Current status of the spontaneous reporting and classification/coding system for herbal and traditional medicine in pharmacovigilance.

BACKGROUND: While the use of herbal and traditional medicine (H&TM) has been extensive worldwide, the current status of H&TM management in pharmacovigilance remains to be investigated. To date, there is little information regarding the use of the classification/coding system (CCS) to detect signals for certain drugs within databases built on the basis of the spontaneous reporting system (SRS). The purpose of this study is to investigate the status of the SRS and CCS for H&TM in the pharmacovigilance systems of various countries around the world. METHODS: An e-mail survey was performed from late December 2018 to early January 2019 with 54 experts in pharmacovigilance. The results based on the information provided by the respondents were summarized. RESULTS: Fourteen experts from 13 countries responded to the survey. Eleven countries/regions were found to already include H&TM in their SRSs, managing only limited range of H&TM. Of the 9 countries/regions that provided the information on the status of CCS for H&TM in their domestic pharmacovigilance systems, only China had a separate CCS for H&TM. CONCLUSION: Revising the current pharmacovigilance systems to include or expand the range of H&TM, and developing an internationally harmonized system to classify and code H&TM suitable to the unique characteristics of H&TM are critical and overall beneficial.

Pharmacopuncture for stroke survivors: A systematic review of randomized controlled trials in South Korea.

BACKGROUND AND PURPOSE: Pharmacopuncture is one of the widely used interventions for stroke in Korea, but there is a lack of such evidence. This study was aimed to summarize the currently available evidence on the use of pharmacopuncture for stroke in the clinical practice of Korean medicine. METHODS: A systematic review of randomized controlled trials (RCTs) to evaluate the efficacy and safety of pharmacopuncture for stroke in Korea was conducted. RESULTS: Pharmacopuncture using bee venom was significantly beneficial for improving motor function and relieving the post-stroke shoulder pain. No serious adverse events were reported. The overall risk of bias of the included studies indicated a certain degree of concern and the level of evidence was low. CONCLUSION: The majority of RCTs have focused on the pain relief effects of bee venom injection. However, the quantity and quality of the evidence are not sufficiently high to draw definitive conclusions on this topic.

Electroacupuncture for post-stroke dysphagia: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Post-stroke dysphagia (PSD) requires effective treatment as it may cause aspiration pneumonia, dehydration, or malnutritution, which can increase the length of hospital stay as well as mortality. In the field of stroke, electroacupuncture (EA) has been widely used, and a number of clinical research papers have been published regarding its effects. This systematic review aims to evaluate the effectiveness of EA for the treatment of PSD. METHODS: Randomized controlled trials evaluating the use of EA in PSD will be included in this meta-analysis. The following electronic databases will be searched from inception to July 31, 2020, using terms relating to EA and PSD: PubMed, the Cochrane Library, the Excerpta Medica Database, China National Knowledge Infrastructure, the Korean Medical Database, KoreaMed, the National Digital Science Library, and the Oriental Medicine Advanced Searching Integrated System. Two reviewers will independently search these databases, select studies for inclusion, and evaluate the quality of the studies. Methodological quality will be assessed using the Cochrane Handbook for Systematic Reviews of Interventions (version 6.0). The primary outcome will be the total effective rate; secondary outcomes will include results of other assessments of dysphagia such as the water drinking test scale and videofluoroscopic swallowing study. We will also investigate the number and severity of adverse events. The Cochrane Review Manager (RevMan) software (version 5.3.5) will be employed to assess bias risk, data integration risk, and meta-analysis risk. Mean difference and standardized mean difference will be used to represent continuous data, while risk ratios will be used for pooled binary data. RESULTS: This study will provide a comprehensive review and evaluation of the available evidence regarding the efficacy and safety of EA as a treatment for PSD. CONCLUSION: This study will clarify whether EA could be an effective and safe treatment for PSD.

Adjunctive herbal medicine treatment for patients with acute ischemic stroke: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: In the East-Asian countries, the combined treatment of Western medicine and herbal medicine has been widely administered. The purpose of this study was to evaluate the efficacy and safety of herbal medicine in the treatment of acute ischemic stroke. METHODS: We searched the PubMed, Cochrane Central Register of Controlled Trials, EMBASE, and CNKI up to January 2017. Randomized Controlled Trials evaluating the effect of adjunctive herbal medicine on acute ischemic stroke were included. RESULTS: A total of 80 studies (8057 patients) were collected. The overall methodological quality was low. In the herbal group, meta-analysis indicated a statistically significant improvement in the neurologic deficits and activity of daily living compared with the non-herbal group. Furthermore, herbal treatments were relatively safe. CONCLUSION: The treatment can induce neurological improvements without side effects. However, concrete conclusions cannot be made due to the methodological problems of the included studies.

The neuritogenic and synaptogenic effects of the ethanolic extract of radix Puerariae in cultured rat hippocampal neurons.

ETHNOPHARMACOLOGICAL RELEVANCE: Radix Puerariae, the root of Pueraria montana var. lobata (Willd.) Sanjappa & Pradeep, is used in Korean traditional medicine to treat neuronal disorders including Parkinson's disease, and its active constituent, puerarin has been reported to have a neuroprotective effect in experimental models of Parkinson's and Alzheimer's disease. AIMS OF THE STUDY: To investigate the neurotrophic effects of these ethnomedicines on the development of central nervous system neurons and the molecular bases of these activities. MATERIALS AND METHODS: Rat embryonic (E19) brain neurons were cultured in the absence or presence of the ethanolic extract of Radix Puerariae (RPE) or puerarin. At predetermined times, cells were fixed and immunostained to visualize neuronal morphologies, or lysed for protein harvesting. Morphometric analyses of neurite outgrowths and synaptogenesis were performed using Image J software. RPE or puerarin-mediated changes in the protein profiles of cultured neurons were assessed by MALDI-TOF-MS/PMF and measuring immunofluorescent intensities. RESULTS: RPE and puerarin alone promoted maximum neurite outgrowths at concentrations of 1µg/ml and 5µM, respectively. At these optimal concentrations, RPE and puerarin provided neurotrophic support by promoting axo-dendritic arbors and synapse formation in cultured neurons. Proteomic study revealed that RPE and puerarin both up-regulated a number of proteins, including dynein light chain 2 (DLC2) and elongation factor 2 (EF2), which are associated with neuritogenesis and synaptic potentiation, respectively. Immunofluorescence intensity measurements confirmed the expressions of the DLC2 and Dync1h1 subunits of dynein in RPE or puerarin treated hippocampal neurons were up-regulated when RPE or puerarin induced changes in neuronal cytoarchitecture. CONCLUSIONS: Our study demonstrates that RPE and puerarin should be considered potentially valuable preventative therapeutics for brain disorders due to their abilities to promote the neuronal cytoarchitecture and the synaptic functionality, which are possibly associated with dynein-dependent regulation of cytoskeletal structures and up-regulation of translation machinery.

Joongpoongtang 05 (JP05) confers neuroprotection via anti-apoptotic activities in Neuro-2a cells during oxygen-glucose deprivation and reperfusion.

To evaluate the anti-apoptotic effects of Joongpoongtang 05 (JP05), a mixture of plant extracts, on a Neuro-2a (N2a) cell model of oxygen and glucose deprivation (OGD)/reperfusion (OGDR), a neuroblastoma cell injury model was induced by OGDR. This model allowed us to investigate cerebral ischemic changes and the protective effects of JP05. JP05 treatment significantly enhanced cell viability and reduced the levels of lactate dehydrogenase, nitric oxide, reactive oxygen species and the oxidants/antioxidants balance in neuronal cells as compared to the untreated OGDR group. Here, JP05 reduced OGDR-induced expressions of heme oxygenase-1 and nitric oxide synthase, which may contribute to the neuroprotection. JP05 also partially reversed the effects of OGDR on NF-κB and activated Akt production. Our findings suggest that JP05 confers neuroprotective effects via anti-apoptotic property against OGDR-induced free radical injury in N2a cells.

Contralateral acupuncture versus ipsilateral acupuncture in the rehabilitation of post-stroke hemiplegic patients: a systematic review.

BACKGROUND: Contralateral acupuncture (CAT) involves inserting needles in the meridian on the side opposite the disease location and is often used in post-stroke rehabilitation. The aim of this systematic review is to summarize and critically evaluate the evidence for and against the effectiveness of CAT for post-stroke rehabilitation as compared to ipsilateral acupuncture (IAT). METHODS: Seventeen databases were searched from their inceptions through June 2010. Prospective clinical trials were included if CAT was tested as the sole treatment or as an adjunct to other treatments for post-stroke rehabilitation and compared to IAT. RESULTS: Eight randomized clinical trials (RCTs) met our inclusion criteria. Four of them reported favorable effects of CAT compared to IAT for at least one outcome. A meta-analysis showed superior effects of CAT compared to IAT on recovery rate (n = 361; risk ratio (RR), 1.12; 95% confidence intervals (CIs), 1.04 to 1.22, P = 0.005). Subgroup analysis also showed favorable effects of using CAT on patients with cerebral infarction (n = 261; RR, 1.15; 95% CIs, 1.04 to 1.27, P = 0.006). Further analysis including patients with cerebral infarction and intracranial hemorrhage, however, failed to show these advantages (n = 100; RR, 1.11; 95% CIs, 0.85 to 1.46, P = 0.43). CONCLUSION: The results of our systematic review and meta-analysis suggest that there is limited evidence for CAT being superior to IAT in the treatment of cerebral infarction. The total number of RCTs included in our analysis was low, however, and the RCTs included had a high risk of bias. Future RCTs appear to be warranted.

Cupping for stroke rehabilitation: a systematic review.

Cupping is often used for stroke rehabilitation in Asian countries. Currently, no systematic review of this topic is available. The aim of this systematic review is to summarize and critically evaluate the evidence for and against the effectiveness of cupping for stroke rehabilitation. Thirteen databases were searched from their inception through March of 2010 without language restrictions. Prospective clinical trials were included if cupping was tested as the sole treatment or as an adjunct to other conventional treatments for stroke rehabilitation. We found 43 potentially relevant articles, of which 5 studies including 3 randomized clinical trials (RCTs) and 2 uncontrolled observational studies (UOSs) met our inclusion criteria. Cupping was compared with acupuncture, electro-acupuncture and warm needling. Some superior effects of cupping were found in two of the RCTs when compared to acupuncture in hemiplegic shoulder pain and high upper-limb myodynamia after stroke. The other RCT failed to show favorable effects of cupping when compared to acupuncture and warm needling in patients with hemiplegic hand edema. The two UOSs reported favorable effects of cupping on aphasia and intractable hiccup after stroke. There are not enough trials to provide evidence for the effectiveness of cupping for stroke rehabilitation because most of the included trials compared the effects with unproven evidence and were not informative. Future RCTs seem warranted but must overcome the methodological shortcomings of the existing evidence.

Moxibustion for stroke rehabilitation: systematic review.

BACKGROUND AND PURPOSE: Positive effects of moxibustion for stroke rehabilitation may be seen in real clinical practice. Currently, no systematic reviews are available. The aim of this systematic review was to analyze the trial data on the effectiveness of moxibustion for stroke rehabilitation. METHODS: Fourteen databases were searched without language restriction. Randomized clinical trials were included if moxibustion was tested as the sole treatment or as an adjunct to other treatments for stroke rehabilitation. RESULTS: Nine randomized clinical trials met our inclusion criteria. Three randomized clinical trials reported favorable effects of moxibustion plus standard care on motor function versus standard care alone (N=142; standardized mean difference=0.72; 95% confidence interval, 0.37 to 1.08; P<0.0001). Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion. CONCLUSION: This systematic review found limited effectiveness of moxibustion as an adjunct to standard care in stroke rehabilitation.