Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial
Background. The association of oral 5-aminosalicylic acid (mesalazine) and enema is effective in treatment of mild-moderate forms of ulcerative colitis. However, no study has been aimed at determining optimal duration of this association in active ulcerative colitis. Aim. To determine whether longer...
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| creator | Paoluzi, P. D'Albasio, G. Pera, A. Porro, G.Bianchi Paoluzi, O.A. Pica, R. Cottone, M. Miglioli, M. Prantera, C. Sturniolo, G. Ardizzone, S. |
| description | Background. The association of oral 5-aminosalicylic acid (mesalazine) and enema is effective in treatment of mild-moderate forms of ulcerative colitis. However, no study has been aimed at determining optimal duration of this association in active ulcerative colitis.
Aim. To determine whether longer duration of therapy: 1. increases the rate of patients achieving remission, and 2. reduces relapse rate during the maintenance period in patients in remission.
Patients and methods. A total of 149 patients, (89 male, 60 female), were randomly assigned to a regimen with 5-aminosalicylic acid tablets 2.4 g/day associated with 5-aminosalycilic enema 2 g/day for a 4-week (n=73) or 8-week regimen (n=76). After this acute therapy, patients were submitted to clinical, endoscopic and histological examinations and those in remission were assigned to a follow-up (maintenance) period with oral mesalazine alone at a dosage of 1.2 g/day. A clinical visit, including laboratory tests, at 6 months and an endoscopic-histological control at 12 months were carried out to exclude symptoms and endoscopic-histological signs of activity. Relapse of disease, i. e., presence of clinical symptoms or abnormal laboratory tests, was confirmed by endoscopy and histology.
Results. At end of acute phase, clinical, endoscopic and histological remission was comparable in the two groups: 42/76 (55%), in the 4-week, and 47/73 patients (64%), in the 8-week regimen. No difference was found stratifying patients according to extension of disease. Of these 89 patients in remission, 75 (34 from 4-week regimen; 41 from 8-week regimen) completed 12 months' follow-up. At end of follow-up, a similar percentage of patients in the 4-week regimen (50%) and 8-week regimen (51 %) were still in remission. No significant difference between cumulative relapse rates of the two groups was found. Stratifying patients according to extension of disease, in the 8-week regimen group, those with left-sided colitis showed a higher remission rate than that of patients with diffuse colitis (66% versus 35%, p |
| doi_str_mv | 10.1016/S1590-8658(02)80072-X |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_72832545</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S159086580280072X</els_id><sourcerecordid>72832545</sourcerecordid><originalsourceid>FETCH-LOGICAL-c363t-da8905b2e6c198df952ba4768b308572e65180323a162ec6504a9906dba867823</originalsourceid><addsrcrecordid>eNqFUU2PFCEQJUbjrqs_QcPJ7B5agR5o2osxG7-STfagJnsjNNSYMjSMQG8y_in_ovTMGI8mVCiK915BPUKec_aKM65ef-FyZJ1WUl8ycaUZG0R394Cccz3orpdKPGz5X8gZeVLKD8YEV5I9JmdcyI2SfHNOft9mG6iNnta0Q9dy2dkZYyo2oNu3oNahp5cztIr9hRGuKMa2_OIwfj9QZ4uxtljPGWYsBdMKoTMG383JQ7YV2lWwuwI0bekS3FrDe6AuBaxY3tAUoduDzTQ3zdRUoCkvoaKDWDPQmtGGp-TR1oYCz077Bfn24f3X60_dze3Hz9fvbjrXq7523uqRyUmAcnzUfjtKMdnNoPTUMy2HVpdcs170lisBrk1lY8eRKT9ZrQYt-gvy8qi7y-nnAqWa9iAHIdgIaSlmELpvQ5QNKI9Al1MpGbZml3G2eW84M6tT5uCUWW0wTJiDU-au8V6cGizTDP4f62RNA7w9AqB98x4hm-IQogOPGVw1PuF_WvwBC3qmkw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>72832545</pqid></control><display><type>article</type><title>Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><creator>Paoluzi, P. ; D'Albasio, G. ; Pera, A. ; Porro, G.Bianchi ; Paoluzi, O.A. ; Pica, R. ; Cottone, M. ; Miglioli, M. ; Prantera, C. ; Sturniolo, G. ; Ardizzone, S.</creator><creatorcontrib>Paoluzi, P. ; D'Albasio, G. ; Pera, A. ; Porro, G.Bianchi ; Paoluzi, O.A. ; Pica, R. ; Cottone, M. ; Miglioli, M. ; Prantera, C. ; Sturniolo, G. ; Ardizzone, S.</creatorcontrib><description>Background. The association of oral 5-aminosalicylic acid (mesalazine) and enema is effective in treatment of mild-moderate forms of ulcerative colitis. However, no study has been aimed at determining optimal duration of this association in active ulcerative colitis.
Aim. To determine whether longer duration of therapy: 1. increases the rate of patients achieving remission, and 2. reduces relapse rate during the maintenance period in patients in remission.
Patients and methods. A total of 149 patients, (89 male, 60 female), were randomly assigned to a regimen with 5-aminosalicylic acid tablets 2.4 g/day associated with 5-aminosalycilic enema 2 g/day for a 4-week (n=73) or 8-week regimen (n=76). After this acute therapy, patients were submitted to clinical, endoscopic and histological examinations and those in remission were assigned to a follow-up (maintenance) period with oral mesalazine alone at a dosage of 1.2 g/day. A clinical visit, including laboratory tests, at 6 months and an endoscopic-histological control at 12 months were carried out to exclude symptoms and endoscopic-histological signs of activity. Relapse of disease, i. e., presence of clinical symptoms or abnormal laboratory tests, was confirmed by endoscopy and histology.
Results. At end of acute phase, clinical, endoscopic and histological remission was comparable in the two groups: 42/76 (55%), in the 4-week, and 47/73 patients (64%), in the 8-week regimen. No difference was found stratifying patients according to extension of disease. Of these 89 patients in remission, 75 (34 from 4-week regimen; 41 from 8-week regimen) completed 12 months' follow-up. At end of follow-up, a similar percentage of patients in the 4-week regimen (50%) and 8-week regimen (51 %) were still in remission. No significant difference between cumulative relapse rates of the two groups was found. Stratifying patients according to extension of disease, in the 8-week regimen group, those with left-sided colitis showed a higher remission rate than that of patients with diffuse colitis (66% versus 35%, p<0.05). All regimens were well tolerated by most patients during the entire study period.
Conclusions. An additional 4 weeks of topical treatment does not increase the remission rate in patients with mild-moderate active ulcerative colitis but seems to reduce the probability of relapse in patients with left-sided colitis.</description><identifier>ISSN: 1590-8658</identifier><identifier>EISSN: 1878-3562</identifier><identifier>DOI: 10.1016/S1590-8658(02)80072-X</identifier><identifier>PMID: 12546514</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>5-aminosalicylic acid ; 5-ASA ; Administration, Oral ; Administration, Topical ; Adult ; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage ; Colitis, Ulcerative - diagnosis ; Colitis, Ulcerative - drug therapy ; Colitis, Ulcerative - prevention & control ; Colonoscopy ; Enema ; Female ; Humans ; Male ; Mesalamine - administration & dosage ; mesalazine ; Middle Aged ; Remission Induction ; Secondary Prevention ; Time Factors ; Treatment Outcome ; ulcerative colitis</subject><ispartof>Digestive and liver disease, 2002-11, Vol.34 (11), p.787-793</ispartof><rights>2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c363t-da8905b2e6c198df952ba4768b308572e65180323a162ec6504a9906dba867823</citedby><cites>FETCH-LOGICAL-c363t-da8905b2e6c198df952ba4768b308572e65180323a162ec6504a9906dba867823</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S1590-8658(02)80072-X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27922,27923,45993</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12546514$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Paoluzi, P.</creatorcontrib><creatorcontrib>D'Albasio, G.</creatorcontrib><creatorcontrib>Pera, A.</creatorcontrib><creatorcontrib>Porro, G.Bianchi</creatorcontrib><creatorcontrib>Paoluzi, O.A.</creatorcontrib><creatorcontrib>Pica, R.</creatorcontrib><creatorcontrib>Cottone, M.</creatorcontrib><creatorcontrib>Miglioli, M.</creatorcontrib><creatorcontrib>Prantera, C.</creatorcontrib><creatorcontrib>Sturniolo, G.</creatorcontrib><creatorcontrib>Ardizzone, S.</creatorcontrib><title>Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial</title><title>Digestive and liver disease</title><addtitle>Dig Liver Dis</addtitle><description>Background. The association of oral 5-aminosalicylic acid (mesalazine) and enema is effective in treatment of mild-moderate forms of ulcerative colitis. However, no study has been aimed at determining optimal duration of this association in active ulcerative colitis.
Aim. To determine whether longer duration of therapy: 1. increases the rate of patients achieving remission, and 2. reduces relapse rate during the maintenance period in patients in remission.
Patients and methods. A total of 149 patients, (89 male, 60 female), were randomly assigned to a regimen with 5-aminosalicylic acid tablets 2.4 g/day associated with 5-aminosalycilic enema 2 g/day for a 4-week (n=73) or 8-week regimen (n=76). After this acute therapy, patients were submitted to clinical, endoscopic and histological examinations and those in remission were assigned to a follow-up (maintenance) period with oral mesalazine alone at a dosage of 1.2 g/day. A clinical visit, including laboratory tests, at 6 months and an endoscopic-histological control at 12 months were carried out to exclude symptoms and endoscopic-histological signs of activity. Relapse of disease, i. e., presence of clinical symptoms or abnormal laboratory tests, was confirmed by endoscopy and histology.
Results. At end of acute phase, clinical, endoscopic and histological remission was comparable in the two groups: 42/76 (55%), in the 4-week, and 47/73 patients (64%), in the 8-week regimen. No difference was found stratifying patients according to extension of disease. Of these 89 patients in remission, 75 (34 from 4-week regimen; 41 from 8-week regimen) completed 12 months' follow-up. At end of follow-up, a similar percentage of patients in the 4-week regimen (50%) and 8-week regimen (51 %) were still in remission. No significant difference between cumulative relapse rates of the two groups was found. Stratifying patients according to extension of disease, in the 8-week regimen group, those with left-sided colitis showed a higher remission rate than that of patients with diffuse colitis (66% versus 35%, p<0.05). All regimens were well tolerated by most patients during the entire study period.
Conclusions. An additional 4 weeks of topical treatment does not increase the remission rate in patients with mild-moderate active ulcerative colitis but seems to reduce the probability of relapse in patients with left-sided colitis.</description><subject>5-aminosalicylic acid</subject><subject>5-ASA</subject><subject>Administration, Oral</subject><subject>Administration, Topical</subject><subject>Adult</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</subject><subject>Colitis, Ulcerative - diagnosis</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Colitis, Ulcerative - prevention & control</subject><subject>Colonoscopy</subject><subject>Enema</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Mesalamine - administration & dosage</subject><subject>mesalazine</subject><subject>Middle Aged</subject><subject>Remission Induction</subject><subject>Secondary Prevention</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>ulcerative colitis</subject><issn>1590-8658</issn><issn>1878-3562</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUU2PFCEQJUbjrqs_QcPJ7B5agR5o2osxG7-STfagJnsjNNSYMjSMQG8y_in_ovTMGI8mVCiK915BPUKec_aKM65ef-FyZJ1WUl8ycaUZG0R394Cccz3orpdKPGz5X8gZeVLKD8YEV5I9JmdcyI2SfHNOft9mG6iNnta0Q9dy2dkZYyo2oNu3oNahp5cztIr9hRGuKMa2_OIwfj9QZ4uxtljPGWYsBdMKoTMG383JQ7YV2lWwuwI0bekS3FrDe6AuBaxY3tAUoduDzTQ3zdRUoCkvoaKDWDPQmtGGp-TR1oYCz077Bfn24f3X60_dze3Hz9fvbjrXq7523uqRyUmAcnzUfjtKMdnNoPTUMy2HVpdcs170lisBrk1lY8eRKT9ZrQYt-gvy8qi7y-nnAqWa9iAHIdgIaSlmELpvQ5QNKI9Al1MpGbZml3G2eW84M6tT5uCUWW0wTJiDU-au8V6cGizTDP4f62RNA7w9AqB98x4hm-IQogOPGVw1PuF_WvwBC3qmkw</recordid><startdate>20021101</startdate><enddate>20021101</enddate><creator>Paoluzi, P.</creator><creator>D'Albasio, G.</creator><creator>Pera, A.</creator><creator>Porro, G.Bianchi</creator><creator>Paoluzi, O.A.</creator><creator>Pica, R.</creator><creator>Cottone, M.</creator><creator>Miglioli, M.</creator><creator>Prantera, C.</creator><creator>Sturniolo, G.</creator><creator>Ardizzone, S.</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20021101</creationdate><title>Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial</title><author>Paoluzi, P. ; D'Albasio, G. ; Pera, A. ; Porro, G.Bianchi ; Paoluzi, O.A. ; Pica, R. ; Cottone, M. ; Miglioli, M. ; Prantera, C. ; Sturniolo, G. ; Ardizzone, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c363t-da8905b2e6c198df952ba4768b308572e65180323a162ec6504a9906dba867823</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>5-aminosalicylic acid</topic><topic>5-ASA</topic><topic>Administration, Oral</topic><topic>Administration, Topical</topic><topic>Adult</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</topic><topic>Colitis, Ulcerative - diagnosis</topic><topic>Colitis, Ulcerative - drug therapy</topic><topic>Colitis, Ulcerative - prevention & control</topic><topic>Colonoscopy</topic><topic>Enema</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Mesalamine - administration & dosage</topic><topic>mesalazine</topic><topic>Middle Aged</topic><topic>Remission Induction</topic><topic>Secondary Prevention</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>ulcerative colitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Paoluzi, P.</creatorcontrib><creatorcontrib>D'Albasio, G.</creatorcontrib><creatorcontrib>Pera, A.</creatorcontrib><creatorcontrib>Porro, G.Bianchi</creatorcontrib><creatorcontrib>Paoluzi, O.A.</creatorcontrib><creatorcontrib>Pica, R.</creatorcontrib><creatorcontrib>Cottone, M.</creatorcontrib><creatorcontrib>Miglioli, M.</creatorcontrib><creatorcontrib>Prantera, C.</creatorcontrib><creatorcontrib>Sturniolo, G.</creatorcontrib><creatorcontrib>Ardizzone, S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Digestive and liver disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Paoluzi, P.</au><au>D'Albasio, G.</au><au>Pera, A.</au><au>Porro, G.Bianchi</au><au>Paoluzi, O.A.</au><au>Pica, R.</au><au>Cottone, M.</au><au>Miglioli, M.</au><au>Prantera, C.</au><au>Sturniolo, G.</au><au>Ardizzone, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial</atitle><jtitle>Digestive and liver disease</jtitle><addtitle>Dig Liver Dis</addtitle><date>2002-11-01</date><risdate>2002</risdate><volume>34</volume><issue>11</issue><spage>787</spage><epage>793</epage><pages>787-793</pages><issn>1590-8658</issn><eissn>1878-3562</eissn><abstract>Background. The association of oral 5-aminosalicylic acid (mesalazine) and enema is effective in treatment of mild-moderate forms of ulcerative colitis. However, no study has been aimed at determining optimal duration of this association in active ulcerative colitis.
Aim. To determine whether longer duration of therapy: 1. increases the rate of patients achieving remission, and 2. reduces relapse rate during the maintenance period in patients in remission.
Patients and methods. A total of 149 patients, (89 male, 60 female), were randomly assigned to a regimen with 5-aminosalicylic acid tablets 2.4 g/day associated with 5-aminosalycilic enema 2 g/day for a 4-week (n=73) or 8-week regimen (n=76). After this acute therapy, patients were submitted to clinical, endoscopic and histological examinations and those in remission were assigned to a follow-up (maintenance) period with oral mesalazine alone at a dosage of 1.2 g/day. A clinical visit, including laboratory tests, at 6 months and an endoscopic-histological control at 12 months were carried out to exclude symptoms and endoscopic-histological signs of activity. Relapse of disease, i. e., presence of clinical symptoms or abnormal laboratory tests, was confirmed by endoscopy and histology.
Results. At end of acute phase, clinical, endoscopic and histological remission was comparable in the two groups: 42/76 (55%), in the 4-week, and 47/73 patients (64%), in the 8-week regimen. No difference was found stratifying patients according to extension of disease. Of these 89 patients in remission, 75 (34 from 4-week regimen; 41 from 8-week regimen) completed 12 months' follow-up. At end of follow-up, a similar percentage of patients in the 4-week regimen (50%) and 8-week regimen (51 %) were still in remission. No significant difference between cumulative relapse rates of the two groups was found. Stratifying patients according to extension of disease, in the 8-week regimen group, those with left-sided colitis showed a higher remission rate than that of patients with diffuse colitis (66% versus 35%, p<0.05). All regimens were well tolerated by most patients during the entire study period.
Conclusions. An additional 4 weeks of topical treatment does not increase the remission rate in patients with mild-moderate active ulcerative colitis but seems to reduce the probability of relapse in patients with left-sided colitis.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>12546514</pmid><doi>10.1016/S1590-8658(02)80072-X</doi><tpages>7</tpages></addata></record> |
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| ispartof | Digestive and liver disease, 2002-11, Vol.34 (11), p.787-793 |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | 5-aminosalicylic acid 5-ASA Administration, Oral Administration, Topical Adult Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Colitis, Ulcerative - diagnosis Colitis, Ulcerative - drug therapy Colitis, Ulcerative - prevention & control Colonoscopy Enema Female Humans Male Mesalamine - administration & dosage mesalazine Middle Aged Remission Induction Secondary Prevention Time Factors Treatment Outcome ulcerative colitis |
| title | Oral and topical 5-aminosalicylic acid (mesalazine) in inducing and maintaining remission in mild-moderate relapse of ulcerative colitis: one-year randomised multicentre trial |
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