scholarly journals Therapeutic Risk and Benefits of Concomitantly Using Herbal Medicines and Conventional Medicines: From the Perspectives of Evidence Based on Randomized Controlled Trials and Clinical Risk Management

2017 ◽  
Vol 2017 ◽  
pp. 1-17 ◽  
Author(s):  
Xiu-lai Zhang ◽  
Meng Chen ◽  
Ling-ling Zhu ◽  
Quan Zhou
Keyword(s):  
Risk Management ◽  
Randomized Controlled Trials ◽  
Time Course ◽  
Herbal Medicines ◽  
Controlled Trials ◽  
Clinical Risk Management ◽  
Reminder System ◽  
Administration Routes ◽  
Randomized Controlled ◽  
Clinical Risk

Despite increased awareness of the potential of herb-drug interactions (HDIs), the lack of rigorous clinical evidence regarding the significance provides a challenge for clinicians and consumers to make rational decisions about the safe combination of herbal and conventional medicines. This review addressed HDIs based on evidence from randomized controlled trials (RCTs). Literature was identified by performing a PubMed search till January 2017. Risk description and clinical risk management were described. Among 74 finally included RCTs, 17 RCTs (22.97%) simply addressed pharmacodynamic HDIs. Fifty-seven RCTs (77.03%) investigated pharmacokinetic HDIs and twenty-eight of them showed potential or actual clinical relevance. The extent of an HDI may be associated with the factors such as pharmacogenomics, dose of active ingredients in herbs, time course of interaction, characteristics of the object drugs (e.g., administration routes and pharmacokinetic profiles), modification of herbal prescription compositions, and coexistence of inducers and inhibitors. Clinical professionals should enhance risk management on HDIs such as increasing awareness of potential changes in therapeutic risk and benefits, inquiring patients about all currently used conventional medicines and herbal medicines and supplements, automatically detecting highly substantial significant HDI by computerized reminder system, selecting the alternatives, adjusting dose, reviewing the appropriateness of physician orders, educating patients to monitor for drug-interaction symptoms, and paying attention to follow-up visit and consultation.

scholarly journals Does Adjuvant Treatment with Chinese Herbal Medicine to Antidiabetic Agents Have Additional Benefits in Patients with Type 2 Diabetes? A System Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-14 ◽  
Author(s):  
De Jin ◽  
Jiaxing Tian ◽  
Qi Bao ◽  
Haiyu Zhang ◽  
Qiyou Ding ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Herbal Medicines ◽  
Controlled Trials ◽  
Antidiabetic Agents ◽  
Chinese Herbal Medicines ◽  
Randomized Controlled ◽  
Chinese Herbal

Introduction. In the present meta-analysis, we aimed to determine the effects of adjuvant treatment with Chinese herbal medicine (CHM) on antidiabetic agents having additional benefits in patients with type 2 diabetes. Methods. Randomized controlled trials were identified by searching the Cochrane Library, PUBMED, EMBASE, MEDLINE, the China National Knowledge Internet, Web of Science, Global Health, International Pharmaceutical Abstracts and the China biology medicine, Wanfang, and VIP databases. The intervention group received CHM as add-on treatment to antidiabetic agents therapy, and the control group received placebos in addition to antidiabetic agents or antidiabetic agents alone. We assessed pooled data, including weighted mean differences and 95% confidence intervals (CIs) using a random-effects model. Results. A total of 125 randomized controlled trials were included. 10 articles were included based on literature screening. All trials contrasted Chinese herbal medicines or Chinese herbal medicines + antidiabetic agents with placebo or antidiabetic agents + placebo and included a total of 2004 individuals with T2DM. All selected trials displayed evidence of high methodological quality and possessed a low risk of bias. Meta-analysis of the trials demonstrated that Chinese herbal medicines resulted in a more favorable blood glucose profile in contrast to placebo (P<0.05). The total efficacy rate differed significantly between the two groups (P<0.001). All ten included studies reported the occurrence of tolerable adverse effects. Conclusions. The results showed that in the intervention group, greater reductions were achieved for glucose control and body weight. The combined use of drugs improves the curative effect and has fewer adverse events and has additional benefits in patients with type 2 diabetes. This trial is registered with PROSPERO (CRD42018093867).

Use of Sham Interventions in Randomized Controlled Trials in Neurosurgery

2020 ◽  
Vol 81 (05) ◽  
pp. 456-462
Author(s):  
Rodrigo Panico Gorayeb ◽  
Maria João Forjaz ◽  
António Gonçalves Ferreira ◽  
Joaquim José Ferreira
Keyword(s):  
Randomized Controlled Trials ◽  
Peripheral Nerves ◽  
Brain Injuries ◽  
Controlled Trials ◽  
Ethical Concerns ◽  
Administration Routes ◽  
Randomized Controlled ◽  
Different Types ◽  
Double Blinded ◽  
Clinical Problems

Abstract Background The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery. Methods This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias. Results From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding. Conclusion Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.

scholarly journals Herbal Medicine for Xerostomia in Cancer Patients: A Systematic Review of Randomized Controlled Trials

2017 ◽  
Vol 17 (2) ◽  
pp. 179-191 ◽  
Author(s):  
Bongki Park ◽  
Hyeonseok Noh ◽  
Dong-Jun Choi
Keyword(s):  
Systematic Review ◽  
Herbal Medicine ◽  
Randomized Controlled Trials ◽  
Cancer Patients ◽  
Herbal Medicines ◽  
Small Sample ◽  
Risk Of Bias ◽  
Dry Mouth ◽  
Controlled Trials ◽  
Randomized Controlled

Background: Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. Objective: The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Materials and Methods: Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Results: Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. Conclusions: We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.

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