Decoction In Patients Research Articles

Efficacy and safety of Sangbaipi Decoction in patients with acute exacerbation of chronic obstructive pulmonary disease: A protocol for systematic review and meta analysis.

Background:Chinese medicine Sangbaipi decoction is extensively applied to the therapy of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in China. However, owing to the low quality, small sample size, and methodological heterogeneity of these studies, this conclusion is not convincing. Consequently, it is necessary to systematically evaluate the clinical efficacy and safety of Sangbaipi Decoction in the treatment of AECOPD patients, and provide high-quality evidence for its clinical application.Methods:We will follow the preferred reporting items for systematic review and meta-analysis (PRISMA) for reporting the results of the review in this study. We will utilize the Review Manage software V5.3.0 (The Nordic Cochrane Center, The Cochrane Collaboration, 2014, Copenhagen, Denmark) to assess the risk of bias and visualize the results. We will use Stata software (version 15.0, StataCorp, College Station, TX) to perform the meta-analysis.Ethics and dissemination:This study is a systematic review and meta-analysis protocol of Sangbaipi decoction on AECOPD, participants were not recruited and data were not collected from participants, so ethical ratification is not required.Results:This study will provide high-quality synthesis of the effectiveness and safety of Sangbaipi decoction for AECOPD. Upon completion, the results will be submitted to a peer-reviewed journal.Conclusion:The efficacy and safety assessment of Sangbaipi decoction for AECOPD will be supported by this protocol.Registration number:PROSPERO CRD 42019138405.

A randomized open label efficacy clinical trial of oral guava leaf decoction in patients with acute infectious diarrhoea

BackgroundDiarrhoea is amongst the first ten causes of death and its treatment faces an increased threat of drug resistance. Previous studies on the guava leaf decoction (GLD) revealed its suitability for use in infectious diarrhoea of unknown etiology. ObjectiveThe objective of this trial was to establish efficacy, dose and safety of GLD prepared from the Indian Sardar variety in adults with acute infectious diarrhoea. MethodsThe current trial was an open efficacy randomized 5-day, parallel group multi-arm interventional study. Amongst 137 adults (18–60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males). Three doses of GLD (6-leaf, 10-leaf and 14-leaf) were compared with controls receiving oral rehydration solution. Decrease in stool frequency and improvement in consistency were the outcomes measured. The data was analyzed using ANOVA, Tukey's post-hoc test, Kruscal-Wallis test and Chi-Square test where applicable. ResultsThe trial showed that the 14-leaf (7.4 g) decoction was the most effective. Administration of the decoction, thrice daily helped the patients regain normalcy in 72 h as opposed to 120 h in controls. Safety of the intervention was reflected by normal levels of haemoglobin, liver and kidney parameters. No adverse events were reported. ConclusionThe 14 leaves decoction was a safe treatment for adult acute uncomplicated diarrhoea of unknown etiology. Moreover due to component synergy and divergent mechanisms of action, it could possibly combat the generation of drug resistance and destruction of gut microbiota. Hence GLD has the potential for development as a first line treatment for diarrhoea. Trial registrationTrial was registered with Clinical Trials Registry - India (CTRI registration number: CTRI/2016/07/007095). The trial was retrospectively registered.

Evaluating the therapeutic efficacy of the Chinese herbal medicine Yishen Tongbi decoction in patients with active rheumatoid arthritis: protocol for a randomized, controlled, noninferiority trial

BackgroundRheumatoid arthritis (RA) is a common chronic autoimmune disease that seriously affects the quality of life of patients because of damage to joints. Presently, RA is mainly treated with disease-modifying antirheumatic drugs (DMARDs) or biological agents; however, they offer limited efficacy in some patients. Therefore, additional therapeutic strategies need to be developed. Yishen Tongbi decoction is a traditional Chinese medicine formulation widely used to treat RA in China. However, currently, there is insufficient evidence to recommend its use for the treatment of RA. Therefore, we aim to verify the efficacy of Yishen Tongbi decoction to treat RA by a noninferiority trial, and to provide a basis for its use with a full-scale clinical trial.Methods/designOne hundred eligible patients with RA will be randomized into two groups of 50 patients. One group will receive Yishen Tongbi decoction and placebo replacing methotrexate (MTX), while the other group will receive MTX and placebo replacing Yishen Tongbi decoction. Patient’s whose visual analogue scale score for pain is greater than 40 mm will be administered nonsteroidal anti-inflammatory drugs (such as enteric-coated diclofenac sodium, 25 mg three times a day); administration of all medications will be recorded. The clinical indicators of patients and their disease activity will be assessed at baseline and at 4, 12 and 24 weeks after treatment initiation. The primary outcome of efficacy will be the proportion of patients who demonstrate a favourable response based on their Clinical Disease Activity Index score at 24 weeks after treatment. All adverse events will be reported.DiscussionTraditional Chinese medicine theory and modern western medicine research have identified the efficacy of Yishen Tongbi decoction to treat RA. Previous clinical observation and efficacy trials of Yishen Tongbi decoction in animal models for the treatment of RA has demonstrated significant effect. Because of the potential benefits of Yishen Tongbi decoction in the treatment of patients with RA, we designed this double-blind, prospective, randomized controlled trial; the results and conclusions of the trail will be published after the completion of the study.Trial registrationChinese Clinical Trials Registry, ChiCTR1900024902. Registered on 3 August 2019.

Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

BackgroundAllergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray.MethodsThe study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded.ResultsAfter the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P < 0.05). No significant between-groups differences were observed for changes in TNSS scores [− 0.298 (95% confidence interval −0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P < 0.001) from baseline, though a more obvious reduction was observed for the BMD group (P < 0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05).ConclusionsThese findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS.Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.

Effectiveness of Xin Jia Xuan Bai Cheng Qi Decoction in treating acute exacerbation of chronic obstructive pulmonary disease: study protocol for a multicentre, randomised, controlled trial

IntroductionAcute exacerbation of chronic obstructive pulmonary disease (AECOPD) brings a serious impact on patients’ quality of life, and has extremely high morbidity and mortality worldwide. Although there are many therapies...

Effectiveness of Fuyuan Xingnao Decoction for patients with diabetes mellitus combined cerebral infarction: Erratum.

Effectiveness of Fuyuan Xingnao Decoction for patients with diabetes mellitus combined cerebral infarction: Erratum.

Acupuncture combined with Buyang Huanwu decoction in treatment of patients with ischemic stroke.

ObjectiveThis study was performed to investigate the effect of acupuncture combined with Buyang Huanwu decoction in patients with ischemic stroke.MethodsIn total, 115 patients with ischemic stroke were recruited and divided into 3 groups. The control group received normal treatment, the acupuncture group received additional acupuncture treatment, and the combined group received additional acupuncture combined with Buyang Huanwu decoction treatment. The National Institutes of Health Stroke Scale (NIHSS) and Chinese Stroke Scale (CSS) were used to evaluate the stroke condition, and the Barthel index (BI) was used to measure life quality. Blood lipids and recurrence were also analyzed.ResultsThe CSS and NIHSS scores were significantly lower in the acupuncture group and combined group than in the control group; however, the BI score was significantly higher in the acupuncture group and combined group. Similarly, the levels of cholesterol, triglycerides, and low-density lipoprotein were all significantly increased, while the level of high-density lipoprotein showed no significant difference in all groups. The recurrence rate was significantly lower in the combined group than in the other two groups.ConclusionAcupuncture combined with Buyang Huanwu decoction could improve the clinical outcomes and reduce the recurrence rates in patients with ischemic stroke.

Efficacy and safety of Shaoyang Xibi decoction in patients with knee osteoarthritis: a multi-center, single-blind, randomized controlled trial

PURPOSETo observe the efficacy and safety of Shaoyang Xibi decoction (SYXBD) in patients with knee osteoarthritis (KOA), and to verify that the theory of “Shaoyang dominating bone” in Traditional Chinese Medicine (TCM) can be applied to KOA treatment. METHODSParticipants were randomly allocated to two groups: SYXBD (treatment group, n = 66) and Meloxicam (control group, n = 66). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 36-Item Short Form Health Survey (SF-36) were used to assess efficacy before the treatment and 8 weeks after the treatment. RESULTSBaseline data before the treatment between the two groups were similar. The WOMAC scores significantly decreased and the SF-36 scores significantly increased after 8- week treatment in both groups compared with before the treatment (P < 0.05). SYXBD significantly decreased pain scores (P < 0.001), physical function scores (P < 0.001) and the total scores (P < 0.001) in WOMAC compared to Meloxicam. SYXBD significantly improved physical function (P = 0.021), bodily pain (P = 0.002) and general health (P = 0.014), with no significant difference in role emotional (P = 0.053), role physical (P = 0.517), vitality (P = 0.241), social function (P = 0.712) and mental health (P = 0.800) in SF-36 compared to Meloxicam. No adverse events were reported in the treatment group while 13 adverse events happened in the control group during the study. CONCLUSIONSYXBD, prepared based on the theory of “Shaoyang dominating bone”, has a better curative efficay and safety in patients with KOA compared with Meloxicam. The TCM theory of “Shaoyang dominating bone” may be useful in KOA treatment.

Effect of Zhu-yuan decoction in patients with chronic rhinosinusitis after functional endoscopic sinus surgery

OBJECTIVETo investigate the effectiveness and safety of Zhu-yuan decoction (ZYD) in patients after functional endoscopic sinus surgery (FESS). METHODSA total of 85 patients were randomized into two groups: 44 were treated with intranasal corticosteroids (INC), and 41 were given Chinese herbal medicine (CHM). Patients with chronic rhinosinusitis (CRS) who underwent FESS were prospectively enrolled in the study. Before surgery, they were evaluated by visual analog scale (VAS), nasal endoscopy, computed tomography (CT), and routine blood test. After surgery, they were randomized to take ZYD or INC for 12 weeks and revaluated by VAS; nasal endoscopy at 4, 8, and 12 weeks; and CT at 12 weeks after surgery. RESULTSIn the both groups, VAS and endoscopy scores decreased significantly at 4, 8, and 12 weeks, and CT scores after treatment declined at 12 weeks compared with baseline scores. No significant differences were observed with regard to postoperative VAS, endoscopy, or CT scores between groups. ZYD, combined with surgery, can reduce VAS, nasal endoscopy, and CT scores and has the same efficacy and safety profile as INC in post-FESS management. No fatalities or major adverse events occurred in either group. CONCLUSIONOur findings suggest that ZYD has similar effects and safety profiles in patients after FESS compared with INC.

Ma-Huang-Fu-Zi-Xi-Xin Decoction for Allergic Rhinitis: A Systematic Review.

Background The treatment effects and safety of Ma-Huang-Fu-Zi-Xi-Xin decoction for patients with allergic rhinitis have yet to be clarified. Objectives The aim of this study is to evaluate the effects and safety of Ma-Huang-Fu-Zi-Xi-Xin decoction in patients with allergic rhinitis. Methods We searched PubMed, EMBASE (Excerpta Medical Database), Cochrane Library, Chinese Cochrane Centre's Controlled Trials Register Platform, Wanfang Chinese Digital Periodical and Conference Database, China National Knowledge Infrastructure (CNKI) Database, and VIP Chinese Science and Technique Journals Database to collect randomized controlled trials of Ma-Huang-Fu-Zi-Xi-Xin decoction (MHFZXXD) for allergic rhinitis (AR) prior to May 8, 2017. RevMan 5.3 software was used to conduct a meta-analysis. GRADE methodology was applied to evaluate the evidence quality for each outcome. Results Six randomized controlled trials (RCTs) involving 576 participants (10–78 years old) were included. A meta-analysis revealed that the overall effect of MHFZXXD for AR was not better than western medical treatment (RR: 0.41; 95% CI: 0.26–0.65; P = 0.0001) for all included studies. However, the evidence quality of these western medical intervention studies was low or very low due to a high risk of bias, small sample sizes, and poor-quality design.

Clinical study on Maxing-Shigan decoction for severe pneumonia of phlegm-heat obstructing lung type

Objective To assess the clinical efficacy of Maxing-Shigan decoction in patients with severe pneumonia due to phlegm-heat obstructing the lung. Methods Sixty patients with severe pneumonia in the TCM Department of Dalian Municipal Central Hospital from January to December 2013 were randomly divided into a control group and a treatment group by random number table method, 30 in each group. The control group was treated with anti-infection, fluid infusion and mechanical ventilation. On the basis of treatment in the control group, the treatment group was also given Maxing-Shigan decoction through nasogastric gavage. The mean arterial pressure (MAP), lactic acid (Lac) and PaO2/FiO2 were compared before and after the treatment in both groups. The scores of the Clinical Pulmonary Infection Score (CPIS) and the Acute Physiology and Chronic Health Evaluation II (APACHEⅡ) were compared between the two groups. Results The total effective rate in the treatment group was significantly higher than that in the control group (80.0% vs. 73.3%; χ2=4.800, P=0.029). In both groups, MAP (treatment group: 102.4 ± 11.9 mmHg vs. 70.4 ± 6.4 mmHg, t=12.972, P=0.000; control group: 101.2 ± 12.5 mmHg vs. 69.8 ± 6.6 mmHg, t=12.1672, P=0.000), PaO2/FiO2 (treatment group: 265.4 ± 19.7 mmHg vs. 78.6 ± 10.5 mmHg, t=45.833, P=0.000; control group: 124.8 ± 13.4 mmHg vs. 79.1 ± 11.1 mmHg; t=14.385, P=0.000) after the treatment were significantly higher than before the treatment, and the Lac level were significantly lower (treatment group: 1.04 ± 0.42 mmol/L vs. 6.37 ± 2.27 mmol/L, t=12.65, P=0.000; control group: 3.88 ± 1.45 mmol/L vs. 6.39 ± 2.32 mmol/L, t=5.025, P=0.000). The improvements in Lac (t＝10.304, P＝0.000) and PaO2/FiO2 (t=32.323, P=0.000) in the treatment group were superior to the control group. The scores of the CPIS (treatment group: 2.2 ± 1.5 vs. 6.7 ± 1.7, t=10.872, P=0.000; control group: 4.5 ± 2.7 vs. 6.8 ± 1.8, t=3.882, P=0.000) and APACHEⅡ(treatment group: 5.3 ± 2.1 vs. 13.8 ± 3.8, t=10.723, P=0.000; control group: 9.3±3.5 vs. 13.7 ± 3.5, t=4.869, P=0.000) after the treatment were significantly lower than before the treatment in both groups, and the changes of CPIS (t=4.079, P=0.000) and APACHEⅡ(t=5.368, P=0.000) in the treatment group were greater than those in the control group. Conclusions Maxing-Shigan decoction has definite therapeutic effects for severe pneumonia due to phlegm-heat obstructing the lung.. Key words: Pneumonia; Severity of Illness Index; Phlegm-heat obstructing lung; Ma Xing Shi Gan Tang; Treatment outcome

Effect of Chinese Medicine XIAOJI Decoction Combined with Platinum-Based Chemotherapy and Transfusion of Cytokine-Induced Killer Cells in Patients with Stage III B/IV Non-Small Cell Lung Cancer

Objective: The aim of this study was to evaluate the clinical efficacy and safety of cytokine-induced killer (CIK) cells in combination with chemotherapy and Chinese Medicine XIAOJI decoction in patients with advanced NSCLC. Methods: A total number of 40 patients with advanced NSCLC were randomly assigned into group A (chemotherapy plus XIAOJI decoction) and group B (chemotherapy plus XIAOJI decoction and CIK cell transfusion). Progression free survival (PFS), disease control rate (DCR), overall response rate (ORR), karnofsky score status (KPS), host cellular immune response and treatment related side effects were assessed. Results: Our results showed that the PFS in the group B was longer than those in the group A (9.1 months vs. 7.2 months, HR 0.323, 95% CI [0.157, 0.663, P=0.002].The ORR and the DCR were found no statistical difference between the two groups (20% vs. 10%, P=0.66 and 95% vs. 70%, P=0.10, respectively). The KPS distribution of curative effect in two groups showed significant different (Z=3.28, P 0.05). While the level of CD3+ and CD4+ were significantly higher after treatment in the group B as compared to that in the group A (P=0.04), the level of CD3+ in the control group was lower after treatment (P=0.04) compared to that in the treatment group. There were no immediate adverse reactions in two groups. Conclusion: This study suggests that CIK cell infusion combined with chemotherapy and XIAOJI decoction improves the survival of patients with advanced NSCLC, which may become more effective therapeutic strategy in patients with advanced lung cancer.

Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial

BackgroundChinese herbal medicine (CHM) has been used in China and some other countries for the treatment of patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatments in patients with FD are lacking. In this trial, we aimed to assess the efficacy and safety of modified LiuJunZi decoction in patients with FD of spleen-deficiency and qi-stagnation syndrome.MethodsWe performed a randomized, double-blind, placebo-controlled trial with patients from five centers. Patients with FD of spleen-deficiency and qi-stagnation syndrome (n = 160) were randomly assigned to groups given CHM modified LiuJunZi decoction or placebo in a 2:1 ratio. Herbal or placebo granules were dissolved in 300 ml of boiled water cooled to 70°C. Patients in both groups were administered 150 ml (50°C) twice daily. The trial included a 4-week treatment period and a 4-week follow-up period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4 and 8. The secondary outcome was the change of radiopaque barium markers emptied from the stomach between week 0 and week 4 of treatment.ResultsCompared with patients in the placebo group, patients in the CHM group showed significant improvements according to the scores of total dyspepsia symptoms and single dyspepsia symptoms obtained from patients (P < 0.01) and investigators (P < 0.01). They also showed an improvement in the number of radiopaque barium markers emptied from the stomach (P < 0.05).ConclusionsCHM modified LiuJunZi decoction appears to offer symptomatic improvement in patients with FD of spleen-deficiency and qi-stagnation syndrome.Trial registrationChinese Clinical Trial Registry (ChiCTR): http://ChiCTR-TRC-10001074

Efficacy of Modified Ban Xia Xie Xin Decoction on Functional Dyspepsia of Cold and Heat in Complexity Syndrome: A Randomized Controlled Trial

Background. Chinese herbal medicine (CHM) has been used in China and elsewhere to treat patients with functional dyspepsia (FD). However, controlled studies supporting the efficacy of such treatment are lacking. Objective. To assess the efficacy and safety of modified Ban xia xie xin decoction in patients with FD of cold and heat in complexity syndrome. Methods. We performed a randomized, double-blind, placebo-controlled trial involving patients from five centers. Patients with FD of cold and heat in complexity syndrome (n = 101) were randomly assigned to groups given either CHM modified Ban Xia Xie Xin decoction or placebo in a 2 : 1 ratio. Herbal or placebo granules were dissolved in 300 mL of boiled water cooled to 70°C. Patients in both groups were administered 150 mL (50°C) twice daily. The trial included a 4-week treatment period and a 4-week followup period. The primary outcomes were dyspepsia symptom scores, measured by the total dyspepsia symptom scale and the single dyspepsia symptom scale at weeks 0, 1, 2, 3, 4, and 8. Results. Compared with patients in the placebo group, patients in the CHM group showed significant improvements according to the total and single dyspepsia symptom scores obtained from patients (P < 0.01) and investigators (P < 0.01). Conclusions. CHM modified Ban Xia Xie Xin decoction appears to offer symptomatic improvement in patients with FD of cold and heat in complexity syndrome. Trial Registration. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-10001074.

Clinical observation on effect of yiqi huoxue recipe in comprehensive treatment on advanced stage of esophageal cancer

To observe the effect of Yiqi Huoxue (Replenishing Qi and activating blood circulation, YQHX) decoction in patients with advanced stage esophageal cancer treated with radiotherapy (RT) and intervention chemotherapy (ICT). In comparing 31 patients who were treated with RT and ICT (Group A), and 31 patients treated with RT and ICT plus YQHX decoction (Group B). Immediate effective rate were 48.4% in Group A and 64.5% in Group B (P > 0.05). The function of bone marrow in Group B was obviously higher than that in Group A. The 1 year metastasis rate in Group A was higher than that in Group B, but the long-term survival rate of Group B was obviously higher than that in Group A (P < 0.05). YQHX decoction could reduce the inhibition of bone marrow caused by radiotherapy and intervention chemotherapy, lower the metastasis rate, prolong the long-term survival rate and improve the quality of life.