The effect of tegaserod on quality of life in patients having co-existence of irritable bowel syndrome and fibromyalgia
Abstract
Abstract
Aim. The aim of this study is to investigate the effect of tegaserod on symptoms and quality of life in patients who have irritable bowel syndrome and fibromyalgia co-existence. Methods. The study was performed between the time March 2005 and September 2005. Two groups were formed; constipation predominant irritable bowel syndrome (IBS-C) patients having co-existence of fibromyalgia (IBS-C plus FMS group, 28 female patients) and IBS-C patients without fibromyalgia (IBS-C group, 28 female patients). Turkish brief version of WHOQOL (World Health Organization Quality of Life) named as WHOQOL-BREF-TR scale was used to determine the QoL of patients. Visual anolog scale was used to determine the severity of pain. Tegaserod 6 mg tablet was given to the study groups administered ½ hours before breakfast and dinner. They were called for control visits at the first and second months of therapy. WHOQOL-BREF-TR scale was answered by patients during these visits. Results. When the total QoL scores of the study groups were compared, there was no difference between the pretreatment values of study groups. But we found a significant difference when the first and second month values of the study groups were compared. (p<0.05). Conclusions. QoL increased in only IBS-C patients but not in patients with a co-existence of fibromyalgia and IBS-C. The reason for this result can be explained by scale related problems as it only determines psychological, environmental and social areas and social and psychological additional support therapies could be required for IBS-C and FMS patients. Although there was no cardiovascular side effects of tegaserod in our study subjects, the drug was withdrawn from market in 2007.
Keywords: Irritable bowel syndrome, fibromyalgia, quality of life
Özet
Amaç. Bu çalışmanın amacı irritabl barsak sendromu ile birlikte fibromyaljisi olan hastalarda tegaserodun semptomlar ile yaşam kalitesine etkisini araştırmaktır. Yöntem. Çalışma Mart 2005 ve Eylül 2005 tarihleri arasında yapıldı. Konstipasyon-baskın irritabl barsak sendromu ile birlikte fibromyaljili hasta grubu (28 bayan) ve yalnızca konstipasyon-baskın irritabl barsak sendromulu hasta grubu (28 bayan) oluşturuldu. Yaşam kalitesinin değerlendirilmesinde WHOQOL (Dünya Sağlık Örgütü yaşam kalitesi ölçeği)’nin Türkçe kısa versiyonu olan WHOQOL-BREF-TR kullanıldı. Ağrının şiddetinin değerlendirilmesinde ise görsel analog ölçek kullanıldı. Her iki gruba da tegaserod 6 mg tablet kahvaltı ve akşam yemeğinden yarım saat önce almaları tavsiye edilerek verildi. Hastalar tedavinin 1. ve 3. aylarında kontrole çağırıldılar. Kontrole geldiklerinde WHOQOL-BREF-TR’deki soruları cevaplamaları istendi. Bulgular. Toplam yaşam kalitesi puanları değerlendirildiğinde her iki grubun tedavi öncesi değerleri arasında anlamlı bir farklılık saptanmadı. Ancak her iki grubun birinci ve ikinci aylarındaki değerleri arasındaki fark anlamlı bulundu (p<0,05). Sonuçlar. WHOQOL-BREF-TR yaşam kalitesi toplam puanları tedavi ile yalnızca konstipasyon baskın irritabl barsak sendromu olan hastalarda arttı. Konstipasyon ve fibromyalji sendromunun birlikte olduğu hastalarda ise artmadı. Bunun nedeni ölçekle ilgili problemler olabilir. Çünkü ölçek psikolojik, çevresel ve sosyal alanları içermektedir ve irritabl barsak sendromuna fibromyalji de eklenince bu tür hastalara tedavide ek psikolojik ve sosyal destek tedavisi verilmesi gerekebilir. Çalışmamızda ilaç ile ilişkili herhangi bir kardiyovasküler yan etkiye rastlanmamakla birlikte kardiyovasküler yan etkileri nedeniyle çalışmanın tamamlanmasından sonra 2007 yılında tegaserodun kullanımı yasaklandı.
Anahtar sözcükler: İrritabl barsak sendromu, fibromyalji, yaşam kalitesi
Keywords
References
- Drossman DA, Camilleri M, Mayer EA,Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology 2002; 123: 2108–31.
- Mayer EA, Fass R, Fullerton S. Intestinal and extraintestinal symptoms in functional gastrointestinal disorders. Eur J Surg 1998 Supp; 583: 29-31.
- Bennett RM. The rational management of fibromyalgia patients. Rheumatic Diseases Clinics of North America 2002; 28: 181–99.
- Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the multicenter criteria committee. Arthritis and Rheumatism; 1990; 30: 160–72.
- El-Serag HB, Olden K, Bjorkman D, Health-related quality of life among persons with irritable bowel syndrome: a systematic review. Aliment Pharmacol Ther 2002; 16: 1171– 85.
- Frank L, Kleinman L, Rentz A, Ciesla G, Kim J J, Zacker, C. Health-related quality of life associated with irritable bowel syndrome: Comparison with other chronic diseases. Clinical Therapeutics 2002; 24: 675–89.
- Koloski NA, Talley NJ, Boyce PM. The impact of functional gastrointestinal disorders on quality of life. American Journal of Gastroenterology 2000; 95: 67–71.
- Grider JR, Foxx-Orenstein AE, Jin JG. 5-Hydroxy-tryptamine4 receptor agonists initiate the peristalic reflex in human, rat, and guinea pig intestine. Gastroenterology 1998; 115: 370-80.
- Fioramonti J, Million M, Bueno L. Investigations on a 5-HT4 agonist (SDZ HTF 919) and its main metabolite in conscious dogs: effects of gastrointestinal motility and impaired gastric emptying. Gastroenterology 1998; 114 (4 Suppl. Pt 2): A752.
- Zimmerman AE. Tegaserod: a 5-HT4 agonist for women with constipation-predominant irritable bowel syndrome. Formulary 2002; 37: 449-61.
- Stoner M, Arcuni J Lee J. A selective 5-HT4 receptor agonist induces cAMP mediated Cl-efflux from rat colonocytes. Gastroenterology 1999; 116 Pt 2: A648.
- Harper H, Power M, Group TW. Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med 1998; 28: 551-8.
- Camilleri M, Heading RC, Thompson WG. Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome. Aliment Pharmacol Ther; 2002; 16: 1407–30.
- Drossman DA, Li Z, Andruzzi E. US householder survey of functional GI disorders: prevalence, sociodemography, and health impact. Dig Dis Sci 1993; 38: 1569– 80.
- Hahn BA, Yan S, Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion 1999; 60: 77–81.
- Gralnek IM, Hays RD, Kilbourne A. The impact of irritable bowel syndrome on health- related quality of life. Gastroenterology 2000; 119: 654-660.
- Drossman DA, Whitehead WE, Toner BB. What determines severity among patients with painful functional bowel disorders? Am J Gastroenterol 2000; 95: 974–80.
- Novick J, Miner P, Krause R. A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2002; 16: 1877–88.
- Mueller-Lissner S, Fumagalli I, Bardhan KD. Tegaserod, a 5-HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Am J Gastroenterol 2001; 15: 1655–66.
- Yunus MB. Aldag JC, Pumphrey LJ. A study of association between current smoking and fibromyalgia symptoms. Arthritis Rheum 2000; 43: 332.
- Lea R, Whorwell PJ. Benefit-risk assessment of tegaserod in irritable bowel syndrome. Drug Saf 2004; 27: 229-42.
- Kellow J, Lee OY, Chang FY. An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome. Gut 2003; 52: 671-6.
- Layer P, KellerJ, Mueller-Lissner S. Tegaserod: Long-term treatment for irritable bowel syndrome patients with constipation in primary care. Digestion 2005; 71:238-44.
- Reilly MC, Barghout V, Mcburney CR, Niecko TE.. Effect of tegaserod on work and daily activity in irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2005; 22: 373–80.
- Gur A, Cevık R, Nas K, Sarac AJ,Ozen S. Quality of life in young fibromyalgia patients
- and effect of depression. APLAR Journal of Rheumatology 2006; 9: 70–8.
- Burckhardt CS, Clark SR, Bennett RM, Fibromyalgia and quality of life: A comperative analysis. J Rheumatol 1993; 20: 475-9.
- Bernard AL, Prince A, Edsall P. Quality of life issues for in fibromyalgia patients. Arthritis Care Res 2000; 13:42-50.
İrritabl barsak sendromu ve fibromiyaljinin birlikte görüldüğü hastalarda tegaserodun yaşam kalitesi üzerine etkisi
Abstract
Amaç. Bu çalışmanın amacı irritabl barsak sendromu ile birlikte fibromyaljisi olan hastalarda tegaserodun semptomlar ile yaşam kalitesine etkisini araştırmaktır. Yöntem. Çalışma Mart 2005 ve Eylül 2005 tarihleri arasında yapıldı. Konstipasyon-baskın irritabl barsak sendromu ile birlikte fibromyaljili hasta grubu (28 bayan) ve yalnızca konstipasyon-baskın irritabl barsak sendromulu hasta grubu (28 bayan) oluşturuldu. Yaşam kalitesinin değerlendirilmesinde WHOQOL (Dünya Sağlık Örgütü yaşam kalitesi ölçeği)’nin Türkçe kısa versiyonu olan WHOQOL-BREF-TR kullanıldı. Ağrının şiddetinin değerlendirilmesinde ise görsel analog ölçek kullanıldı. Her iki gruba da tegaserod 6 mg tablet kahvaltı ve akşam yemeğinden yarım saat önce almaları tavsiye edilerek verildi. Hastalar tedavinin 1. ve 3. aylarında kontrole çağırıldılar. Kontrole geldiklerinde WHOQOL-BREF-TR’deki soruları cevaplamaları istendi. Bulgular. Toplam yaşam kalitesi puanları değerlendirildiğinde her iki grubun tedavi öncesi değerleri arasında anlamlı bir farklılık saptanmadı. Ancak her iki grubun birinci ve ikinci aylarındaki değerleri arasındaki fark anlamlı bulundu (p
References
- Drossman DA, Camilleri M, Mayer EA,Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology 2002; 123: 2108–31.
- Mayer EA, Fass R, Fullerton S. Intestinal and extraintestinal symptoms in functional gastrointestinal disorders. Eur J Surg 1998 Supp; 583: 29-31.
- Bennett RM. The rational management of fibromyalgia patients. Rheumatic Diseases Clinics of North America 2002; 28: 181–99.
- Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the multicenter criteria committee. Arthritis and Rheumatism; 1990; 30: 160–72.
- El-Serag HB, Olden K, Bjorkman D, Health-related quality of life among persons with irritable bowel syndrome: a systematic review. Aliment Pharmacol Ther 2002; 16: 1171– 85.
- Frank L, Kleinman L, Rentz A, Ciesla G, Kim J J, Zacker, C. Health-related quality of life associated with irritable bowel syndrome: Comparison with other chronic diseases. Clinical Therapeutics 2002; 24: 675–89.
- Koloski NA, Talley NJ, Boyce PM. The impact of functional gastrointestinal disorders on quality of life. American Journal of Gastroenterology 2000; 95: 67–71.
- Grider JR, Foxx-Orenstein AE, Jin JG. 5-Hydroxy-tryptamine4 receptor agonists initiate the peristalic reflex in human, rat, and guinea pig intestine. Gastroenterology 1998; 115: 370-80.
- Fioramonti J, Million M, Bueno L. Investigations on a 5-HT4 agonist (SDZ HTF 919) and its main metabolite in conscious dogs: effects of gastrointestinal motility and impaired gastric emptying. Gastroenterology 1998; 114 (4 Suppl. Pt 2): A752.
- Zimmerman AE. Tegaserod: a 5-HT4 agonist for women with constipation-predominant irritable bowel syndrome. Formulary 2002; 37: 449-61.
- Stoner M, Arcuni J Lee J. A selective 5-HT4 receptor agonist induces cAMP mediated Cl-efflux from rat colonocytes. Gastroenterology 1999; 116 Pt 2: A648.
- Harper H, Power M, Group TW. Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med 1998; 28: 551-8.
- Camilleri M, Heading RC, Thompson WG. Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome. Aliment Pharmacol Ther; 2002; 16: 1407–30.
- Drossman DA, Li Z, Andruzzi E. US householder survey of functional GI disorders: prevalence, sociodemography, and health impact. Dig Dis Sci 1993; 38: 1569– 80.
- Hahn BA, Yan S, Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion 1999; 60: 77–81.
- Gralnek IM, Hays RD, Kilbourne A. The impact of irritable bowel syndrome on health- related quality of life. Gastroenterology 2000; 119: 654-660.
- Drossman DA, Whitehead WE, Toner BB. What determines severity among patients with painful functional bowel disorders? Am J Gastroenterol 2000; 95: 974–80.
- Novick J, Miner P, Krause R. A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2002; 16: 1877–88.
- Mueller-Lissner S, Fumagalli I, Bardhan KD. Tegaserod, a 5-HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Am J Gastroenterol 2001; 15: 1655–66.
- Yunus MB. Aldag JC, Pumphrey LJ. A study of association between current smoking and fibromyalgia symptoms. Arthritis Rheum 2000; 43: 332.
- Lea R, Whorwell PJ. Benefit-risk assessment of tegaserod in irritable bowel syndrome. Drug Saf 2004; 27: 229-42.
- Kellow J, Lee OY, Chang FY. An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome. Gut 2003; 52: 671-6.
- Layer P, KellerJ, Mueller-Lissner S. Tegaserod: Long-term treatment for irritable bowel syndrome patients with constipation in primary care. Digestion 2005; 71:238-44.
- Reilly MC, Barghout V, Mcburney CR, Niecko TE.. Effect of tegaserod on work and daily activity in irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2005; 22: 373–80.
- Gur A, Cevık R, Nas K, Sarac AJ,Ozen S. Quality of life in young fibromyalgia patients
- and effect of depression. APLAR Journal of Rheumatology 2006; 9: 70–8.
- Burckhardt CS, Clark SR, Bennett RM, Fibromyalgia and quality of life: A comperative analysis. J Rheumatol 1993; 20: 475-9.
- Bernard AL, Prince A, Edsall P. Quality of life issues for in fibromyalgia patients. Arthritis Care Res 2000; 13:42-50.
Details
| Primary Language | English |
|---|---|
| Journal Section | Medical Science Research Articles |
| Authors | |
| Publication Date | March 16, 2009 |
| Published in Issue | Year 2009Volume: 31 Issue: 1 |