Effect of a novel herbal vaginal suppository containing myrtle and oak gall in the treatment of vaginitis: a randomized clinical trial

Abstract

Background

Uncomplicated infections such as candidiasis, bacterial vaginosis (BV), or trichomoniasis are easy to diagnose and treat. However, about 8% of patients will have a more complicated course with failure to respond to treatment or rapid recurrence of symptoms. There are many suggestions in Traditional Persian Medicine like myrtle (Myrtus communis L.) and oak gall (Quercus infectoria G.Olivier) for treatment of vaginitis.

Objectives

A clinical trial was designed to assess the efficacy of a novel herbal suppository, containing myrtle and oak gall (MOGS) in treatment of vaginitis.

Methods

In a parallel randomized clinical trial, 120 women with vaginitis were randomly assigned to MOGS, metronidazole, or placebo. Formulation was simulated from traditional Persian manuscripts and MGOS was prepared after pharmaceutical optimization processing as well as quantification of gallic acid by HPLC. The study was double-blind for MOGS and placebo and single-blind for metronidazole group.

Results

MOGS effectively improved vaginal discharge (p = 0.024 for BV and 0.018 for trichomoniasis) and pH (compared to placebo (p = 0.013) and metronidazole (p = 0.001)). Both MOGS and metronidazole could reverse whiff test. Metronidazole was the best medication for making Nugent score negative (p = 0.005) as well as the best therapy according to laboratory findings to treat BV in comparison with placebo (p = 0.021). While for trichomoniasis, MOGS could improve the disease more successfully (p = 0.001). Both MOGS and metronidazole treated mixed vaginitis (p = 0.002).

Conclusion

MOGS would be a chance for developing new treatment for trichomoniasis.

Graphical abstract

This is a preview of subscription content, log in to check access.

Fig. 1

Abbreviations

ADR:

Adverse Drug Reaction

BMI:

Body Mass Index

BV:

Bacterial vaginosis

CAM:

Complementary and Alternative Medicine

Dif:

difference

MOGS:

Myrtle and Oak Gall suppository

PEG:

Polyethylene glycol

TPM:

Traditional Persian Medicine

TV:

Trichomonas vaginitis

References

  1. 1.

    Mills BB. Vaginitis: beyond the basics. Obstet Gynecol Clin N Am. 2017;44:159–77. https://doi.org/10.1016/j.ogc.2017.02.010.

    Article  Google Scholar 

  2. 2.

    Paladine HL, Desai UA. Vaginitis: diagnosis and treatment. Am Fam Physician. 2018;97(5):321–9.

    PubMed  Google Scholar 

  3. 3.

    Bautista CT, Wurapa E, Sateren WB, Morris S, Hollingsworth B, Sanchez JL. Bacterial vaginosis: a synthesis of the literature on etiology, prevalence, risk factors, and relationship with chlamydia and gonorrhea infections. Mil Med Res. 2016;3. https://doi.org/10.1186/s40779-016-0074-5.

  4. 4.

    van Schalkwyk J, Yudin MH, Allen V, Bouchard C, Boucher M, Boucoiran I, et al. Vulvovaginitis: screening for and management of trichomoniasis, vulvovaginal candidiasis, and bacterial vaginosis. J Obstet Gynaecol Can. 2015;37:266–74. https://doi.org/10.1016/S1701-2163(15)30316-9.

    PubMed  Article  Google Scholar 

  5. 5.

    Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol. 1988;158:819–28. https://doi.org/10.1016/0002-9378(88)90078-6.

    CAS  PubMed  Article  Google Scholar 

  6. 6.

    Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recommendation and Reports. 2015;64(3):1–137.

    Google Scholar 

  7. 7.

    Ifeanyi OE, Chinedum OK, Chijioke UO. Trichomonas vaginalis: complications and treatment. International Journal of Current Research in Medical Sciences. 2018; https://doi.org/10.22192/ijcrms.2018.04.05.012.

  8. 8.

    Wølner-Hanssen P, Krieger JN, Stevens CE, Kiviat NB, Koutsky L, Critchlow C, et al. Clinical manifestations of vaginal trichomoniasis. JAMA. 1989;261:571–6. https://doi.org/10.1001/jama.1989.03420040109029.

    PubMed  Article  Google Scholar 

  9. 9.

    Singh J, Kalia N, Kaur M. Recurrent vulvovaginal infections: etiology, diagnosis, treatment and management. In: Singh P, editor. Infectious diseases and your health. Singapore: Springer; 2018. p. 257–89.

    Google Scholar 

  10. 10.

    Schwebke JR, Burgess D. Trichomoniasis. Clin Microbiol Rev. 2004;17:794–803. https://doi.org/10.1128/CMR.17.4.794-803.2004.

    PubMed  PubMed Central  Article  Google Scholar 

  11. 11.

    Edwards T, Burke P, Smalley H, Hobbs G. Trichomonas vaginalis: clinical relevance, pathogenicity and diagnosis. Crit Rev Microbiol. 2016:1–12. https://doi.org/10.3109/1040841X.2014.958050.

  12. 12.

    Muzny CA, Schwebke JR. The clinical spectrum of Trichomonas vaginalis infection and challenges to management. Sex Transm Infect. 2013;89:423–5. https://doi.org/10.1136/sextrans-2012-050893.

    PubMed  Article  Google Scholar 

  13. 13.

    Homayouni A, Bastani P, Ziyadi S, Mohammad-Alizadeh-Charandabi S, Ghalibaf M, Mortazavian AM, et al. Effects of probiotics on the recurrence of bacterial vaginosis: a review. Journal of Lower Genital Tract Diseas. 2014; https://doi.org/10.1097/LGT.0b013e31829156ec.

  14. 14.

    Bradshaw CS, Morton AN, Hocking J, Garland SM, Morris MB, Moss LM, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006;193:1478–86. https://doi.org/10.1086/503780.

    PubMed  Article  Google Scholar 

  15. 15.

    Obiero J, Rulisa S, Ogongo P, Wiysonge CS. Nifuratel-Nystatin combination for the treatment of mixed infections of bacterial vaginosis, vulvovaginal candidiasis, and trichomonal vaginitis. The Cochrane Database of Systematic Reviews. 2018. https://doi.org/10.1002/14651858.CD013012.

  16. 16.

    Mahboubi M. Systematic review: the potency of Zataria multiflora Boiss. in treatment of vaginal infections. Infectio. 2018; https://doi.org/10.22354/in.v22i2.712.

  17. 17.

    Nyirjesy P, Robinson J, Mathew L, Lev-Sagie A, Reyes I, Culhane JF. Alternative therapies in women with chronic vaginitis. Obstet Gynecol. 2011;117:856–61. https://doi.org/10.1097/AOG.0b013e31820b07d5.

    PubMed  Article  Google Scholar 

  18. 18.

    Felix TC, de Brito Röder DVD, dos Santos Pedroso R. Alternative and complementary therapies for vulvovaginal candidiasis. Folia Microbiol (Praha). 2018;64:133–41. https://doi.org/10.1007/s12223-018-0652-x.

    CAS  Article  Google Scholar 

  19. 19.

    Askari SF, Mohagheghzadeh A, Azadi A, Namavar Jahromi B, Tansaz M, Badr P. A brief review on vaginal drug delivery in traditional Persian medicine. Traditional and Integrative Medicine. 2018;3(4):224–30.

    Google Scholar 

  20. 20.

    Askari SF, Azadi A, Namavar Jahromi B, Tansaz M, MirzapourNasiri A, Mohagheghzadeh A, et al. A comprehensive review about Quercus infectoria G. Olivier Gall Research Journal of Pharmacognosy. 2019;7(1):69–77.

    Google Scholar 

  21. 21.

    Ghaeni Heravi SM. Qarabadin-e salehi. Badr P, Mohagheghzadeh a, shams Ardekani MR, editors. Chogan pub: Tehran; 2013.

    Google Scholar 

  22. 22.

    Aghili Shirazi MH. Qarabadin-e kabir. Research Institute for Islamic and Complementary Medicine: Tehran; 2007.

    Google Scholar 

  23. 23.

    Azam KM. Qarabadin-e azam. Almai: Tehran; 2014.

    Google Scholar 

  24. 24.

    Avicenna H. The canon of medicine. Sharafkandi a, translator. Tehran: Soroush Press; 1997.

    Google Scholar 

  25. 25.

    Tonkaboni MM. Tohfat almomenin. Rahimi R, shams Ardekani MR, Farjadmand F, editors. Tehran: Shahid Beheshti University of Medical Sciences; 2007.

    Google Scholar 

  26. 26.

    Aghili MH. Makhzan aladvia. Shams Ardakani MR, Rahimi R, Farjadmand F, editors. Tehran: Tehran University of Medical Sciences pub; 2009.

    Google Scholar 

  27. 27.

    Mansouri SM. Kefaye Mansouri. Research Institute for Islamic and Complementary Medicine: Tehran; 2003.

    Google Scholar 

  28. 28.

    Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–45. https://doi.org/10.1038/clpt.1981.154.

    CAS  PubMed  Article  Google Scholar 

  29. 29.

    Ardestani MM, Aliahmadi A, Toliat T, Dalimi A, Momeni Z, Rahimi R. Antimicrobial activity of Quercus infectoria gall and its active constituent, gallic acid, against vaginal pathogens. Traditional and Integrative Medicine. 2019;4(1):12–21.

    Google Scholar 

  30. 30.

    Bhalerao S, Mohite S, Kulkarni S, Deo V, Shrikhande B. Effect of Lucronil® tablets in the patients with leucorrhea: an open clinical trial. International Journal of Science and Research. 2016;5(10):1338–42.

    Google Scholar 

  31. 31.

    Zare A, Moshfeghy Z, Zarshenas MM, Namavar Jahromi B, Akbarzadeh M, Sayadi M. Quercus brantii Lindl. Vaginal cream versus placebo on Bacterial Vaginosis: A randomized clinical trial. Quercus brantii Lindl Vaginal cream versus placebo on bacterial vaginosis: a randomized clinical trial Journal of Herbal Medicine. 2019;16:100247. https://doi.org/10.1016/j.hermed.2018.11.003.

  32. 32.

    Masoudi M, Miraj S, Rafieian-Kopaei M. Comparison of the effects of Myrtus communis L, Berberis vulgaris and metronidazole vaginal gel alone for the treatment of bacterial vaginosis. J Clin Diagn Res. 2016. https://doi.org/10.7860/JCDR/2016/17211.7392.

  33. 33.

    Viana AFSC, da Silva FV, Fernandes HDB, Oliveira IS, Braga MA, Nunes PIG, et al. Gastroprotective effect of (−)-myrtenol against ethanol-induced acute gastric lesions: possible mechanisms. J Pharm Pharmacol. 2016;68:1085–92. https://doi.org/10.1111/jphp.12583.

    CAS  PubMed  Article  Google Scholar 

  34. 34.

    Kaur G, Hamid H, Ali A, Alam MS, Athar M. Antiinflammatory evaluation of alcoholic extract of galls of Quercus infectoria. J Ethnopharmacol. 2004;90:285–92. https://doi.org/10.1016/j.jep.2003.10.009.

    PubMed  Article  Google Scholar 

  35. 35.

    Darogha SN. Antibacterial activity of Quercus infectoria extracts against bacterial isolated from wound infection. Journal of Kirkuk University Scientific Studies. 2009;4(1):20–30.

    Google Scholar 

  36. 36.

    Basri D, Ha F, Jantan I. Antibacterial activity of the galls of Quercus infectoria. Malaysian Journal of Science. 2005;24(1):257–62.

    Google Scholar 

  37. 37.

    Alem G, Mekonnen Y, Tiruneh M, Mulu A. In vitro antibacterial activity of crude preparation of myrtle (Myrtus communis) on common human pathogens. Ethiop Med J. 2008;46(1):63–9.

    PubMed  Google Scholar 

  38. 38.

    Mansouri S, Foroumadi A, Ghaneie T, Najar AG. Antibacterial activity of the crude extracts and fractionated constituents of Myrtus communis. Pharm Biol. 2001;39:399–401. https://doi.org/10.1076/phbi.39.5.399.5889.

    Article  Google Scholar 

  39. 39.

    Schwebke JR, Hillier SL, Sobel JD, McGregor JA, Sweet RL. Validity of the vaginal gram stain for the diagnosis of bacterial vaginosis. Obstet Gynecol. 1996;88:573–6. https://doi.org/10.1016/0029-7844(96)00233-5.

    CAS  PubMed  Article  Google Scholar 

  40. 40.

    Modak T, Arora P, Agnes C, Ray R, Goswami S, Ghosh P, et al. Diagnosis of bacterial vaginosis in cases of abnormal vaginal discharge: comparison of clinical and microbiological criteria. The Journal of Infection in Developing Countries. 2011;5(5):353–60.

    PubMed  Article  Google Scholar 

  41. 41.

    Mahmoudvand H, Badparva E, Baharvand Z, Salehi LH. Anti-trichomonas vaginalis activities and apoptotic effects of some Iranian medicinal plants. Trop Biomed. 2018;35(2):347–53.

    Google Scholar 

  42. 42.

    Khalilzadeh S, Eftekhar T, Rahimi R, Mehriardestani M, Tabarrai M. An evidence-based review of medicinal plants used for the treatment of vaginitis by Avicenna in “the Canon of Medicine”. Galen Medical Journal. 2019; https://doi.org/10.31661/gmj.v8i0.1270.

Download references

Author information

Affiliations

Authors

Contributions

Design of the study, B.N.J., A.D., A.A., P.B. and A.M.; Lab work and acquisition clinical data, S.F.A.; Drafting the article and revising, S.F.A., B.N.J., M.T., A.D., A.A. and A.M.; Supervision, B.N.J., A.D., P.B., A.Z., A.A. and A.M. All authors are in agreement with the content of the manuscript.

Corresponding author

Correspondence to Abdolali Mohagheghzadeh.

Ethics declarations

Conflict of interest

The authors declare that they have no conflicts of interest.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Festschrift in honor of late Professor Dr. Seyed Hadi Samsam-Shariat, Isfahan School of Pharmacy

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Askari, S.F., Jahromi, B.N., Dehghanian, A. et al. Effect of a novel herbal vaginal suppository containing myrtle and oak gall in the treatment of vaginitis: a randomized clinical trial. DARU J Pharm Sci (2020). https://doi.org/10.1007/s40199-020-00365-6

Download citation

Keywords

  • Myrtle
  • Oak gall
  • Traditional Persian medicine
  • Suppository