Comparative study on efficacy and safety of atorvastatin in combination with ezetimibe and atorvastatin monotherapy among patients with dyslipidemia – A randomized and double-blind study

Background: Dyslipidemia is defined as the high-density lipoprotein and apolipoprotein A (apo A) levels <10th percentile and/or total cholesterol, triglycerides, low-density lipoprotein (LDL), apolipoprotein B, or Lipoprotein (a) levels more than the 90th percentile. Aim and Objectives: This study aimed to compare the efficacy and safety of the fixed-dose combination of Atorvastatin and Ezetimibe with Atorvastatin monotherapy among patients with dyslipidemia. Materials and Methods: The present study was a randomized, double-blinded, prospective, and parallel-group study. Ninety-two outpatients of age in between 18 and 70 years from the Department of General Medicine who attended the hospital for the treatment of dyslipidemia were selected as study participants. Among 92 patients, 12 patients did not meet the study criteria. The remaining 80 patients were divided into two treatment groups at random and under double-blind conditions (39 in Group A and 41 in Group B). Each patient in both groups was followed for a period of 4 weeks after initiation of therapy. Total cholesterol and LDL-cholesterol levels were recorded at day 1, 2 weeks, and 4 weeks of therapy. Results: In this study, by the end of the study period (4 weeks), tablet Atorvastatin + tablet Ezetimibe combination therapy showed statistical significance difference in reducing mean total cholesterol and mean serum LDL levels in dyslipidemia cases than the group receiving Atorvastatin monotherapy. Conclusion: Atorvastatin in combination with Ezetimibe was more efficacious than Atorvastatin monotherapy in reducing total blood cholesterol and serum LDL levels. Atorvastatin plus Ezetimibe is equally safer as Atorvastatin monotherapy and well tolerated with fewer adverse effects.

A comparative study on efficacy and safety of tablet duloxetine 60 mg and tablet gabapentin 300 mg among patients with diabetic polyneuropathy – A randomized double-blind study

Background: Diabetic peripheral neuropathy is defined as the presence of symptoms and signs of peripheral nerve damage among patients with diabetes, after ruling out other potential causes. Diabetic neuropathies are one among the most common long-term complications of diabetes. About 60% of diabetic patients are affected by neuropathy. Aim and Objectives: This study aims to study the efficacy and safety of tablet duloxetine 60 mg and tablet gabapentin 300 mg among patients with diabetic polyneuropathy. Materials and Methods: This study was randomized, comparative, double-blind parallel group study which was conducted for a period of 6 months. Sixty patients with diabetic polyneuropathic pain were randomly allocated into two groups. One group received duloxetine 60 mg and other group received gabapentin 300 mg. Efficacy was assessed using visual analog scale (VAS), short form of McGill pain questionnaire, and patients global impression of change score. Safety was assessed using adverse drug reaction profile. Results: In the duloxetine group, the mean VAS score at the baseline was 54.97 ± 6.75, and at 3 months, it was 20.07 ± 5.32 which was statistically significant. In the gabapentin group, the mean score at baseline was 53.57 ± 7.85, and at 3 months, it was 26.57 ± 4.39 which was also statistically significant. The difference between the baseline and 3rd month mean McGill score in both groups was statistically significant. Conclusions: We found that both duloxetine 60 mg once daily and gabapentin 300 mg once daily are effective in the treatment of diabetic polyneuropathic pain. However, duloxetine 60 mg once daily is more efficacious than gabapentin 300 mg once daily in the treatment of diabetic neuropathic pain. Both the drugs are well tolerated but gabapentin is better tolerated than duloxetine.

A Phase Ⅲ Clinical Observation of Yishen Yangxin Anshen Tablets in Treatment of Insomnia with Deficiency of Heart Blood and Insufficiency of Kidney Essence / 中国实验方剂学杂志

ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ2=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.

Clinical Observation and Research on Prevention and Treatment of Epilepsy Complicated with Cognitive Impairment by Quyu Dingxian Zhengtong Mixture for Dispelling Stasis and Resolving Phlegm / 中国实验方剂学杂志

ObjectiveTo observe the clinical efficacy and safety of Chinese medicinal mixture for dispelling stasis and resolving phlegm combined with western medicine in the treatment of epilepsy combined with cognitive impairment by randomized， double-blind， placebo-controlled， parallel-group trial. MethodA total of 123 inpatients and outpatients with epilepsy complicated with cognitive impairment admitted to the department of neurology at Longhua Hospital from October 2020 to October 2021 were randomly assigned into a control group （62 cases， carbamazepine + placebo） and a treatment group （61 cases， carbamazepine + Quyu Dingxian Zhengtong mixture） by random number table method. In the treatment group， 4 cases were exfoliated and eliminated. In the control group， 3 cases fell off. Finally， 57 cases in the treatment group and 59 cases in the control group were included. The total course of treatment for both groups was 12 weeks. The clinical efficacy， efficacy for traditional Chinese medicine （TCM） syndromes， and incidence of adverse reactions were compared between two groups. The changes of seizure frequency， abnormal rate of electroencephalogram （EEG）， cognitive function score， serum homocysteine （HCY）， folic acid， and vitamin B12 （B12） were measured and compared before and after treatment. ResultAfter 12 weeks of treatment， the treatment group had higher clinical efficacy ［92.98% （53/57） vs 79.66% （47/59）， χ2=4.327， P<0.05］ and efficacy for TCM syndromes ［96.49% （55/57） vs 84.75% （50/59）， χ2=4.660， P<0.05］ than the control group. The treatment group was superior to the control group in reducing the seizure frequency （Z=-3.938， P<0.01） and improving the Montreal cognitive assessment （MoCA） score （t=4.333， P<0.01） and mini-mental state examination （MMSE） score （t=9.531， P<0.01）. The variations in serum HCY， folic acid， and B12 in the treatment group were less than those in the control group （t=-7.233， t=-7.972， t=-6.871， P<0.01）. After treatment， the abnormal rate of EEG in the treatment group was lower than that in the control group （χ2=4.437， P<0.05）. The incidence of adverse reactions in the treatment group （1.75%， 1/57） was lower than that （13.56%， 8/59） in the control group （corrected χ2=4.116， P<0.05）. ConclusionChinese medicinal mixture for dispelling stasis and resolving phlegm in combination with western medicine had better efficacy and safety than western medicine alone in the treatment of epilepsy complicated with cognitive impairment. Specifically， the combination outperformed western medicine alone in terms of clinical efficacy， efficacy for TCM syndromes， reduction in seizure frequency， abnormal rate of EEG， adverse reactions， improvement of cognitive function， and variations in serum folic acid， B12， and HCY values. Chinese medicinal mixture for dispelling stasis and resolving phlegm may improve the clinical efficacy and safety by changing the metabolism of folic acid， B12， and HCY in serum of the patients with epilepsy complicated with cognitive impairment.

An auxiliary device for double-blind placebo acupuncture research / 中国针灸

This device is an auxiliary device with reasonable design for placebo acupuncture research, so as to make double-blind placebo acupuncture control possible. This new auxiliary acupuncture device includes an acupuncture device and a placebo acupuncture device with exactly the same appearance. Both of them are composed of a hemispherical base and a telescopic tube. Through the rotation of the telescopic tube in the notch of the base, the insertion angle of needles can be adjusted from 15 degrees to 165 degrees. The operation of twisting and lifting and inserting can be carried out through the horizontal rotation and vertical sliding of the telescopic tube. A silicone needle pad is arranged in the base, which can simulate the blocking feeling of skin and muscle during needle insertion. The bottom of the base is attached with hydrogel, which has good fixity. The auxiliary device is applicable to multiple parts of the human body and can effectively reduce the risk of unblinding.

Effect and Safety of Kangfuyan Capsules () for Relieving Chronic Pelvic Pain: A Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effect and safety of Kangfuyan Capsules () for treating pelvic inflammatory disease (PID) in patients with chronic pelvic pain (CPP) in a multicenter, randomized, controlled, double-blind, parallel-group clinical trial.@*METHODS@#Totally, 240 PID patients with CPP were randomized into 2 groups using a computer generated random number at a 1:1 ratio from 10 hospitals in China between September 2014 and November 2015. Patients received either oral Kangfuyan Capsules or Gongyanping Capsules (, control); the regimen for both groups comprised 4 capsules (3 times daily) for 12 weeks, with follow-up visit 4 weeks after treatment. The visual analogue scale (VAS) scores, clinical responses, remarkable cure rates for each symptom, and quality of life scores were assessed at baseline, and after 1, 2, and 3 months. Adverse events were also recorded.@*RESULTS@#The VAS scores were significantly lower (P<0.05), whereas the clinical responses, remarkable cure rates for lower abdominal pain, uterine tenderness, adnexal mass, and adnexal tenderness, and Health-related quality of life (EQ-5D) scores were higher in the Kangfuyan group than in the control group at 3 months (P<0.05). Common treatment-related adverse events included high hepatic enzyme levels, reduced hemoglobin levels, and elevated platelet counts, although all the adverse events were either mild or moderate in severity.@*CONCLUSION@#Compared with Gongyanping therapy, Kangfuyan therapy yielded markedly better analgesia effects for CPP caused by PID, with obvious long-term efficacy and good safety. (Registration No. ChiCTR190022732).

Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial / 中西医结合学报

BACKGROUND@#Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.@*OBJECTIVE@#This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m@*MAIN OUTCOME MEASURES@#The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.@*RESULTS@#A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.@*CONCLUSION@#SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.@*TRIAL REGISTRATION NUMBER@#NCT02063100 on ClinicalTrials.gov.

Uso de complexo homeopático reduz o parasitismo por carrapatos e amplia o intervalo de tempo entre tratamentos com acaricidas / Homeopathic complex decreases tick parasitism and increases the interval between treatments with acaricides

O presente trabalho avaliou a segurança e eficácia de 2 formulações homeopáticas no tratamento populacional de bovinos naturalmente parasitados com carrapatos da espécie Rhipicephalus (Boophilus) microplus. Foram realizados 2 experimentos utilizando complexos homeopáticos distintos, ambos com 20 vacas adultas, raça holandesa, em diferentes estágios de lactação, distribuídas em grupo controle (n= 10) e grupo tratado (n= 10) num estudo randomizado com duplo cego. A contagem de carrapatos foi registrada nos dias 7, 14, 21 e 28 após o tratamento homeopático e, posteriormente, em intervalos de 15 dias até o dia 140 do Experimento 01 e o dia 197 do Experimento 02. A formulação homeopática utilizada no Experimento 01 apresentou eficácia de 21,1%, sendo necessária intervenção com tratamento convencional durante o período de 140 dias. A eficácia do complexo homeopático no Experimento 02 foi de 6,7%. Os resultados foram seguros e eficazes na terapia antiparasitária, tendo bons resultados quando complementados com o uso racional e correto de acaricidas. (AU)

In the present study evaluated the efficacy of 2 homeopathic formulas in the treatment of cattle naturally with Rhipicephalus (Boophilus) microplus ticks. Two experiments were carried out using different combinations of homeopathic medicines, with 20 adult Holstein cows, in different stages of lactation, allocated to the control (n= 10) and treated (n= 10) groups in a randomized double-blind placebo-controlled trial. Tick count was performed on days 7, 14, 21 and 28 after homeopathic treatment ,and then at 15-day intervals up to day 140 in Experiment 1 and day 197 in Experiment 2. Efficacy in Experiment 1 was 21.1%, while conventional intervention was required along the 140-day period. Efficacy in Experiment 2 was 6.7%. The results indicate that the tested homeopathic formulas were safe and efficacious, outcomes being satisfactory when homeopathic treatment was combined with rational and correct conventional treatment. (AU)

Indomethacin for preventing post-endoscopic retrograd cholangiopancreatography pancreatitis by rectal administration: a Meta-analysis of randomized controlled trial / 中国基层医药

Objective@#To assess the effectiveness and safety of indomethacin in preventing post-endoscopic retrograd cholangiopancreatography pancreatitis(PEP) by rectal administration.@*Methods@#Retrieved from PubMed, Cochrane Library, CNKI, VIP, CBM and Wanfang database, randomized blinding placebo-controlled trails about indomethacin for preventing PEP by rectal administration were included from establishment to December 2017 and comprehensively evaluated.Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, assessed the risk bias of included studies, and then Meta-analysis was performed using the RevMan 5.3 software.@*Results@#A total of 8 RCTs involving 3240 patients were included.The results of Meta-analysis showed that indomethacin could reduce the incidence of PEP(OR=0.57, 95% CI: 0.45-0.73, P<0.00 001) and moderate or severe PEP(OR=0.51, 95% CI: 0.30-0.85, P=0.010). The adverse reactions of indomethacin was gastrointestinal bleeding, and there was no statistically significant difference between indomethacin and placebo(OR=0.63, 95% CI: 0.25-1.52, P=0.300).@*Conclusion@#Indomethacin is safe and effective in reducing the incidence of PEP by rectal administration.

The study on the effect of ginkgo biloba extracts on MnSOD activity in the treatment of tardive dyskinesia / 中国神经精神疾病杂志

To investigate if ginkgo biloba extract (Egb-761) can improve tardive dyskinesia (TD) symptoms through increasing the activity of plasma MnSOD. Methods We enrolled a total of 384 schizophrenia patients including 157 TD patients and 227 non-TD patients, as well as 280 normal subjects. The difference of MnSOD level in plasma among these groups were compared. TD patients were then randomly divided into two groups. The treatment group (n=77) and the placebo group (n=75) were treated with 240 mg of Egb-761 or placebo per day for 12 weeks, respectively. The abnormal involuntary movement scale (AIMS) and the positive and negative symptoms scale (PANSS) were used to evaluate the severity of the symptoms in baseline, the sixth week and the twelfth week after treatment. The level of MnSOD activity in plasma was also detected before and after the treatment. Results The level of MnSOD activity was lower in schizophrenia groups than in healthy control group (P＜0.01). In addition, the level of MnSOD activity was significantly lower in TD group than in non-TD group (P＜0.05). Repeated measures analysis of variance showed that group effect (F=4.00, P=0.05), time effect (F=32.17, P＜0.01) and interactive effect of group and time (F=39.04, P＜0.01) were significant in AIMS total score. The AIMS total score of treatment group was significantly lower than that of placebo group at 6-week and 12-week time points (all P＜0.01). Repeated measures analysis of variance showed that time effect (F=23.04, P＜0.01) and interactive effect of group and time (F=6.41, P＜0.05) were significant in the level of MnSOD activity. In addition, the level of MnSOD at baseline was significantly correlated with the reduction of AIMS total score during the treatment period (r=0.27, P=0.018). Conclusion Treatment of Egb-761 can improve symptoms of TD and activity of MnSOD.

Efficacy and safety of pazufloxacin mesylate eye drops for bacterial conjunctivitis:a multicenter randomized, double-masked, parallel controlled clinical trial / 中华实验眼科杂志

Objective To compare the clinical efficacy and safety following the topical application of pazufloxacin mesylate eye drops with levofloxacin eye drops (LOFX) for bacterial conjunctivitis.Methods A multicenter,randomized,investigator-masked,parallel-controlled clinical trial was performed.Five hundred and twenty eyes of 520 patients with bacterial conjunctivitis were enrolled from March to October 2008 in seven ophthalmic centers in China.The patients were randomized into trial group and control group in 3 ∶ 1 ratio with the 390 eyes in the trial group and 130 eyes in the control group.Pazufloxacin mesylate eye drops was topically used 4 times per day for consecutively 7-14 days in the trial group,and levofloxacin eye drops was used in the same way in the control group.Microbiological cultures for conjunctiva sac secretions and drug sensitive test were carried out before and at the end of the administration of eye drops.The signs and symptoms were observed and scored before treatment and 0,3,7 and 14days after treatment.The adverse events following the administration of the eye drops were evaluated and compared.Results The intention to treat analysis (ITT) showed that the cure rate was 59.38％ in the trial group and 60.47％ in the control group,with the effective rate 88.80％ and 86.05％,respectively,with an insignificant difference between the two groups (x2 =0.12,P =0.72).The clinically evaluable analysis (CE) exhibited that the cure rates were 63.48％ in the trial group and 63.87％ in the control group,with the effective rate 92.46％ and 88.24％,whichwas not significantly different between them (x2 =0.54,P=0.46).The modified-ITT analysis (mITT) showed that the cure rates were 60.57％ in the trial group and 62.07％ in the control group,with the effective rate 90.32％ and 88.51％,without significant difference between the two groups (P＞0.05).Based on microbiologically evaluable analysis (ME),the clinical cure rates were 63.71％ and 63.41％ in the trial group and control group,and the effective rates were 93.44％ and 90.24％,respectively.There was no significantly difference between the both groups (P＞0.05).In the trial group and control group,the bacterial eradication rate was 89.42％ and 90.80％ based on ITT,90.11％ and 92.77％ based on CE,respectively.There was no significant difference in incidences of adverse events following the administration of the drug between the trial group and control group,including ocular tolerance,burning sensation,pricking and itching (P =0.34).Conclusions The effectiveness and adverse response were resemble between Pazufloxacin mesylate eye drops and LOFV following the topical application for bacterial conjunctivitis,which indicate that Pazufloxacin mesylate eye drops is effective and safe.

Effects of 0.01％ and 0.02 ％ atropine eye drops on pupil diameter and accommodation amplitude in myopic children: one-year randomized, double blind, controlled trail / 中华实验眼科杂志

Objective To evaluate the effects of 0.0％ and 0.02％ atropine on pupil diameter (PD) and accommodation amplitude (AMP) in myopic children and analyze its relation factors.Methods A prospective randomized controlled trial design was adopted.One hundred and ninety-three myopia children were included from June to October,2016 in the First Affiliated Hospital of Zhengzhou University,all the children completed one-year follow-up.All the children were divided into three groups randomly,with 72,74 and 80 myopic children in 0.01％ atropine group,0.02％ atropine group and control group,respectively.The myopic children in 0.01％ atropine group and 0.02％ atropine group wore single-vision spectacle lenses and were treated with 0.01％ and 0.02％ atropine eye drops nightly,respectively.The myopic children in the control group wore spectacle lenses only.The PD and AMP were measured at baseline,and 4,8 and 12 months after treatment.Results There were no significant difference of baselinePD and AMP among the three groups (F=9.321,P=0.820;F=13.209,P=0.220).Compared with basline,after 12 months,the PD increased by 0.75,0.84 and 0.02 mm in 0.01％ atropine group,0.02％ atropine group and control group,respectively.There were statistically significant differences of PD among three groups at different time points (Fgroup =2.168,P=0.013;Ftime =2.139,P=0.015;Finteraction =2.148,P=0.001).Compared with baseline,the PD of 0.01％ atropine group and 0.02％ atropine group were increased 4,8 and 12 months after treatment,and the difference was statistically significant (all at P＜0.001).The PD was stable in control group.After 12 months,the AMP were reduced by 1.25,1.12 and 0.28 D in 0.01％ atropine group,0.02％ atropine group and control group,respectively.There were statistically significant differences of AMP among the three groups at the different time points (Fgroup =18.346,P =0.034;Ftime =1.823,P =0.002;Fintercation =3.239,P =0.023).Compared with baseline,the AMP of 0.01％ atropine group and 0.02％ atropine group were increased 4,8 and 12 months after treatment,and the differences were statistically significant (all at P＜0.05).The AMP remained stable in control group.The change of PD in 0.01％ atropine group and 0.02％ atropine group was correlated with age,baseline PD and baseline eye axis length,respectively (β =0.060,P =0.019;β =-0.440,P＜0.001;β =-0.37,P =0.045).The change in AMP of the atropine group was significantly correlated with the baseline adjustment range (β =-0.71,P＜0.001).Conclusions 0.01％ and 0.02％ atropine show similar effects on pupil diameter and accommodation amplitude after 12 months of treatment in myopic children.

Indomethacin for preventing post-endoscopic retrograd cholangiopancreatography pancreatitis by rectal administration: a Meta-analysis of randomized controlled trial / 中国基层医药

Objective To assess the effectiveness and safety of indomethacin in preventing post-endoscopic retrograd cholangiopancreatography pancreatitis (PEP) by rectal administration.Methods Retrieved from PubMed,Cochrane Library,CNKI,VIP,CBM and Wanfang database,randomized blinding placebo-controlled trails about indomethacin for preventing PEP by rectal administration were included from establishment to December 2017 and comprehensively evaluated.Two reviewers independently screened literature according to the inclusion and exclusion criteria,extracted data,assessed the risk bias of included studies,and then Meta-analysis was performed using the RevMan 5.3 software.Results A total of 8 RCTs involving 3240 patients were included.The results of Meta-analysis showed that indomethacin could reduce the incidence of PEP(OR =0.57,95％ CI:0.45-0.73,P ＜ 0.00 001) and moderate or severe PEP(OR =0.51,95 ％ CI:0.30-0.85,P =0.010).The adverse reactions of i ndomethacin was gastrointestinal bleeding,and there was no statistically significant difference between indomethacin and placebo(OR =0.63,95％ CI:0.25-1.52,P =0.300).Conclusion Indomethacin is safe and effective in reducing the incidence of PEP by rectal administration.

A Randomized Double-blind Placebo-controlled Trial on the Effect of Magnesium Oxide in Patients With Chronic Constipation

BACKGROUND/AIMS: Magnesium oxide (MgO) has been frequently used as a treatment for chronic constipation (CC) since the 1980s in Japan. The aim of this study is to evaluate its therapeutic effects of MgO in Japanese CC patients. METHODS: We conducted a randomized, double-blind placebo-controlled study. Thirty-four female patients with mild to moderate constipation were randomly assigned to either placebo (n = 17) or MgO group (n = 17) 0.5 g × 3/day for 28 days. Primary endpoint was overall improvement over the 4-week study period. Secondary endpoints were changes from baseline in spontaneous bowel movement (SBM), response rates of complete spontaneous bowel movement (CSBM), stool form, colonic transit time (CTT), abdominal symptom, and quality of life. RESULTS: One patient failed to complete the medication regimen and was omitted from analysis: data from 16 placebo and 17 MgO patients were analyzed. The primary endpoint was met by 25.0% of placebo vs 70.6% of MgO group (P = 0.015). MgO significantly improved SBM changes compared to placebo (P = 0.002). However, MgO did not significantly improved response rates of CSBM compared to placebo (P = 0.76). In addition, MgO significantly improved Bristol stool form scale changes (P < 0.001) and significantly improved CTT compared to the placebo group (P < 0.001). MgO significantly improved the Japanese version of the patient assessment of constipation quality of life (P = 0.003). CONCLUSION: Our placebo-controlled study demonstrated that MgO was effective treatment for improving defecation status and shortened CTT in Japanese CC patients with mild to moderate symptoms.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial / 대한통증학회지

BACKGROUND: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). METHODS: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. RESULTS: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was 34.2 ± 9.9 and 37.9 ± 10.6 years in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. CONCLUSIONS: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

Lidocaine as a diluent for Benzathine Penicillin G for injection pain in children with rheumatic fever and rheumatic heart disease: A randomized double-blind crossover study

@#<p style="text-align: justify;"><strong>BACKGROUND</strong>: Rheumatic fever (RF) and Rheumatic heart disease (RHD) patients Rheumatic Heart Disease (RHD) patients necessitate secondary prophylaxis with benzathine penicillin G (BPG) injection every 3 weeks to prevent recurrences and complications. Patients with rheumatic fever on regular benzathine penicillin G injection usually experience moderate to severe pain resulting to poor compliance to treatment. </p><p style="text-align: justify;"><strong>OBJECTIVES:</strong> This study aims to compare the effect of BPG diluted in lidocaine hydrochloride 1%  versus diluted water in reducing injection pain in patients with RF and RHD.</p><p style="text-align: justify;"><strong>METHODS</strong>: This is a randomized double-blind crossover study conducted at the PCMC OPD. Thirty-three patients diagnosed with RF and RHD were divided into 2 groups; the first group received BPG diluted in sterile water followed by BPG diluted in lidocaine hydrochloride  1% after 21 days, the second group received the same medication in reverse order. Pain scale was measured using Universal pain assessment tool immediately after injection. Paired T test was used to compare the pain score results of the two groups.</p><p style="text-align: justify;"><strong>RESULTS:</strong> Pain score was significantly less in patients who received BPG diluted in lidocaine hydrochloride 1%; from an average pain score of 4.88 to 0.63 (p<0.0001), among those who received BPG diluted in sterile water. No adverse effects were seen in all patients.</p><p style="text-align: justify;"><strong>CONCLUSION:</strong> This study concluded that BPG diluted in lidocaine hydrochloride 1% significantly and safely reduced post-injection pain. In all patients diagnosed with RF and RHD, BPG injection should be diluted in lidocaine hydrochloride 1% to decrease injection pain and improve patient's compliance.</p>

Efficacy and safety of Choudongning Capsule in children with Tourette’s syndrome of spleen deficiency and phlegm accumulation in phase II clinic / 中草药

Objective To evaluate the efficacy and safety of Choudongning (CDN) Capsule in children with Tourette’s syndrome of spleen deficiency and phlegm accumulation. Methods A stratified-block randomized, parallel-controlled, double-blind, double- dummy, multi-center trials were designed for clinical study. A total of 240 patients were enrolled and separated randomly into experimental group and positive control group in the rate of 1:1. Patients in the experimental group orally took CDN Capsule and simulated Tiapridal Tablets; The patients in positive control group took Tiapridal Tablets and simulated CDN Capsule. Treatment course lasted for 6 weeks. The clinical efficacy and integrals of YGTSS twitch, the factor scores of motor tics and vocal tics, YGTSS social function damage, traditional Chinese medicine syndrome efficacy were observed to evaluate its security. Results The total effective rate of YGTSS twitch clinical efficacy was 71.19% in the experimental group and 67.50% in the positive control group, respectively. The results of non-inferiority test indicated that the efficacy of experimental group was not worse than that in the positive control group. There was no significant difference between two groups in YGTSS twitch integrals, motor tics and vocal tics’ factor scores, YGTSS social function damage, and traditional Chinese medicine syndrome efficacy. Only two ADRs (1.67%) in the experimental group and six ADRs (5%) in the positive control group were observed during clinical trials. The incidence of ADRs in the experimental group was lower than that in the positive control group with no statistical difference. Conclusion CDN Capsule have similar efficacy on the treatment of Tourette’s syndrome of spleen deficiency and phlegm accumulation contrast to Tiapridal Tablets, with lower adverse reactions and better safety.

A multicenter, large-sample, randomized clinical trial on improving the median survival time of advanced non-small cell lung cancer by combination of Ginseng Rg3 and chemotherapy / 中华肿瘤杂志

Objective@#To observe the efficacy of the combination of chemotherapy and Ginseng Rg3 on advanced non-small cell lung cancer(NSCLC).@*Methods@#In the multi-center, large-sample, randomized, double blind trial, 414 patients with Ⅲ-Ⅳ NSCLC were enrolled.199 were in the experimental group and 215 the control group. The patients in the experimental group were treated with the standard first-line chemotherapy combined with Ginseng Rg3. The patients in the control group were treated with the same chemotherapy combined with placebo. Median overall survival (OS), Karnofsky performance scale (KPS), Traditional Chinese Medicine (TCM) symptoms score and side effects of two groups were observed as main indexes.@*Results@#The median OS were 12.03 months in the experimental group, which was significantly better than that in the control group (8.46 months, P<0.05). Hemoglobin and white blood cells were decreased after the first and second cycle of treatment in both groups. Both adverse events were significantly milder in the treatment group (P<0.05). In addition, after two courses of treatment, the KPS of patients was 78.95±9.14 in the experimental group and 76.77±9.15 in the control group, while the TCM symptoms score was 2.45±1.73 in the experimental group and 2.92±2.06 in the control group, with significant difference (P<0.05).@*Conclusions@#Combination of TCM with Western medicine such as chemotherapy could prolong the survival of patients with advanced NSCLC. The combined therapy improved patients′ symptoms and reduced chemotherapy induced myelosuppression.

Research on project evaluation of scientific research projects based on "double-blind, random, centralized, grouping, independent evaluation system" / 中华医学科研管理杂志

Objective The evaluation management of scientific research projects is the core work content of scientific research management institutions at all levels.The primary causes of bias in project evaluation are the acquaintance social network relationship and the unit-based unitism,especially in the case of small academic circles.The purpose of this essay is to study how to circumvent this problem,to select projects objectively and fairly,and to benefit the evaluation and management of scientific research projects at all levels.Methods Including information construction,expert database construction,expert rotation system,expert avoidance system,supervision and examination system,peer-expert review and strengthen the expert project evaluation.For the first time,we proposed a double-blind,random,centralized,and group-based independent evaluation system.Results This method has a positiveeffect on view.Conclusions In the case where the relative or absolute numberof experts in a single field is small,implementing a series of normative systems and measures through organizational management can avoid interference factors that affect the project evaluation effectively and achieve more scientific and fair results.

Efficacy and safety of duloxetine for depression in China :a meta-analysis / 中华行为医学与脑科学杂志

Objective To systematically evaluate the efficacy and adverse effects of duloxetine in the treatment of domestic depression patients,and compare with those who were treated with SSRIs drugs in the same period to explore the difference between them to guide the clinical medication.Methods A search was conducted in CBMdisc,Wanfang database,CNKI,VIP,Pubmed.The double-blind randomized controlled trials on duloxetine for depression in China were collected.The quality of the included trials was assessed according to the Cochrane Handbook 5.0,and the systematic analysis was conducted by using RevMan 5.3 soft ware.Results Seven double-blind randomized controlled trials (two of duloxetine versus fluoxetine,five of duloxetine versus paroxetine) involving 1 193 patients were included.The results of rmeta-analysis showed that:①After 6-8 weeks of treatment,there were no significant differences in the effective rate (RR =1.02,95％CI=0.78-1.32,Z=0.12,P=0.90),and the final cure rate (RR=0.95,95％CI=0.75-1.19,Z=0.47,P=0.64) between the duloxetine and fluoxetine/paroxetine groups.②Adverse reactions:the incidence rate was not significantly different between duloxetine and fluoxetine/paroxetine groups (RR =1.03,95％ CI =0.86-1.23,Z=0.32,P=0.75).Conclusion After 6-8 weeks of treatment,there are no significant differences in the effective rate and the final cure rate between duloxetine and fluoxetine/paroxetine.There is no significantly difference in common adverse reactions.