{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T10:16:26Z","timestamp":1788257786282,"version":"build-2803163510"},"reference-count":7,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2018,8,9]],"date-time":"2018-08-09T00:00:00Z","timestamp":1533772800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hepatology Research"],"published-print":{"date-parts":[[2018,12]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>A novel jelly lactulose preparation (SK\u20101202) has been developed to improve compliance and reduce the elevation of blood glucose levels in diabetic patients. To compare the equivalence in the efficacy and safety of SK\u20101202 and an approved commercially available syrup preparation, we undertook a randomized multicenter cross\u2010over study in hyperammonemia patients with liver cirrhosis who were taking lactulose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Forty\u2010four patients were enrolled and took each preparation for 2\u00a0weeks. Efficacy was evaluated using the Number Connection Test, blood ammonia concentration, coma grade, and the flapping tremor grade. Safety was evaluated by the number of adverse events observed, vital signs, and laboratory tests. We also examined the acceptability of each preparation using questionnaires evaluating sweetness, aftertaste, ease of use, and preference of the preparations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were no differences in efficacy or safety between SK\u20101202 and the approved syrup preparation. With regard to the acceptability evaluation, given over 80% of the participants chose the SK\u20101202 preparation, it appears to be preferred by patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>It is expected that SK\u20101202 could represent a useful agent for patients with hepatic encephalopathy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hepr.13228","type":"journal-article","created":{"date-parts":[[2018,7,13]],"date-time":"2018-07-13T23:59:29Z","timestamp":1531526369000},"page":"1178-1183","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Cross\u2010over study in hyperammonemia patients for efficacy, safety, and acceptability of a new lactulose preparation (SK\u20101202) compared to approved drug"],"prefix":"10.1111","volume":"48","author":[{"given":"Hitoshi","family":"Yoshiji","sequence":"first","affiliation":[{"name":"Third Department of Internal Medicine Nara Medical University  Kashihara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyasu","family":"Karino","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Sapporo\u2010Kosei General Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyuki","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Hepatology Toranomon Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumitaka","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Hepatology Toranomon Hospital Kajigaya  Kawasaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Uejima","sequence":"additional","affiliation":[{"name":"Third Department of Internal Medicine Nara Medical University  Kashihara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Aikata","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Metabolism Hiroshima University  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuaki","family":"Chayama","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Metabolism Hiroshima University  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisakazu","family":"Iwai","sequence":"additional","affiliation":[{"name":"Sanwa Kagaku Kenkyusho Co., Ltd.  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4257-8666","authenticated-orcid":false,"given":"Eiji","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Sanwa Kagaku Kenkyusho Co., Ltd.  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromitsu","family":"Kumada","sequence":"additional","affiliation":[{"name":"Department of Hepatology Toranomon Hospital Kajigaya  Kawasaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,8,9]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/qjmed\/hcp152"},{"key":"e_1_2_6_3_1","unstructured":"NHS Choices.Lactulose. Available at:https:\/\/beta.nhs.uk\/medicines\/lactulose\/Accessed February 5 2018."},{"key":"e_1_2_6_4_1","unstructured":"American Liver Foundation.HE123 \u2013 Diagnosis Treatment and Support. Lactulose & Hepatic Encephalopathy. Available at:http:\/\/he123.liverfoundation.org\/treatment\u2010basics\/treatment\u2010medications\/lactulose\/Accessed February 5 2018."},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-016-1216-y"},{"key":"e_1_2_6_6_1","first-page":"207","article-title":"Clinical effect of lactulose on hepatic encephalopathy and hyperammonemia. Comparison with fladiomycin by double\u2010blind cross\u2010over method","volume":"24","author":"Koizumi T","year":"1975","journal-title":"J New Rem Clin"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hepres.2004.07.001"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-012-0624-x"}],"container-title":["Hepatology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhepr.13228","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hepr.13228","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,15]],"date-time":"2023-09-15T04:21:43Z","timestamp":1694751703000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hepr.13228"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8,9]]},"references-count":7,"journal-issue":{"issue":"13","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["10.1111\/hepr.13228"],"URL":"https:\/\/doi.org\/10.1111\/hepr.13228","archive":["Portico"],"relation":{},"ISSN":["1386-6346","1872-034X"],"issn-type":[{"value":"1386-6346","type":"print"},{"value":"1872-034X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8,9]]},"assertion":[{"value":"2018-05-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-07-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-09","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}