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UW Internal Medicine Primary Care Conference David Rabago, MD 1-17-2007

Nasal irrigation for recurrent rhinosinusitis and chronic sinus complaints: a 3-part multi-method study. UW Internal Medicine Primary Care Conference David Rabago, MD 1-17-2007 http://www.fammed.wisc.edu/research/projects/nasalirrigation.html. Objectives. Review basics of rhinosinusitis

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UW Internal Medicine Primary Care Conference David Rabago, MD 1-17-2007

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  1. Nasal irrigation for recurrent rhinosinusitis and chronic sinus complaints: a 3-part multi-method study UW Internal Medicine Primary Care Conference David Rabago, MD 1-17-2007 http://www.fammed.wisc.edu/research/projects/nasalirrigation.html

  2. Objectives • Review basics of rhinosinusitis • Introduce nasal irrigation • Describe 3 studies • Discuss future directions

  3. Rhinosinusitis: Why do we care? • One of 10 most common ambulatory Dx’s, 26.7 million office/ED visits annually • 5th leading cause of Abx Rx (13 million ‘92) • 85-98% of dx get Abx • $5.8 billion direct & indirect costs • Patients care about RS • RS often refractory to treatment • Prevalence chronic RS 134/1000 • Serious complications

  4. Anatomy

  5. Anatomy

  6. Pathophysiology • Insult triggers inflammatory cascade involving cytokines, macrophages, mediators • Allergic response involves IgE, Eos • Blood vessels dilate • Capillary permeability increases • More mucus secretion • Coordinated ciliary action disrupted, slow • Sinus ostia occluded

  7. Pathologic Sinus infectious/allergic/ irritant Secretions thicken, pH changes Ostial occlusion Ciliary damage Mucosal Thickening/,  further blockage Bacterial or viral growth Inflammation Bacterial infection, viral infection

  8. URIs Allergic rhinitis Tobacco Polyps Dental infections Swimming/diving Cocaine abuse Foreign body Septal deviation Hypertrophic turbinates Abnl ostiomeatal complex Cystic fibrosis Diabetes Immune deficiencies Predisposing conditions

  9. Nasal Irrigation • Definition • Saline in the nasal cavity • Synonyms • Jala Neti, Neti Pot Therapy, Nasal Lavage, Hypertonic Saline Lavage • Irrigant/Concentration/Volume: variable • Vessels • cupped hand, bulb syringe, spray bottle, Water Pic™, Neti™pot, Sinucleanse™, Rhinomer™, Naso Cup…

  10. Cultural and Medical History • Used for centuries as part of Ayurvedic tradition of Medicine • Medical References to nasal irrigation since 1890’s • Used as Post-Op adjunctive care for nasal surgery • Anecdotal evidence for efficacy in sinusitis. • Ten RCTs

  11. Nasal Irrigation cup

  12. Where does the solution go?

  13. Where does the solution go? before irrigation after irrigation

  14. Biological Rationale

  15. Three studies • Phase 1: fastidious RCT in the short term • Phase 2: pragmatic prospective long-term case series • Phase 3: qualitative study

  16. Phase 1: Objective/Design • Does daily NI improve sinus symptoms and quality of life, and decrease medication use in adults with chronic sinus complaints and a history of sinusitis compared to ‘standard of care’? • Randomized Controlled Trial, Intention to Treat, Primary Care and Specialty Clinics

  17. Subject Participation in Phases 1, 2 and 3 76 subjects consented & randomized Phase 1: Original RCT (6 mos.) HSNI n = 52 Standard of Care n = 24 Opt out: n = 12 Follow-up Study n = 40 Follow up study: n = 14 Phase 2: Follow-up study (12 mos.) Single HSNI use group: n = 54 All Subjects using HSNI in Phases 1 & 2: n = 66 Phase 3: Qualitative study Qualitative Study: 28 Qualitative Interviews

  18. Patients: Inclusion Criteria • 18-65 • 2 ICD-9 diagnoses of acute sinusitis, or 1 of chronic sinusitis, per year for 2 years • not pregnant • not a nasal irrigation user • score of 3-6/6 ‘nasal symptoms impact’ question • able to perform nasal irrigation

  19. Intervention: Informational Meeting • Introduction • Personal Histories • Education • Consent/Randomization • 52 Experimental Arm • 24 Control Arm • Film/Demonstration/Practice

  20. Interventions • Control: Routine care for sinus c/o • Experimental: Routine care for sinus c/o plus daily nasal irrigation x 6 months • Concentration: ~ 2 X normal saline • pH:~8.0 buffered with baking soda • Volume: 135 ml per nostril

  21. Primary Outcomes:Quality of Life Measures • MOS-Short Form-12 (0-100) • Rhinosinusitis Disability Index (0-100) • Single Item Assessment (1-7) • “Please evaluate the overall severity of your sinus symptoms since you enrolled in the study” • Each assessed at baseline,1.5, 3, and 6 mos • Reminder calls

  22. Secondary Outcomes • Daily adherence log • Bi-weekly symptom and medication log • Side Effects • Satisfaction

  23. Results: Randomization, Compliance,Completion Rate • Effective randomization • 69/76 (90.7%) subjects completed study • Adherence to daily use 87% • 96% questionnaire completion rate

  24. Clinical Relevance: Number Needed To Treat • SIA and RSDI: “What % of subjects achieved ~ 15% improvement?” • Symptoms: “What % of subjects reported symptoms or med use < 50% of 2-wk periods?” • Meds: “What % of subjects reported medication use >25% of 2-week blocks?”

  25. NNT for Rhinosinusitis Index and Single-Item Q

  26. NNT for Symptoms and Medications at 6 months

  27. Satisfaction and Side Effects • 42/44 “will continue to use” • 44/44 “would recommend” • 10/44 reported side effects: burning, tearing, h/a, nosebleed • 8/10 indicated they were “insignificant” • 2/10 “significant” but did not change overall satisfaction • most were able to improve side effects by dilution or alternating days of therapy

  28. Phase 1 Conclusions • In a controlled setting, daily nasal irrigation: • Improved quality of life • Decreased sinus symptoms • Decreased antibiotic use • Decreased nasal spray use • Well-tolerated • High satisfaction

  29. Phase 2: Objective • To assess nasal irrigation use-patterns adherence, efficacy, side-effects, and satisfaction in a long-term (12 mos) standard clinical setting

  30. Subject Participation in Phases 1, 2 and 3 76 subjects consented & randomized Phase 1: Original RCT (6 mos.) HSNI n = 52 Standard of Care n = 24 Opt out: n = 12 Follow-up Study n = 40 Follow up study: n = 14 Phase 2: Follow-up study (12 mos.) Single HSNI use group: n = 54 All Subjects using HSNI in Phases 1 & 2: n = 66 Phase 3: Qualitative study Qualitative Study : 28 Qualitative Interviews

  31. Ph 2 Inclusion Criteria/Intervention • All 76 subjects from Phase I invited to participate • 54 (71%) consented • Former control subjects trained in nasal irrigation • Both groups used nasal irrigation as desired

  32. Ph 2 Primary Outcomes:Quality of Life Measures • Rhinosinusitis Disability Index (0-100) • Single Item Assessment (1-7) • Sino-Nasal Outcomes Test (SNOT-20) • Each assessed at 6 and18 mos

  33. Ph 2 Secondary Outcomes • Frequency and Pattern of Nasal Irrigation Use • Sinus Symptom Severity and Frequency • Side Effects • Satisfaction

  34. Age QoL Scores Gender Race/Ethnicity Education Allergy Hx Nasal Surgical Hx ICD-9 Code Clinic Type Results:Similar Baseline Characteristics

  35. Results: Compliance and Completion Rates • 54/54 (100%) subjects completed study • 85% questionnaire completion rate

  36. Intervention RSDI: Improved SIA: Improved SNOT-20: Stable “Control” RSDI: Improved 22.5% SIA: Improved 38% SNOT-20:Improved 36% Results: Primary Outcomes

  37. Results: Secondary Outcomes • Frequency • 2.4 irrigations/week • Pattern • 35% Scheduled • 65% When Symptomatic • 5% Not at all

  38. Results: Secondary Outcomes • Side effects: (9% nasal irritation and burning) • Satisfaction: 96% overall will continue to use and recommend

  39. Phase 2: Overall results • Initial Control Subs: Matched gains by initial nasal irrigation users • Initial Experimental Subs: Continued stable improvement • Both groups stable use 2-3x per week • Continued satisfaction

  40. Phase 3: Objective • Qualitatively assess attitudes and practices regarding use of saline nasal irrigation • (How did they do it?) • (How can we help our pts do it?)

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