SAFE, EFFECTIVE PRACTICAL NON- DRUG TREATMENT STRATEGIES

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1 SAFE, EFFECTIVE PRACTICAL NON- DRUG TREATMENT STRATEGIES Gregory Chernish MD

2 WE ARE UNCOMFORTABLE WITH NON- DRUG TREATMENTS BECAUSE On the surface, it appears there is frequently a lack of evidence

3 GREG CHERNISH MD Assistant Professor, Family Medicine Medical Director, HealthPoint Clinic Course Representative, University of Manitoba Medical School Non-drug Medical Systems University of Manitoba Liaison, National Working Group on CAM in UME Prairie Representative, Chronic Non-Cancer Pain Program Committee, Section of Family Physicians with Special Interests and Focused Practices, College of Family Physicians of Canada Alumnus Chengdu College of Traditional Chinese Medicine

4 OBJECTIVE #1 Develop the expertise to carve out a comfortable place in your clinical practice to discuss an EBM approach to non-drug strategies for some chronic conditions: In a shared decision making model In response to patient queries for options and as a first-line approach

5 OBJECTIVE #2 Develop academic expertise to analyze guidelines, analyses and data involving non-drug treatment methods in a nonbiased fashion leading to practical, specific treatment recommendations

6 CONFLICTS OF INTERESTS No 3 rd party funding No industry funding

7 SHARED DECISION MAKING

8 WHAT DO PATIENTS WANT?

9 HIERARCHY OF PATIENT-CENTERED GOALS & VALUES Risk aversion QOL Symptom management Maintenance of function, rehabilitation Surgical deferral Preservation of higher consciousness Prevention of suicide, accidental death

10 NOT EBM

11 EBM CDSR 2015

12 Searching out best evidence for nondrug options forces us to SCRATCH SNIFF & DIG

13 WHEN WE READ LACK OF EVIDENCE NO EVIDENCE No data Negative data Conflicting data Low on the EBM hierarchy data Traditional evidence only

14 HOW GOOD IS THE EVIDENCE? IF RCTS ARE THE ONLY GOOD EVIDENCE HOW GOOD CAN THE EVIDENCE BE FOR NDT S? Active placebos Narrow vs comprehensive outcomes Unregulated products, treatments Inactive treatments Industry sponsorship

15 NO DATA TRADITIONAL DATA 15

16 ACTIVE LACEBOS

17 GERAC TRIALS 2006 LBP (NOT INCLUDED COCHRANE 2005 ACUPUNCTURE LBP REVIEW) N=1000 Tx response after 6 months: 33% improvement pain 47.6% verum acupuncture 44.2% sham Standard tx biweekly consultation: PT, NSAID s

18 Howick, J. (2011). The Philosophy of evidence-based medicine. Oxford: Wiley-Blackwell

19 Purpose of Phase I drug trials is to examine dosing relative to blood levels of parent drug and metabolites and looking DRUG VS NON-DRUG META- ANALYSES for potential adverse reactions. No drugs make it to RCT s without first making sure that the drug is being dosed at levels producing effects observed in preclinical models. WHAT ABOUT NHPs?

20 PREMATURE CLINICAL TRIALS High Quality High Powered Study Design With Poor Quality Products NCCAM/NCCIH: Glucosamine Saw Palmetto Black Cohosh St. John s Wort

21 GUIDELINE BIAS Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. CDSR Acupuncture for Migraine Headache (2009)

22 TOP GUIDELINE JULY 2012 Management of Primary Headache in Adults 70 pages drugs; 1 page non-drug strategies 1 sentence in 8 page headache management summary Non-drug treatments missing completely from Quick Reference Guide

23 INDUSTRY PONSORSHIP Good or bad?

24 NARROW VS BROAD OUTCOME MEASUREMENTS

25 the findings are not definitive, but we found that immersion in water, relaxation, acupuncture and massage all gave pain relief and better satisfaction with pain relief some important outcomes were rarely or never included (for example sense of control, breastfeeding, mother and baby interaction, costs and infant outcomes). PAIN MGMT LABOUR CDSR 2012

26 IS THIS EXPERTISE FOR SHARED DECISION MAKING? Given the frequent uncertainty in herbal product quality, which impacts the product's efficacy and safety, few (if any) herbal products currently fit the criteria to proactively recommend an herb Up to Date 2015 Herbal Medicines and Dietary Supplements

27 German MD s must pass exam on herbal medicine 80% regularly prescribe herbs OR IS THERE ROOM FOR IMPROVEMENT? A 2004 EU directive requires manufacturers of all over-thecounter herbal products to register and license the product with the European Agency for the Evaluation of Medicinal Products. A premarket evaluation of quality and safety of the product is required. Companies need to carry out post-marketing surveillance and report serious adverse events. Up to Date 2015 Herbal Medicines and Dietary Supplements

28 THE SNIFFLETONS Denis and Marie are in their mid-30s, children Lorne and Bambi are 12 and 13 Marie brought in the children yesterday with symptoms of fever, rhinitis, sore throat, dry cough and profound malaise You diagnosed viral URTI and recommended symptomatic treatment

29 Denis brings the children in again today, reporting they are worse. Isn t there something we can take? We re going to Disneyland

30 ECHINACEA Historical Use

31 ECHINACEA E. angustifolia E. purpurea

32 MODERN USE Listed on US National Formulary NCCAM survey 20 % used in past year

33 MOA No consensus on active principle although products standardized for echinosides. Demonstrated effects include: Specific and non-specific immunostimulation CBR activation Possible bacteriocidal/viracidal effect

34 EVIDENCE Long history of use in North America prior to antibiotic Era. Due to the significant differences in the preparations tested, it was difficult to draw strong conclusions In general, trials investigating Echinacea for preventing colds did not show statistically significant reductions in illness occurrence. However, nearly all prevention trials pointed in the direction of small preventive effects. Our exploratory meta-analyses suggest that at least some Echinacea preparations may reduce the relative risk of catching a cold by 10% to 20%. CDSR June 2013

35 While there are some hints that both alcoholic extracts and pressed juices that are based primarily on the aerial parts of E. purpurea have beneficial effects on cold symptoms in adults, the evidence for clinically relevant treatment effects is weak CDSR June 2013

36 RISKS Generally regarded as safe May cause allergic reactions in those allergic to ragweed, mums, marigolds or daisies May influence CYP 3A4, CYP1A2 Possible increased warfarin clearance; other interactions minor Possibly safe in pregnancy 1 case report possible aggravation pemphigus

37 CHILDREN 7% of children 2-11 may experience a rash

38 PREPARATIONS Echinacin Echinaguard Echinaforce Echinaforce Junior

39

40 NEW PROPOSED OUTCOME MEASURES # antibiotic prescriptions for URTI Satisfaction with recommendation/self-efficacy # repeat visits for URTI

41 EVIDENCE INFORMED BOTTOM LINE Some Echinacea purpurea preparations may have a mild-moderate effect in preventing and treating the common cold. Echinaforce, Echinaguard, and Echinacin brands with most evidence. Risks and costs are low for these products, adverse events rare.

42 Most colds are caused by a virus. Antibiotics are not effective for viral infections. ECHINACEA & COLDS The usual course and duration of illness is up to one and a half weeks for patients with a cold; symptoms persist an additional three days on average in smokers. Echinacea may have a small to modest effect on reducing the severity and length of viral upper respiratory infections. Side-effects and interactions with medication are rare. Don t use Echinacea in children younger than twelve without discussion with your doctor; some children develop rash and allergic symptoms to Echinacea. Don t use this herb if you are allergic to ragweed, marigold, mums or daisies; Echinacea is related to these plants. Discuss use with your doctor if you have an autoimmune condition, or are taking any medications. PATIENT HANDOUT Echinacea products vary tremendously and some products may not contain any Echinacea at all. Products which have some scientific evidence for effectiveness, safety and quality are: Echinaforce (Bioforce AG) 2 tablets 3x daily (Available at Superstore cost approximately $ tablets) Echinagard (Nature s Way) liquid 20 drops every 2 hours in water for the first day then 20 drops 3 times daily for up to 10 days Echinacin (Madaus) 5 ml 3 x daily Results are best when started at the first signs of a cold and continued for not more than 10 days.

43 48 yo female CINDY Blood pressure 135/85 last year, now 105/ 70 Fhx CVD Twin sister with HER2 +ve breast Ca Non-smoker Waist 36 Chol 6.6 HDL.1.2

44

45

46 LINUM USITATISSIMUM Lignans ALA Fibre Peptides

47 FLAX-PAD N=110 RCT SBP 10 mm Hg lower, and DBP 7 mm Hg lower in the flaxseed group compared with placebo at 6 months Patients who entered the trial with a SBP 140 mm Hg at baseline obtained a significant reduction of 15 mm Hg in SBP and 7 mm Hg in DBP from flaxseed. The antihypertensive effect was selective in hypertensive patients. Rodiguez-Leyva et al. (2013). Hypertension. 62(6):1081-9

48 MOA Circulating α-linolenic acid levels correlated with SBP and DBP, and lignan levels correlated with changes in DBP?anti-inflammatory, antioxidant?ace-inhibitor

49

50 FLAX & Median 8.5 wks n=1381 LDL -.16 LIPIDS ANOTHER Tc -.19 SURROGATE? Tg 0 Effect > women, high lipids Oil no effect CDSR 2015 Pan et al

51 Flax is an indirect source of lignans. Precursor SDG converted in colon to enterolactone. Lignans have weak estrogenic and anti-estrogenic action. FLAX & ESTROGEN These lignans alter estrogen metabolism to produce less active estrogen metabolites. Preliminary evidence shows enterolactone and estradiol inhibit each other's proliferative effect on estrogen-dependent breast cancer cells. This competition might reduce endogenous estrogen binding to estrogen receptors, resulting in an antiestrogen effect. NMD 2015

52 SOGC 2006 CYCLICAL MASTALGIA RECOMMENDATION #7 Flaxseed should be considered as a first-line treatment for cyclic mastalgia

53 MENOPAUSE Not likely effective for flushes No conclusions re: bone health

54 Breast Cancer: RCT 25 g flax 40 d before surgery decreased tumour proliferation markers Thompson RU et al Clin Cancer Res May 15;11(10): Up to 50% women with breast cancer take flax Mason et al 2013 Appl. Physiol. Nutr. Metab. 39: (201 FLAX & CANCER Aromatase Inhibitors: Results do not support strong effects of FS on AI activity for selected breast tumor characteristics or serum steroid hormone levels McCann et al Nutr Cancer. 2014;66(4): Prostate Cancer: 30 g/day before prostatectomy reduced testosterone and tumour proliferation markers Demark et al Cancer Epidemiol Biomarkers Prev 2008;17:

55 RISKS OIL (not seeds) may be associated risk of premature birth from 3%-12% Berard, unpublished 2008 Unknown effect in pregnancy, breastfeeding May reduce platelet adhesiveness Drug interactions theoretical Hormonal effects not altogether clear Family & friends

56 Linatine Cyanogenic glycosides > thiocyanates Phytates, oxalates Cadmium, selenium ANTI-NUTRIENTS, TOXINS

57 DOSE Not more than 1-3 tablespoons ground flax/day Avoid flax oil, defatted flax Bake or toast seeds

58 Many of your patients are taking flax. EBM BOTTOM LINE Flax may have negative effects on female fertility g ground flax may have significant effects on blood pressure and blood lipids; whether these effects translate into decreased CVD is not known.

59 EBM BOTTOM LINE Flax effects on circulating sex hormones in men and women not entirely clear but may be beneficial in cancer; prudence suggested in hormone dependent cancers. Other risks including hypotension seem low. Flax should be cooked before eating to avoid antinutrients; avoid whole flax and flax oil.

60 PATIENT HANDOUT

61 LEILA 34 yo BMI 28, amenorrheic since stopping OCP 1 year ago Pelvic US N FBS, hormonal testing N DHEAS mildly elevated

62 SHARED DECISION - MAKING I d like to try and do this without medications

63 UP TO DATE 2015 For women with PCOS who want to become pregnant, fertility pills or injections are often needed to help women ovulate.

64 Lifestyle intervention remains the optimal treatment strategy for PCOS women. A relatively small weight loss (5 %) can improve IR, hyperandrogenism, menstrual function, fertility. Rondanelli et al Focus on metabolic and nutritional correlates of polycystic ovary syndrome and update on nutritional management of these critical phenomena (incl Vit D). Arch Gynecol Obstet Dec 290(6):

65 STEP 1 Diet

66

67 STEP 2 Avoid: lignans, whey powder, drinking calories

68 STEP 3 Exercise

69 STEP 4

70 ADITIONALLY USED FOR LPD Mastalgia Hyperprolactinemia Irregular cycles PMDD PMS PPMS

71 MOA Dopaminergic Anti-androgenic?

72 SAFETY No known toxicity

73 Vitex agnus-castus EFFICACY Three RCTs investigated clinical effectiveness for Vitex agnuscastus for oligo/amenorrhoea and PCOS. One RCT demonstrated equivalence for Bromocriptine and Vitex agnus-castus. NMD (2015)

74 INTERACTIONS Theoretical interactions but none proven or reported

75 STEP 5 Acupuncture

76 Repeated low-frequency EA treatment reduces serum AMH levels immediately after 16 weeks of intervention (a short-term effect), and reduces ovarian volume at follow-up 16 weeks after end of intervention (a longterm effect) as determined by MRI. Physical exercise did not influence AMH levels or ovarian volume. Leonhardt Acta Obstet Gynecol Scand Mar 94 (3):

77 STEP 6 Medication

78 EBM BOTTOM LINE Vitex may be an inexpensive, safe treatment for PMS and PCOS in conjunction with weight loss and a low glycemic diet. Acupuncture adds further benefit. Side-effects and interactions are rare. Many formulations are available. Nature s Way is a readily available, consistent product.

79 Vitex agnus castus is a Mediterranean plant whose berries have been used as medicine for centuries. VITEX PATIENT HANDOUT Vitex is safe, inexpensive, unlikely to interact with other medications and has been used for pre-menstrual symptoms, menopausal symptoms and to stimulate regular menstrual cycles in polycystic ovarian syndrome. Many different formulations are available. Nature s Way brand has a good safety record.

80 PENNY 50 yo LMP>1 yr VMS, irritable mood, sleep disturbed, vaginal dryness FHx heart disease, mother breast cancer BP 110/60, non-smoker, cholesterol 3.5 HDL 1.5 Regular exercise, BMI 20 What are my options?

81 Cimicifuga racemosa Historical use

82 A number of herbal treatments have been promoted as a "natural" remedy for hot flashes. In UP TO DATE 2015 HERBAL TREATMENTS fact, many postmenopausal women use black cohosh for hot flashes, but clinical trials have shown that it is not more effective than placebo. In addition, there are safety concerns about some herbs, including black cohosh, which might stimulate breast tissue (similar to estrogen). Herbal treatments are not recommended for hot flashes or other menopausal symptoms.

83 NO ESTROGENIC ACTIVITY Lupu 2003 Fraudenstein 2002 Liske 2002 etc.

84 Richard J Santen, MD DISCLOSURES Grant/Research/Clinical Trial Support: Pfizer [Menopause (Bazedoxifene and conjugated equine estrogens]

85 The most consistent evidence is for a specific commercial NATURAL MEDICINES DATABASE 2015 extract (Remifemin). Some evidence shows that it significantly reduces menopausal symptom indices, vaginal dryness and hot flash frequency compared to placebo. Preliminary clinical research also suggests that it is comparable to hormonal therapy including low-dose transdermal estradiol (Estraderm) 25 mcg every 7 days (Nappi 2005), tibolone 2.5 mg (Bai 2007) or conjugated equine estrogens (Premarin) mg (Stoll 1987)

86 PREVIOUS BREAST CANCER 2006 Canadian Consensus Conference on Menopause gives estrogen-dependant tumours, including estrogen receptor-positive breast cancer, as a contraindication for use. NIH 2004 workshop concluded that in women treated for breast cancer only standard care screening for recurrence and metastases need take place with black cohosh use. Roberts 2010 Maturitas Volume 66, Issue 4, August 2010, Pages Others advise non-use during active chemotherapy or radiotherapy.

87 BONE Conflicting evidence HEALTH

88 69 cases worldwide HEPATOXICITY TESCHKE 2010 Only 7 involved commercial product No positive re-exposure tests Toxicity considered in only 1 with no confounders No hepatotoxicity in >5000 patients clinical trials

89 NASER 2011 n=1117, no change LFT s No animal model for toxicity NPN

90 USP REVIEW cases possible, no probable Discontinue use and consult a healthcare practitioner if you have a liver disorder or develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice.

91 6 reports 4 Swiss Herbal: analysis: no BC 2 others not analyzed HEALTH CANADA 2013

92 MOA Many active constituents. Extracts have no estrogenic effects: no change FSH, LH, prolactin. In a narrow dose range they have beneficial effects on climacteric symptoms possibly due to several compounds with dopaminergic, noradrenergic, serotoninergic and GABAergic actions that act together in the hypothalamus.

93 MOA Mu receptor agonist. Anti-inflammatory compounds. In vitro anti-proliferative effects, possible +ve bone health. NMD updated 2014

94 SIDE-EFFECTS INTERACTIONS In vitro, BC is a C P450 inhibitor In vivo, C P 450 effect not shown with Remifemin No toxicity identified for Remifemin or Klimadynon 1/40 report fatigue

95 HALT NCCAM N= groups:bc, MH, MH +soy, HT, placebo HT stopped 2002 WHI 5 arms n=351; too small to detect any but large effects

96 HALT We asked the makers of Remifemin if they would supply drug but they said no. Pure world had strict manufacturing guidelines and provided product we could encapsulate. Plus they supply much of the product that goes into Black Cohosh products in the US. Katherine Newton PI March 21/15 personal communication

97 TROUBLE!

98 Klimadynon and Remifemin 2.8 mg and 2 mg triterpenes HALT trial 5 mg triterpenes BC alone and 6.25 mg in combo pill-neither were commercial products, but formulated specifically for trial Remifemin is an isopropyl alcohol extract, whereas the products we tested are ethanol extracts. The implications of these different extraction techniques are unknown.

99 Cochrane NAMS ACOG SOGC German Commission E AAFP Up To Date Insufficient Evidence Not Effective Not Effective Not recommended Safe and Effective Difficult Not recommended

100 PREPARATIONS NPN Safe Effective High Quality -NHPD

101 Remifemin and Klimadynon are Black Cohosh extracts which are safe and seem to have significant effects on VMS and on other symptoms of menopause Cost is approximately $30/month EBM BOTTOM LINE Other products definitely not recommended due to concerns re toxicity and dosage Effects apparent after 2 weeks Remifemin proven safe up to 6-12 months No toxicity/interactions identified with either product, no risk of DVT etc. No hormonal effects

102 PATIENT HANDOUT

103 ISLA 30 yo Traumatic divorce, in new relationship Rumination, insomnia, anxiety, decreased memory & concentration, sadness, anhedonia; mild-moderate MDD OCP No Phx depression

104 WANTS I want to feel better!!!

105 SHARED DECISION-MAKING I don t want to take anything that will make me gain weight or interfere with my new sex life. I want an exit strategy for any intervention.

106 ST. JOHN S WORT #1 Prescription antidepressant Germany

107 UP TO DATE Given the inconsistent evidence for efficacy, and the lack of regulated standardized herbal products, we suggest not treating depression with St. John's Wort. There are also multiple interactions between St. John s Wort and many commonly used medications.

108 NICE Although there is evidence that St John s wort may be of benefit in mild or moderate depression, healthcare professionals should not prescribe or advise its use by patients because of uncertainty about appropriate doses, variation in the nature of preparations and potential serious interactions with other drugs (including oral contraceptives, anticoagulants and anticonvulsants).

109 N=5489, 4-12 weeks, mild-moderate major depression Efficacy COCHRANE 2008 Response rate: 54% vs. 52 % SSRI s vs 36% placebo Safety: Any AE: 46.7% vs. 53.9% SSRI s Discontinuation: 3.6% vs. 6.8% SSRI s

110 COCHRANE The available evidence suggests that the hypericum extracts tested in the included trials: a) are superior to placebo in patients with major depression b) are similarly effective as standard antidepressants c) and have fewer side effects than standard antidepressants.

111 MOA Most products standardized to hypericin or hyperforin content Active components unknown:?hyperforin NOT an MAOI Likely multiple neurotransmitter effects Anti-inflammatory effect

112 TOXICITY Rare instances, massive doses Unknown: breastfeeding, pregnancy Theoretical: serotonin syndrome Phototoxicity

113 INTERACTIONS SJW is a p450 inducer (3A4 and others) Increased metabolism leads to decreased level of other drugs using 3A4 e.g. amiodarone, cyclosporine, anti retrovirals, dabigatran, digoxin, antidepressants, digoxin, OCP, omeprazole, statins, sumatriptan, verapamil, warfarin

114 INCREASED SUICIDALITY; DISCONTINUATION SYNDROME Not reported!

115 PEDIATRIC/ DOLESCENT USE CHILDREN POSSIBLY SAFE when used orally, and appropriately, short-term. St. John's wort extracts seem to be safe when used for up to 8 weeks in children aged 6-17 years NMD 2015

116 PREPARATIONS KIRA (Lichter Pharma LI 160 Formula) Perika (Nature s Way WS 5570 Formula)

117 PROPOS ED OUTCOME MEASURES Orgasmia Steady weight Easy withdrawal Improved mood, sleep, memory, concentration, energy

118 EVIDENCE BASED BOTTOM LINE KIRA and Perika brand SJW extract work as well as SSRI s with less adverse effects, dangers and toxicity Perika is easily available locally, KIRA on internet Drug interactions are possible through cytochrome P450 induction May be a good choice for those with mild-moderate MDD not taking other meds who want efficacy without sideeffects.

119 PATIENT HANDOUT

120 GARTH 63 yo, metabolic syndrome, ^BP, Medial compartment OA of 1 knee, moderately severe Glucosamine, chondroitin x 6 months, no help Physiotherapy, weight loss, quads exercises, HA injection Hypertension, CVD What can I do?

121 WANTS I want to avoid a knee replacement if possible and I want to be able to continue to play with my grandchild

122 I don t want to get addicted to anything or have anything affect my heart or stomach. DON T WANTS

123 AFCP TOOLS for PRACTICE 2014 Corticosteroid shots and knees: A match made in osteoarthritis heaven? Clinical Question: What is the effectiveness of intra- articular corticosteroid injections in knee osteoarthritis?

124 Corticosteroid intra-articular knee injections reduce osteoarthritis pain~40% more than placebo and 1 in every 3-5 patients injected will have global symptom improvement in the first four weeks. BOTTOM LINE Long-term pain relief is less certain but serious adverse events, like joint infection, are very rare (one in >14,000).

125 DIGGING DEEPER Maximum improvement pain10 days At 5 weeks +, no improvement Function: no improvement at any time Increased X-ray changes=decreased efficacy

126 AFCP TFP GLUCASOMINE 2014 Bottom Line Multiple meta-analyses indicate that glucosamine does not reliably improve pain or function in osteoarthritis

127 JOINT SPACE NARROWING Results vary with only one result reaching clinical significance (>0.5mm) 5 at 0.51mm less narrowing (more cartilage) than placebo This is a surrogate marker!!

128 BUT The primary outcome measures recommended for clinical trials of OA comprise 4 core domains: pain, physical function, patient global assessment & joint imaging (for studies of at least 1 year)

129 Multiple meta-analyses show heterogeneous results (largest:25 studies, n=4963) In general: GLUCOSAMINE FOR KNEE OSTEOARTHRITIS COCHRANE (2009) Effect sizes of (small) to (moderate) with change in pain score vs. placebo = (approx) 0.4/10 DONA brand pharmaceutical grade glucosamine sulfate: Effect size=-1.1 (large) with a change in pain score about 3/20 Small effect on function Side effects = placebo

130 GLUCOSAMINE SULPHATE DONA Brand

131 MOA Glucosamine is a substrate for articular cartilage glycosaminoglycan synthesis and cartilage matrix production; stimulates chondrocyte and synovial cell metabolism Glucosamine has anti-inflammatory activity not related to prostaglandin metabolism

132 POOLSUP, N. ET AL. Glucosamine long-term treatment and the progression of knee osteoarthritis: systematic review of randomized controlled trials. Ann Pharmacother 2005; 39:

133 Glucosamine sulfate was more effective than placebo in delaying structural progression in knee OA. The risk of disease progression was reduced by 54% POOLSUP, N. ET AL 2005 The number-needed-to-treat was 9. The pooled effect sizes for pain reduction and improvement in physical function were 0.41 and 0.46), respectively, in favor of glucosamine sulfate. Glucosamine sulfate caused no more adverse effects than placebo.

134 WU ET AL "Efficacies of different preparations of glucosamine for the treatment of osteoarthritis: A meta-analysis of randomised, double-blind, placebocontrolled trials. Pooled data knee, HIP: GS and GH; largest study GH n=630; ES Function 24 weeks (moderate) n=3159 GS, GH International Journal of Clinical Practice 67 (6):

135 This study provides evidence to support improved joint function in patients with knee OA treated with glucosamine sulphate (GS) for more than 6 months. However, pain is not alleviated after 6 months of GS therapy. Glucosamine hydrochloride is ineffective for relieving pain in OA patients.

136 DONA brand Glucosamine Sulphate 1500 mg once daily likely improve knee joint function after 6 months treatment. EVIDENCE BASED BOTTOM LINE Further improvement is expected up to 2 years. Disease modifying effect appears to slow progression of knee OA.

137 EVIDENC E BASED BOTTOM LINE Effect on pain more certain in severe joint narrowing Other joints less well researched, may be some effect on spine Cost about $35/month Side-effects=placebo 8% of Canadians use glucosamine

138 SHARED DECISION MAKING DONA glucosamine may delay requirement for TKR, improve pain and function over months and years. No effects on heart, kidneys, GI system. No possibility of accidental death for patient or family.

139 Glucosamine sulphate is a prescription medication in Europe, used for decades as a treatment for osteoarthritis. There is some controversy as to its effectiveness as a treatment, possibly because many different formulations have been studied. GLUCOSAMINE The evidence seems to point in the direction that the Dona brand of glucosamine sulphate (Rotta Pharmaceuticals) may have a small to moderate effect to reduce pain and improve function in osteoarthritis of the knee and spine and slow progression of osteoarthritis in the knee. Dona is available over the counter in North America at a cost of about $30/month for the standard dose of mg pills once daily, and also available on the DONA website. Dona should be taken for at least 6 months to determine if there will be a positive effect. It may be continued for up to two years with some evidence pointing to continued improvement up to this time. Any effects on other types of osteoarthritis are unclear. PATIENT HANDOUT Side-effects are very rare and have not been serious. Formulations other than DONA are unlikely to be effective.

140 Saw Palmetto

141 Historical Use for BPH Egypt 15 th century North America 18 th century Listed in USP early 1900 s

142 German commission E Urination Problems in BPH stage 1 and 2 Note: this medication relieves only the symptoms associated with an enlarged prostate without reducing the enlargement. Please consult a physician at regular intervals.

143 NMD 2015 Saw palmetto is used for symptoms of benign prostatic hyperplasia (BPH) to improve sexual vigor, and as an aphrodisiac. It is also used to treat chronic nonbacterial prostatitis/chronic pelvic pain syndrome, and to stimulate hair growth.

144 Possibly effective: TURP Clinical research shows that taking saw palmetto 320 mg daily for two months prior to surgery reduces the duration of surgery, the development of intraoperative complications, blood loss, the duration of catheterization, and the length of hospitalization compared to placebo

145 Possibly ineffective: BPH Research on saw palmetto for treating symptoms of BPH is inconsistent and contradictory. Several clinical studies lasting up to three years have shown that orally administered saw palmetto provides mild to moderate improvement in urinary symptoms such as frequent urination, painful urination, hesitancy, urgency, and perineal heaviness. Some studies also show that saw palmetto decreases nocturia, improves peak and mean urinary flow, and lowers residual urine volume in patients with BPH

146 Some of these studies suggest that saw palmetto is comparable in efficacy to finasteride (Proscar) and saw palmetto might be better tolerated. Some data also suggests that saw palmetto might have a positive effect on sexual dysfunction associated with BPH. However, saw palmetto does not seem to reduce prostate size or prostate-specific antigen (PSA) levels like finasteride.

147 Some clinical research also shows that a specific commercial product containing saw palmetto and stinging nettle root (PRO 160/120) might be comparable to finasteride (Proscar) for relieving symptoms of BPH and modestly improves some BPH symptoms compared to placebo. Other research shows that this commercial product may be comparable to tamsulosin for reducing symptoms of lower urinary tract symptoms in patients with BPH

148 A meta-analysis of saw palmetto studies suggests that saw palmetto might modestly reduce nocturia and some measures of BPH symptoms compared to placebo, but it might not improve other measures of BPH symptoms or measures of peak urine flow. Another meta-analysis found that moderate to longterm saw palmetto treatment does not significantly improve lower urinary tract symptoms associated with BPH, maximal flow rate, nocturia scores, or prostate volume compared to placebo. Interestingly, relatively short-term treatment from 12 weeks to 6 months seemed to improve overall BPH symptom scores compared to placebo

149 The reason for these confusing and inconsistent research findings is not clear. Differences may be due to different study methodologies, different patients, different symptom measurement methods, and differences in the saw palmetto products used in studies. Research shows significant variation in the chemical composition of commercially available saw palmetto extracts which might explain different study findings.

150 Most clinical studies, including studies with both positive and negative findings, have used liposterolic extracts of saw palmetto berry containing approximately 80% and 90% free fatty acids

151 One of the most commonly studied products is Permixon (Pierre Fabre Medicament). This formulation is also similar to Super Saw Palmetto (Enzymatic Therapy), Saw Palmetto (Centrum), Standardized Saw Palmetto Extract (Nature's Way), and others. -NMD 2015

152 Adverse effects/toxicity/interactions Toxicity considered rare May have anti-platelet effect No effect on PSA -NMD 2015

153 MOA anti-alpha 1 -adrenoceptor activity in vitro, but not in vivo Saw palmetto extract has demonstrated inhibition of androgen activity via competition with DHT at the androgen receptor in several animal and human tissue culture studies In a placebo controlled study of 35 patients with benign prostatic hypertrophy (BPH) treated with saw palmetto three months prior to transvesical adenomectomy, nuclear and cytosolic concentrations of estrogen and androgen receptors were examined, and the authors suggested that inactivation of androgen receptors may occur secondary to blockade of estrogen receptors Anti-inflammatory effects?antiproliferative effects NMD 2015

154 EBM Bottom Line Saw palmetto is widely used for BPH symptoms in Europe, both as monotherapy, and in combination products Although some studies suggest symptoms of BPH may improve, prostate size and PSA are unchanged There is great variability in available products

155 Brands most used, most studied, more likely to work Permixon * PRO 160/120 ( Saw Palmetto/Stinging Nettle) * This formulation is also similar to Super Saw Palmetto (Enzymatic Therapy), Saw Palmetto (Centrum), Standardized Saw Palmetto Extract (Nature's Way), and others. NMD 2015

156 SAW PALMETTO Saw Palmetto is widely used for benign prostatic hypertrophy (BPH) symptoms in Europe, both as monotherapy, and in combination products. Although some studies suggest symptoms of BPH may improve, prostate size and prostate specific antigen are unchanged. There is great variability in available products. Brands most used, most studied, and more likely to work: PRO 160/120 (Saw Palmetto/Stinging Nettle) AND Permixon PATIENT HANDOUT However, these products are not readily available in Canada. Similar products include: Super Saw Palmetto (Enzymatic Therapy) Saw Palmetto (Centrum) Standardized Saw Palmetto Extract (Nature's Way) Gregory Chernish MD

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