Process. Plan for today. Update in Women s Health. Criteria 7/27/2017

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1 Plan for today Update in Women s Health Judith Walsh MD, MPH University of California, San Francisco Women s Health Center of Excellence Division of General Internal Medicine Review some of the most significant published advances in the Women s Health medical literature over the past two years Top articles Key articles Guidelines Assess the strength and scope of the evidence presented in the selected literature Apply this new information to our clinical practice Take home points SGIM Annual Meetings 2016 and 2017 Erin Contratto MD, Bimla Schwarz, MD and Lydia Pace MD Process Criteria How new/innovative is this information? Strength of the evidence? How will it change my practice? 16 Journals March Feb Independent reviewers: ranked 1 4 stars 1

$OCPs and Cancer Binge Eating Cranberry and UTIs Tomosynthesis Lymphedema & blood draws Hormone therapy and CVD Osteoporosis Treatment Atypical fractures ISSUES AFFECTING REPRODUCTIVE AGE WOMEN Case$

2 OCPs and Cancer Binge Eating Cranberry and UTIs Tomosynthesis Lymphedema & blood draws Hormone therapy and CVD Osteoporosis Treatment Atypical fractures ISSUES AFFECTING REPRODUCTIVE AGE WOMEN Case The News 39 year old woman who has been on OCPs since she was 19,when she started them for irregular and painful menses. She does not desire children and is happy with her light and relatively painless menses. She would like to continue but is worried that they may not be safe for women after 40. What do you tell her? Lifetime cancer risk and combined oral contraceptives: the Royal College of General Practitioners' Oral Contraception Study Iversen et al. AJOG

3 UK Royal College of General Practitioners' Oral Contraception Study 46,022 women recruited Followed for up to 44 years 4661 ever COC users with at least one cancer during 884,895 woman years of observation 2341 never COC users with at least one cancer during 388,505 woman years of observation. Results Previous concerns of any increased risk of breast and cervical cancer lost within five years of stopping COC no evidence of increased risk of either cancer recurring with time. Suggests earlier diagnosis rather than true harm Increased risk of lung cancer was seen only among ever users who smoked Iversen et al. AJOG 2017 Important cancer reductions persist many years after stopping COC use Poisson regression to estimate incidence rate ratios (IRR) between ever and never COC users adjusted for age, parity, smoking, and social class Ever use of COC associated with reduced cancer: Endometrial (IRR 0 66, 99% CI ) Ovarian (IRR 0 67, 99% CI ) Colorectal (IRR 0 81, 99%CI ) Lymphatic/ (IRR 0 74, 99%CI ) Hematopoietic Iversen et al. AJOG 2017 Implications for practice Hormonal contraception may be important for cancer prevention Especially if BMI>30 Even if she were not seeking contraception Even if she were 50 years of age Levonorgestrel Intrauterine Device as an Endometrial Cancer Prevention Strategy in Obese Women: A Cost Effectiveness Analysis Dottino JA, et al. Ob Gyn

4 Case: HPV 25 year old woman received 2 doses of HPV vaccine several years ago and wants to know if she should restart the HPV series? You tell her HPV VACCINE A. Since last dose > 12 months ago, she should restart the full 3 dose series. B. If she received 2 doses before age 15, no further doses are needed. C. HPV vaccine is only 2 doses now, regardless of age. Background: HPV vaccination 9v HPV vaccine Gardasil 9 (Merck ) FDA approved Dec : only vaccine distributed in US 6,11 (genital warts) 16, ,33,45,52,58 (oncogenic) The News Two vs Three Doses of Human Papillomavirus Vaccine New Policy for the Second Decade of the Vaccination Program Markowitz et al. JAMA Immunogenicity of 9 valent HPV vaccine Using 2 Dose Regimen in Girls and Boys vs a 3 Dose Regimen in Women Iversen et al. JAMA boys & girls ages % seroconversion 4 weeks after 2 nd dose ACIP Dec 2016 (Advisory Committee on Immunization Practices) Routine vaccine yo 2 dose series ages 9 14 (0, 6 12mo) 15 26: 3 dose series (0, 1 2, 6 mo) MMWR Dec 16, 2016 MMWR Dec 16,

5 Conclusion How many doses of HPV vaccine should patients receive? SCREENING PELVIC EXAMINATION If 2 doses initiated before age 15 years, no further doses. If series started after age 15, 3 doses given. If vaccination schedule is interrupted, do not restart series. MMWR Dec 16, 2016 Henrietta Screening Pelvic Examination? Henrietta is a 36year old woman who comes to see you for a well woman preventive examination. You perform a Pap with HPV co-testing. She recalls that in the past you have done a bimanual examination in order to check her ovaries. She wants to know why you did not do that today. A part of preventive health care for women for many years Not needed for contraception or STD screening What is the goal of a screening pelvic examination? 5

6 Pelvic Exam at the Well-Woman Visit ACOG Committee Opinion 534; August 2012 Women younger than 21 years Pelvic exam only when indicated by medical history Screen for GC, chlamydia with vaginal swab or urine Women aged 21 years or older ACOG recommends an annual pelvic examination No evidence supports or refutes routine exam if low risk If asymptomatic, pelvic exam should be a shared decision Individual risk factors, patient expectations, and medico-legal concerns may influence these decisions If TAH-BSO, decision left to the patient if asymptomatic Screening Pelvic Examination: ACP Evidence Report Review of 52 studies No evidence supporting the use of pelvic examination in asymptomatic average risk women May cause pain, discomfort, fear, anxiety and embarrassment in about 30% of young women Routine Pelvic Examination? USPSTF Recommendations Diagnostic accuracy for detecting ovarian cancer or BV is low Rarely detects non-cervical cancer or other treatable conditions ACP recommends against performing screening pelvic examination in asymptomatic, non-pregnant adult women Ann Intern Med. 2014;161:67-72 No studies assessing effectiveness of pelvic examination in reducing all cause mortality, cancer and disease specific morbidity and mortality or improving QOL Evaluated diagnostic accuracy and potential harms for ovarian cancer, bacterial vaginosis, trichomoniasis and genital herpes Current evidence is insufficient to assess the balance of benefits and harms for performing screening pelvic examinations in asymptomatic women for the early detection and treatment of a range of gynecologic conditions USPST F Final Recommendation

7 Does YOUr PatIent need a pelvic exam? Clinicians who choose to perform pelvic examinations in asymptomatic women should be aware that there is uncertain benefit and there is the potential to cause harm through a positive test result and subsequent testing BINGE EATING DISORDER Case 38 yo woman presents to discuss weight loss options. She has difficulty with portion control and describes weekly episodes of eating large quantities of food in a short period of time. She feels that she cannot control herself during these binges. Recently she consumed an entire bag of Oreos in 30 minutes. She does not induce vomiting or exercise excessively after binges. BMI is 29. What therapy will prevent binge eating & reduce weight? A. sibutramine B. self directed cognitive behavior therapy C. lisdexamfetamine D. sertraline Binge Eating Disorder Most common eating disorder in the US Lifetime prevalence women 3.5% (vs men 2%) obese 5 30% DSM V Criteria recurrent (>1x/wk) over 3 mo brief (<2 hrs) psychologically distressed binge eating: consume larger amounts of food than most people would under similar circumstances & lack control over eating Current treatment guidelines are conflicting (American Psychiatric Association, National Institute for Health & Care Excellence) 7

8 News: Lisdexamfetamine for Binge Eating disorders Binge Eating Disorders in Adults: A systematic Review and Meta analysis Brownley et al. Annals of Internal Medicine Objective: summarize evidence about benefits & harms of psychological & pharmacologic therapies for adults with binge eating disorder. Methods: Systematic review Funding: AHRQ Results 34 trials with low/medium risk of bias Female: 77% Mean age: years Mean BMI: Treatments: 6 weeks 6 months Brownley et al. Annals Therapy Binge Eating Disorder Therapies Second generation antidepressants* Therapist led CBT Lisdexamfetamine Topiramate Abstinence from binge eating Improved (RR 1.67) Improved (RR 4.95) Improved (RR 2.61) Moderate benefit (58 64% vs 29 30%) 2trials Depression symptoms Improved (MD 1.97) No change Weight No change No change Decreased ( %) Decreased (4.7kg) * citalopram, escitalopram, duloxetine, bupropion, fluvoxamine, paroxetine, sertraline Brownley et al. Annals 2016 Harms of Treatment Not reported in Psychological studies 20/25 pharmacologic studies 3 Trials = lisdexamfetamine Sympathetic nervous system arousal: RR 4.28 Insomnia: RR 2.8 (CI ) GI upset: RR 2.71 General sleep disturbances: RR 2.19 Headache: RR 1.63 Brownley et al. Annals

9 Conclusions In adults with binge eating disorder: Increase abstinence from binge eating therapist led CBT topiramate lisdexamfetamine 2 nd generation antidepressants (i.e. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) Reduce weight topiramate lisdexamfetamine UTIs Brownley et al. Annals 2016 Case Nellie Natural is here for her annual visit. She mentions mild UTI symptoms for 4 days. UA is + for LE and nitrites. She's not a fan of medications, tends to prefer natural supplements, and asks you if antibiotics are truly necessary. You tell her: A. Antibiotics may lower her risk of pyelonephritis B. She can try ibuprofen 400 tid instead of an antibiotic C. More than 2/3 of typical UTIs resolve on their own D. All of the above Case Nellie Natural is here for her annual visit. She mentions mild UTI symptoms for 4 days. UA is + for LE and nitrites. She's not a fan of medications, tends to prefer natural supplements, and asks you if antibiotics are truly necessary. You tell her: A. Antibiotics may lower her risk of pyelonephritis B. She can try ibuprofen 400 tid instead of an antibiotic C. More than 2/3 of typical UTIs resolve on their own D. All of the above 9

10 The News Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. Gagyor et al. BMJ 2015;351:h6544. Objective: Can uncomplicated UTI be treated with ibuprofen to reduce antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications? Methods Double blind randomized multicenter trial of 42 GPs in Germany Intervention: 779 women, up to age 65, with suspected UTI randomized Fosfomycin 3 g sachet x 1 day or Ibuprofen 400 tid x 3 days Women scored their daily symptoms and activity impairment Safety data collected q 6mo, between Inclusion criteria: Dysuria, frequency, urgency, +/ lower abdominal pain Exclusion criteria: Fever, loin tenderness Pregnancy, renal disease UTI within 2 wks Urinary catheterization Contraindication to NSAIDs Selected outcome Results Ibuprofen n=241 Fosfomycin n=243 Courses of antibiotic within 28d RR 66.5% ( ) Mean duration of symptoms 5.6 days 4.6 days P<0.001 % Patients symptoms free 70% 82% P=0.004 at day 7 % Patients with recurrence of 6% 11% P=0.049 UTI (d 15 28) Number of patients with 5 1 P=0.12 pyelonephritis Number of patients with GI symptoms 6 15 NS Conclusions Women with mild to moderate symptoms may benefit Nonparticipants had higher symptom scores Reminder: Treatment of asymptomatic bacteruria not recommended Cochrane review showed no benefit of antibiotics to prevent: symptomatic UTI complications death Cochrane Kidney and Transplant Group. Antibiotics for asymptomatic bacteruria; 8 APR

11 Cranberry juice Nellie has just one more question: My mother told me cranberry juice treats UTI s, is this true? You tell her A) There is no evidence on cranberry juice and UTIs B) Cranberry juice/capsules have not been proved effective at preventing UTI C) Cranberry juice/capsules prevent UTIs for nursing home patients D) Wrong juice try orange juice Background Cranberry proanthocyanidins inhibit adherence of E. coli to uroepithelial cells Prior studies UTI prophylaxis women 78.5 yrs 300mL (~10 oz) = 36mg daily x 6 months decreased bacteria & pyuria Howell et al. N Engl J Med Lavigne et al. Clin Microbiol Infect Avorn et al. JAMA The News Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes. Juthani Mehta et al. JAMA Objectives effect of 2 cranberry capsules/day (72mg proanthocyanidin) bacteriuria + pyuria women nursing home residents Methods Study Design Double blind placebo controlled, efficacy RCT 21 Nursing Homes: Aug 2012 Oct 2014 Outcomes Bacteriuria (>100K CFU) + pyuria (WBC) assessed q 2 months, followed 12 months Exclusion criteria chronic suppressive antibiotics ESRD Unable to provide baseline clean catch urine specimen warfarin hx of nephrolithiasis indwelling bladder catheter nursing home residence < 4 weeks Juthani Mehta et al. JAMA

12 Outcome Results No Differences Cranberry tablets (n=92) Placebo (n=93) Bacteriuria + pyuria 29.1% 29.0% Symptomatic UTI All cause hospitalization MDR GNB Bacteriuria 9 24 Conclusions Cranberry capsules unlikely to prevent UTI for women >65 years, residing in nursing homes Supported by Cochrane Review 2012 Cranberry unlikely to prevent UTI over 12 months Antibiotics for suspected UTI Total antimicrobials Juthani Mehta et al. JAMA Take Home Nellie can try ibuprofen for her UTI. She should be counseled to call if her symptoms persist, and to watch for possible pyelonephritis. Two thirds of UTIS resolved on their own Women who take ibuprofen are more likely to need additional antibiotic therapy, but still less likely to receive antibiotics overall. If she likes cranberry juice, she should drink it, but there is no evidence that it will prevent or treat UTIs Mammography Screening The Ongoing Saga 12

Case Ms. Smith is a 50 year old woman who just had her first screening mammogram which shows heterogeneously dense breasts but no other abnormalities.

You say: No, Digital (2D) mammograms, every 2 years are fine for you Yes, Digital 3D mammograms (tomosynthesis), every 3 years 2D or 3D mammograms every 1 year are fine Let s

13 Case Ms. Smith is a 50 year old woman who just had her first screening mammogram which shows heterogeneously dense breasts but no other abnormalities. Menarche at 12, first child at 32 No history of a breast biopsy No fhx of breast cancer She asks if she should have one of those 3D mammograms? You say: No, Digital (2D) mammograms, every 2 years are fine for you Yes, Digital 3D mammograms (tomosynthesis), every 3 years 2D or 3D mammograms every 1 year are fine Let s review your risk for developing breast cancer and your preferences Digital Breast Tomosynthesis Digital Breast Tomosynthesis (DBT) as a primary screening strategy? Yaffe Breast Cancer Research :209 13

14 Background 50% of breasts are dense Tomosynthesis (3D mammography) Now available ~22% of U.S. facilities Variably covered by insurance Wang et al, Mayo Clin Proc

Process. Plan for today. Update in Women s Health. Criteria 5/23/17

Process. Plan for today. Update in Women s Health. Criteria 5/23/17 Plan for today Update in Women s Health Judith Walsh MD, MPH Division of General Internal Medicine Women s Health Center of Excellence Review some of the most significant published advances in the Women