scholarly journals A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Effect of Qishen Yiqi Dripping Pills on Exercise Endurance and Quality of Life in Patients with Coronary Heart Disease after Percutaneous Coronary Intervention

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Linghua Yu ◽  
Xiaoyan Lu ◽  
Xianlun Li ◽  
Hong Jiang ◽  
Ruihua Sun ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Coronary Heart Disease ◽  
Coronary Intervention ◽  
Efficacy And Safety ◽  
Efficacy Evaluation ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Percutaneous Coronary ◽  
Exercise Endurance

Background. Percutaneous coronary intervention (PCI) is widely used in China, but it does not fundamentally improve exercise endurance or reduce mortality associated with cardiovascular disease. Standardized cardiac rehabilitation (CR) can reduce the mortality associated with coronary heart disease and reduce the need for repeated PCI procedures. Currently, research on CR after PCI is mainly based on traditional exercise prescription, while research on TCM is limited. Often, the combination of traditional Chinese medicine (TCM) and exercise rehabilitation is adopted, from which it is difficult to determine the unique advantages of TCM. Qishen Yiqi dripping pills (QSYQ) can improve myocardial energy metabolism and alleviate myocardial reperfusion injury after PCI. This paper describes the protocol for the clinical assessment of QSYQ on CR. Methods. A randomized, double-blind, placebo-controlled trial will be used to evaluate the efficacy and safety of QSYQ on improving exercise endurance and quality of life. We plan to recruit 66 patients with stable angina pectoris with Qi deficiency and blood stasis syndrome differentiation after PCI from the China-Japan Friendship Hospital. On the basis of conventional drug treatment, QSYQ or placebo will be used for 12 weeks. PeakVO2 will be the main efficacy evaluation index, while Seattle scale and quality of life scale will be the secondary efficacy evaluation indexes. Discussion. CR therapy with integrated traditional Chinese and Western medicine has been developed as a treatment modality in China and has been included in the expert consensus of TCM diagnosis and treatment. A rigorous trial design will ensure objective and scientific evaluation of the efficacy and safety of QSYQ in improving exercise endurance and quality of life in patients with PCI. Trial Registration. This trial is registered with Clinical trial registration in China: ChiCTR2000040838 (registration date: December 11, 2020).

scholarly journals Preventive Efficacy and Safety of Yiqi-Wenjing-Fang Granules on Oxaliplatin-Induced Peripheral Neuropathy: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Zhancheng Gu ◽  
Guoli Wei ◽  
Liangjun Zhu ◽  
Lingjun Zhu ◽  
Jing Hu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group I ◽  
Preventive Efficacy

Background. Oxaliplatin-induced peripheral neuropathy (OIPN) is one of the most common side effects of oxaliplatin, which can cause reduction and cessation of oxaliplatin-based chemotherapy and significantly affect patients’ quality of life. However, no drug has got recognition to prevent or treat OIPN. Yiqi-Wenjing-Fang (YWF) is a joint name of Chinese medicine prescriptions with similar effects of tonifying qi and warming meridians, represented by Huangqi Guizhi Wuwu decoction (HGWD) and Danggui Sini decoction (DSD), both from “Treatise on Cold Pathogenic and Miscellaneous Diseases.” YWF granules, including HGWD granules and DSD granules, have been, respectively, demonstrated to be effective in preventing OIPN in previous small-sample observations. The purpose of this study is to enlarge the sample size for further evaluation of the preventive efficacy and safety of YWF granules on OIPN. Methods and Analysis. This study is a randomized, double-blind, placebo-controlled, and multicenter clinical trial. 360 postoperative patients with stage IIa-IIIc colorectal cancer will be randomly assigned into placebo-control group, intervention group I, and intervention group II, taking the mimetic granules of YWF as placebo, HGWD granules and DSD granules, respectively. All subjects will receive oxaliplatin-based chemotherapy regimen at the same time. EORTC QLQ-CIPN20 will be used to assess the degree of OIPN as the primary outcome measure. The grades of OIPN, quality of life, chemotherapeutic efficacy, and the number of completed chemotherapy cycles are selected as the secondary outcome measures. Discussion. Based on the condition of no recognized effective drugs in preventing OIPN, evidence-based medical study will be conducted for seeking a breakthrough in the field of Chinese herb medicine. This protocol could provide reliable and systemic research basis about the efficacy of YWF granules and the differentiation of two classical prescriptions of YWF on preventing OIPN objectively. Trial Registration. This study was registered at ClinicalTrials.gov on 26 December 2020 (ID: https://clinicaltrials.gov/ct2/show/NCT04690283).

scholarly journals Clinical Efficacy and Safety of Low-Level Laser Therapy in Patients with Perennial Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 10 (4) ◽  
pp. 772
Author(s):  
Hahn Jin Jung ◽  
Young-Jun Chung ◽  
Young-Seok Choi ◽  
Phil Sang Chung ◽  
Ji-Hun Mo
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Low Level Laser Therapy ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Sham Treatment ◽  
Double Blind Placebo ◽  
Level Laser

Allergic rhinitis (AR) is a common disease that interferes with the daily activities and reduces the quality of life. Conventional treatments often do not provide complete resolution of the symptoms, and many new treatment modalities have been tried. This study aimed to evaluate the efficacy and safety of low-level laser therapy (LLLT) for AR in a randomized, double-blind, placebo-controlled trial. Patients diagnosed with AR were randomly allocated to receive LLLT or sham treatment. The primary outcome was a change in the reflective total nasal symptom score (TNSS). The secondary outcome was quality of life scores assessed using the Rhinoconjunctivitis Quality of Life Questionnaire. Incidences of adverse events were also recorded. Among 67 randomized subjects, 41 subjects (22 in LLLT group and 19 in sham treatment group) were included for efficacy analysis. The LLLT group showed a significantly improved TNSS score compared to the sham treatment group for decreasing AR symptom severity (p = 0.011) and improving quality of life regarding nasal symptoms (p = 0.036) at the end of treatment. Throughout the treatment period, no severe adverse events occurred. This clinical trial showed that LLLT is an effective and safe option for the management of AR regarding symptom relief and quality of life improvement.

scholarly journals The Relationship Between Self Care and Quality of Life Among Coronary Heart Disease Patient After Receiving Percutaneous Coronary Intervention: A Systematic Review

2021 ◽  
pp. 155-171
Author(s):  
. Herdiman ◽  
Heri Harsono
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Coronary Heart Disease ◽  
Percutaneous Coronary Intervention ◽  
Heart Disease ◽  
Self Care ◽  
Coronary Intervention ◽  
Percutaneous Coronary ◽  
The Relationship

Coronary Heart Disease is a chronic disease with the highest morbidity and mortality rates in the world. Management is needed in the form of self-care management as a core element for CHD patients in order to improve the quality of life. Until now, there has been no comprehensive summary regarding self-care and quality of life for CHD patients with stents attached. This study aims to summarize research studies that link self-care and QOL in CHD patients after receiving Percutaneous coronary intervention. Systematic review using three databases (PubMed, ScienDirect, Google Scholar) for previous studies published in the last 10 years (2010–2020). The Joana Bright Institute format and PRISMA guidelines were used to assess the quality of studies and assist in the selection of articles. Data was extracted and summarized by the author using data extraction tools from JBI. Five articles from 2,729 studies were included. The results show inconsistency, namely three studies have a significant relationship and two studies have an insignificant relationship. All questionnaire domains used in the five articles state that the self-care domain of smoking cessation and exercise are correlated with the QOL domain of physical function, body pain, vitality, mental health, symptom domains and satisfaction. Only three articles reported the strength of the relationship (r = 0.117–0.64) and two articles didn’t report the strength of the relationship. By knowing self-care and QOL of CHD patients after receiving PCI, it’s hoped that the hospital can better understand and provide promotive/preventive education related to self-care management so that the patient’s QOL increases significantly.   Keywords: Self-care, quality of life, Coronary Heart Disease, Percutaneous Coronary Intervention, Systematic Review

scholarly journals A traditional Chinese medicine therapy for coronary heart disease after percutaneous coronary intervention: a meta-analysis of randomized, double-blind, placebo-controlled trials

2018 ◽  
Vol 38 (5) ◽  
Author(s):  
Ruixue Chen ◽  
Ya Xiao ◽  
Minghao Chen ◽  
Jingyi He ◽  
Mengtian Huang ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Percutaneous Coronary Intervention ◽  
Heart Disease ◽  
Chinese Medicine ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Percutaneous Coronary

Huoxue Huayu therapy (HXHY) has been widely used to treat cardiovascular diseases in traditional Chinese medicine (TCM) such as hypertension and coronary heart disease (CHD). The present study describes a meta-analysis of a series of prospective randomized, double-blind, placebo-controlled trials conducted to evaluate the effect of HXHY on patients with CHD after percutaneous coronary intervention (PCI). The Cochrane Library, PubMed, EMBASE, the China National Knowledge Infrastructure (CNKI), the Chinese Biomedical Literature database, and the Wanfang database were searched up until June 2018. A series of randomized controlled clinical trials were included and the subjects were patients with CHD who had undergone PCI. The experimental group was treated with HXHY therapy, and the control group was treated with placebo; meanwhile, all the patients accepted conventional Western medicine. Review Manager 5.3 software was used for the statistical analysis. Ten trials were included in the final study. The overall risk of bias assessment was low. HXHY had a greater beneficial effect on reducing the in-stent restenosis (ISR) rate (RR = 0.57, 95% confidence interval [CI] [0.40–0.80], P=0.001) and the degree of restenosis (MD = −8.89, 95% CI [−10.62 to −7.17], P<0.00001) compared with Placebo. Moreover, HXHY was determined to be more effective in improving Seattle Angina Questionnaires (SAQ) and the revascularization rate (RR = 0.54, 95% CI [0.32–0.90], P=0.02) compared with Placebo, whereas the rate of death and MI of patients treated with HXHY were no different from those treated with the placebo (P>0.05). Therefore, HXHY is an effective and safe therapy for CHD patients after PCI.

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