Comparison of the percentage of medical success for Phytovagex vaginal suppository and Metronidazole oral tablet in women with bacterial vaginosis

Document Type : Original Article

Authors

1 Instructor, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad,Iran.

2 M.Sc. student of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran

3 Assisstant Professor, Department of Traditional Medicine, Pharmacological Research Center of Medicinal Plants, Faculty of Traditional Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Assistant Professor, Department of Pharmacology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

4 Professor, Department of Biostatistics, School of Health , Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Introduction: Bacterial Vaginosis is the most common cause of vaginitis that itself is responsible for 50% of all cases of vaginitis. Metronidazole is considered the first line for treatment, but it is reported that there is carcinogen and resistance to metronidazole. With regard to anti-bacterial effects of medicinal herbs such as Nigella sativa (the trade name of Phytovagex) on microbic organism, this study was done with aim to compare the remedial success percentage of Phytovagex vaginal suppository with Metronidazole oral tablet in women with bacterial vaginosis.
Methods: This triple-blind randomized clinical trial was done on 57 women with bacterial vaginosis referred to health centers subclass of health center No 2 in Mashhad at 2015-2016. The research units were randomly divided into intervention and control groups. The intervention group received Phytovagex vaginal suppository 1% once a day and placebo tablet twice a day for seven days, and control group received metronidazole tablet 250 mg twice a day and placebo vaginal suppository once a day for seven days. 7-10 days after treatment, the success percentage of treatment was investigated at each group by clinical standards. Data was analyzed by SPSS software (version 16) and independent t-test, Chi-square, Macnemar and Exact Fisher tests. P< 0.05 was considered significant.
Results: The success percentage of treatment of bacterial vaginosis was 74.2% in Phytovagex vaginal suppository group and 69.2% in Metronidazole tablet group that was not statistically significant (P>0.05).
Conclusions: Phytovagex vaginal suppository is as effective as Metronidazole tablet in treatment of bacterial vaginosis and can be an appropriate alternative to treat bacterial vaginosis.

Keywords

References

  1. Ryan KJ, Berkowitz RS, Barbieri RL, Dunaif A. Kistner's gynecology and women's health. New York: Mosby Incorporated; 1999.
  2. Novak E, Berek JS. Berek & Novak's gynecology. Philadelphia: Lippincott Williams & Wilkins; 2012.
  3. Hacker NF, Gambone JC, Hobel CJ. Hacker & Moore's essentials of obstetrics and gynecology. New York: Elsevier Health Sciences; 2015.
  4. Varney H, Kriebs JM, Gegor CL. Varney's midwifery. Massachusetts: Jones & Bartlett Learning; 2004. P. 445-7.
  5. Marshall JE, Raynor MD. Myles' textbook for midwives. New York: Elsevier Health Sciences; 2014.
  6. Dadhwal V, Hariprasad R, Mittal S, Kapil A. Prevalence of bacterial vaginosis in pregnant women and predictive value of clinical diagnosis. Arch Gynecol Obstet 2010; 281(1):101-4.
  7. Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001–2004 national health and nutrition examination survey data. Obstet Gynecol 2007; 109(1):114-20.
  8. Borjian S, Shojaei H, Shabanian M, Deris F. Diagnosis of gardenella associated vaginosis in Borujen women's outpatient Clinic, 2000. J Shahrekord Univ Med Sci 2002; 3(4):38-44. (Persian).
  9. Farahmand M, Abedini M, Hashemi Z. Prevalence of vaginitis in Iranian women--symptoms and clinical association. Med Sci J Islamic Azad Univ Tehran Med Branch 2012; 22(1):62-8. (Persain).
  10. Mitchell H. Vaginal discharge--causes, diagnosis, and treatment. BMJ 2004; 328(7451):1306-8.
  11. Brandt M, Abels C, May T, Lohmann K, Schmidts-Winkler I, Hoyme U. Intravaginally applied metronidazole is as effective as orally applied in the treatment of bacterial vaginosis, but exhibits significantly less side effects. Eur J Obstet Gynecol Reprod Biol 2008; 141(2):158-62.
  12. Zahiroddin R, Dibajnia P, Ershadi M. Metronidazole exacerbates Schizophrenia neuropsychiatry symptoms about two cases. J Microbiol Knowl 2009; 1(4):59-62. (Persian).
  13. Sohrabi D, Alipour M, Awsat Mellati A. Effect of metronidazole on spermatogenesis, plasma gonadotrophins and testosterone in rats. Int J Reprod BioMed 2007; 5(2):69-72
  14. Nagaraja P. Antibiotic resistance of Gardnerella vaginalis in recurrent bacterial vaginosis. Indian J Med Microbiol 2008; 26(2):155-7.
  15. Cowan MM. Plant products as antimicrobial agents. Clin Microbiol Rev 1999; 12(4):564-82.
  16. Mosaddegh M, Naghibi FI. Traditional medicine: past & present. Tradit Med Mater Med 2002; 1:2-20.
  17. Mohammadzadeh F, Dolatian M, Jorjani M, Majd HA, Borumandnia N. Comparing the therapeutic effects of garlic tablet and oral metronidazole on bacterial vaginosis: a randomized controlled clinical trial. Iran Red Crescent Med J 2014; 16(7):e19118.
  18. Mohammadzadeh Z, Mohammadalizadeh Charandabi S, Farshbaf Khalili A, Javadzadeh Y. The effect of hypericum perforatum vaginal gel in treatment of bacterial vaginosis. Iran J Obstet Gynecol Infertil 2013; 16(56):17-27. (Persian).
  19. Simbar M, Azarbad Z, Mojab F, Majd HA. A comparative study of the therapeutic effects of the Zataria multiflora vaginal cream and metronidazole vaginal gel on bacterial vaginosis. Phytomedicine 2008; 15(12):1025-31.
  20. Nickavar B, Mojab F, Javidnia K, Amoli MA. Chemical composition of the fixed and volatile oils of Nigella sativa L. from Iran. Z Naturforsch C 2003; 58(9-10):629-31.
  21. El-Dakhakhny M, Madi N, Lembert N, Ammon H. Nigella sativa oil, nigellone and derived thymoquinone inhibit synthesis of 5-lipoxygenase products in polymorphonuclear leukocytes from rats. J Ethnopharmacol 2002; 81(2):161-4.
  22. Vahdati-Mashhadian N, Rakhshandeh H, Omidi A. An investigation on LD50 and subacute hepatic toxicity of Nigella sativa seed extracts in mice. Pharmazie 2005; 60(7):544-7.
  23. Hosseinzadeh H, Fazly Bazzaz BS, Haghi MM. Antibacterial activity of total extracts and essential oil of Nigella sativa L. seeds in mice. Pharmacologyonline 2007; 2:429-35.
  24. Bakathir HA, Abbas NA. Detection of the antibacterial effect of nigella sativa ground seedswith water. Afr J Tradit Complement Altern Med 2011; 8(2):159-64.
  25. Sabzali S, Bakhtiyari S, Rostamzad A, Zamanian Azodi M. Comparison of antibacterial effect of Thymbra spicata’s essential oils with common therapeutic antibiotics. Res Med 2013; 36(5):1-6.
  26. Alves P, Castro J, Sousa C, Cereija TB, Cerca N. Gardnerella vaginalis outcompetes 29 other bacterial species isolated from patients with bacterial vaginosis, using in an in vitro biofilm formation model. J Infect Dis 2014; 210(4):593-6.
  27. Chaieb K, Kouidhi B, Jrah H, Mahdouani K, Bakhrouf A. Antibacterial activity of Thymoquinone, an active principle of Nigella sativa and its potency to prevent bacterial biofilm formation. BMC Complement Altern Med 2011; 11(1):29.
  28. Delirejh N, Morshedi A, Athari SS. Survey of the effect of powder nigella sativa (black seed) in increscent of monocyte phagocytosis in quinea pig. Horizon Med Sci 2010; 16(3):55-63.
  29. Agarwal R, Kharya MD, Shrivastava R. Antimicrobial & anthelmintic activities of the essential oil of Nigella sativa Linn. Indian J Exp Biol 1979; 17(11):1264-5.
  30. Sovizi B. comparison of the effect of Nigella Sative suppository with Clotrimazole vaginal tablet in treatment of vaginal candidiasis. [PhD Dissertation]. Mashhad, Iran: Mashhad University of Medical Sciences, School of Medicine; 2007. (Persian).
  31. Akloul R, Benkaci-Ali F, Zerrouki M, Eppe G. Composition and biological activities of the essential oil of Nigella sativa seeds isolated by accelerated microwave steam distillation with cryogenic grinding. Am J Essent Oils Natur Prod 2014; 1(3):23-33.
  32. El-Tahir KE, Bakeet DM. The black seed Nigella sativa Linnaeus-A mine for multi cures: a plea for urgent clinical evaluation of its volatile oil. J Taibah Univ Med Sci 2006; 1(1):1-19.
  33. Morsi NM. Antimicrobial effect of crude extracts of Nigella sativa on multiple antibiotics-resistant bacteria. Acta Microbiol Pol 2000; 49(1):63-74.
  34. Hanafy MS, Hatem ME. Studies on the antimicrobial activity of Nigella sativa seed (black cumin). J Ethnopharmacol 1991; 34(2-3):275-8.
  35. Arici M, Sagdic O, Gecgel U. Antibacterial effect of Turkish black cumin (Nigella sativa L.) oils. Grasas Aceit 2005; 56(4):259-62.
  36. Salman MT, Khan RA, Shukla I. Antimicrobial activity of Nigella sativa Linn. seed oil against multi-drug resistant bacteria from clinical isolates. Indian J Natl Prod Res 2008; 7(1):10-4.
The Iranian Journal of Obstetrics, Gynecology and Infertility
Volume 20, Issue 3
June 2017
Pages 29-39

Files

Share

How to cite

Statistics