An Overview of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Formula Granules

Abstract

Objective. To summarize the characteristics and the outcomes of the Randomized Placebo-Controlled Trials of Chinese Herbal Medicine Granules manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd. Methods. Databases including China National Knowledge Infrastructure, VIP, Wanfang, PubMed, Cochrane Library, and clinicaltrials.gov were searched in March 2018 for relevant randomized controlled trials (RCTs). Two reviewers independently screened for and selected studies, extracted data, and checked data extraction. Methodological quality was evaluated using the Cochrane Risk of Bias tool. For the outcome, the characteristics of the study, the cure rate, the effectiveness rate, and advert events were described with a method of bibliometrics. Also, we performed meta-analysis only if there were ≥2 studies treated by the same intervention and evaluated by the same outcome. Results. A total of 40 placebo-controlled RCTs treated for 17 diseases were included in our analysis involving 4,632 patients. 16 of 19 studies treated by CHM granules only showed positive result in patients with HBV, HCV, fever, depression, nonalcoholic fatty liver disease, AIDS, and asthma while negative result was shown in patients with migraine. 17 of 21 studies treated by combination therapy against conventional therapy showed positive result in patients with HBV, herpes simplex keratitis, COPD, liver cirrhotic ascites, Parkinson’s disease, and diabetic peripheral neuropathy while negative result was shown in patients with myasthenia gravis, angina pectoris, and depression. The pooled result cannot demonstrate that the notifying kidney formula granules had the superior effect with placebo on the clearance of serum HBV DNA and HBeAg in HBV carriers with a RR (and the 95% CI) of 2.97 [0.74,11.91] and 1.99 [0.93,4.29], respectively. But, the CHM granules can reduce within-group HBV DNA levels by more than 2 lgIU/ml; the RR (and 95% CI) was 4.64 [2.89,7.45]. Qizhu granules had a significant effect on clearance of HCV RNA with a RR (and 95% CI) of 6.26 [2.16,18.16]. And, the heat-clearing and detoxifying formula granules were superior to placebo in resolution of cold symptom among patients with fever with a RR and 95% CI of 2.58 [1.40,4.74]. Based on the conventional therapy, the pooled result demonstrated that the Regulating liver formula granules were superior to placebo on the clearance of serum HBeAg in chronic hepatitis B patients with a RR (and the 95% CI) of 1.73 [1.30,2.31]. The EeChen decoction granules were superior to placebo in COPD patients with a RR (and the 95% CI) of 1.13 [1.06,1.22]. 28 of the 40 studies reported adverse events. There were 51 adverse events in CHM formula granules group or combination group (n=2,483) and 26 in control group (n=2,122) totally. Most of the adverse symptoms spontaneously resolved after completing the courses of treatment and the other adverse symptoms improved after symptomatic treatment. Conclusion. 16 of 19 studies treated by CHM granules only showed positive result in 7 diseases and negative result in 1 disease. 17 of 21 studies treated by combination therapy against conventional therapy showed positive result in 6 diseases and negative result in 3 diseases. However, both the absolute and relative effectiveness of CHM formula granules compared with placebo need to be considered clinically.

Herbal Granules of Heat-Clearing and Detoxifying for Children with Mild Hand, Foot, and Mouth Disease: A Bayesian Network Meta-Analysis

“…As reported, the heat-clearing and detoxifying therapy has been proved to reduce the progressive rate of mild HFMD and healing time of rash or oral ulcer [ 18 , 19 ], and HGs-HD were superior to placebo in resolution of fever symptom [ 20 ]. They could relieve the clinical symptoms, such as fever, rash, vesicles, and ulcers, by regulating the human immune response, boosting the body's resistance to inflammation, and preventing infective pathogens from invasion [ 21 , 22 ].…”

A Narrative Review of Management Strategies for Common Symptoms in Advanced CKD

“…Serotonin reuptake inhibitors (e.g., citalopram, escitalopram, fluoxetine, paroxetine, sertraline) [139][140][141] Serotonin -norepinephrine reuptake inhibitors (e.g., Venlafaxine, duloxetine, mirtazapine) [139][140][141] Atypical antidepressants (e.g., bupropion, trazodone, nefazodone) [139][140][141] Tricyclic antidepressants (e.g., Amitriptyline) [139][140][141] Address contributing factors (e.g., pain, itching and mood disorders) Psychotherapy and cognitive behavioral therapy 131 Exercise 132,133 Acupuncture 134 Magnesium 135 Chinese herbal medicine 136 Electroconvulsive therapy 137 Social support 138 Address concerns related to spirituality and religion 138 Relaxation techniques 138 J o u r n a l P r e -p r o o f…”

“…These interventions included psychotherapy and CBT, 131 exercise intervention, 132 , 133 acupuncture, 134 magnesium, 135 and Chinese herbal medicine ( Table 1 ). 136 Electroconvulsive therapy is usually reserved for treatment of major depression that is nonresponsive to all other modalities of treatment and is particularly useful in treating very severe cases of depression. 137 Other nonpharmacologic approaches have been used to manage depression and anxiety, with variable success.…”