Evaluation of the Therapeutic Effect of 15 ppm Silver Nanoparticle Spray Compared to Clotrimazole 1% on Candida Vaginitis: A Randomized Controlled Clinical Trial
-
Maryam Aghaei
,
Maryam Kianpour
,
Farahnaz Mardanian
,
Farnoosh Farahbod
,
Fariba Fahami
,
Mehdi Ghahremantermeh
Abstract
Objective: In vitro and in vivo researches have shown that silver nanoparticles have more antimicrobial properties with a lower concentration than antifungal agents against candida vaginitis. Therefore, this study evaluated the therapeutic effect of silver nanoparticles (Nivasha spray15ppm) compared to clotrimazole 1% vaginal cream on candida vaginitis.
Materials and methods: In this clinical trial study, 110 women with confirmed candida vaginitis randomly were divided into test (n=58) and control (n=52) groups. Silver nanoparticles spray with an applicator (Nivasha 15 ppm), and clotrimazole 1% were administered to test and control groups, respectively. Then, within ten days, post-intervention checkup and patient self-reported for treatment results were recorded in checklists and the data were analyzed statistically.
Results: The improvement rate in test group (98.0%) was 1.44 times higher than in control (67.9%). Moreover, disease symptoms after the intervention (including unusual secretions, itching and burning, redness) in test group were significantly less than in the control, but there was no significant difference in the ratio of edema in two groups) p=0.071(. Furthermore, the average recovery time (days) of all symptoms in test group was lower than control (p<0.05). Finally, the rate of patients' satisfaction with the treatment process in the test group (76.9%) was more than control (46.6%) (p=0.004).
Conclusion: Nivasha spray had more effectiveness compared to the clotrimazole 1%. Therefore, it can be used as an alternative drug in the treatment of Candida vaginitis.
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2. Kent HL. Epidemiology of vaginitis. American journal of obstetrics and gynecology. 1991;165(4):1168-76.
3. Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, et al. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011;108 Suppl 1(Suppl 1):4680-7
4. Sobel JD. Bacterial vaginosis. Annu Rev Med. 2000;51:349-56.
5. Aali B, Tohidi A. Prevalence of candida vaginits among symptomatic patients in kerman. Journal of Inflammatory Diseases. 2000;4(1):42-8.
6. Turovskiy Y, Sutyak Noll K, Chikindas ML. The aetiology of bacterial vaginosis. Journal of applied microbiology. 2011;110(5):1105-28.
7. Schumann JA, Plasner S. Trichomoniasis. StatPearls [Internet]: StatPearls Publishing; 2021.
8. Akbarzadeh M, Bonyadpoure B, Pacshir K, Mohagheghzadeh A. Causes and clinical symptoms of vaginal candidiasis in patients referring to selective clinics of Shiraz University of Medical Sciences (2009). Journal of Arak University of Medical Sciences. 2010;13(3):12-20.
9. Vacheva-Dobrevski R, Kovachev S, Nacheva A, Stoev S, Vasilev N. Comparative study of itraconazole and fluconazole therapy in vaginal candidosis. Akush Ginekol (Sofiia). 2004;43(1):20-3.
10. Mashburn J. Vaginal infections update. J Midwifery Womens Health. 2012;57(6):629-34.
11. Ece G, Samlioglu P, Akkoclu G, Atalay S, Kose S. The evaluation of the distribution of yeast like fungi'Candida Species' at a tertiary care center in western Turkey. International Journal of Medical Sciences. 2012;9(7):617.
12. Mohmmed HR, Musa JA, Mhawish MZ, Hussein FJ, Kareem ZH. COMPARATIVE STUDY OF CADIDA ALBICANS IN IRAQ. World Bulletin of Public Health. 2022;9:142-8.
13. Hosseini SS, Ghaemi E, Niknejad F, Joshaghani H, Rabiee M, Azadi F, et al. Investigation of the relationship between different Candida species and some risk factors affecting the incidence of Vulvovaginal Candidiasis. The Iranian Journal of Obstetrics, Gynecol Infert. 2019;22(7):13-22.
14. Sasani E, Rafat Z, Ashrafi K, Salimi Y, Zandi M, Soltani S, Hashemi F, Hashemi SJ. Vulvovaginal candidiasis in Iran: A systematic review and meta-analysis on the epidemiology, clinical manifestations, demographic characteristics, risk factors, etiologic agents and laboratory diagnosis. Microbial pathogenesis. 2021;154:104802.
15. Sobel JD, Suprapaneni S. Candida parapsilosis vaginal infection—a new site of azole drug resistance. Curr Infect Dis Rep. 2018; 20(11):43.
16. Parveen SD. An approach to etiology, diagnosis and management of different types of candidiasis. Journal of Yeast and Fungal Research. 2013;4(6):63-74.
17. Saturnino A, Sisenando H, Pereira AR, Vale A, Pires LM, de Araújo JT, et al. vulvovaginitis: Vaginal ph changes and associated microflora. Acta Cir Bras. 2005;20:266-9.
18. Bonyadpour B, Akbarzdeh M, Mohagheghzadeh AA. Characterization of Candida species isolated from cases of vulvovaginitis in women referring to selected gynecological clinics. Journal of Midwifery and Reproductive Health. 2016;4(4):741-7.
19. Hainer BL, Gibson MV. Vaginitis: diagnosis and treatment. American family physician. 2011;83(7):807-15.
20. Arastehfar A, Kargar ML, Mohammadi SR, Roudbary M, Ghods N, Haghighi L, Daneshnia F, Tavakoli M, Jafarzadeh J, Hedayati MT, Wang H. A high rate of recurrent vulvovaginal candidiasis and therapeutic failure of azole derivatives among Iranian women. Frontiers in microbiology. 2021;12:655069.
21. Shakuntala C, Kaur KP. SHORT ANOVAGINAL DISTANCE, A RISK FACTOR FOR RECURRENT VAGINITIS. INDIAN JOURNAL OF SEXUALLY TRANSMITTED DISEASES. 2005;26(1):33.
22. Rahimzadeh-Torabi L, Doudi M, Naghsh N, Golshani Z. Comparing the antifungal effects of gold and silver nanoparticles isolated from patients with vulvovaginal candidiasis in-vitro. KAUMS Journal (FEYZ). 2016;20(4):331-9.
23. Sánchez-Moreno P, De Vicente J, Nardecchia S, Marchal JA, Boulaiz H. Thermo-sensitive nanomaterials: recent advance in synthesis and biomedical applications. Nanomaterials. 2018;8(11):935.
24. Barkat MA, Beg S, Naim M, Pottoo FH, Singh SP, Ahmad FJ. Current progress in synthesis, characterization and applications of silver nanoparticles: precepts and prospects. Recent Patents on Anti-Infective Drug Discovery. 2018;13(1):53-69.
25. Mohammed AE, Al-Qahtani A, Al-Mutairi A, Al-Shamri B, Aabed K. Antibacterial and cytotoxic potential of biosynthesized silver nanoparticles by some plant extracts. Nanomaterials. 2018;8(6):382.
26. Jafarzadeh M, Salouti M, Shokri R. Antifungal Activity of Silver Nanoparticles, Copper Nanoparticles, Their Combination and with Amphotericin B against Candida glabrata In vitro and In vivo. Journal of Arak University of Medical Sciences. 2017;20(6):12-21.
27. Lotfali E, Toreyhi H, Sharabiani KM, Fattahi A, Soheili A, Ghasemi R, et al. Comparison of antifungal properties of gold, silver, and selenium nanoparticles against amphotericin b-resistant Candida glabrata clinical isolates. Avicenna Journal of Medical Biotechnology. 2021;13(1):47.
28. Dodangeh N, Kheirkhah M, Abolghasemi J, Mojab F, Farshad F. Comparison of the effects of glycyrrhiza glabra vaginal cream and clotrimazole on the symptoms of fungal vulvovaginitis. Iran Journal of Nursing. 2019;32(117):24-34.
29. Boroumand Z, Golmakani N, Mazloum SR, Dadgar S, Golmohamadzadeh S. The effect of spray silver nanoparticles (Nivasha) on intensity of cesarean wound pain; A randomized clinical trial. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2018;21(9):83-92.
30. Patra JK, Das G, Fraceto LF, Campos EVR, Rodriguez-Torres MdP, Acosta-Torres LS, et al. Nano based drug delivery systems: recent developments and future prospects. J Nanobiotechnology. 2018;16(1):71.
31. Panáček A, Kolář M, Večeřová R, Prucek R, Soukupová J, Kryštof V, et al. Antifungal activity of silver nanoparticles against Candida spp. Biomaterials. 2009;30(31):6333-40.
32. Perween N, Khan H, Fatima N. Silver nanoparticles: an upcoming therapeutic agent for the resistant Candida infections. J Microbiol Exp. 2019;7:49-54.
33. Kim K-J, Sung WS, Suh BK, Moon S-K, Choi J-S, Kim JG, et al. Antifungal activity and mode of action of silver nano-particles on Candida albicans. Biometals. 2009;22(2):235-42.
34. Jia D, Sun W. Silver nanoparticles offer a synergistic effect with fluconazole against fluconazole-resistant Candida albicans by abrogating drug efflux pumps and increasing endogenous ROS. Infect Genet Evol. 2021;93:104937.
35. Nasrollahi A, Pourshamsian K, Mansourkiaee P. Antifungal activity of silver nanoparticles on some of fungi. 2011:233-239.
36. Lopez-Carrizales M, Velasco KI, Castillo C, Flores A, Magaña M, Martinez-Castanon GA, et al. In vitro synergism of silver nanoparticles with antibiotics as an alternative treatment in multiresistant uropathogens. Antibiotics. 2018;7(2):50.
37. Mbakwem-Aniebo C, Osadebe AU, Athanasonny E, Okonko IO. Prevalence of Candida spp. and age-related disparities amongst women presenting with vaginitis at the Obstetrics and Gynaecology (O&G) Clinic in a Tertiary hospital in Port Harcourt, Nigeria. African Health Sciences. 2020;20(1):51-8.
38. Emeribe AU, Nasir IA, Onyia J, Ifunanya AL. Prevalence of vulvovaginal candidiasis among nonpregnant women attending a tertiary health care facility in Abuja, Nigeria. Research and Reports in Tropical Medicine. 2015;6:37-42.
39. Alo M, Anyim C, Onyebuchi A, Okonkwo E. Prevalence of asymptomatic co-infection of candidiasis and vaginal trichomoniasis among pregnant women in Abakaliki, South-Eastern Nigeria. Prevalence. 2012;2(7):87-91.
40. Zeng X, Zhang Y, Zhang T, Xue Y, Xu H, An R. Risk
factors of vulvovaginal candidiasis among women of reproductive age in Xi’an: a cross-sectional study. Biomed Res Int. 2018;2018:9703754.
41. Meneses ML, Recalde M, Martin PL, Pardo AG. Antifungal activity of silver nanoparticles and clotrimazole against Candida spp. Brazilian Journal of Pharmaceutical Sciences. 2022;58.
42. Husni R, Chrabieh R, Dib RW, Vazquez J, Guimaraes T, Fernández A, et al. Timing for step-down therapy of candidemia in non-neutropenic patients: an international multi-center study. Mediterr J Hematol Infect Dis. 2021;13(1):e2021031.
2. Kent HL. Epidemiology of vaginitis. American journal of obstetrics and gynecology. 1991;165(4):1168-76.
3. Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, et al. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011;108 Suppl 1(Suppl 1):4680-7
4. Sobel JD. Bacterial vaginosis. Annu Rev Med. 2000;51:349-56.
5. Aali B, Tohidi A. Prevalence of candida vaginits among symptomatic patients in kerman. Journal of Inflammatory Diseases. 2000;4(1):42-8.
6. Turovskiy Y, Sutyak Noll K, Chikindas ML. The aetiology of bacterial vaginosis. Journal of applied microbiology. 2011;110(5):1105-28.
7. Schumann JA, Plasner S. Trichomoniasis. StatPearls [Internet]: StatPearls Publishing; 2021.
8. Akbarzadeh M, Bonyadpoure B, Pacshir K, Mohagheghzadeh A. Causes and clinical symptoms of vaginal candidiasis in patients referring to selective clinics of Shiraz University of Medical Sciences (2009). Journal of Arak University of Medical Sciences. 2010;13(3):12-20.
9. Vacheva-Dobrevski R, Kovachev S, Nacheva A, Stoev S, Vasilev N. Comparative study of itraconazole and fluconazole therapy in vaginal candidosis. Akush Ginekol (Sofiia). 2004;43(1):20-3.
10. Mashburn J. Vaginal infections update. J Midwifery Womens Health. 2012;57(6):629-34.
11. Ece G, Samlioglu P, Akkoclu G, Atalay S, Kose S. The evaluation of the distribution of yeast like fungi'Candida Species' at a tertiary care center in western Turkey. International Journal of Medical Sciences. 2012;9(7):617.
12. Mohmmed HR, Musa JA, Mhawish MZ, Hussein FJ, Kareem ZH. COMPARATIVE STUDY OF CADIDA ALBICANS IN IRAQ. World Bulletin of Public Health. 2022;9:142-8.
13. Hosseini SS, Ghaemi E, Niknejad F, Joshaghani H, Rabiee M, Azadi F, et al. Investigation of the relationship between different Candida species and some risk factors affecting the incidence of Vulvovaginal Candidiasis. The Iranian Journal of Obstetrics, Gynecol Infert. 2019;22(7):13-22.
14. Sasani E, Rafat Z, Ashrafi K, Salimi Y, Zandi M, Soltani S, Hashemi F, Hashemi SJ. Vulvovaginal candidiasis in Iran: A systematic review and meta-analysis on the epidemiology, clinical manifestations, demographic characteristics, risk factors, etiologic agents and laboratory diagnosis. Microbial pathogenesis. 2021;154:104802.
15. Sobel JD, Suprapaneni S. Candida parapsilosis vaginal infection—a new site of azole drug resistance. Curr Infect Dis Rep. 2018; 20(11):43.
16. Parveen SD. An approach to etiology, diagnosis and management of different types of candidiasis. Journal of Yeast and Fungal Research. 2013;4(6):63-74.
17. Saturnino A, Sisenando H, Pereira AR, Vale A, Pires LM, de Araújo JT, et al. vulvovaginitis: Vaginal ph changes and associated microflora. Acta Cir Bras. 2005;20:266-9.
18. Bonyadpour B, Akbarzdeh M, Mohagheghzadeh AA. Characterization of Candida species isolated from cases of vulvovaginitis in women referring to selected gynecological clinics. Journal of Midwifery and Reproductive Health. 2016;4(4):741-7.
19. Hainer BL, Gibson MV. Vaginitis: diagnosis and treatment. American family physician. 2011;83(7):807-15.
20. Arastehfar A, Kargar ML, Mohammadi SR, Roudbary M, Ghods N, Haghighi L, Daneshnia F, Tavakoli M, Jafarzadeh J, Hedayati MT, Wang H. A high rate of recurrent vulvovaginal candidiasis and therapeutic failure of azole derivatives among Iranian women. Frontiers in microbiology. 2021;12:655069.
21. Shakuntala C, Kaur KP. SHORT ANOVAGINAL DISTANCE, A RISK FACTOR FOR RECURRENT VAGINITIS. INDIAN JOURNAL OF SEXUALLY TRANSMITTED DISEASES. 2005;26(1):33.
22. Rahimzadeh-Torabi L, Doudi M, Naghsh N, Golshani Z. Comparing the antifungal effects of gold and silver nanoparticles isolated from patients with vulvovaginal candidiasis in-vitro. KAUMS Journal (FEYZ). 2016;20(4):331-9.
23. Sánchez-Moreno P, De Vicente J, Nardecchia S, Marchal JA, Boulaiz H. Thermo-sensitive nanomaterials: recent advance in synthesis and biomedical applications. Nanomaterials. 2018;8(11):935.
24. Barkat MA, Beg S, Naim M, Pottoo FH, Singh SP, Ahmad FJ. Current progress in synthesis, characterization and applications of silver nanoparticles: precepts and prospects. Recent Patents on Anti-Infective Drug Discovery. 2018;13(1):53-69.
25. Mohammed AE, Al-Qahtani A, Al-Mutairi A, Al-Shamri B, Aabed K. Antibacterial and cytotoxic potential of biosynthesized silver nanoparticles by some plant extracts. Nanomaterials. 2018;8(6):382.
26. Jafarzadeh M, Salouti M, Shokri R. Antifungal Activity of Silver Nanoparticles, Copper Nanoparticles, Their Combination and with Amphotericin B against Candida glabrata In vitro and In vivo. Journal of Arak University of Medical Sciences. 2017;20(6):12-21.
27. Lotfali E, Toreyhi H, Sharabiani KM, Fattahi A, Soheili A, Ghasemi R, et al. Comparison of antifungal properties of gold, silver, and selenium nanoparticles against amphotericin b-resistant Candida glabrata clinical isolates. Avicenna Journal of Medical Biotechnology. 2021;13(1):47.
28. Dodangeh N, Kheirkhah M, Abolghasemi J, Mojab F, Farshad F. Comparison of the effects of glycyrrhiza glabra vaginal cream and clotrimazole on the symptoms of fungal vulvovaginitis. Iran Journal of Nursing. 2019;32(117):24-34.
29. Boroumand Z, Golmakani N, Mazloum SR, Dadgar S, Golmohamadzadeh S. The effect of spray silver nanoparticles (Nivasha) on intensity of cesarean wound pain; A randomized clinical trial. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2018;21(9):83-92.
30. Patra JK, Das G, Fraceto LF, Campos EVR, Rodriguez-Torres MdP, Acosta-Torres LS, et al. Nano based drug delivery systems: recent developments and future prospects. J Nanobiotechnology. 2018;16(1):71.
31. Panáček A, Kolář M, Večeřová R, Prucek R, Soukupová J, Kryštof V, et al. Antifungal activity of silver nanoparticles against Candida spp. Biomaterials. 2009;30(31):6333-40.
32. Perween N, Khan H, Fatima N. Silver nanoparticles: an upcoming therapeutic agent for the resistant Candida infections. J Microbiol Exp. 2019;7:49-54.
33. Kim K-J, Sung WS, Suh BK, Moon S-K, Choi J-S, Kim JG, et al. Antifungal activity and mode of action of silver nano-particles on Candida albicans. Biometals. 2009;22(2):235-42.
34. Jia D, Sun W. Silver nanoparticles offer a synergistic effect with fluconazole against fluconazole-resistant Candida albicans by abrogating drug efflux pumps and increasing endogenous ROS. Infect Genet Evol. 2021;93:104937.
35. Nasrollahi A, Pourshamsian K, Mansourkiaee P. Antifungal activity of silver nanoparticles on some of fungi. 2011:233-239.
36. Lopez-Carrizales M, Velasco KI, Castillo C, Flores A, Magaña M, Martinez-Castanon GA, et al. In vitro synergism of silver nanoparticles with antibiotics as an alternative treatment in multiresistant uropathogens. Antibiotics. 2018;7(2):50.
37. Mbakwem-Aniebo C, Osadebe AU, Athanasonny E, Okonko IO. Prevalence of Candida spp. and age-related disparities amongst women presenting with vaginitis at the Obstetrics and Gynaecology (O&G) Clinic in a Tertiary hospital in Port Harcourt, Nigeria. African Health Sciences. 2020;20(1):51-8.
38. Emeribe AU, Nasir IA, Onyia J, Ifunanya AL. Prevalence of vulvovaginal candidiasis among nonpregnant women attending a tertiary health care facility in Abuja, Nigeria. Research and Reports in Tropical Medicine. 2015;6:37-42.
39. Alo M, Anyim C, Onyebuchi A, Okonkwo E. Prevalence of asymptomatic co-infection of candidiasis and vaginal trichomoniasis among pregnant women in Abakaliki, South-Eastern Nigeria. Prevalence. 2012;2(7):87-91.
40. Zeng X, Zhang Y, Zhang T, Xue Y, Xu H, An R. Risk
factors of vulvovaginal candidiasis among women of reproductive age in Xi’an: a cross-sectional study. Biomed Res Int. 2018;2018:9703754.
41. Meneses ML, Recalde M, Martin PL, Pardo AG. Antifungal activity of silver nanoparticles and clotrimazole against Candida spp. Brazilian Journal of Pharmaceutical Sciences. 2022;58.
42. Husni R, Chrabieh R, Dib RW, Vazquez J, Guimaraes T, Fernández A, et al. Timing for step-down therapy of candidemia in non-neutropenic patients: an international multi-center study. Mediterr J Hematol Infect Dis. 2021;13(1):e2021031.
| Files | ||
| Issue | Vol 17, No 4 (December 2023) | |
| Section | Original Articles | |
| DOI | https://doi.org/10.18502/jfrh.v17i4.14598 | |
| Keywords | ||
| Silver Nanoparticles Candida Vaginitis Clotrimazole In vitro In vivo | ||
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How to Cite
1.
Aghaei M, Kianpour M, Mardanian F, Farahbod F, Fahami F, Ghahremantermeh M. Evaluation of the Therapeutic Effect of 15 ppm Silver Nanoparticle Spray Compared to Clotrimazole 1% on Candida Vaginitis: A Randomized Controlled Clinical Trial. J Family Reprod Health. 2023;17(4):255-263.
