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Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation.

ABSTRACT: We developed a protocol for a prospective registry to prove the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation. We plan on recruiting 1000 inpatients receiving integrative Korean medicine treatment for lumbar intervertebral disc herniation at four spine specialized Korean medical hospitals. Patients enrolled in the registry will be evaluated at the time of hospitalization, 2 weeks after hospitalization, at discharge, and 6 months after hospitalization on predefined outcome variables such as intensity of back and leg pain, Oswestry Disability Index, quality of life, Patient Global Impression of Change, and adverse effects. The protocol of this study was registered in CRIS (KCT0003709) and Clinical trial gov (NCT03750591). This study is significant in that it cannot only be a basis for safety-related evidence of complementary alternative medicine, which has been lacking, but it also gives clear evidence on the effectiveness and validity of treatment effects such as accompaniment of stenosis, sex, age, and type of disc herniation.

SUBMITTER: Lee YJ

PROVIDER: S-EPMC7249894 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation.

Lee Yoon Jae YJ Kim Jongho J Kim Me-Riong MR Kim Joowon J Kim Min-Young MY Cho Hyun-Woo HW Lee Sook-Hyun SH Ha Inhyuk I

Medicine 20200501 21

We developed a protocol for a prospective registry to prove the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation. We plan on recruiting 1000 inpatients receiving integrative Korean medicine treatment for lumbar intervertebral disc herniation at four spine specialized Korean medical hospitals. Patients enrolled in the registry will be evaluated at the time of hospitalization, 2 weeks after hospitalization, ...[more]

PMID: 32481274

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Project description:Symptomatic cervical intervertebral disc herniation (IDH) presenting as neck pain accompanied by arm pain is a common affliction whose prevalence continues to rise, and is a frequent reason for integrative inpatient care using complementary and alternative medicine (CAM) in Korea. However, studies on its long term effects are scarce.A total 165 patients with cervical IDH admitted between January 2011 and September 2014 to a hospital that provides conventional and Korean medicine integrative treatment with CAM as the main modality were observed in a prospective observational study. Patients underwent CAM treatment administered by Korean medicine doctors (KMDs) in accordance with a predetermined protocol for the length of hospital stay, and additional conventional treatment by medical doctors (MDs) as referred by KMDs. Short term outcomes were assessed at discharge and long term follow-ups were conducted through phone interviews after discharge. Numeric rating scale (NRS) of neck and radiating arm pain, neck disability index (NDI), 5-point patient global impression of change (PGIC), and factors influencing long term satisfaction rates in PGIC were assessed.Of 165 patients who received inpatient treatment 20.8?±?11.2 days, 117 completed the long term follow-up up at 625.36?±?196.7 days post-admission. Difference in NRS between admission and discharge in the long term follow-up group (n?=?117) was 2.71 (95% CI, 2.33, 3.09) for neck pain, 2.33 (95% CI, 1.9, 2.77) for arm pain, and that of NDI 14.6 (95% CI, 11.89, 17.32), and corresponding scores in the non-long term follow-up group (n?=?48) were 2.83 (95% CI, 2.22, 3.45) for neck pain, 2.48 (95% CI, 1.84, 3.12) for arm pain, and that of NDI was 14.86 (95% CI, 10.41, 19.3). Difference in long term NRS of neck pain and arm pain from baseline was 3.15 (95% CI, 2.67, 3.64), and 2.64 (95% CI, 1.99, 3.29), respectively. PGIC was reported to be "satisfactory" or higher in 79.5% of patients at long term follow-up.Though the observational nature of this study limits us from drawing a more decisive conclusion, these results suggest that integrative treatment focused on CAM in cervical IDH inpatients may achieve favorable results in pain and functional improvement.ClinicalTrials.gov Identifier: NCT02257723. Registered October 2, 2014.

Project description:A survey study was conducted in Korean medicine doctors who provide nonsurgical integrative treatment for cervical disc herniation (CDH) at spine-specialty hospitals to assess usual treatment practices, diagnosis and treatment methods, and related adverse events for CDH. The questionnaire was jointly developed by clinical experts and methodology experts and was administered to 197 Korean medicine doctors (response rate: 84.9% (n = 197/232)) practicing at spine-specialty Korean medicine hospitals for analysis of general sociodemographic information, practice patterns of CDH including diagnosis and treatment strategies, CDH prognosis, and treatment safety. The average clinical experience of respondents was 9.3±6.4 years, and 4.0±1.8 weeks were regarded to be needed for CDH pain to decrease by 50% and 9.1±3.4 weeks to decrease by 80%. Eight-Principle Pattern and Meridian System Identification were the most commonly used Korean medicine syndrome differentiation methods, and CDH was most often considered to be a result of Qi stagnation and Blood coagulation. The Spurling test was reported to be important in physical examination, and magnetic resonance (MR) images were mostly used for diagnosis and treatment of CDH of various diagnostic tools. Treatment mainly consisted of a nonsurgical, integrative multimodal approach comprising acupuncture, pharmacopuncture, herbal medicine, and Chuna manual therapy. Shinbaro pharmacopuncture and Chungpa-jun, which are well-established herbal treatments supported by evidence, were considered to be of high importance in CDH treatment. With regard to safety, acupuncture was considered to be the safest, while bee venom pharmacopuncture was of highest concern due to potential hypersensitivity. This study is the first report to investigate current practice patterns and approach of Korean medicine doctors to CDH treatment. This data may be of significance to Korean medicine doctors in drawing clinical guidelines and conducting randomized controlled trials (RCTs) to generate high-level evidence on the effectiveness of nonsurgical integrative medicine treatments for CDH.

Project description:Intervertebral disc herniation (IVDH) is an important pathology in humans and also in dogs. While the molecular disease mechanisms are well investigated in humans, little is known about the inflammatory mediators in naturally occurring canine IVDH. The objective of this study was to investigate whether the involved proinflammatory cytokines in human IVDH are also key cytokines in canine IVDH and thus to elucidate the suitability of the dog as a model for human trials. 59 samples from 25 dogs with surgically confirmed thoracolumbar IVDH were collected and classified in three subgroups: herniated (H), affected non-herniated (NH) disc, and adjacent non-affected (NA) disc. Discs from 11 healthy dogs acted as controls (C). Samples were analyzed for IL-1, IL-6, IL-8, and TNF-? expression (qPCR/ELISA) as well as cell infiltration and activation of the MAP kinase pathways (immunohistochemistry). Gene and protein expression of all key cytokines could be detected in IVDH affected dogs. Canine IVDH was significantly associated with a higher gene expression of IL-6 (H?>?C, NH?>?C) and TNF-? (H?>?C, NH?>?C, NA?>?C) and a significant down-regulation of IL-1? (H?<?C). Dogs with spontaneous pain had significantly higher IL-6 mRNA compared to those with pain arising only upon palpation. An inter-donor comparison (H and HN relative to NA) revealed a significant increase of IL-6 gene expression (H?>?NA, NH?>?NA). IL-8 (H?>?C, NA?>?C) and TNF-? (NH?>?C) protein levels were significantly increased in diseased dogs while inversely, IL-6 protein levels were significantly higher in patients with better clinical outcome. Aside from resident IVD cells, mostly monocytes and macrophages were found in extruded material, with concomitant activation of extracellular signal-regulated kinase p38 in the majority of samples. Dogs with spontaneous IVDH might provide a useful model for human disc diseases. Although the expression of key cytokines found in human IVDH was also demonstrated in canine tissue, the inflammatory mechanisms accompanying canine IVDH diverges partially from humans, which will require further investigations in the future. In dogs, IL-6 seems to play an important pathological role and may represent a new potential therapeutic target for canine patients.

Dataset Information

Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation.

Publications

Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation.

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