%); reduction in calciuria and oxaluria	Stone-free patients (%)
Conclusion	Thiazide + bran superior. 3/11 (27%) stones compared with the 11/17 (65%) in the bran group.	Stones/patient/year lower in the thiazide group (0.13 versus 0.31), with statistically significant difference.	Urinary calcium decreased to 50% of the pretreatment values; stone rate improved more in the two drugs Tx groups	Recurrence of 19% (4 cases) and 7% (1 case) in groups B-C, respectively compared to 59% (10 cases) of group A, p = 0.003
Randomization	Yes; however method not described	Yes; however method not described	Yes; however method not described	Yes; however method not described
Allocation concealment	Unclear	Unclear	Unclear	Unclear
Blinding participants	No	No	No	No
Blinding outcome assessor	No	No	No	No
Loss-to-FUP	Not reported	Yes, 35/175	Yes, 11/75	No
Selective reporting	Unclear	Unclear	Unclear	No
Intention-to-treat	Yes	No	No	No
Other bias	No	No	No	No

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[1] Correspondence to: Mauricio de Carvalho. Universidade Federal do Paraná and Pontifícia Universidade Católica do Paraná. Rua General Carneiro, nº 181, Curitiba, PR, Brazil. CEP: 80060-900. E-mail: carvalho@mais.sul.com.br