Scandinavian Journal of Gastroenterology
ISSN: 0036-5521 (Print) 1502-7708 (Online) Journal homepage: http://www.tandfonline.com/loi/igas20
Ispaghula Husk May Relieve Gastrointestinal Symptoms in Ulcerative Colitis in Remission C. Hallert, M. Kaldma & B. G. Petersson To cite this article: C. Hallert, M. Kaldma & B. G. Petersson (1991) Ispaghula Husk May Relieve Gastrointestinal Symptoms in Ulcerative Colitis in Remission, Scandinavian Journal of Gastroenterology, 26:7, 747-750 To link to this article: http://dx.doi.org/10.3109/00365529108998594
Published online: 08 Jul 2009.
Submit your article to this journal
Article views: 40
View related articles
Citing articles: 3 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=igas20 Download by: [Australian National University]
Date: 08 November 2015, At: 12:27
Ispaghula Husk May Relieve Gastrointestinal Symptoms in Ulcerative Colitis in Remission C. HALLERT, M. KALDMA & B.-G. PETERSSON Dept. of Internal Medicine, Central Hospital, Norrkoping, and Dept. of Surgery, Central Hospital, Vaxjo, Sweden
Downloaded by [Australian National University] at 12:27 08 November 2015
Hallert C, Kaldma M, Petersson B-G. Ispaghula husk may relieve gastrointestinal symptoms in ulcerative colitis in remission. Scand J Gastroenterol1991,26,747-750 The efficiency of ispaghula husk in relieving gastrointestinal symptoms in patients with ulcerative colitis in remission was studied in a placebo-controlled trial running for 4 months. Twenty-nine patients (81%) completed the trial; four withdrew after colitis relapse (three while receiving placebo).Grading of symptoms judged ispaghula to be consistently superior to placebo ( p < 0.001) and associated with a significantly higher rate of improvement (69%) than placebo (24%) ( p < 0.001). The results show that ispaghula can be helpful in the management of gastrointestinal symptoms in quiescent ulcerative colitis. Key words: Dietary fibre; ispaghula; ulcerative colitis Claes Hallert, M. D . , Dept. of Internal Medicine, Central Hospital, S-601 82 Norrkoping, Sweden
It is not unusual for patients with ulcerative colitis in remission to complain of disturbances in bowel habit. The exact diagnosis is usually difficult to establish, and many patients may have their symptoms erroneously attributed to the colitis. Isgar et al. (1) analysed the symptom pattern in a series of such patients and found evidence of a predominant motility disturbance similar to the irritable bowel syndrome. Since treatment can be a problem (2), their observation prompted us to carry out a placebo-controlled study of ispaghula husk in a series of such patients. PATIENTS AND METHODS We invited adult patients with ulcerative colitis in remission, on questioning reporting complaints of disturbance in bowel habit. The study was designed as a double-blind, placebo-controlled, crossover trial preceded by a 2-week screening period with placebo. The two test periods ran for 2 months each, and the patients were randomly assigned to take ispaghula or placebo, while continuing their regular medication. For evaluation, a questionnaire was admin-
istered after the screening period and at the end of each test period. It comprised eight items, intended to reflect last week’s abdominal pain, diarrhoea, loose stools when pain present, urgency when pain present, bloating, incomplete evacuation, mucus discharge, and constipation, all graded by scoring on 10-point visual analogue scales. To be included, the patients had to report at least three of these eight symptoms at the end of the screening period. Thirty-six patients (22 women) with histologically proved ulcerative colitis (duration, 11 years; range, 1-28 years) were recruited among 76 patients screened at three outpatient clinics in southeast Sweden (Vaxjo (surgery), Norrkoping, and South Hospital, Stockholm (internal medicine)) over a 6-month period. The mean age was 43 years (20-75 years). As assessed by radiology and sigmoidoscopy , 14 patients had total colitis, 14 distal colitis, and 8 proctitis. At entry all were judged to be in remission clinically and sigmoidoscopically. Twenty-five patients were receiving medication regularly, mostly sulphasalazine (70%). The patients were randomized to treatment
Downloaded by [Australian National University] at 12:27 08 November 2015
148
C. Hallert et al.
with either flavoured lactose-free ispaghula husk (Vi-Siblin@S granules, Parke-Davis) or placebo (crushed crispbread with low content (17.3%) of non-gel-forming dietary fibre). A dose of one sachet of Vi-Siblin S (4g rough granules containing 3.52 g testa ispaghula, 88% gel-forming dietary fibre) or placebo twice daily was recommended. The test protocol allowed patients who were feeling worse during either test period to be switched to the next period or to leave the trial. Patients were excluded when showing signs of acute colitis, difficulties in swallowing, mental instability, or unwillingness to participate or when requiring change in their ongoing medication. The results were analysed on an explanatory basis taking into account only patients who were eligible and complied with the protocol. If a patient withdrew from the study, the last available data were used in the final analysis. The significance tests were done two-sided and were carried out at the 5% level. The statistical calculations were done with the Student’s paired t test. Comparisons of proportions were done with the Yates correction. The study was approved by the local ethics committee. RESULTS Ispaghula was well tolerated, safe, and superior to placebo in alleviating the gastrointestinal symptoms of the colitis patients. Twenty-nine patients (81%) completed the trial. Four felt worse during their last test period (all while taking placebo) and terminated sooner than intended. There were seven dropouts (19%) before the first assessment. Four patients withdrew after colitis relapse (three while taking placebo and one while taking ispaghula), one because of increased abdominal pain (placebo), and two patients because of non-compliance. Ispaghula versus placebo Treatment with ispaghula was consistently more efficient than placebo in relieving gastrointestinal symptoms and was associated with a
lower score on all of the eight scales (mean, 0.92; 95% confidence interval (CI), 0.52 to 1.30) ( p < 0.001) (Fig. 1). Twenty (69%) of the 29 patients reported generally less symptoms while taking ispaghula, compared with 7 (24%) who felt better with placebo ( p < 0.001). Addressing the possibility of a carry-over effect, analysis of outcome disclosed no difference in scores between the patients starting with ispaghula and those starting with placebo (Fig. 2). Ispaghula and placebo versus base line Treatment with ispaghula and, to a lesser extent, placebo both led to improvement of the symptoms reported at base line (Fig. 1). During ispaghula treatment scores decreased a mean of 1.90(95% CI,0.86to2.99) ( p < O.OOl),compared with 0.99 (95% CI, 0.42 to 1.52) ( p < 0.001) for placebo. At base line the patients reported 5.9 (SEM, 0.20) symptoms (out of possibly eight). This number was reduced during both treatments, by 26% during the ispaghula period to 4.3 (SEM, 0.39) ( p < 0.001), and by 16% during placebo to 5.0 (SEM, 0.36) ( p < 0.05), with no significant difference seen between ispaghula and placebo. Throughout the study only minor new symptoms occurred, at similar rates during both test periods. DISCUSSION Patients with ulcerative colitis have traditionally been told to keep their dietary fibre intake low, to reduce mechanical irritation of their damaged mucosa and possibly lessen the risk of colitis relapse. This idea has apparently lost much of its early appeal, since today few would implicate dietary fibre as a cause of colitis relapse (3). This is corroborated by the results of the present study and the vast experience of others (4) using various high-fibre diets in the preparation for colonoscopy . Indeed, in a recent analysis of factors predicting colitis relapse, Leo et al. ( 5 ) reported a low-fibre diet to be one main factor associated with a high risk of relapse, besides a history of numerous
>
10
Ispaghula in Ulcerative Colitis
0Pre-study
lspaghula
749
Placebo
9
4
Downloaded by [Australian National University] at 12:27 08 November 2015
3 2 1 A dominal C arrhoea pain
Loose stools
Urgency -~
Bloating IncomDlete - evacuation
h c u s Constipation
Fig. 1. Gastrointestinal symptoms in 29 colitis patients, as scored on the questionnaire at base line and after 2 months of taking ispaghula or placebo.
relapses and the presence of extraintestinal manifestations. We found ispaghula to be superior to placebo in relieving gastrointestinal symptoms in colitis patients in remission. The favourable response to ispaghula could be explained by its alleged impact on gastrointestinal motility; indeed, in keeping with the observation of Rao et al. (6) of proximal constipation and distal irritability as basic features
"n
"i
8
8
7
Pre-study
of the colonic motility in ulcerative colitis, the response was found to be most prominent on the items 'diarrhoea' and 'constipation'. The questionnaire having several items in common with current criteria for the irritable bowel syndrome (7) may raise the question of coexisting irritable bowel syndrome in our patients. With regard to this point, we failed to obtain conclusive details of an early bowel habit existing
Placebo
lspaghula
Pre-study
lspaghula
Placebo
Fig. 2. Changes in the mean of the eight usual analogue scores ('global score') in patients starting with placebo (n = 13) (left) and patients starting with ispaghula (n = 16) (right).
Downloaded by [Australian National University] at 12:27 08 November 2015
750
C.Hallert et al.
before the colitis but still regard the idea as untenable in view of the inherent difficulties in distinguishing the two conditions on the basis of symptoms alone (6). We were careful to use a brand of ispaghula husk free of lactose and with a high bulking capacity, yet producing little gas on incubation (8). It proved to be well tolerated in patients of all ages irrespective of duration and extent of disease, raising doubts about the suggestion that patients with total colitis are particularly prone to show intolerance towards unabsorbed carbohydrates (9). Some patients continued to take ispaghula at an even higher dosage than recommended during the trial, which would imply that in colitis patients the daily dosage range is yet to be determined. Our study shows that ispaghula is efficient and safe in alleviating gastrointestinal symptoms in quiescent colitis. We found a greater number of patients improving with ispaghula than with placebo, suggesting a role for ispaghula in the routine management of colitis patients. This is not contradicted by the observation of Friedman et al. (10) of its protective effects on the colonic epithelial cells of high-risk patients. ACKNOWLEDGEMENTS We are grateful to Ass. Prof. Hans Reichard and Received 12 November 1990 Accepted 7 March 1991
Dr. Alice Engqvist for recruiting colitis patients and to Mrs. Ulla Andersson and Mrs. Monica Boman-Galiamoutsa for assisting in the study. REFERENCES
1. Isgar B, Harman M, Kaye MD, Whorwell PJ. Symptoms of irritable bowel syndrome in ulcerative colitis in remission. Gut 1983,24, 190-192 2. Bayless TM, Harris ML. Inflammatory bowel disease and irritable bowel syndrome. Med Clin North Am 1990,74,21-28 3. Blumberg RS. Relapse of chronic inflammatory bowel disease. Gastroenterology 1990,98,792-796 4. Crondstedt J, Andersson M, Jonsson B, The11 I. Addition of wheat fibre to a normal diet in preparation for colonoscopy. Scand J Gastroenterol 1983, 18(suppl 86), 13 5. Leo S , Leandro G , Di Matteo G, et al. Ulcerative colitis in remission: is it possible to predict the risk of relapse? Digestion 1989,44,217-221 6. Manning AP,Thompson WG, Heaton KW, Morris AF. Towards positive diagnosis of the irritable colon. Br Med J 1978,2,653-654 7. Rao SSC, Holdsworth CD, Read NW. Symptoms and stool patterns in patients with ulcerative colitis. Gut 1988,29, 342-345 8. Tomlin J. Which fibre is the best for the colon? Scand J Gastroenteroll987,22(suppl129), 100-104 9. Rao SSC, Read NW, Holdsworth CD. Is the diarrhea in ulcerative colitis related to impaired colonic salvage of carbohydrates? Gut 1987, 28, 1090-1094 10.Friedman E, Lightdale C, Winawer S. Effects of psyllium fiber and short-chain organic acids derived from fiber breakdown on the colonic epithelial cells from high-risk patients. Cancer Lett 1988,43,121124
ISSN: 0036-5521 (Print) 1502-7708 (Online) Journal homepage: http://www.tandfonline.com/loi/igas20
Ispaghula Husk May Relieve Gastrointestinal Symptoms in Ulcerative Colitis in Remission C. Hallert, M. Kaldma & B. G. Petersson To cite this article: C. Hallert, M. Kaldma & B. G. Petersson (1991) Ispaghula Husk May Relieve Gastrointestinal Symptoms in Ulcerative Colitis in Remission, Scandinavian Journal of Gastroenterology, 26:7, 747-750 To link to this article: http://dx.doi.org/10.3109/00365529108998594
Published online: 08 Jul 2009.
Submit your article to this journal
Article views: 40
View related articles
Citing articles: 3 View citing articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=igas20 Download by: [Australian National University]
Date: 08 November 2015, At: 12:27
Ispaghula Husk May Relieve Gastrointestinal Symptoms in Ulcerative Colitis in Remission C. HALLERT, M. KALDMA & B.-G. PETERSSON Dept. of Internal Medicine, Central Hospital, Norrkoping, and Dept. of Surgery, Central Hospital, Vaxjo, Sweden
Downloaded by [Australian National University] at 12:27 08 November 2015
Hallert C, Kaldma M, Petersson B-G. Ispaghula husk may relieve gastrointestinal symptoms in ulcerative colitis in remission. Scand J Gastroenterol1991,26,747-750 The efficiency of ispaghula husk in relieving gastrointestinal symptoms in patients with ulcerative colitis in remission was studied in a placebo-controlled trial running for 4 months. Twenty-nine patients (81%) completed the trial; four withdrew after colitis relapse (three while receiving placebo).Grading of symptoms judged ispaghula to be consistently superior to placebo ( p < 0.001) and associated with a significantly higher rate of improvement (69%) than placebo (24%) ( p < 0.001). The results show that ispaghula can be helpful in the management of gastrointestinal symptoms in quiescent ulcerative colitis. Key words: Dietary fibre; ispaghula; ulcerative colitis Claes Hallert, M. D . , Dept. of Internal Medicine, Central Hospital, S-601 82 Norrkoping, Sweden
It is not unusual for patients with ulcerative colitis in remission to complain of disturbances in bowel habit. The exact diagnosis is usually difficult to establish, and many patients may have their symptoms erroneously attributed to the colitis. Isgar et al. (1) analysed the symptom pattern in a series of such patients and found evidence of a predominant motility disturbance similar to the irritable bowel syndrome. Since treatment can be a problem (2), their observation prompted us to carry out a placebo-controlled study of ispaghula husk in a series of such patients. PATIENTS AND METHODS We invited adult patients with ulcerative colitis in remission, on questioning reporting complaints of disturbance in bowel habit. The study was designed as a double-blind, placebo-controlled, crossover trial preceded by a 2-week screening period with placebo. The two test periods ran for 2 months each, and the patients were randomly assigned to take ispaghula or placebo, while continuing their regular medication. For evaluation, a questionnaire was admin-
istered after the screening period and at the end of each test period. It comprised eight items, intended to reflect last week’s abdominal pain, diarrhoea, loose stools when pain present, urgency when pain present, bloating, incomplete evacuation, mucus discharge, and constipation, all graded by scoring on 10-point visual analogue scales. To be included, the patients had to report at least three of these eight symptoms at the end of the screening period. Thirty-six patients (22 women) with histologically proved ulcerative colitis (duration, 11 years; range, 1-28 years) were recruited among 76 patients screened at three outpatient clinics in southeast Sweden (Vaxjo (surgery), Norrkoping, and South Hospital, Stockholm (internal medicine)) over a 6-month period. The mean age was 43 years (20-75 years). As assessed by radiology and sigmoidoscopy , 14 patients had total colitis, 14 distal colitis, and 8 proctitis. At entry all were judged to be in remission clinically and sigmoidoscopically. Twenty-five patients were receiving medication regularly, mostly sulphasalazine (70%). The patients were randomized to treatment
Downloaded by [Australian National University] at 12:27 08 November 2015
148
C. Hallert et al.
with either flavoured lactose-free ispaghula husk (Vi-Siblin@S granules, Parke-Davis) or placebo (crushed crispbread with low content (17.3%) of non-gel-forming dietary fibre). A dose of one sachet of Vi-Siblin S (4g rough granules containing 3.52 g testa ispaghula, 88% gel-forming dietary fibre) or placebo twice daily was recommended. The test protocol allowed patients who were feeling worse during either test period to be switched to the next period or to leave the trial. Patients were excluded when showing signs of acute colitis, difficulties in swallowing, mental instability, or unwillingness to participate or when requiring change in their ongoing medication. The results were analysed on an explanatory basis taking into account only patients who were eligible and complied with the protocol. If a patient withdrew from the study, the last available data were used in the final analysis. The significance tests were done two-sided and were carried out at the 5% level. The statistical calculations were done with the Student’s paired t test. Comparisons of proportions were done with the Yates correction. The study was approved by the local ethics committee. RESULTS Ispaghula was well tolerated, safe, and superior to placebo in alleviating the gastrointestinal symptoms of the colitis patients. Twenty-nine patients (81%) completed the trial. Four felt worse during their last test period (all while taking placebo) and terminated sooner than intended. There were seven dropouts (19%) before the first assessment. Four patients withdrew after colitis relapse (three while taking placebo and one while taking ispaghula), one because of increased abdominal pain (placebo), and two patients because of non-compliance. Ispaghula versus placebo Treatment with ispaghula was consistently more efficient than placebo in relieving gastrointestinal symptoms and was associated with a
lower score on all of the eight scales (mean, 0.92; 95% confidence interval (CI), 0.52 to 1.30) ( p < 0.001) (Fig. 1). Twenty (69%) of the 29 patients reported generally less symptoms while taking ispaghula, compared with 7 (24%) who felt better with placebo ( p < 0.001). Addressing the possibility of a carry-over effect, analysis of outcome disclosed no difference in scores between the patients starting with ispaghula and those starting with placebo (Fig. 2). Ispaghula and placebo versus base line Treatment with ispaghula and, to a lesser extent, placebo both led to improvement of the symptoms reported at base line (Fig. 1). During ispaghula treatment scores decreased a mean of 1.90(95% CI,0.86to2.99) ( p < O.OOl),compared with 0.99 (95% CI, 0.42 to 1.52) ( p < 0.001) for placebo. At base line the patients reported 5.9 (SEM, 0.20) symptoms (out of possibly eight). This number was reduced during both treatments, by 26% during the ispaghula period to 4.3 (SEM, 0.39) ( p < 0.001), and by 16% during placebo to 5.0 (SEM, 0.36) ( p < 0.05), with no significant difference seen between ispaghula and placebo. Throughout the study only minor new symptoms occurred, at similar rates during both test periods. DISCUSSION Patients with ulcerative colitis have traditionally been told to keep their dietary fibre intake low, to reduce mechanical irritation of their damaged mucosa and possibly lessen the risk of colitis relapse. This idea has apparently lost much of its early appeal, since today few would implicate dietary fibre as a cause of colitis relapse (3). This is corroborated by the results of the present study and the vast experience of others (4) using various high-fibre diets in the preparation for colonoscopy . Indeed, in a recent analysis of factors predicting colitis relapse, Leo et al. ( 5 ) reported a low-fibre diet to be one main factor associated with a high risk of relapse, besides a history of numerous
>
10
Ispaghula in Ulcerative Colitis
0Pre-study
lspaghula
749
Placebo
9
4
Downloaded by [Australian National University] at 12:27 08 November 2015
3 2 1 A dominal C arrhoea pain
Loose stools
Urgency -~
Bloating IncomDlete - evacuation
h c u s Constipation
Fig. 1. Gastrointestinal symptoms in 29 colitis patients, as scored on the questionnaire at base line and after 2 months of taking ispaghula or placebo.
relapses and the presence of extraintestinal manifestations. We found ispaghula to be superior to placebo in relieving gastrointestinal symptoms in colitis patients in remission. The favourable response to ispaghula could be explained by its alleged impact on gastrointestinal motility; indeed, in keeping with the observation of Rao et al. (6) of proximal constipation and distal irritability as basic features
"n
"i
8
8
7
Pre-study
of the colonic motility in ulcerative colitis, the response was found to be most prominent on the items 'diarrhoea' and 'constipation'. The questionnaire having several items in common with current criteria for the irritable bowel syndrome (7) may raise the question of coexisting irritable bowel syndrome in our patients. With regard to this point, we failed to obtain conclusive details of an early bowel habit existing
Placebo
lspaghula
Pre-study
lspaghula
Placebo
Fig. 2. Changes in the mean of the eight usual analogue scores ('global score') in patients starting with placebo (n = 13) (left) and patients starting with ispaghula (n = 16) (right).
Downloaded by [Australian National University] at 12:27 08 November 2015
750
C.Hallert et al.
before the colitis but still regard the idea as untenable in view of the inherent difficulties in distinguishing the two conditions on the basis of symptoms alone (6). We were careful to use a brand of ispaghula husk free of lactose and with a high bulking capacity, yet producing little gas on incubation (8). It proved to be well tolerated in patients of all ages irrespective of duration and extent of disease, raising doubts about the suggestion that patients with total colitis are particularly prone to show intolerance towards unabsorbed carbohydrates (9). Some patients continued to take ispaghula at an even higher dosage than recommended during the trial, which would imply that in colitis patients the daily dosage range is yet to be determined. Our study shows that ispaghula is efficient and safe in alleviating gastrointestinal symptoms in quiescent colitis. We found a greater number of patients improving with ispaghula than with placebo, suggesting a role for ispaghula in the routine management of colitis patients. This is not contradicted by the observation of Friedman et al. (10) of its protective effects on the colonic epithelial cells of high-risk patients. ACKNOWLEDGEMENTS We are grateful to Ass. Prof. Hans Reichard and Received 12 November 1990 Accepted 7 March 1991
Dr. Alice Engqvist for recruiting colitis patients and to Mrs. Ulla Andersson and Mrs. Monica Boman-Galiamoutsa for assisting in the study. REFERENCES
1. Isgar B, Harman M, Kaye MD, Whorwell PJ. Symptoms of irritable bowel syndrome in ulcerative colitis in remission. Gut 1983,24, 190-192 2. Bayless TM, Harris ML. Inflammatory bowel disease and irritable bowel syndrome. Med Clin North Am 1990,74,21-28 3. Blumberg RS. Relapse of chronic inflammatory bowel disease. Gastroenterology 1990,98,792-796 4. Crondstedt J, Andersson M, Jonsson B, The11 I. Addition of wheat fibre to a normal diet in preparation for colonoscopy. Scand J Gastroenterol 1983, 18(suppl 86), 13 5. Leo S , Leandro G , Di Matteo G, et al. Ulcerative colitis in remission: is it possible to predict the risk of relapse? Digestion 1989,44,217-221 6. Manning AP,Thompson WG, Heaton KW, Morris AF. Towards positive diagnosis of the irritable colon. Br Med J 1978,2,653-654 7. Rao SSC, Holdsworth CD, Read NW. Symptoms and stool patterns in patients with ulcerative colitis. Gut 1988,29, 342-345 8. Tomlin J. Which fibre is the best for the colon? Scand J Gastroenteroll987,22(suppl129), 100-104 9. Rao SSC, Read NW, Holdsworth CD. Is the diarrhea in ulcerative colitis related to impaired colonic salvage of carbohydrates? Gut 1987, 28, 1090-1094 10.Friedman E, Lightdale C, Winawer S. Effects of psyllium fiber and short-chain organic acids derived from fiber breakdown on the colonic epithelial cells from high-risk patients. Cancer Lett 1988,43,121124
