Efficacy and Safety of Runzao Zhiyang Capsule as an Add-On Therapy for Chronic Eczema: A Systematic Review and Meta-Analysis

Background. Runzao Zhiyang capsule (RZC), an oral Chinese herbal medicine, has been widely used for chronic eczema in China for many years. This study aims to evaluate the efficacy and safety of RZC as an add-on therapy to conventional treatment for chronic eczema. Methods. Randomized controlled trials (RCTs) assessing the efficacy and safety of RZC as an add-on therapy for chronic eczema were retrieved from eight literature databases from their inception to 31 August, 2020, including CNKI, WanFang, VIP, Sinomed, PubMed, Cochrane Library, Web of Science, and Embase. The Cochrane risk of bias tool was used to assess the methodological quality of the included studies. The data were analyzed by RevMan5.3 software. Results. A total of 18 RCTs involving 1896 patients with chronic eczema were included. Compared with no oral treatment, RZC was superior on the total efficacy rate (TER) (RR = 1.45, 95% CI: 1.23 to 1.72, P < 0.0001 ), Eczema Area and Severity Index (EASI) (MD = −0.73, 95% CI: −0.90 to −0.56, P < 0.00001 ), and Visual Analogue Scale (VAS) for pruritus (MD = −2.76, 95%CI: −4.53 to −0.99, P = 0.002 ). Similar results were also seen in a randomized, placebo-controlled trial. Compared with the antihistamine (AH) group, TER in the RZC combined with AH group was significantly higher (RR = 1.32, 95% CI: 1.21 to 1.43, P < 0.00001 ), and the EASI score (MD = −0.29, 95% CI: −0.38 to −0.20, P < 0.001 ), the VAS score (MD = −0.19, 95% CI: −0.23 to −0.15, P < 0.00001 ), and the level of serum total IgE (MD = −9.83 ng/ml, 95% CI: −11.66 to −8.00 ng/ml, P < 0.00001 ) decreased more significantly in the RZC combined with AH group. In terms of safety, mild gastrointestinal diseases occurred more frequently in the RZC group, and no serious adverse effect was reported. Conclusions. RZC as an add-on therapy to conventional treatment shows good effects on chronic eczema, and there is no severe side effect from short-term use of RZC. However, due to suboptimal quality of the included studies, more large-sample and high-quality RCTs are needed to improve the evidence quality.

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Efficacy and Safety of Qingpeng Ointment for Subacute and Chronic Eczema: A Systematic Review and Meta-Analysis

BioMed Research International ◽

10.1155/2021/5594953 ◽

2021 ◽

Vol 2021 ◽

pp. 1-14

Author(s):

Yan Li ◽

Ming Li ◽

Boyang Zhou ◽

Zhou Liu ◽

Linfeng Li

Keyword(s):

Combined Therapy ◽

Meta Analysis ◽

Biomedical Literature ◽

Cochrane Library ◽

Efficacy Rate ◽

Efficacy And Safety ◽

China National Knowledge Infrastructure ◽

Evidence Quality ◽

The Cochrane Library ◽

Chronic Eczema

Objective. To evaluate the efficacy and safety of Qingpeng ointment for the treatment of subacute and chronic eczema. Method. Randomized controlled trials (RCTs) on Qingpeng ointment for subacute and chronic eczema were searched on PubMed, the Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature Database, and Chinese Science and Technology Periodical Journal from their inception to 30 November 2020. Quality assessment and data analysis were performed by Review Manager 5.3. Results. A total of 26 RCTs were included. Qingpeng ointment could significantly improve the total efficacy rate (TER) ( RR = 2.60 , 95% CI: 2.11 to 3.21, P < 0.00001 ), reduce the total symptom score (TSS) ( SMD = − 2.35 , 95% CI: -3.74 to -0.97, P = 0.0009 ), and decrease visual analogue scale (VAS) for pruritus ( MD = − 3.86 , 95% CI: -4.41 to -3.31, P < 0.00001 ) compared with the placebo. The TER of Qingpeng ointment was similar to that of topical corticosteroid (TCS) ( RR = 0.96 , 95% CI: 0.88 to 1.03, P = 0.25 ), and the TSSs between Qingpeng ointment and medium or low potency TCS were not significantly different ( SMD = − 0.05 , 95% CI: -0.22 to 0.12, P = 0.54 ). However, Qingpeng ointment was not superior to TCS in reducing VAS score ( SMD = 0.48 , 95% CI: 0.00 to 0.96, P = 0.05 ). In addition, Qingpeng ointment combined with TCS performed better than TCS alone in all three outcomes. For safety, nothing but skin irritative reactions occurred in the Qingpeng ointment group, and its incidence of skin irritative reactions was similar to those of the placebo ( RR = 1.47 , 95% CI: 0.61 to 3.55, P = 0.40 ) and TCS ( RR = 1.82 , 95% CI: 0.79 to 4.22, P = 0.16 ). The combined therapy did not increase the risk of skin irritative reactions ( RR = 0.69 , 95% CI: 0.27 to 1.78, P = 0.44 ). Conclusion. Qingpeng ointment is an effective and safe treatment for subacute and chronic eczema. It is also an add-on treatment to TCS for eczema. However, due to the suboptimal quality of the included studies, more large-sample and high-quality RCTs are needed to improve the evidence quality.

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An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽

10.1093/neuros/nyx363 ◽

2017 ◽

Vol 83 (1) ◽

pp. 146-153 ◽

Cited By ~ 2

Author(s):

Pierre-Yves Borius ◽

Stéphanie Ranque Garnier ◽

Karine Baumstarck ◽

Frédéric Castinetti ◽

Anne Donnet ◽

...

Keyword(s):

Quality Of Life ◽

Pain Relief ◽

Cancer Pain ◽

Controlled Trial ◽

Analgesic Efficacy ◽

Standards Of Care ◽

Control Group ◽

Efficacy And Safety ◽

Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

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Comparative efficacy and safety of oral or transdermal opioids in the treatment of knee or hip osteoarthritis: a systematic review and Bayesian network meta-analysis protocol

BMJ Open ◽

10.1136/bmjopen-2018-022142 ◽

2018 ◽

Vol 8 (10) ◽

pp. e022142

Author(s):

Jun Wang ◽

Yin Wang ◽

Hui Zhang ◽

Ming Lu ◽

Weilu Gao ◽

...

Keyword(s):

Bayesian Network ◽

Meta Analysis ◽

Hip Osteoarthritis ◽

Sensitivity Analyses ◽

Cochrane Library ◽

Efficacy And Safety ◽

Meta Analyses ◽

Transdermal Opioids ◽

And Function

IntroductionOsteoarthritis is a common degenerative joint disease that eventually leads to disability and poor quality of life. The main symptoms are joint pain and mobility disorders. If the patient has severe pain or other analgesics are contraindicated, opioids may be a viable treatment option. To evaluate and compare the efficacy and safety of opioids in the treatment of knee or hip osteoarthritis, we will integrate direct and indirect evidence using a Bayesian network meta-analysis to establish hierarchies of these drugs.Methods and analysisWe will search the Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and PsycINFO databases as well as published and unpublished research in international registries and regulatory agency websites for osteoarthritis reports published prior to 5 January 2018. There will be no restrictions on the language. Randomised clinical trials that compare oral or transdermal opioids with other various opioids, placebo or no treatment for patients with knee or hip osteoarthritis will be included. The primary outcomes of efficacy will be pain and function. We will use pain and function scales to evaluate the main outcomes. The secondary outcomes of safety will be defined as the proportion of patients who have stopped treatment due to side effects. Pairwise meta-analyses and Bayesian network meta-analyses will be performed for all related outcome measures. We will conduct subgroup analyses and sensitivity analyses to assess the robustness of our findings. The Grading of Recommendations, Assessment, Development and Evaluations framework will be used to assess the quality of the evidence contributing to each network assessment.Ethics and disseminationThis study does not require formal ethical approval because individual patient data will not be included. The findings will be disseminated through peer-reviewed publications or conference presentations.PROSPERO registration numberCRD42018085503.

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Does propofol ameliorate occurrence of postoperative cognitive dysfunction after general anaesthesia? A protocol of systematic review

Systematic Reviews ◽

10.1186/s13643-021-01610-y ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Xi Zhao ◽

Ze-qing Huang

Keyword(s):

Systematic Review ◽

Cognitive Dysfunction ◽

Short Term Memory ◽

Meta Analysis ◽

Postoperative Cognitive Dysfunction ◽

Biomedical Literature ◽

Cochrane Library ◽

Efficacy And Safety ◽

China National Knowledge Infrastructure

Abstract Background Postoperative cognitive dysfunction (POCD) is a common condition after general anesthesia (GA). Previous studies have reported that propofol can ameliorate the occurrence of such disorder. However, its results are still inconsistent. Therefore, this systematic review will assess the efficacy and safety of propofol on POCD after GA. Methods Literature sources will be sought from inception to the present in Cochrane Library, MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure for randomized controlled trials (RCTs) assessing the administration of propofol on POCD after GA. All searches will be carried out without limitations to language and publication status. Outcomes comprise of cognitive impairments changes, impairments in short-term memory, concentration, language comprehension, social integration, quality of life, and adverse events. Cochrane risk of bias tool will be utilized to assess study quality. We will evaluate the quality of evidence for each outcome using Grading of Recommendations Assessment, Development and Evaluation approach. A narrative synthesis or a meta-analysis will be undertaken as appropriate. Discussion This study will systematically and comprehensively search literature and integrate evidence on the efficacy and safety of propofol on POCD after GA. Our findings will be of interest to clinicians and health-related policy makers. Systematic review registration PROSPERO CRD42020164096

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Efficacy and Safety of Modified Yunu-Jian in Patients with Periodontitis: A Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/5147439 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Yuanyuan Yue ◽

Meng Gao ◽

Yanru Deng ◽

Jiemin Shao ◽

Yingguang Sun

Keyword(s):

Western Medicine ◽

Combined Therapy ◽

Meta Analysis ◽

Effective Rate ◽

Cochrane Library ◽

Efficacy And Safety ◽

China National Knowledge Infrastructure ◽

Knowledge Infrastructure ◽

Oral Inflammation

Background. Modified Yunu-Jian (mYJ), a Chinese medicine (CM) formula, is thought to clear heat and nourish yin. Clinically, it is often used to treat oral inflammation. However, its efficacy remains controversial. Methods. The study aims to evaluate the efficacy and safety of mYJ for treating patients with periodontitis. We searched electronic databases (PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Wanfang database, VIP database, and CBM) from inception to December 2020. Only randomized controlled trials investigating modified Yunu-Jian, with or without other medications, against controlled intervention in the treatment of patients diagnosed with periodontitis were included. Both Review Manager 5.3 and Stata 15.0 software were used to analyze the data. The Cochrane Collaborations risk of bias tool was used to assess the quality of the methods. Results. Thirteen clinical trials, involving 1179 participants, were included in our investigation. The results showed that the combination of mYJ with western medicine improved the total effective rate compared with western medicine alone (RR = 1.17, 95% CI (1.12, 1.23), P < 0.00001). The sensitivity analysis and Harbord’s test ( P = 0.255) both showed that the results were statistically robust. Moreover, the periodontal indexes (GI, SBI, PLI, and PD; P < 0.00001) of patients with periodontitis were also significantly improved after receiving the combined therapy. No serious adverse reactions were observed in the experimental groups. Conclusions. Evidence from the meta-analysis suggested that mYJ appeared to be effective and relatively safe for treating periodontitis. Because of the low quality of the methods used in the included RCTs, further studies with larger sample sizes and well-designed models are required to confirm our findings.

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A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue

Medicines ◽

10.3390/medicines8090047 ◽

2021 ◽

Vol 8 (9) ◽

pp. 47

Author(s):

Abhijit Rathi ◽

Swati B. Jadhav ◽

Neha Shah

Keyword(s):

Treatment Efficacy ◽

Controlled Trial ◽

Placebo Treatment ◽

Efficacy And Safety ◽

Double Blind ◽

Time Points ◽

Randomized Controlled ◽

Cognitive Disturbances ◽

Oral Supplements

Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients’ functional status and quality of life.

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Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Trials ◽

10.1186/s13063-020-04721-4 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Hongyu Yue ◽

Shuang Zhou ◽

Huangan Wu ◽

Xuan Yin ◽

Shanshan Li ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Symptom Scale ◽

Significance Level

Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

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Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/1980491 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8

Author(s):

Xiaofan Chen ◽

Heyun Nie ◽

Wenjun Liu ◽

Xu Zhou ◽

Jianhua Nie ◽

...

Keyword(s):

Controlled Trial ◽

Gastrointestinal Diseases ◽

Ethics Committee ◽

Gastrointestinal Disorders ◽

Evidence Based ◽

Research Model ◽

Efficacy And Safety ◽

Medical Treatments ◽

Study Population ◽

Double Blinded

Background. There is a worldwide epidemic of nonorganic gastrointestinal disorders (NOGDs), which are a class of disorders that cause various discomforts and ultimately progress into organic gastrointestinal diseases. Because of the unsatisfactory efficacy of Western medical treatments, traditional Chinese medicine (TCM) is becoming a promising complementary and alternative treatment to manage NOGDs. Objectives. To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX), a newly developed dietary TCM formula, on the syndrome of spleen qi deficiency (SQD) in patients with NOGDs. Methods/Design. This study is a multicenter, randomized, double-blinded, parallel, and placebo-controlled trial that will last for 2 years. All qualified subjects with NOGDs and SQD will be included. The study population will be divided into the HGMX and placebo groups. To assess the efficacy of HGMX, we will mainly focus on changes in SQD symptoms scored by a Spleen Qi Deficiency Symptoms Grading and Quantifying Scale and evaluate changes in gastrin-17, the negative Helicobacter pylori conversion rate, body weight, body mass index, and gastroscopy findings. The safety of HGMX will be assessed by recording adverse events (AEs), severe AEs, treatment-related AEs and withdrawal due to AEs. Discussion. This trial is part of our study series that intends to validate the potential of HGMX in the management of chronic gastrointestinal diseases. This series of RCTs is the first committed to the evaluation of a dietary TCM formula and will hopefully establish an evidence-based clinical research model for dietary TCM formulas. Ethics. The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (NCT03019042).

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Efficacy and Safety of PARACHUTE® Device: systematic review

Revista da Associação Médica Brasileira ◽

10.1590/1806-9282.64.09.853 ◽

2018 ◽

Vol 64 (9) ◽

pp. 853-860 ◽

Cited By ~ 1

Author(s):

Roberta da Silva Teixeira ◽

Bruna Medeiros Gonçalves de Veras ◽

Kátia Marie Simões e Senna ◽

Rosângela Caetano

Keyword(s):

Quality Of Life ◽

Myocardial Infarction ◽

Heart Failure ◽

Systematic Review ◽

Left Ventricular ◽

Cochrane Library ◽

Efficacy And Safety ◽

Frequent Event

SUMMARY INTRODUCTION Heart failure due to an acute myocardial infarction is a very frequent event, with a tendency to increase according to improvements in the treatment of acute conditions which have led to larger numbers of infarction survivors. OBJECTIVE The aim of this study is to synthesize the evidence, through a systematic review, on efficacy and safety of the device in patients with this basic condition. METHODS Studies published between January 2002 and October 2016 were analysed, having as reference databases Embase, Medline, Cochrane Library, Lilacs, Web of Science and Scopus. The selection of studies, data extraction and methodological quality assessment of studies were examined by two independent reviewers, with disagreements resolved by consensus. RESULTS Only prospective studies without control group were identified. Six studies were included, with averages of 34 participants and follow-up of 13 months. Clinical, functional, hemodynamic and quality of life outcomes were evaluated. The highest mortality rate was 8.4% with 12-month follow-up for unspecified cardiovascular reasons, and heart failure rehospitalization was 29.4% with 36-month follow-up. Statistically significant improvements were found only in some of the studies which evaluating changes in left ventricular volume indices, the distance measured by the six-minute walk test, New York Heart Association functional classification, and quality of life, in pre and post-procedure analysis. CONCLUSIONS The present review indicates that no available quality evidence can assert efficacy and safety of PARACHUTE® in the treatment of heart failure after apical or anterior wall myocardial infarction.

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Efficacy and safety of two Ayurvedic dosage forms for Allergic rhinitis: Study protocol for an open-label randomized controlled trial

10.21203/rs.2.13359/v2 ◽

2019 ◽

Author(s):

JM Dahanayake ◽

Pathirage Kamal Perera ◽

P Galappaththy ◽

D Samaranayake

Keyword(s):

Quality Of Life ◽

Allergic Rhinitis ◽

Controlled Trial ◽

Dosage Forms ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled ◽

Nasal Symptoms ◽

Freeze Dried

Abstract Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and it’s ready to use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis. Study design: This is a three arm, open label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratidine Patients with symptoms of AR will be allocated randomly into the 3 arms after a 1 week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the 3 arms prior to visit 1, at the end of 28 days, end of the and second months of follow up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and Health Related Quality of Life questionnaire are used as secondary end points. Discussion: This clinical trial will be able to provide evidence based scientific data on Ayurvedic dosage form, TMD12 and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions. Trial registration:ISRCTN18149439 (06 May 2019) Keywords: Allergic rhinitis, Ayurvedic dosage forms, Tamalakyadi decoctions, Randomized controlled trial

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