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Common Office Problems

Common Office Problems. G. Michael Allan Associate Professor, Family Med, U of A. Objectives. Neuro Bell’s Palsy Gabapentin in Chronic Pain. X-ray Backs Women’s Health Pap Testing (Cleaning the Cervix & Lubricant use) Hot Flashes: Treatment Options Incontinence MSK: Miscellaneous

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Common Office Problems

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  1. Common Office Problems G. Michael Allan Associate Professor, Family Med, U of A

  2. Objectives • Neuro • Bell’s Palsy • Gabapentin in Chronic Pain. • X-ray Backs • Women’s Health • Pap Testing (Cleaning the Cervix & Lubricant use) • Hot Flashes: Treatment Options • Incontinence • MSK: • Miscellaneous • Anemia, Constipation,

  3. Neuro

  4. Bell’s Palsy: What to do and not to do? Clinical Question: Do corticosteroids or anti-viral medications provide any benefit to patients with Bell’s Palsy?

  5. Bell’s Palsy: What to do and not to do? Scottish study1: 551 pts, within 72 hours,10 days of Acyclovir 400mg 5x/d & Prednisolone 25mg BID together or each separate or placebo. Prednisolone vs placebo for complete recovery: 3 months, 83% vs 64%, NNT =6 9 months, 94% vs 82%, NNT =8 Acyclovir no advantage over placebo. Scandinavian study2: 839 pts, within 72 hours, Valcyclovir 1000mg TID x 7days & Prednisolone (60mg x5days then tapered by 10 mg/day) or each separately or placebo. Prednisolone vs placebo for complete recovery at 12 months, NNT =7 Valcyclovir no advantage over placebo. Acyclovir1 or Valycylovir2 added to Prednisolone no advantage.

  6. Bell’s Palsy: What to do and not to do? Before Cochrane concluded insufficient evidence to recommend either anti-virals3 or corticosteroids4 for Bell’s palsy. 2007 Japanese study:5 valcyclovir added to prednisolone statistically significantly improved recovery over prednisolone alone (NNT 15). However, Study smaller (296 pts), high drop-out, & unblinded. Another Japanese study same year = no benefit adding valcyclovir to prednisolone.6 2 most recent studies1,2 larger, superior methodologically, and found anti-viral therapies added to prednisolone provides no benefit over prednisolone alone. Dosing of Prednisolone and Prednisone is equal (e.g. Prednisolone 25mg BID equals Prednisone 25mg BID).

  7. Bell’s Palsy: What to do and not to do? Bottom-line: The best evidence indicates that corticosteroids (in doses of Prednisolone 25mg BID or 60mg x 5days then tapered by 10mg/day) improve the odds of complete recovery from Bell’s Palsy Anti-virals, used either alone or in addition to prednisolone, offer no advantage.

  8. Gabapentin & Chronic Pain: Missing Evidence and Real Effect? Clinical Question: What is the evidence to support gabapentin (or pregabalin) in chronic peripheral neuropathic pain?

  9. Gabapentin & Chronic Pain: Missing Evidence and Real Effect? Review: 20 RCT Gabapentin for off-label use (17/20 pain)1 8 never published (40%) Outcomes in 12 published studies 4 used planned primary outcome. Of 180 predefined secondary, 122 (68%) not reported Meta-Analysis of all trials (including unpublished)2 Moderate-marked improvement in pain for 13-17.5% more, NNT = 6-8 (2 weeks) Efficacy greatest post-herpetic neuralgia. No benefit for acute pain or in dose escalation >900mg (with >adverse events) Adverse events: NNH 8 (dizziness, somnolence, confusion, etc)

  10. Gabapentin & Chronic Pain: Missing Evidence and Real Effect? Cochrane review3 (published only): relief in chronic pain, NNT 3-4 Another review:4 similar numbers but worse with unpublished trials.2 Pregabalin best case: Chronic pain relief NNT 4-5 but only published data.5 Drug Review6 (+ unpublished trials), intermittently >placebo but not consistent. No direct trial evidence of superiority over gabapentin. One trial active comparator: Pregabalin not >placebo but TCA were. Other reviews: TCA similar7 or perhaps superior7,8 to gabapentin or pregabalin. Possible time & trial quality bias7 Publication bias & selective reporting likely more in industry funded research, non-profit funded RCTs also selectively report outcomes9

  11. Gabapentin & Chronic Pain: Missing Evidence and Real Effect? Bottom-line: The apparent benefit of gabapentin in chronic pain was exaggerated by publication and reporting biases. In carefully selected patients with peripheral neuropathic pain, gabapentin may offer moderate+ pain relief for 1 in every 6-8 patients but causes adverse events in a similar number. No trial evidence pregabalin > gabapentin

  12. What if they say, “What if,…” A 40 year old ♀ hospital cleaner is in concerned about her back pain for almost 10 weeks. Her range motion is 50%, tender in paraspinal muscles around L3-5. occasional radiation into buttock & upper legs. Her neuro exam is normal She wants to know what is causing this! She isn’t satisfied with you explanation and would like an x-ray.

  13. Law of Unintended Consequences RCT, UK, 421 GP pts, low-back pain ≥ 6 weeks 60% female, mean age 39, back pain x 10 weeks At 3 months Stat diff in: Still in pain: 74% X-ray vs 65%, NNH 12 Had f/u doctor visit: 53% X-ray vs 30%, NNH 5 Self rated health status: 5% worse in X-ray group. After 6 more months Few borderline worse (disability & pain) but not Stat Sign However, ≥80% of both groups want X-rays. Those with x-rays more satisfied with visit. X-rays findings did not correlate to clinical BMJ. 2001 Feb 17;322:400-5.

  14. More evidence,… Meta-analysis1 of 6 trails, 1804 pts. Imaging vs usual: 4 X-ray, 2 CT or MRI Short term and Long-term outcomes of pain, function, quality of life, mental health and patient satisfaction did not differ sign Pain at 3 months was borderline worse with x-ray (SMD 0.19, CI -0.01 to 0.39) Same comparing MRI vs X-ray2 1. Lancet. 2009;373:463-72. 2. JAMA 2003;289:2810–8.

  15. Women’s Health

  16. Cooling the Hot Flashes • A 51 year old woman is having a terrible time with hot flashes. Her family history includes breast cancer. • You say: There’s lots to try but none work like HRT • True: Well-designed Meta-analysis of 43 RCT’s • SSRI/SNRI (mid dose)= 1.13 ↓Hot Flashes/d (vs placebo) • Clonidine (≤0.075mg BID) = 0.95 - 1.63 ↓Hot flashes/d • Gabapentin (300mg TID) = 2.05 ↓Hot flashes/d • Soy Isoflavone Extract (50-70mg/d)= 0.97-1.22 ↓ • Endometrial safety with Isoflavone still unresolved. • Estrogen best (2.5-3 ↓ Hot flashes/d) JAMA 2006; 295: 2057-71.

  17. Cleaning: Yes or No You are about to show the PAP test to a med student and she asks about cleaning-swabbing the cervix before the PAP test. You say: Cleaning of the Cervix will enhance the Quality of the PAP test. False1 RCT, 616 ♀, Family Practice, No difference 1. Can Fam Physician 2007;53:1328-1329.

  18. PAP Case: I Forgot more than you Know You are brining you med student in to observe her first PAP test. As you start, the medical student asks “Is that lubricant? Our gynecology professor says it wrecks the PAP test.” You say: Lubricant on a Speculum will not impact the PAP test?

  19. PAP testing: Lubricant • 4 RCTs address this question. • The largest RCT1: 2906 patients • Water soluble lubricant on speculum vs. tap water • No difference in quality of cytology • Two smaller RCTs: • 182 patients2 and 70 patients3: No difference in PAP test adequacy.2,3 • Quasi-randomized (randomized months), 3460 PAP tests4 • No difference in PAP test adequacy • Conventional cervical cytology smears (glass slide) were used in all studies1-4

  20. PAP testing: Lubricant • No RCT assessed lubricant on liquid-based PAP • Retrospective review of 4068 liquid-based pap tests • 15 (0.4%) obscuring material causing misinterpretation of pap • ~ ½ may related to lubricant use (+ technologist inexperience)6 • Two studies applied lubricant directly into liquid-based cervical cytology samples7,8 • One ↓ cell counts (after dilution) but adequacy not assessed/reported7 • Other demonstrated no impact on liquid based PAP outcomes8 • One RCT also examined if lubricant affected testing for Chlamydia and found no affect after 5535 samples.4 (Gonorrhea to uncommon to assess)

  21. PAP cleaning & Bottom-line • Bottom-line: A small amount of water soluble lubricant on a speculum does not reduce the quality of the PAP test and probably does not effect microbiologic results either. The present evidence suggests liquid-based PAP tests would be minimally effected or not at all. 1) Can Fam Physician 2007;53:1328-1329.

  22. Incontinence: Diagnosis • You med student just saw a 50 year female with incontinence and has planned a large work-up. • You say: I bet I could get the Dx with 2 questions? • True (probably): Mid size diagnostic cohort • Accuracy Overall: correct 62%, partially correct (Mixed) 23%, and 15% wrong • Kappa : 3IQ (?s) = 0.65 – 0.69 & Specialists (gold standard) Dx = 0.65 • In the last 3 months did you leak urine during • Physical activity: coughing, sneezing, lifting, or exercise, • You had the urge to go but couldn’t make it fast enough. Ann Intern Med. 2006;144:715-723

  23. Incontinence: Treatments • Our 50 year old has mixed incontinence. What might work? • You say: Nothing works! • False: Sys rev & Meta: 96 studies (14 K pts) • Findings • Works: Oxybutynin (5-10mg), Tolterodine (4mg), Pelvic floor exercise • Probable: Duloxetine (20-80mg) • Possibly help (mixed): medical device (pessary), injected bulking agents; topical HRT. • No help: electric/magnetic stimulation, • Harm: Oral HRT Ann Intern Med 2008; 148; 459-73.

  24. MSK

  25. OA: Topical NSAIDs A 50 year old male is with knee OA. He finds NSAIDs irritating to the stomach but doesn’t get much help from Acetaminophen. He has heard that creams may work. You say: Topical NSAIDs are less effective than oral NSAIDs in knee OA. False RCT 622pts, oral vs topical, No diff except AE 2 Meta vs placebo, ES=0.40, NNT 5 J Rheumatolo 2004;31(10): 2002-12. BMJ 2004;329(7461):324. www.Bandolier.com March 05

  26. Tennis Elbow: First do,… J. McEnroe (42) has lateral epicondylitis & has tried NSAIDs (Topical & oral), splint & physio. He wonders about steroid injections. He wonders what works.

  27. Tennis Elbow: First do,… Steroid Injection1 RCT, 198 pts, 3 arms (injection/physio/usual) Results: physio < pain meds 6 weeks Injection = NNT 8 52 wks Injection = NNH 4 Injections= ↑ recurrences & poor long term outcome

  28. Tennis Elbow: First do,… Transdermal Nitro2 Placebo vs ¼ Nitro 5mg/24hr patch (95 elbows) Nitro group: ↑ strength & ↓ pain/tenderness Asymptomatic ADL (6 mon): AB =21% or NNT 5 Side-effects frequent (12% quit, NNH=8) 1. BMJ 2006;333:939 2. Am J Sports Med 2003;31:915–20

  29. Rotator Cuff Injections: Horseshoes & Hand-grenades You are teaching a medical student to inject a sub-acromial bursa for rotator cuff but she is nervous You say: Don’t worry, close is good enough. True (likely). RCT, 106 pts, mean 51 yrs, 61% ♀, Rot cuff >3 months RCT virtually no difference between radiologically guided bursa injection and buttock injection BMJ 2009;338:a3112

  30. Grab-bag

  31. All Plugged Up & No Way to Go A 42 y.o. female has chronic constipation. BM’s are q4 days & she is uncomfortable 50% of the time. She wants to start Docusate You say: Docusate doesn’t work True: Sys Review of >50 trials & 13 therapies1 Best Evidence for Polyethylene Glycol (8 T - 743pts): 2-3bm/wk, NNT=2 Lactulose (10 T – 700 pts): 1-3 extra BM/wk, NNT=4 Psyllium (9 T – 997 pts): 1-3 extra BM/wk Am J Gastroenterol 2005; 100: 936-71. 2) Am J Gastroenterol. 2007;102(7):1436-41.

  32. Constipation Continued • PEG dose is 17g daily & has been used X6 months2 • Poor Evidence for/against (Trial #): Bran*, Colchicine*, Stimulant (Senna)*, Sorbital, Methylcellulose, Misoprostal, Docusate • (* mixed evidence, perhaps may be beneficial) Am J Gastroenterol 2005; 100: 936-71. 2) Am J Gastroenterol. 2007;102(7):1436-41.

  33. Iron: A Plug for Therapy 80 y.o. ♀ with fatigue has ongoing anemia (Hgb 101 + Ferritin 8). Unchanged x 4 yrs & scope then -ve. Iron causes her constipation. You say: A low dose of iron works as well and doesn’t cause constipation. True: RCT, 90 elderly anemic x2m (150, 50, 15mg) Hgb ↑ significantly (14 Hgb points), no diff between doses AE ↑ significantly as dose ↑, Dropout 15mg vs 150mg NNH = 5 15mg elemental iron = 2.5 ml’s of Fer-In-Sol Am J Med 2005; 118: 1142-7 30mg of elemental iron = Ferrous sulphate 150mg

  34. “Butt-Out!” A 35 y.o. ♂ is considering quitting smoking. She would like a pill but is nervous about Varencline. You say: The only other option is Buproprion False: Meta-analysis; Bupropion (16 studies, 5K pts), Nortriptyline (5 studies, 1K pts) Nortrip 75-100mg = Bup 150/300mg (NNT = 11) Drop-out: Nortrip (4-9%), Bup (7-12%). 10 weeks: Nortrip $22 & Bup $175 Hughes JR, et al The Cochrane Library, 2004, Issue 3, Art. NO CD 000031.

  35. “Sticks and Stones,…?” A 34 y.o. ♂ was Dx with a stone 2 nights ago in ER. He’s referred to urology but it will be 18 days. He is hoping for something to help. You say: Sorry, but we only have pain relief. False: Sys Rev, 9 Trials (693 pts), Distal 1/3 of ureter & Absolute benefit for stones ≥5mm twice that for <5mm (31% versus 15%) Stone pass: 47% vs 78%, NNT = 4 at 4wks, nifedipine 30mg, terazosin 5mg, doxazosin 4mg or tamusolin 0.4mg for 4 weeks. 1) Lancet 2006; 368: 1171-9. 2) Ann Emerg Med 2007; 50:552-63

  36. Care of Elderly

  37. Drug withdrawal You see a 81 year old, new to you, in the a nursing home (he is on 10 medications). He is demented & incontinent. You say: (To the family) He’d likely feel & be better with less meds. True: Cohort,1 190 pts, mean age 81, 31% ♂, 93% dementia/incontinent, 45%+ CVD, Mean 7 drugs. Stopped mean 2.8 drugs, 10% “failure” Death 21% (vs 45%) & hospitalization 12% (vs 30%) Other research shows polypharmacy increasing (200% x 10 yrs) in elderly2 & associated with increased mortality3 1) IMAJ 2007;9:430–434. 2) Dr Ross Upshur (pc). 3) Drugs Aging. 2009;26:1039-48.

  38. First line to withdraw • Okay, you are going to start to withdraw medicines. Which do you start with? • DART-AD: 165 pts, mean 85, 76% female, long-term care (high quality) • Withdraw antipsychotic (placebo) or continue • Outcomes • Behavior: NPI behavior score worsened by 1.7% (2.4 /144). Not stat sign. • Mortality: at 2 years, 71% continued anti-psychotic vs 46% placebo, (Diff = 25%, NNT 4) • Patients on anti-psychotics deserve a break Lancet Neurol 2009; 8:151–57. PLoS Med 5(4): e76.doi:10.1371/journal.pmed.0050076

  39. First line to withdraw • Okay, you are going to start to withdraw medicines. Which do you start with? • DART-AD: 165 pts, mean 85, 76% female, long-term care (high quality) • Withdraw antipsychotic (placebo) or continue • Outcomes • Behavior: NPI behavior score worsened by 1.7% (2.4 /144). Not stat sign. • Mortality: at 2 years, 71% continued anti-psychotic vs 46% placebo, (Diff = 25%, NNT 4) • Patients on anti-psychotics deserve a break Lancet Neurol 2009; 8:151–57. PLoS Med 5(4): e76.doi:10.1371/journal.pmed.0050076

  40. Why is Santa both fat and jolly? • An elderly overweight male toy distributor is in. H won’t talk about weight loss (“I’ve lived forever”). • Question: What is the mortality risk of being overweight for older patients? • Cohort age 70-74: 4,931 ♂ (x 8.1 yrs) & 5,042 ♀ (x9.6yrs).1 • Best BMI is 25-30 (overweight) • At the low end of normal (BMI ~20) similar to BMI 35 • Inactivity generally more important: increase risk 28% men and double in women • Other studies support.2 J Am Geriatr Soc 2010; 58:234–241. 2. NEJM 2006; 3553: 779-87. JAMA 2006; 296:79-86. J Am Geriatr Soc 2005; 53: 2112-8. J Am Geriatr Soc 57:2232–2238, 2009.

  41. Why is Santa both fat and jolly?

  42. The End

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