Dataset Information

Responder Analysis of Daikenchuto Treatment for Constipation in Poststroke Patients: A Subanalysis of a Randomized Control Trial.

ABSTRACT: A traditional Japanese medicine, daikenchuto (DKT), is used for treating abdominal bloating and pain with coldness. In modern medicine, it is used to treat postoperative intestinal dysfunction and ileus. We previously showed the effective improvement in functional constipation with DKT in poststroke patients. However, response prediction for the treatment has not been elucidated. We investigated the data from the prior trial (UMIN000007393) to predict the DKT treatment response. We assessed the efficacy of DKT for chronic constipation in poststroke patients. Neurogenic bowel dysfunction score (NBDS) and the Gastrointestinal Symptom Rating Scale-constipation subscale (GSRS-C) score were newly analyzed comparing the pre- and postintervention data after intake of 15 g of DKT extract granule daily for 4 weeks. Single and multiple regression analyses were performed to examine the correlations between the changes in NBDS, GSRS-C score, patient characteristics, clinical symptom score, gas volume in the gut, and serum calcitonin gene-related peptide level. The total NBDS and GSRS-C score were significantly reduced after DKT administration. The total NBDS, GSRS-C score, and gas volume score at baseline were significantly correlated with the change in these scores. Higher NBDS and GSRS-C scores and more gas volume in the gut may be possible predictors of response to DKT when treating constipation.

SUBMITTER: Arita R

PROVIDER: S-EPMC6906340 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature

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Responder Analysis of Daikenchuto Treatment for Constipation in Poststroke Patients: A Subanalysis of a Randomized Control Trial.

Arita Ryutaro R Numata Takehiro T Takayama Shin S Obara Taku T Kikuchi Akiko A Ohsawa Minoru M Suzuki Akifumi A Yokota Takashi T Kusaba Mizue M Yaegashi Nobuo N Ishii Tadashi T

Journal of evidence-based integrative medicine 20190101

A traditional Japanese medicine, daikenchuto (DKT), is used for treating abdominal bloating and pain with coldness. In modern medicine, it is used to treat postoperative intestinal dysfunction and ileus. We previously showed the effective improvement in functional constipation with DKT in poststroke patients. However, response prediction for the treatment has not been elucidated. We investigated the data from the prior trial (UMIN000007393) to predict the DKT treatment response. We assessed the ...[more]

PMID: 31823650

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Project description:BackgroundWe hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT).MethodsWe used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours.ResultsWe included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short.ConclusionsWe found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials.Trial registration numberURL: https://www.Clinicaltrialsgov ; Unique identifier: NCT03192332.

Project description:Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive training and learn compensatory strategies for enhancing daily living activities.This study will use a two-arm, assessor-blinded, parallel, randomized controlled trial design, involving 40 patients who present a left- or right-sided unilateral vascular lesion poststroke and a clinical diagnosis of upper limb apraxia. Participants will be randomized to either a combined functional rehabilitation or a traditional health education group. The experimental group will receive an 8-week combined functional program at home, including physical and occupational therapy focused on restorative and compensatory techniques for upper limb apraxia, 3 days per week in 30-min intervention periods. The control group will receive a conventional health education program once a month over 8 weeks, based on improving awareness of physical and functional limitations and facilitating the adaptation of patients to the home. Study outcomes will be assessed immediately postintervention and at the 2-month follow-up. The primary outcome measure will be basic activities of daily living skills as assessed with the Barthel Index. Secondary outcome measures will include the following: 1) the Lawton and Brody Instrumental Activities of Daily Living Scale, 2) the Observation and Scoring of ADL-Activities, 3) the De Renzi Test for Ideational Apraxia, 4) the De Renzi Test for Ideomotor Apraxia, 5) Recognition of Gestures, 6) the Test of Upper Limb Apraxia (TULIA), and 7) the Quality of Life Scale For Stroke (ECVI-38).This trial is expected to clarify the effectiveness of a combined functional rehabilitation approach compared to a conservative intervention for improving upper limb movement and function in poststroke patients.Clinical Trial Gov number NCT02199093 . The protocol registration was received 23 July 2014. Participant enrollment began on 1 May 2014. The trial is expected to be completed in March 2016.

Dataset Information

Responder Analysis of Daikenchuto Treatment for Constipation in Poststroke Patients: A Subanalysis of a Randomized Control Trial.

Publications

Responder Analysis of Daikenchuto Treatment for Constipation in Poststroke Patients: A Subanalysis of a Randomized Control Trial.

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