back to basics: boric acid, alternate solution for intravaginal colonization by melinda zeron...

Back ToBack To BASICBASICs:s:BBoricoric acid,acid, AAlternate lternate

SSolutionolution forfor IIntravaginal ntravaginal CColonizationolonization

by Melinda Zeron Mullins by Melinda Zeron Mullins

and Teresa Woodand Teresa Wood

BABE Study!BABE Study!BBoric oric AAcid’scid’s BBroadening roadening

EEvidencevidence



BABELICIOUS ObjectivesBABELICIOUS Objectives

Explore Biases of Evidence Based Medicine Expose our own Biases (Babelicious Biases) The truth about TRUTHS Overview of Bacterial Vaginosis ‘facts’ Review current research, treatment, side effects Review His/Herstory of Boric Acid Our Story: Getting started, Getting stopped Zen and the Art of Residency Research Where are we now, and Where to next?

? Biases of EBM? Biases of EBMOnly study the study-able (little white pills)Only study the cost-effective (little white pills)Only study the placebo controlled (little white pills)Only study if your expensive team is large enough to fund a

bunch of grant writers, ethics tacklers, evidence gatherers, project designers, recruiters--READ: Pharmaceutical Company!

Ask specific questions, avoid the ones you don’t want the answers to…

Fund the former onlyIgnore inconvenient truths &/or fail to prove them

Researcher biasesResearcher biasesWomen have ideas about their bodies Old treatments aren’t all bad, just because the evidence is

lacking (e.g. furosemide)New treatments aren’t better just because evidence says

they are better than placeboPlacebo is significant: therapeutic alliance HUGE!!!Epistemology/“How we come to know things” has changed

100s of times through the centuries, & will continue to change... It’s always matter of current opinion.

EBM has utility! That it’s the law is its main flaw.Oh, yes, and that Boric Acid works…

‘‘FACTS’ about BVFACTS’ about BV

World’s most common vaginal infection Not a Sexually Transmitted Infection (STI) Bacterial overgrowth or translocation Associated with risk of preterm labour,

post-surgical infx, endometritis, spontaneous abortion, STI transmission (including HIV), sexual dysfunction

Who cares?Who cares? Symptoms included: Vaginal

discomfort, discharge changes (consistency, color, odor), dyspareunia

Can be very distressing, embarrassing, frustrating

Asymptomatic BV does not need Rx Rx: metronidazole po or pv Rx success rate 70-80%, but…

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‘‘Facts’ about metronidazole RxFacts’ about metronidazole Rx

Successful treatment in 70-80% of cases (1 month)

Early recurrence rate too HIGH: 49-66% (1 year) Side effects 10-20% of women Side effects include a major FAUX-PAS*:

A SECONDARY VAGINAL INFECTION w/ CANDIDIASIS!!!

* translation: FAUX-PAS! = MUST NOT!

Women May Not Take Well Women May Not Take Well to this News…to this News…











THERE MAY BE HOPETHERE MAY BE HOPEBoric Acid : used for >100 years for the Tx of vaginal infxn’s, as an

wound/eye wash, for acne/athlete’s foot In peanut butter, wine, grapes, peaches, sea-water B(OH)3, considered as toxic as sea salt. Cheap, easily accessible, easy to use vaginal caps Good evidence shows BORIC ACID is effective for acute,

chronic and recurrent candidal infx’s M.D.’s use for BOTH vaginitis (fungal) & BV NOT YET PROVEN FOR USE in BV! Could offer a single EBM Tx for 2 most common vaginal

infections: Fungal Vaginitis & BV

This sounds like a job for…

SUPERBABES!SUPERBABES!

GET ME OUTA THIS BOX!GET ME OUTA THIS BOX!

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are needed to see this picture.

Don’t you think one vaginal infection is bad enough??!!

Have no Fear…Have no Fear…

Resident Researchers are Here!Resident Researchers are Here!



BASICally…BASICally…

a volunteer-based, randomized, double-blinded, placebo controlled, multi-center study for women symptomatic of a BV infection

SHAZAM!

> 45 volunteers, recruited by M.D.’s Randomized to boric acid, metronidazole or

placebo intravaginal capsules (15/ group) 10 day Tx, 1week + 1 month follow-up Immediate Cure Rates, Side Effect Profile and

One-month Cure Rates vs. Recurrence Powered to show Boric Acid vs. Placebo ‘Pilot sized’ for comparison to metronidazole

PAZAOW!


Who’s out?Who’s out?･ Age <16 or post-menopausal･ (-)ve swabs (no matter what else +)･Menstruating at Dx･ Severe symptoms: placebo not ethical･ Current STI (G/C, Trich, HSV, warts)･ Current yeast infection Hx/PE/Swab･ History of PID, or high risk for STI･ Allergy to latex or flagyl･ Pregnant, lactating, or at high risk for pregnancy

POW!

There’s more: There’s more: Who else is out!Who else is out!

･ any concurrent vaginal injury/irritation ･ any vulvar, vaginal or medical condition that

might confound Rx response ･ Cervical neoplasia or recent Laser Rx ･ Use of any antifungal or antibiotic or alternative

medicine 2 wks pre-study･ Concurrent use of lithium, anti-coagulants or

disulfiram drugs

Bazoloopa!

So…Who’s in?So…Who’s in?･ Premenopausal women (age 16-50) ･ Preg. test (-)ve on day of enrollment･ Documented BV infx by (+)ve swab +/- (+)ve whiff

test/pH >4.5･ Able to follow study protocol･ Agree to no new meds, no ETOH, no intercourse, no

douche, no intravag. Products (tampons, meds, devices)･ No current STI on Hx/PE/Swabs ･ Reliable for proper follow-up

BAM!

Where we are nowWhere we are now

5 clinics across Victoria~10 G.P.’s 1 gynecologist 2 nurses and many MOAs!Registered for publication

On our marks, we’re set… !

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are needed to see this picture.

D’Oh!!!D’Oh!!!

July: Get UBC Ethics--FASTJuly: Get UBC Ethics--FAST 1st residents to call Dr.Berkowitz1st residents to call Dr.Berkowitz December: Fast UBC Ethics!December: Fast UBC Ethics! WAIT! Not UBC-->VIHA: Van Isld Health AuthWAIT! Not UBC-->VIHA: Van Isld Health Auth ???? *sigh* … January ???? *sigh* … January February: VIHA--NO, Silly!February: VIHA--NO, Silly! Actually…UBC 1st, then VIHA!Actually…UBC 1st, then VIHA! HOLD EVERYTHING: Nothing before HC…HOLD EVERYTHING: Nothing before HC… ???? HC ???????? HC ???? Yup, you heard me: Yup, you heard me: Health Canada!Health Canada!

WHAM!

WollopingWHACK!

WOWSERS!

Getting started, Getting stoppedGetting started, Getting stoppedPending UBC ethicsPending HC “No objection” letterAwaiting permission to apply to VIHAHA HA HA HA HA HA HA

Ethically Disillusioned… yet Delusionally Ethical,SUPERBABES REGROUP…

WonderBabe, I think we might need BatBabe for this one…

I agree! But isn’t Dr. BatBABETrouton busy working

on FLOW?…

We interrupt this episode for an

important safety announcement!

Zen and the Art of Residency Zen and the Art of Residency ResearchResearch

Learn to Breathe

Breathe

Learn to Laugh

Laugh

Learn to Meditate

Just Be

(the be-all, end-all

of LIFE is Being)

Oh, YES… Back to BASICs…Oh, YES… Back to BASICs…

Expand team: Dr. Konia Trouton on the scene!Recruit R1’s interested in joining study!!!

Advantage: dirty groundwork is doneDisadvantage: can’t learn from own mistakes--we’ve already made themYour job: Run the study with us! Get results!

We are committed to completing this, and getting an answer to our question! So…

Stay Tuned…Stay Tuned…SuperBABES are joined by other heroic residents to tackle the next stage of research project in our next exciting episode of: Back to Basics!!!

S U P E R B A B E S S U P E R B A B E S !!

This (re)programming was This (re)programming was brought to you by:brought to you by:

Dr. Melinda Zeron Mullins (SuperBABE)and Dr. Teresa Wood (WonderBABE)

Many thanks to those who helped us get here:Many thanks to those who helped us get here:Dr. Trevor Cohen Fearless Team Leader Dr. Konia Trouton Fearless Team Leader

Dr. Ellen Wiebe SuperResearchAdvisor by Proxy

Dr. Kendra Daniels SuperBABE at large

Dr. Eugene Leduc SuperReasearchAdvisor

Dr. Berkowitz SuperStatsGuy

Dr. Doug McGee SuperStar Doc/Researcher

Island Sexual Health Society/Women’s Health Clinic

And of course…And of course…EXTRA SUPER THANKS TOEXTRA SUPER THANKS TO

our own SUPERBABES…our own SUPERBABES… Hayden, Geoff, and Alfie

Back ToBack To BASICBASICs:s:BBoricoric acid,acid, AAlternate lternate

SSolutionolution forfor IIntravaginal ntravaginal CColonizationolonization



Where to next, Babes?Where to next, Babes?

We’ve got a few plans brewing…

back to basics: boric acid, alternate solution for intravaginal colonization by melinda zeron...

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