Evidence map›Paper›PMID 26585569›Full record

Trial reportBMC gastroenterology2015

An open-label prospective randomized multicenter study of intensive versus weekly granulocyte and monocyte apheresis in active crohn's disease.

Naoki Yoshimura, Yoko Yokoyama, Katsuyoshi Matsuoka, Hiroki Takahashi, Ryuichi Iwakiri, Takayuki Yamamoto, Tomoo Nakagawa, Takumi Fukuchi, Satoshi Motoya, Reiko Kunisaki and 17 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 1 country.

Naoki YoshimuraDepartment of internal medicine, Division of IBD, Tokyo Yamate Medical Centre, Tokyo, Japan. ynaokun@yahoo.co.jp.
Yoko YokoyamaDivision of Internal Medicine, Department of Inflammatory Bowel Disease, Hyogo College of Medicine, Hyogo, Japan. yoko0502@hyo-med.ac.jp.
Katsuyoshi MatsuokaDepartment of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan. matsuoka@z2.keio.jp.
Hiroki TakahashiDepartment of General Medicine, National Hospital Organization, Sendai Medical Centre, Miyagi, Japan. hiro-ki@snh.go.jp.
Ryuichi IwakiriDivision of Gastroenterology, Department of Internal Medicine, Saga Medical School, Saga, Japan. iwakiri@cc.saga-u.ac.jp.
Takayuki YamamotoInflammatory Bowel Disease Centre, Yokkaichi Hazu Medical Centre, Mie, Japan. nao-taka@sannet.ne.jp.
Tomoo NakagawaDepartment of Gastroenterology and Hepatology, Chiba University Hospital, Chiba, Japan. tom20852@yahoo.co.jp.
Takumi FukuchiDepartment of Gastroenterology and Hepatology, Osakafu Saiseikai Nakatsu Hospital, Osaka, Japan. takuleotakuleo@yahoo.co.jp.
Satoshi MotoyaIBD Center, Sapporo Kosei General Hospital, Hokkaido, Japan. sa-motoya@nifty.com.
Reiko KunisakiInflammatory Bowel Centre, Yokohama City University Medical Centre, Kanagawa, Japan. reikok@urahp.yokohama-cu.ac.jp.
Shingo KatoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Saitama Medical Centre, Saitama Medical University, Saitama, Japan. skato@saitama-med.ac.jp.
Fumihito HiraiDepartment of Gastroenterology Fukuoka University Chikushi Hospital, Fukuoka, Japan. fuhirai@yahoo.co.jp.
Yoh IshiguroDepartment of Gastroenterology and Hematology, Hirosaki National Hospital, Aomori, Japan. yishihki@gmail.com.
Satoshi TanidaDepartment of Gastroenterology and Metabolism, Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan. stanida@med.nagoya-cu.ac.jp.
Sakiko HiraokaDepartment of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan. sakikoh@cc.okayama-u.ac.jp.
Keiichi MitsuyamaDivision of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Centre, Kurume University School of Medicine, Fukuoka, Japan. ibd@med.kurume-u.ac.jp.
Shunji IshiharaDepartment of Internal Medicine II, Faculty of Medicine, Shimane University, Izumo, Japan. si360405@med.shimane-u.ac.jp.
Shinji TanakaDepartment of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan. colon@hiroshima-u.ac.jp.
Michiro OtakaDivision of Gastroenterology, Kobari General Hospital & Juntendo University, Chiba, Japan. mootaka@juntendo.ac.jp.
Taro OsadaDepartment of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan. otaro@juntendo.ac.jp.
Takashi KagayaDepartment of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan. kagaya@m-kanazawa.jp.
Yasuo SuzukiInternal Medicine, Toho University Sakura Medical Centre, Chiba, Japan. yasuo-suzuki@sakura.med.toho-u.ac.jp.
Hiroshi NakaseDepartment of Gastroenterology and Endoscopic Medicine, Kyoto University Hospital, Kyoto, Japan. hiropy_n@kuhp.kyoto-u.ac.jp.
Hiroyuki HanaiCentre for Gastroenterology and Inflammatory Bowel Disease Research, Hamamatsu South Hospital, Shizuoka, Japan. hanai@hamamatsu-minami.com.
Kenji WatanabeDepartment of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan. kenjiw@med.osaka-cu.ac.jp.
Nobuhito KashiwagiResearch division, JIMRO Co., Ltd, Gunma, Japan. kashiwagin@jimro.co.jp.
Toshifumi HibiKitasato Institute Hospital, Centre for Advanced IBD Research and Treatment, Kitasato University, 108-8642 Minato-ku, Tokyo, Japan. thibi@insti.kitasato-u.ac.jp.
Chiba University Hospital · JPFukuoka University · JPHirosaki National Hospital · JPHiroshima University Hospital · JPHyogo Medical University · JPJIMRO (Japan) · JPJuntendo University · JPKanazawa University Hospital · JPKitasato University · JPKobari General Hospital · JPKurume University · JPKyoto University Hospital · JPNagoya City University · JPOkayama University · JPOsaka City University · JPSaga Medical School Hospital · JPSaiseikai Nakatsu Hospital · JPSaitama Medical University · JPSapporo Kosei General Hospital · JPSendai Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGranulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active Crohn's disease (CD). However, with routine weekly therapy, it may take several weeks to achieve remission. This study was performed to assess clinical efficacy and safety of intensive GMA in patients with active CD.

methodsIn an open-label, prospective, randomized multicentre setting, 104 patients with CD activity index (CDAI) of 200 to 450 received intensive GMA, at two sessions per week (n = 55) or one session per week (n = 49). Clinical remission was defined as a CDAI score <150. Patients in each arm could receive up to 10 GMA sessions. However, GMA treatment could be discontinued when CDAI decreased to <150 (clinical remission level).

resultsOf the 104 patients, 99 were available for efficacy evaluation as per protocol, 45 in the weekly GMA group, and 54 in the intensive GMA group. Remission was achieved in 16 of 45 patients (35.6 %) in the weekly GMA and in 19 of 54 (35.2 %) in the intensive GMA (NS). Further, the mean time to remission was 35.4 ± 5.3 days in the weekly GMA and 21.7 ± 2.7 days in the intensive GMA (P = 0.0373). Elevated leucocytes and erythrocyte sedimentation rate were significantly improved by intensive GMA, from 8005/μL to 6950/μL (P = 0.0461) and from 54.5 mm/hr to 30.0 mm/hr (P = 0.0059), respectively. In both arms, GMA was well tolerated and was without safety concern.

conclusionsIn this study, with respect to remission rate, intensive GMA was not superior to weekly GMA, but the time to remission was significantly shorter in the former without increasing the incidence of side effects. UMIN registration # 000003666.

Indexed as

GranulocytesMonocytesAdolescentAdsorptionAdultAgedChildCrohn DiseaseFemaleHumansLeukapheresisMaleMiddle AgedProspective StudiesRemission InductionTreatment Outcome

Identifiers

PMID26585569
PMCPMC4653849
OpenAlexW2180154765

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.