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1 Natural Approaches to Women s Health Urinary Tract Infections! FOR PROFESSIONAL USE ONLY Prepared By: Rishma Walji, ND, RAc, PhD CCCEP File # I-P Accreditation Date: November 22, 2016 Expiry Date: November 22, 2017 CEUs 0.5
2 Commercial Disclosure This learning activity has received financial support from WN Pharmaceuticals in the form of program development fees. This learning activity has received in-kind support from WN Pharmaceuticals in the form of logistical support. Disclaimer For Professional Use Only This information is provided for educational purposes only and is not intended for self-diagnosis or self-treatment of a condition that should be interpreted by a qualified health care provider. While the information in this document has been carefully reviewed and reflects current clinical and scientific knowledge, it is subject to change. The Author, Expert Reviewers and Presenter declare no real or perceived conflict with the sponsor company.
3 Instructions Carefully watch this lesson. Complete and submit the on-line quiz. Study each question in the post-test and select the answer which you believe to be most correct. To successfully pass this lesson, a grade of 70% is required. Complete and submit the on-line Program Evaluation form. If you pass, you will receive your Statement of Attendance via or mail for your own records. Introduction Throughout a woman s reproductive life menarche to menopause women face health issues that are specific to their hormones and genetic composition. According to Statistics Canada, women make healthier lifestyle choices and are quicker to react to signs of illness. Women are more likely to consider their health when making food choices as well as complementary and alternative health advice.
4 Learning Objectives Goal: To educate pharmacists on the natural treatment options for urinary tract infections (UTIs). Objectives: After completing this session, the pharmacist should be able to: Summarize the prevalence and etiology of UTIs. Describe the physical, behavioral, and psychological symptoms associated with UTIs. Explain the diet, lifestyle & natural health product options available for the treatment of UTIs. Explain the safety and efficacy of these options. Urinary Tract Infections Case MK is a 36-year-old female who arrives at your pharmacy to fill a prescription for Nitrofurantoin. Her family doctor has just diagnosed a urinary tract infection her third in the past 6 months. MK has discussed these recurrent episodes with her family doctor, who has offered prophylactic antibiotics, but MK is not keen on using daily antibiotics. She would like to discuss preventative treatments with you. What would your recommendations be and why?
5 Introduction to UTIs Urinary tract infections (UTIs) are microbial infections that occur anywhere along the urinary tract urethra, bladder, ureters or kidneys (Mazzulli, 2012). The female urethra is particularly prone to bacterial infection via migration from the anus or vagina (Head, 2008) and subsequent ascension of bacteria typically results in cystitis (Jepson et al., 2013). Presents with bacteruria (typically > 100,000 cfu/ml) and symptoms such as urinary frequency, urgency, pain/burning on urination, foul smelling/cloudy urine and other features of dysuria (Mazzulli, 2012; Jepson et al., 2013). As many as 50% of women report having one UTI by age 30, and up to 25% of women report recurrence within 6 months of their first UTI (Mazzulli, 2012). Etiology & Pathogenesis of UTIs Associated with altered vaginal and colonic flora (Head, 2008) % due to E. coli, 5-15% due to gram positive S. saprophyticus, remaining cases due to enteric gram negative species like Klebsiella and Proteus species (Mazzulli, 2012). Both E. coli and Proteus attach to uroepithelial cells by proteinaceous appendages called fimbriae (Head, 2008). E. coli adhere via type 1 pili long, hairy-surface organelles with a mannose binding FimH, a protein that acts as an adhesive. Adhered bacteria can invade bladder cells and form biofilms (Wellens et al., 2008)
6 Risk Factors for UTIs More frequent or intense sexual intercourse Spermicide use Tampon use New sexual partner in the last year or multiple partners Age at first UTI 15 years Maternal history of UTIs Diabetes Pregnancy History of UTIs Heavy use of antibiotics alteration of natural flora Dysfunctional voiding patterns in which there is increased tone of the external sphincter during micturition (Nickel, 2005; Head et al., 2008; Epp et al., 2010; Kodner & Thomas Gupton, 2010) Recurrent UTIs (rutis) Recurrent UTIs are defined as 2 infections in 6 months, or 3 or more infections in 1 year (Kranjcec et al., 2013) 20-30% of women will develop recurrent UTIs (Grin et al., 2013) Currently, long-term prophylactic or post-coital antibiotics are employed to reduce recurrence (Kranjcec et al., 2013). Concerns regarding efficacy, cost, side effects and potential antibiotic resistance and destruction of normal flora have prompted advocacy of alternative prophylactics such as cranberry, probiotics and d-mannose (Amdaker et al., 2011; Kranjcec et al., 2013).
7 Dietary Recommendations for UTIs Drink more water - maintains urinary flow and flushes bacteria (Head, 2008). Drink fresh fruit juices, especially berry juices - reduces recurrence of UTIs (Kontiokari et al., 2003). Reduce coffee, diet soda and caffeine intake - reduces risk of urgency and progression of UTI symptoms (Maserejian et al., 2013). Reduce alcohol intake - frequent use ( 1-3 times/week) is associated with UTIs resistant to ampicillin and cephalosporin antibiotics (Head, 2008). Consume fermented milk products containing probiotics - reduces recurrence of UTIs (Kontiokari et al., 2003). Avoid simple sugars and refined carbohydrates suppress neutrophil response (Sanchez et al., 1973) & can propagate bacterial growth. Lifestyle Recommendations for UTIs Maintain appropriate toilet hygiene wipe from front to back to avoid contaminating the urethra with feces (Nickel, 2005). Avoid use of diaphragm/spermicide contraception (Epp et al., 2010). Avoid/reduce use of tampons (Nickel, 2005). The American College of Obstetricians and Gynecologists District II NYS recommends urinating after sexual intercourse to prevent recurrent cystitis (Ballester et al., 2013). Few controlled studies support this practice, but anecdotal evidence suggests benefit (Kodner et al., 2010).
8 NHP Recommendations for UTIs We will review the possible role of the following NHPs in the management of UTIs: Cranberry Extract Probiotics D-mannose Powder Cranberry Extract Introduction American cranberry (Vaccinum macrocarpon) was historically used by North American Indians to treat UTIs (Hisano et al., 2012). The majority of human studies have focused on cranberry juice for prevention of UTIs, with initial findings suggesting benefit (Jepson et al., 2013). However, recent Cochrane Review (Jepson et al., 2013) suggests the benefit is minimal at best with poor adherence to juice intake. More recent data indicates that specific active constituents, proanthocyanidins (PACs), are responsible for the benefits of cranberry, suggesting standardized extracts may be more effective than juice consumption and future research should focus here (Jepson et al., 2013).
9 Cranberry Extract Mechanism of Action Prevents adhesion of type 1 and p-fimbriae strains (particularly E. coli) to the uroepithelium (Hisano et al., 2012) Prevents biofilm formation (Davidson et al., 2013). May increase nitric oxide production antimicrobial (Vasileiou et al., 2013). Anti-inflammatory effects symptom relief (Vasileiou et al., 2013). Cranberry Extract Evidence RCT to compare the effectiveness of cranberry extract with low-dose trimethoprim (TMP) in the prevention of rutis in older women ( 45 yoa) (McMurdo et al., 2009). 173 women with two or more antibiotic-treated UTIs in the previous 12 months were randomized to receive either 500 mg of cranberry extract (PAC content not specified) or 100 mg TMP for 6 months. 39/137 participants had an antibiotic-treated UTI (25 in cranberry group; 14 in TMP group). Time to first recurrent UTI: 84.5 days in cranberry group; 91 days in TMP group (not statistically significant). Authors concluded: TMP had very limited advantage over cranberry, with more adverse effects. Cranberry may present a natural option which does not carry the risk of antimicrobial resistance or super-infection with C. difficile or fungi.
10 Cranberry Extract Evidence cont d A randomized, double-blind non-inferiority trial in premenopausal women with rutis to test 12-month prophylaxis of trimethoprim-sulfamethoxazole (TMP- SMX) (480 mg/d) or cranberry capsules (500 mg bid, 9.1mg/g PAC) (Beerepoot et al., 2011). After 12 months the mean number of patients with at least 1 symptomatic UTI was higher in the cranberry group than in the TMP-SMX group (4.0 vs. 1.8; p=0.2). Median time to first symptomatic UTI was 4 months for cranberry and 8 months for TMP-SMX group. After 1 month, TMP-SMX, trimethoprim, amoxicillin and ciprofloxacin resistance rates were significantly increased in the TMP-SMX group, but not the cranberry group. The authors concluded that TMP-SMX was more effective than cranberry to prevent rutis, but at the expense of emerging antibiotic resistance. Cranberry Extract Evidence cont d A randomized, double blind, controlled, dose dependent clinical trial to evaluate the efficacy of a proanthocyanidin standardized whole cranberry (Vaccinium macrocarpon) powder (PS-WCP, 1.5% PAC) on infections of the urinary tract (Sengupta et al., 2011). 60 female participants with a history of rutis, and currently culture positive with mild symptoms of UTI, were randomly selected to participate and assigned to one of three groups: 1. Untreated control group (n=16) 2. Cranberry low dose (250 mg encapsulated PS-WCP bid) (n=21) 3. Cranberry high dose (500 mg encapsulated PS-WCP bid)(n=23)
11 Cranberry Extract Evidence cont d Sengupta et al., 2011 cont d 18/44 subjects in treatment groups had complete relief & remission from urological symptoms. Compared to baseline, subjects in both treatment groups reported significant improvement of symptoms at 10 days; no improvement in untreated group. Both treatment groups exhibited significant reduction of E. coli load after 10 days of treatment. At study end (90 days), E.coli in urine was reduced 65% (p<0.0001) in high dose group, 35% (p=0.0151) in low dose group; no change in untreated subjects (p=0.7234). Authors concluded this cranberry product can be suggested as an alternative/adjunct measure to conventional antibiotic therapy for recurrent urinary tract infections in women. However, in a 2012 Cochrane review, they concluded that Evidence from clinical trials does not support the use of cranberry products (juice, powder or tablets) for the prevention of UTIs. Cranberry Extract Dosage Recommended doses of dried, concentrated juice extract range from 600 to > 1200 mg/d divided into 2-3 doses (Hisano et al., 2012) mg/d extract (1.5% PAC) have been used (McMurdo et al., 2008; Beerepoot et al., 2011) PAC standardized extracts delivering 72 mg PAC/d (36 mg morning & evening) may offer protection against bacterial adhesion and virulence in the urinary tract (Howell et al., 2010). Adverse Effects Extracts generally well tolerated; no serious adverse events(mcmurdo et al., 2009; Beerepoot et al., 2011; Sengupta et al., 2011). Gastrointestinal upset (nausea, vomiting, diarrhea, constipation), mild rash/urticaria, vaginal complaints (not specified) are possible (McMurdo et al., 2009; Beerepoot et al., 2011).
12 Cranberry Extract Drug Interactions (Hisano et al., 2012) The effect of purified PAC on drug metabolism is unknown. Flavonoids in cranberry can affect cytochrome P450 enzymes and are aromatase inhibitors. Cranberry juice confers a significant reduction in the activity of nifedipine oxidase(cyp3a4) oral clearance and serum concentration. Cranberry juice (only in large quantities) cause changes in the international normalized ratio (INR) and prothrombin time (PT) in patients using warfarin (Rindone 2006). Cautions and Contraindications Known allergy to Vaccinum species or plants of the Ericaceae family. May cause thrombocytopenia and nephrolithiasis; effect not fully established (Hisano et al., 2012). Probiotics Introduction Live microorganisms which when administered in adequate amounts confer a health benefit on the host (FAO/WHO, 2002). They have GRAS (generally regarded as safe) status (Amdekar et al., 2011) Lactobacillus is an important part of the normal flora, which is commonly found in the mouth, gastrointestinal tract and female genitourinary tract (Amdekar et al., 2011). Reduction in the number of Lactobacillus increases risk of UTI (Amdekar et al., 2011).
13 Probiotics Mechanism of Action (Cadieux et al., 2009; Amdekar et al., 2011; Chapman et al., 2013) Maintains acidic ph via production of lactic acid & hydrogen peroxide. Antimicrobial activity. Prevents colonization by pathogen. Stimulates host immunity. Degrades toxins created by pathogen. Probiotics Evidence Randomized, placebo-controlled phase 2 trial of intravaginal probiotic Lactobacillus crispatus for prevention of ruti (Stapleton et al., 2011) 100 women (18-40 yoa) with history of ruti received antimicrobials for acute UTI, then randomized to receive vaginal probiotic (10 8 CFU/mL) or placebo daily for 5 days, then once weekly for 10 weeks. ruti occurred in 7/48 (15%) of women receiving probiotic compared with 13/48 (27%) of placebo. High level vaginal colonization with L. crispatus throughout follow-up was associated with significant reduction in ruti only for probiotic (relative risk for probiotic 0.07; relative risk for placebo, 1.1; P< 0.01) L. crispatus intravaginal probiotic after treatment for cystitis is associated with reduction in ruti.
14 Probiotics Evidence cont d Randomized, double-blind, noninferiority trial of oral capsules of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 probiotic vs. trimethoprim-sulfamethoxazole (TMP-SMX) for prevention of ruti in postmenopausal women (Beerepoot et al., 2012) 252 women randomized to 12 months of either 480 mg qd TMP-SMX or probiotic (10 9 CFU/cap) bid. Primary end points were the mean number of symptomatic UTIs, proportion of participants with at least 1 UTI during 12 months, time to first UTI, and development of antibiotic resistance by E. coli. Probiotics Evidence cont d (Beerepoot et al., 2013 cont d) TMP-SMX Group Probiotic Group Conclusions Mean # Symptomatic UTIs 1 year before randomization After prophylaxis Proportion of subjects w/ 1 UTI in 12 months % 79.1% Median time to 1 st UTI 6 months 3 months The betweentreatment difference of 0.4 UTIs per year (95% CI, 0.4 to 1.5) was outside the noninferiority margin. However, unlike TMP- SMX, lactobacilli do not increase antibiotic resistance. Antibiotic Resistance Increased from 20% - 40% to 80% - 95%. No resistance
15 Probiotics Evidence cont d Systematic review and meta-analysis of current RCTs to determine the efficacy of probiotic Lactobacillus species in preventing ruti (Grin et al., 2013). Data from 127 patients in two studies of intravaginal application were included. Only 1 study looked at oral dosage and used an ineffectual strain, so was excluded. A statistically significant decrease in ruti was found in patients given Lactobacillus, denoted by pooled risk ratio of 0.51 (95% CI , p=0.05). Authors concluded probiotic strains of Lactobacillus are safe and effective for prevention of ruti in adult women. Probiotics Dosage Intravaginal: L.crispatus 10 8 CFU/mL for 5 days, followed by once weekly for 10 weeks (Stapleton et al., 2011). Oral: L. rhamnosus GR-1 and L. reuteri RC-14 shown to restore vaginal flora in 1 month using 10 8 CFU qd and in 14 days using 10 9 CFU bid, respectively (Reid et al., 2001a, 2001b).
16 Probiotics Adverse Effects Intravaginal: Application of L. crispatus has been associated with moderate vaginal discharge and genital irritation in both treatment and placebo groups, suggesting the base medium for the suppository may be the cause (Stapleton et al., 2011). Oral: No serious adverse effect with oral administration of L. rhamnosus GR-1 and L. reuteri RC-14 (Beerepoot et al., 2013). May cause nausea, vomiting, diarrhea or constipation. Flatulence is common with oral probiotic use, but subsides with continued therapy. Probiotics Drug Interactions Take 2-3 hours away from antibiotics in order to preserve activity of antibiotics and probiotics. Cautions and Contraindications Immunocompromised, chronically ill, hospitalized patients with gastrointestinal disorders and indwelling catheters may be predisposed to probiotic sepsis (D Souza et al. 2002; Verna et al. 2010).
17 D-Mannose Powder Introduction D-mannose is a simple sugar important in human metabolism, especially in the glycosylation of certain proteins. Mechanism of Action D-mannose binds to the type 1 pili of enteric bacteria blocking their adhesion to uroepithelial cells (Wellens et al., 2008; Kranjcec et al., Inhibits epithelial invasion by bacteria and subsequent biofilm formation (Wellens et al., 2008). D-Mannose Powder Evidence 6 month, prospective RCT to determine the effect of regular intake of D-mannose powder (2 g/d) on reducing the rate of ruti compared to standard Nitrofurantoin (50 mg/d) prophylaxis and no intervention (n=308) (Kranjcec et al., 2013). Patients in D-mannose and Nitrofurantoin groups had a significantly lower risk of ruti compared to no prophylaxis group (RR and 0.335, P<0.0001). The difference between D-mannose and Nitrofurantoin groups was not significant. D-mannose powder was equally efficient in UTI prevention as standard Nitrofurantoin prophylaxis.
18 D-Mannose Powder Dosage 2 grams per day dissolved in 200 ml of water (Kranjcec et al., 2013). Adverse Effects Diarrhea reported by 8 of 103 participants and did not require discontinuation (Kranjcec et al., 2013) Drug Interactions, Cautions and Contraindications None known. Case Study Review Case Highlights Patient: MK, 36-year-old female CCs: active UTI, 3 rd in past 6 months Social History: Does not want to use prophylactic antibiotics Current Medications: Current Rx for Nitrofurantoin
19 Case Study Conclusions The guidelines of the European Association of Urology suggest that, because of possible adverse events and concern about selecting resistant pathogens, antimicrobial prophylaxis should be considered only after counseling, behavioural modification and non-antimicrobial measures have been attempted (Davidson et al., 2013). Based on these guidelines and MK s desire to avoid antibiotic prophylaxis, you can suggest the following dietary and lifestyle modifications, and NHP recommendations: Diet Case Study Conclusions Drink plenty of water to maintain urinary flow and flush bacteria. Try cranberry juice/berry juice to control symptoms via anti-inflammatory mechanisms. Reduce coffee, diet soda, caffeine and alcohol to minimize progression of UTI symptoms. Avoid simple sugars and refined carbohydrates. Consume fermented milk products, with probiotics. Lifestyle Practice post-coital urinary voiding to flush bacteria that may enter the urethra. Avoid spermicides.
20 Case Study Conclusions NHP Recommendations Cranberry extract: mg/d (ideally with standardized PAC content: ~ 72 mg/d). Probiotics: Due to her nitrofurantoin prescription, MK is at risk of altered microflora in the gastrointestinal and genitourinary tracts. MK s rutis reflect currently altered microflora. A multi-strain probiotic capsule containing at least 5 billion CFUs 3-4 times per day to replenish gastrointestinal flora. Orally L. rhamnosus GR-1 and L. reuteri RC-14, minimum of 1 billion CFU/d for 1 month to restore vaginal microflora. For greater effect in reducing rutis, intravaginal probiotics containing L. crispatus at 10 8 CFUs/mL or other vaginal strains (e.g. L. gasseri, L. rhamnosus) may be more effective. D-mannose powder: 2 g/d dissolved in 200 ml of water. Practical Considerations for the Pharmacist Offer advice and recommendations to patients regarding the use of natural health products. Advise the patient to: Inform their health care provider and pharmacist which natural health products they are taking. Maintain a list of natural health products that they are using and take it with them to their medical appointments. If they are contemplating starting to take natural health products, consult with their health care provider and pharmacist to ensure there are no risks of NHP-medication interaction.
21 Conclusions Women face health concerns throughout their lifetime that are unique to their physiology, hormones and genetic composition. Given that women tend to make healthier lifestyle choices, they are also more apt to seek alternative health advice, often turning to their pharmacists as a first line of information. Although many NHPs do promote and enhance good health, they are only safe when used under the right conditions. As a first line of information for the majority of Canadians, a pharmacist can advise patients if an NHP is right for them on an individualized basis, discussing benefits and risks.
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