Safety Of Chinese Herbal Medicine Research Articles

Clinical Efficacy and Safety of Chinese Herbal Medicine in the Treatment of Uremic Pruritus: A Meta-Analysis of Randomized Controlled Trials.

Uremic pruritus is a disturbing and refractory symptom in patients with advanced chronic kidney disease. Chinese herbal medicine has been reported to alleviate uremic pruritus. To investigate the effects of Chinese herbal medicine, we conducted a systematic review and meta-analysis on patients with uremic pruritus. We searched databases (prior to 3 May 2022) for randomized controlled trials on the effects of Chinese herbal medicine in treating uremic pruritus. Our meta-analysis included 3311 patients from 50 randomized controlled trials. In patients with uremic pruritus, adjunctive Chinese herbal medicine significantly improved overall effectiveness (risk ratio 1.29, 95% CI 1.23 to 1.35), quality of life, renal function, reduced pruritus score, and inflammatory biomarkers compared to control groups with hemodialysis alone or with anti-pruritic treatments. Chinese herbal medicine treatment showed a time-dependent tendency in improving the visual analog scale of dialysis patients. Compared to control groups, no significantly higher risk of adverse events in patients taking Chinese herbal medicine (risk ratio 0.60, 95% CI 0.22 to 1.63). Chinese herbal medicine appears to be effective and safe in complementing the treatment of patients with uremic pruritus.

Adding Chinese Herbal Medicine to Routine Care is Associated With a Lower Risk of Rheumatoid Arthritis Among Patients With Asthma: A Population-Based Retrospective Cohort Study.

Objective: Due to the shared pathogenesis of asthma and rheumatoid arthritis (RA), patients with asthma were found to have a higher risk of RA. While the benefits and safety of Chinese herbal medicine (CHM) for asthma have been reported, the scientific evidence regarding its effect on RA is limited. This longitudinal cohort study aimed to determine the relation between CHM use and RA risk in patients with asthma. Methods: Using the nationwide claims data, we enrolled 33,963 patients 20–80 years of age who were newly diagnosed with asthma and simultaneously free of RA between 2000 and 2007. From this sample, we utilized propensity score matching to create sets of participants as treatment and control groups, which comprised 13,440 CHM users and 13,440 non-CHM users. The incidence rate and hazard ratio (HR) for RA between the two groups were estimated at the end of 2013. A Cox proportional hazards model was constructed to examine the impact of the CHM use on the risk of RA. Results: The cumulative incidence of RA was substantially lower in the CHM user group. In the follow-up period, 214 patients in the CHM user group (1.92 per 1,000 person-years) and 359 patients in the non-CHM user group (2.92 per 1,000 person-years) developed RA (adjusted HR = 0.63, 95% confidence interval: 0.54–0.75). Of the commonly-prescribed formulae, nine CHM products were associated with a lower RA risk: Xiao-Qing-Long-Tang, Ma-Xing-Gan-Shi-Tang, Ding-Chuan-Tang, Xin-Yi-Qing-Fei-Tang, Bei Mu, Jie Geng, Xing Ren, Da Huang, and San Chi. Conclusion: This study found that patients with asthma who received CHM treatment, in addition to the conventional therapy, had a lower risk of RA. Use of CHM treatment may be integrated into conventional therapy to reduce subsequent RA risk among asthma patients.

Chinese Herbal Medicine for Functional Dyspepsia With Psychological Disorders: A Systematic Review and Meta-Analysis

Background and AimsFunctional dyspepsia (FD) is closely associated with gut–brain interaction disorder (DGBI), characterized by the interaction of gastrointestinal symptoms and central nervous system dysregulation. Chinese herbal medicine (CHM) has a good concurrent effect in the treatment of FD, especially for patients with concurrent psychological disorders. A meta-analysis was designed to evaluate the efficacy and safety of CHMs in the treatment of FD.MethodsThe PubMed, Embase, Cochrane Library, Web of Science, Chinese Biological Medical Database (CBM), Wanfang Data, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal Database (VIP) were searched to collect randomized controlled trials of FD treated with CHM. The retrieval time limit is from the establishment of the database till 11 April 2022. Two researchers independently searched databases, screened documents, extracted data, and evaluated the risk of bias of included studies. RevMan 5.4 software was used for meta-analysis.ResultsA total of 11 studies including 951 patients were included. The study was divided into two parts. The first part included 5 clinical trials, including 471 patients. The experimental group was treated only with CHM and the control group was only treated with placebo. The results of first part showed that the total effective rate of CHM in the treatment of FD was higher than that in the placebo group (84.5 vs. 49.4%) [relative risk (RR) = 1.76; 95% confidence interval (CI) (1.13, 2.75); P = 0.01]. In addition, CHM treatment could reduce the total symptom score [standardized mean difference (SMD) = −10.05; 95% CI (−13.50, −6.59); Z = 5.70; P < 0.0001] and depression score [SMD = −7.68; 95% CI (−14.43, −0.94); Z = 2.23; P = 0.03]. The second part included 6 clinical trials, including 480 patients. The experimental group was only treated with CHM and the control group was treated with prokinetic agents combined with flupentixol melitracen (deanxit). The results of second part showed that the total effective rate of CHM in the treatment of FD was higher than that of the control group (92.6 vs. 78.8%) [RR = 1.17; 95% CI (1.09, 1.26), P < 0.0001]. In addition, CHM treatment could reduce HAMA score [mean difference (MD) = −3.19; 95% CI (−3.79, −2.59); Z = 10.40; P < 0.00001], HAMD score [MD = −4.32; 95% CI (−6.04, −2.61); Z = 4.94; P < 0.00001], and gastric emptying rate [MD = 12.62; 95% CI (5.84, 19.40); Z = 3.65; P = 0.0003]. The results of the two parts of the meta-analysis showed no serious adverse reactions, and there was no significant difference in the adverse reactions between the experimental group and the control group [MD = 1.14; 95% CI (0.53, 2.42); Z = 0.33; P = 0.74]; [MD = 0.14; 95% CI (0.01, 2.67); Z = 1.30; P = 0.19].ConclusionThe current evidence shows that CHM treatment has great potential and safety in alleviating the symptoms of FD and improving the psychological disorders of anxiety and depression in patients with FD. Limited by the quantity and quality of the included studies and other biases, the above conclusions need more high-quality studies to be verified.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier [CRD42022311129].

The effectiveness and safety of Chinese herbal medicine in infertile women with luteal phase deficiency: a systematic review and meta-analysis.

Chinese herbal medicine (CHM) has been reported to treat infertile women with luteal phase deficiency (LPD) in some clinical studies, however, the efficacy and safety of CHM for LPD are still under controversy. Here, we aim to evaluate the efficacy and safety of CHM using meta-analysis, and further compare it with conventional Western therapies (CWT) to elucidate the improvement in progestin and clinical pregnancy rates. Eight randomized controlled trials (RCTs) involving 465 women were included in our systematic review; these RCTs compared CHM with CWT in treating LPD in infertile women. The methodological quality of the included RCTs was assessed according to the Cochrane risk-of-bias assessment criteria. The data were analyzed by Review Manager 5.3 software. We estimated the risk ratio (RR) for dichotomous data and calculated the mean difference for continuous data. In contrast to CWT, CHM was superior in improving clinical pregnancy rates (RR 0.19; 95% CI: 0.11-0.27; P<0.001), increasing progesterone levels in the luteal phase [mean difference (MD) 2.28; 95% CI: 1.91-2.64; P<0.001] and luteal phase estrogen (MD 9.88; 95% CI: 4.53-15.24; P=0.0003), reducing traditional Chinese medicine (TCM) syndrome scores (MD -3.06; 95% CI: -3.95 to -2.17; P<0.001), and the incidence of adverse reactions (RR 0.12; 95% CI: 0.02-0.70; P=0.02). Evidence from eight small studies suggested that CHM has a therapeutic effect on infertile women with luteal insufficiency. We indicated that CHM may improve the level of progesterone and estradiol in the luteal phase, and the clinical pregnancy rate, with few side effects based on the current studies. However, given the relatively small number of included studies, further studies about the higher quality of study designs, larger population and the underlying mechanism are required to elucidate the role of CHM in LPD treatment.

Outcome of the efficacy of Chinese herbal medicine for functional constipation: A systematic review and meta-analysis.

BACKGROUNDFunctional constipation (FC) is a common and chronic gastrointestinal disease and its treatment remains challenging. AIMTo evaluate the efficacy and safety of Chinese herbal medicine (CHM) on efficacy rate, global symptoms, bowel movements and the Bristol Stool Scale score in patients with FC by summarizing current available randomized controlled trials (RCTs).METHODSRCTs with CHM to treat FC were identified by a systematic search of six databases from inception to October 20, 2020. Two independent reviewers assessed the quality of the included articles and extracted data. Meta-analyses were performed to odds ratio (OR), mean differences (MD) and 95% confidence interval (CI) using random-effects models. Subgroup analyses and sensitivity analyses were used to explore and interpret the sources of heterogeneity. The funnel plot, Begg’s test and Egger’s test were used to detect publication bias.RESULTSNinety-seven studies involving 8693 patients were included in this work. CHM was significantly associated with a higher efficacy rate (OR: 3.62, 95%CI: 3.19-4.11, P < 0.00001) less severe global symptoms (OR: 4.03, 95%CI: 3.49-4.65, P < 0.00001) compared with control treatment, with the low heterogeneity between studies (I2 = 0%, P = 0.76). CHM was also associated with more frequent bowel movements (MD 0.83, 95%CI: 0.67-0.98, P < 0.00001), a lower score on the Bristol Stool Scale (OR: 1.63, 95%CI: 1.15-2.32, P < 0.006), and a not significant recurrence rate (OR: 0.47, 95%CI: 0.22-0.99, P = 0.05). No serious adverse effects of CHM were reported.CONCLUSIONIn this meta-analysis, we found that CHM may have potential benefits in increasing the number of bowel movements, improving stool characteristics and alleviating global symptoms in FC patients. However, a firm conclusion could not be reached because of the poor quality of the included trials. Further trials with higher quality are required.

Efficacy and safety of Chinese herbal medicine for vascular dementia

Abstract Introduction: As a common type of clinical dementia, the prevalence rate of vascular dementia (VaD) increased rapidly in recent years, damaging both patients’ health and social-economic prospect. There is currently no effective treatment for VaD, though western medicines can slightly improve patients’ cognitive function, but not brought a significant improvement in daily life ability. Chinese herbal medicine (CHM) has been widely employed to treat dementia for more than 2000years in China. Despite the proliferation of relevant literature, there is still a lack of evidence to prove the effectiveness and safety of such therapy. Therefore, this systematic review and meta-analysis protocol is aimed to assess the efficacy and safety of CHM for VaD. Methods and analysis: Six English databases (PubMed, Web of Science, Embase, Springer, CENTRAL and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wan fang Database, Chinese Scientific Journals Database &lt;VIP&gt;, China National Knowledge Infrastructure Database &lt;CNKI&gt; and Chinese Biomedical Literature Database &lt;CBM&gt;) will be searched from the inception to July 1st, 2020. Randomized controlled trials, which participants with VaD receiving various CHM therapy versus control group, will be included in this study. Two researchers will independently obtain data, screen eligible trials, and evaluate the quality of literature. Any disagreement will be settled by a discussion with the third investigator. A comprehensive meta-analysis will be conducted using the Cochrane collaboration software (Review Manager 5.3). Ethics and dissemination: Since this article is a protocol that does not involve patients and personal information collection, ethical approval is therefore not required. This systematic review will be published in a peer-reviewed journal, presented at conferences, and will be shared on social media platforms. The review will be disseminated in a peer-reviewed journal or conference presentation. INPLASY registration number: INPLASY 202210098.

Effects of Chinese Herbal Medicine on ovarian functions in the patients with endometriosis: A systematic review and meta-analysis of randomized controlled trials

When using Chinese Herbal Medicine (CHM) to treat endometriosis, the effects of CHM on the ovarian function have received little attention. This systematic review and meta-analysis aimed to evaluate the effects and safety of CHM on the ovarian function in patients with endometriosis. Eight electronic databases were searched from their inception to March 2, 2021. We compared those receiving CHM with controls, all studies included were randomized controlled trials (RCTs). Statistical analysis was performed using standard mean difference of hormonal levels: Estradiol(E2), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH). Subgroup analysis and sensitivity analysis were conducted. A total of 844 patients from 11 RCTs were included. In E2 levels, the analysis revealed a significant effect in favor of CHM group compared with the control group (SMD = 3.05, 95%CI = 0.29 to 1.32, P = 0.002). After subgroup analyses, there were still significant effects in both non-operative subgroup (SMD = 2.04, 95%CI = 0.04 to 1.88, P = 0.04) and post-operative subgroup (SMD = 2.19, 95%CI = 0.08 to 1.42, P = 0.03). There were no significant differences between the two subgroups in both FSH levels (P > 0.05) and LH levels (P > 0.05), and the subgroup analyses showed similar results. No adverse events were reported. CHM may improve ovarian function in patients with endometriosis through increasing E2 levels whether there is surgery or not, which may indicate a referable and safe treatment for endometriosis. Due to the weak evidence, high-quality clinical trials are needed to support this conclusion. (PROSPERO ID is CRD42021240162)

Correction to: Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.

Correction to: Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.

Efficacy of Chinese herbal medicine for tPA thrombolysis in experimental stroke: A systematic review and meta-analysis

BackgroundTissue-type plasminogen activator (tPA) remains the sole FDA approved thrombolytic drug for ischemic stroke. But delayed thrombolytic therapy with tPA may increase the risk of hemorrhagic transformation. Many Chinese herbal medicines have been used as tPA helpers to enhance the capacity of tPA and minimize the risk of hemorrhagic transformation. The efficacy of Chinese herbal medicines on tPA thrombolysis is not systematically analyzed. MethodsWe searched the following three databases up to January 2022: Web of Science, PubMed, and Scopus. Studies that reported the efficacy and safety of Chinese herbal medicines on tPA thrombolysis in experimental stroke were included. The efficacy outcomes were neurological score and infarct volume, the safety outcomes were cerebral hemorrhage and blood brain barrier (BBB) damage. We used the checklist of CAMARADES to assess the quality of included studies. Standardized mean difference (SMD) with 95% confidence intervals were used to assess all the outcomes. Subgroup analyses were performed to explore the sources of heterogeneity. Trim and fill method and Egger's test were used to assess the potential publication bias. Sensitivity analyses were used to identify the stability of the results. ResultsA total of nine studies including 11 Chinese herbal medicines fulfilled the inclusion criteria and were subsequently analyzed. The pooled data demonstrated that Chinese herbal medicines improved neurological score (2.23 SMD, 1.42–3.04), infarct volume (1.08 SMD, 0.62–1.54), attenuated cerebral hemorrhage (1.87 SMD, 1.34–2.4), and BBB dysfunction (1.9 SMD, 1.35–2.45) following tPA thrombolysis in experimental stroke. Subgroup analysis indicated that the route of drug delivery, dosage of tPA, and stroke model used may be factors inducing heterogeneity and influencing the efficacy. ConclusionTreatment with Chinese herbal medicines significantly improved neurological score and infarct volume, reduced cerebral hemorrhage and BBB damage after tPA thrombolysis. This study supports Chinese herbal medicine as an adjuvant therapy in reducing the side effects of tPA thrombolysis after acute ischemic stroke. The results should be interpreted with more caution since this article was based on animal studies.

Preventive effect and safety of Chinese herbal medicine for oral mucositis during radiotherapy in patients with head and neck cancer: Study protocol for a randomized trial

BackgroundOral mucositis (OM) is a common side effect of radiotherapy (RT) that can have severe implications in patients with head and neck cancer (HNC). Traditional Chinese medicine (TCM) formula is widely applied in treating OM, but little substantial evidence exists to clarify it effects. The study intends to determine whether the TCM-based prescription in treating HNC with RT can improve the OM when compared with RT alone. MethodsA single-center, randomized, two-arm parallel-group, open-label controlled clinical trial will be conducted to determine whether the Zi-Yin-Liang-Ge-San (ZYLGS), which contains Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis, combined with RT can improve the incidence and severity of OM. Two hundred participants will randomly 1:1 to receive at least 6 weeks of RT plus ZYLGS powder or control. The primary outcome measures are onset, gradation of OM (Common Terminology Criteria for Adverse Events v5.0), and oral pain (visual analogue scale). The secondary outcome measures include nutritional status, the EORTC Quality of Life Core Questionnaire and head and neck module. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, serious adverse events, and blood and biochemical analysis will be recorded to evaluate the safety. Visits will be performed for each week during the RT treatment period and then 2 weeks in the follow-up period. DiscussionThe study's result will provide a high-level evidence for TCM-based formulation for HNC patients with RT on the effect of OM prevention and management.

Efficacy and Safety of Chinese Herbal Medicine for Knee Osteoarthritis: Systematic Review and Meta-analysis of Randomized Controlled Trials

PurposeThis study aims to evaluate the effectiveness and safety of oral Chinese herbal medicine (CHM) in the treatment of knee osteoarthritis (KOA). Study DesignSystematic review and meta-analysis of randomized controlled trials (RCTs). Materials and methodsA computer was used to retrieve all RCTs of CHM in the treatment of KOA from 7 databases (PubMed; Embase; Cochrane Central Register of Controlled Trials; China National Knowledge Infrastructure; Chinese VIP Information Database; Chinese Biomedical Database and Wanfang Med Database) from the establishment to August 2021. The literature was organized using NoteExpress, and literature screening and data extraction were conducted by two researchers independently by the inclusion and exclusion criteria. Quality evaluation was performed using GRADE, and the meta-analysis was performed using RevMan5.4. ResultsA total of 31 RCTs and 3115 cases are included. The following meta-analysis results are observed: (1) WOMAC: CHM vs. placebo (SMD = −0.87, 95% CI: −1.27 to −0.47, P < 0.0001), CHM vs. Western medicine (SMD = −1.64, 95% CI: −2.09 to −1.19, P < 0.00001), and CHM + Western medicine vs. Western medicine (SMD = −2.17, 95% CI: −3.01 to −1.33, P < 0.00001); (2) VAS: CHM vs. Western medicine (SMD = −1.02, 95% CI: −1.63 to −0.41, P < 0.00001) and CHM + Western medicine vs. Western medicine (SMD = −2.68, 95% CI: −4.36 to −1.00, P < 0.00001); (3) Lequesne severity index: CHM vs. Western medicine (SMD = −0.90, 95% CI: −1.40 to −0.39, P = 0.0005) and CHM + Western medicine vs. Western medicine (SMD = −0.94, 95% CI: −1.36 to −0.52, P < 0.0001); (4) Lysholm knee joint function score: CHM vs. Western medicine (MD = 9.10, 95% CI: 4.20 to 14.01, P = 0.0003), and CHM + Western medicine vs. Western medicine in a single trial (MD = 21.15, 95% CI: 19.71 to 22.59, P < 0.00001); (5) SOD: in a single trial, CHM vs. Western medicine (MD = 1.62, 95% CI: 0.9 to 2.30, P < 0.00001) and CHM + Western medicine vs. Western medicine (MD = 17.08, 95% CI: 10.71 to 23.44, P < 0.00001); (6) TNF-α: CHM vs. Western medicine (SMD = −1.90, 95% CI: −2.04 to −0.14, P = 0.02) and CHM + Western medicine vs. Western medicine (SMD = −2.32, 95% CI: −4.33 to −0.30, P = 0.02); (7) IL-1β: CHM vs. Western medicine (SMD = −1.60, 95% CI: −2.36 to −0.84, P < 0.0001); and (8) IL-6: in a single trial, CHM vs. Western medicine (MD = −0.75, 95% CI: −1.20 to −0.30, P = 0.001) and CHM + Western medicine vs. Western medicine (MD = −3.18, 95% CI: −6.24 to −0.12, P = 0.04). ConclusionThe efficacy of CHM in the treatment of KOA is superior to those of placebo and Western medicine. At the same time, the combination of CHM + Western medicine is superior to Western medicine alone in the treatment of KOA. However, due to the existence of certain biases in the included studies, and the need for further study on the effective components of Chinese medicine, a positive conclusion on the efficacy of traditional CHM in the treatment of KOA cannot be drawn and needs to be confirmed by high-quality clinical RCTs.

Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.

Hypertension is one of the most challenging public health problems worldwide. Previous studies suggested that the Songling Xuemaikang capsule (SXC)-a Chinese herbal formula-was effective for essential hypertension. However, the efficacy of SXC monotherapy for hypertension remains unclear. We aimed to compare the blood pressure (BP)-lowering efficacy and safety of SXC versus losartan in patients with essential hypertension. In this multicenter, randomized, double-blind, noninferiority trial in China, patients 18 to 65 years of age with mild essential hypertension were randomly allocated to receive either SXC or losartan for 8 weeks. The primary outcome was the change in sitting diastolic BP from baseline to 8 weeks, with a predefined noninferiority margin of -2.5 mm Hg. Of the 755 patients who entered a 2-week run-in period, 628 patients (327 women and 301 men; mean [SD] age, 52.6 [9.2] years) were randomly assigned to the SXC (n=314) or losartan (n=314) group. The primary analysis based on the intention-to-treat principle showed that the change in diastolic BP from baseline to 8 weeks was similar between the SXC and losartan groups (-7.9 [8.0] versus -8.1 [7.9]). The lower boundary of 95% CI (mean difference, -0.24 [95% CI, -1.51 to 1.03]) was above the margin of -2.5 mm Hg, showing noninferiority. Results were consistent with per-protocol analysis. SXC produced greater improvements in total hypertension symptom score (-5.7 [4.2] versus -5.0 [4.0]; P=0.020) and total cholesterol (-0.1 [1.0] versus 0.1 [1.2]; P=0.025). There were no differences between groups in the other BP and patient-reported outcomes. Incidence and severity of adverse events were similar between groups. SXC was well tolerated and demonstrated noninferior to losartan in BP lowering in patients with mild hypertension. SXC might be an alternative for mild hypertension, particularly for patients with a preference for natural medicine. URL: www.chictr.org.cn; Unique identifier: ChiCTR-IPR-16008108.

The Effects and Safety of Chinese Herbal Medicine on Blood Lipid Profiles in Placebo-Controlled Weight-Loss Trials: A Systematic Review and Meta-Analysis

This study was conducted to assess the effects and safety of Chinese herbal medicine (CHM) on blood lipids among adults with overweight or obesity. Fourteen bibliographic databases were comprehensively searched, from their respective inceptions up to April 2021, for randomised placebo-controlled weight-loss trials using CHM formulation on total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol over ≥4 weeks. Data collection, risk of bias assessment, and statistical analyses were guided by the Cochrane Handbook (v6.1). Continuous outcomes were expressed as the mean difference with 95% confidence intervals, and categorical outcomes were expressed as a risk ratio with 95% confidence intervals. All analyses were two-tailed with a statistical significance of p < 0.05. Fifteen eligible studies with 1,533 participants were included in this meta-analysis. Findings from meta-analyses indicated that CHM interventions, compared to placebo, reduced triglyceride (MD −0.21 mmol/L, 95% CI −0.41 to −0.02, I2 = 81%) and increased HDL cholesterol (MD 0.16 mmol/L, 95% CI 0.04 to 0.27, I2 = 94%) over a median of 12 weeks. The reduction in total cholesterol and LDL cholesterol were not statistically significant. Furthermore, the tendency of reduced triglycerides was identified among overweight participants with high baseline triglycerides. Attrition rates and frequency of adverse events were indifferent between the two groups. CHM may provide lipid-modulating benefits on triglycerides and HDL cholesterol among participants with overweight/obesity, with the tendency for significant triglyceride reduction observed among overweight participants with high baseline triglycerides. However, rigorously conducted randomised controlled trials with larger sample sizes are required to validate these findings.

The Efficacy and Safety of Chinese Herbal Medicine in the Treatment of Knee Osteoarthritis: An Updated Systematic Review and Meta-Analysis of 56 Randomized Controlled Trials.

Objective This systematic review and meta-analysis were performed to investigate the efficacy and safety of Chinese herbal medicine (CHM) in the treatment of knee osteoarthritis (KOA). Methods An electronic search was conducted in eight databases (PubMed, EMBASE, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese VIP Database, and Wanfang Database) from inception until December 2019. The risk of bias assessment of the included RCTs was evaluated by Cochrane collaboration's tool. The inclusion criteria were RCTs that investigated the efficacy and safety of CHM in the treatment of KOA, with no restrictions on publication status or language. The exclusion criteria included nonrandomized or quasi-RCTs, no clear KOA diagnostic approach, combined Chinese medicinal herbs with other traditional Chinese medicine treatment modalities, and published using repeated data and missing data. We computed the relative risk (RR) and the standard mean difference (SMD) for dichotomous outcomes and continuous outcomes, respectively. When heterogeneity was detected or there was significant statistical heterogeneity (P < 0.05 or I2 > 50%), a random-effects model was employed, followed by further subgroup analysis and metaregression estimations to ascertain the origins of heterogeneity. Otherwise, we used a fixed-effects model (P ≥ 0.05 or I2 ≤ 50%). The primary outcome measures were visual analog score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm score, and Lequesne index. Secondary outcome measures were the total clinical effective rate and adverse events. The meta-analysis was performed using the Stata 14.0 software. Results A total of 56 RCTs comprising 5350 patients met the inclusion criteria. This meta-analysis showed that application of CHM as adjuvant therapy or monotherapy for KOA can significantly decrease VAS, WOMAC, and the Lequesne index and improve the Lysholm score as well as the total effective rate. In addition, this treatment has fewer adverse effects, suggesting that CHM is generally safe and well tolerated among patients with KOA. Conclusion Our study offers supportive evidence that CHM, either adjuvant therapy or monotherapy, reduces the VAS, WOMAC, and Lequesne index and improves the Lysholm score and overall effective rate in patients with KOA. Additionally, CHM was well tolerated and safe in KOA patients. We found frequently used CHMs that might contribute to the formulation of a herbal formula that could be considered for further clinical use. However, given the heterogeneity and limited sample size in this study, larger multicenter and high-quality RCTs are needed to validate the benefits of CHM in the treatment of KOA.

Efficacy and Safety of Chinese Herbal Medicine for Endometriosis Associated Pain.

Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Chinese herbal medicine (CHM) has been used for endometriosis for many years in Asian populations. This is a retrospective study in a territory teaching hospital of the China Academy of Chinese Medical Sciences in Beijing, China to compare the short- and long-term effectiveness and safety of CHM for endometriosis associated pain (EAP) before and after CHM treatment. A total of 338 out of 1143 women confirmed with endometriosis by ultrasonogram or surgery within three months received a CHM decoction twice a day for at least 3 and up to 24 months. All data were collected by a Structured Medical Records of Endometriosis (SMRE) in every clinic visit covering the whole treatment period. Pain score, evaluated by Numeric Rating Scale, was significantly decreased from 3rd to 12th month in women with moderate or severe pain. Frequency and severity rating of menstrual symptoms, evaluated by Cox Menstrual Symptom Scale, were significantly decreased in women with any pain level. Psychological changes rated by Self-rating Anxiety Scale (SAS) were significantly lower in 3, 6, 12, and 24 months of treatment, but those by Self-rating Depression Scale (SDS) was significantly decreased in six months of treatment. There was no severe adverse event but only minor side-effects. In conclusion, our study showed that CHM relieved EAP and related symptoms with minimal side-effects after treatment. A large-scale randomized and placebo-controlled trial could be designed to confirm the efficacy and safety.

Mechanism of hepatotoxicity induced by ethanol extract of Dysosma versipellis based on "quantity-weight-evidence" network toxicology

In this study, the toxicological/pharmacological research method of &quot;quantity-weight-evidence&quot; network was first proposed and practiced to supplement the existing methodology of network toxicology. We transformed the traditional qualitative network into a quantitative network in this study by attributing weights to toxic component content and target frequency, which improved the reliability of data and provided a research idea for the systematic safety evaluation and toxicological research of Chinese medicinal herbs. Firstly, 50% ethanol extract of Dysosma versipellis(DV) was administrated to rats via gavage and the potential hepatotoxic components were identified by serum pharmacochemistry. Then, the component targets were obtained from SwissTargetPrediction, PharmMapper and other online databases, and the target weights were given according to the relative content of components and target fishing frequency. Meanwhile, the targets of hepatotoxicity were predicted from online databases such as Comparative Toxicology Database(CTD) and GeneCards. Subsequently, protein-protein interaction analysis and KEGG pathway enrichment were performed with the STRING database. Finally, the quantitative network of &quot;toxic components-weighted targets-pathways&quot; was constructed. Eleven potential toxic compounds were predicted, including podophyllotoxin, podophyllotoxone, deoxypodophyllotoxin, and 6-methoxypodophyllotoxin. A total of 106 hepatotoxic targets and 65 weighted targets(e.g., Cdk2, Egfr, and Cyp2 c9) were identified. The results of Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment showed that these targets could act on PI3 K-AKT, MAPK, and Ras signaling pathways to play a role in inflammatory response and oxidative stress. However, traditional network toxicology showed that 51 targets such as AKT1, Alb, and Stat3 may lead to hepatotoxicity by mediating inflammation and cell proliferation. In conclusion, we proposed &quot;quantity-weight-evidence&quot; network toxicology in this study and used it to study the mechanism of DV-induced hepatotoxicity in rats. This study confirms the feasibility of this new methodology in toxicological evaluation and further improves the systematic evaluation of the safety of Chinese medicinal herbs.

Efficacy and safety of acupuncture combined Chinese herbal medicine for diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis.

Background:Acupuncture combined with Chinese herbal medicine has been widely utilized for pain management in patients with diabetic peripheral neuropathy (DPN). However, its results are still inconsistent, and no systematic review has specifically addressed this issue. Thus, this systematic review will comprehensively and systematically investigate the effectiveness and safety of acupuncture combined with Chinese herbal medicine for pain relief in DPN.Methods:Randomized controlled trials on acupuncture combined with Chinese herbal medicine treatment of DPN published before September of 2021 will be searched in 9 databases including Medline, Web of Science, PubMed, Cochrane Library, Excerpta Medica Database, Sinomed, China National Knowledge Infrastructure, WanFang, and China Science and Technology Journal Database. The methodological assessment performed using the risk of bias assessment tool of Cochrane, and the level of evidence quality for the main results will be evaluated by a recommended grading, evaluation, formulation, and evaluation system approach. Bayesian network meta-analysis will be conducted using STATA V.14.0 and WinBUGS V.1.4.3.Results:This study will provide a high-quality comprehensive evaluation of the safety of acupuncture combined with Chinese herbal medicine for treating DPN.Conclusion:This systematic review will evaluate the efficacy and safety of Chinese herbal medicine combined with acupuncture in the treatment of DPN, and provide the latest evidence for clinical application.Ethics and dissemination:The protocol of the systematic review does not require ethical approval because it does not involve humans. This article will be published in peer-reviewed journals and presented at relevant conferences.Registration number: INPLASY2021100004.

Efficacy and safety of Chinese herbal medicine for mammary nodules: A systematic review and meta-analysis

Background: Chinese herbal medicine (CHM) is often used in China to treat patients with mammary nodules (MMND), and treating them by CHM can not only achieve good efficacy, but also reduce adverse reactions in clinic. However, the efficacy of CHM in the treatment of MMND has not been systematically assessed right now. Methods: From the establishment of 11 electronic databases to February 1, 2022, a comprehensive literature search was conducted to evaluate the efficacy and safety of CHM in the treatment of MMND. Relevant trials were screened in NoteExpress, and the risks of bias were assessed with Cochrane Collaboration’s tool. Results: This study included 22 randomized controlled trials involving 3839 participants. Meta-analysis revealed that CHM had a significant clinical effect in treating MMND. Compared with chemical drugs, CHM had certain advantages in alleviating the size, range, hardness and pain of the lump, decreasing the TCM syndrome score and reducing the packed cell volume and whole blood viscosity. And it could obviously reduce the occurrence of adverse reactions. In combination with chemical drugs, CHM could significantly improve the level of sex hormone secretion and ultrasound indicators. Ru-pi-xiao was the most commonly used formula for the treatment of MMND, and Bupleuri Radix was the most frequently used single Chinese herb. Conclusion: CHM had certain advantages in treating MMND without obvious adverse reactions. However, due to the poor methodological quality of the included trials, well-designed, long-term follow-up randomized controlled trials will be required in future to provide strong clinical evidence for the CHM treatment of MMND. (PROSPERO No. CRD42020170939.)

Chinese Herbal Medicine Used With or Without Conventional Western Therapy for COVID-19: an evidence review of clinical studies

Objective: To present the evidence of the effectiveness and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy on COVID-19. Methods: Clinical studies on effectiveness and safety of CHM for COVID-19 were included. We summarized general characteristics of included studies, evaluated methodological quality of randomized controlled trials (RCTs), analyzed the use of CHM, estimated the effectiveness and safety of CHM. Results: A total of 58 clinical studies were identified including RCTs (17.24%, 10), non-randomized controlled trials (1.72%, 1), retrospective studies with a control group (18.97%, 11), case-series (20.69%, 12) and case-reports (41.38%, 24). No high methodological quality RCTs were identified. The most frequently tested Chinese patent medicine, Chinese herbal medicine injection or prescribed herbal decoction were: Lianhua Qingwen granule/capsule, Xuebijing injection and Maxing Shigan Tang. In terms of aggravation rate, pooled analyses showed that there had statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, 6 RCTs;RR 0.37, 95% CI 0.22 to 0.64, 4 retrospective studies with control group), that is, CHM plus conventional western therapy appeared better than conventional western therapy in reducing aggravation rate. In addition, compared with conventional western therapy, CHM plus conventional western therapy had potential advantages in increasing the resolution rate and shortening the duration of fever, cough and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the number of patients with inflammatory disappearance or shortening the time from receiving treatment to beginning of inflammation disappearance. For adverse events, pooled data showed that there was no statistical difference between the CHM and the control groups. Conclusion: Current low certainty evidence suggests that there may be a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.

An Overview of Systematic Reviews of Chinese Herbal Medicine for Alzheimer's Disease.

Background: Multiple systematic reviews (SRs) have been conducted to evaluate the efficacy and safety of Chinese herbal medicine (CHM) in patients with Alzheimer’s disease (AD). Here, we aim to perform an overview to assess the methodological quality and quality of evidence of the SRs to provide convincing data on the treatment of AD with CHM. Method: Six electronic databases including Chinese and English were searched, until April 31, 2021. Two researchers independently screen documents and extract data according to the predesigned rules. A Measure Tool to Assessment System Reviews 2 (AMSTAR-2) was used to investigate the methodological quality, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to determine the quality of evidence for outcomes. Results: Twelve qualified SRs including 163 randomized controlled trials were reviewed. The methodological quality of the included SRs was considered extremely low assessed through AMSTAR-2. Compared with western medicines (WM) alone, CHM as an adjuvant treatment has shown significant effects in improving Mini-mental State Examination, Alzheimer’s Disease Assessment Scale-Cognitive, and Clinical Dementia Rating scores. The same is true for CHM alone. Regarding the effect on Activities Daily Living, neither the single CHM nor the combination with WM has an obvious effect. For the total effective rate, both single CHM and the combination with WM shown significant effects. Nine SRs suggested that CHM as adjuvant therapy or single-use had fewer adverse events than WM. Additionally, the quality of evidence for the main outcome was reviewed as low or extremely low according to GRADE profiler data. Conclusion: Current evidence suggests that CHM may be beneficial in improving the cognitive function of AD patients. However, we should be cautious about the evidence due to methodological flaws and low quality. High-quality RCTs are further needed to confirm the efficacy and safety of CHM for AD.