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Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

ABSTRACT: BACKGROUND:Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP. METHODS:This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20?min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed. DISCUSSION:The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation. TRIAL REGISTRATION:Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.

SUBMITTER: Sung WS

PROVIDER: S-EPMC6935187 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

Sung Won-Suk WS Jeon Sae-Rom SR Hong Ye-Jin YJ Kim Tae-Hun TH Shin Seungwon S Lee Hyun-Jong HJ Seo Byung-Kwan BK Park Yeon-Cheol YC Kim Eun-Jung EJ Nam Dong-Woo DW

Trials 20191227 1

<h4>Background</h4>Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP. ...[more]

PMID: 31882016

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Project description:ObjectivesTo report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP).DesignObservational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months.Settings/locationOsher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH.SubjectsCLBP patients seeking care at OCC or non-OCC BWH clinics.InterventionsIntegrative or conventional care for CLBP as prescribed by the treating clinician(s).Outcome measuresQuality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes.ResultsTotal adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale.ConclusionsWhen adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

Project description:BackgroundInsomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.MethodsPeople with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.ResultsTwenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks' follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.ConclusionsElectroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registrationClinical Research Information Service, KCT0002162 . Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016).

Project description:BackgroundMeta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend therapeutic hypothermia. New data are available on the adverse effects of therapeutic hypothermia, notably infectious complications. The risk/benefit ratio of therapeutic hypothermia after nonshockable cardiac arrest is unclear.MethodsHYPERION is a multicenter (22 French ICUs) trial with blinded outcome assessment in which 584 patients with successfully resuscitated nonshockable cardiac arrest are allocated at random to either TTM between 32.5 and 33.5°C (therapeutic hypothermia) or TTM between 36.5 and 37.5°C (therapeutic normothermia) for 24 hours. Both groups are managed with therapeutic normothermia for the next 24 hours. TTM is achieved using locally available equipment. The primary outcome is day-90 neurological status assessed by the Cerebral Performance Categories (CPC) Scale with dichotomization of the results (1 + 2 versus 3 + 4 + 5). The primary outcome is assessed by a blinded psychologist during a semi-structured telephone interview of the patient or next of kin. Secondary outcomes are day-90 mortality, hospital mortality, severe adverse events, infections, and neurocognitive performance. The planned sample size of 584 patients will enable us to detect a 9% absolute difference in day-90 neurological status with 80% power, assuming a 14% event rate in the control group and a two-sided Type 1 error rate of 4.9%. Two interim analyses will be performed, after inclusion of 200 and 400 patients, respectively.DiscussionThe HYPERION trial is a multicenter, randomized, controlled, assessor-blinded, superiority trial that may provide an answer to an issue of everyday relevance, namely, whether TTM is beneficial in comatose patients resuscitated after nonshockable cardiac arrest. Furthermore, it will provide new data on the tolerance and adverse events (especially infectious complications) of TTM at 32.5-33.5°C.Trial registrationClinicalTrials.gov: NCT01994772 .

Project description:Ethnopharmacological relevanceTibetan traditional medicine CheeZheng Pain-Relieving Plaster (CZPRP) is frequently used as an over-the-counter external analgesic for musculoskeletal pain; however, its evidence for low back pain (LBP) has not been evaluated.Aim of the studyThis study aims to assess the efficacy and safety of CZPRP for both acute, subacute and chronic LBP through a systematic review and meta-analysis of clinical trials.Materials and methodsPubMed, CENTRAL, CNKI, CQVIP, and Wanfang databases were searched through April 20, 2020 for randomized controlled trials of CZPRP for LBP. Eligible comparators were placebo, active treatment, or usual care. Clinical outcomes included pain severity, lower back function score, pain-free rate, and adverse events (AEs). Qualitative evaluations were conducted using the Cochrane risk of bias assessment tools. Quantitative analyses were conducted using a random-effects model.ResultsThis study includes 1674 LBP patients from nine clinical studies. Pooled analyses among subjects with acute LBP show 1) significant pain reductions (mean difference -0.84, 95% confidence interval[CI] -1.31, -0.37) in CZPRP plus diclofenac versus diclofenac, 2) significant improvements in lower back function (standard mean difference -1.50, 95% CI -2.16, -0.85) in CZPRP versus diclofenac, and 3) a higher pain-free rate in CZPRP alone (risk ratio 1.48, 95% CI 1.16, 1.89; I2 = 61%) or CZPRP plus nonsteroidal anti-inflammatory drugs (NSAIDs) (risk ratio 1.66, 95% CI 1.14, 2.40; I2 = 0%) versus NSAIDs. However, in a heterogeneous population with mixed LBP subtypes, there was no significant difference in pain outcomes between CZPRP and diclofenac. Additionally, CZPRP use did not increase AEs compared with no CZPRP (p = 0.40). All nine studies are associated with moderate to high risk of bias.ConclusionsThe use of CZPRP is associated with improved acute LBP outcomes compared to diclofenac. However, due to the moderate to high risk of bias of the studies, future rigorous randomized controlled trials are needed to evaluate the effects of CZPRP for acute and chronic LBP.

Dataset Information

Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

Publications

Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

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