Traditional Chinese medicine for insomnia: Recommendation mapping of the global clinical guidelines.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese Medicine (TCM) represents a rich repository of empirically-developed traditional medicines. The findings call for more rigorous study into the efficacy, safety, and mechanisms of action of TCM remedies to strengthen the evidence base. AIM OF THE STUDY: To systematically review the quality of insomnia clinical practice guidelines that involve TCM recommendations and to summarize the certainty of evidence supporting the recommendations, strength, and consistency of recommendations, providing valuable research references for the development of future insomnia guidelines. MATERIALS AND METHODS: We systematically searched PubMed, Web of Science, Embase, CNKI, Wanfang, Chinese Biomedical Literature Database, Chinese Medical Association, Chinese Sleep Research Society, Medsci, Medlive, British National Institute of Health and Clinical Excellence (NICE), and the International Guidelines Collaboration Network (GIN) for clinical practice guidelines on insomnia from inception to March 5, 2023. Four evaluators conducted independent assessments of the quality of the guidelines by employing the AGREE II tool. Subsequently, the guideline recommendations were consolidated and presented as evidence maps. RESULTS: Thirteen clinical practice guidelines addressing insomnia, encompassing 211 recommendations (consisting of 127 evidence-based and 84 expert consensus recommendations), were deemed eligible for inclusion in our analysis. The evaluation results revealed an overall suboptimal quality, with the "scope and purpose" domain achieving the highest score (58.1%), while the "applicability" domain garnered the lowest score (13.0%). Specifically, it was observed that 74.8% (n = 95) of the evidence-based recommendations were supported by evidence of either very low or low certainty, in contrast to the expert consensus recommendations, which accounted for 61.9% (n = 52). We subsequently synthesized 44 recommendations into four evidence maps, focusing on proprietary Chinese medicines, Chinese medicine prescriptions, acupuncture, and massage, respectively. Notably, Chinese herbal remedies and acupuncture exhibited robust support, substantiated by high-certainty evidence, exemplified by interventions such as Xuefu Zhuyu decoction, spleen decoction, body acupuncture, and ear acupuncture, resulting in solid recommendations. Conversely, proprietary Chinese medicines needed more high-certainty evidence, predominantly yielding weak recommendations. As for other therapies, the level of certainty was predominantly categorized as low or very low. Recommendations about magnetic therapy, bathing, and fumigation relied primarily on expert consensus, needing more substantive clinical research evidence, consequently forming weak recommendations. Hot ironing and acupoint injection recommendations were weakly endorsed, primarily based on observational studies. Furthermore, interventions like qigong, gua sha, and moxibustion displayed a relatively limited number of clinical studies, necessitating further exploration to ascertain their efficacy. CONCLUSIONS: Our analysis revealed a need for substantial improvement in the quality of all the included guidelines related to insomnia. Notably, recommendations for Traditional Chinese Medicine (TCM) treatments predominantly rely on low-certainty evidence. This study represents a pioneering effort in the utilization of recommendation mapping to both present and identify existing gaps in the evidence landscape within TCM therapies, thus setting the stage for future research initiatives. The evidence supporting TCM therapy recommendations must be fortified to achieve a more substantial level of recommendation and higher certainty. Consequently, there exists a critical and pressing demand for high-quality clinical investigations dedicated to TCM, with a specific focus on ascertaining its long-term efficacy, safety, and potential side effects in the context of insomnia treatment. These endeavors are poised to establish a robust scientific foundation to inform the development of TCM therapy recommendations within the insomnia guidelines.

Traditional Chinese medicine for smoking cessation: An umbrella review of systematic reviews and meta-analysis of randomized controlled trials.

INTRODUCTION: Traditional Chinese medicine (TCM) may have special advantages in facilitating smoking cessation, but consensus on effectiveness is lacking. We aim to comprehensively review, update, and refine current evidence on TCM effectiveness and safety. METHODS: Nine databases were searched from their inception up to 28 February 2023. Systematic reviews (SRs) and meta-analysis of TCM for smoking cessation were identified and retrieved. Additional databases and hand searches of RCTs from included SRs were performed for data pooling. Cochrane ROB tools and AMSTAR-2 were used to evaluate the methodological quality of RCTs and SRs, respectively. RCT data are presented as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI) using RevMan 5.4. RESULTS: Thirteen SRs involving 265 studies with 33081 participants were included. Among these 265 studies, 157 were duplicates (58.36%) and 52 were non-RCTs (19.62%). Combined with the remaining 56 RCTs identified through hand searches, 88 RCTs involving 12434 participants were finally included for data synthesis. All the SRs focused on acupoint stimulation, and the majority were of low or very low quality. The methodological quality of RCTs was either unclear or high risk. For continuous abstinence rate, TCM external interventions were better than placebo in 6 months to 1 year (RR=1.60; 95% CI: 1.14-2.25; I2=27%; n=5533 participants). Compared with placebo, TCM external application was effective in reducing nicotine withdrawal symptoms, and the effect was gradually stable and obvious in the fourth week (MD= -4.46; 95% CI: -5.43 - -3.49; n=165 participants). Twelve RCTs reported adverse events as outcome indicators for safety evaluation, and no serious adverse events occurred. CONCLUSIONS: Despite the methodological limitations of the original studies, our review suggests that TCM intervention shows potential effectiveness on the continuous abstinence rate. Extending the intervention time can enhance the effect of TCM on nicotine withdrawal symptoms. Referred to adverse events, more data for safety evaluation are required.

Systematic review and meta-analysis of Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: Evidence for clinical practice and future trials.

Introduction: Diarrhea-predominant irritable bowel syndrome (IBS-D) significantly decreases the quality of life of patients and their families, and affects patients' mental health. No specific western medications are available. Ancient classical Chinese medical texts have recognized Tongxie Yaofang (TXYF) as a therapy for diarrhea which is widely used in clinical practice. Standard TXYF prescription (S-TXYF) is composed of four herbal medicines: Atractylodes macrocephala Koidz. [Asteraceae; Rhizoma Atractylodis Macrocephalae.], Paeonia lactiflora Pall. [Ranunculaceae; Paeoniae Radix Alba], Citrus × aurantium L. [Rutaceae; Citri Reticulatae Pericarpium] and Saposhnikovia divaricata (Turcz. ex Ledeb.) Schischk. [Umbelliferae; Saposhnikoviae Radix]. This review aimed to evaluate the therapeutic effects and safety of S-TXYF for IBS-D. Methods: Eight English and Chinese electronic databases were searched from their inception to 25 December 2021 for randomized controlled trials (RCTs) comparing S-TXYF with placebo, western medications or no treatment for IBS-D. The primary outcome was the global improvement of IBS-D symptoms. Data were analyzed using Cochrane's Revman 5.4 software. Evidence certainty was assessed using the online GRADEpro tool for the primary outcome. Results: Eleven RCTs involving 985 adults with IBS-D were included. For global improvement of symptoms, S-TXYF was superior to western medication and placebo (moderate evidence by GRADE). Regarding the improvement of stool consistency, stool frequency and abdominal pain, S-TXYF was significantly effective than placebo. In addition, S-TXYF was superior to western medication on improving the quality of life and relieving anxiety. Six trials reported adverse events: five of them reported (non-serious) adverse events occurred in both groups, and one trial reported that 3 cases with adverse events (constipation, elevation in liver-enzyme, nausea) occurred in S-TXYF group and 3 cases with adverse events (abdominal distension, nausea) occurred in placebo group. Conclusion: Although current results showed that S-TXYF may have potential to treat IBS-D and its use appears to be safe, no a clear and confirmed conclusion can be drawn from our review as the overall inadequate design of the included trials reviewed. So more rigorous trials are warranted to establish confirmed evidence on its benefits and safety.

Chinese Herbal Medicine for Mild Cognitive Impairment: A Systematic Review of Randomized Controlled Trials.

Objectives: This study aims to explore the benefits and harms of Chinese Herbal Medicine (CHM) for mild cognitive impairment (MCI). Methods: Electronic searching was conducted in two English and four Chinese databases till 2021 December. Randomized clinical trials on CHM compared to no intervention, placebo or other therapies for MCI were included. Results: Forty-nine RCTs (48 finished trials and 1 protocol) were identified. The overall methodological quality of included trials was relatively low. This review found that compared to no intervention or placebo, CHM can significantly decrease the number of patients who progressed to dementia (RR 0.36, 95% CI 0.22-0.58) and increase the cognitive function assessed by MMSE (MD 1.96, 95% CI 1.41-2.50) and MoCA (MD 2.44, 95% CI 1.57-3.31). The subgroup analysis of different CHM showed that Ginko leaf tablets can significantly improve the cognitive function compared to no intervention or placebo when assessed by MMSE (MD 2.03, 95% CI 1.18-2.88) and MoCA (MD 3.11, 95% CI 1.90-4.33). Compared to western medicine, CHM can significantly increase the score of MMSE (MD 0.88 95% CI 0.46-1.30) and MoCA (MD 0.87, 95% CI 0.33-1.41), but there was no significant difference on the score of ADL (SMD -0.61, 95% CI -1.49 to 0.27). None of the RCTs reported on the quality of life. Of 22 RCTs that reported adverse events, there was no statistical difference between the CHM and the control group. Conclusions: CHM, Ginko leaf extracts in particular, could help to prevent progression into dementia and to improve cognitive function and ability of daily living activities. More qualified RCTs were needed to confirm the conclusion due to the low quality of current trials. Systematic Review Registration: Unique Identifier: CRD42020157148.

[Systematic review of efficacy and safety of Ginkgo biloba extract 50 in treatment of ischemic stroke].

The present study aimed to systematically evaluate the efficacy and safety of Ginkgo biloba extract 50(GBE50) in the treatment of ischemic stroke. The databases including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library were searched for randomized controlled trial(RCT) of GBE50 for the treatment of ischemic stroke reported between database inception and May 2020. The methodological quality of the included RCTs was evaluated via the Cochrane risk of bias tool. The RevMan 5.4 was used for Meta-analysis. Sixteen RCTs were included, involving 1 615 patients with acute ischemic stroke. Most of the included RCTs reported the methods of random sequence generation, but only two performed the concealment of random sequence. All RCTs failed in blinding. Two RCTs reported the information of cases lost to follow-up and drop-outs. Since the number was small, the baselines of groups remained balanced. All RCTs reported key outcomes of ischemic stroke, which made selective reporting bias in a low risk. Meta-analysis results revealed that GBE50 combined with routine therapies could effectively lower the score of the National Institutes of Health stroke scale(NIHSS) and restore cognitive function and daily activity in ischemic stroke patients. Compared with routine therapies, the combination is advantageous in treating patients with ischemic stroke. However, high-quality multicenter RCTs with large sample sizes are still required for verification.

Diagnosis and Treatment for Mild Cognitive Impairment: A Systematic Review of Clinical Practice Guidelines and Consensus Statements.

Background: Mild cognitive impairment (MCI) is an important stage between the normal cognitive decline of aging and dementia. The aim of this study was to compare and harmonize the recommendations for the diagnosis and treatment of MCI based on current clinical practice guidelines. Methods: We searched the PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, and Chinese Biological Medicine Database from their inception date to April 24, 2021 to identify all published guidelines on MCI. The qualities of the eligible guidelines were appraised by two reviewers using the Appraisal of Guidelines for Research and Evaluation II instrument. Results: Thirteen guidance documents (four guidelines and nine consensus statements) with specific recommendations were included. Nine guidelines and consensus statements covered the screening and diagnosis of MCI. The evaluation of the documents showed that neuropsychological testing and biomarker assessments were the most common recommendations for the diagnosis of MCI. Nine of the 13 guidance documents covered the treatment and management of MCI. The recommendations for the treatment and management were classified into four categories, namely: intervention for risk reduction, pharmacologic interventions, non-pharmacologic interventions, and counseling. Regarding pharmacological interventions, three guidelines recommend no pharmacologic intervention. The use of cholinesterase inhibitors for MCI is contraindicated in three guidance documents, whereas one proposes that cholinesterase inhibitors and memantine should be deprescribed. EHb761®, Chinese herbal decoctions, and Chinese traditional patent medicine are recommended in two documents. A total of seven guidance documents recommend non-pharmacological interventions, including physical activity interventions, cognitive interventions, dietary and nutritional interventions, and acupuncture. Conclusion: An updated search for possible evidence on the diagnosis and treatment of MCI is needed. Potentially effective diagnoses and treatments, either conventional or complementary, and alternative therapies should be highly valued and addressed in correlation with the supporting evidence.

[Consideration on establishing evaluation system of clinical practice guidelines in traditional Chinese medicine].

Standardization is the technical support for the development of traditional Chinese medicine(TCM), and the guidelines have become the main component of the core standards of TCM technology. With the rise and development of evidence-based medicine in China, more than 500 guidelines have been issued in China, and the number is still increasing, but the quality of guidelines still lags far behind the international level. Similarly, the formulation of evidence-based clinical practice guidelines for TCM has gradually attracted the attention of the industry, but the quality is not so good, and most guidelines are not really evidence-based guidelines. Only reliable guidelines can fully and effectively play the role of clinical guidance. In order to comprehensively improve the scientificity and credibility of the guidelines, guideline evaluation can be used as a means to improve the quality of the guidelines. For the development of traditional Chinese medicine, it has become an urgent task to establish a complete evaluation standard system of guidelines, especially the evaluation standard system that conforms to the technical characteristics of traditional Chinese medicine. In this paper, the advantages and limitations of a series of domestic and foreign guideline evaluation tools were systematically analyzed, and the thinking and difficulties to establish the evaluation system of TCM guidelines were put forward, with a purpose to further improve the quality of TCM clinical practice guidelines, so that they can be better applied in clinical practice to enhance the clinical efficacy of TCM and ensure the quality of medical services.

[Quality evaluation recommendation list and interpretation of traditional Chinese medicine clinical practice guidelines].

Based on the idea of establishing a complete guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believes that a complete guideline evaluation system of traditional Chinese medicine clinical practice should be divided into three parts: quality evaluation, clinical applicability evaluation and clinical application investigation. According to the different purposes, different evaluators, different evaluation methods and different evaluation time points in the guideline evaluation, the quality evaluation recommendation list, the clinical applicability evaluation recommendation list and the clinical application questionnaire were formed. Among them, the purpose of quality evaluation is to evaluate the methodological quality in the guideline development process, in order to measure whether the entire guideline development process is scientifically rigorous. The evaluators must be the methodologists with an evidence-based medicine background. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. By referring to the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM by considering the characteristics of TCM field. In this paper, the author introduces the whole list of quality evaluation recommendations, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

[Applicability evaluation recommendation list and interpretation of traditional Chinese medicine clinical practice guidelines].

The development of the guidelines should not only meet the rigorous methodological requirements, but also ensure the credibility or enforceability of the guideline recommendations when they are applied in clinical practice. Based on the idea of establi-shing a perfect guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believed that a complete evaluation system of clinical practice guidelines in the field of TCM shall be divided into three parts: quality evaluation, applicability evaluation and clinical application investigation. Among them, applicability evaluation refers to the evaluation of the degree of fit between the guideline and clinical practice, that is, whether the guidelines have good readability and clinical applicability to promote clinical application. The evaluators are clinical experts in the related fields of TCM. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. Based on the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM. In this paper, the author introduces the whole list of quality evaluation, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

[Systematic review on clinical efficacy and safety of Cheezheng Pain Relieving Plaster for soft tissue injury].

To systematically evaluate the clinical efficacy and safety of Cheezheng Pain Relieving Plaster in the treatment of soft tissue injury. Four Chinese databases(namely CNKI, WanFang, VIP, CBM) and 2 English databases(namely PubMed, Cochrane Library) were retrieved from the establishment of each database to March 2019. The randomized controlled trials of Cheezheng Pain Relieving Plaster compared with routine therapy in treatment of soft tissue injury were included. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool. Five studies were included, and 367 patients were enrolled. None of the included studies reported randomized concealment, blinding, follow-up and dropping off. The results showed that Cheezheng Pain Relieving Plaster may have advantages in alleviating joint pain, swelling, tenderness and dysfunction and other symptoms, with no serious adverse reaction. Compared with routine therapy, Cheezheng Pain Relieving Plaster may have advantages in the treatment of soft tissue injury. However, due to the quality of the included RCTs, the conclusions of this study were limited. In addition, to produce high-quality evidences for the clinical application of Cheezheng Pain Relieving Plaster, the conclusions of this study shall be further verified with large-sample, scientifically designed and strictly implemented clinical trials.

[Bibliometric analysis and quality assessment of clinical evidence on Xiaotong Tiegao].

Many clinical studies on Cheezheng Xiaotong Tiegao have been accumulated since it was launched in 1993,but they have not been comprehensively analyzed and evaluated. This study systematically retrieved relevant studies in six databases at home and abroad as of December 2017. This study analyzed the statistics of the included studies in several aspects,including publication time,region,fund,disease category and type of study. In this study,various tools were used to evaluate the methodological quality of included studies,such as the Cochrane collaboration's tool for assessing the risk of bias in randomized trials,MINORS,IHE,AMSTAR2.The results showed that the literatures were mainly published from 2010 to 2011,and a total of 28 projects were financially supported.The most involved disease was arthropathy. The randomized controlled trials were the majority in the included studies,but the quality was low,and most of the literatures didn't report the allocation concealment and blinding. This study comprehensively reflected the current situations and shortcomings of the clinical studies of Cheezheng Xiaotong Tiegao,and put forward several suggestions,in the expectation of providing a reference for the future clinical research direction of Cheezheng Xiaotong Tiegao.

Dioscorea nipponica Makino: a systematic review on its ethnobotany, phytochemical and pharmacological profiles.

Dioscorea nipponica Makino is a perennial twining herbs belonging to the family Dioscoreaceae, which is mainly distributed in the northeastern, northern, eastern and central regions of China. Traditionally, the rhizome of this herb has been commonly used by Miao and Meng ethnic groups of China to treat rheumatoid arthritis, pain in the legs and lumbar area, Kashin Beck disease, bruises, sprains, chronic bronchitis, cough and asthma. Modern pharmacological studies have discovered that this herb possesses anti-tumor, anti-inflammatory, anti-diuretic, analgesic, anti-tussive, panting-calming and phlegm-dispelling activities, along with enhancing immune function and improving cardiovascular health. In recent years, both fat-soluble and water-soluble steroidal saponins were isolated from the rhizomes of D. nipponica using silica gel column chromatography, thin layer chromatography and high performance liquid chromatography methods. Saponin and sapogenins are mainly responsible for most of the pharmacological effects of this plant. Further, the chemical components of the aboveground parts contain more than 10 kinds of phenanthrene derivatives. The present review summarizes the knowledge concerning the geographical distribution, chemical composition, pharmacological effects, toxicology studies and clinical applications of D. nipponica.

[Reporting criteria for clinical experts consensus of Chinese medicine].

Due to its own characteristics and research status, traditional Chinese medicine research often faces the reality of "insufficient evidence" or "very low quality" when making clinical practice guidelines. Therefore, in many cases, clinical decision-making of traditional Chinese medicine should rely mainly on expert consensus to achieve. A clear and detailed list of expert consensus report specifications will provide a good reporting tool for Chinese clinical expert consensus makers, which is very important for promoting the quality of consensus production and the promotion and application of consensus results. The author consulted the internationally published authoritative expert consensus, summarized the main points of the reports, combined with the formulation process of the clinical experts consensus of Chinese medicine, and the demonstration of clinical experts and methodologists, and then formulated the list of items for clinical expert consensus reports adapt to the field of Chinese medicine. This article introduces the entire list of items and elaborates on the key parts. It is expected to provide reference for the standardization of future clinical expert consensus reports.