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.

Chinese herbal injections in combination with radiotherapy for advanced pancreatic cancer: A systematic review and network meta-analysis.

Background: Advanced pancreatic cancer (APC) is a fatal disease with limited treatment options. This study aims to evaluate the effectiveness and safety of different Chinese herbal injections (CHIs) as adjuvants for radiotherapy (RT) in APC and compare their treatment potentials using network meta-analysis. Methods: We systematically searched three English and four Chinese databases for randomized controlled trials (RCTs) from inception to July 25, 2023. The primary outcome was the objective response rate (ORR). Secondary outcomes included Karnofsky performance status (KPS) score, overall survival (OS), and adverse events (AEs). The treatment potentials of different CHIs were ranked using the surface under the cumulative ranking curve (SUCRA). The Cochrane RoB 2 tool and CINeMA were used for quality assessment and evidence grading. Results: Eighteen RCTs involving 1199 patients were included. Five CHIs were evaluated. Compound Kushen injection (CKI) combined with RT significantly improved ORR compared to RT alone (RR 1.49, 95 % CrI 1.21-1.86). Kanglaite (KLT) plus RT (RR 1.58, 95 % CrI 1.20-2.16) and CKI plus RT (RR 1.49, 95 % CrI 1.16-1.95) were associated with improved KPS score compared to radiation monotherapy, with KLT+RT being the highest rank (SUCRA 72.28 %). Regarding AEs, CKI plus RT was the most favorable in reducing the incidence of leukopenia (SUCRA 90.37 %) and nausea/vomiting (SUCRA 85.79 %). Conclusions: CKI may be the optimal choice of CHIs to combine with RT for APC as it may improve clinical response, quality of life, and reduce AEs. High-quality trials are necessary to establish a robust body of evidence. Protocol registration: PROSPERO, CRD42023396828.

Approach to Assess Adequacy of Acupuncture in Randomized Controlled Trials: A Systematic Review.

OBJECTIVE: To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials (RCTs) for proposing a new improved instrument. METHODS: A systematic literature search was carried out in 7 electronic databases from inception until 21st November 2022. Any study evaluating the adequacy or quality of acupuncture, specifying specific acupuncture treatment-related factors as criteria of subgroup analysis, or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was included. Basic information, characteristics and contents of acupuncture adequacy assessment were presented as frequencies and percentages. RESULTS: Forty studies were included in this systematic review. Thirty-five studies (87.50%) were systematic reviews, none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy; of 5 methodological studies, only 1 study used a relatively formal method. Thirty-two studies (82.05%) assessed the components of acupuncture, while 7 (17.95%) assessed the overall quality of acupuncture. An independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies (74.35%), whereas as one part of a methodological quality assessment scale in 10 (25.65%). Only 9 (23.00%) studies used the assessment results for subgroup analysis, sensitivity analysis or the criteria for inclusion in the meta-analysis. CONCLUSION: Assessment contents for adequacy or quality of acupuncture in RCTs hadn't still reached consensus and no widely used assessment tools appeared. The methodology of available assessment instruments/scales is far from formal and rigorous. A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.

Chinese herbal medicine for drug-induced liver injury in patients with HIV/AIDS: A systematic review of randomized controlled trials.

Background: To explore the effectiveness and safety of Chinese herbal medicine (CHM) for drug-induced liver injury (DILI) in patients with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Methods: A systematic search was made of eight databases (Pubmed, Cochrane Library, Web of Science, Embase, CNKI, Wanfang, VIP, Sinomed) and two trial registries (WHO ICTRP, ClinicalTrials.gov) from inception to September 2022. The effect size was presented as risk ratio (RR) or mean difference (MD) with their 95% confidence interval (CI). The Cochrane Risk of Bias and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tools were used for quality appraisal. Results: Ten randomized controlled trials (RCTs) involving 732 participants were included. Comparing CHM alone with routine treatment, the CHM group showed lower aspartate aminotransferase (MD=-11.47 U/L, 95%CI[-13.05, -9.89], low certainty), lower alanine aminotransferase (MD=-2.68 U/L, 95%CI[-4.27, -1.08], low certainty), lower total bilirubin (MD=-4.31 mmol/L, 95%CI[-5.66, -2.96], low certainty), lower bilirubin direct (MD=-3.19 mmol/L, 95%CI[-3.87, -2.51], low certainty), and higher effective rate (assessed by symptoms and liver indicators) (RR=1.13, 95%CI[1.06, 1.20], low certainty). A significant difference was also found in CHM plus routine treatment versus routine treatment in the previous outcomes. No significant difference was found on helper T cells among these comparisons. Only one RCT reported safety of CHM and found no adverse reaction during the trial. Conclusions: CHM may improve the liver function indices and effective rate for HIV/AIDS patients with DILI. However, the sample size was small and quality was low. Larger-samples of high-quality trials are needed.

Effectiveness and Safety of Chinese Medicine at Shenque (CV 8) for Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Primary dysmenorrhea (PD) is the most common complaint associated with menstruation and affects up to three-quarters of women at some stage of their reproductive life. In Chinese medicine, navel therapy, treatment provided at Shenque (CV 8), is used as a treatment option for PD. OBJECTIVE: To evaluate the effect of navel therapy on pain relief and quality of life in women with PD, compared with Western medicine (WM). METHODS: China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), SinoMed and Wanfang Database, MEDLINE, the Cochrane Library, Embase, Web of Science, and the International Clinical Trial Registry of the U.S. National Institutes of Health were searched from their inceptions to April 1, 2021. Randomized controlled trials (RCTs) assessing therapeutic effects of navel therapy on PD were eligible for inclusion. RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool. RESULTS: Totally 24 RCTs involving 2,614 participants were identified. Interventions applied to acupuncture point CV 8 included: herbal patching, moxibustion or combined navel therapy (using at least 2 types of stimulation). Compared to placebo, there was a significant effect in favor of navel therapy on reducing overall menstrual symptom scores at the end of treatment [mean difference: -0.82, 95% confidence interval (CI): -1.00 to -0.64, n=90; 1 RCT]. As compared with Western medicine, navel therapy had a superior effect on pain intensity as assessed by Visual Analogue Scale at the end of treatment [standardized mean difference (SMD): -0.64, 95% CI: -1.22 to -0.06, I2=80%, n=262; 3 RCTs]; on symptom resolution rate at 3-month follow-up (risk ratio: 1.94, 95% CI: 1.47 to 2.56, n=1527, I2=38%; 13 RCTs); and on global menstrual symptoms score at the end of treatment (SMD: -0.67, 95% CI: -0.90 to -0.45, I2=63%, n=990; 12 RCTs). Subgroup analyses showed either a better or an equivalent effect comparing navel therapy with Western medicine. No major adverse events were reported. The methodological quality of included trials was poor overall. CONCLUSIONS: Navel therapy appears to be more effective than Western medicine in decreasing menstrual pain and improving overall symptoms of PD. However, these findings need to be confirmed by well-designed clinical trials with adequate sample size (Systematic review registration at PROSPERO, No. CRD42021240350).

The Effect of Auriculotherapy on Situational Anxiety Trigged by Examinations: A Randomized Pilot Trial.

BACKGROUND: Auriculotherapy may activate the parasympathetic nerve system and reduce anxiety levels. Short-term auriculotherapy's effects and safety on university students' anxiety levels was assessed prior to exams. METHODS: A randomized, controlled pilot trial was conducted. The day before the exam, university students were randomly allocated to the auriculotherapy group (AA, n = 13) or the waiting-list group (WG, n = 13). Baseline measures were taken 4 weeks before the exam at Time point (TP 0); at 7.30 a.m. on the day before the exam (TP I); at 11 a.m. before auriculotherapy (TP II); 30 min after AA (TP III); and at 7.30 a.m. before the exam (TP IV). The outcomes were the State-Trait-Anxiety Inventory (STAI); quality of night-sleep, Visual Analogue scale (VAS) for anxiety, and salivary cortisol. Adverse events were also recorded. RESULTS: A total of 26 students participated in this study and became more anxious as assessed by STAI in TPII (p = 0.002) and TPIV (p = 0.000) than TP0. AA reduced the STAI in TPIII (p = 0.045) and PIV (p = 0.001) and the VAS (p = 0.012) in TPIV. Cortisol was reduced in TPIII (p = 0.004), and the AA slept better (p = 0.014) at TPIV. Discomfort at the auricular site was reported in only one AA participant. CONCLUSIONS: Auriculotherapy appeared safe and effective in reducing anxiety levels before university exams.

Acupuncture for cancer-related conditions: An overview of systematic reviews.

BACKGROUND: Acupuncture is commonly used for cancer-related conditions worldwide, and evidence is increasing year on year. There is a need to summarize the evidence of acupuncture for cancer-related conditions comprehensively and critically. OBJECTIVE: To evaluate and summarize the systematic reviews (SRs) that assess the effects and safety of acupuncture for cancer-related conditions, and to inform clinical practice and future studies. METHODS: A comprehensive search was conducted on Pubmed, Embase, the Cochrane Library, Web of Science, CNKI, VIP, Sinomed, and Wanfang from their inception to October 16, 2021. SRs of randomized controlled trials (RCTs) on acupuncture for cancer-related conditions were to be included. Two reviewers screened the eligible articles, and four reviewers in pair extracted data and assessed the methodological quality/risk of bias of all included reviews by AMSTAR 2 and ROBIS tools. The overlap of primary studies was measured by calculating corrected covered areas. Data from the included reviews were synthesized with a summary of meta-analysis or narrative description. RESULTS: Fifty-one SRs of RCTs on acupuncture for cancer-related conditions were included and synthesized. The methodological quality of SRs included 1 "high", 5 "low" and 45 "very low" by AMSTAR 2. Sixteen SRs assessed as low risk of bias (31.37%), and 35 SRs had high risk of bias (68.63%) by ROBIS. Acupuncture showed effective on systemic conditions in relation to different cancers, including cancer-related pain (17 SRs, 80 RCTs), fatigue (7 SRs, 18 RCTs), insomnia (4 SRs, 10 RCTs), quality of life (2 SRs, 15 RCTs); conditions in relation to chemo-radiotherapy, including nausea and vomiting (3 SRs, 36 RCTs) and bone marrow suppression (2 SRs, 21 RCTs); and conditions in relation to specific cancers, including breast cancer-related menopause (3 SRs, 6 RCTs), hot flashes (12 SRs, 13 RCTs), arthralgia (5 SRs, 10 RCTs), and nasopharyngeal cancer-related dysphagia (1 SRs, 7 RCTs). Acupuncture appeared to have benefit for patients with lymphoedema (3 SRs, 3 RCTs), gastrointestinal function (5 SRs, 27 RCTs), and xerostomia (4 SRs, 7 RCTs). Limited evidence showed inconsistent results on acupuncture for chemotherapy-induced peripheral neuropathy (3 SRs, 6 RCTs), depression and anxiety (3 SRs, 9 RCTs). Acupuncture was regarded as a safe therapy for cancer patients as no severe adverse events related were reported. CONCLUSION: Evidence from SRs showed that acupuncture is beneficial to cancer survivors with cancer-related pain, fatigue, insomnia, improved quality of life, nausea and vomiting, bone marrow suppression, menopausal symptoms, arthralgia, and dysphagia, and may also be potential for lymphoedema, gastrointestinal function, and xerostomia. For neuropathy, depression and anxiety, acupuncture should be used as an option based on individual conditions. Acupuncture is relatively safe without serious adverse events. More well-designed clinical trials of acupuncture are recommended on cancer-related depression and anxiety, arthralgia, xerostomia, gastrointestinal dysfunction and dysphagia.

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.

Warm needle acupuncture for osteoarthritis: A systematic review and meta-analysis.

BACKGROUND: Warm needle acupuncture (WA) is considered a potential intervention in the treatment of osteoarthritis (OA). PURPOSE: To systematically evaluate the clinical efficacy and safety of WA in the treatment of OA. STUDY DESIGN: Systematic review and meta-analysis METHODS: Fourteen databases were searched from their inception until May 2022. Randomized controlled trials (RCTs) of WA for treating OA were identified. Study selection and data extraction were performed by two independent reviewers. The Cochrane risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation program were used to assess all included RCTs. RESULTS: A total of 66 RCTs met the inclusion criteria for this review. Most of the included studies had an unclear risk of bias, and the certainty of the evidence was very low. Twenty-four RCTs compared the effects of WA with those of oral drug therapies. Meta-analysis showed superior effects of WA for the total effective rate (risk ratio (RR): 1.22, 95% confidence interval (CI): 1.17 to 1.27, I2 = 26%, p < 0.001, 24 studies, n = 2278), pain, and function. Eight RCTs compared the effects of WA+drug therapy, and meta-analysis showed favorable effects for the total effective rate (RR: 1.27, 95% CI: 1.18 to 1.35, I2 =0%, p < 0.001, 8 studies, n = 646). Eight RCTs compared the effects of WA and intra-articular sodium hyaluronate (IASH) injection on OA and found equivalent effects of WA on the symptoms of OA. Twenty-eight RCTs compared the effects of WA+IASH injection with those of IASH injection, and meta-analysis showed superior effects of WA+IASH in terms of the total effective rate (RR: 1.15, 95% CI: 1.11 to 1.19, I2 =27.3%, p < 0.001, 25 studies, n = 2208), pain, and function. None of the RCTs reported serious adverse events. CONCLUSIONS: WA may have some distinct advantages in the treatment of OA. However, well-designed RCTs with larger sample sizes are needed.

Acupuncture as a post-stroke treatment option: A narrative review of clinical guideline recommendations.

BACKGROUND: Acupuncture may be useful to treat the various clusters of symptoms occurring after a stroke. The use of evidence to underpin clinical practice and treatment guidelines (CPGs and TGs respectively) varies from country to country and may affect what recommendations are made by guideline developers. PURPOSE: To examine the extent to which international clinical and treatment guidelines on post-stroke treatment mention the role of acupuncture and to identify what symptoms they recommend for its use. METHOD: Scoping of national and international websites of CPGs and TGs r on the after care and rehabilitation of stroke patients provided by professional and government organisations was conducted. The presence/absence of recommendations and the underpinning evidence was appraised for the use of acupuncture for symptoms following stroke. RESULTS: Of 84 CPGs and TGs on post stroke after-care identified from 27 countries between 2001 and 2021, 49 made statements about acupuncture. Positive recommendations on the use of acupuncture were identified for 15 symptom areas from 11 countries for: stroke rehabilitation, dysphagia, shoulder pain, motor recovery, walking, balance, spasticity, upper limb extremity impairment, post-stroke pain, central post stroke pain, cognitive disorder, depression, and sleep problems. Thirty-five CPGs (2001-2018) from 18 countries published over the same period were identified that made no mention of acupuncture and therefore no recommendations were made on its use. CONCLUSIONS: Currently, evidence used by international guideline developers varies and this influences whether a positive or negative recommendation is made. Recommendations to use acupuncture should be based on the best available evidence which has been quality appraised.

Effect of Acupoint Hot Compress on Postpartum Urinary Retention After Vaginal Delivery: A Randomized Clinical Trial.

Importance: Acupoint hot compress during the early postpartum period may benefit patients after a vaginal delivery, but the evidence of this effect is limited. Objective: To assess whether acupoint hot compress involving the abdominal, lumbosacral, and plantar regions could reduce the incidence of postpartum urinary retention, relieve postpartum uterine contraction pain, prevent emotional disorders, and promote lactation. Design, Setting, and Participants: This multicenter randomized clinical trial was conducted at 12 hospitals in China. Pregnant patients were screened for eligibility (n = 13 949) and enrolled after vaginal delivery (n = 1200) between January 17 and August 15, 2021; data collection was completed on August 18, 2021. After vaginal delivery, these participants were randomized 1:1 to either the intervention group or control group. Statistical analysis was based on per-protocol population. Interventions: Participants in the control group received routine postpartum care. Participants in the intervention group received routine postpartum care plus 3 sessions of a 4-hour acupoint hot compress involving the abdominal, lumbosacral, and plantar regions within 30 minutes, 24 hours, and 48 hours after delivery. Main Outcomes and Measures: The primary outcome was the incidence of postpartum urinary retention, defined as the first urination occurring more than 6.5 hours after delivery and/or use of an indwelling catheter within 72 hours after delivery. The secondary outcomes were postpartum uterine contraction pain intensity (assessed with the visual analog scale [VAS]), depressive symptoms (assessed with the Edinburgh Postnatal Depression Scale), and lactation conditions (including lactation initiation time, breastfeeding milk volume, feeding mood and times, and newborn weight). Results: Of the 1200 participants randomized, 1085 completed the study (537 in the intervention group and 548 in the control group, with a median [IQR] age of 26.0 [24.0-29.0] years). Participants in the intervention group compared with the control group had significantly decreased incidence of postpartum urinary retention (relative risk [RR], 0.58; 95% CI, 0.35-0.98; P = .03); improved postpartum uterine contraction pain when measured at 6.5 hours (median [IQR] VAS score, 1 [1-2] vs 2 [1-2]; P < .001), 28.5 hours (median [IQR] VAS score, 1 [0-1] vs 1 [1-2]; P < .001), 52.5 hours (median [IQR] VAS score, 1 [0-1] vs 1 [0-1]; P < .001), and 76.5 hours (median [IQR] VAS score, 0 [0-1] vs 0 [0-1]; P = .01) after delivery; reduced depressive symptoms (RR, 0.73; 95% CI, 0.54-0.98; P = .01); and increased breastfeeding milk volume measured at 28.5, 52.5, and 76.5 hours after delivery. No adverse events occurred in either of the 2 groups. Conclusions and Relevance: Results of this trial showed that acupoint hot compress after vaginal delivery decreased postpartum urinary retention, uterine contraction pain, and depressive symptoms and increased breastfeeding milk volume. Acupoint hot compress may be considered as an adjunctive intervention in postnatal care that meets patient self-care needs. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000038417.

Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized, multiple-blind, placebo-controlled trial.

INTRODUCTION: Diarrhea-predominant irritable bowel syndrome (IBS-D) is a bowel disease with a high incidence. It significantly reduces the quality of life of patients and affects the patient's daily activities and mental health. No specific therapeutic medications for IBS-D have been found. Published clinical trials suggest that Chinese herbal formula Tongxie Yaofang (TXYF) for IBS-D may be effective. However, high-quality clinical evidence supporting its use in IBS-D is still lacking. This trial aims to evaluate the therapeutic effects and safety of TXYF for IBS-D in adults. METHODS/DESIGN: A randomized, multiple-blind, placebo-controlled trial will be conducted. It will consist of an 8-week intervention followed by a 3-month follow-up period. The target sample size is 96 IBS-D patients aged 18 to 65 years. The eligible participants will be randomly allocated to either TXYF or placebo group in a ratio of 1:1. Participants in the experimental group will take TXYF granules, while participants in the control group will be given TXYF placebo granules. The primary outcome will be the degree of IBS symptom severity measured using the scale of IBS symptom severity score. The secondary outcomes include: (a) stool frequency, and (b) stool consistency measured using the Bristol stool scale, (c) quality of life measured using the scale of IBS-quality of life, (d) anxiety measured using the self-rating anxiety scale, (e) depression measured by the self-rating depression scale, and (f) the safety of using TXYF and placebo. Safety monitoring and assessment will be undertaken throughout treatment. DISCUSSION: Chinese herbal formula TXYF consists of four Chinese herbs: Atractylodes macrocephala Koidz., Paeonia lactiflora Pall ., Citrus × aurantium L ., and Radix saposhnikoviae. It has been used for diarrhea for hundreds of years and may have a potential benefit in treating adults with IBS-D, but due to lack of high-quality evidence, we designed a randomized, multiple-blind, placebo-controlled trial to evaluate its therapeutic effects and safety. This trial will provide important data to guide the clinical practice of TXYF for the treatment of IBS-D in adults. TRIAL REGISTRATION: ISRCTN registry ISRCTN12453166 . Registered on 23 March 2021.

Cochrane systematic reviews on traditional Chinese medicine: What matters-the quantity or quality of evidence?

BACKGROUND: Systematic reviews on traditional Chinese medicine (TCM) are constantly increasing. However, if these reviews are to be of practical value, the evidence needs to be relevant, valid, and adequately reported. Cochrane Systematic Reviews (CSRs) are considered as high-quality systematic reviews that can inform health care decision making. Our aim was to provide an overview of the scope, findings, quality and impact of CSRs on the benefits and harms associated with TCM interventions for the treatment and prevention of disease to provide new information for clinical practice and future research. METHODS: The Cochrane Database of Systematic Reviews was searched up to May 2021, and descriptive characteristics were extracted. The correspondence between the questions asked in the CSRs and the available evidence, conclusions and certainty of findings (according to GRADE assessment), methodological quality (AMSTAR 2), and impact (Altmetric Attention Score [AAS], total citations by guideline, and total citations in Web of Science [WoS]) of CSRs were extracted. Tabular and graphical summaries of these descriptive characteristics were constructed. RESULTS: Of 104 CSRs on TCM identified, 70 diseases belonged to 16 disease systems and contained 1642 primary studies with 157,943 participants. Interventions included Chinese herbal medicine (n = 70), acupuncture (n = 28), TCM exercises (n = 4), and moxibustion (n = 2). Among 1642 primary studies, 662 studies included an intervention group treated with at least one TCM therapy and 980 studies included a combination of therapies. Promising outcomes from the 104 CSRs were divided into endpoint outcomes (34 diseases), doctor- or patient-reported outcomes (27 diseases), and surrogate outcomes (37 diseases). Despite the presence of promising outcomes, only 5/104 CSRs drew overall positive conclusions, 42 CSRs concluded the evidence was insufficient, and 54 failed to draw firm conclusions. GRADE assessments were reported in 41.3% of the CSRs, and the ratings were mostly low or very low. Comparing the questions asked and results obtained, there was frequently a lack of information about specific outcomes. Only 16 CSRs obtained results for all outcomes listed in the methods section. According to AMSTAR 2, 51 CSRs (49.0%) were of low quality. The total number of citations in the WoS was 2135 (mean ± SD: 20.8 ± 21.2), and 38.5% of the CSRs had been cited in guidelines 95 times. CONCLUSION: Although TCM is commonly used, evidence of its effectiveness remains largely inconclusive. Rigorous high-quality trials are needed to support the performance of high-quality reviews and to increase the evidence base. It is critical to emphasize quality over quantity in future TCM research.

Traditional Chinese Medicine for HIV-Associated Acute Herpes Zoster: A Systematic Review and Meta-Analysis of Randomized Trials.

BACKGROUND: Herpes zoster (HZ) is a common infection in individuals with acquired immunodeficiency syndrome (AIDS) patients. Traditional Chinese medicine (TCM) has been used widely in clinical practice for HZ, which remains not supportive of evidence. This review aimed to evaluate the effectiveness and safety of TCM in treating HIV-associated HZ. METHODS: Nine electronic databases were searched for randomized controlled trials (RCTs) testing TCM in treating HIV-associated HZ. Data were extracted on citations, interventions, and outcomes, by two authors independently. For the quality evaluation, Cochrane risk-of-bias tool 2.0 was used. Meta-analyses were performed by Revman5.3 software. Effect estimation presented as risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data with their 95% confidence interval (CI). RESULTS: Twelve RCTs (n = 644) were included; the majority of them had a high or unclear risk of bias. Meta-analysis showed that pain intensity (VAS 0-5) in the Chinese herbal medicine (CHM) group was lower than it in the drugs group (MD = -0.87, 95% CI [-1.69, -0.04], two trials, n = 93). Duration of herpes-related pain (days) of patients in the combination group was shorter than those in the drugs group (MD = -9.19, 95% CI [-16.73, -1.65], n = 144). The incidence of postherpetic neuralgia (PHN) in the combination group was lower than in the drugs group (RR = 0.49, 95% CI [0.25, 0.99], n = 202). As for cure rate (complete absence of pain and herpes), two trials showed that CHM was better than drugs (RR = 1.58, 95% CI [1.13, 2.22], n = 93), five trials showed combination treatment was better than drugs (RR = 1.40, 95% CI [1.08, 1.82], n = 224). The cure rate in the acupuncture group was more than that in the drugs group (RR = 1.99, 95% CI [1.18, 3.36], n = 120). Four trials reported adverse effects and found no serious adverse events occurred. CONCLUSION: CHM and acupuncture demonstrate more benefits than drugs in pain relief, cure rate improvement, and incidence reduction of PHN. However, given the data limitation and TCM therapies' diversity, the conclusions need to be verified in future trials.

Traditional Chinese Medicine in Cancer Care: An Overview of 5834 Randomized Controlled Trials Published in Chinese.

BACKGROUND: Traditional Chinese medicine (TCM) is widely integrated into cancer care in China. An overview in 2011 identified 2384 randomized and non-randomized controlled trials (RCTs, non-RCTs) on TCM for cancer published in the Chinese literature. This article summarizes updated evidence of RCTs on TCM for cancer care. METHODS: We searched 4 main Chinese databases: China National Knowledge Infrastructure, Chinese Scientific Journal Database, SinoMed, and Wanfang. RCTs on TCM used in cancer care were analyzed in this bibliometric study. RESULTS: Of 5834 RCTs (477 157 cancer patients), only 62 RCTs were indexed in MEDLINE. The top 3 cancers treated were lung, stomach, and breast cancer. About 4752 RCTs (81.45%) tested TCM combined with conventional treatment, and 1082 RCTs (18.55%) used TCM alone for treating symptoms and side-effects. Herbal medicine was the most frequently used TCM modality (5087 RCTs; 87.20%). The most frequently reported outcome was symptom improvement (3712 RCTs; 63.63%) followed by quality of life (2725 RCTs; 46.71%), and biomarkers (2384 RCTs; 40.86%). The majority of RCTs (4051; 69.44%) concluded there were beneficial effects using either TCM alone or TCM plus conventional treatment compared with conventional treatment. CONCLUSION: Substantial randomized trials demonstrated different types/stages of cancer were treated by various TCM modalities, alone or in combination with conventional medicine. Further evaluation on the effects and safety of TCM modalities focusing on outcomes such as quality of life is required.

Chinese Herbal Medicine Xingnaojing Injection for Acute Ischemic Stroke: An Overview of Systematic Reviews and Meta-Analyses.

Background: Xingnaojing injection (XNJ) is the only Chinese herbal injection approved for both intracerebral hemorrhage and ischemic stroke (IS) first-aid on ambulances in China; many systematic reviews (SRs) and meta-analyses (MAs) of XNJ on stroke have been published. The purpose of this research was to evaluate and summarize the current evidence on XNJ for IS. Methods: A comprehensive search was conducted for SRs and MAs of XNJ on IS in seven databases up to January 1, 2021. Two authors independently identified SRs and MAs, extracted data, assessed the quality of the included SRs and MAs using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2), and assessed quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Results: A total of 10 SRs met the inclusion criteria. The quality of included SRs using AMSTAR 2 was critically low as the critical items were poorly reported. Only 10% of SRs reported 50% of the 16 items, while the remaining 90% SRs reported just less than half of the items on AMSTAR 2. For GRADE, 7 (35%) of outcomes had low-quality evidence, 10 (50%) with very low, and 3 (15%) with moderate quality evidence. Very low to low quality of evidence indicated XNJ plus conventional therapy (CT) alleviated the neurological deficits of acute IS. Moderate-quality evidence showed XNJ plus CT reduced mortality when compared to Danshen injection plus CT, and very low-quality evidence showed XNJ plus CT could not improve the degree of coma, while low-quality evidence indicated the opposite. Mild adverse events in the CT group were less than those in the XNJ plus CT group, and there were no serious adverse events, but there was no statistical difference between the two groups. The included 10 SRs indicated that XNJ was used for acute IS, but only four SRs (40%) reported the course of disease. Conclusion: XNJ appears to be effective and safe for acute IS in improving the neurological deficits, but the evidence is not robust enough. However, whether administering XNJ immediately after or within 24 h of IS is best remains unknown due to the lack of data. Well-designed large-scale randomized controlled trials with measurable outcomes are required in future studies.

Therapeutic effects and safety of oral Chinese patent medicine for COVID-19: A rapid systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Chinese patent medicine (CPM) is an indispensable part of traditional Chinese medicine. Coronavirus Disease 2019 (COVID-19) manifests is an acute respiratory infectious disease. This systematic review aimed to evaluate the therapeutic effects and safety of oral CPM for COVID-19. METHODS: We included randomized controlled trials (RCTs) that tested oral CPM for the treatment of COVID-19 identified from publications in CNKI, Wanfang, VIP, Web of Science, SinoMed, PubMed, Embase, BioRxiv, MedRxiv and arXiv before November 2nd, 2020. The risk of bias for each trial was assessed using the Cochrane Risk of Bias Tool 2.0. RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool. RESULTS: Seven RCTs including 1079 participants were identified. The overall bias was assessed as "-high risk of bias" for all included trials. Oral CPM investigated were: Lianhua Qingwen capsule/granules (LHQW), Jinhua Qinggan granules (JHQG), Huoxiang Zhengqi dripping pills (HXZQ), Toujie Quwen granules (TJQW) and Lianhua Qingke granules (LHQK). Compared with conventional western therapy alone for people with COVID-19: regarding the main outcomes, the results showed that oral CPM combined with conventional western therapy improved cure rate (RR = 1.20, 95 % CI 1.04-1.38, involving LHQW and TJQW), reduced aggravation rate (RR = 0.50, 95 % CI 0.29 - 0.85, involving LHQW, JHQG, LHQK and TJQW); with regard to additional outcomes, the results showed that add-on oral CPM shortened the duration of fever, cough and fatigue, improved the recovery rate of cough and fatigue, and increased the improvement and recovery rate of chest CT manifestations. There were some differences in therapeutic effects among various CPMs for the same COVID-19 outcome. The use of TJQW and LHQG appeared not to increase the risk of adverse events, but JHQG may cause mild diarrhea. CONCLUSION: Low-certainty or very low-certainty evidence demonstrated that oral CPM may have add-on potential therapeutic effects for patients with non-serious COVID-19. These findings need to be further confirmed by well-designed clinical trials with adequate sample sizes.

Clinical Application of Chinese Herbal Injection for Cancer Care: Evidence-Mapping of the Systematic Reviews, Meta-analyses, and Randomized Controlled Trials.

Background and objective: Cancer is a life-threatening disease worldwide and current standard therapy cannot fulfill all clinical needs. Chinese herbal injections have been widely used for cancer in Chinese and Western hospitals in China. This study aimed to apply evidence mapping in order to provide an overview of the clinical application of Chinese herbal injections in cancer care based on randomized controlled trials, systematic reviews, and meta-analyses. Methods and results: Seven databases were systematically searched for eligible randomized controlled trials, systematic reviews, and meta-analyses for ten Chinese herbal injections used in cancer treatment and covered in the Chinese national essential health insurance program. Excel 2016 and RStudio were used to integrate and process the data. In total 366 randomized controlled trials and 48 systematic reviews and meta-analyses were included in the evidence mapping of herbal medicines including; Compound Kushen, Shenqi Fuzheng, Aidi, Kangai, Kanglaite, Xiaoaiping, Cinobufacin, Brucea javanica oil emulsion, Polyporus polysaccharide injection, and Astragalus polysaccharide for injection. Health insurance restricts the scope of clinical application for these herbal injections. The numbers of studies published increased, especially around 2013-2015. The most studied cancer types were lung cancer (118, 32.2%), colorectal cancer (39, 10.7%), and gastric cancer (39, 10.7%), and the most used injections were Compound Kushen (78, 21.3%), Shenqi Fuzheng (76, 20.8%), and Aidi (63, 17.2%). The most consistently reported benefits were observed for Compound Kushen, Shenqi Fuzheng, Aidi, and Kangai for tumor response, quality of life, myelosuppression, and enhancing immunity. Conclusion: The current evidence mapping provides an overview of the outcomes and effects of Chinese herbal injections used in cancer care, and offers information on their clinical application which warrants further evidence-based research in order to inform clinical and policy decision-making.

Eye acupuncture for pain conditions: a scoping review of clinical studies.

BACKGROUND: Chinese eye acupuncture, focuses on treating different diseases by applying needle stimulation around the orbit of the eye. Since 1970, it has been used in China for the management of pain-related disorders. This scoping review systematically collected clinical studies on the use of eye acupuncture to treat pain conditions and identify any adverse events. METHODS: Six databases including PubMed, the Cochrane Library, CNKI, VIP, Wan Fang Data and SinoMed were searched from 1970 to March 2019. Randomized controlled trials (RCTs), clinical controlled trials (CCTs) and case series on eye-acupuncture for pain conditions meeting the inclusion criteria were identified. Data were extracted on patients, interventions, details of eye acupuncture, control treatments and outcomes. RESULTS: Searches identified 81 clinical studies and a trend demonstrating an increasing number of published studies. All studies were conducted in China and published in Chinese. These included, 45 (55.6%) RCTs, 5 (6.2%) CCTs, and 31 (38.3%) case series, treating 7113 patients with 44 different pain-related diseases or symptoms. The most frequently reported conditions were headache (18, 16.2%), acute lumbar pain (7, 6.3%) and lumbar disc herniation (7, 6.3%). Treatment using small needles (φ0.25 × 13 mm), retained ≤30 min, needling the horizontal outer orbital edge and the avoidance of manipulation during treatment were the most frequent descriptions of the interventions used. Eye acupuncture was used alone in about half of the studies and of the remaining studies it was combined with other treatment. All studies suggested some beneficial effects including: pain relief, improved quality of life and mental health, and 18 (22.2%) adverse events. CONCLUSION: Eye acupuncture, predominantly studied in China, may be a promising intervention for managing diverse pain conditions. However, given the variety of study designs and reported treatment outcomes, conclusions about the evidence for eye acupuncture for specific conditions are not possible at this stage.

Clinical reasoning in traditional medicine exemplified by the clinical encounter of Korean medicine: a narrative review.

BACKGROUND: Clinical reasoning is generally defined to be a way of thinking for diagnostic or therapeutic decision making in clinical practice. Different cognitive models have been proposed for the clinical reasoning which takes place during the clinical encounter with a patient. This may have similarities with similar approaches used in Traditional Korean Medicine (TKM). Jinchal, the clinical encounter, has specific features in TKM and different Jinchal processes are closely related to several underlying cognitive models in clinical reasoning. It is a necessary process to see the patient, but in TKM, the method has a characteristic aspect and emphasis is placed on importance. METHODS: Experts consensus were reached through panel discussion. Narrative description on the concept of clinical reasoning and explanation on Jinchal process in TKM were suggested. RESULTS: This article analyses the Jinchal process using theoretical concepts from four authentic KM schools of clinical reasoning which are currently used in contemporary practice. CONCLUSION: Future research should focus on the similarities and differences in understanding clinical reasoning in KM as well as the broader field of traditional East Asian Medicine.