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It acknowledges that there is often an their intestines have become over-responsive to overlap between the different disorders and that tadalafil 5mg, as certain stimuli that would otherwise not cause they are common tadalafil 5 mg, there is a high possibility of co- symptoms 20mg tadalafil. Recording symptoms in a diary over a existence with other diseases 2.5 mg tadalafil. The disorders affect- period of a few weeks may identify those factors ing bowel dysfunction include IBS tadalafil 10mg, functional that cause an exacerbation of symptoms tadalafil 2.5mg. These bloating tadalafil 2.5 mg, functional constipation and functional may be related to diet 5mg tadalafil, stress or almost any activity diarrhea 10 mg tadalafil. Reassurance should be given that IBS is or discomfort tadalafil 10 mg. IBS can co-exist with any of the not a cancer and does not increase the risk of cancer other functional bowel disorders. Symptoms must have begun at least 6 ing on medication. How easy it is to do this will months prior to the patient presenting, and been depend on the local services available. In the first present during the previous 3 months, to indicate instance it may be something the woman can current disease activity27: recurrent abdominal pain explore with her own family or a close friend/ or discomfort for at least 3 days per month associ- confidant. Unduly • Improvement with defecation restrictive diets have not been shown to be effec- • Onset associated with a change in frequency of tive. When constipation is troublesome, increasing stool dietary fiber will help; if diarrhea is a problem, re- • Onset associated with a change in form (appear- ducing the amount of dietary fructose may help; if ance) of stool. Diagnosis If symptoms are more severe or not controlled IBS is a diagnosis based on symptoms and the by life-style adjustments, specific treatment should exclusion of organic disease. A full history and be offered depending on the most troublesome physical examination will reveal the need for fur- symptoms at the time. If there are none of the follow- symptoms are likely to wax and wane and that ing ‘alarm’ symptoms or signs, then a diagnosis of pharmacological treatment should be discontinued IBS can be made and treatment commenced28. The precise medi- cystograph cation used will depend on local availability. Hyo- • Tuberculosis: general examination + chest X-ray scine butylbromide has been shown to be effective for pulmonary tuberculosis. Staining/culture of and well tolerated for the treatment of recurrent urine for tuberculosis especially if sterile pyuria crampy abdominal pain in a dose of 10mg 3 times • Overactive bladder: women complain that when daily. It is poorly absorbed from the gastrointestinal 30 they feel the need to void they have to rush to tract and exerts its effects mainly by local action. They do not complain of pain Bulking agents and antidiarrheals • Endometriosis: can occasionally affect the These are indicated only if there are associated symp- bladder and would cause hematuria. Bulking agents do clude inflammation, autoimmune mechanisms (there not improve symptoms of IBS unless there is asso- is an association with systemic lupus erythematosus, ciated constipation. Likewise loperamide in a dose of Sjögren’s syndrome and inflammatory bowel dis- 2–4mg up to 4 times daily improves diarrhea, but 32 29 ease), and abnormalities of the bladder wall. Tricyclic antidepressants Diagnosis Amitriptyline in a dose of 10–25mg at night, may The pain of BPS is typically suprapubic, it may be be of benefit for patients whose pain does not im- a sharp pain but can also be more of a burning or prove with the above suggestions. It characteristically occurs as the bladder fills, and is relieved by voiding33. The pain must be accompanied by at least one other urinary BLADDER PAIN SYNDROME symptom, which in practice usually means multiple The bladder is a significant pelvic organ that can be symptoms including urinary symptoms related to involved in a number of disease processes causing intercourse. Sometimes there is referred pain to the chronic pain. In order to clarify the criteria for back, groin or vagina, and pain may be worse dur- diagnosing chronic pain arising in the bladder, the ing menstruation. Physical examination may reveal European Society for the Study of Interstitial bladder tenderness but is otherwise unremarkable. Cystitis in 2008 proposed that the term bladder Urinalysis is normal. The woman ‘Chronic pelvic pain (>6 months), pressure or records her fluid input as well as her perception of discomfort, perceived to be related to the urinary pain and the amount of urine she passes each time bladder is accompanied by at least one other urin- she voids over a 3-day period. Women should also ary symptom such as persistent urge to void or note any foods or drinks that make the pain worse. Confusable diseases that could cause the symptoms should be excluded’31. Treatment The main treatable diseases (‘confusable diseases’) This must begin with a full explanation of the con- that need to be excluded are: dition, that symptoms are likely to fluctuate over • Urinary tract infection: microscopy/culture of time, but worsening is uncommon, and there is no urine (if facilities available) or response to association with later development of bladder can- antibiotics cer. Many sufferers of BPS find that certain foods • Chlamydia infection of the urethra: history, and drinks make their symptoms worse. Acidic and sexual risk factors, swabs or urine tests if avail- spicy foods, coffee, tea, carbonated and alcoholic able (see Chapter 17) drinks seem to be the most troublesome. Avoiding • Schistosomiasis: microscopy urine and stool, these substances may be helpful34. Fluid restriction biopsy of cervix should not be advised as this can increase pain. With this cause of pain, evidence for this is lacking38. It is the woman is encouraged to very slowly increase unlikely that repeat surgery for adhesions will im- the time between each act of voiding, so gently prove chronic pelvic pain and may make it worse. Analgesics such as It is better to counsel the patient, provide pain paracetamol and NSAIDs can be taken if necessary. It dietary advice so that bloating and constipation are works in a number of ways to reduce pain, increase avoided. It is not being prescribed as ovary syndrome’, when an ovary left in situ at the an antidepressant. In both these circumstances ovulation PELVIC FLOOR MUSCLE DYSFUNCTION suppression is usually helpful6. Repeat surgery is likely to be difficult and should not be undertaken The pelvic floor muscles play a vital role in: main- by the inexperienced. Weakening of the pelvic floor muscles as CHRONIC PELVIC PAIN a result of difficult childbirth and/or repeated childbearing can increase the risk of genital pro- If the history and examination do not point to any lapse and urinary stress incontinence. Overactive, specific cause of the pain, reassurance is vital and chronically tense, pelvic muscles are associated with analgesia as described earlier should be made avail- constipation, BPS, dyspareunia and endometriosis able. Hormonal treatment as explained above for and it is often difficult to determine whether the endometriosis is often also helpful. A history of sexual abuse is another risk 37 PSYCHOLOGICAL ASPECTS OF PAIN factor. MANAGEMENT When a muscle becomes chronically tense there is often a specific sensitive area within the muscle The psyche has an important role to play in the per- that can be localized by palpation during vaginal ception of pain. Want- ments and alleviated in certain positions so that ing to know the cause of physical pain is normal. Health workers must likely to improve when associated conditions such explain ‘negative findings’ carefully to their client as IBS, BPS or endometriosis are controlled. Involving a ADHESIONS close relative or friend in the discussion may be beneficial. Adhesions may develop in the pelvis from pelvic inflammatory disease, endometriosis, appendicitis Behavioral and other therapies and after any surgical procedure, such as cesarean section, salpingectomy, ovarian cystectomy and Unfortunately, access to psychological help is not hysterectomy. Although often presumed to be the readily available in under-resourced countries, but 76 Chronic Pelvic Pain if the possibility exists it should be utilized. En- identifiable disease process, but this will only be couraging gentle resumption of activities can be determined after full history taking, physical exami- beneficial together with setting obtainable goals nation and basic investigations. Taking an interest in dromes tend to fluctuate in intensity over time and the client’s progress and keeping the door open for are rarely cured; however they do not progress to them to return if they feel they are not improving become malignant diseases. Clients who are clinically ditions tend to be poorly managed in under- depressed need to be appropriately referred for resourced countries because of the high work load effective management. However caring clinicians can easily help most women, even when only basic resources Traditional healers, complementary therapy are available, resulting in professional satisfaction and and herbal remedies clients who will not be a strain on the health sector. Traditional healers play an important role in the REFERENCES health care of many people in under-resourced countries. In: Classification of Chronic Pain, 2nd seek spiritual help from traditional healers this edn, IASP Task Force on Taxonomy. Seattle: IASP should not be discouraged, as long as these clients Press, 1994. Guide to Pain try to identify healers who are registered with local Management in Low-Resourced Settings. Seattle: IASP relevant associations and need to be aware that the Press, 2008. National Institute of Neurological Disorders and Stroke. Chronic pelvic pain as a form of complex found) in the framework of home-based care pro- regional pain syndrome. This could reduce the patient burden for the 797–803 (see p. Green-top Recognized complementary medical practice, guideline no. Attitudes of women and women want to use them, this should be en- with chronic pelvic pain to the consultation: a qualita- couraged41. Guide to Pain CONCLUSIONS Management in Low-Resourced Settings. Pelvic pain syndromes: clinical fea- in the etiology of chronic pain, and the quality of tures and management. In: Pasricha PJ, Willis WD, interactions with health providers whom women Gebhart GF, eds. Chronic Abdominal and Visceral Pain: The- ory and Practice. USA: Informa Healthcare, 2007;479–93 consult will have a major impact on whether a suc- 10. Optimal management of chronic cessful outcome for individual women is achieved. Available 77 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS from: http://www. Asymptomatic micro- 1480–91 scopic hematuria: clinical significance and evaluation. Consensus Urology 2011;17:1–7 report: clinical perspectives, mechanisms, diagnosis and 12. The use of ultra- management of irritable bowel syndrome. Aliment Phar- sound-based ‘soft markers’ for the prediction of pelvic macol Ther 2002;16:1407–30 pathology in women with chronic pelvic pain – can we 29. BJOG 2006;113:251–6 sis and therapy of irritable bowel syndrome. Available from: http:// and paracetamol-controlled study on the efficacy and www. Epidemiology of endome- of patients with recurrent crampy abdominal pain. Clin Obstet Gynecol Aliment Pharmacol Ther 2006;23:1741–8 2010;53:389–96 31. N Engl J Med 2009;360: Diagnostic criteria, classification and nomenclature for 268–79 painful bladder syndrome/interstitial cystitis: an ESSIC 16. Available from: Clin Obstet Gynecol 2010;53:429–38 http://www. EAU guidelines symptomatology help in the diagnosis of endometriosis? ESHRE guidelines for the diagnosis and treatment of 33. Implanon versus triggers in interstitial cystitis/bladder pain syndrome medroxyprogesterone acetate: effects on pain scores in patients. Female Pelvic Med Reconstr Surg 2011;17:36–9 patients with symptomatic endometriosis – a pilot study. Interstitial cystitis: a Contraception 2009;79:29–34 pathophysiology and treatment update. Advances in the medical management of Gynecol 2002;45:259–72 endometriosis. Profiles, doses, and side effects of drugs used Med Clin N Am 2011;95:55–73 in pain management. Pelvic to Pain Management in Low-Resourced Settings. The role of laparoscopy in the chronic pelvic FreeBooks/default. Psy- arthritis and nonsteroidal anti-inflammatory drugs chological factors in chronic pain. Guide to Pain Management in Low-Resourced Settings Livingstone, 1997;249–66 (book on the internet). The functional gastrointestinal disorders from: http://www. ESHRE guidelines for the diagnosis and treatment of 26. Systematic review: the influence of geography endometriosis. Available and ethnicity in irritable bowel syndrome. As pain is very subjective and as such pre-condition for this is that the first visit works out difficult to assess, studies show a broad range of 1 well for the girl and is not, as often, traumatizing. Pain perception is You will find more on this very important issue in also influenced by cultural background.

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Comparison of ipratropium bromide and 6 fenoterol in asthma and chronic bronchitis 20 mg tadalafil. SHORT bronchodilating effects of salmeterol tadalafil 2.5 mg, salbutamol and ipratropium bromide in patients with chronic obstructive pulmonary disease tadalafil 10mg. Kinetics of action of 6-POWDER salbutamol inhaled from a metered dose inhaler (MDI) and a "Diskhaler" tadalafil 5 mg. Comparison of Formoterol and Terbutalin on 110 1 asthmatic children tadalafil 20mg. The effect of bronchodilator aerosols on the peak 4 expiratory flow rate in asthmatic patients 2.5 mg tadalafil. Comparative randomized blind cross over study 1 between salbutamol and the fenoterol-ipratropium association (IK 6) in patients with bronchial asthma tadalafil 10 mg. SHORT with inhaled formoterol tadalafil 20 mg, a long-acting beta 2-adrenergic agonist 2.5mg tadalafil. The Aerolizer[TM] dry powder inhaler 5 allows successful administration of formoterol to pediatric and adult patients with varying degrees of asthma 5mg tadalafil. Micheli F, Cersosimo MG, Scorticati MC, Velez M, Gonzalez S. Bronchodilating effects 6-DELIVERY of salbutamol from a novel inhaler Airmax. SHORT 2 agonist, inhaled twice daily, in stable asthmatic subjects. Quick-relief medications for asthma Page 101 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Milledge JS. Bronchodilator effect of 1 aerosol salbutamol in infantile bronchial asthma. Total reversibility 6-DESIGN testing as indicator of the clinical efficacy of formoterol in COPD. Long-acting inhaled beta -agonists in2 5 asthma therapy. Effect of terbutaline on 6-POWDER mucociliary clearance in asthmatic and healthy subjects after inhalation from a pressurised inhaler and a dry powder inhaler. Pediatric 5 emergency department outcomes comparing levalbuterol vs. Clinical trial of salbutamol on bronchial asthma in children. High-dose inhaled 3 budesonide may substitute for oral therapy after an acute asthma attack. Beta 2-agonists 6-POWDER administered by a dry powder inhaler can be used in acute asthma. Hypokalaemic effect of 5 salbutamol and terbutaline in bronchial asthma. Negro Alvarez JM, Miralles Lopez JC, Felix Toledo R, et al. Pressurised 6-POWDER metered-dose inhalers (MDIs) versus dry powder inhalers devices (DPIs) to rapid-acting inhaled b2-agonists for asthma in children. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, Group 6 SMARTS. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Newhouse MT, Nantel NP, Chambers CB, Pratt B, Parry-Billings M. Protection against 6-POWDER methacholine-induced bronchospasm: salbutamol pMDI versus Clickhaler DPI. Newnham DM, Ingram CG, Earnshaw J, Palmer JB, Dhillon DP. SHORT Salmeterol provides prolonged protection against exercise-induced bronchoconstriction in a majority of subjects with mild, stable asthma. Quick-relief medications for asthma Page 102 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Newnham DM, Wheeldon NM, Lipworth BJ, McDevitt DG. Relative Beta 5 2 adrenoceptor selectivity of inhaled Fenoterol and Salbutamol. SHORT asthmatic preschool children from formoterol administered by mechanically actuated dry-powder inhaler and spacer. SHORT on adenosine monophosphate and histamine reactivity in asthma. SHORT a long-lasting beta 2-adrenoceptor agonist, against methacholine- induced bronchoconstriction. Bronchodilating effect of formoterol but not of 5 salmeterol in two asthmatic patients. Salbutamol dry powder 6-POWDER inhaler: efficacy, tolerability, and acceptability study. Long-term effects of inhaled beta 2-agonists on 1 bronchial hyperresponsiveness in asthmatics. Outcomes and humanistic issues related to treatment of 5 acute bronchospasm. Double-blind trial of a new bronchodilator in 3 asthmatic children. Assessing the effects of 4 racemic and single-enantiomer albuterol on airway secretions in long- term intubated patients. The effects of inhaled albuterol and salmeterol in 6-LONG VS. SHORT 2- to 5-year-old asthmatic children as measured by impulse oscillometry. Bricanyl Turbuhaler in the treatment of 6-POWDER asthma: a six week multi-centre study carried out in Sweden, the United Kingdom, Denmark, Norway and Finland. Tolerability of short-term, high-dose formoterol in healthy 5 volunteers and patients with asthma. Comparison between fenoterol and 6-DESIGN salbutamol in asthmatic patients. Palmqvist M, Balder B, Lowhagen O, Melander B, Svedmyr N, 6-LONG VS. Late asthmatic reaction decreased after pretreatment with salbutamol and formoterol, a new long-acting beta 2-agonist. Salmeterol is a partial beta-2- 5 agonist in relation to formoterol in asthmatic patients. Comparison of the relative 6 efficacy of formoterol and salmeterol in asthmatic patients. Quick-relief medications for asthma Page 103 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Pansegrouw DF, Weich DJ, Le Roux FP. Airway reactivity is a determinant of bronchodilator 6 responsiveness after methacholine-induced bronchoconstriction. Effects of prolonged administration of 3 pirbuterol by mouth in chronic asthma. Patessio A, Podda A, Carone M, Trombetta N, Donner CF. SHORT effect and duration of action of formoterol aerosol on exercise-induced asthma. Variability of onset and 5 duration of effect of salmeterol and formoterol in patients with moderate and severe stable asthma. Formoterol--where does it fit in the current guidelines? Pauwels RA, Hargreave FE, Camus P, Bukoski M, Stahl E. A 1-year 6-POWDER comparison of turbuhaler vs pressurized metered-dose inhaler in asthmatic patients. SHORT medication in asthma: a worldwide safety and effectiveness trial. Pearlman D, Milgrom H, Andriano K, Feldman J, Ziehmer B. Long-acting beta 2-agonist salmeterol compared with 6-LONG VS. SHORT salmeterol with albuterol in the treatment of mild-to-moderate asthma. SHORT compared with salbutamol in large-scale multicentre studies. Cardiopulmonary 3 effects of terbutaline and a bronchodilator combination in chronic obstructive pulmonary disease. Comparison of 6-DELIVERY innovator and generic salbutamol inhalers: a double-blind randomized study of efficacy and tolerance. Pleskow W, LaForce CF, Yegen U, Matos D, Della Cioppa G. SHORT Formoterol delivered via the dry powder Aerolizer inhaler versus albuterol MDI and placebo in mild-to-moderate asthma: a randomized, double-blind, double-dummy trial. Comparison of formoterol, 6 salbutamol and salmeterol in methacholine-induced severe bronchoconstriction. Quick-relief medications for asthma Page 104 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Price DB, Cargill K, Wolfe S, Darby H. Salmeterol xinafoate: an analysis 6-DESIGN of outcomes and cost-effectiveness using a primary care database. Quebe-Fehling E, Brambilla R, Bromly CL, Fishwick K, Walters EH, 6-LONG VS. The duration of action of inhaled formoterol dry powder. Effect of different inhaled 6-DESIGN bronchodilators on recovery from methacholine-induced BROCHOPROVOCATION bronchoconstriction in asthmatic children. The cost effectiveness of levalbuterol versus racemic albuterol. Comparison of the 6 effects of salmeterol and formoterol on airway tone and responsiveness over 24 hours in bronchial asthma. Prolonged protection against methacholine-induced bronchoconstriction by the inhaled beta 2-agonist formoterol. Randell J, Hamalainen KM, Leinonen M, Keski-Karhu J, Silvasti M, 6-DELIVERY Tukiainen H. Salbutamol via Easyhaler(TM) multidose dry powder inhaler produces equivalent relief of histamine-induced bronchoconstriction to salbutamol via pressurised metered-dose inhaler. A comparison of salmeterol with salbutamol inhalation in 1 treatment of mild to moderate asthma. Effects of on-demand beta -agonist2 6-DESIGN inhalation in moderate-to-severe asthma. SHORT single dose salmeterol affect exercise capacity in asthmatic men? Quick-relief medications for asthma Page 105 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Rosenborg J, Bengtsson T, Larsson P, Blomgren A, Persson G, Lotvall 6-LONG VS. Relative systemic dose potency tolerability of inhaled formoterol salbutamol healthy subjects and asthmatics. Rosenborg J, Bengtsson T, Larsson P, Blomgren A, Persson G, Lotvall 6-LONG VS. Relative systemic dose potency and tolerability of inhaled formoterol and salbutamol in healthy subjects and asthmatics. Rosenborg J, Larsson P, Rott Z, Bocskei C, Poczi M, Juhasz G. SHORT Assessment of a relative therapeutic index between inhaled formoterol and salbutamol in asthma patients. Rosenborg J, Larsson R, Rott Z, Bocskei C, Poczi M, Juhasz G. SHORT Relative therapeutic index between inhaled formoterol and salbutamol in asthma patients. SHORT salmeterol therapy compared with as-needed albuterol use on airway hyperresponsiveness. Double-blind, randomized, comparative study on the efficacy 1 and tolerability of terbutaline versus fenoterol, in nebulization, in pediatric asthmatic patients. A comparative 6 bronchodilator study of salbutamol and salbutamol sulphate that were administered by metered-dose inhalers. Rutten-van Molken MP, Custers F, van Doorslaer EK, et al. SHORT of performance of four instruments in evaluating the effects of salmeterol on asthma quality of life. Bronchodilator effects of 6 terbutaline and epinephrine in obstructive lung disease. Cardiovascular effects of beta- 6 agonists in patients with asthma and COPD: a meta-analysis. Meta-analysis: respiratory 6 tolerance to regular beta -agonist use in patients with asthma. Single-dose comparison of formoterol (Oxis) Turbuhaler 6 6-POWDER mug and formoterol Aerolizer 12 mug in moderate to severe asthma: A randomised, crossover study.

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How similar is the population to the population to whom the intervention would be applied? What was the funding source and role of funder in the study? NCS Page 64 of 71 Final Report Update 1 Drug Effectiveness Review Project Appendix C tadalafil 10mg. Results of literature search Total number of citations identified through searches: 1688 (284)* Citations excluded at the title/abstract-level: 1121 (206) Full-text articles retrieved for more detailed evaluation: 567 (78) Articles excluded at full-text level: 452 (47) Reasons for exclusion include: not English language 10 mg tadalafil, wrong outcome tadalafil 2.5mg, drug not included 20 mg tadalafil, population not included tadalafil 5mg, wrong publication type tadalafil 5 mg, wrong study design 5 mg tadalafil, insufficient duration Included studies: 115 (31) Head-to-Head trials: 54 (1) Active-controlled trials: 1 (1) Placebo-controlled trials: 42 (15) Observational studies: 8 (4) Systematic Reviews: 4 (4) Other: 6 (6) * Totals in parenthesis reflect results of literature search specific to update 1 NCS Page 65 of 71 Final Report Update 1 Drug Effectiveness Review Project Appendix D tadalafil 10 mg. Listing of excluded studies Excluded studies Reasons for exclusion Active-controlled trials Khanna P 2.5 mg tadalafil, Shah A tadalafil 20 mg. Assessment of sensory Outcome not included perceptions and patient reference for intranasal corticosteroid sprays in allergic rhinitis. Barnes ML, Biallosterski BT, Gray RD, Fardon TC, Study design not included Lipworth BJ. Decongestant effects of nasal xylometazoline and mometasone furoate in persistent allergic rhinitis. Study design not included Increased nasal airflow with budesonide compared with desloratadine during the allergy season. Comparison of Study design not included intranasal hypertonic dead sea saline spray and intranasal aqueous triamcinolone spray in seasonal allergic rhinitis. Comparison of Study design not included the efficacy of inhaled budesonide and oral choline in patients with allergic rhinitis. Zieglmayer UP, Horak F, Toth J, Marks B, Berger Study design not included UE, Burtin B. Efficacy and safety of an oral formulation of cetirizine and prolonged-release pseudoephedrine versus budesonide nasal spray in the management of nasal congestion in allergic rhinitis. Effects of intranasal corticosteroid on nasal adenosine monophosphate challenge in persistent allergic rhinitis. Short-term lower-leg growth Intervention not included rate and urine cortisol excretion in children treated with ciclesonide. A 2-week, Population not included crossover study to investigate the effect of fluticasone furoate nasal spray on short-term growth in children with allergic rhinitis. Nave R, Wingertzahn MA, Brookman S, Kaida S, Population not included Matsunaga T. Safety, tolerability, and exposure of ciclesonide nasal spray in healthy and asymptomatic subjects with seasonal allergic rhinitis. NCS Page 66 of 71 Final Report Update 1 Drug Effectiveness Review Project Excluded studies Reasons for exclusion Rowe-Jones JM, Medcalf M, Durham SR, Richards Population not included DH, Mackay IS. Functional endoscopic sinus surgery: 5 year follow up and results of a prospective, randomised, stratified, double-blind, placebo controlled study of postoperative fluticasone propionate aqueous nasal spray. Observational studies Bousquet J, Neukirch F, Bousquet PJ, et al. Severity Outcome not included and impairment of allergic rhinitis in patients consulting in primary care. Development Outcome not included of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis. Otolaryngology--head and neck surgery: Official journal of American Academy of Otolaryngology-Head and Neck Surgery. Influence of Population not included allergy on the symptoms and treatment of nasal polyposis. Population not included Intranasal corticosteroid use is associated with lower rates of bacterial recovery in chronic rhinosinusitis. Evaluation of Population not included efficacy of topical corticosteroid for the clinical treatment of nasal polyposis: searching for clinical events that may predict response to treatment. NCS Page 67 of 71 Final Report Update 1 Drug Effectiveness Review Project Appendix E. Adverseeffectsinhead-to-headtrials Age Withdrawals Study % female Treatments dueto Samplesize Rhinitis (totaldaily adverse Throat Trialduration type doseinmcg) events Headache soreness Epistaxis Nasarritation Al-Moh aimeid 30y ears BU D400ȝg 5. N=136 62% BEC336 NS NS 2%;NS 2wks SAR Ra tner1996 44yrs New vs. FLUT 200 NS NS 3wks SAR Stern1997 Age NR BUD128/256 0. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Dana Selover, MD Tracy Dana, MLS Colleen Smith, PharmD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Marian McDonagh, PharmD, Principal Investigator, Drug Effectiveness Review Project Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. Final Report Update 1 Drug Effectiveness Review Project TABLE OF CONTENTS Evidence Table 1. Head-to-head trials in patients with SAR………………………………………….. Placebo-controlled trials in patients with SAR………………………………………..... Quality assessment of head-to-head trials in patients with SAR…………………..... Quality assessment of placebo-controlled trials in patients with SAR……………... Placebo-controlled trials in children with SAR………………………………………... Quality assessment of placebo-controlled trials in children with SAR……………... Head-to-head trials in patients with PAR………………………………………………145 Evidence Table 5a. Placebo-controlled trials in patients with PAR………………………………. Quality assessment of head-to-head trials in patients with PAR……………………241 Evidence Table 6a. Quality assessment of placebo-controlled trials in patients with PAR…….. Placebo-controlled trials in children with PAR………………………………………... Quality assessment of placebo-controlled trials in children with PAR……………... Trials in patients with non-allergic rhinitis…………………………………... Quality assessment of trials in patients with non-allergic rhinitis………. Quality assessment of placebo-controlled trials of harms outcomes…. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions Be rge r P aralle l-group,single - Adult and adole sce ntsw ith spring TAAAQ 220m cg daily W ash-out pe riod x5days N R 2003 blind,R CT S AR forat le ast 24m os. F P 200m cg daily involving discontinuation U S A M ultice nte r P ositive e picutane ousorintrade rm al of allrhinitism e dications (F air) te st toone orm ore of grassortre e S tudyduration:3w e e ks R un-in:none ------------- polle nand/oroutdoorm olds K aise r TN S S (the sum of discharge , 2004 stuffine ss,itching,and sne e zing U S A score sre corde d the m orning of random izationvisit plusscore sfrom 3 of the 4pre viousdaysw e re re quire d toe qualat le ast 42(of a possible 84) pointsforpatie ntstocontinue inthe study. NCS Page 3 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d Be rge r P atie nt re porte d se ve rity(0=abse nt to M e anage (ye ars):31. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s Be rge r TNS S TAAAQ =F P (data N R ) 2003 TN S S m ode rate :TAAAQ (n=69)=39% im prove m e nt from base line vsF P (n=76)=36% im prove m e nt from base line (p=N S ) U S A TN S S se ve re :TAAAQ (n=79)=38% im prove m e nt from base line vsF P (n=71)=41% im prove m e nt from base line (p=N S ) (F air) IN S S m ode rate and se ve re diffe re nce inm e anchange from base line w asstatisticallysignificant TAAAQ =F P (p=N S ) ------------- INS S (m e ane stim ate d from graph): K aise r N asal discharge :-0. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts Be rge r R e porte d bypatie nt TAAAQ (n=148)vsF P (n=147)(any W ithdraw als(ove rall):8 K aise rre -analyze d Be rge re t 2003 R e sponse sto2S AQ ite m s causality,(%);possiblyre late d,(%)) W ithdraw als(adve rse e ve nts):aldata toe xam ine the e ffe cts U S A prospe ctive lyde fine d as He adache :10(6. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions Gross P aralle l-group,single - Adult and adole sce ntsw ith fall TAAAQ 220m cg daily F P W ash-out pe riod x5days N o 2002 blind,R CT (ragw e e d)AR forat le ast 24m onths. NCS Page 7 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d Gross P atie nt re porte d nasalsym ptom M e anage (ye ars):38. R Q L Q n=349 (F air) itching/te aring/re dne ss)tw ice daily Black4. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s Gross TAAAQ vsF P 2002 TNS S :49. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts Gross R e porte d bypatie nt via daily TAAAQ (n=172)vsF P (n=180)(possibly W ithdraw als(ove rall):10 Applicationre actioninclude d 2002 que stionnaire s re late d,(%);probablyre late d,(%)): W ithdraw als(adve rse e ve nts):post-dose burning,stinging, U S A Bodyasa w hole :2(1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions R atne r P lace bo-controlle d Adult patie ntsw ith m ode rate to F P 200m cg inthe m orning + R un-inpe riod 4-14days Chlorphe niram ine 4m g 1992 D ouble -blind se ve re S AR forat le ast 24m onths place bointhe e ve ning W ash-out:none table ts U S A R CT P ositive skinte st toM ountainCe dar, BD P 168m cg tw ice daily (F air) M ultice nte r Juniperusashei P lace botw ice daily N orm aladre nalfunction W om e nof non-childbe aring pote ntial S tudyduration:2w e e ks At le ast 200/400pointsonIN S S onat le ast 4out of 7daysof run-inpe riod NCS Page 11 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d R atne r N asale xam days1,8,and 15and M e anage (ye ars):37. NCS Page 12 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s R atne r F P vsBD P vsP L 1992 INS S (clinician-rate d,patie nt-rate d): U S A F orallIN S S F P =BD P >P L (P <0. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts R atne r Elicite d byinve stigatorat F P (n=106)vsBD P (103)vsP L (n=104) W ithdraw als(ove rall):4 Authorsonlyliste d adve rse 1992 e ach clinic visit S ore throat:2(2%)vs2(2%)vs1(1%) W ithdraw als(adve rse e ve nts):e ve ntsif re porte d by3orm ore U S A Blood innasalm ucus:6(6%)vs1(1%)vs 2(place bogroup for patie ntsacrosstre atm e nt (F air) 2(%) insom nia,obje ctionable odor groups N asalburning:5(5%)vs2(2%)vs4(4%) of studydrug) Epistaxis:3(3%)vs2(2%)vs0 Allce nte rsw e re inTe xasw ith He adache :0vs1(1%)vs3(3%) analle rge nspe cific tothat Anye ve nt:19(18%)vs10(10%)vs19(18%) re gion. NCS Page 14 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions Graft P lace bo-controlle d Adult and adole sce nt (at le ast 12 M F 200m cg inthe m orning +R un-inpe riod:none N o 1996 D ouble -blind ye arsold)ptsw ith S AR forat le ast 24place bointhe e ve ning W ash-out pe riod:1dayto U S A P aralle lgroup m onths BD P 168m cg tw ice daily stop nasal,oral,orocular (F air) R CT P ositive skinprickte st toragw e e d P lace botw ice daily de conge stants. O ral M ultice nte r W om e nof non-childbe aring statusor antihistam ine sfora using acce ptable form of birth control S tudyduration:8w e e ks variable am ount of tim e F re e of nasaland non-nasal de pe nding ondurationof sym ptom s(score le ssthanore qual action to1)and TN S S le ssthanore qualto S yste m ic corticoste roids 2at scre e ning and base line. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d Graft IN S S :4nasalsym ptom s M e anage (ye ars):34. GlobalEvaluationbypatie nt and M D at e ach visit Com pliance e valuate d w ith phone callday15and 43 Adve rse e ve nts(safe ty)re vie w e d w ith M D at e ach visit. NCS Page 16 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s Graft M F (n=114)vsBD P (n=112)vsP L (n=104) 1996 The ave rage proportionof m inim alsym ptom days(am and pm score save rage d VH(old)and VH(ne w )re spe ctive ly(p=0. F N (ne w )n=34)vsVH(ne w )n=-33vsF N (old)n=36vsVH(old)n=29 Ye s:31(91)vs20(61)vs33(92)vs16(55) N o:3(9)vs13(39)vs3(9)vs13(45) F N (ne w )=F N (old)(p=N S )Each active drug >VH(old)and VH(ne w ) re spe ctive ly(p=0. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts R atne r R e porte d bypt R hinitis(34%)and he adache (8%)w e re the W ithdraw als(ove rall):14 68pt e xclude d from one 1996 m ost fre que ntlyre porte d drug-re late d AE, W ithdraw als(adve rse e ve nts):ce nte rdue tolow polle ncnt U S A and the m ost se ve re. P re se nt:11(20)vs7(13)vs23(42)vs21 N S diffe re nce fore ye (40) 68patie ntse xclude d due to sym ptom sb/nVHand active F N (ne w )>F N (old)(p=0. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions W e lsh S ingle -Blind (Crom olyn Adult and adole sce nt pt w ith a history D B:BD P AQ 168m cg tw ice R un-in:Ye sx14daysin supple m e ntal 1987 vsF N ) of ragw e e d S AR for24m os. BD P AQ and P L w e re de live re d inm e te re d-dose , m anualpum p nasalspray containing m icrocrystalline ce llulose , carboxym e thylce llulose sodium ,de xtrose , be nzalkonium chloride , polysorbate 80,and 0. Be conase AQ consistsof a m icrocrystalline suspe nsionof be clom e thasone dipropionate m onohydrate inthisaque ous m e dium. NCS Page 31 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d W e lsh INS S :P t ke pt dailyre cord of M e anage (ye ars):28 Hayfe ve rscore (m e an N R /N R /120 F N vsCR vsBD P 1987 sym ptom sbe ginning July11toS e pt F e m ale ge nde r:33(27. P t diaryinclude d re cord of tim e R ace not re porte d of 24):15. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s W e lsh F N vsBD P AQ 1987 Total hay fe ve rscore s: U S A Base line (F N n=30vsBD P AQ n=29):3. NCS Page 33 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts W e lsh N ot re porte d F N vsCR vsBD P AQ vsP L W ithdraw als(ove rall):22 F N isN asalide 1987 Nasal burning: W ithdraw als(adve rse e ve nts): U S A 10(33%)vs.

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