Efficacy and safety of Tanreqing injection for cough caused by acute trachea-bronchitis disease: A systematic review and meta-analysis of randomized controlled trials.

ETHNOPHARMACOLOGICAL RELEVANCE: Tanreqing injection (TRQI) is an intravenous herbal preparation derived from 5 types of traditional Chinese medicines including Scutellariae Radix, Lonicerae Japonicae Flos, Forsythiae Fructus, bear bile powder and goral horn, incorporating baicalin, chlorogenic acid, ursodeoxycholic acid, and goose deoxycholic acid and other compounds known for anti-inflammatory properties, is widely used in China to treat cough caused by acute trachea-bronchitis disease (ATB). AIM OF THE STUDY: To investigate the clinical efficacy and safety of Tanreqing injection (TRQI) with and without Western medicine (WM) for cough caused by acute trachea-bronchitis (ATB). MATERIALS AND METHODS: We systematically searched eight databases, including CENTRAL, Embase, PubMed, Science Direct, Wiley, China National Knowledge Infrastructure, Chinese Biomedical Literature Database and WanFang, from inception to August 2023 for randomized clinical trials (RCTs) on TRQI for cough caused by ATB. The critical outcomes of interest were time to symptom disappearance, including time for cough symptom to disappear and time to improve cough and sputum production. Important outcomes included symptom disappearance rate, adverse events (AEs) and lung function. We carried out random-effects meta-analysis using Review Manager 5.4 and assessed the certainty of evidence utilizing the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: A total of 2872 citations were identified by our search, of which 26 eligible RCTs enrolled 2731 participants. Low to moderate certainty evidence showed that when compared with WM, TRQI plus WM treatment was associated with a favorable effect on the time for cough symptom to disappear (MD -2.21 d, 95% CI -2.64 to -1.78), time to improve cough and sputum production (MD -0.68 d, 95% CI -0.83 to -0.53), symptom disappearance rate (RR 1.37, 95% CI 1.20 to 1.55), forced vital capacity, and forced expiratory volume in 1 s (MD 0.38 L, 95% CI 0.26 to 0.50; MD 2.92%, 95% CI 1.29 to 4.56, respectively). In terms of AEs, there was no association between TRQI plus WM and WM (RR 0.55, 95% CI 0.14 to 2.21; low-certainty evidence). Very low certainty evidence showed that TRQI alone was associated with reduced time to improve cough and sputum (MD -0.14 d, 95% CI -0.26 to -0.02) and increased symptom disappearance rate (RR 1.89, 95% CI 1.24 to 2.88; low certainty evidence) compared to WM. CONCLUSIONS: The overall efficacy of TRQI or WM for ATB cough is better than that of WM, and TRQI also effectively improve symptoms in patients with similar adverse events. However, due to the lack of methodological rigor of included studies, the present findings should be interpreted with caution. We advocate better high-quality and convincing clinical studies to be performed to prove the effectiveness and safety of TRQIs.

Efficacy and safety of Shenqi Dihuang decoction for lupus nephritis: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Lupus Nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE). However, the treatment of lupus nephritis using traditional Chinese medicine remains controversial. AIM OF THE STUDY: To assess the efficacy and safety of Shenqi Dihuang decoction in the treatment of LN and review the clinical guidelines. MATERIALS AND METHODS: Six databases (China National Knowledge Infrastructure, Wanfang, PubMed, China Biology Medicine, the Cochrane Library, and Embase) were searched from their inception to September 10, 2022, for randomized controlled trials on the treatment of lupus nephritis using Shenqi Dihuang decoction. We conducted a meta-analysis of random effects using Review Manager 5.4 and assessed the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. RESULTS: A total of 15,790 citations were identified, from which 14 eligible randomized controlled trials that enrolled 1002 participants were selected for this systematic review. Low-to-moderate certainty of evidence indicated that when compared with Western medicine, Shenqi Dihuang decoction combined with Western medicine was associated with favorable effects on clinical efficacy (risk ratio (RR) = 1.25, 95% confidence interval (CI): 1.15-1.37), vascular endothelial growth factor (mean difference (MD) = -30.90, 95% CI: -40.18 to -21.63), serum level (MD = -4.81 µmol L-1, 95% CI: -17.14 to 7.53), complement C3 (MD = -0.14 g L-1, 95% CI: -0.23 to -0.04), erythrocyte sedimentation rate (MD = -11.87 mm h-1, 95% CI: -22.01 to -1.73), and SLE disease activity score (MD = -3.38, 95% CI: -4.15 to -2.61), and exhibited a lower risk of infection (RR = 0.2, 95% CI: 0.05-0.90), gastrointestinal reaction (RR = 0.47, 95% CI: 0.17-1.28), and insomnia (RR = 0.29, 95% CI: 0.09-0.92). CONCLUSIONS: This systematic review provides a potential reference for understanding the efficacy and safety of Shenqi Dihuang decoction combined with Western medicine for treating patients with lupus nephritis. However, owing to the limited quality of the studies included in this review, lack of mycophenolate mofetil control, and high heterogeneity among the included studies, the current findings should be interpreted with caution. Therefore, the efficacy and safety of Shenqi Dihuang decoction in patients with PN still require further verification through future high-quality clinical studies.

Development of a reporting guideline for systematic reviews of animal experiments in the field of traditional Chinese medicine.

OBJECTIVE: In recent years, there are several systematic reviews published on animal experiments of Traditional Chinese medicine (TCM). PRISMA (preferred reporting items for systematic reviews and meta-analysis) guidelines provide a guarantee for significantly improving the reporting quality of systematic reviews (SRs) and meta-analysis (MAs) to a certain extent; however, there are still certain defects found in the quality of SRs/MAs of animal experiments of TCM. It has been found that especially, the descriptions of the rationale and animal characteristics of TCM interventions are inadequate. As a result, we have developed a novel reporting guideline for SRs/MAs of animal experimental in the field of TCM (PRISMA-ATCM) to overcome these problems. METHODS: PRISMA-ATCM reporting guidelines were formed by analyzing both the status and quality of published SRs/MAs of animal experiments and consulting experts in the related fields, and then by Delphi consultation, consensus meeting and revision. RESULTS: Among the 27 items on the PRISMA checklist, Title (1), Structured summary (2), Rationale (3), Objectives (4), Protocol and registration (5), Eligibility criteria (6), Data items (11), Planned methods of analysis (14), Study characteristics (18), Summary of evidence (24), Limitations (25), and Funding (27) have been extensively revised and expanded, to specifically include the details about TCM intervention and animal characteristics. In addition, illustrative examples and explanations have been provided for each item. CONCLUSION: PRISMA-ATCM could markedly improve the quality SRs/MAs of animal experiments in the field of TCM.

Comparative effectiveness of multiple acupuncture therapies for primary insomnia: a systematic review and network meta-analysis of randomized trial.

BACKGROUND: Acupuncture has been widely practiced for primary insomnia (PI). However, the relative benefit and harm among acupuncture therapies remain uncertain. OBJECTIVES: To compare and evaluate the effect differences of multiple acupuncture therapies for patients with PI. METHODS: Systematic literature search for randomized controlled trials (RCTs). Pairs of reviewers independently conducted literature screening, data extraction, and risk of bias assessment. Meta-analysis was conducted using R and Stata software. The Grading of Recommendations Assessment, Development, and Evaluation system (GRADE) was used to assess certainty of evidence and interpret results. RESULTS: Fifty-seven RCTs with 4678 patients were included. Compared with usual treatment, multiple acupuncture therapies showed a better effect for Pittsburgh sleep quality index score. And acupoints catgut embedding (ACE) was proved to be the most effective with a moderate certainty of evidence; auricular acupressure or auricular acupuncture plus manual acupuncture (AP + MA), electroacupuncture plus acupoint application (EA + APA), and intradermal needle (IN) might be also the most effective with low certainty of evidence. ACE, ACE + MA, AP + MA, EA, EA + APA, HPN, MA and PBN + MA showed significantly improvement in effective rate when compared with usual treatment. Insufficient evidence reported on Epworth Sleepiness Scale, Athens Insomnia Scale, and recurrence rate. The most common slight adverse events mainly included hematoma, pain, headache, and bleeding. CONCLUSIONS: With moderate to low certainty of evidence, multiple acupuncture therapies showed impressive insomnia improvement, especially ACE, AP + MA, and EA + APA. Differences between therapies were small or insignificant and based-on low or very low certainty of evidence.

Electro-acupuncture vs. sham electro-acupuncture for chronic severe functional constipation: A systematic review and meta-analysis.

OBJECTIVES: To assess the efficacy of electro-acupuncture (EA) relative to sham electro-acupuncture (sham EA) in treating chronic severe functional constipation (CSFC). METHODS: A comprehensive search for relevant studies published between January 1, 1951 and May 14, 2020 was conducted in PubMed, the Cochrane Library, Chinese Biomedical Literature Database, Web of Science, and EMbase. Two investigators independently selected studies, extracted data, and assessed the quality of the included studies. The software Endnote X9 was used for screening articles, and the Review Manager 5.3 for analyzing data. RESULTS: The meta-analyses involved 6 studies and 1457 individuals. The pooled results favored the EA group for the increase of complete spontaneous bowel movements (CSBMs) per week in the fourth week (MD = 0.80, P = 0.001) during treatment, and further improved in the eight weeks (MD = 1.25, P < 0.001). During the follow-up period, significant changes in CSBMs per week were seen in the experimental group (MD = 1.38, P = 0.008); the effect decreased in the twelfth week (MD = 0.87, P < 0.001). There was no significant difference in the Bristol stool scale score between the two groups in the fourth week (MD = 0.40, P = 0.08), but significant differences were observed in the eighth week (MD = 0.40, P = 0.03). A significant reduction in patient assessment of constipation quality of life (PAC-QOL) score were observed in the EA group during treatment (SMD = -0.83, P < 0.001). No serious adverse events were reported. CONCLUSIONS: EA had favorable effects on CSFC, and the longer the treatment duration was, the better was the effect, but the effect showed a certain period of validity. However, the results may be influenced by the clinical heterogeneity of acupuncture points, depth of needling, intensity, and frequency of EA.

The reporting quality and risk of bias of randomized controlled trials of acupuncture for migraine: Methodological study based on STRICTA and RoB 2.0.

OBJECTIVES: To investigate the reporting quality and risk of bias of randomized controlled trials (RCTs) of acupuncture for migraine, to facilitate and improve the quality of RCTs of acupuncture for migraine. METHODS: The Cochrane Library, PubMed and EMBASE were searched from inception to June 11, 2019 using a comprehensive search strategy. The reporting quality and risk of bias of included RCTs were independently evaluated by two investigators using STRICTA and RoB 2.0. Any disagreement was resolved by a third investigator. RESULTS: A total of 28 eligible RCTs were published in 24 academic journals from 1994 to 2018. Based on STRICTA, four sub-items including "details of other interventions'' (1/28, 4 %), "setting and context of treatment" (9/28, 32 %), "the extent to which treatment was varied" (11/28, 39 %), and "number of needle insertions per subject per session" (13/28, 46 %), showed low reporting quality. A total of 32 different outcomes were reported in 28 RCTs, and based on RoB 2.0, nine (9/28, 32 %) RCTs were judged to be high RoB, three of which were owing to deviations from intended interventions; 11(11/28, 39 %) RCTs elicited some concerns; and eight (8/28, 29 %) RCTs were low RoB for their outcomes. CONCLUSIONS: The reporting quality and risk of bias of RCTs of acupuncture for migraine remain suboptimal. Therefore, all stakeholders should make a contribution to improve the quality of RCTs of acupuncture for migraine using STRICTA and RoB 2.0, while not limiting this approach solely to studies on migraine, using STRICTA and RoB 2.0 tools.

The effectiveness and safety of acupuncture for depression: An overview of meta-analyses.

PURPOSE: To provide an overview of existing meta-analysis (MAs) on the efficacy and safety of acupuncture for depression, and assess the methodological quality and the strength of evidence of the included MAs. METHODS: We searched MAs of randomized trials that have evaluated the effects of acupuncture on depression in three international and three Chinese databases from their inception until August 2019. The methodological quality of included MAs was evaluated with the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), and the strength of evidence with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). We used the intra-class correlation coefficient (ICC) to assess reviewer agreement in the pre-experiment. RESULTS: We included 31 MAs and 59 RCTs. The results of included MAs were conflicting, our meta-analyses found that acupuncture may confer small benefit in reducing the severity of depression by end of treatment than no treatment/wait list/treatment as usual(SMD -0.74, 95% CI -1.06 to -0.41, eight trials, 624 participants), control acupuncture (invasive, non-invasive sham controls) (SMD 0.27, 95% CI -0.51 to -0.04, 20 trials, 1055 participants), antidepressants(Selective serotonin reuptake inhibitors (SSRI)/ Tetracyclic antidepressants(TCAs)) (SMD -0.28, 95% CI -0.46 to -0.10, 30 trials, 3068 participants), acupuncture plus antidepressants versus antidepressants(SSRI/TCAs) (SMD -0.99, 95% CI -1.37 to -0.61, 17 trials, 1110 participants). Subgroup analyses showed that there was no difference between electro-acupuncture and invasive control (P = 0.37), electro-acupuncture and non-invasive control (P = 0.90), manual acupuncture and Tetracyclic antidepressants (P = 0.57), electro-acupuncture and Tetracyclic antidepressants (P = 0.07). Six MAs concluded that acupuncture reduced the incidence of adverse events compared with antidepressants. The evaluation with AMSTAR-2 showed that the quality of included MAs was low or critically low. The results of the GRADE evaluation showed that the strength of evidence was low to very low for most outcomes. CONCLUSIONS: Although acupuncture appears to be more effective and safer than no treatment, control acupuncture and antidepressants, the quality of the available evidence was very low. Further methodologically rigorous and adequately powered primary studies are needed to confirm the effectiveness of acupuncture for depression.

The effectiveness of acupuncture for Parkinson's disease: An overview of systematic reviews.

OBJECTIVES: Acupuncture is an alternative therapy for Parkinson's disease (PD), but its efficacy and safety are controversial. This overview aimed to summarize the existing evidence from systematic reviews (SRs) and meta-analyses (MAs) in order to assess the effectiveness of acupuncture as a treatment for PD. METHODS: Seven electronic databases were searched from their inception until July 2019. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) and Assessment of Multiple Systematic Reviews 2 (AMSTAR2) checklists were used to assess evidence quality and methodological quality, respectively. The outcomes of study were calculated using mean differences (MDs) and risk ratios (RRs) with 95 % confidence intervals (CIs). A meta-analysis was performed using RevMan 5.3 software. RESULTS: A total of 12 SRs/MAs were included. All 12 SRs/MAs had more than one critical weakness in AMSTAR 2 and were considered of critically low methodological quality. The quality of evidence was unsatisfactory according to the GRADE checklist. Meta-analyses showed that acupuncture combined with drug for the treatment of PD can significantly improve the total effectiveness rate compared with drug alone (RR = 1.25, 95 % CI 1.16-1.34, P < 0.001). It was also found that acupuncture combined with drug significantly improved the UPDRS I-IV total summed scores (WMD=-6.18, 95 % CI -10.32 to -2.04, P < 0.001) and Webster scores (WMD=-4.20, 95 % CI -7.59 to -0.81, P < 0.001). CONCLUSION: Acupuncture might improve the UPDRS score, Webster score, and total effective rate in treatment of PD. It might be a safe and useful adjunctive treatment for patients with PD. However, we should interpret the findings of these reviews with caution, considering the overall limited methodological and reporting quality.

CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : Recommendations, explanation and elaboration.

BACKGROUND: N-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM. METHODS: We registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist. RESULTS: The checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions. CONCLUSIONS: CENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.

Using single-patient (n-of-1) trials to determine effectiveness of traditional Chinese medicine on chemotherapy-induced leukopenia in gastric cancer: a feasibility study.

BACKGROUND: Gastric cancer has been the second cause of cancer death worldwide. Chemical comprehensive treatment programs primarily were the main therapy method with modest efficacy to gastric cancer. Traditional Chinese medicine (TCM) has been reported to alleviate adverse events induced by chemotherapy, but has not yet developed clinical trials to test and needs scientific evidence for making policy. Single-patient (N-of-1) trials might be an eligible study design for TCM since it well represented the individualized treatment philosophy of TCM. The aim of this study is to obtain information necessary to design a more series trial. METHODS: Individuals who underwent gastrectomy were included. Each patient suffered 3-week standard chemotherapy and 3-day treatment periods (decoction with Astragalus mongholicus and Semen Cuscutae or placebo: decoction without Astragalus mongholicus and Semen Cuscutae). Each trial lasted up to a maximum of 30 weeks or a minimum of 20 weeks. Staffs and participants were blinded to the randomization. This study was approved by Ethics Committee of First Hospital, Lanzhou University in November, 2014. RESULTS: From August, 2014 to March, 2015, 6 participants were included. There were 16 cycles compared between intervention and control decoction (2.28, 95% CI: 1.24-5.47), P<0.0001. The quality of life (QoL) score after the trial was reported is a little higher than before, t=3.87, P=0.01. Two participants reported symptoms had improved after taken trial decoction. CONCLUSIONS: This is the first N-of-1 trials of testing the effectiveness of TCM decoction on alleviative treatment to gastric cancer. The feasibility study will help to develop a practical design for the more series trial.

Potential Facilitators and Barriers to Awareness of N-of-1 Trials for Physicians in Traditional Chinese Medicine.

Context • N-of-1 trials are multiple crossover trials with randomized and blinded methods, conducted with a single participant to evaluate the effectiveness and safety of a therapy. They can be a helpful tool for enriching clinical research for traditional Chinese medicine (TCM), but the approach has gained little traction in TCM. Information is needed before supporters of the trials can pursue a change to that status. Objective • The study intended to obtain data needed to support TCM clinicians' adoption of N-of-1 trials. Methods • TCM clinicians were interviewed using a dedicated questionnaire between May 15, 2014, and July 31, 2014. Setting • The study took place at 4 teaching hospitals (Lanzhou City, China). Participants • Participants were TCM clinicians at the 4 hospitals. Outcome Measures • The survey included questions to obtain information on (1) the various methods that the TCM physicians used to obtain information about how to develop and conduct clinical trials, (2) their knowledge and experience with traditional clinical trials, (3) their awareness of the concept and methodology of N-of-1 trials, and (4) their needs and willingness to receive training about such trials. Descriptive statistics were used. Results • One-hundred-and-six clinicians, with a median age of 32 ± 9 y, participated in the survey. Most received information on research methods from a medical database (77%) or academic conferences (65%). Eighty-two percent of the clinicians had read papers about clinical trials, and 84% of the material read were medical articles in Mandarin. Of the participants, 57% had designed and carried out clinical trials during the 5 y before the survey, and among those participants, 26% had performed randomized controlled trials (RCTs), 28% had carried out retrospective studies, 16% had conducted observational studies, and 30% had completed case reports. For those studies, the results of 7% had been published in the Science Citation Index (SCI), 47% in the Chinese Science Citation Database (CSCD), and 31% in provincial journals; 15% were unpublished. Only 37% had heard of an N-of-1 trial, and only 5% understood what the term means. Most intermediate clinicians thought it is necessary to train different groups of clinicians using N-of-1 trials that included clinicians and patients. Conclusions • The results highlight the possible interest of TCM clinicians in the methods of N-of-1 trials; meanwhile, the study's data stress the need for appropriate medical education and recommendations based on available evidence. Further efforts in the area should emphasize the benefits for patients and funders. The training is necessary in TCM clinical practice to improve the evidence quality of studies on TCM.

Do the CONSORT and STRICTA Checklists Improve the Reporting Quality of Acupuncture and Moxibustion Randomized Controlled Trials Published in Chinese Journals? A Systematic Review and Analysis of Trends.

BACKGROUND: We investigated whether there had been an improvement in the quality of reporting for randomised controlled trials of acupuncture and moxibustion published in Chinese journals. We compared the compliance rate for the quality of reporting following the publication of both the STRICTA and CONSORT recommendations in China. METHODS: Four Chinese databases were searched for RCTs of acupuncture from January 1978 through to December 2012. The CONSORT and STRICTA checklists were used to assess the quality of reporting. Data were collected using a standardised form. All included RCTs were divided into three distinct time periods based on the time that CONSORT and STRICTA were introduced in China, respectively. Pearson's χ2 test and/or Fisher's exact test were used to assess differences in reporting among three groups. PRINCIPAL FINDINGS: A total of 1978 RCTs were identified. Although the percentage of all the items has increased over time with the introduction of CONSORT and STRICTA in China, the actual compliance in several important methodological components, including sample size calculation (0% vs. 0% vs. 1.2%, for pre-CONSORT and pre-STRICTA, post-CONSORT but pre-STRICTA, and post-CONSORT and post-STRICTA, respectively), randomisation sequence generation (1.4% vs. 15% vs. 26.3%) and implementation (0% vs. 0% vs. 1.3%), allocation concealment (0% vs. 1.4% vs. 4.9%), and blinding (0% vs. 5.7% vs. 9.1%), remains low. Moreover, no RCTs have reported the setting and context of treatment and no descriptions of the participating acupuncturists have been provided thus far. CONCLUSIONS: Overall, the quality of the reporting of RCTs of acupuncture and moxibustion published in Chinese journals has improved since CONSORT and STRICTA were introduced in China, though the actual compliance rate of some important items were still low as of 2012. In the future, Chinese journals should enhance the adoption of the CONSORT and STRICTA statement to improve the reporting quality of the RCTs of acupuncture and moxibustion and to ensure the truth and reliability of the conclusions.