Report an error   


Submitted: 05 June 2013 Modified: 29 May 2017
HERDIN Record #: PCHRD13060512552821

A prospective six-week randomized controlled trial on the efficacy and safety of sodium bicarbonate, citric acid, sodium citrate, and tartaric acid compound compared to potassium citrate in the dissolution of renal stones.

1Michael E. Chua,
2Manuel C. See IV,
3Saturnino L. Luna Jr.
Institute of Urology - St. Luke's Medical Center

Abstract

OBJECTIVE: To determine the efficacy and safety of sodium bicarbonate, citric acid, sodium citrate, and tartaric acid (compound drug) in comparison to potassium citrate in the treatment of kidney stones.


METHODS: Prospective randomized controlled trial of patients with kidney stones recruited from February to October 2011 at Out-patient Department was conducted. Ninety subjects, consented and eligible, were enrolled in this study. Random allocation of subjects into two groups was done using computer generated randomization. Subjects assigned to group I were treated with the compound drug(12 grams/day); while group II subjects were given potassium citrate(60mEq/day) for 6 weeks. Urinary pH levels were examined weekly and the effect of medical treatment on stone size changes was evaluated by ultrasonography every two weeks in the six-week treatment period. Intention to treat analysis was done with 95% confidence level(CI). Statistical analysis of results was determined using analysis of variance (ANOVA) with multiple repeated measures for between group urinary pH changes and chi square for between groups difference in stone size changes.


RESULTS: A total of 74 subjects completed the study with a dropout rate of 18%, which was mainly due to geographic and financial reasons. Demographic and baseline stone characteristics of both groups were not significantly different. Treatment outcome between the two groups based on stone size changes (in general and both radiolucent and radioopaque stones subgroups) did not show any significant statistic difference. The pH level changes over six-week treatment period between the two groups showed a total mean pH difference of 0.445, (95% CI: 0.213, 0.677), which was statistically significant (P<0.001) in favor of Group I. Both treatment regimens were well-tolerated with very few non-serious medication adverse effects.


CONCLUSION:  Urinary alkalinization with sodium bicarbonate, citric acid, sodium citrate, and tartaric acid is a well-tolerated and highly effective treatment resulting in dissolution of non-obstructing kidney stones and is comparable to the gold standard potassium citrate.

1.
Publication Type:
Journal
Publication Sub Type:
Journal Article, Original
Title:
Philippine Journal of Urology
Frequency:
Semi-Annual
Publication Date:
January-June 2012
Volume:
22
Issue:
1
Page(s):
6-12
Publisher:
Philippine Urological Association

LocationCall NumberAvailable FormatAvailability
Philippine Council for Health Research and Development Library Fulltext (Request Document)
1. Pak, CY C, Fuller , C , Sakhaee, K , Preminger, G M, Britton , F . "Long-term treatment of calcium nephrolithiasis with potassium citrate. " J Urol 134, 11, 1985
2. Cameron , M . "Uric acid nephrolithiasis. " Urol Clin N Am 34, 335-336, 2007
3. Caudarella, R . "Urinary citrate and renal stone disease: The preventive role of alkali citrate treatment. " Arch Ital Urol Androl 81(3): 182-187, 2009
4. "Inhibition of growth of urinary type calcium hydrogen phosphate dihydrate crystals by tartaric acid and tamarind. " Current Science 88, 1232-1238, 2005
5. Walsh PC, Retic AB (editors): Campbell. Philadelphia: WB Saunders Co, 2011.
6. Preminger, G M, Harvey , J A, Pak, CY C. "Comparative efficacy of "specific" potassium citrate therapy versus conservative management in nephrolithiasis of mild to moderate severity. " J Urol 134, 658, 1985
7. Barcelo , P , Wuhl , 0 , Servitge, E , Rousaud , A , Pak, CY C. "Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis. " J Urol 150, 1761, 1993
8. Arcinas, R , Bolong, D . "The effect of alkali citrate as medical treatment in the prevention and dissolution of calcium nephrolithiasis: A meta-analysis of randomized controlled trials. " JUrol 185(4): 895, 2011
9. Premgamone , A , Sriboonlue, P , Disatapornjaroen, W , Maskasem , S , Sinsupan , N , Apinives , C . "A long-term study on the efficacy of a herbal plant, Orthosiphon grandiflorus, and sodium potassium citrate in renal calculi treatment. " Southeast Asian J Trop Med Public Health 32(3): 654-660, 2001
10. Finlayson, B . "Stability of first dissociable proton of uric acid. " J Chem Engin Data 19, 94-97, 1994
11. Davids , M R, Edoute , Y , Jungas , R L. "Facilitating an understanding of integrative physiology: Emphasis on the composition of body fluid compartments. " Can J Physiol Pharmacol 80, 835-850, 2002
12. Trinchieri , A . "Dissolution of radiolucent renal stones by oral alkalinization with potassium citrate/ potassium bicarbonate." Arch Ital Urol Androl 81(3): 188-191, 2009
13. Pak, CY C. "Citraturic response to oral citric acid load." J Urol 147, 975, 1992
14. Tiselius, H G. "The effect of pH on the urinary inhibition of calcium oxalate crystal growth. " Br J Urol 53, 470, 1981
15. Pak, CY C, Fuller , C . "Idiopathic hypocitraturic calcium oxalate nephrolithiasis successfully treated with potassium citrate. " Ann Intern Med 104, 33, 1986
16. Rumenapf , G , Schwille , P O. "The influence of oral alkali citrate on intestinal calcium absorption in healthy man. " Clin Sci 73, 117, 1987
17. Hofbauer, J , Hobarth , K . "Alkali citrate prophylaxis in idiopathic recurrent calcium oxalate urolithiasis-a prospective randomized study. " Br J Urol 73, 362, 1994
18. Berg, C , Larsson, L , Tiselius, H G. "Effects of different doses of alkaline citrate on urine composition and crystallization of calcium oxalate." Br J Urol 18, 13, 1990