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Back To BASIC s: B oric acid, A lternate S olution for I ntravaginal C olonization

Back To BASIC s: B oric acid, A lternate S olution for I ntravaginal C olonization. by Melinda Zeron Mullins and Teresa Wood. BABE Study! B oric A cid’s B roadening E vidence. by Melinda Zeron Mullins and Teresa Wood. BABELICIOUS Objectives. Explore Biases of Evidence Based Medicine

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Back To BASIC s: B oric acid, A lternate S olution for I ntravaginal C olonization

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  1. Back ToBASICs:Boricacid,Alternate SolutionforIntravaginal Colonization by Melinda Zeron Mullins and Teresa Wood

  2. BABE Study!Boric Acid’sBroadening Evidence by Melinda Zeron Mullins and Teresa Wood

  3. BABELICIOUS 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?

  4. ? Biases of EBM Only 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 only Ignore inconvenient truths &/or fail to prove them

  5. Researcher biases Women 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 placebo Placebo 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…

  6. ‘FACTS’ 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

  7. 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…

  8. ‘Facts’ 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!

  9. Women May Not Take Well to this News…

  10. THERE MAY BE HOPE Boric 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

  11. This sounds like a job for… SUPERBABES!

  12. GET ME OUTA THIS BOX! Don’t you think one vaginal infection is bad enough??!!

  13. Have no Fear… Resident Researchers are Here!

  14. BASICally… SHAZAM! a volunteer-based, randomized, double-blinded, placebo controlled, multi-center study for women symptomatic of a BV infection

  15. PAZAOW! • > 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

  16. POW! 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

  17. Bazoloopa! There’s more: 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

  18. 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!

  19. Where 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… !

  20. WOWSERS! D’Oh!!! Wolloping WHACK! • July: Get UBC Ethics--FAST • 1st residents to call Dr.Berkowitz • December: Fast UBC Ethics! • WAIT! Not UBC-->VIHA: Van Isld Health Auth • ???? *sigh* … January • February: VIHA--NO, Silly! • Actually…UBC 1st, then VIHA! • HOLD EVERYTHING: Nothing before HC… • ???? HC ???? • Yup, you heard me: Health Canada! WHAM!

  21. Getting started, Getting stopped Pending UBC ethics Pending HC “No objection” letter Awaiting permission to apply to VIHA HA HA HA HA HA HA HA Ethically Disillusioned… yet Delusionally Ethical, SUPERBABES REGROUP… I agree! But isn’t Dr. BatBABE Trouton busy working on FLOW?… WonderBabe, I think we might need BatBabe for this one…

  22. We interrupt this episode for an important safety announcement!

  23. Zen and the Art of Residency Research Learn to Breathe Breathe Learn to Laugh Laugh Learn to Meditate Just Be (the be-all, end-all of LIFE is Being)

  24. Oh, YES… Back to BASICs… Expand team: Dr. Konia Trouton on the scene! Recruit R1’s interested in joining study!!! Advantage: dirty groundwork is done Disadvantage: can’t learn from own mistakes--we’ve already made them Your job: Run the study with us! Get results! We are committed to completing this, and getting an answer to our question! So…

  25. 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 !

  26. This (re)programming was brought to you by: Dr. Melinda Zeron Mullins (SuperBABE) and Dr. Teresa Wood (WonderBABE) 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

  27. And of course…EXTRA SUPER THANKS TOour own SUPERBABES… Hayden, Geoff, and Alfie

  28. Back ToBASICs:Boricacid,Alternate SolutionforIntravaginal Colonization by Melinda Zeron Mullins and Teresa Wood

  29. Where to next, Babes? We’ve got a few plans brewing…

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