Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.
Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
ObjectiveTo systematically review the effect of self-management intervention on the prevention and management of lymphedema in breast cancer patients. MethodsThe Cochrane Library, Embase, PubMed, Web of Science, CINAHL, PsycINFO, SinoMed, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on self-management intervention on the prevention and management of lymphedema in breast cancer patients, from inception to June 16. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.4 software. ResultsA total of 37 references were included, comprising 25 randomized controlled trials (RCTs), 12 controlled clinical trials (CCTs), and a total of 3 697 patients. There were 26 studies in the meta-analysis, and the results of the meta-analysis showed that, compared with the control group, patients in the intervention group exhibited better performance in lymphedema management-related behaviors (SMD=2.65, 95%CI 1.53 to 3.78, P<0.01), symptoms related to lymphedema (SMD=?2.01, 95%CI ?3.66 to ?0.37, P<0.05), occurrence of lymphedema (RR=0.37, 95%CI 0.32 to 0.45, P<0.01), upper limb function (SMD=?1.88, 95%CI ?2.83 to ?0.92, P<0.01), quality of life (SMD=2.79, 95%CI 2.05 to 3.54, P<0.01), and the difference was statistically significant. The intervention mainly included information support, material support, emotional support and decision support. ConclusionThere are currently a variety of self-management interventions, but they mainly focus on information support. Self-management interventions can improve the self-management behavior of breast cancer patients with lymphedema and reduce the impact of lymphedema on patients.
Objective To determine the efficacy and safety of external fixation versus intramedulllary nailing in the treatment of adult tibial shaft fracture. Methods We searched the specialized trials register of The Cochrane Collaboration’s Bone, Joint and Muscule Trauma Group, The Cochrane Library (CENTRAL), MEDLINE (1966 to March 2006), EMBASE (1980 to March 2006) and PUBMED (1966 to March 2006). We also handsearched some Chinese orthopedic journals. Randomized controlled trials (RCTs) and quasi-randomized trials (quasi-RCTs) comparing external fixation versus intramedullary nailing for tibial shaft fractures in adults were included. The quality of these trials was critically assessed. We used the Cochrane Collaboration’s RevMan 4.2.8 for data analyses. Result Three RCTs and two quasi-RCTs involving a total of 279 patients were included. The results of meta-analyses showed that external fixation for tibial shaft fractures in adults may increase the infection rate [RR 2.45, 95%CI (1.31,4.61), P=0.005], and the malunion rate [RR 2.85, 95%CI (1.20,6.79), P=0.02] but may reduce the duration of hospitalization [RR –5.50, 95%CI (–6.99,–4.01)]. The nonunion rate, delayed healing rate, and healing time, were comparable between external fixation and intramedulllary nailing. Conclusion The trials available for this systematic review are too few and small for reliable estimates of the relative effects of external fixation and intramedulllary nailing. Further studies are needed to determine these effects , especially for patients who have GustiloШ C fractures.
Objective To conduct a meta-analysis of the evidence on the efficacy and safety of hyperbaric oxygen therapy for vascular cognitive impairment. Methods China National Knowledge Infrastructure, Chongqing VIP, Wanfang, SinoMed, PubMed, Embase, CINHAL, Cochrance Library were searched for all literatures on randomized controlled trials of hyperbaric oxygen therapy for vascular cognitive impairment from the establishment of databases to May 2022. Literature screening was performed by Endnote X9 software, and meta-analysis was performed by RevMan 5.4.1 software. Results A total of 36 papers were included, with 3093 patients, including 1549 cases in the observation group (hyperbaric oxygen combined with drug treatment) and 1544 cases in the control group (drug treatment alone). Compared with the control group, the effective rate of the observation group [relative risk=1.23, 95% confidence interval (CI) (1.15, 1.30), P<0.00001], the scores of Mini Mental Status Examination [mean difference (MD)=3.19, 95%CI (2.66, 3.73), P<0.00001], and the scores of Montreal Cognitive Assessment [MD=2.98, 95%CI (2.07, 3.89), P<0.00001] were better than those of the control group. There was no significant difference in adverse reactions between the observation group and the control group (P>0.05). For the scores of Activities of Daily Living, subgroup analysis showed high heterogeneity among studies, so pooled analysis was not performed. Conclusion Compared with drug therapy alone, hyperbaric oxygen combined with drug therapy can improve the cognitive function of patients with vascular cognitive impairment to a certain extent without increasing adverse reactions.
Objective To assess the efficacy and safety of tacalcitol and calcitriol on vitiligo. Methods?We searched the MEDLINE (1966 to June 2008), Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 4, 2008), OVID (1978 to June 2008), EMbase (1980 to June 2008), CBM (1978 to June 2008), CNKI (1979 to June 2008) to collect randomized controlled trials (RCTs). We also hand searched relevant journals and conference proceedings. The language was confined to English and Chinese. We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed meta-analyses by using the Cochrane Collaboration’s RevMan 4.2 software. Results?Ffiteen trials involving 120 patients in 5 self-control trials and 793 patients in other 10 randomized controlled trials were included and assessed. The time of repigmentation onset of good responders and normal responders in the side treated with a combination of topical talcitol and NB-UVB was shorter than that in the control group [WMD= –?75, 95%CI (–?93.93, –?56.07); WMD= –?48, 95%CI (–?76.36, –?19.64)]. The mean number and cumulative dose of excimer light exposures for initial repigmentation in the side treated with tacalcitol and 308-nm monochromatic excimer light were less than those in the control group [WMD= –?0.78, 95%CI (–?1.02, –?0.54; WMD= –?1.06, 95%CI (–?1.36, –?0.76)]. The mean number of UVA exposures for initial repigmentation and complete repigmentation in the side treated with calcipotriol and PUVA were less than those in the control group [WMD= –?2.67, 95%CI (–?3.06, –?2.28); WMD= –?2.67, 95%CI (–?3.42, –?1.92)], and the cumulative UVA dose for iniitial and complete repigmentation in the combination group were also lower than those in the control group [WMD= –?25.68, 95%CI (–?29.44, –?21.92); WMD= –?27.14, 95%CI (–?34.80, –?19.48)]. The mean time of initial pigmentation was much shorter in the group treated with calcipotriol and corticosteroid was shorter than that in the control group [WMD= –?3.87, 95%CI (–?5.45, –?2.29)]. Conclusion?The limited evidence indicated that combination of topical tacalcitol with NB-UVB or monochromatic excimer light, or the combination of topical calcipotriol with PUVA or corticosteroid shortened the time of repigmentation and decreased the cumulative irradiation dose. The side effects were limited. No obvious effect was seen on re-pigmentation degree.
Objective To investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.
Objective To assess the efficacy of naloxone for cardio-pulmonary-cerebral resuscitation (CPCR). Methods Randomized controlled trials (RCTs) involving naloxone for CPCR were identified from MEDLINE (1966 – Jun.2006), EMbase (1974 - Jun.2006), PubMed, The Cochrane Library (Issue2,2006), CBM(1978 - Jun.2006) and CNKI (1994 - Jun.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 Ten RCTs were included. The quality of included RCTs was low. All the patients were in-patients or out-patients receiving CPCR due to cardial arrest at the age of 18-75 years. Meta-analysis indicated that the resuscitation rate in naloxone group was significantly higher than the placebo group (Plt;0.00001). And the recovery of the brain function in naloxone group was better than in the placebo group(Plt;0.00001) Conclusions Naloxone is effective for CPCR and it may ameliorate its prognosis. Because of the low quality of included trials and the small sample size, more RCTs are required to assess the efficacy of naloxone for CPCR.
Objective To evaluate the current situation of randomized controlled trials/ clinical controlled trials (RCT/CCT) on chronic gastritis and whether it could offer reliable evidence for clinical practice in China. Method RCT/CCT on chronic gastritis from eight Chinese clinical journals were searched manually and assessed according to international standard. Results 823 issues containing 213 therapeutic articles were searched and 81 RCT/CCT were identified and assessed. Conclusions The quantity and quality of RCT/CCT on Chronic gastritis in China could not meet the need of clinical practice. RCT/CCT of western medical therapy are much better than those of traditional Chinese therapy and integrated traditional Chinese and western medical therapy ones.
Objective To establish a Chinese clinical controlled trials database of neurology. Methods We identified relevant studies by electronic searching of CBMdisc from 1978 to April 2002, and the Library of Evidence-Based Medicine (Chinese). We also searched manually 11 journals and 4 conference proceedings relevant to neurological diseases. The studies included in this database should be controlled studies relevant to treatment on neurological disease, randomized or only controlled without randomization. Results 3 641 studies were included in this database. Conclusions The Chinese neurological trials database was established. This database will provide Chinese evidence on treatments of various neurological diseases. Studies in this database will also be included in the Cochrane Library to facilitate systematic reviewers.
