Objective To evaluate the effectiveness and safety of Lipo-prostaglandin E1 injection in treating viral hepatitis.Methods We searched MEDLINE, EMBASE, The Cochrane Library and CNKI from 1978 to June 2007. We identified randomized control led trials of Kai Shi injection versus other medicines or blank controlin treating viral hepatitis. The quality of included trials was evaluated independently by two reviewers. Meta-analyses were performed with The Cochrane Collaboration’s RevMan 4.2.7 software. Results Fourteen studies involving 1 218 patients were included, one of these compared lipo-prostaglandin E1 injection versus Mai Anding injection, one compared lipo-prostaglandin E1 injection versus potassium-magnesium aspartate injection, and the other 12 compared Lipo-prostaglandin E1 injection versus blank control. Allincluded studies were assessed in terms of randomization, allocation concealment and blinding; and all were graded C(poor quality). Meta-analyses showed that, the total effective rate was significantly higher in the lipo-prostaglandin E1 injection group[RR 1.45, 95%CI (1.29, 1.63)] and the mortality was lower[RR 0.66, 95%CI (0.53, 0.83)] compared with the blank control group, but the incidence of phlebitis was significantlyhigher [RR 7.70, 95%CI (2.57, 23.07)]. There was no significant di f ference between Mai Anding inject ion and lipo-prostaglandin E1 injection in the total effective rate, but Lipo-prostaglandin E1 injection was more effective in improving patients’ liver functions. Compared with potassium-magnesium aspartate injection, the total effective rate was significantly higher in the lipo-prostaglandin E1 injection group[RR1.54, 95%CI (1.14, 2.08)].Conclusion The evidence currently available shows that the effectiveness and safety of lipo-prostaglandin E1 injection are not significantly different from those of Mai Anding injection for patients with viral hepatitis. Compared with potassium-magnesium aspartate injection, Lipo-prostaglandin E1 injection could significantly improve the total effective rate, but since we only include 1 relevant randomized trials, the strength of this evidence is weak. When compared with the blank control, Lipo-prostaglandin E1 injection significantly improved the total effective rate, decreased mortality but increased the incidence of side effects and the existing evidence is insufficiant to show whether Lipo-prostaglandin E1 injection improves patients’ liver functions.
Objective To assess the efficacy and safety of Chinese medicinal herbs for treating endometriosis. Methods We searched Cochrane Library, MEDLINE, EMBASE, CBM (from establishment to 2003). Randomized controlled trials (RCTs) and quasi-randomized controlled trials of patients with endometriosis were included. The quality of included studies such as randomization, blinding, allocation concealment and loss of follow up were evaluated and meta-analysis was performed by RevMan 4.3 software. Results Ten RCTs or quasi-RCTs involving 1 120 patients were included. Because of different therapies in the treatment and control groups, the results of outcome were described separately. Most of included studies suggested that the effects of traditional Chinese medicine (TCM) on general effect, pregnancy rate improvement and alleviating dysmenorrhoea were similar to Danazol or Tamoxifen, only a few studies showed better effects. There was no evidence to support that TCM was more effective than western medicine in reducing the size of endometriotic cysts. Only one study mentioned the recurrence rate and showed that TCM enema had lower recurrence rate than oral Tamoxifen with OR 0.17, 95%CI 0.04 to 0.67. Five studies mentioned adverse reactions and showed TCM had fewer adverse effects than western medicine. Conclusions Chinese medicinal herbs are effective in treating endometriosis with fewer adverse effects. The evidence is not b enough because of low quality of the included studies. Therefore, more high quality randomized controlled trials are required.
ObjectiveTo evaluate the efficacy of intravenous glutamine on patients with severe acute pancreatitis.
MethodsThe Cochrane Library, PubMed, EMbase, CNKI and CBM databases were searched up to January 2013. Randomized controlled trials (RCTs) that compared non-glutamine nutrition with intravenous glutamine supplemented nutrition in patients with severe acute pancreatitis were included. A method recommended by the Cochrane Collaboration was used to perform a meta-analysis of those RCTs.
ResultsFour RCTs involving a total of 190 participants were included. Analysis of these RCTs revealed the presence of statistical homogeneity among them. Results showed that glutamine dipeptide had a positive effect on reducing the mortality rate[OR=0.26, 95%CI (0.09, 0.73), P=0.01], length of hospital stay[WMD=-4.85 d, 95%CI (-6.67, -3.03) d, P<0.001], and the rate of complications[OR=0.41, 95%CI (0.22, 0.78), P=0.006]. No serious adverse effects were found.
ConclusionCurrent best evidence demonstrates that glutamine is effective for severe acute pancreatitis. Further high quality trials are required and parameters of nutritional condition and hospital cost should be considered in future RCTs with sufficient size and rigorous design.
ObjectiveTo systematically evaluate the efficacy and safety of Polypill on cardiovascular risk factors.
MethodSuch databases as Embase, Cochrane Library, PubMed, Web of Science, China National Knowledge Infrastracture, WanFang, and China Biology Medicine Disc were searched from their establishment to May 2015 for randomized controlled trials on the efficacy and safety of Polypillon on cardiovascular risk factors. Meta-analyses were performed by using the RevMan 5.2 software.
ResultsSix studies were included which all came from overseas including 1 155 patients treated with Polypill and 1 149 treated with placebo or single or combined medicaiton. The meta-analysis showed that:when compared with the controls, Polypills could significantly reduce systolic blood pressure[WMD=-9.39 mm Hg (1 mm Hg=0.133 kPa), 95%CI (-14.44, -4.33) mm Hg, P=0.0003], diastolic blood pressure[WMD=-5.32 mm Hg, 95%CI (-8.10, -2.55) mm Hg, P=0.0002], total cholesterol[WMD=-1.11 mmol/L, 95%CI (-1.48, -0.74) mmol/L, P<0.00001], and low density lipoprotein[WMD=-0.91 mmol/L, 95%CI (-1.25, -0.57) mmol/L, P<0.00001]. However, those who took Polypill were easier to discontinue medication [OR=1.49, 95%CI (1.19, 1.87), P=0.0005]. In the respect of adverse effects, there was no significant difference between the two groups[OR=1.47, 95%CI (0.67, 3.25), P=0.34].
ConclusionsThe efficacy of Polypill on cardiovascular risk factors is obvious. Polypills can significantly reduce blood pressure and lipids. Tolerability is lower in those taking Polypills, but the difference is minor. There is no significant difference in the respect of adverse effects.
Objective To evaluate the efficacy and safety of the treatment of chronic prostatitis(CP) in China. Methods We search the related original studies about the treatment for Chinese CP all over the world, and only included randomized controlled trials (RCTs). MEDLINE(1966-2007.5), PubMed (1966-2007.5), EMBASE(1988-2007.05), and four Chinese databases were electronically searched and 6 related journals were handsearched. The studies included in the references of eligible studies were additionally searched. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinion were settled by discussion or consulted by the expert. Meta-analysis was performed by using Rev Man 4.2 software.Results Nine original studies involving 917 participants met inclusion criteria. Compared withplacebo, prostant, Wenglitong, Chuanshentong, alpha-blockers, bioflabonoid and porstat could reduce the NIH-chronic prostatitis symptom index[RR1.99, 95% CI（1.60, 2.48）； RR2.76 95% CI(2.13，3.57)； RR2.49, 95% CI(1.24, 4.97)； WMD -5.90，95%CI（-8.12，-3.68）； WMD -2.50, 95%CI（-4.85，-0.15）；WMD -6.07， 95%CI(-7.92， -4.22)]. Alpha-blockers, Wengl itong, bioflabonoid and porstat can also reduce the symtom index of pain.Conclusion Drug interventions could improve NIH-CPSI and total symptoms of CP in some degree, but can not improve all symptoms, future RCTs must use an appropriate sample size and optimal duration and follow-up of participants. It is important to improve the quality of internal original studies.
ObjectiveTo systematically review the efficacy and safety of Molnupiravir in the treatment of COVID-19. MethodsThe CNKI, VIP, WanFang Data, PubMed, Web of Science, Cochrane Library, and Epistemonikos COVID-19 L·OVE databases were electronically searched to collect randomized controlled trials (RCTs) related to Molnupiravir therapy for COVID-19 from inception to July, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. ResultsA total of 9 RCTs involving 32 086 patients were included. The meta-analysis results revealed that no significant differences were observed in the 28-29 day hospitalization rate, the 28-29 day mortality rate, 14-15 day PCR test conversion rate, or adverse event incidence between the two groups. However, there was a significant increase in adverse events related to four types of systemic organ diseases in the Monolaurin group. Conclusion?Current evidence shows that the safety profile of Monolaurin and its potential benefits for COVID-19 patients with a high risk of progressing to severe illness is unclear. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectiveTo evaluate the safety and clinical efficacy of transurethral holmium laser enucleation of the prostate (HoLEP) versus transurethral plasma kinetic enucleation of the prostate (PKEP) in the treatment of benign prostate hyperplasia (BPH).MethodsRandomized controlled trials of HoLEP versus PKEP in the treatment of BPH published between January 2000 and March 2021 were searched in PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Chongqing VIP database, and Wanfang database. Operative duration, estimated intraoperative blood loss, average duration of urinary catheterization, average duration of bladder irrigation, average length of hospital stay, and postoperative complications were used as safety evaluation indicators. Postoperative International Prostatic Symptomatic Score (IPSS), postoperative maximum urinary flow rate (Qmax), postoperative quality of life (QoL), and postvoid residual (PVR) were used as effective evaluation indicators.ResultsA total of 14 randomized controlled trials were included in this study, with a total of 1 478 patients (744 in the HoLEP group and 734 in the PKEP group). The results of the meta-analysis showed that the intraoperative blood loss in the HoLEP group was less than that in the PKEP group [weighted mean difference (WMD)=?25.95 mL, 95% confidence interval (CI) (?31.65, 20.25) mL, P=0.025], the average duration of urinary catheterization [WMD=?10.35 h, 95%CI (?18.25, ?2.45) h, P=0.042], average duration of bladder irrigation [WMD=?10.28 h, 95%CI (?17.52, ?3.04) h, P=0.038], and average length of hospital stay [WMD=?1.24 d, 95%CI (?1.85, ?0.62) d, P=0.033] in the HoLEP group were shorter than those in the PKEP group, and the incidence of postoperative complications [risk ratio=0.70, 95%CI (0.56, 0.87), P=0.047] and 6-month postoperative Qmax [WMD=?0.89 m/s, 95%CI (?1.74, ?0.05) m/s, P=0.037] in the HoLEP group were lower than those in the PKEP group. However, there was no significant difference in the operative duration, 3-month postoperative IPSS, 3-month postoperative Qmax, 3-month postoperative QoL, 3-month postoperative PVR, 6-month postoperative IPSS, 6-month postoperative QoL, or 6-month postoperative PVR between the two groups (P>0.05).ConclusionsIn the treatment of BPH, the effectiveness of HoLEP does not differ from that of PKEP, but HoLEP is safer. The conclusions of this study need to be verified in more precisely designed and larger sample-sized multi-center randomized controlled trials.
ObjectiveTo investigate the current situation of randomized controlled trials (RCTs) of thrombin like enzyme research and the ability to provide a reliable basis for the clinical practice.
MethodsRCTs identified from four Chinese databases up to the year 2012 were assessed according to international standard, including SinoMed (1978-2012), CNKI (1979-2012), Wanfang Data (1986-2012), and VIP (1989-2012).
ResultsA total of 2358 articles were searched and 53 RCTs were identified. The results showed that the quality of these articles was not high enough to meet the needs of clinical practice in China.
ConclusionIn China, current quantity and quality of RCTs of thrombin like enzyme can not meet the need of clinical practice. In order to improve the prevention and treatment of hemorrhagic diseases, and surgical bleeding, especially for patients lacking clotting factor, more high-quality RCTs are required.
High-quality randomized controlled trials (RCTs) are regarded as the gold standard for assessing the efficiency and safety of drugs. However, conducting RCTs is expensive and time consumed, and providing timely evidence by RCTs for regulatory agencies and medical decision-makers can be challenging, particularly for new or emerging serious diseases. Additionally, the strict design of RCTs often results in a weakly external validity, making it difficult to provide the evidence of the clinical efficacy and safety of drugs in a broader population. In contrast, large simple clinical trials (LSTs) can expedite the research process and provide better extrapolation and reliable evidence at a lower cost. This article presents the development, features, and distinctions between LSTs and RCTs, as well as special considerations when conducting LSTs, in accordance with literature and guidance principles from regulatory agencies both from China and other countries. Furthermore, this paper assesses the potential of real-world data to bolster the development of LSTs, offering relevant researchers’ insight and guidance on how to conduct LSTs.
Objective To assess the efficacy and safety of efalizumab in the treatment of psoriasis. Methods Randomized controlled trials (RCT) on efalizumab in the treatment of psoriasis were identified from The Cochrane Library ( issue 1, 2006) , specialized trials registered in Cochrane Skin Group (2006), MEDLINE (1966 - 2006) and EMBASE (1974 - 2006). The quality of the trials was assessed by two reviewers independently. RevMan 4.2.7 software provided by the Cochrane Collaboration was used for statistical analysis. Results Three RCTs involving 1 651 patients were included, all of which were of high methodological quality. All the patients were diagnosed as chronic moderate to severe plaque psoriasis with the age of 18-75 years. Meta-analysis indicated that at week 12, significantly more patients in both 1mg/kg/w and 2 mg/kg/w efalizumab subcutaneous groups achieved PASI50, PASI75, PASI90 improvement compared to the placebo group (Plt;0.0001), while there was no significant difference in PASI50, PASI75 and PASI90 responses between 1mg and 2mg efalizumab groups (P gt;0.05). No serious adverse effects were identified. Extended treatment for another 12w may contribute to further efficacy without increasing toxicty. Conclusions Efalizumab 12w therapy is safe and effective for treating adult patients with moderate to severe plaque psoriasis. More RCTs are required to assess the efficacy of the extended treatment.
