Skip to main content
Top
Published in: Clinical Phytoscience 1/2015

Open Access 01-12-2015 | Original contribution

Safety of Canephron® N for the treatment of urinary tract infections in the first trimester of pregnancy

Author: Volodymir Medved

Published in: Clinical Phytoscience | Issue 1/2015

Login to get access

Abstract

Background

Urinary tract infections (UTIs) are among the most commonly occurring bacterial infections, particularly in pregnant women. Canephron® N (Bionorica, Germany) is a phytotherapeutic medicinal product that has pleiotrophic effects on the urinary system, including diuretic, spasmolytic, anti-inflammatory, antimicrobial and nephroprotective effects. The purpose of this retrospective study was to assess the safety of Canephron® N when used in the first trimester of pregnancy for the treatment of UTIs.

Methods

This was a retrospective, multi-center study that evaluated the effects of Canephron® N in 384 women who had used the herbal drug during the first trimester of pregnancy (between 2004 and 2009), and whose pregnancies ended in live births. The endpoints assessed in this study were the presence of congenital defects in the newborn.

Results

There were no significant differences in the incidence of congenital malformations in newborns whose mothers had taken Canephron® N in the first trimester of pregnancy, compared to the national statistical data for the Kiev population during the same period. The majority of newborns (>65 %) whose mothers had received Canephron® N during the first trimester of pregnancy had Apgar scores of 8 or above, indicating an excellent safety status.

Conclusions

The results from our study indicate that the use of Canephron® N during the first trimester of pregnancy was not associated with any teratogenic, embryotoxic or fetotoxic effects on the fetus.
Literature
1.
go back to reference Matuszkiewicz-Rowinska J, Malyszko J, Wieliczko M. Urinary tract infections in pregnancy: old and new unresolved diagnostic and therapeutic problems. Arch Med Sci. 2015;11:67–77.PubMedCentralCrossRefPubMed Matuszkiewicz-Rowinska J, Malyszko J, Wieliczko M. Urinary tract infections in pregnancy: old and new unresolved diagnostic and therapeutic problems. Arch Med Sci. 2015;11:67–77.PubMedCentralCrossRefPubMed
3.
go back to reference Ronald AR, Pattullo AL. The natural history of urinary infection in adults. Med Clin North Am. 1991;75:299–312.PubMed Ronald AR, Pattullo AL. The natural history of urinary infection in adults. Med Clin North Am. 1991;75:299–312.PubMed
4.
go back to reference McKenna DS, Matson S, Northern I. Maternal group B streptococcal (GBS) genital tract colonization at term in women who have asymptomatic GBS bacteriuria. Infect Dis Obstet Gynecol. 2003;11:203–7.PubMedCentralCrossRefPubMed McKenna DS, Matson S, Northern I. Maternal group B streptococcal (GBS) genital tract colonization at term in women who have asymptomatic GBS bacteriuria. Infect Dis Obstet Gynecol. 2003;11:203–7.PubMedCentralCrossRefPubMed
6.
go back to reference Rizvi M, Khan F, Shukla I, Malik A. Shaheen. Rising prevalence of antimicrobial resistance in urinary tract infections during pregnancy: necessity for exploring newer treatment options. J Lab Physicians. 2011;3:98–103.PubMedCentralCrossRefPubMed Rizvi M, Khan F, Shukla I, Malik A. Shaheen. Rising prevalence of antimicrobial resistance in urinary tract infections during pregnancy: necessity for exploring newer treatment options. J Lab Physicians. 2011;3:98–103.PubMedCentralCrossRefPubMed
7.
go back to reference Nahum GG, Uhl K, Kennedy DL. Antibiotic use in pregnancy and lactation: what is and is not known about teratogenic and toxic risks. Obstet Gynecol. 2006;107:1120–38.CrossRefPubMed Nahum GG, Uhl K, Kennedy DL. Antibiotic use in pregnancy and lactation: what is and is not known about teratogenic and toxic risks. Obstet Gynecol. 2006;107:1120–38.CrossRefPubMed
8.
go back to reference Pacifici GM. Placental transfer of antibiotics administered to the mother: a review. Int J Clin Pharmacol Ther. 2006;44:57–63.CrossRefPubMed Pacifici GM. Placental transfer of antibiotics administered to the mother: a review. Int J Clin Pharmacol Ther. 2006;44:57–63.CrossRefPubMed
9.
go back to reference Lamont HF, Blogg HJ, Lamont RF. Safety of antimicrobial treatment during pregnancy: a current review of resistance, immunomodulation and teratogenicity. Expert Opin Drug Saf. 2014;13:1569–81.CrossRefPubMed Lamont HF, Blogg HJ, Lamont RF. Safety of antimicrobial treatment during pregnancy: a current review of resistance, immunomodulation and teratogenicity. Expert Opin Drug Saf. 2014;13:1569–81.CrossRefPubMed
10.
go back to reference Nicolle LE. Short-term therapy for urinary tract infection: success and failure. Int J Antimicrob Agents. 2008;31 Suppl 1:S40–5.CrossRefPubMed Nicolle LE. Short-term therapy for urinary tract infection: success and failure. Int J Antimicrob Agents. 2008;31 Suppl 1:S40–5.CrossRefPubMed
11.
go back to reference Rao GA, Mann JR, Shoaibi A, Bennett CL, Nahhas G, Sutton SS, et al. Azithromycin and levofloxacin use and increased risk of cardiac arrhythmia and death. Ann Fam Med. 2014;12:121–7.PubMedCentralCrossRefPubMed Rao GA, Mann JR, Shoaibi A, Bennett CL, Nahhas G, Sutton SS, et al. Azithromycin and levofloxacin use and increased risk of cardiac arrhythmia and death. Ann Fam Med. 2014;12:121–7.PubMedCentralCrossRefPubMed
12.
go back to reference Martinez de TB. Antibiotic use and misuse during pregnancy and delivery: benefits and risks. Int J Environ Res Public Health. 2014;11:7993–8009.CrossRef Martinez de TB. Antibiotic use and misuse during pregnancy and delivery: benefits and risks. Int J Environ Res Public Health. 2014;11:7993–8009.CrossRef
13.
go back to reference Van Boeckel TP, Gandra S, Ashok A, Caudron Q, Grenfell BT, Levin SA, et al. Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data. Lancet Infect Dis. 2014;14:742–50.CrossRefPubMed Van Boeckel TP, Gandra S, Ashok A, Caudron Q, Grenfell BT, Levin SA, et al. Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data. Lancet Infect Dis. 2014;14:742–50.CrossRefPubMed
14.
go back to reference Haloui M, Louedec L, Michel JB, Lyoussi B. Experimental diuretic effects of Rosmarinus officinalis and Centaurium erythraea. J Ethnopharmacol. 2000;71:465–72.CrossRefPubMed Haloui M, Louedec L, Michel JB, Lyoussi B. Experimental diuretic effects of Rosmarinus officinalis and Centaurium erythraea. J Ethnopharmacol. 2000;71:465–72.CrossRefPubMed
15.
go back to reference Yarnell E. Botanical medicines or the urinary tract. World J Urol. 2002;20:285–95.PubMed Yarnell E. Botanical medicines or the urinary tract. World J Urol. 2002;20:285–95.PubMed
16.
go back to reference Yamahara J, Konoshima I, Sawada I, Fujimura H. Biologically active principles of crude drugs: pharmacological actions of Swertia japonica extracts, swertiamarine and gentianine. Yakugaku Zasshi. 1978;98:1446–51.PubMed Yamahara J, Konoshima I, Sawada I, Fujimura H. Biologically active principles of crude drugs: pharmacological actions of Swertia japonica extracts, swertiamarine and gentianine. Yakugaku Zasshi. 1978;98:1446–51.PubMed
17.
go back to reference Abdul-Ghani AS, El-Lati SG, Sacaan A. Anticonvulsant effects of some Arab medicinal plants. Int J Crude Drug Res. 1987;25:39–43. Abdul-Ghani AS, El-Lati SG, Sacaan A. Anticonvulsant effects of some Arab medicinal plants. Int J Crude Drug Res. 1987;25:39–43.
18.
go back to reference Gracza L, Koch H. Lo¨ffler E. Isolierung von rosmarin saure aus symphytum officinale und ihre antiinflammatorische wirksamkeit in einem in-vitro.Modell. Arch Pharm. 1985;318:1090–5.CrossRef Gracza L, Koch H. Lo¨ffler E. Isolierung von rosmarin saure aus symphytum officinale und ihre antiinflammatorische wirksamkeit in einem in-vitro.Modell. Arch Pharm. 1985;318:1090–5.CrossRef
19.
go back to reference Rampart M, Beetjens JR, Bult H. Complementdependent stimulation of prostacyclin biosynthesis; inhibition by rosmarinic acid. Biochem Pharmacol. 1986;35:1397–400.CrossRefPubMed Rampart M, Beetjens JR, Bult H. Complementdependent stimulation of prostacyclin biosynthesis; inhibition by rosmarinic acid. Biochem Pharmacol. 1986;35:1397–400.CrossRefPubMed
20.
go back to reference Valentao P, Fernandes E, Carvalho F. Hydroxyl radical and hypochlorous acid scavenging activity of small centaury (Centaurium erythraea) infusion. A comparative study with green tea (Camellia sinensis). Phytomedicine. 2003;10:517–22.CrossRefPubMed Valentao P, Fernandes E, Carvalho F. Hydroxyl radical and hypochlorous acid scavenging activity of small centaury (Centaurium erythraea) infusion. A comparative study with green tea (Camellia sinensis). Phytomedicine. 2003;10:517–22.CrossRefPubMed
21.
go back to reference European Scientific Cooperative on Phytotherapy. Centaurii herba (Centaury herb). In: ESCOP Monographs. 2nd ed. Stuttgart, Germany, and New York: Thieme-Verlag; 2003. p. 70–3. European Scientific Cooperative on Phytotherapy. Centaurii herba (Centaury herb). In: ESCOP Monographs. 2nd ed. Stuttgart, Germany, and New York: Thieme-Verlag; 2003. p. 70–3.
22.
go back to reference European Scientific Cooperative on Phytotherapy. Rosmarini folium (Rosemary leaves). In: ESCOP Monographs. 2nd ed. Stuttgart, Germany, and New York: Thieme-Verlag; 2003. p. 429–36. European Scientific Cooperative on Phytotherapy. Rosmarini folium (Rosemary leaves). In: ESCOP Monographs. 2nd ed. Stuttgart, Germany, and New York: Thieme-Verlag; 2003. p. 429–36.
23.
go back to reference Kumarasamy Y, Nahar L, Cox PJ. Bioactivity of secoiridoid glycosides from Centaurium erythraea. Phytomedicine. 2003;10:344–7.CrossRefPubMed Kumarasamy Y, Nahar L, Cox PJ. Bioactivity of secoiridoid glycosides from Centaurium erythraea. Phytomedicine. 2003;10:344–7.CrossRefPubMed
24.
go back to reference Kumarasamy Y, Nahar L, Sarker SD. Bioactivity of gentiopicroside from the aerial parts of Centaurium erythraea. Fitoterapia. 2003;74:151–4.CrossRefPubMed Kumarasamy Y, Nahar L, Sarker SD. Bioactivity of gentiopicroside from the aerial parts of Centaurium erythraea. Fitoterapia. 2003;74:151–4.CrossRefPubMed
25.
go back to reference Sterner W, Heisler E, Popp HO, Fischer H. Studien uber die canephron-wirkung bei chronischen nierenerkrankungen. Phys Med Rehabil. 1973;14:239–58. Sterner W, Heisler E, Popp HO, Fischer H. Studien uber die canephron-wirkung bei chronischen nierenerkrankungen. Phys Med Rehabil. 1973;14:239–58.
26.
go back to reference Gaybullaev AA, Kariev SS. Effects of the herbal combination Canephron® N on urinary risk factors of idiopathic calcium urolithiasis in an open study. Z Phytother. 2013;34:16–20.CrossRef Gaybullaev AA, Kariev SS. Effects of the herbal combination Canephron® N on urinary risk factors of idiopathic calcium urolithiasis in an open study. Z Phytother. 2013;34:16–20.CrossRef
27.
go back to reference Naber KG. Efficacy and safety of the phytotherapeutic drug Canephron® N in prevention and treatment of urogenital and gestational disease: review of clinical experience in Eastern Europe and Central Asia. Res Rep Urol. 2013;5:39–46.PubMedCentralPubMed Naber KG. Efficacy and safety of the phytotherapeutic drug Canephron® N in prevention and treatment of urogenital and gestational disease: review of clinical experience in Eastern Europe and Central Asia. Res Rep Urol. 2013;5:39–46.PubMedCentralPubMed
28.
go back to reference Bai J, Wong FW, Bauman A, Mohsin M. Parity and pregnancy outcomes. Am J Obstet Gynecol. 2002;186:274–8.CrossRefPubMed Bai J, Wong FW, Bauman A, Mohsin M. Parity and pregnancy outcomes. Am J Obstet Gynecol. 2002;186:274–8.CrossRefPubMed
30.
go back to reference Casey BM, McIntire DD, Leveno KJ. The continuing value of the Apgar score for the assessment of newborn infants. N Engl J Med. 2001;344:467–71.CrossRefPubMed Casey BM, McIntire DD, Leveno KJ. The continuing value of the Apgar score for the assessment of newborn infants. N Engl J Med. 2001;344:467–71.CrossRefPubMed
31.
go back to reference Gilbert NM, O’Brien VP, Hultgren S, Macones G, Lewis WG, Lewis AL. Urinary tract infection as a preventable cause of pregnancy complications: opportunities, challenges, and a global call to action. Glob Adv Health Med. 2013;2:59–69.PubMedCentralCrossRefPubMed Gilbert NM, O’Brien VP, Hultgren S, Macones G, Lewis WG, Lewis AL. Urinary tract infection as a preventable cause of pregnancy complications: opportunities, challenges, and a global call to action. Glob Adv Health Med. 2013;2:59–69.PubMedCentralCrossRefPubMed
32.
go back to reference Schnarr J, Smaill F. Asymptomatic bacteriuria and symptomatic urinary tract infections in pregnancy. Eur J Clin Invest. 2008;38 Suppl 2:50–7.CrossRefPubMed Schnarr J, Smaill F. Asymptomatic bacteriuria and symptomatic urinary tract infections in pregnancy. Eur J Clin Invest. 2008;38 Suppl 2:50–7.CrossRefPubMed
33.
go back to reference Bolton M, Horvath Jr DJ, Li B, Cortado H, Newsom D, White P, et al. Intrauterine growth restriction is a direct consequence of localized maternal uropathogenic Escherichia coli cystitis. PLoS One. 2012;7:e33897.PubMedCentralCrossRefPubMed Bolton M, Horvath Jr DJ, Li B, Cortado H, Newsom D, White P, et al. Intrauterine growth restriction is a direct consequence of localized maternal uropathogenic Escherichia coli cystitis. PLoS One. 2012;7:e33897.PubMedCentralCrossRefPubMed
34.
go back to reference Gilbert-Barness E. Teratogenic causes of malformations. Ann Clin Lab Sci. 2010;40:99–114.PubMed Gilbert-Barness E. Teratogenic causes of malformations. Ann Clin Lab Sci. 2010;40:99–114.PubMed
35.
go back to reference Medved VI, Bykova LM, Danylkiv OE, Shkabarovskaya EN. Pathogenic justification and efficiency of improved therapy of pyelonephritis in pregnant women with diabetes mellitus. Womens Reprod Health. 2015;2:35–8. Medved VI, Bykova LM, Danylkiv OE, Shkabarovskaya EN. Pathogenic justification and efficiency of improved therapy of pyelonephritis in pregnant women with diabetes mellitus. Womens Reprod Health. 2015;2:35–8.
36.
go back to reference Ordzhonikidze NV, Yemelyanova AI, Petrova SB. Complication prevention and treatment in pregnants and puerperants with urinary tract diseases. Obstet Gynecol. 2009;6:41–5. Ordzhonikidze NV, Yemelyanova AI, Petrova SB. Complication prevention and treatment in pregnants and puerperants with urinary tract diseases. Obstet Gynecol. 2009;6:41–5.
37.
go back to reference Potapo VA, Demchenko TV, Medvedev MV. Pathogenetic therapy of gestational toxicosis in patients with renal disease. Health Ukraine. 2004;5:1–2. Potapo VA, Demchenko TV, Medvedev MV. Pathogenetic therapy of gestational toxicosis in patients with renal disease. Health Ukraine. 2004;5:1–2.
38.
go back to reference Medved VI, Islamova EV. To the question on safety of the preparation Canephron® N in the obstetric practice. Med Aspects Womens Health. 2009;4:32–5. Medved VI, Islamova EV. To the question on safety of the preparation Canephron® N in the obstetric practice. Med Aspects Womens Health. 2009;4:32–5.
39.
go back to reference Repina MA, Kolchina VA, Kuzmina-Krutetskaya SR, Stambulova OA, Golubenko NA. Phytopreparations in the treatment of renal diseases in pregnant women and long-term safety results in born children. J Obstet Womens Dis. 2006;1:50–6. Repina MA, Kolchina VA, Kuzmina-Krutetskaya SR, Stambulova OA, Golubenko NA. Phytopreparations in the treatment of renal diseases in pregnant women and long-term safety results in born children. J Obstet Womens Dis. 2006;1:50–6.
Metadata
Title
Safety of Canephron® N for the treatment of urinary tract infections in the first trimester of pregnancy
Author
Volodymir Medved
Publication date
01-12-2015
Publisher
Springer Berlin Heidelberg
Published in
Clinical Phytoscience / Issue 1/2015
Electronic ISSN: 2199-1197
DOI
https://doi.org/10.1186/s40816-015-0012-1

Other articles of this Issue 1/2015

Clinical Phytoscience 1/2015 Go to the issue