Safety Of Chinese Patent Medicine Research Articles

Comparative efficacy and safety of Chinese patent medicines for primary insomnia: a systematic review and network meta-analysis of 109 randomized trials

Comparative efficacy and safety of Chinese patent medicines for primary insomnia: a systematic review and network meta-analysis of 109 randomized trials

Comparative efficacy and safety of Chinese patent medicines as an adjunctive therapy for diabetic peripheral neuropathy: systematic review and network meta-analysis of randomized controlled trials

Context Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes mellitus. Chinese patent medicines (CPMs) are widely used in clinical practice to treat DPN. Objective This study aims to summarize the latest evidence on the harms and benefits of CPMs as adjunctive therapy for DPN. Materials and methods We conducted searches for randomized controlled trials (RCTs) evaluating CPMs in conjunction with mecobalamin (Mec) or alpha-lipoic acid (αLA) across eight databases up to July 2024. The surface under the cumulative ranking area (SUCRA) was utilized to assess the clinical efficacy rate (CER), the peroneal motor nerve conduction velocity (pMNCV), the peroneal sensory nerve conduction velocity (pSNCV), the median motor nerve conduction velocity (mMNCV), and the median sensory nerve conduction velocity (mSNCV). Results The search yielded 128 eligible studies with 31 CPMs with Mec and 39 eligible studies with 17 CPMs with αLA. SUCRA rankings indicated that, when combined with Mec, Mailuoning liquid (lMLN) was the most effective regimen for CER, Honghua injection (iHH) for pMNCV, Maixuekang capsule (cMXK) for pSNCV, Dengzhanxixin injection (iDZXX) for mMNCV, and Tongxinluo capsule (cTXL) for mSNCV. Combined with αLA, Danhong injection (iDH) showed the highest efficacy for CER, pSNCV, and mSNCV, while Xueshuantong injection (iXShT) was the most effective for pMNCV and mMNCV. Conclusion This network meta-analysis confirms the efficacy and safety of 37 CPMs combined with Mec or αLA for treating DPN. However, given the potential risk of bias and the very low certainty of the evidence, these recommendations should be adopted with caution.

Methodology quality was inadequate for observational studies investigating drug safety of Chinese patent medicine using real-world data: A cross-sectional survey.

Methodology quality was inadequate for observational studies investigating drug safety of Chinese patent medicine using real-world data: A cross-sectional survey.

Comparison of the Efficacy and Safety of 12 Chinese Patent Medicines for Treating Primary Osteoporosis Patients: A Systematic Review and Network Meta-Analysis

Objective: To elucidate the effectiveness and safety of different traditional Chinese medicines (TCMs) for treating primary osteoporosis (POP) using network meta-analysis. Materials and Methods: We conducted a systematic review and network meta-analysis to assess the efficacy and safety of Chinese patent medicine (CPM) combined with conventional Western medicine for POP treatment. From March 5, 2004, to March 5, 2024, electronic databases such as the Cochrane Library, VIP, PubMed, Embase, CBM, Wanfang, CNKI, and Web of Science were comprehensively searched. Only randomized controlled trials (RCTs) were included in this systematic review. After screening and data extraction, the Cochrane risk of bias evaluation tool was utilized to assess the methodological quality of the included studies. Stata 15.1 was utilized to synthesize the data. Results: In total, 44 studies involving 4859 patients were included. There were 2577 patients in the treatment group and 2282 in the control group, with 12 types of CPMs. Qing'e Pill, in combination with conventional treatment, significantly improved the total effective rate [relative risk (RR) = 2.57, 95% confidence interval (CI) (1.32, 5.00)]. In combination with conventional treatment, Liuwei Dihuang Pill significantly increased the bone mass density (BMD) of the lumbar spine [WMD = 0.17, 95% CI (0.05, 0.28)] and femoral neck [WMD = 0.23, 95% CI (0.11, 0.35)]. Furthermore, Hugu capsules effectively decreased the VAS score [WMD = −2.48, 95% CI (−3.85, −1.11)]. The presence of the genus Gusongbao markedly decreased the serum ALP concentration [WMD = −15.67, 95% CI (−32.73, 1.39)]. In all studies, no serious adverse reactions were noted, with most studies suggesting only mild gastrointestinal reactions. Conclusions: CPM and conventional treatment combo enhances POP therapy; each CPM offers unique benefits. More high-quality RCTs needed for conclusions. Meds tailored to patient traits in clinics.

Network Meta-analysis of Chinese patent medicines in treatment of chronic pulmonary heart disease

Network Meta-analysis was performed to compare the efficacy and safety of Chinese patent medicines in treating chronic pulmonary heart disease. CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, EMbase, and Cochrane Library were searched for randomized controlled trial(RCT) of treating chronic pulmonary heart disease with Chinese patent medicines with the time interval from inception to December 2023. The Cochrane risk-of-bias tool was used for quality assessment of the included articles. RevMan 5.4 and Stata 17.0 were employed to establish the risk of bias map and perform the network Meta-analysis, respectively. Ultimately, a total of 95 RCTs involving 8 787 cases and 11 different Chinese patent medicines were included. Network Meta-analysis yielded the following results based on the surface under the cumulative ranking curve(SUCRA).(1)In terms of cardiac function improves clinical total effective rate, SUCRA the top three were Wenxin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(2)For improving forced expiratory volume in the first se-cond(FEV1), SUCRA the top three were Danting Feixin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Bufei Huoxue Capsules + conventional western medicine.(3)Regarding increasing the FEV1/forced vital capacity(FVC%) value, SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Shexiang Baoxin Pills + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(4)In terms of increasing the partial pressure of oxygen(PaO_2), SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(5)In terms of reducing the partial pressure of carbon dioxide(PaCO_2), SUCRA the top three were Tongxinluo Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(6)In terms of increasing left ventricular ejection fraction(LVEF), SUCRA the top three were Bufei Huoxue Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(7)In terms of decreasing brain natriu-retic peptide(BNP), SUCRA the top three were Compound Danshen Dropping Pills + conventional western medicine, Qili Qiangxin Capsules + conventional western medicine, and Tongxinluo Capsules + conventional western medicine.(8)In terms of improving the hematocrit level, SUCRA the top three were Qishen Yiqi Dropping Pills + conventional western medicine, Compound Danshen Dropping Pills + conventional western medicine, and Tongxinluo Capsules + conventional western medicine. In terms of safety, 26 RCTs reported adverse reactions, which primarily involved the circulatory and digestive systems. The combination of Chinese patent medicines with conventional western medicine has demonstrated enhanced therapeutic effects on chronic pulmonary heart disease. However, due to the varying quality and sample sizes of included studies and the absence of direct comparisons between Chinese patent medicines, the conclusions should be further validated by multicenter studies with larger sample sizes and higher methodological rigor.

Efficacy and safety assessment of traditional Chinese patent medicine for dyslipidemia: a systematic review of randomized clinical trials with meta-analysis and trial sequential analysis.

The overall prevalence of dyslipidemia continues to increase, which poses a significant risk for coronary artery disease. Some patients with dyslipidemia do not respond to or benefit from conventional lipid-lowering therapy, which warrants the need for alternative and complementary therapies. Chinese patent medicine (CPM) has shown great potential in the treatment of dyslipidemia, but its clinical value needs to be further explored. This study aims to systematically evaluate the efficacy and safety of CPM in treating dyslipidemia. This study was registered in INPLASY as INPLASY202330090. The randomized controlled trials included in this study were published in January 2013 to March 2023 and retrieved from the Web of Science, PubMed, Embase, Cochrane Library, SinoMed, China National Knowledge Internet, WanFang, and VIP. The bias risk in the study was independently evaluated by two reviewers using the Cochrane Randomized Trial Bias Risk Tool (RoB 2) Review Manager 5.4 software was used for the overall effect analysis and subgroup analysis of four blood lipids, and the trial sequential analysis (TSA) was conducted to check the results. A total of 69 studies were included, involving 6,993 participants. The methodological quality was in the middle level. Meta-analysis showed that CPM markedly improved the levels of total cholesterol (TC) [mean difference (MD) =-0.54 mmol/L; 95% confidence interval (CI): -0.71 to -0.37; P<0.001], triglyceride (TG) (MD =-0.43 mmol/L; 95% CI: -0.53 to -0.33; P<0.001), low-density lipoprotein cholesterol (LDL-C) (MD =-0.40 mmol/L; 95% CI: -0.50 to -0.30; P<0.001) and increased levels of high-density lipoprotein cholesterol (HDL-C) (MD =0.23 mmol/L; 95% CI: 0.18 to 0.27; P<0.001), in patients with dyslipidemia. Though CPM did not differ significantly from statins when used alone, it could improve lipid profile better in all cases when used in combination with statins and with drugs used for comorbidities or co-morbidities. Subgroup analysis found that the efficacy of pill formulations was superior to other formulations, and CPM showed better lipid-lowering response in the context of comorbidity. The TSA confirmed the robustness of the analysis of the LDL-C level. No significant difference was observed in the incidence of adverse events between the treatment group and the control group [risk ratio (RR) =0.89; 95% CI: 0.69-1.16; P=0.40]. CPM can yield superior therapeutic effects in ameliorating dyslipidemia without exacerbating adverse effects as an alternative and complementary therapy. In addition, the therapeutic effect can be improved by emphasizing pill formulation and strengthening the standardization of syndromes.

Comparative efficacy and safety of Chinese patent medicines of iron deficiency anemia during pregnancy: A network meta-analysis

BACKGROUND Iron deficiency anemia (IDA) is a prevalent nutritional disorder during pregnancy. Clinical studies indicate that incorporating Chinese patent medicines (CPMs) with oral iron (OI) in treating IDA in pregnancy can reduce adverse effects and improve clinical outcomes. Nonetheless, the comparative efficacy of different CPMs remains unclear. AIM To assess the safety and effectiveness of different CPMs for treating IDA during pregnancy using network meta-analysis. METHODS We conducted a search for randomized controlled trials (RCTs) that combined CPM and OI for IDA treatment in pregnancy, spanning from 2013 to the present. Data analysis was performed using Rev Man 5.3 and Stata 14.0 on literature that satisfied the quality criteria. RESULTS The analysis included 45 RCTs, encompassing 4422 pregnant patients with IDA. Six CPMs were examined, including Shengxuebao Mixture, Shengxuening Tablets (SXN), Yiqi Weixue CPMs (YQWX), Jianpi Shengxue CPMs (JPSX), Yiqi Buxue Tablets, and Compound Hongyi Buxue Oral Liquid (FFHY). Findings indicated that FFHY + OI significantly improved the clinical effective rate. SXN + OI was most effective in boosting red blood cells counts and hemoglobin levels. YQWX + OI showed superior results in improving serum ferritin, and SXN + OI was most effective in increasing serum iron levels. JPSX + OI was optimal in reducing adverse pregnancy outcomes, while YQBX + OI effectively minimized adverse events. A cluster analysis suggested that SXN + OI could be the potentially optimal therapeutic regimen for IDA in pregnancy. CONCLUSION This study demonstrates that the combination of OI with CPMs offers better outcomes than OI alone. Based on clinical efficacy and other measured outcomes, SXN + OI emerges as the most effective treatment modality for improving the health of pregnant patients with IDA.

Efficacy and safety of Chinese patent medicines for tension-type headache: Systematic review and network meta-analysis

ObjectiveThe high incidence of Tension-type headache (TTH) has led to significant social and economic challenges. Given the widespread use of Chinese patent medicines (CPM) for TTH patients, this study aim to evaluate the efficacy of different CPMs in treating TTH by network meta-analysis. MethodsEight databases were conducted to identify CPMs-related randomized controlled trials (RCTs) from database inception date to August 2023. The primary outcome was clinical efficiency rate. The secondary outcomes were numerical rating scale (NRS), frequency of headache, duration of headache, hamilton anxiety scale (HAMA), hamilton depression Scale (HAMD) and adverse reactions. ROB 2.0 were used for quality evaluation. Stata 15.1 and R 3.5.3 software were used for Bayesian network meta-analysis. ResultsA total of forty-one RCTs were included, involving 3,996 patients and 8 CPMs. The network meta-analysis revealed that Shugan Jieyu capsule plus western medicine (WM) was the best choice of CPM for improving clinical efficiency rate [vs. WM: relative risk (RR) = 7.31, 95 % confidence interval (CI): (1.65, 56.71)]. Yangxue Qingnao granule plus WM was superior to other therapeutic combinations in reducing duration of headache [vs. WM: MD = 1.05, 95%CI(0.74, 1.40)]. Jieyu pill plus WM might have best effect in reducing HAMD [vs. WM: MD = 7.15, 95%CI(-3.77, 18.14)], HAMA scores [vs. WM: MD = −7.41, 95%CI(-13.39, −1.42)], and NRS scores [vs. WM: mean difference (MD) = 2.01, 95%CI(1.47, 2.55)]. In terms of the frequency of headache, although Yangxue Qingnao granule plus WM and Toutong-ning capsule plus WM performed best, the optimal CPMs in reducing the frequency of headache remain to be further explored. Furthermore, due to the limited safety evidence available, reliable safety conclusions could not be drawn. ConclusionCPM can effectively improve headache symptoms, clinical efficiency, and quality of life in patients with TTH. However, research with high quality and large sample sizes is needed for further investigation due to the limitations of this study.

Clinical use and efficacy of Chinese patent medicines for external use containing pyritum, a mineral medicine mainly used for oral administration: A systematic review.

Pyritum, a mineral drug, has been used primarily orally in traditional medicine to treat traumatic injuries, broken tendons, and fractures. Due to growing concerns about the accumulation of heavy metals in the body, this systematic review aims to evaluate the efficacy and safety of Chinese patent medicine containing pyritum for external use (CPMPE) to determine the effectiveness of external use of pyritum. A literature search was performed through China National Knowledge Infrastructure, Wanfang, EMBASE, Cochrane Library, and PubMed from inception to February 2023. "Pyrite," "pyritum," "zirantong," "traditional medicine," "oriental medicine," etc, were the keywords from the database. In this systematic review, RCTs and case reports were referred to analyze the efficacy rate and clinical status of CPMPE. About 36 studies were reviewed. Of 36 studies, 23 were RCTs and 13 were case reports. The total effective rate in 34 studies was used to evaluate the efficacy of CPMPE for various disease classifications. The effectiveness of CPMPE was confirmed in case reports, and RCTs showed that using CPMPE as a single or combined treatment had a more significant effect than not using CPMPE in anorectal diseases, orthopedic diseases, obstetrics and gynecology diseases, and skin diseases. This review concluded that CPMPE might be a safe and effective alternative treatment method for various diseases and has potential benefits in preventing postoperative complications, reducing pain, relieving symptoms, and accelerating healing compared to the control group, which employs unused CPMPE.

Efficacy and safety of Chinese patent medicine combined with 5-aminosalicylic acid for patients with ulcerative colitis: A network meta-analysis of randomized controlled trials

ObjectivesGiven the widespread use of Chinese patent medicines (CPMs) in combination with 5-aminosalicylic acid (5-ASA) for Ulcerative colitis (UC) patients, this study aimed to evaluate the efficacy and safety of nine CPMs combined with 5-ASA in the treatment of UC. MethodsA systematic literature search was conducted in eight databases from inception to May 2023 to identify eligible RCTs evaluating the effects of CPM combined with 5-ASA for the treatment of UC. The methodological quality of the included RCTs was assessed using the Cochrane risk of bias tool in Review Manager 5.4. The primary outcome of the meta-analysis was the overall response rate. The secondary outcomes included excellent rate, disease activity index (DAI), IL-6, IL-8, and TNF-α levels, mean platelet volume (MPV), fibrinogen (FIB) levels, recurrence rate, and adverse event rate. Network meta-analysis was performed using Review Manager 5.4 and Stata 15.0. ResultsIn total, 70 RCTs including 5973 patients and 10 treatment regimens were included. The combination of Kangfuxin Liquid (KFL) and 5-ASA showed the greatest efficacy in improving FIB levels and the overall response rate. Bupi Yichang Pill (BYP) combined with 5-ASA was associated with the fewest adverse events and the lowest recurrence rate. Hudi Enteric-coated Capsule (HEC) combined with 5-ASA ranked first in improving DAI. ZhiKang Capsule (ZKC), ChangYanNing Capsule (CYN), and Danshen Injection (DSI) combined with 5-ASA ranked first in improving IL-6, IL-10, and TNF-α levels, respectively. Shenling Baizhu Powder (SBP) combined with 5-ASA was associated with the highest excellent rate. ConclusionsCPM combined with 5-ASA may be more effective than 5-ASA alone for treating UC. Besides, CPM combined with 5-ASA could better reduce the recurrence rate and adverse event rate in UC patients. The current meta-analysis provides statistical evidence for clinical application.Systematic Review Registration: International Prospective Register of Systematic Reviews (PROSPERO), No. CRD42023433672.

Efficacy and safety of Chinese patent medicine in the adjuvant treatment of prostate cancer: A Bayesian network meta-analysis.

Prostate cancer is the most common cancer in men. In China, traditional Chinese medicine is used to treat prostate cancer. However, there is a lack of evidence for differences in the effectiveness and safety of different Chinese patent medicines. Therefore, we conducted this Network Meta-analysis to investigate the efficacy and safety of different Chinese patent medicines in the treatment of prostate cancer. We systematically search PubMed, Web of Science, Embase, Cochrane library, CNKI database, VIP database, wanfang database, and SinoMed Randomized controlled trials of Chinese patent medicines for the treatment of prostate cancer sores included in the database were retrieved until June 1, 2023. The included studies were assessed for risk of bias using Cochrane randomized controlled trial Bias risk Assessment tool. The main outcome indicators were Efficacy, Prostate Specific Antigen, and adverse reaction. Since different courses of treatment were used in the included studies, we used Bayesian mesh meta-regression to investigate the effects of treatment courses on efficacy and safety. Twenty-seven articles were included, involving 1885 patients. Including 9 kinds of Chinese patent medicine. The results of Network Meta-analysis show that: ① efficacy: compared with androgen antagonists, Bruceolic oil emulsion (relative risk = 1.70, 95% credibility interval [CI] (1.30, 2.29)), Compound Kushen injection (relative risk = 1.39, 95%CI (1.19, 1.70)) had significant advantages. There was no significant difference among all Chinese patent medicines (P > .05). The top 3 Chinese patent medicines were Bruceolic oil emulsion, Zhibodihuang pill, Compound Kushen injection. ② Prostate specific antigen: compared with androgen antagonists, Bruceolic oil emulsion (mean difference [MD] = -10.4, 95%CI [-17.6, -3.21]), Compound Kushen injection (MD = -4.46, 95%CI [-8.80, -1.70]), Shenfu injection (MD = -14.7, 95%CI [-23.4, -6.01]) had significant advantages. The top 3 Chinese patent medicines were Shenfu injection, Bruceolic oil emulsion, Compound Kushen injection. adverse reaction: compared with androgen antagonists, there was no significant difference among all PCM (P > .05). Compared with androgen antagonists, Chinese patent medicine has significant difference in effectiveness. The effect of Chinese patent medicine is little affected by the course of treatment and dose. From comprehensive analysis, Bruceolic oil emulsion combined with androgen antagonist is the best intervention measures.

Evidence map of clinical research on Chinese patent medicines for post-acute myocardial infarction heart failure

An evidence map was established to comprehensively sort out the clinical research in the treatment of post-acute myocardial infarction heart failure(P-AMI-HF) with Chinese patent medicines, so as to reveal the distribution of evidence in this field. CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, and EMbase were searched for the randomized controlled trial(RCT), systematic reviews/Meta-analysis, and guidelines/consensus in this field. The evidence was analyzed and displayed in the form of a combination of text, charts, bubble charts, and bar charts, and the quality of RCT, systematic reviews/Meta-analysis, and guidelines/consensus were evaluated by RoB 1.0, AMSTAR2, and AGREE Ⅱ, respectively. A total of 163 RCTs, 4 systematic reviews/Meta-analysis, 1 network Meta-analysis, 2 observational studies, and 5 guidelines/consensus were included. In recent years, the total number of publications in this field has shown an upward trend. There were a variety of Chinese patent medicines in the treatment of P-AMI-HF, among which Shenfu Injection received the most attention. The clinical RCT and systematic reviews/Meta-analysis generally had poor quality, and the RCT mostly had a small size, a single center, and a short cycle. The outcome indicators mainly included cardiac function indicators, myocardial injury markers, total response rate, hemodynamic indicators, and safety indicators, while the characteristic efficacy indicators of TCM received insufficient attention. The development processes of some guidelines/consensus lack standardization, which compromised their authority and rationality. Chinese patent medicines have advantages in the treatment of P-AMI-HF, while there are also problems, which remain to be solved by more high-quality evidence. That is, more large-sample and multi-center clinical studies should be carried out in the future, and the formulation process of relevant systematic reviews/Meta-analysis and guideline/consensus should be standardized and the quality of evidence should be improved. In this way, the effectiveness and safety of Chinese patent medicines in the treatment of P-AMI-HF can be explored.

'Risk-benefit' assessment for comprehensive safety evaluation of Chinese patent medicines containing four common toxic ingredients: an analysis of clinical risk factors.

Chinese patent medicines are specialty preparations in China that are produced using traditional prescriptions processed by modern pharmaceutical technology. They contain complex ingredients and much attention is paid to their clinical safety. Demonstrating the clinical safety of Chinese patent medicines containing toxic ingredients in modern pharmacological studies has become one of the urgent issues to be solved for the safe use of clinical medicines. The aim of this research is to evaluate the safety of Chinese patent medicines containing toxic ingredients by applying the risk-benefit assessment method. Additionally, a database of 'toxic ingredients-toxic Chinese herbal medicines-adverse reactions' will be established to explore the relationship between toxic ingredients and adverse reactions. This will lay the foundation for the rational clinical use of Chinese patent medicines containing toxic ingredients. 1) Establish a database of 'toxic Chinese herbal medicines-toxic ingredients-toxic Chinese patent medicines' to count the Chinese patent medicines containing toxic ingredients in the 2020 edition of Chinese Pharmacopoeia. 2) Filtered the clinical studies, extracted the drug-related ADEs, and analyzed the characteristics and correlations of these ADEs. 3) Finally, this section summarizes the causes of ADEs related to Chinese patent medicines containing toxic ingredients and extracts the main risk factors to provide a reference for further study. 1) There are four main types of Chinese patent medicines containing toxic ingredients. These include medicines with diester aconitine metabolites, mineral composition, Araceae metabolites, and hydrogen cyanide. 2) Digestive system, skin and its appendages, and allergic reactions were the main types of ADEs related to four types of Chinese patent medicines containing toxic ingredients. 3) There are four primary risk factors associated with the clinical use of Chinese patent medicines containing toxic ingredients: medicine, medication, individual and regulatory factors.

Comparative efficacy and safety of Chinese patent medicines of acute ischemic stroke: A network meta-analysis.

Acute ischemic stroke (AIS) is characterized by high morbidity, disability, mortality, recurrence, and economic burden. Clinical trials have demonstrated that the clinical efficacy of combining oral Chinese patent medicines (CPMs) with chemical drugs (CDs) is better than that of CDs alone. In this study, we performed a network meta-analysis (NMA) of RCTs to assess the efficacy of different CPMs in combination with CDs in the treatment of AIS. Search 6 databases from the beginning to January 10, 2023. The Cochrane Risk of Bias tool assessed the methodological quality of the included studies. The NMA was then performed using the STATA 13.0 program. The surface under the cumulative ranking curve (SUCRA) probability values were applied to rank the studied treatments, and cluster analysis was used to compare the effects of CPMs between 2 different outcomes. A total of 94 eligible RCTs, involving 9581 participants, were included in this analysis. Nine CPMs, including Nao-mai-li granule (NML), Nao-mai-tai granule (NMT), Qi-long granule (QL), Long-sheng-zhi capsule (LSZ), Nao-xin-tong capsule (NXT), Nao-xue-shu oral liquid (NXS), Tong-xin-luo capsule (TXL), Xiao-shuan-chang-rong capsule (XSCR), and Xue-shuan-xin-mai-ning capsule (XSXMN) were included. Regarding the clinical effective rate, all types of CPMs + CDs treatments were significantly better than CDs treatments alone, with significant differences among the 9 selected CPMs. Compared with CDs, results showed that NXS + CDs performed best in improving clinical effective rate [OR = 4.73; 95% CI: 1.26-17.78; (SUCRA: 76.1%)]. TXL + CDs showed the most effective effect in alleviating National Institutes of Health Stroke Scale (NIHSS) [MD = -3.84; 95% CI: -5.23, -2.45; (SUCRA: 81.6%)]; NXT + CDs were most effective in improving Barthel index [MD = 13.05; 95% CI: 3.98-22.12; (SUCRA: 63.5%)]. Combined with other outcome indicators and the results of cluster analysis, NXS + CDs may assist in the potential optimal treatment regimen for AIS. In conclusion, CPMs were found to be beneficial as adjuvant therapy in patients with AIS. Taking into account the clinical effective rate and other outcomes, NXS + CDs may be the most effective option to improve the condition of AIS patients.

Efficacy and safety of Chinese patent medicine compound preparation combined with routine treatment in vitiligo: A Bayesian network meta-analysis.

Treating vitiligo in clinical practice is challenging. Furthermore, oral drugs used in Western medicine have considerable side effects and are unsuitable for long-term treatment. In contrast, Chinese patent medicines (CPMs) are more suitable for long-term oral vitiligo treatment, but medical evidence of their efficacy and safety is lacking. Therefore, in this study, the efficacy and safety of CPMs were evaluated and ranked using a Bayesian network meta-analysis. Seven Chinese and English databases were searched for all relevant articles published up to February 2023. The Bayesian network meta-analysis method was used to analyze the extracted data to evaluate efficacy and safety. Six common CPMs for treating vitiligo were selected in our study, and 48 targeted articles and 4446 patients were included. This study showed that Qubai Babuqi tablets (QT) were the most effective for short-term treatment of vitiligo, and that vitiligo capsules or pills (VCP) were the most effective for long-term treatment, together with compound Quchong Banjiuju pills (QP). In terms of surface area under the cumulative ranking curve (SUCRA) values, the order of efficacy of each treatment was as follows: QT (92.18%) > Taohong Qingxue pills (TP) (63.81%) > VCP (55.53%) > QP (50.72%) > Bailing tablets or capsules (BTC) (49.01%) > Baishi pills (BP) (35.69%)>routine therapy (RT) (3.1%) in terms of total effective rate and QT (92.05%) > VCP (71.50%) > QP (66.60%) > TP (42.95%) > BTC (39.66%) > BP (36.60%)>RT (0.6%) in terms of improvement rate. In addition, the safety of the 6 CPMs did not significantly differ in terms of adverse effects. The SUCRA values indicated that QT performed slightly worse than other drugs. In treating vitiligo, QT is most effective but only suitable for short-term administration owing to its poor safety. VCP and QP could be used as first-choice long-term medications. TP may positively affect repigmentation in patients with limited lesion areas.

Comparative Efficacy and Safety of Chinese Patent Medicines for Cervical High-risk Human Papillomavirus Infection: A Bayesian Network Meta-analysis.

Background: Many Chinese patent medicines have been reported to show anti-tumor cell effects on cervical cancer. To estimate the comparative effectiveness and safety of Chinese patent medicines for cervical high-risk human papillomavirus (HR-HPV) infection. Methods: Randomized controlled trials (RCTs) of Chinese patent medicines for HR-HPV infection were searched in eight databases until 31 August 2022, and two review authors independently extracted data and assessed the risk of bias. Outcomes concerning efficacy were evaluated as odds ratio (OR) and 95% credible intervals (CrI) utilizing R 4.1.2 and Stata 16.1. The protocol was registered on the International Prospective Register of Systematic Reviews (CRD42022351120). Results: We ultimately identified 60 RCTs that involved 5,951 participants and 8 interventions. Chinese patent medicines combined with recombinant human interferon (rhIFN) have better treatment effects than rhIFN alone. The results showed that Baofukang suppository (BFK) combined with rhIFN is greater for the rate of HR-HPV clearance follow-up at 6 months (SUCRA = 78.16%). Kushen gel (KS) combined with rhIFN ranked first for the rate of HR-HPV clearance after treatment (SUCRA = 90.77%). Furthermore, KS + rhIFN is most likely to be the best intervention for improving the clinical effectiveness rate (SUCRA = 87.39%). Adverse reactions were not statistically significant in BFK + rhIFN versus BFK, BFK + rhIFN versus rhIFN, and BFK versus rhIFN. Conclusion: The combination of Chinese patent medicines with rhIFN may demonstrate a higher efficacy than rhIFN alone in clearing the virus and improving cervical symptoms. Weighing with the clinical comprehensive efficacy, BFK + rhIFN and KS + rhIFN maybe the optimal treatments for cervical HR-HPV infection. However, more high-quality randomized controlled trials are needed in the future to further confirm the efficacy and safety of proprietary Chinese medicines for cervical HR-HPV infection.

Traditional Chinese Patent Medicine in the Treatment of Alzheimer's Disease: A Systematic Review and Network Meta-Analysis.

The objective of this study was to evaluate the efficacy and safety of Chinese patent medicine compared with western medicine in the treatment of Alzheimer's disease using the Network Meta-analysis. This study retrieved relevant studies from 7 databases, and the retrieval time was from the establishment of each database to June 2022. After the screening, data extraction, and quality assessment, 47 studies were finally analyzed, involving 11 Chinese patent medicines. The results demonstrated that Chinese patent medicine intervention was superior to oral western medicine treatment in improving the patient's condition as assessed by the Mini-mental State Examination (MMSE), Activities of Daily Living (ADL), effective rate, and Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-Cog). Particularly, the effect of Chinese patent medicine combined with western medicine intervention was prominent. Meanwhile, Chinese patent medicine intervention in AD did not significantly increase the risk of adverse reactions. The results of the Network Meta-analysis demonstrated that Chinese patent medicine combined with western medicine had statistically significant differences in the MMSE score, ADL score, effective rate, and ADAS-Cog score, compared with both western medicine alone and Chinese patent medicine alone. In terms of adverse reactions, the difference between Chinese patent medicine intervention and simple oral western medicine was statistically significant. The results of further ranking probability analysis demonstrated that Chinese patent medicine combined with western medicine intervention ranked first in terms of MMSE, ADL, effective rate, and ADAS-Cog. Additionally, oral Chinese patent medicine intervention alone ranked first in reducing adverse reactions. In the funnel plots of the MMSE, ADL, and effective rate, most studies were symmetrically distributed on both sides of the midline, where small sample effects and publication bias might exist to some extent. However, this conclusion still needs to be combined with clinical syndrome differentiation and treatment, and more large-sample, multi-center, high-quality studies are needed for further verification.

Network Meta-analysis of Chinese patent medicine containing Hirudo in treatment of atherosclerosis

This study aimed to evaluate the efficacy and safety of Chinese patent medicines containing Hirudo in the treatment of atherosclerosis(AS) by network Meta-analysis, and to provide evidence-based reference for clinical treatment of AS. The clinical randomized controlled trial(RCT) on the treatment of atherosclerosis with Chinese patent medicines containing Hirudo were searched in CNKI, Wanfang, VIP, SinoMed, PubMed and EMbase from the establishment of the databases to July 1, 2022. And data extraction and quality assessment of the included RCT was performed according to the Cochrane standards. Stata 17 and ADDIS 1.16.5 were then used for Bayesian model network Meta-analysis. Finally, 67 RCTs with a total sample size of 6 826 cases were included, 3 569 cases in the experimental group and 3 257 cases in the control group, involving three oral Chinese patent medicines. Network Meta-analysis showed that in terms of reducing intima-media thickness(IMT), the top three Chinese patent medicines were Tongxinluo Capsules+sta-tins&gt;Maixuekang Capsules+statins&gt;Maixuekang Capsules. In terms of reducing plaque area, the top one was Maixuekang Capsules+sta-tins, and the other Chinese patent medicines had similar efficacy. For lowering AS Crouse scores, the top three were Maixuekang Capsules&gt;Tongxinluo Capsules+statins&gt;Naoxintong Capsules. For decreasing plaque number, the top three were Naoxintong Capsules+sta-tins&gt;Tongxinluo Capsules+statins&gt;Tongxinluo Capsules. With regard to adverse reactions/events, Naoxintong Capsules+statins had the lo-west incidence. In conclusion, in Chinese patent medicines containing Hirudo for the treatment of AS, Tongxinluo Capsules+statins, Maixuekang Capsules, Maixuekang Capsules+statins, and Naoxintong Capsules+statins were the primary choices to reduce IMT, AS Crouse scores, plaque area, and plaque number, respectively. The efficacy of Chinese patent medicines containing Hirudo with or without statins was more significant than that of statins alone in the four outcome indexes. Additionally, the treatment of AS should be evaluated comprehensively, and attention should be paid to Chinese patent medicines or their combination with western medicine, to optimize the treatment effect and minimize adverse reactions as the benchmark.

The effectiveness and safety of Chinese Patent Medicines based on syndrome differentiation in patients following percutaneous coronary intervention due to acute coronary syndrome (CPM trial): A nationwide Cohort Study

BackgroundThe incidence of cardiovascular events remains not unusual in patients following percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS). Chinese patent medicine (CPM) therapy based on syndrome differentiation in addition to conventional medicine (CM) had been expected to further reduce the risk of cardiovascular events. PurposeTo assess the effectiveness and safety of CPM based on syndrome differentiation in patients following PCI due to ACS. Study designNationwide prospective cohort study. MethodsCPM study was conducted in 40 centers in mainland China. Patients following PCI due to ACS entered to syndrome differentiation-based CPM (SDCPM) or CM group according to whether they received CPM or not. The CPM comprised Guanxin Danshen dripping pills, Qishen Yiqi dripping pills, or Danlou tablets, and was used correspondingly with the syndrome differentiation of traditional Chinese medicine. The follow-up time was 36 months. The primary endpoint was composed of cardiac death, non-fatal myocardial infarction and urgent revascularization. The secondary endpoint included rehospitalization due to ACS, heart failure, stroke, other thrombotic events. Seattle Angina Questionnaire (SAQ) was used to evaluate quality of life. ResultsBetween February 2012 and December 2018, ascertainment of the primary endpoint was completed in 2,724 patients of follow-up. 1,380 patients were in SDCPM group. At a median follow-up of 541 (interquartile range 513 – 564) days, the primary endpoint occurred in 126 (8.61%) patients in SDCPM group and 167 (11.62%) patients in CM group (adjusted hazard ratio [HR] = 0.70; [95% confidence interval [CI] 0.55 – 0.89]; p = 0.003). The secondary endpoint occurred in 144 (9.84%) patients in SDCPM group and 197 (13.71%) patients in CM group (adjusted HR = 0.66; [95% CI 0.53 – 0.82]; p < 0.001). The SAQ score in SDCPM group was higher than CM group (366.78 ± 70.19 vs 356.43 ± 73.80, p < 0.001). There were no significant differences of adverse events between two groups. ConclusionIn patients following PCI due to ACS, SDCPM in addition to CM treatment reduced the primary and secondary endpoints, as well as improved the quality of life without adverse events.

Evidence mapping of clinical research on prevention and treatment of essential hypertension with Chinese patent medicines in recent six years

In this study, the evidence mapping was employed to systematically analyze the clinical research literature and learn the distribution of evidence on the prevention and treatment of essential hypertension with Chinese patent medicines in recent six years. CNKI, Wanfang, VIP, SinoMed, PubMed, and Cochrane Library were searched for the relevant literature published from January 2016 to December 2021. The distribution characteristics of evidence were analyzed and presented in charts combined with words. A total of 263 studies were selected, including 238 intervention studies, 17 systematic reviews/Meta-analysis, and 8 observation studies. A total of 72 Chinese patent medicines were involved, among which Songling Xuemaikang Capsules had the highest frequency. In China, the attention to the treatment of essential hypertension with Chinese patent medicines was insufficient, as manifested by the declining number of published literature and the low quality of studies. There were cases of off-label use and medication without syndrome differentiation in clinical practice. Some outcome indicators failed to embody the characteristics of traditional Chinese medicine and there were cases ignoring the end-point outcome indicators. The overall quality of systematic reviews/Meta-analysis was low, and a variety of studies failed to draw valid conclusions. In the future, it is necessary to standardize the clinical medication and improve the quality of randomized controlled trial(RCT), so as to produce high-quality evidence-based medical evidence and provide strong support for the efficacy and safety of Chinese patent medicines in the prevention and treatment of essential hypertension.