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Intravaginal Vitamin C

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Intravaginal Vitamin C

Review question/objective

The objective of this review is to identify the effectiveness of intravaginal vitamin C compared to intravaginal placebo for the treatment of adult women with bacterial vaginosis.

Background

Bacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing age.1,2It accounts for almost half of all cases of vaginal discharge and malodor,1,3and is associated with serious adverse pregnancy and postpartum related outcomes as well as increased risk of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) acquisition and transmission.4

Globally, the prevalence of BV varies considerably between countries and between ethnic groups within countries.5 According to a recent systematic review evaluating the global epidemiology of BV by world region, Sub-Saharan Africa has the highest prevalence rates, estimated to be up to 58% of the study population.5 The same systematic review estimates BV prevalence in the study population to be as high as 51% in East Asia and the Pacific, 32% in South and Southeast Asia, 8% in Australia and New Zealand, 50% in the Middle East and North Africa, 28% in Eastern Europe and Central Asia, 23% in Western Europe, 30% in North America, and 49% in Latin America and the Caribbean.5

Bacterial vaginosisis is a polymicrobial clinical syndrome characterized by a reduction in hydrogen peroxide producing lactobacillus and an overgrowth of obligate anaerobic bacteria such as Gardnerella vaginalis.6,7 Changes in normal vaginal flora concentrations cause increased vaginal pH and contribute to the other characteristic findings and symptoms of BV, including vaginal discharge, malodor and presence of clue cells.

Sexual risk factors associated with BV include new sex partners, multiple sex partners, women who have sex with women,8,9 and receptive oral sex.10 Other risk factors include poverty,2 black race,2 douching,2,11 smoking,6 low vitamin D levels in pregnancy,12 chronic stress,13,14menstruation,15,16 and having an IUD.17,18 Negative risk factors that have shown to be protective against BV include condom use,9,17,19–21 circumcision of male partners,22–24 and hormonal contraceptive use.17,19,25–27

Bacterial vaginosisis associated with numerous severe adverse health outcomes, including adverse pregnancy related outcomes such as miscarriage, premature labor and delivery,28 premature rupture of fetal membranes,29chorioamnionitis, and postpartum endometritis.30 Adverse surgical related outcomes associated with BV include posthysterectomy and postabortive pelvic inflammatory disease (PID)29,30 and endometrial microbial colonization.31 Additionally, BV is associated with increased risk for acquisition and transmission of STDs including gonorrhea,32 chlamydia,33 trichomoniasis,11,32,33 herpes,22 and HIV.32,34–36 New study findings also show that BV increases the risk of cervical intraepithelia neoplasia and squamous intraepithelial lesions.3 Not only is BV related to adverse physical outcomes, it has been shown to cause emotional sequela and an economic burden as well.38–40

Women suffering from BV have reported feelings of shame, embarrassment, frustration, humiliation, depression and self-consciousness, leading to social isolation, intentional intimacy abstinence, and overall reduction in quality of life.38,39

In the US alonebacterial vaginosisassociated perinatal complications cost an estimated $1.4 billion dollars per year.40Although there is no documentation as to the direct cost of BV associated postpartum or postoperative complications, with over 300,000 new cases of postpartum infection and over 1 million new cases of PID annually, it is likely that the economic burden associated with BV is substantial. In addition to costs due to complications, economic burden secondary to poor job performance and missed workdays because of BV associated vaginal odor has been reported by women in the US.39

Bacterial vaginosisisis diagnosed using Amsel criteria and/or evaluation of a gram stained vaginal smear using Nugent criteria.3,41 Diagnosis using Amsel criteria requires at least three out of the following four criteria: homogeneous, thin, grayish-white discharge; vaginal pH>4.5; positive fishy odor (Whiff-amine test); and/or presence of clue cells on wet mount.42 Diagnosis using Nugent criteria requires laboratory examination of the number of lactobacilli, Gardnerellabacteroides, and gram-negative bacilli present.43

Several guidelines exist detailing the current recommended and alternative treatment regimens for BV in non-pregnant (Table 1) and pregnant (Table 2) women.

Table 1
Table 1:

Current guideline recommendations for bacterial vaginosis treatment in non-pregnant women

Table 1
Table 1:

Continued

Table 2
Table 2:

Current guideline recommendations for bacterial vaginosis treatment in pregnant women

CDC: Centers for Disease Control and Prevention 3 ; IUSTI/WHO: International Union Against Sexually Transmitted Infections 44 ; BASHH: British Association for Sexual Health and HIV 41 ; SMoH: Singapore Ministry of Health 45

CDC: Centers for Disease Control and Prevention 3 ; IUSTI/WHO: International Union Against Sexually Transmitted Infections 44 ; BASHH: British Association for Sexual Health and HIV 41 ; SMoH: Singapore Ministry of Health 45

There are many complications and adverse reactions associated with the current treatment regimens for BV. Metronidazole and clindamycin are both associated with multiple side effects, which increase potential for non-compliance. Oral metronidazole can cause nausea, vomiting and gastrointestinal upset.46 Concomitant use of alcohol can worsen these symptoms. Additionally, oral metronidazole has multiple drug-drug interactions including warfarin and oral contraceptives. Vaginal metronidazole can cause vaginitis and vaginal candidiasis.46 Oral clindamycin can cause nausea, vomiting, diarrhea and in rare cases, pseudomembranous colitis.46 Vaginal clindamycin can cause vaginitis and vaginal candidiasis and can weaken latex condoms and diaphragms.3 According to the CDC, neither vaginal preparation is recommended in pregnancy due to lack of systemic absorption and concern over preterm delivery with sub therapeutic treatment of BV.3 However, some guidelines include vaginal preparations as first line therapy for BV in pregnancy,41,45 while others make generalized statements about the safety of the medications in pregnancy but do not make specific recommendations for BV treatment during pregnancy.44

Extensive literature exists on the efficacy of current treatments including the antibiotics clindamycin and metronidazole with many studies showing 70–90% resolution of BV one month after administration.6 However, BV recurrence after treatment is common with up to 20% recurrence within one month of treatment,47 up to 30% recurrence within three months of treatment,6 and more than 50% within six months of treatment.4 Recent advances in molecular testing have shown that a bacterial biofilm plays a significant role in the pathogenesis of BV.48 A recent study evaluating the biofilm associated with BV showed that metronidazole therapy suppressed the concentration of anaerobes but did not eradicate the biofilm.49 Other studies involving antibiotic treatment for BV have shown metronidazole and clindamycin resistance,50–52 raising concerns over the significance of antibiotic resistance and microbial mutations. These concerns, as well as concerns over potential medication side effects and noncompliance, have led to greater interest in alternative therapeutic interventions for the management of BV.53

Although many studies addressing alternative therapies for BV management have been conducted in recent years, there are no evidence-based guidelines recommending alternative therapeutic interventions to date. Several recent randomized controlled trialshave evaluated the effectiveness of intravaginal vitamin C as an alternative option for treatment and prevention of BV.54–59Study results indicate that vitamin C 250mg tablets inserted intravaginally once daily for six consecutive days are more effective than placebo54,55 and as effective as metronidazole vaginal gel at treating bacterial vaginosis.56 Additionally, study results indicate that vitamin C 250mg tablets inserted intravaginally once daily for six consecutive days improves abnormal vaginal microflora growth and lowers abnormally high vaginal pH.57,58Furthermore, study results indicate that vitamin C 250mg tablets inserted intravaginally once daily for six consecutive days per month for six months is effective for preventing recurring BV.59Intravaginal vitamin C is thought to work by acidifying the vagina and lower the pH, which slows the overgrowth of pathogens allowing normal vaginal flora to re-establish.60Despite the promising results of these individual studies, a gap in literature remains as, to date,there is no systematic review that has studied the effectiveness of intravaginal vitamin C on cure rate of BV.

Inclusion criteria

Types of participants

This review will consider studies that include women (ages 15 years and older) with bacterial vaginosis, excluding women with HIV and/or those who were concomitantly using antibiotics. These women will be excluded in order to determine factors that may be exclusive to the disease process.

Types of intervention(s)/phenomena of interest

This review will consider studies that compare treatment regimens of intravaginal vitamin C (ascorbic acid) with placebo.

Types of outcomes

This review will consider studies that include the following outcome measures: cure rate defined by the presence and/or absence of Amsel criteria or Nugent criteria. Diagnosis using Amsel criteria requires at least three out of four criteria: homogeneous, thin, grayish-white discharge; vaginal pH>4.5; positive fishy odor (Whiff-amine test); and/or presence of clue cells on wet mount.42 Diagnosis using Nugent criteria requires laboratory examination of the number of lactobacilli, Gardnerella bacteroides, and gram-negative bacilli present.43 A Nugent score of 7 or greater is positive for BV.Any follow-up time will be considered in the review. Secondary outcomes and adverse events are beyond the scope of this review and, therefore, will not be considered as part of the outcomes inclusion criteria.

Types of studies

This review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies for inclusion.

This review will also consider descriptive epidemiological study designs including case series, individual case reports, and descriptive cross sectional studies for inclusion.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE, EMBASE and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in any date will be considered for inclusion in the review.Studies published in English language will be considered for inclusion in the review.

The databases to be searched include:

MEDLINE

EMBASE

CINAHL

Cochrane Central Trials Register

ProQuest Nursing & Allied Health Source

PsycINFO

The search for unpublished studies will follow the same three-step strategy described above. The databases, search engines, and search mechanisms to be searched include:

Mednar

Clinical trials.org

Current controlled trials

ProQuest Dissertations & Theses (PQDT)

Initial keywords to be used will be:

Bacterial vaginosis

vaginitis

ascorbic acid

vitamin.

All studies identified during the database search will be assessed for relevance to the review based on the information provided in the title, abstract, and description/MeSH terms. A full report will be retrieved for all studies that meet inclusion criteria. Studies identified from reference list searches will be assessed for relevance based on study title.

Assessment of methodological quality

Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data extraction

Data will be extracted by two independent reviewers using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for missing information or data clarification.

Data synthesis

Quantitative data will, where possible be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as risk ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.

Conflicts of interest

All of the reviewers have no conflicts of interest.

Acknowledgements

There is no external funding for this review. This systematic review will partially fullfill degree requirements for successful completion of the primary reviewer's degree in Doctor of Nursing Practice at Texas Christian University.

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Appendix I: Appraisal instruments

MAStARIappraisal instrument

Figure
Figure
Figure
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Figure
Figure

Appendix II: Data extraction instruments

MAStARI data extraction instrument

Figure
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Keywords:

bacterial vaginosis; vaginitis; ascorbic acid; vitamin c; treatment

© 2015 by Lippincott williams & Wilkins, Inc.

Intravaginal Vitamin C

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