Effect Of Chinese Patent Medicine Research Articles

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.

A retrospective study on the effect of Chinese patent medicine combined with conventional treatment on the survival outcomes of 313 patients with stage II-III NSCLC.

We aim to explore the effect of Chinese Patent Medicine (CPM), including Huisheng oral solution (HSOS) on the 4-year survival rate of patients with stage II and III non-small cell lung cancer, and assess the association between blood coagulation indicators and survival outcomes. 313 patients diagnosed with stage II and III NSCLC were collected during 2015-2016. Kaplan-Meier method and Cox proportional hazard model were applied to analyze the factors affecting the 4-year survival rate of patients. According to the effect of CPM, the medicine prescribed in this study could be classified into two types. The proportion of patients who received "Fuzheng Quyu" CPM for more than three months was higher than the proportion of patients who received other two types of CPM for more than three months. Medical records of 313 patients with NSCLC were analyzed. 4-year survival rate for patients received CPM more than 6 months and 3 months were higher than those received CPM less than 3 months (P = 0.028 and P = 0.021 respectively. In addition, 4-year survival rate for patients who received HSOS for more than 3 months was higher than those who received HSOS for less than 3 months (P = 0.041). Patients with elevated preoperative fibrinogen (FIB) level and those without surgery had an increased mortality risk (HR = 1.98, P < 0.01, and HR = 2.76, P < 0.01 respectively). The medium and long-term use of CPM/HSOS was positively associated with higher survival rate in NSCLC patients. Patients with high-level preoperative FIB level and those without surgery might have a poor prognosis in the following years.

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.

Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines

Due to the lack of specialized guidance, the post-marketing research on clinical effectiveness of Chinese patent medicines demonstrates varied quality and lacks high-quality evidence, failing to meet the demands of policy-making, clinical decision-making, and industrial decision-making. To address this issue, this project gathered experts in clinical medicine, clinical pharmacy, evidence-based medicine, drug epidemiology, medical ethics, and policy and regulation in China. They referred to the model of international post-marketing research on medicines and developed Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines under the framework of relevant laws and regulations and technical guidance documents in China. The guidelines were developed with consideration to the characteristics of Chinese patent medicines, China's national conditions, and all the stakeholders including marketing authorization holders, clinical researchers, drug administration, and users. The development of the guidelines followed the requirements for developing group standards set by the China Association of Chinese Medicine. The guidelines fully implement the concept of full life-cycle research, emphasizing the combination of traditional Chinese medicine(TCM) theory, human use experience, and clinical trials and pay attention to the compliance, scientificity, and ethics of research. The guidelines clarify the topic selection and decision-making path of the post-marketing research on effectiveness of Chinese patent medicines through six steps: determining research purpose, analyzing drug characteristics, evaluating research basis, proposing clinical orientation, clarifying research purpose, and implementing classified research. The general principles of research design and implementation were clarified from eight aspects: research type, research objects, sample size, efficacy indicators, bias, missing data, evidence level, and practicality. It focuses on the research on the TCM syndrome-based efficacy evaluation, clinical value-oriented mechanism of action, and the effectiveness of Chinese patent medicines with different routes of administration. The guidelines provide a universal methodological basis for the post-marketing research on clinical effectiveness of Chinese patent medicines.

Topical Chinese patent medicines for chronic musculoskeletal pain: systematic review and trial sequential analysis

PurposeChronic musculoskeletal pain (CMP) is defined as persistent or recurrent pain that occurs in the joints, musculo-soft tissue, spine or bones for more than three months and is not completely curable. Although topical Chinese patent medicine (CPM) is the most extensively utilized medication in Asia and is widely used for pain management, its efficacy remains controversial. This article presents a systematic review of clinical studies on the therapeutic properties of topical CPM for CMP patients to better inform clinical decision-making and provide additional and safer treatment options for patients with CMP.MethodWe performed a comprehensive search on PubMed, Cochrane Library, web of science and Chinese databases (CNKI and WanFang data) from 2010 to 2022. In all the studies, knee osteoarthritis, cervical spondylosis, low back pain, and periarthritis of shoulder met the International Pain Association definition of chronic musculoskeletal pain. We included only randomized controlled trials (RCTs) using topical CPM primarily for chronic musculoskeletal pain in adults. To determine the effect of topical CPM on clinical symptoms, we extracted the Visual Analog Scale (VAS, range 0–10) and the Western Ontario and McMaster Universities Arthritis Index pain scores (WOMAC pain, range 0–20), in which the lower the score, the better the results. We also accepted the comprehensive outcome criteria developed by the Chinese National Institute of Rheumatology as an endpoint (total effectiveness rate, range 0–100%, higher score = better outcome), which assesses the overall pain, physical function and wellness. Finally, trial sequential analysis of VAS pain score and total effectiveness rate was performed using TSA software.ResultsTwenty-six randomized controlled trials (n = 3180 participants) compared topical CPM with oral Nonsteroidal Anti-inflammatory Drugs (NSAIDs) (n = 15), topical NSAIDs (n = 9), physiotherapy (n = 5), exercise therapy (n = 4), and intra-articular Sodium hyaluronate injection (n = 2). Sixteen studies found that topical CPM was statistically significant in improving CMP pain (measured by VAS pain and Womac pain scores)(p < 0.05), and 12 studies found topical CPMs to be more clinically effective (assessed by ≥ 30% reduction in symptom severity) in treating patients with CMP (p < 0.05). Trial sequential analysis indicates that the current available evidence is robust, and further studies cannot reverse this result. In most of the studies, randomisation, allocation concealment and blinding were not sufficiently described, and no placebo-controlled trials were identified.ConclusionMost studies showed superior analgesic effects of topical CPM over various control treatments, suggesting that topical CPM may be effective for CMP and is an additional, safe and reasonable treatment option. These reported benefits should be validated in higher-quality RCTs.

Effects of adjunctive Chinese patent medicine on outcome of viral encephalitis in children: A multicenter retrospective study in China

BackgroundSome patients with viral encephalitis in China seek treatment with Chinese patent medicine (CPM) to improve their symptoms, but few studies have focused on the impact of CPM on the prognosis of viral encephalitis (VE). The aim of this multicenter retrospective study was to assess the benefit of adjunctive CPM therapy on the outcome of children with VE in China. MethodsThis study retrospectively included 834 children with viral encephalitis who were hospitalized at five medical institutions from 2018 to 2021. Univariate and multivariate logistic regression was used to assess the effect of CPM on sequelae in patients with VE. 1:1 propensity score matching was used to exclude the effect of confounding factors. Forest plots were used to observe the effect of CPM on the prognosis of VE in different subgroups. ResultsThere were fewer patients with sequelae in the group of patients using CPM regardless of whether they were matched or not. The results of multivariate logistic regression analysis showed that the use of CPM was an independent protective factor for the development of sequelae in VE patients (OR = 0.063, 95 % CI: 0.011–0.350, p = 0.002). Subgroup analyses showed that CPM was a protective factor for the development of sequelae regardless of the presence or absence of coma and comorbidities. In addition, we evaluated other outcome indicators and found shorter duration of illness, fever and headache in children with EV in the CPM group. ConclusionAdjunctive CPM therapy may significantly reduce sequelae in children with VE, as well as effectively alleviate patients' clinical symptoms. However, more prospective studies and clinical trials are needed to further evaluate its efficacy and safety.

Oral Chinese patent medicines for diabetic kidney disease: An overview of systematic reviews

Diabetic kidney disease (DKD) has become a global public health problem with a significant disease burden. A number of Chinese patent medicines (CPMs) are widely used in the treatment of DKD in China. An overview of systematic reviews (SRs) can summarize the overall evidence of its effectiveness and safety for both practice and research. SRs and/or meta-analyses based on randomized controlled trials (RCTs) of oral CPMs for DKD were identified. Eight databases were searched from their inception to October 2021. The AMSTAR 2 tool was applied to appraise the methodological quality of the included SRs by two authors. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to summarize the certainty of evidence of the included reviews. A total of 88 SRs were included, of which three were published as abstracts only. The methodological quality using the AMSTAR 2 approach was assessed as "low" for five SRs and "critically low" for 80 SRs. Renal end-point events and quality of life were not reported in all SRs. Most of the reviews reported surrogate outcomes. Serum creatinine and 24-hour urinary total protein were the two most commonly reported indicators, and regrettably, no high-quality evidence with GRADE assessment was found. Regarding safety, except for Tripterygium glycosides tablet, other CPMs had mild adverse effects. Due to the lack of end-point outcomes and high-quality evidence, the effectiveness and safety of oral CPMs for DKD remain uncertain. Future studies with more critical methodological designs are needed to provide robust evidence. A core outcome set for adults with DKD could help improve the consistency and relevance of outcomes from clinical trials.

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.

Effectiveness of Chinese patent medicine in the treatment of influenza: A protocol for systematic review and meta-analysis.

Background:Western medicine mainly uses antiviral drugs to treat influenza. However, anti-influenza virus drugs have been reported to have high levels of drug resistance and varying degrees of adverse reactions. In addition, Western medicine uses vaccination to prevent influenza, but vaccination cannot ensure complete prevention. Vaccines have a certain lag and cannot prevent the constantly mutating influenza virus. At present, there are still certain limitations in the prevention of influenza. In recent years, traditional Chinese medicine has been used more and more widely in the prevention and treatment of influenza and improvement of influenza-like symptoms, and related clinical efficacy control studies have reached a certain number. Therefore, the purpose of this study is to systematically evaluate the effectiveness of Chinese patent medicine in the treatment of influenza.Methods:Computer search of PubMed, Cochrane Library, Embase, CNKI, Wangfang and VIP database, search for randomized controlled trials of Chinese patent medicines therapy on influenza, the search time limit is to build the database until October 2021. Two researchers screened the retrieved literature and collected relevant patient information and data. The final included literature was meta analyzed by Rev man5.4 software.Results:The effectiveness and safety of Chinese patent medicines in the treatment of patients with influenza will be systematically evaluated.Conclusion:Systematic collection and analysis of clinical randomized controlled trials of Chinese patent medicines for the treatment of influenza, with a view to providing basic information for clinical decision-making and related research.Registration number:INPLASY2021100064 (https://inplasy.com/inplasy-2021- 10-0064/).

Comparing the effectiveness of Chinese patent medicines containing red yeast rice on hyperlipidaemia: A network meta-analysis of randomized controlled trials.

IntroductionThe purpose of this study was to evaluate the therapeutic effectiveness of Chinese patent medicines containing red yeast rice for the treatment of hyperlipidaemia.MethodsRelevant literature published until 13 August 2021, was retrieved from six electronic databases. Randomized clinical trials of Chinese patent medicines containing red yeast rice in patients with hyperlipidaemia were included in the review. Network meta‐analysis was performed using Stata 13.1 software. Methodological quality was assessed using the Cochrane risk of bias tool. The surface under the cumulative ranking (SUCRA) curve probability values were used to rank the treatments.ResultsThis study included 47 trials involving 4824 subjects. In terms of reduced total cholesterol levels, Xuezhikang (SUCRA: 84.5%) had the highest probability of being the most effective formulation, with Simvastatin (66.4%) and Zhibitai (65.4%) ranked second and third, respectively. Xuezhikang also had the highest probability of reducing low‐density lipoprotein cholesterol levels to the greatest extent (SUCRA: 82.6%) with Simvastatin (SUCRA: 74.9%) and Zhibituo (SUCRA: 52.8%) being the second and third choices, respectively. For reduced triglyceride levels, Zhibituo (SUCRA: 80.2%) exhibited the highest probability of being the most effective, with Xuezhikang (SUCRA: 63.4%) and Simvastatin (SUCRA: 57.6%) in second and third places, respectively. Finally, in terms of improving high‐density lipoprotein cholesterol levels, Zhibituo (SUCRA: 90.1%) had the highest probability of being the most effective, with Simvastatin (SUCRA: 82.1%) and Xuezhikang (SUCRA: 51.1%) ranked second and third, respectively.ConclusionsXuezhikang was found to have the highest probability of being the most effective formulation for reducing total cholesterol and low‐density lipoprotein cholesterol levels, while Zhibituo had the highest probability of being the most effective for controlling triglyceride and high‐density lipoprotein cholesterol levels. The studies included in the review exhibited certain limitations and, therefore, more rigorously designed studies should be performed.Trial registration: INPLASY registration number: INPLASY202130017.

Effect of Chinese patent medicine Si-Mo-Tang oral liquid for functional dyspepsia: A systematic review and meta-analysis of randomized controlled trials.

BackgroundSi-Mo-Tang oral liquid (SMT) has been widely used to treat functional dyspepsia (FD), but the effectiveness is still controversial. A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to assess the efficacy and adverse effects of SMT for FD.MethodsInvestigators searched for articles with publication dates to June 21, 2016, from 9 English and Chinese electronic databases. Comparisons were SMT alone or SMT in combination with western medicine as experimental intervention, and western medicine or placebo as the control. We used the Cochrane collaboration tool for assessing risk of bias to evaluate methodologies. Data were synthesized with RevMan 5.3 software. (PROSPERO Registration #CRD42016042003)ResultsTwenty-seven RCTs were included in the review, involving 2,713 participants: 1,383 subjects were in the experimental group and 1,330 in the control group. SMT showed a significant improvement in clinical efficacy (RR 1.14; 95% CI 1.09, 1.20; P<0.00001), but the heterogeneity was also significant (P = 0.0002, I2 = 56%). Because of the different interventions in the 2 groups, we performed subgroup and sensitivity analyses to investigate potential sources of heterogeneity. The heterogeneity was smaller after subgroup analysis and the exclusion of a study by Zhu from 2009. The corresponding pooled RR has no obvious change (RR 1.17; 95% CI 1.13, 1.21; P<0.00001). Subgroup analysis by age and drugs administered in control interventions between SMT and western medicine also showed improvement in the efficacy rate. But a data synthesis that excluded high risk of bias in the blinding of participants and personnel showed no significant difference (RR 1.14; 95% CI 0.97, 1.35; P = 0.12). Three studies measured gastric emptying. Two of these studies reported no significant difference between the experimental and control groups, while 1 study showed that SMT reduced the time of gastric emptying. The relapse rate and adverse effects had no difference between 2 groups.ConclusionsThis meta-analysis suggests that SMT is an effective and safe therapy option for patients with FD. However, because of the high clinical heterogeneity, poor quality, high risk of bias and small sample size of some included studies, further standardized large-scale and strictly designed studies are needed.

Therapeutic effect of Chinese patent medicine “Wuhuanghu” on porcine infectious pleuropneumonia and its acute and subchronic toxicity as well as evaluation of safety pharmacology

Chinese patent medicines play an important role in veterinary clinical use. The aim of this study is to research the anti-infection effect of Chinese patent medicine “Wuhuanghu” for the treatment of porcine infectious pleuropneumonia and to evaluate the safety of “Wuhuanghu” in order to provide a comprehensive understanding of its toxicity. The anti-infection results showed that the treatment with “Wuhuanghu” could significantly inhibit pneumonia and decrement of the pneumonia in high, medium and low doses of “Wuhuanghu” groups were 70.97%, 61.29% and 58.06% respectively. The acute toxicity test showed that rats in the highest group (5000mg/kg) had no death and no abnormal response, suggesting the LD50 of “Wuhuanghu” was more than 5000mg/kg. The subchronic toxicity study showed that hematology indexes in all groups had no obvious differences; blood biochemical index, only albumin and total cholesterol in middle and low doses of “Wuhuanghu” groups were significantly decreased when compared with control group. The clinical pathology showed that the target organ of “Wuhuanghu” was liver. The safety pharmacology study indicated that “Wuhuanghu” had no side effects on rats. In conclusion, “Wuhuanghu” has therapeutic and protective effects to porcine infectious pleuropneumonia in a dose-dependent manner and “Wuhuanghu” is a safe veterinary medicine.

A Satisfaction Survey of Current Medicines Used for Migraine Therapy in China: Is Chinese Patent Medicine Effective Compared with Western Medicine for the Acute Treatment of Migraine?

To investigate the patient satisfaction with medications commonly used for migraine therapy in patients seen in headache clinic in China with emphasis on the evaluation of Chinese patent medicine (CPM) in relieving acute migraine attack. Patients admitted at headache clinics in the neurological departments of four hospitals during April to October 2011 were enrolled in the investigation. The questionnaire was designed based on the validation of a diagnostic questionnaire for a population-based survey in China in 2009. Among 219 eligible patients, 58% had used CPM at the acute attack of migraine while the guideline-recommended treatments were seldom used. However, patients using CPMs were less satisfied than those using Western Medicines (WMs) in either single medication groups or mixed medication groups (P < 0.05). Fifty-eight percent of the eligible respondents in Guangdong and Guangxi Province had used CPM at the acute attack of migraine, but based on our data, the effect of CPM on treating migraine attack was poor with low satisfaction compared with WMs. However, many factors may bias or explain our findings. This suggests the need for accelerated research in understanding patient choice, treatment availability, and use of medications.

Evaluation of the add-on effect of chinese patent medicine for patients with stable or unstable angina: a systematic review and meta-analysis.

Chinese herbal medicine (CHM) has been widely used as an adjunct to western medicine in treating angina in China. We carried out this systematic review to evaluate the effectiveness of CHM on top of western medicine for angina. This meta-analysis included 46 randomized control trials with 4212 patients. For trials that included stable angina patients, the CHM group had significant lower incidence of total heart events (relative risk (RR) = 0.50, 95% confidence interval (CI) 0.33–0.78), myocardial infarction (RR = 0.32, 95% CI 0.14–0.72), heart failure (RR = 0.37, 95% CI 0.15–0.91), and angina (RR = 0.46, 95% CI 0.30–0.71) than that of control group. For trials that included unstable angina patients, CHM led to significantly lower occurrence of total heart events (RR = 0.46, 95% CI 0.32–0.66), myocardial infarction (RR = 0.37, 95% CI 0.26–0.54), and angina (RR = 0.36, 95%CI 0.26–0.51). Likewise, for trials that included stable or unstable angina patients, the rates of myocardial infarction (RR = 0.34, 95% CI 0.17–0.68) and angina (RR = 0.46, 95% CI 0.30–0.70) in CHM group were significantly lower than that in control group. In conclusion, CHM is very likely to be able to improve the survival of angina patients who are already receiving western medicine.