LITERATURE REVIEW

ALTERNATIVE THERAPIES EORBACTERIAL VAGINOSIS: A LITERATUREREVIEW AND ACCEPTABILITY SURVEY

Elizabeth K. Boskey. PhD, MPH,

Objective This article reviews current research into non-antibi-otic treatments tor bacterial vaginosis and assesses interest in theuse of alternative therapies for women's health in a non-represen-tative sample of women.Design Literature re\iew and online survey.Subjects A convenience sample of 192 women was selectedfrom an online community devoted to the discussion ofwomen's health.Results " Data on altemative treatments for bacterial vaginosisare mixed. Studies have shown both positive and null effects forprobiotic- and lactic acid-based treatments. The results of antisep-tic studies were more uniformly positive, but the studies were

generally not placebo-controlled. Women in the survey popula-tion were both interested in and experienced with alternative andcomplementary therapies for reproductive health problems44% of them had used home or natural remedies to treat vaginalinfections or menstrual problems, and only 20% indicated thatantibiotics and antiflingals would be their treatment of choice.Conclusions Women are interested in alternative treatmentsfor women's health problems such as yeast infections and bacteri-al vaginosis. Although such treatments have been investigated,further researchparticularly in the form of high-quality, ran-domized, controlled trialsi.s strongly indicated. {Altern TherHealth Med. 2005;U(5):38-43.)

Elizabeth R. Boskey, PhD, MPH, CHES, is an adjunct professorin the Department of Preventative Medicine and CommunityHealth at the State University of New York Health ScienceCenter in Brooklyn, NY.

Bacterial vaginosis is characterized by an increase inthe vaginal pM from a healthy, acidic pH of ~4 to amore neutral pH of >4.5. This change is due to anovergrowth of anaerobic bacteria and a concomitantdecrease in the number of acid and ll^O^-producinglactohacilli. which are the microbial guards for vaginal health.'This understanding of bacterial vaginosis as a disruption in thenormal vaginal ecosystem, as well as recent media coverage ofantibiotic resistance and a growing movement toward "natural"therapies.' have led to increasing interest in non-antibiotic treat-ments for bacterial vaginosis.

Most proposed non-antibiotic therapies for bacterial vagi-nosis fall into two categoriesprobiotic therapies, which aim toprovide the bacteria to directly supplement or restore a woman'shealthy lactohacillus-dommated flora (eg, lactobacillus capsulesand yogurt-based treatments'"), and acid-restoring therapiessuch as BufferGel (Reprotect. Inc. Baltimore, Md) and lactic acidgels and creams, which aim to make the vagina a hostile environ-ment to the acid-sensitive bacterial vaginosis organisms, therebypromoting native lactobacillus regrowth.'"'"' Natural antibiotics.

such as tea tree oil. are being studied for use in treating bacterialvaginosis and are frequently recommended by word of mouth inwomen's communities.'"

This article reviews current research into non-antibiotictreatments for bacterial vaginosis. Additionally, to assess thepotential for interest in non-antibiotic therapies, a survey wasdeveloped for web-based administration to a convenience sam-ple of women with an expre.ssed interest in vaginal health. Asample of 192 women was acquired by posting a time-limitedinvitation to participate in the survey to an online communityfocusing on women's reproductive health.

MATERIALS AND METHODSLiterature Review

A search of the literature for all articles containing the key-words "bacterial vaginosis" and "treatment" was conducted.Wherever possible, articles that discussed only antibiotic treat-ment of bacterial vaginosis were eliminated and all other articleswere retrieved and individually reviewed for inclusion. Inclusioncriteria were 1) the article must describe a treatment trial forbacterial vaginosisa decision was made to include trials of anysize since alternative therapy trials are frequently small. 2) thearticle must include at least one treatment that is not one of thestandard antibiotic therapies for bacterial vaginosis (eg, metron-idazole. clindamycin), 3) trials of natural antibiotics (eg, tea treeoil) were acceptable because they are not part of standard pre-

38 ALTERNATIVE THEIUPIES, SHPT/OCT 2005. VOL II, NO, 5 Altemative Therapies for Bacterial Vaginosis

scription regimens. Articles that met the inclu.sion criteria werealso drawn from the reference sections of the selected literature.

Data AbstractionThe following data were systematically abstracted from

each study: number of subjects, type of study design, tested com-pounds, whether a placebo was used, whether the compoundwas administered orally or vaginally, study duration, and results.

SurveyDesign

The survey was designed using a paid online survey toolSurvey Monkey (SurveyMonkey.com, Portland, Ore)whichallows for an unlimited number of respondents, the use ofresponse-specific skip patterns, and many options for surveystructure. The Institutional Review Board (IRB) approved sur-vey consists of 4 sections: 1) an active consent section thatrequires 4 confirmatory an.swers before the participant canproceed to the main survey; 2) questions about the demo-graphics of study participants and ascertainment ot where the)'were recruited into the survey: '') questions about experiencewith vaginal infections or problems and experience with pre-scribed, over-the-counter, and natural or home remedies; and4) questions about provider choice for reproductive healthproblems and general use of complementary and alternativemedical systems. Participants taking the survey could only goforwardthey could not go back to change previous surveyanswersand could opt out of the survey at any time. Skippatterns were used to end the survey early for those who didnot consent or who were not eligible {ie. people who havetaken the survey before and male respondents) and to skipquestions that were not relevant to them based on earlierresponses. Answers were not required for reproductive healthquestions but were required for the demographic and consentsections. The investigator's contact information was providedat the end of the survey in case participants had concerns orquestions.

RecruitmentSurvey recruitment was through a post to a woman's

health community on an online journal website (ie, www.live-journal.com). The community had approximately 1,300members and was monitored by another 700 individuals whoare part of the larger site where the community is located.The invitation included permission to forward a link to thesurvey website to friends.

The survey recruitment post had a disclaimer section writ-ten written by the 1KB. with detailed disclosure on possibleissues with anonymity. This was necessary because althoughthe survey collected no identifying data, it did collect the com-puter's Internet protocal (IP) address to prevent people fromtaking the survey multiple times, and it also left a "cookie" onthe participant's computer. The disclosure included detailedinstructions on how to remove the cookie file from the comput-

er and the survey URL from the web browser's History file. Thesurvey was available for 3 weeks, and a second post referringpeople to the initial recruitment message was placed 4 daysbefore the study closed.

AnalysisThe survey was analyzed by simple descriptive statistics

becau.se of the non-random nature of the sampling procedure.The survey was intended to demonstrate only whether there isan interest in alternative therapies for vaginal infections amonga non-representative sample of women with an avowed interestin women's health.

RESULTSLiterature Review Results

Eighteen studies that examined treatments for bacterialvaginosis with medications other than commercial antibioticswere identified. The treatments could largely be broken downinto the 3 categories of antiseptics, probiotics, and acidifica-tion devices, but one trial also examined the spermicidenono\ynol-9 as a treatment regimen. Studies varied in quality,witb more than half of them having no control group or non-randomized controls (Table 1). Most studies were small, andthey varied considerably in design. Not surprisingly, becausenegative studies are rarely published, most of the availablestudies showed a positive effect for the alternative therapies.Only 3 of the studies bad ambivalent or negative results.'""'Although design quality was problematic in many of the stud-ies, the results suggest that all 3 main methodsprobiotics,antiseptics, and acidification agents-^are potentially usefulnon-antibiotic therapies for bacteria! vaginosis.

Survey ResultsThe women who cbose to participate in the survey were

primarily white, college-educated women in their late tetnsand 20s (Table 2), as would be expected based on the recruit-ment method. The majority of these women (74%) have wor-ried about their vaginal health at one time or another, butmore of them sought advice from a non-healthcare profession-al than went to a doctor for care. Slightly more than one-thirdof the population (39%) had been diagnosed with a vaginalinfection (eg, bacterial vaginosis, yeast infection) or sexuallytransmitted disease at some point in the past, and more thanhalf (60%) of those diagnosed with a vaginal infection were pre-scribed antibiotics. Most women (56%) saw MDs for tbeirreproductive healthcare, although a similar number were seenby nurse practitioners, and a substantial minority (14%) wereunwilling to seek care.

Use of home remedies and alternative therapies in thispopulation was high (Table 2). Almost half (45%) of the womenhave used home or alternative remedies for vaginal infectionsin the pasta slightly higher percentage than those who hadused an over-the-counter yeast infection treatment without see-ing a doctor (37%). When asked what their first choice for a

Alternative Therapies for R.icterial Vaginosis ALTERNATIVE THEKAlMhS. S E P T / O C T 2 0 0 5 , V O L II, N O . 5 39

TABLE 1 Review of ihe Literature on Ndu-Aiitibiotic Treatments for Bacterial Vaginosis

Study Number of Study Type Tested Compounds Treatment Placebo- Oral/ Length ofParticipants Category Controlled Vaginal Foiiowup

Result.s

Reid etal 2001' 10 Feasibility' L rhaimwsus CR-1 + Probiotic No Oral 4 weeks. OgaiiismsrecoveredfhiiT! thevn^giiasLjcrmcntum RC-14 ] 2 ueeks of most women. Six women v\ith abiior-suspension in milk (3 women) mal flora had resolution within 1 week

Reid etal 2001' 42 Feasibilit)' /. rtmmihmis CR-l + Probiotic Inactive Oral 42 days One treatment group withstudy i.fcwwitum W-\A or from treat- tiR-l/RC-14 had good resolution

L rlhimmms C,C, ment of B\' bi' Nugent .scortall womenwere i-linicall\' heaitliv

Chimura 1998''* 16 Trial Bio-Three Probiotic No Vaginal 3 days Significant decreases in vaginal dis-charge, redness, and pi I as well as a44% rnicrobiologic cure rate

Parent etal 1996" 32 Multicenter. n.J].Jactobacilli and Probioticrandomized Estriol (Gynoflor) plus estriol

Vaginal 4 weeks Gynoflor was effective in treatingBV

Shalev et al 1996' 20-BV. Crosso\'er yogurt ivif b L18-Canditia trial luidophilux

8 - Both

Probiotic Pasteurized Oral 6 months. Increase in L aeidopbinlus isolatedyogurt in women in treatment group.

Significant decrease in B\' intreatment group

Chimura et al1995**

Pattman et al1994'

11 Trial Intravaginal yogurt Probiotic No Vaginal 3 days Treatment led to significantdecreases in vaginal discharge,redness, and pH as well as a 54%microbiologic cure rate

Audit Gynatren vaccine Probiotic(/. aclihpliihis lysate) vaccine

No Neitber - 6 mo Potentially effective for reducingrecurrent B\' if used withmetronidazole

Neri et al 1993'" 84 - Open 1) Yogurt douche Probiotic, Treatment Vaginal 2 months Both treatments effective at treatingpregnant randomized 2) Acetic add tampon and tampon refusals B\'. but yogurt substantially more so

Fredricsson et al1987"

61 1) Acetic acid ielly Probiotic. No Vaginal 1 month The alternative treatments wererandomized 2) Dinoestrol creme acid gel, only rarel)' effecti\'e. All were

3) ComETiercial yogurt hormone substantially less effective than4} Metronidazole metronidazole

van deWijgertetal 98 Drug safety BufferGel2001'^ trial

Acid gel No Vaginal 14 days Prevalence of BV declinedsignificantly in study population

Boeke et al 1993'' 125 Randomized 1) Oral metronidazole Acid Yes Both 3 months Lactic add ineffective in treating BVclinical trial 2) Vaginal lactic acid suppositor\'

Hoist et al 1990'* 10 - Pilot study Ijctal gelpregnant

Acid gel No Vaginal 8 weeks Lactal effective in treating BV

Anderschetal 114-62 Randomized 1) Oral metronidazole Acid gel1986'"' withBV trial 2} Vaginal lactate gelWewalka et al 70 Randomized 1) Betadine suppositories Antiseptic,2002'" trial 2)/.ij/j.wm capsules. probiotic

No Both 8 da\'s Lactate gel as effective asmetroTiidazole in treating BV.

No Vaginal 10 days Patients in botli groups improved bothclinically and subjectively. Betadinehad a stronger long-tenn ertkt

Petersen et al 180 - 73 Randomized, 1) Dequaliiiium chloride Antiseptic2002" with BV double-blind 2) Povidone iodineBlackwell 1991'" 1 Case study Tea tree oil. vaginal Antiseptic

pessaries

No Vaginal 4 weeks Both treatments effective intreating BV

No \'aginal 1 montb Vaginal flora and pH resolved tonormal after self-treatment

Ison et al 1987-" 79 Randomized, I) X'aginal ClorhexidiTie Antisepticsingle-blind 2) Oral Metronidazole

No Botli 28davs Clorhexidine as effective asmetronidazole in treating BV

Richardson et al 278 CSWs Randomized, Nonoxynol-9 Spermicide Yes2001'' U2BV double-blind

Vaginal Median -50 weeks

No difference in B\' incidence betweentreatment and placebo groups

Artitic in Japanese. B\'-lla(lcrJa! vaginosis; CSVV=tommercial sra workers

4 0 A L T E R N A T I V E T H E R A P I E S . S E T T / O C T 2 0 0 5 , V O L II , N O . 5 Alteniiitive Therapies for Bacterial Vaginosis

Demographic Questions

Age (years)

I/VBLE 3 Types of Complementary and Alternative Medicine (CAM)Providers and Practices L'sed by Survey Participants

CAM providers or products used (all tbat apply)

NoneAcupunctureOsteopathic medicineCbiropractic medicineHomeopathyNaturopatbic medicineAromatherapyTherapeutic massageAyurvedic tberapyQigongReikiTherapeutic touchDietary supplements (not prescribed by an Mi))Other oriental medicine systemOther CAM practice not listedSkipped

n

7183

202422291911

152

604

1130

%

37.04.21.6

L0.412.511,515,19.90.50.57.81.0

31.32.15.7

15.6

acidophilus tablets were used in an attempt to replenish healthyvaginal flora. Herbal teas were the second tnost common thera-pywhen their use was indicated, it was usually for either painrelief or as an emmenagogue. Non-bacterial acidfying remediesalso were common, as was garlicone of the more frequentlydiscussed home remedies for a yeast infection. Both acidificationtreatments and garlic are intended to make the vaginal and uri-nary environments more hostile to non-healthy flora. Althoughnormal vaginal flora thrive at low pH, the bacteria associatedwith bacterial vaginosis do not, and garlic has establishedantimicrobial properties. Alternative pain relief tlierapies alsowere frequently used to relieve menstrual cramping.

DISCUSSIONThe literature on non-antibiotic therapies for bacterial

vaginosis is mixed. Whereas sotiie studies show these therapiesto be useful, others find no effect, and the overall study qualityis poor. Probiotics,''" acidification agents.'- " '^ and antisep-tics'"'"-"all show promise for treating bacterial vaginosisthrough clinical studies and have a firm theoretical basis forwhy they should be effective. Some studies have found theseagents to be ineffective, however, and it is important that high-quality, clinical trials be pursued."''

Women are interested in non-antibiotic therapies for vagi-nal infections. Only 20% of survey respondents preferredantibiotics; most would be happy using any therapy that waseffective; and more than one-third indicated a preference for aprobiotic. natural, ornon-aiitibiotic therapy. Almost half of thepopulation had, in fact, used home or natural remedies to treatvaginal or menstrual problems in the past^more women thanhad purchased over-the-counter treatments with or withoutphysician approval. Even many of the women who did not indi-cate a preference for a non-antibiotic therapy would be willing

TABLE 4 Types of Home or Natural Remedies Used by SurveyParticipants for Vaginal or Menstrual Problems*

Yogurt:Acidophilus tablets:Boric:Vinegar:Cranberry:Garlic:Heating:

Herbal teas:

Herbs and essential oils:

Intoxicants:

Special baths and rinses;

Supplements:

Therapies:

Either eaten or applied vaginally (n=48)Eaten or inserted (n=4)Acid vaginal suppositories (n-2)When specified, as a rinse or douche (n=6)Juice or pills (n= Hi)Either eaten or inserted (n=13)Pads, packs, hot baths, andcompresses (n-10)ttickiding parsleyteinmenagogue), thyme,tansy (pregnanc) teniiination/emmena-gogue), raspberr)', ginger, chamomile,molasses, and peppermint (n=23)Including black cohosh, blue cohosh,pennyroyal, evening primrose oil, dong quai,Chinese herbs, yarroiv. calendula oil.tea tree oil (n=9)Alcohoi, marijuana (n=2)Epsom sa!t, oatmeal, baking soda,peroxide (n=8)Lysine (for 1ISV-1 outbreaks), calcium, mag-nesium, vitamin C (emmenagogue) (n=5)Massage, acupuncture (n=2)

"Number of women mentioning the llierapy is in parenthesis. Most commonreasons for use of therapies, when given, were cramps, yeast infections, and uri-nary tract iiifectiDiis, When a specific use, olher than the above, was meiilioiiedfor a therapy, it is listed in paremhests.

to use oneequivalent numbers of women were willitig to useantibiotics, probiotics. home remedies, and over-the-counter,non-antihiotif therapies.

Current use of alternative therapies for general health inthis population was similar to (hat seen in a national survey in1997.' Approximately 42% of the study population used at leastone such therapy, with tnore than a third of the populationusing dietary supplements that ha\'e previously been reportedto be frequently used by women." Interestingly, these womenused a wide range of home remedies for their reproductivehealth problems. Although this is partially explained by thesource of the population being a woman's health communitywhere several of these treatments are discussed, the frequencyof use is surprising. The most common therapies used, yogurtor acidophilus. garlic, and cranberry, are easily prepared orpurchased, and do have some scientific basis for effect.'"'^ '^

The biggest limitation to this study is the non-representa-tive source of the survey population and the relatively low-response rate. However, the survey does show a strong interestin natural and alternative therapies by women in this sampleand will hopefully help to provide an impetus to futureresearch in this area. High-quality clinical trials of non-antibi-otic tberapies for vaginal infections need to be conducted.There is a market for these treatmentsthey just need to betested and developed.

42 AIJFRNATIVE THERAPIES, SErT/OCT 2005, VOI, 11, NO, 5 Alternative Therapies for Bacterial Vaginosis

Refrrentes1. Boris S, Bardes C. Role played hy Uuiohuiiih i:i lonrrolliiig the popiiialion of vaginal

jialhogeiLs. ,UJIrnfti'i liitnt. 20(XI; 2:543-54fi.2, l-isenberg D.M. Davis RB, Ediier SL. et al. Trends in alternative mediiine u\e in ihe

United Stales. 1090-1997: results ofa tiilliiw-up naiional survey. JAMA. 1998;

Reid tl. Brute AV\', leaser N, et al. Oral probiotics ran resolve urogenital int'ectiotis.FEMS Imtnmu'l Mfil Miirolml 20(11: 30:49-52.Reid c;, Beiieniiaii I). Huini-ciianii C. Bruce AW. Probiotic iMctohacillus dose required ti>restore and maiiUaiii a mimial \aijinal flora. ffiM.S'/mmuMiVjUft/.W/froi/iV. 2001; 32(1);37-4I.Chimura T. [Fxobgical ireaimejii ut'bacterial vaginosis and vaginitis with Bii>-Lhrft|.I/Ill JAiiiibn-t. 1998; 51:759-7i.;3-Japanese.Parent D. Bossens M. Bayol D et al. Therapy ol'battcrial vaginosis using exogenously-applied Lactobacilli acidiiphili and a low dose of estriol: a placebo-controlled multicen-tric clinical trial. Arznamitteljor.'iihung. 1996; 4t):68-73.Shaiev E. Ballinii S, Weiner E, Colodner R. Keness V. Ingestinn of yogurt containingl.aiiiibacillus acidopliilus compared with pasteurized yogurt as prophylaxis for recur-rent candidal vaginitis and bacterial vaginosis. Arik Fam Med. 199B; 5:593-596.Chimura T. Kunayama T. Murayama K. Numazaki M. lEcoUigical treatment of bacterialvagmosis].JptiJ Aritibiiil. 1995; 48:4 32-43 6. Japanese.Pattman RS, Sankar KN, Watson PC, VVardropper AC. .An audit ol Gynatren (aLutohiuillu\ iiailophilus lynphilisate) vaccination in women with rectirrent bacterialvaginosis-/H//5m4/aS. 1994:5:299.Neri A. Sabah C, Samra Z. Bacterial vagiiwsis iti pregnancy treated with yoghurt. AdaOhstcl CrneolSiiiml. 199:i; 72:17-19-Fredrics.son B. Englund K, Weintraub L, Olund A. Nord (.'?., Fcologica! trealnient utbacterial vaginosis. t(iwirtl987; 1:271),van df VVijgert J. Fullern A. Kelly C. et al. Phase 1 Trial o( the Topical MicrobicideBiitter