{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,29]],"date-time":"2024-01-29T03:13:05Z","timestamp":1706497985697},"reference-count":30,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2019,5,30]],"date-time":"2019-05-30T00:00:00Z","timestamp":1559174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Urology"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Suplatast tosilate, a Th2 cytokine inhibitor, was predicted to relieve interstitial cystitis symptoms. Four studies with suplatast tosilate in Japanese interstitial cystitis patients have been conducted: a single\u2010arm clinical study, a phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> dose\u2010ranging trial, a phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> trial with placebo, and a second phase <jats:styled-content style=\"fixed-case\">PIII<\/jats:styled-content> trial with placebo. Treatment efficacy was observed in the first two studies; however, in the phase <jats:styled-content style=\"fixed-case\">PIII<\/jats:styled-content> trials, no significant difference in interstitial cystitis symptom score changes was observed between suplatast tosilate and placebo. We summarized these four studies to investigate factors causing the difference in observed efficacy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Placebo effects in the first two studies and differences regarding study design between the four studies were considered to be possible factors. Therefore, placebo effects were investigated by comparing interstitial cystitis symptom score changes, and the study designs were compared to investigate the effects on observed efficacy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Interstitial cystitis symptom score changes in the phase <jats:styled-content style=\"fixed-case\">PII<\/jats:styled-content> treatment groups increased in a dose\u2010dependent manner and showed an almost linear relationship with interstitial cystitis symptom score changes observed in placebo groups of 2 phase <jats:styled-content style=\"fixed-case\">PIII<\/jats:styled-content> studies. A major difference regarding the phase <jats:styled-content style=\"fixed-case\">PIII<\/jats:styled-content> study design was the use of diagnostic hydrodistention. Diagnostic hydrodistention and its washout period were applied only in the phase <jats:styled-content style=\"fixed-case\">PIII<\/jats:styled-content> trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Comparison of interstitial cystitis symptom score changes suggested that the placebo effect was very small. Use of diagnostic hydrodistention was considered to be a major difference in the population characteristics of the studies and may have resulted in different observed efficacies. Diagnostic hydrodistention, which potentially influences the treatment effect, is probably not essential for trials of suplatast in interstitial cystitis patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/iju.13968","type":"journal-article","created":{"date-parts":[[2019,5,30]],"date-time":"2019-05-30T09:22:36Z","timestamp":1559208156000},"page":"4-11","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Suplatast tosilate in patients with interstitial cystitis: Efficacy and treatment possibilities, with suggestions for future assessments"],"prefix":"10.1111","volume":"26","author":[{"given":"Tomohiro","family":"Ueda","sequence":"first","affiliation":[{"name":"International Consultation on Interstitial Cystitis Japan Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukio","family":"Homma","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Medical Center Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Yoshimura","sequence":"additional","affiliation":[{"name":"Department of Urology University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,5,30]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"1455","volume-title":"Incontinence","author":"Hanno PM","year":"2005"},{"key":"e_1_2_9_3_1","first-page":"330","volume-title":"Campbell\u2010Walsh Urology","author":"Hanno PM","year":"2006"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410X.2000.00855.x"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)65195-6"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)64075-X"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200767020-00004"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442-2042.2008.02208.x"},{"key":"e_1_2_9_9_1","unstructured":"Diagnosis and treatment of interstitial cystiitis\/bladder pain syndrome. American Urological Association (AUA) Guideline.2011."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/194589240201600609"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2007.07044.x"},{"issue":"1","key":"e_1_2_9_12_1","doi-asserted-by":"crossref","first-page":"S30","DOI":"10.1111\/j.1757-5672.2009.00044.x","article-title":"Interstitial cystitis and the therapeutic effect of suplatast tosilate","volume":"1","author":"Hayashi Y","year":"2009","journal-title":"LUTS"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2006.10.036"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(05)66917-0"},{"key":"e_1_2_9_15_1","first-page":"74","volume-title":"2nd International Consultation on Interstitial Cystitis, Japan (ICICJ)","author":"Ueda T","year":"2008"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61706-2"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1353\/pbm.0.0115"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ju.0000083020.06212.3d"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2009.09086.x"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007990903438295"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2007.05.027"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1590\/S1677-55382009000400011"},{"key":"e_1_2_9_23_1","first-page":"1049","article-title":"OAB syndrome and interstitial cystitis","volume":"16","author":"Ueda T","year":"2003","journal-title":"Hinnyoukigeka"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1442-2042.2003.00664.x"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-008-0640-9"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.20074"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1152\/physiolgenomics.00055.2003"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2006.04.033"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442-2042.2009.02326.x"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442-2042.2008.02179.x"},{"key":"e_1_2_9_31_1","unstructured":"UedaT Inventor;N.M.A. Co. Ltd. Assignee.Method of diagnosing a lower urinary tract disorder. United States patent No. 8010185.2011."}],"container-title":["International Journal of Urology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iju.13968","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/iju.13968","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iju.13968","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T21:58:24Z","timestamp":1694383104000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/iju.13968"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,5,30]]},"references-count":30,"journal-issue":{"issue":"S1","published-print":{"date-parts":[[2019,6]]}},"alternative-id":["10.1111\/iju.13968"],"URL":"https:\/\/doi.org\/10.1111\/iju.13968","archive":["Portico"],"relation":{},"ISSN":["0919-8172","1442-2042"],"issn-type":[{"value":"0919-8172","type":"print"},{"value":"1442-2042","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,5,30]]},"assertion":[{"value":"2019-03-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-03-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-05-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}