The Efficacy Of (chlordiazepoxide & clidinium) plus hyoscine N- butylbromide IN Treatment Of Irritable Bowel Syndrome

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1 The Efficacy Of (chlordiazepoxide & clidinium) plus hyoscine N- butylbromide IN Treatment Of Irritable Bowel Syndrome Hassan KH. Rajab University of Tikrit, college of medicine, Department of clinical pharmacology Summary Irritable bowel syndrome (IBS) is one of the commonest disorder of the gastrointestinal tract, IBS is long standing dysfunction associated with abdominal pain for which no organic cause can be found. a fifty three patients were included in this study all of them diagnosed as irritable bowel syndrome clinically after excluding organic causes. The patients receive a treatment with " librax " (chlordiazepoxide 5 mg & clidinium 2.5 mg ) before meal twice daily plus " spasmopan"( hyoscine N- butylbromide 10 mg ) after meal three times daily. The treatment continue for month.the results showed an improvement in 68% of the patients. No significant differences observe except in female, age group of years old, patients with positive family history of the disease & patients with psychotic disorders (stress, worried & anxiety ). Initiation of combine drugs therapy plus psychotherapy a good approach in treatment of irritable bowel syndrome. Introduction Irritable bowel syndrome (IBS) is one of the commonest disorder of the gastrointestinal tract, IBS is long standing dysfunction associated with abdominal pain for which no organic cause can be found. Bowel habit is disturbed by diarrhea or constipation occurring alone or alternatively (1) The prevalence of irritable bowel syndrome is % of population (2), (15-20)% (3) & 7.26% (4 ) Irritable bowel syndrome caused by (1,5,6,7,8): 1-psycholgical disturbance especially anxiety, stress individual & worried person 2-some relate the onset of symptoms to an attack of infectious diarrhea. 3-in other, food may precipitate the symptoms The syndrome more frequent in women than men between age( 20-40) years old. the commonest symptoms are :1-abdomial pain relief by defecation, refered to right or left iliac fossa or to hypogastrium. 2-bowel habit variable. 3-painless morning diarrhea. 4- abdomial distension due to excessive flatus. 5- sensation of incomplete emptying of the rectum. 6-audible borborygmi. 7- nausea, headache, tiredness, dyspepsia, atypical chest pain. 8- palpable tender distended bowel. 9- mucus in stool(1,13). The diagnostic evaluation of IBS comprises a limited routine laboratory investigation, and endoscopic exploration to exclude organic disease of the gastrointestinal tract & to look for what we called it a red flags as shown in table -1- (1,6,9).

2 Table-1-(6) Red Flags in Evaluating for Irritable Bowel Syndrome Anemia Family history of colon cancer or inflammatory bowel disease Fever Heme-positive stools New or recent onset in patient older than 50 years Nocturnal symptoms Palpable abdominal or rectal mass Persistent diarrhea or severe constipation Recent antibiotic use Rectal bleeding Weight loss After exclusion of the organic bowel disease the diagnosis based on Rome I Criteria & Rome II Criteria as shown in table 2 (6,10,11,12). Table -2- Criteria of diagnosis of IBS. Rome I Criteria At least three months of continuous or recurrent symptoms of abdominal pain that is: Relieved by defecation Associated with a change in stool consistency Associated with a change in frequency of stool Plus two or more of the following greater than 25 percent of the time: Altered stool frequency (more than three per day or less than three per week) Altered stool form (lumpy, hard or watery, loose) Altered stool passage (straining, urgency, or incomplete evacuation) Passage of mucus Bloating or feeling of abdominal distention Rome II Criteria 12 or more weeks of continuous or recurrent abdominal pain or discomfort Plus at least two of the following: Relieved by defecation Associated with change in frequency of stool Associated with a change in form (appearance) of stool Current pharmacological treatment option of irritable bowel syndrome are limited and lack specificity (1,2). Table 4 show many medication used in treatment of irritable bowel syndrome (6,7,9) :

3 Table -3- Medications Used in the Management of Irritable Bowel Syndrome Predominant symptom Medications Dosage Comment Diarrhea Constipation Abdominal pain Loperamide (Imodium) Cholestyramine (Questran) Alosetron Fiber Osmotic laxative Antispasmodics and anticholinergics (e.g., dicyclomine [Bentyl], hyoscyamine [Levsin]) Tricyclic antidepressant (e.g., amitriptyline [Elavil]) 2 to 4 mg up to four times a day 4 g one to six times a day 1 mg per day titrated to two times a day if tolerated Start low and titrate up to 20 to 30 g a day Magnesium citrate, lactulose, or polyethylene glycol dosed as appropriate Dicyclomine, 10 to 20 mg, two to four times a day Start amitriptyline, 10 to 25 mg at bedtime or twice daily, or desipramine (Norpramin), 50 mg three times a day Use as needed or prophylactically in times of anticipated stress Second-line agent Restricted use in female patients only May worsen bloating Used as needed only Needs to be given daily, not as needed, therefore generally reserved for patients with more severe pain Tegaserod (Zelnorm) FDA approved for shortterm treatment of women Gas or Simethicone 40 to 125 mg up to four Anecdotal evidence only bloating (Mylanta) times a day as needed Comorbid depression or anxiety Antidepressants or anxiolytics as indicated Dose as appropriate Treating depression has been shown to improve bowel symptoms The aim of the study is to evaluate the efficacy of librax & spasmopan in treatment of IBS Patients and methods During a 10-month period, 53 out patients with IBS, after exclusion of organic bowel pathology and meeting Rome I Criteria & Rome II Criteria for the diagnosis of irritable bowel syndrome were included in this study.they were assessed using the Personality Questionnaire [ including age, sex, psychological state ( stress, anxiety & worried ), family history of the disease, social habits ( drinking & smoker ) & history of antibiotic intake within the last six month prior development of the disease ]. The diagnosis ( was done by physician ) is established on the basis of typical symptoms and specific exclusion of relevant differential diagnoses.the heart of the diagnostic evaluation comprises a limited routine laboratory investigation, and endoscopic exploration to exclude organic disease of the gastrointestinal tract.. All the patient receive a treatment regimen with " librax " (chlordiazepoxide 5 mg & clidinium 2.5 mg ) before meal twice daily plus " spasmopan"( hyoscine N- butylbromide

4 10 mg ) after meal three times daily. The treatment continue for month. Statistical analysis was done by using Chi square. Results This study included a fifty three patients their ages range between years old ( mean = years of old ), 21( 39.6%) of them were Male & 32 (60.4%) of them Female, 28 of them were under stress, 31 of them were anxious, 17 of them were worried, 2 of them were drinker, 20 of them were smoker, 6 of them of positive antibiotic intake in the last 6 months & 13 of them had positive family history of the disease(ibs). The efficacy of the treatment was positive in 36 patients ( 68%) & negative in 17 patients (32%). The efficacy of the treatment according to the age group were 3 out of 3,9 out of 18, 18 out of 25 & 6 out of 7 respectively, there is a statistical significant difference in age group rang as showed in table -4-. The efficacy among male was 10 (48%) & 26 (81%) was the efficacy among female, there is a statistical significant difference between male and female as showed in table -5-. The efficacy among smokers and non smokers was 35% & 30.3% respectively, there is no statistical significant difference between them as shown in table -6-. The efficacy among patients with positive & negative family history of irritable bowel syndrome was 61.5% & 22.5% respectively, there is a statistical significant difference between them as shown in table -7-. The efficacy among patients under stress / not under stress 43% &94% respectively, there is a statistical significant difference between them as showed in table -8-, The efficacy among patients under anxiety / non anxiety patients 55% & 86.4% respectively, there is a statistical significant difference between them as showed in table -9-. The efficacy among patients under anxiety / non anxiety patients 65% & 69.4% respectively, there is a statistical significant difference between them as showed in table -10- Table-4- The efficacy of treatment & age of patients : Age range Total No. Positive results % Negative results % Significance Less than 20 years % 0 0% N.S* years % 9 50% S** years % 7 28% N.S* More than % 1 14% N.S* years Total *N.S : statistically not significant / Table-5- The efficacy of treatment & sex of patients : sex Total No. Positive results & % Negative results & % Significance male % 11 52% S** Female % 6 19% Total Table-6-The efficacy among the smoker & non-smoker patients Smoker state Total No. Positive response &% Negative response &% Significance Smoker % 13 65% N.S* Non-smoker % % N.*S : statistically not significant

5 Table-7- The efficacy among positive & negative family history of the disease patients family history Total No. Positive response &% Negative response&% Significance Positive history % % S** Negative history % % Table-8- The efficacy according to stress state of the patients State of stress Total No. Positive response &% Negative response &% Significance Under stress % 16 57% S** Not under stress % 1 4% Table-9- The efficacy according to anxiety state of the patients Anxiety state Total No. Positive response & % Negative response & % Significance positive % 14 45% S** negative % % Table-10- The efficacy according to the worried state of the patients Worried state Total No. Positive response & % Negative response &% Significance positive % 6 35% S** negative % % *S : statistically significant Discussion This study was demonstrated that irritable bowel syndrome is more common in female than in male ( 60.4% & 39.6%) respectively. This is in agreement with irritable bowel syndrome more common in female aged years(1), women are affected more often than men (13) & female to male ratio 1.5:1(11,14). This study was demonstrate that the etiology of irritable bowel syndrome as follow psychiatric causes ( anxiety, stress & worried ), positive famil history of the disease, positive history of taken antibiotic in the last 6 months & those with social habits( especially smoker), this in agreement with (1,15,5,6,7,13,16 ). The diagnosis of irritable bowel syndrome was done depending on clinical features and Rome ( τ& π) criteria after excluding of organic causes be cretin investigational methods and this in agreement with (4,10,11,16, 17). The efficacy of our treatment in this study was 68% by using combination of librax ( consist of chlordizepoxide & clidinium bromide ) plus spasmopan" ( hyoscine N- butylbromide ). Librax of both anxiolytic & sedative effects while spasmopan anticholinergic of both decreasing gastrointestinal motility & anti-secretary effects, both drug may be use in treatment of irritable bowel syndrome alone or in combination, although there is no specific treatment of irritable bowel syndrome the present treatment is symptomatic treatment only. This in agreement with previous findings (18,19). While other studies use each element alone in treatment of irritable bowel syndrome as with (16,20). The deference among age groups not significant with exception of years age range which shows a significant deference. This may contribute to the fact that these female group is a group of sensitive & more liable to follow physician opinion than male. The deference among sex was significant deference. This mat contribute to the fact that these age group is a group of activity &

6 working which could be consider as psychotherapy in one hand & in the other hand such job providing a body tiredness with their worried about their job to get no problems in it all contribute to a high efficacy & response to treatment. No significant deference found among smoker patients so smoking no affecting treatment results in irritable bowel syndrome. A significant deference found in the patients of psychiatric disorders & those of positive family history of the disease, this could be contribute to the environmental causes of illness. sometimes a hereditary & social factors to be consider (21 ). Conclusion : 1- irritable bowel syndrome a Multicomponent disorder. 2- no specific treatment found but symptomatic treatment consider. 3- psychiatric disorder play a role in the results of treatment. 4- younger age group years old identical to initiate both medical & psychiatric therapy to over come the disorder. Recommendation 1. start both medical & psychiatric therapy at the same time on management of irritable bowel syndrome using of single therapy consider in chronic disorder to be symptomatic therapy according to patient complaining References 1- Christopher.R.W.Edwards and Ian.A.D.Bouchier Davidsons principle and practice of medicine. Churchill Livingstone Educational Lowpriced Books scheme funded by the British Government, U.K. p. p Pattee PL, Thompson WG. Drug treatment of the irritable bowel syndrome Journal: Drugs. Augus1992 ; 44:200-6, Foxx-Orenstein,-A-E; Clarida,-J-C. Irritable bowel syndrome in women: the physician patient relationship evolving. J- Am-Osteopath-Assoc Dec; 101(12 Suppl Pt 2): S Thompson WG. Irritable bowel syndrome: pathogenesis and management Journal: Lancet. 19June 1993 ;341: ,. 5- Drossman DA. Do psychosocial factors define symptom severity and patient status in irritable bowel syndrome? Am J Med 1999;107:41S-50S. 6- Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE. Rome II: the functional gastrointestinal disorders: diagnosis, pathophysiology, and treatment: a multinational consensus. Gut 1999;45(suppl 2): Monnikes,-H; Tebbe,-J-J; Hildebrandt,-M; Arck,-P; Osmanoglou,-E; Rose,-M; Klapp, B; Wiedenmann,-B; Heymann-Monnikes,-I. Role of stress in functional gastrointestinal disorders. Evidence for stress-induced alterations in gastrointestinal motility and sensitivity. Dig-Dis. 2001; 19(3): Drossman DA. Irritable bowel syndrome and sexual/physical abuse history. Eur J Gastroenterol Hepatol 1997;9: Paterson WG, Thompson WG, Vanner SJ, Faloon TR, Rosser WW, Birtwhistle RW, et al. Recommendations for the management of irritable bowel syndrome in family practice. CMAJ 1999;161: Tovey,-Philip. A single-blind trial of reflexology for irritable bowel syndrome. Br-J Gen-Pract Jan; 52(474): Pan,-G; Lu,-S; Ke,-M; Han,-S; Guo,-H; Fang,-X. Epidemiologic study of the irritable bowel syndrome in Beijing: stratified randomized study by cluster sampling. Chin-Med-J (Engl) Jan; 113(1): Vanner SJ, Depew WT, Paterson WG, DaCosta LR, Groll AG, Simon JB, et al. Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome. Am J Gastroenterol 1999;94: Maxwell,-P-R; Rink,-E; Kumar,-D; Mendall,-M-A.Antibiotics increase functional abdominal symptoms. Am-J- Gastroenterol Jan; 97(1): 104-8: 14- Fock,-K-M; Chew,-C-N; Tay,-L-K; Peh,- L-H; Chan,-S; Pang,-E-P. Psychiatric illness, personality traits and the irritable

7 bowel syndrome. Ann-Acad-Med- Singapore Nov; 30(6): Mayer EA. Emerging disease model for functional gastrointestinal disorders. Am J Med 1999;107: 12S-19S 16- Farhadi,-A; Bruninga,-K; Fields,-J; Keshavarzian,-A. Irritable bowel syndrome: an update on therapeutic modalities. Expert-Opin-Investig-Drugs Jul; 10(7): Ragnarsson,-G; Hallbook,-O; Bodemar,-G. Abdominal symptoms and anorectal function in health and irritable bowel syndrome. Scand-J-Gastroenterol Aug; 36(8): Iraqi Drugs Guide National Board for the selection of drugs and the central drug information Bureau, Baghdad, Iraq. First edition. p.p Tougas,-G. Irritable bowel syndrome: new approaches to its pharmacological management. Can-J-Gastroenterol Oct; 15 Suppl B: 12B-13B 20- David F.Altman. Drugs used in Gastroentistinal Diseases. In the Basic and clinical pharmacology, edited by Bertram G.Katzun. MeCraw-Hill. New-York, 8th U.S.A p.p 385 and Levy,-R-L; Jones,-K-R; Whitehead,-W-E; Feld,-S-I; Talley,-N-J; Corey,-L-A. Irritable bowel syndrome in twins: heredity and social learning both contribute to etiology. Gastroenterology Oct; 121(4):

IBS Irritable Bowel syndrome Therapeutics II PHCL 430

Salman Bin AbdulAziz University College Of Pharmacy IBS Irritable Bowel syndrome Therapeutics II PHCL 430 Email:- ahmedadel.pharmd@gmail.com Ahmed A AlAmer PharmD R.S is 32-year-old woman experiences intermittent