Real-world observations and impacts of Chinese herbal medicine for migraine: results of a registry-based cohort study.

Background: Migraine is a prevalent, recurrent condition with substantial disease burden. Chinese herbal medicine (CHM) has been used frequently for migraine in controlled clinical settings. This study is to summarise the characteristics of patients who seek clinical care in a tertiary Chinese medicine hospital in China; to gather their preferences and values of using CHM; to explore the effect of CHM for migraine and its comorbidities in a real-world setting, and to collect first-hand expertise of clinicians' practice pattern in prescribing CHM for migraine. Methods: This registry-based cohort study was prospectively conducted at Guangdong Provincial Hospital of Chinese Medicine from December 2020 to May 2022. Adult migraine patients seeking their initial anti-migraine clinical care at the hospital were consecutively recruited and followed up for 12 weeks. Practitioners specialised in headache management prescribed individualised treatments without research interference. Standardised case report forms were employed to gather information on patients' preferences and perspective of seeking clinical care, as well as to assess participants' migraine severity, comorbidities, and quality of life, at 4-weeks intervals. Various analytical methods were utilised based on the computed data. Results: In this study, we observed 248 participants. Of these, 73 received CHM treatment for 28 days or longer. Notably, these participants exhibited a greater disease severity, compared to those treated with CHM for less than 28 days. Of the 248 participants, 83.47% of them expected CHM would effectively reduce the severity of their migraine, around 50% expected effects for migraine-associated comorbidities, while 51.61% expressing concerns about potential side effects. CHM appeared to be effective in reducing monthly migraine days and pain intensity, improving patients' quality of life, and potentially reducing comorbid anxiety, with a minimum of 28 days CHM treatment. Herbs such as gan cao, gui zhi, chuan xiong, fu ling, bai zhu, yan hu suo, etc. were frequently prescribed for migraine, based on patients' specific symptoms. Conclusion: CHM appeared to be beneficial for migraine and comorbid anxiety in real-world clinical practice when used continuously for 28 days or more. Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR2000041003.

Current status and implementation strategies of patient education in core outcome set development.

OBJECTIVE: Patient participation is essential for Core Outcome Set (COS) development studies. Patient education during participation may help patients better express their views in COS studies. This study aimed to investigate the current status of patient participation and the specified educational information in COS studies. METHODS: We conducted a systematic review of COS development studies. Information on patient participation in COS research, and especially details of patient education, was analyzed. RESULTS: In total, 146 COS development studies were included in this review. Of these, 125 studies (85.6%) mentioned patient participation. Most studies did not provide explicit information on patient participation. Some studies mentioned recruiting patients, but ultimately, none of them responded. Six studies reported conducting patient education through workshops, creating patient forums, or providing videos and slides. However, these studies did not provide details on education. Twenty-three studies used the plain language to explain patient outcomes. CONCLUSION: COS developers are increasingly focusing on patient participation. However, only a few COS studies have explicitly reported conducting measures related to patient education. Further patient education is necessary when they participate in the development of a new Core Outcome Set. PRACTICE IMPLICATION: This article provides implementation strategies related to patient education for future COS development studies.

Topical Traditional Chinese Medicines for Cancer Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND AND OBJECTIVES: Safe and effective management of cancer-related pain is a worldwide challenge. In the search for treatment options, natural products used in Chinese herbal medicines (CHMs) have received attention in clinical studies for their effects on cancer-related pain. The objective of this systematic review is to evaluate the clinical evidence for topically applied CHMs as adjunctive treatments for cancer pain management. METHODS: Nine biomedical databases and 4 clinical trial registries were searched for randomized-controlled trials (RCTs) that reported measures of pain and/or quality of life. Risk of bias was assessed using the Cochrane tool. Meta-analysis employed mean difference (MD) with 95% confidence intervals (random effects). RESULTS: Twenty (20) RCTs (1636 participants) met the inclusion criteria. Meta-analyses were grouped based on the comparisons and outcome measures. For pain intensity, there was a greater reduction in the topical CHM group versus placebo (MD -0.72 [-1.04, -0.40]), no difference when compared to tramadol (MD -0.15 [-0.38, 0.08]), and a greater reduction when topical CHMs were combined with conventional analgesic medications (MD -0.67 [-0.93, -0.40]). Analgesic onset time was reduced in the CHM group compared to tramadol (MD -26.02 [-27.57, -24.47] minutes), and for CHMs combined with conventional medications (MD -19.17 [-21.83, -16.52] minutes). When CHMs were combined with analgesic medications, improvements were found for duration of analgesia (MD 1.65 [0.78, 2.51] hours), analgesic maintenance dose (MD -31.72 [-50.43, -13.01] milligrams/day), and quality of life. CONCLUSION: Addition of topical CHMs to conventional analgesic medications was associated with improved outcomes for pain intensity, some other pain-related outcomes, and measures of quality of life. Limitations included methodological issues in some studies and considerable heterogeneity in some pooled results.

Orally administered Chinese herbal therapy to assist post-surgical recovery for chronic rhinosinusitis-A systematic review and meta-analysis.

This systematic review and meta-analysis aims to: assess the effectiveness and safety of orally administered Chinese herbal medicines (CHMs) as adjuncts to the post-surgical management of chronic rhinosinusitis (CRS); inform clinicians of the current evidence; identify the best available evidence; and suggest directions for further research. Randomised controlled trials (RCTs) were identified from searches of nine databases plus clinical trial registries. Participants were adults and/or children diagnosed with sinusitis or rhinosinusitis, with or without nasal polyps, who had received surgery. Interventions were CHMs used orally following surgery for CRS as additions to conventional post-surgical management. Controls received conventional post-surgical management without CHMs. Studies reported results for Sino-Nasal Outcome Test (SNOT), visual analogue scales (VAS), Lund-Mackay computed tomography score (LM), Lund-Kennedy endoscopic score (LK), mucociliary transport time (MTT), mucociliary transport rate (MTR), mucociliary clearance (MC) or quality of life (QoL). Twenty-one RCTs were included. All used oral CHMs following functional endoscopic sinus surgery (FESS). The pooled results showed no significant difference between groups for SNOT-20 at the end of treatment (EoT) but there was a significant difference at follow up (FU) in favour of additional CHMs. The VAS for total nasal symptoms (VAS-TNS) showed greater improvements in the CHM groups at EoT and FU. Only FU data were reported for LM which showed greater improvement in the CHM groups. LK showed greater improvements at EoT and FU. The measures of mucociliary transport (MTT, MTR, and MC) each showed significantly greater improvement at EoT in the group that received additional CHMs. No study reported QoL. Adverse events were not serious, but reporting was incomplete. The meta-analyses suggested the addition of oral CHMs to conventional management following FESS may improve recovery. However, most studies were not blinded, and substantial heterogeneity was evident in some meta-analyses. Blinded studies are required to further investigate the roles of oral CHMs in post-surgical recovery. Systematic review registration number: The protocol was registered in PROSPERO (CRD42019119586).

Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese and Western medicine.

Integrated traditional Chinese medicine (TCM) and Western medicine (WM) is a new medical science grounded in the knowledge bases of both TCM and WM, which then forms a unique modern medical system in China. Integrated TCM and WM has a long history in China, and has made important achievements in the process of clinical diagnosis and treatment. However, the methodological defects in currently published clinical practice guidelines limit its development. The organic integration of TCM and WM is a deeper integration of TCM and WM. To realize the progression of "integration" to "organic integration", a targeted and standardized guideline development methodology is needed. Therefore, the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

ADAR1 Zα domain P195A mutation activates the MDA5-dependent RNA-sensing signaling pathway in brain without decreasing overall RNA editing.

Variants of the RNA-editing enzyme ADAR1 cause Aicardi-Goutières syndrome (AGS), in which severe inflammation occurs in the brain due to innate immune activation. Here, we analyze the RNA-editing status and innate immune activation in an AGS mouse model that carries the Adar P195A mutation in the N terminus of the ADAR1 p150 isoform, the equivalent of the P193A human Zα variant causal for disease. This mutation alone can cause interferon-stimulated gene (ISG) expression in the brain, especially in the periventricular areas, reflecting the pathologic feature of AGS. However, in these mice, ISG expression does not correlate with an overall decrease in RNA editing. Rather, the enhanced ISG expression in the brain due to the P195A mutant is dose dependent. Our findings indicate that ADAR1 can regulate innate immune responses through Z-RNA binding without changing overall RNA editing.

Acupuncture and moxibustion for endometriosis: A systematic review and analysis.

OBJECTIVES: This study aimed to examine the effect of acupuncture on symptoms and health-related quality of life in patients with endometriosis. METHODS: Nine biomedical databases were searched to April 2022 to identify randomized controlled trials of acupuncture and/or moxibustion used alone or as adjunct to guideline-recommended pharmacotherapy for the treatment of endometriosis. One reviewer extracted data and another verified the data. A random effects model was used to calculate mean differences. RESULTS: Fifteen trials involving 1018 patients met the inclusion criteria, but diversity in comparisons and outcome measures prevented meta-analysis. Compared to sham acupuncture, manual acupuncture was more effective at reducing dysmenorrhea VAS pain score (mean difference [MD] - 2.40, 95 % CI [- 2.80, - 2.00]; moderate certainty evidence), pelvic pain VAS score (MD - 2.65, 95 % CI [- 3.40, - 1.90]; high certainty evidence) and dyspareunia VAS scores (MD - 2.88, [- 3.83, - 1.93]), lessened the size of ovarian cyst (MD - 3.88, 95 % CI [- 7.06, - 0.70]), and improved quality of life. Compared to conventional therapy, manual acupuncture plus conventional therapy and warm needle alone resulted in greater improvements in quality of life than conventional therapy. Among the six studies that reported safety, fewer adverse events were reported in participants who received acupuncture or moxibustion. CONCLUSIONS: Low to moderate certainty evidence from single studies showed that manual acupuncture may improve pain-related symptoms and quality of life; however, there is insufficient evidence on the overall effectiveness of acupuncture and moxibustion for endometriosis.

Clinical evidence for acupuncture for adult asthma: Systematic review and meta-analysis of randomised sham/placebo-controlled trials.

OBJECTIVE: Acupuncture is a widely used asthma therapy, but the benefits remain uncertain. This study aimed to access the effectiveness of acupuncture for treatment of asthma in adults. METHODS: Five English databases and four Chinese databases were searched from inception to November 2021. Randomised sham/placebo-controlled trials meeting inclusion criteria were included. Risk of bias was evaluated according to the Cochrane Review Handbook, and data analysis was performed in RevMan 5.4.1. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) profiler. RESULTS: Sixteen randomised controlled trials (RCTs) were included in the meta-analysis. Results indicated that acupuncture was well-tolerated and could improve FEV1% compared with sham/placebo acupuncture [MD 6.11, 95% CI 0.54-11.68, I2 = 93%, number of participants (n) = 603]. Acupuncture also improved Cai's Asthma Quality of Life Questionnaire (AQLQ) (MD 7.26, 95% CI 5.02-9.50, I2 = 0, n = 358), and reduced the asthma symptom score (SMD -2.73, 95% CI -3.59 to -1.87, I2 = 65%, n = 120). One study showed acupuncture increased the Asthma Control Test (ACT) score (MD 2.00, 95% CI 0.90-3.10, n = 111), and decreased exacerbation frequency (MD -1.00, 95% CI -1.55 to -1.45, n = 111). Other lung function and medication use parameters were not statistically significant. CONCLUSIONS: Acupuncture versus sham/placebo control appeared to improve quality of life, FEV1%, symptoms, and asthma control, and reduced exacerbation frequency per year. Further studies with appropriate controls, more participants, and high-quality evidence are needed.

Barbel regeneration and function divergence in red-tail catfish (Hemibagrus wyckioides) based on the chromosome-level genomes and comparative transcriptomes.

Catfish (Siluriformes) are one of the most diverse vertebrate orders and are characterized by whisker-like barbels, which are important sensory organs in most of teleosts. However, their specific biological functions are still unclear. Red-tail catfish (Hemibagrus wyckioides) is well-known catfish species with four pairs of barbels, of which the maxillary barbels reach two-thirds of the body length. In this study, a 776.58 Mb high-quality chromosome-level genome was assembled into 29 chromosomes. Comparative genome data indicated that the barbeled regeneration gene ccl33 has expanded into 11 tandemly duplicated copies. Transcriptome data revealed the functional differentiation of different barbels and suggested that the maxillary barbel might be necessary for water temperature perception. Taste receptor genes were also characterized in teleosts with different food habits. Selection pressures were revealed to affect the sugar-based solute transport domain of the sweet taste receptor gene t1r2 in carnivorous fishes. In addition, the bitter taste receptor gene t2r200 was found to be lost from the genomes of four catfish species. Therefore, our study provides a genomic foundation for understanding the regeneration and functional differentiation of barbels in red-tail catfish and also reveals novel insights into the feeding evolution of fish species with different feeding habits.

Chinese herbal therapy in the management of rhinosinusitis-A systematic review and meta-analysis.

This systematic review aims to assess the effects and safety of Chinese herbal medicines (CHMs) in the management of rhinosinusitis (RS); inform clinicians of the current state of the evidence; identify the best available evidence; and suggest further directions for research. Five English and four Chinese language databases, and four clinical trial registries were searched. Eligible studies were randomised controlled trials (RCTs). Participants were diagnosed with RS based on established criteria. Test interventions were CHMs administered orally and/or nasally, excluding injections and displacement techniques. Control interventions included placebos, no additional treatment, and conventional non-invasive treatments including pharmacotherapies and/or nasal irrigation, and/or inhalations. Polyposis and post-surgical recovery were excluded. Outcomes were Sino-Nasal Outcome Test (SNOT), visual analogue scales (VAS), Lund-Mackay computed tomography score (LM), Lund-Kennedy Endoscopic score (LK), Mucociliary transport time (MTT), Mucociliary transport rate (MTR), quality of life and adverse events (AEs). Risk of bias used the Cochrane tool. Meta-analysis in Review Manager 5.4.1 used random effects for mean difference (MD) or risk ratio (RR) with 95% confidence intervals. Heterogeneity was assessed as I2. Thirty-four RCTs were included, 30 of chronic RS (CRS) and four of acute RS (ARS). These enrolled 3,752 participants. Five RCTs blinded participants. For CRS, comparisons with placebo showed greater improvements in the CHM groups for SNOT-20 and VAS-TNS (total nasal symptoms). Blinded comparisons with pharmacotherapies showed no differences between groups in the degree of improvement for SNOT-20, VAS-TNS, and LM, suggesting these CHMs had similar effects, at least in the short term. In ARS, pooled results found improved scores on VAS-TNS and LK suggesting a benefit for combining these CHMs with pharmacotherapies. Limitations included inadequacies in study design and methodological reporting, and insufficient reporting of AEs. Heterogeneity in some pooled results precluded strong conclusions. Further well-designed studies are needed to test whether the results are replicable. Systematic review registration number: PROSPERO (CRD42019119586).

An AGS-associated mutation in ADAR1 catalytic domain results in early-onset and MDA5-dependent encephalopathy with IFN pathway activation in the brain.

BACKGROUND: Aicardi-Goutières syndrome (AGS) is a severe neurodegenerative disease with clinical features of early-onset encephalopathy and progressive loss of intellectual abilities and motor control. Gene mutations in seven protein-coding genes have been found to be associated with AGS. However, the causative role of these mutations in the early-onset neuropathogenesis has not been demonstrated in animal models, and the mechanism of neurodegeneration of AGS remains ambiguous. METHODS: Via CRISPR/Cas-9 technology, we established a mutant mouse model in which a genetic mutation found in AGS patients at the ADAR1 coding gene (Adar) loci was introduced into the mouse genome. A mouse model carrying double gene mutations encoding ADAR1 and MDA-5 was prepared using a breeding strategy. Phenotype, gene expression, RNA sequencing, innate immune pathway activation, and pathologic studies including RNA in situ hybridization (ISH) and immunohistochemistry were used for characterization of the mouse models to determine potential disease mechanisms. RESULTS: We established a mouse model bearing a mutation in the catalytic domain of ADAR1, the D1113H mutation found in AGS patients. With this mouse model, we demonstrated a causative role of this mutation for the early-onset brain injuries in AGS and determined the signaling pathway underlying the neuropathogenesis. First, this mutation altered the RNA editing profile in neural transcripts and led to robust IFN-stimulated gene (ISG) expression in the brain. By ISH, the brains of mutant mice showed an unusual, multifocal increased expression of ISGs that was cell-type dependent. Early-onset astrocytosis and microgliosis and later stage calcification in the deep white matter areas were observed in the mutant mice. Brain ISG activation and neuroglial reaction were completely prevented in the Adar D1113H mutant mice by blocking RNA sensing through deletion of the cytosolic RNA receptor MDA-5. CONCLUSIONS: The Adar D1113H mutation in the ADAR1 catalytic domain results in early-onset and MDA5-dependent encephalopathy with IFN pathway activation in the mouse brain.

Chinese herbal medicine for migraine management: A hospital-based retrospective analysis of electronic medical records.

Background: Migraine is a chronic neurological disease causing significant socioeconomic burden and impaired quality of life. Chinese medicine is commonly used for migraine in China. Clinical trials have generated evidence of the effectiveness of Chinese medicine therapies for migraine. However, little is known about how to use these therapies to treat migraine in real-world clinical settings. Methods: In this retrospective study, we analyzed data from the electronic medical records (EMRs) of 2,023 migraine patients who attended the Guangdong Provincial Hospital of Chinese Medicine (GPHCM) between July 2018 and July 2020. Results: More than three-quarters (77.21%) of the patients were female. Most (78.20%) of the patients were aged between 18 and 50 years, 18.49% were aged above 50 years, and the remaining 3.31% were under 18 years. Sleep disorders were the most documented comorbidity occurring in 27.29% of patients, and more common in females (29.77%) than male (18.87%). Fatigue was the most frequently reported trigger of migraine attacks among all patients (9.39%), while menstruation was the most common trigger for female patients (10.24%). Less than a quarter of patients (21.01%) reported a history of taking analgesic medication for their migraine. The median treatment duration reported by the patients was 10 days. Chinese herbal medicine (CHM) was the predominant treatment for migraine at the hospital (88.48%), while pharmacotherapies were prescribed to 28.97% of the patients. CHM was prescribed more often as a sole treatment (53.58% of patients) than combined with pharmacotherapies (27.39% of patients). Among patients who reported improvements after taking CHM, the most frequently used herbs were fu ling and chuan xiong, the most frequent patented CHM product was tong tian oral solution, and the main herbal formulae were chuan xiong cha tiao san and yi qi cong ming tang. Conclusion: CHM formulae, such as chuan xiong cha tiao san and yi qi cong ming tang, patented CHM product tong tian oral solution, and some herbs are potentially effective treatments for migraine. As such, CHM can be used as an alternative to conventional pharmacotherapies for migraine and is worth further evaluation in randomized controlled trials.

Natural products for migraine: Data-mining analyses of Chinese Medicine classical literature.

Background: Treatment effect of current pharmacotherapies for migraine is unsatisfying. Discovering new anti-migraine natural products and nutraceuticals from large collections of Chinese medicine classical literature may assist to address this gap. Methods: We conducted a comprehensive search in the Encyclopedia of Traditional Chinese Medicine (version 5.0) to obtain migraine-related citations, then screened and scored these citations to identify clinical management of migraine using oral herbal medicine in history. Information of formulae, herbs and symptoms were further extracted. After standardisation, these data were analysed using frequency analysis and the Apriori algorithm. Anti-migraine effects and mechanisms of actions of the main herbs and formula were summarised. Results: Among 614 eligible citations, the most frequently used formula was chuan xiong cha tiao san (CXCTS), and the most frequently used herb was chuan xiong. Dietary medicinal herbs including gan cao, bai zhi, bo he, tian ma and sheng jiang were identified. Strong associations were constructed among the herb ingredients of CXCTS formula. Symptoms of chronic duration and unilateral headache were closely related with herbs of chuan xiong, gan cao, fang feng, qiang huo and cha. Symptoms of vomiting and nausea were specifically related to herbs of sheng jiang and ban xia. Conclusion: The herb ingredients of CXCTS which presented anti-migraine effects with reliable evidence of anti-migraine actions can be selected as potential drug discovery candidates, while dietary medicinal herbs including sheng jiang, bo he, cha, bai zhi, tian ma, and gan cao can be further explored as nutraceuticals for migraine.

Efficacy and Safety of Oral Chinese Herbal Medicine for Migraine: A Systematic Review and Meta-Analyses Using Robust Variance Estimation Model.

Background: Migraine is a prevalent headache disorder with significant impacts on patients' quality of life and economic burden. Chinese herbal medicine (CHM) is commonly prescribed for migraine in China. This review aimed to provide a rigorous evaluation of evidence on the efficacy of oral CHM for migraine and explore the correlation between its effect size and treatment duration. Methods: We searched nine digital databases (PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, AMED, BioMedical Literature, CNKI, CQVIP, and Wanfang Data) from their inceptions to May 2021, with the language being restricted to Chinese and English. Randomized, placebo-controlled trials using oral CHM to treat adult migraine were included. Data screening and extraction were conducted by two independent reviewers. The methodological quality of randomized controlled trials (RCTs) was assessed using the Cochrane Risk of Bias tool. Meta-analyses were conducted to estimate the effect size using a random effect model, and a robust variance estimation (RVE) model was constructed to explore the correlation between treatment effects and treatment duration. The certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation. Publication bias was tested using a funnel plot and Egger's test. Results: A total of 18 RCTs involving 3,015 participants were included. Results of the meta-analyses showed that, at the end of the treatment phase, CHM was more efficacious than placebo in reducing migraine frequency, migraine days, and pain severity, and increasing response rate. Additionally, CHM showed superior effects to placebo in lowering migraine frequency and pain severity at the end of the 4-week follow-up. The RVE model suggested that the benefits of CHM for migraine frequency and pain intensity increased as treatment duration extended. The number of adverse events reported by the CHM and placebo groups was comparable. The certainty of the evidence was graded as "moderate." No publication bias was detected. Conclusion: Oral CHM appeared to be more efficacious than placebo for reducing migraine frequency and pain severity. Greater treatment effects were associated with longer treatment duration. The oral CHM was well tolerated. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42021270719.

Acupuncture Therapies for Individuals with Overweight or Obesity: An Overview of Systematic Reviews.

Purpose: An increasing number of people are affected by overweight or obesity, and the personal and social health burden is growing rapidly. Acupuncture is gaining popularity as an alternative treatment to manage weight. This research aims to update and synthesize the evidence of acupuncture therapies from systematic reviews for treating overweight and obesity. Methods: Nine databases were searched from their inception to March 2022. Overweight or obesity was classified using standard diagnostic criteria. Published systematic reviews that included randomized controlled trials and quasi-randomized studies were eligible. Quality was assessed via the AMSTAR-2 scale and risk of bias using the ROBIS tool. Results: Thirty-eight systematic reviews were identified. Acupuncture therapies and auricular acupoint stimulation showed benefits in terms of reducing body weight and body mass index. Catgut embedding therapy and abdominal acupuncture are currently not in widespread use with insufficient evidence. Acupuncture therapies appear to be safe. Most of the reviews were assessed as having high risk of bias and low confidence in the findings. Conclusion: There is a need for larger and more methodologically sound randomized controlled trials to evaluate the effectiveness of acupuncture therapies for individuals who are affected by overweight or obesity.

[Technical recommendations for pragmatic randomized controlled trials of heat-sensitive moxibustion in community (â ¡): organization, implementation and follow-up visits].

Based on the community research experience of heat-sensitive moxibustion, this study explained technical recommendations for pragmatic randomized controlled trials (pRCTs) of heat-sensitive moxibustion in community from 7 aspects: selection of community research sites, ethical approval and registration, patient recruitment, training of standard operating procedures, ensuring patient compliance, quality control of follow-up visits and patient safety, which aimed to reduce the difficulty of research execution and improve the quality of pRCTs implementation and follow-up visits of heat-sensitive moxibustion.

Application of the Delphi Method in the Construction of an Evaluating and Grading Scale for Evidence of Disease Prevention and Treatment in Ancient Books of Traditional Chinese Medicine.

Objective: This study aimed to develop a scale for evaluating and grading the evidence of prevention and treatment in ancient books of traditional Chinese medicine (TCM), in view of providing a reference for TCM clinicians, supporting the compilation or revision of evidence-based practice guidelines for TCM, improving the level of evidence-based research on ancient TCM books, and supplementing the development of evidence-based ancient TCM books. Methods: The Delphi method was used for consultation among 40 experts in relevant fields. Excel 2016 and SPSS 21.0 were used to analyze the positive coefficient, authority coefficient, degree of concentration, degree of coordination, and degree of expert consensus. Results: In the first round of the questionnaire, a total of 17 evaluation indexes were formulated in three aspects: 5 were deleted, 1 was modified according to the expert opinions, and no additional index was added. In addition, quantitative standards, weight assignment, and grading standards were developed according to the findings of the expert consultation. The positive coefficients of experts in the first and second rounds of questionnaires were 87.5% and 82.9%, respectively. The authority coefficient was 0.835 (>0.7). The coefficient of variation of the first and second rounds were 0.14∼0.29 and 0.09∼0.27, respectively. Kendall's coefficient of concordance of the first and second rounds were 0.135 (p < 0.05) and 0.081 (p < 0.05), respectively. Conclusion: The evaluation indexes and quantitative reference values of the developed scale conform to the characteristics of prevention and treatment evidence in ancient TCM books. It can provide a useful exploration tool for the evaluation and grading of evidences in TCM ancient books.

Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study.

INTRODUCTION: Migraine is a disabling, recurrent headache disorder with complex comorbidities. Conventional treatments for migraine are unsatisfactory, with side effects and limited effectiveness. Chinese herbal medicine (CHM) has been used as an alternative or complementary treatment option for migraine in China. Currently, the existing evidence of benefit of CHM for migraine has been generated from randomised clinical trials using standardised intervention with a focus on internal validity hence with limited external validity. Moreover, CHM individualised intervention design, patients' preferences and concerns, and clinicians' experience are critical to clinical decision making and therapeutic success. This real-world observational study aims to gather practice-based evidence of effects and safety of CHM for migraine in the context of integrating Chinese medicine diagnostic procedures, patients' preferences and matters relevant to clinical decision making. METHODS AND ANALYSIS: The study is being undertaken at the Guangdong Provincial Hospital of Chinese Medicine (GPHCM) from December 2020 to May 2022. We anticipate that approximately 400 adult migraineurs will be enrolled and observed on their migraine severity, analgesic consumption, quality of life, anxiety, depression and insomnia at baseline and then every four weeks over 12 weeks. Treatments, diagnostic information, and patient-reported most bothersome symptoms will be collected from patient clinical records. Patient's demographic data, preferences and concerns on CHM treatments will also be gathered at baseline and be analysed. Factors related to clinical outcomes will be explored with multiple correlation and multivariable regression analyses. Effects of CHM will be evaluated using generalised estimated equation, based on clinical outcome data. DISCUSSION: This study will provide comprehensive evidence of CHM for migraine in the context of evidence-based practice. TRIAL REGISTRATION NUMBER: ChiCTR2000041003.

Comparative effectiveness of phlegm-heat clearing Chinese medicine injections for AECOPD: A systematic review and network meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Qingkailing (QKL), Reduning (RDN), Xiyanping (XYP), Tanreqing (TRQ) and Yuxingcao (YXC) injections are all phlegm-heat clearing Chinese medicine (CM) injections composed of the extract from traditional CM materials. Evidence from clinical studies and animal experiments indicates that the above CM injections are effective supplementary therapy for acute exacerbation chronic obstructive pulmonary disease (AECOPD), and clinicians are faced with a difficult choice on the optimal phlegm-heat clearing CM injection for AECOPD. AIM OF THE STUDY: This systematic review and Bayesian network meta-analysis aimed to evaluate the comparative effectiveness of five commonly used phlegm-heat clearing CM injections for COPD. MATERIALS AND METHODS: A pairwise and network meta-analyses were performed to assess the effectiveness of QKL, RDN, TRQ, XYP and YXC on AECOPD. Randomized controlled trials (RCTs) were identified by searching English and Chinese databases. The primary outcome was lung function (forced expiration volume [FEV1] and forced vital capacity [FVC]), blood gas analysis index was secondary outcome measure. Winbugs and Stata 15.0 software were used for data analysis. RESULTS: A total of 57 RCTs were included. The pairwise analyses showed that each of the injections combined with routine treatment were superior to routine treatment alone [FEV1: QKL, MD 0.20, 95% CI (0.06, 0.35); RDN, MD 0.24, 95% CI (0.08, 0.40); TRQ, MD 0.24, 95% CI (0.19, 0.29); XYP, MD 0.26, 95% CI (0.20, 0.32); YXC MD 0.73, 95% CI (0.06, 1.41)]. The network meta-analysis provided the following rank of lung function improvement: FEV1: YXC > TRQ > XYP > RDN > QKL; FVC: YXC > TRQ > QKL > RDN > XYP. RDN and YXC ranked highest in blood gas analysis index. RDN was the highest ranked injection for effectiveness, followed by QKL, TRQ, XYP, then YXC. Most of the injections appeared safe, with severe adverse events rarely reported. CONCLUSION: This study suggests that YXC and TRQ are the most effective therapies in treating AECOPD patients. RDN and YXC are more effective in the alleviation of clinical symptoms. Given that the safety of YXC is controversial, TRQ and RDN may be preferable as phlegm-heat clearing CM injections in the adjuvant treatment of AECOPD.