Safety Of Chinese Herbal Formula Research Articles

Effectiveness and safety of Chinese herbal formula combined with western medicine for ankylosing spondylitis: A protocol for systematic review and meta-analysis.

Background:Ankylosing spondylitis (AS) is a chronic progressive inflammatory disease of the spine, which mainly invades the sacroiliac joint, spine, and large joints near the trunk, leading to fibrous and skeletal ankylosis and deformity, and can cause damage to the eyes, lung, cardiovascular, kidney and other organs. Chinese herbal formulas (CHF) is an important interventions of Traditional Chinese Medicine (TCM), and CHFs combined with western medicine are widely used in clinical practice to treat AS.Methods:Eight databases will be systematically retrieved from their inceptions to March 2021. Only randomized controlled trials (RCTs) of CHFs combined with western medicine for AS treatment will meet the inclusion criteria. The primary outcomes we focus on include clinical effectiveness rate, TCM syndrome score, TCM symptom score, Bath ankylosing spondylitis disease activity index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), chest expansion, nocturnal spinal pain, adverse reactions, erythrocyte sedimentation rate (ESR), and C protein response (CRP). The research screening, data extraction, and risk of bias assessment will be performed independently by 2 researchers, and divergence will be solved by a third researcher. Revman 5.3 software will be used for meta-analysis. The confidence of evidence will be graded using grading of recommendations assessment, development, and evaluation (GRADE) algorithm and methodological quality will be assessed adopting risk of bias in systematic reviews (ROBIS).Results:This systematic review (SR) will provide evidence-based medical evidence for AS therapy by CHF combined with western medicine and we will submit the findings of this SR for peer-review publication.Conclusions:This SR will provide latest and updated summary proof for assessing the effectiveness and safety of CHF combined with western medicine for AS.Registration number:INPLASY 202150089.

The effectiveness and safety of Chinese herbal formulas on skin photoaging: A protocol for systematic review and meta-analysis.

Background:Skin photoaging (SP) is a complex and complicated process of skin characteristic changes caused by excessive sunlight. Wrinkles, looseness, coarseness, and increase or loss of pigment are the main clinical manifestations of the disease. The pathogenesis of SP mainly involving oxidative stress, inflammatory reaction, immune dysregulation and DNA damage, and so on. In recent years, traditional Chinese medicine, as an significant form of complementary and alternative medicine, has attracted the more and more attention within the field of health care and indicated a desirable effect on SP. Chinese herbal formula (CHF) is an essential part of traditional Chinese medicine interventions, and the number of clinical trails on SP treated by CHFs have shown a growing trend. Therefore, we developed this systematic review and meta-analysis protocol to assess the effectiveness and safety of CHFs in the therapy of SP, so as to provide reliable evidence-based evidence for clinical decision-making.Methods:A overall literature retrieval will be carried out in 9 electronic journal database. We will include randomized controlled trials (RCTs) on CHFs alone or combined with routine western medicine measures in the treatment of SP. The outcomes we focused on are consists of symptom score (skin relaxation, telangiectasia, pore coarseness, pigmentation, etc), total effective rate, and adverse reactions. Meta-analysis will be performed using Stata 13.0 software. Literature retrieval and screening, data extraction, risk of bias assessment of RCTs, evidence confidence rating by grading of recommendations assessment, development, and evaluation method and methodological quality assessment of systematic review by assessment of multiple systematic reviews-2 will be conducted independently by 2 reviewers, and disagreements will be resolved through discussion or judged by a third senior reviewer.Results:This systematic review and meta-analysis will pool the proof of RCTs on SP treated by CHFs alone or combined with conventional western medicine treatments. The findings of this study will be presented at relevant conferences and submitted to peer-reviewed journals for publication.Conclusion:We expect that the results of this systematic review will provide comprehensive and reliable evidence for clinicians and policy makers.Registration number:INPLASY 2020120005

Efficacy and safety of SQJZ herbal mixtures on nonmotor symptoms in Parkinson disease patients: Protocol for a randomized, double-blind, placebo-controlled trial.

Background:As a multisystemic neurodegenerative disorder, Parkinson disease (PD) has a broad spectrum of symptoms including motor and nonmotor symptoms (NMS). As shown in studies, NMS can also impact patient's quality of life, and many of them often go untreated. Chinese herbal medicines with multiconstituent may alleviate NMS in PD patients. This research is carried out to assess the efficacy and safety of a Chinese herbal formula for NMS, with its Chinese name acronym of SQJZ.Methods/design:It will be a multicenter, randomized, double-blind, placebo-controlled trial. Idiopathic PD with a Hoehn and Yahr scale score ≤4, aged 18 to 80 years, will be involved. About 240 patients will be randomly assigned to either SQJZ or placebo in a 2:1 ratio. There is a 2-week run-in period before the randomization, and the follow-up will be 24 weeks, including 12-week treatment period, with visit once every 4 weeks and 12-week washout follow-up. All participants are asked to maintain the regular medication schedule. SQJZ formula will consist of Chinese herbs with effects for insomnia, constipation, anxiety, and so on. The primary outcome will be measured using NMS scale, and secondary outcomes will include unified PD rating scale, PD sleep scale, the Parkinson fatigue scale, the constipation severity instrument, and PD Questionnaire-39. The primary efficacy analysis will be based on the intention-to-treat method, and mixed-model repeated-measures analyses will be used.Discussion:The findings from this research might provide evidence of the efficacy and safety of SQJZ Chinese herbal formula for treating NMS in PD patients. The results will sustain the broader use of SQJZ formula in PD.

Efficacy and Safety of a Chinese Herbal Formula (Invigorating Kidney and Strengthening Spleen) in Chronic Hepatitis B Virus Carrier: Results from a Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial

A Chinese Herbal Formula (CHF) has acquired a certain therapeutic effect on chronic HBV infection. To assess the efficacy and safety of CHF on HBV replication in chronic HBV carriers, we performed a randomized, double-blind, and placebo-controlled trial involving patients from 16 centers. A total of 300 confirmed chronic HBV carriers were randomized at baseline in a ratio of 2 : 1 to receive either CHF or placebo for 52 weeks. The results showed that a greater proportion of CHF than placebo treated patients achieved virological response at week 52; the mean decline of serum HBsAg levels in the CHF group dropped more obviously than that in the control group at all stages of the treatment; however, the rates of HBeAg loss and seroconversion had no difference between the two groups. Meanwhile, were presented significant increases in IFN-γ; IL-2 levels and reductions in IL-4 and IL-10 levels in the treatment group compared to the control group at week 52. There were no drug-related serious adverse events. In conclusion, the treatment with 52-week CHF is safe and effective in inhibiting HBV replication in chronic HBV carriers. The ability of the compound to modulate host immune function probably contributed to this effect.