OBJECTIVES: To assess the effects of mormodica charantia for type 2 diabetes mellitus.
SEARCH METHODS: Several electronic databases were searched, among these were The Cochrane Library (Issue 1, 2012), MEDLINE, EMBASE, CINAHL, SIGLE and LILACS (all up to February 2012), combined with handsearches. No language restriction was used.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared momordica charantia with placebo or a control intervention, with or without pharmacological or non-pharmacological interventions.
DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. Risk of bias of the trials was evaluated using the parameters of randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias. A meta-analysis was not performed given the quality of data and the variability of preparations of momordica charantia used in the interventions (no similar preparation was tested twice).
MAIN RESULTS: Four randomised controlled trials with up to three months duration and investigating 479 participants met the inclusion criteria. Risk of bias of these trials (only two studies were published as a full peer-reviewed publication) was generally high. Two RCTs compared the effects of preparations from different parts of the momordica charantia plant with placebo on glycaemic control in type 2 diabetes mellitus. There was no statistically significant difference in the glycaemic control with momordica charantia preparations compared to placebo. When momordica charantia was compared to metformin or glibenclamide, there was also no significant change in reliable parameters of glycaemic control. No serious adverse effects were reported in any trial. No trial investigated death from any cause, morbidity, health-related quality of life or costs.
AUTHORS' CONCLUSIONS: There is insufficient evidence on the effects of momordica charantia for type 2 diabetes mellitus. Further studies are therefore required to address the issues of standardization and the quality control of preparations. For medical nutritional therapy, further observational trials evaluating the effects of momordica charantia are needed before RCTs are established to guide any recommendations in clinical practice.
METHOD: The Cochrane Central Register of Controlled Trials (1996 to Feb 2019) and MEDLINE (1966 to Feb 2019) were searched, including the related randomised control trials and reviewed articles to find unpublished trials or trials not obtained via electronic searches. Inclusion criteria for the studies included comparing recovery time, recording clinician satisfaction, and assessing the adverse effects of ketofol.
RESULTS: Eleven trials consisting of a total of 1274 patients met our criteria and were included in this meta-analysis. Five trials compared ketofol with a single agent, while six trials compared ketofol with combined agents. While comparing between ketofol and a single agent (either ketamine or propofol), ketofol showed significant effect on recovery time (MD: -9.88, 95% CI: - 14.30 to - 5.46; P = 0.0003; I2 = 92%). However, no significant difference was observed while comparing ketofol with combined agents (RR: 0.75, 95% CI: - 6.24 to 7.74; P < 0.001; I2 = 98%). During single-agent comparison, ketofol showed no significant differences in terms of clinician satisfaction (RR: 2.86, 95% CI: 0.64 to 12.69; P = 0.001; I2 = 90%), airway obstruction (RR: 0.72, 95% CI: 0.35 to 11.48; P = 0.81; I2 = 0%), apnoea (RR: 0.9, 95% CI: 0.33 to 2.44; P = 0.88; I2 = 0%), desaturation (RR: 1.11, 95% CI: 0.64 to 1.94; P = 0.28; I2 = 21%), nausea (RR: 0.52, 95% CI: 0.91 to 1.41; P = 0.2; I2 = 38%), and vomiting (RR: 0.63, 95% CI: 0.25 to 1.61; P = 0.18; I2 = 42%). During comparison with combined agents, ketofol was more effective in reducing hypotension (RR: 4.2, 95% CI: 0.2 to 0.85; P = 0.76; I2 = 0%), but no differences were observed in terms of bradycardia (RR: 0.70, 95% CI: 0.14 to 03.63; P = 0.09; I2 = 53%), desaturation (RR: 1.9, 95% CI: 0.15 to 23.6; P = 0.11; I2 = 61%), and respiratory depression (RR: 1.98, 95% CI: 0.18 to 21.94; P = 0.12; I2 = 59%).
CONCLUSION: There is low certainty of evidence that ketofol improves recovery time and moderate certainty of evidence that it reduces the frequency of hypotension. There was no significant difference in terms of other adverse effects when compared to other either single or combined agents.
TRIAL REGISTRATION: PROSPERO CRD42019127278 .
METHODS: This is a prospective randomized study for evaluation of 84 etonogestrel implant (Implanon) users with prolonged or frequent bleeding. They were assigned to either receiving a COCP containing 20 mcg ethinyl estradiol/150 mg desogestrel for two continuous cycle or NSAID; mefenamic acid 500 mg TDS for 5 days, 21 days apart for two cycles. Bleeding pattern during the treatment was recorded and analyzed.
RESULTS: A total of 32 women (76.2%) in COCP group and 15 women (35.7%) in NSAID group stop bleeding within 7 days after the initiation of treatment which was statistically significant (P
OBJECTIVES: To compare the effectiveness of anticoagulant therapies for the treatment of deep vein thrombosis in pregnancy. The anticoagulant drugs included are UFH, low molecular weight heparin (LMWH) and warfarin.
SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2010) and reference lists of retrieved studies.
SELECTION CRITERIA: Randomised controlled trials comparing any combination of warfarin, UFH, LMWH and placebo in pregnant women.
DATA COLLECTION AND ANALYSIS: We used methods described in the Cochrane Handbooks for Systemic Reviews of Interventions for assessing the eligibility of studies identified by the search strategy. A minimum of two review authors independently assessed each study.
MAIN RESULTS: We did not identify any eligible studies for inclusion in the review.We identified three potential studies; after assessing eligibility, we excluded all three as they did not meet the prespecified inclusion criteria. One study compared LMWH and UFH in pregnant women with previous thromboembolic events and, for most of these women, anticoagulants were used as thromboprophylaxis. There were only three women who had a thromboembolic event during the current pregnancy and it was unclear whether the anticoagulant was used as therapy or prophylaxis. We excluded one study because it included only women undergoing caesarean birth. The third study was not a randomised trial.
AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials on the effectiveness of anticoagulation for deep vein thrombosis in pregnancy. Further studies are required.
METHODS: Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16.
RESULTS: In total, 2383 women from 17 mainly European countries were enrolled in the study: 2122 with T1D and 261 with T2D; mean age was 31 and 33 years, and duration of diabetes was 15 and 6 years, respectively. For women with T1D or T2D, 63% and 75%, respectively, received basal and rapid-acting insulin, 36% and 3% rapid-acting insulin only, 0.7% and 14.0% basal insulin only, 0.2% and 5.4% premix insulin, 0.0% and 1.2% injectable glucagon-like peptide-1 receptor agonist treatment without insulin. In women with T1D or T2D, respectively, during early pregnancy, 59% and 62% had HbA1c <7.0% (53 mmol/mol); 16% and 36% reported not taking folic acid before or during early pregnancy. Overall, >40% of women had ≥1 chronic concomitant condition (predominantly thyroid disease or hypertension). Retinopathy was the most commonly reported diabetic complication. The most commonly reported previous pregnancy complication was miscarriage.
CONCLUSIONS: Baseline data from this large multinational population of women with pre-existing diabetes indicate that sub-optimal glycemic control, poor pregnancy planning, and chronic concomitant conditions were common in early pregnancy.
METHODS: We selected randomized controlled trials, assessing efficacy of antibiotics for the treatment of leptospirosis as a case study. A pairwise meta-analysis was conducted using a random effect model, assuming that different studies assessed different but related treatment effects. The analysis was then extended to a network meta-analysis, which consists of direct and indirect evidence in a network of antibiotics trials, using a suite of multivariate meta-analysis routines of STATA (mvmeta command). We also assessed an assumption of 'consistency' that estimates of treatment effects from direct and indirect evidence are in agreement.
RESULTS: Seven randomised controlled trials were identified for this analysis. These RCTs assessed the efficacy of antibiotics such as penicillin, doxycycline and cephalosporin for the treatment of human leptospirosis. These studies made comparisons between antibiotics (i.e. an antibiotic versus alternative antibiotic) in the primary study and a placebo, except for cephalosporin. These studies were sufficient to allow the creation of a network for the network meta-analysis; a closed loop in which three comparator antibiotics were connected to each other through a polygon. The comparison of penicillin versus the placebo has the largest contribution to the entire network (31.8%). The assessment of rank probabilities indicated that penicillin presented the greatest likelihood of improving efficacy among the evaluated antibiotics for treating leptospirosis.
CONCLUSIONS: Findings suggest that network meta-analysis, a meta-analysis comparing multiple treatments, is feasible and should be considered as better precision of effect estimates for decisions when several antibiotic options are available for the treatment of leptospirosis.
METHODS: A retrospective cohort study of 200 patients on dabigatran and warfarin from January 2009 till September 2016 was carried out. Data were collected for 100 patients on dabigatran and 100 patients on warfarin.
RESULTS: The mean follow-up period was 340.7±322.3 days for dabigatran group and 410.5±321.2 days for warfarin group. The mean time in therapeutic range (TTR) was 52±18.7%. The mean CHA2DS2 -VASc score for dabigatran group was 4.4±1.1 while 5.0±1.5 for warfarin group. None in dabigatran group experienced ischemic stroke compared to one patient in warfarin group (p=0.316). There was one patient in dabigatran group suffered from ICH compared to none in warfarin group (p=0.316). Four patients in warfarin group experienced minor bleeding, while none from dabigatran group (p=0.043).
CONCLUSION: Overall bleeding events were significantly lower in dabigatran group compared to warfarin group. In the presence of suboptimal TTR rates and inconveniences with warfarin therapy, non-vitamin-K antagonist oral anticoagulants (NOAC) are the preferred agents for stroke prevention in elderly Asian patients for nonvalvular AF.
MATERIALS AND METHODS: A double-blind, parallel, randomized control trial was conducted with 219 university students who were divided into three trial groups using block randomization: CPC, CHX and placebo groups. Clinical oral examinations to assess dental plaque accumulation (modified Quigley-Hein Plaque Index), gingival health (Löe and Silness Gingival Index) and tooth staining (modified Lobene Stain Index) were performed at baseline and at 6 weeks.
RESULTS: Plaque and gingivitis scores were not significantly different among participants at baseline. After 6 weeks, plaque and gingivitis scores between the CPC and placebo groups and between the CHX and placebo groups were found to be significantly different. However, there was no significant difference between the CPC and CHX groups. The staining scores of participants in the CPC group were lower than those in the CHX group, but the difference was not significant. Taste alteration and numbness were more common among participants in the CHX group than in the CPC group. No significant difference in the perception of a burning sensation was observed.
CONCLUSIONS: The 0.05% CPC mouthwash was as efficient as 0.12% CHX mouthwash in reducing dental plaque accumulation and gingival inflammation with fewer side effects, supporting its use as an adjunct to toothbrushing.
MATERIALS AND METHODS: A retrospective review of case notes on adult psoriasis patients treated with biologics in Hospital Sultanah Aminah Johor Bahru Malaysia, between January 2006 and December 2020. Drug survival was analysed using the Kaplan-Meier method.
RESULTS: By December 2020, 100 patients with 154 treatment courses of biologics were included in the study. Male to female ratio was 1:1. The mean age at onset was 31.36 ± 11.72 years. Ustekinumab was the most frequently prescribed biologics (39%), followed by adalimumab (29.2%), secukinumab (14.9%), etanercept (13%), and infliximab (3.2%). Overall median drug survival for biologics was 25 months (interquartile range [IQR]= 12.0-.0). The median drug survival for ustekinumab was 35 months (IQR, 12-93); followed by 25 months (IQR, 12.0-), 18 months (IQR, 7-85), 17 months (IQR, 11-43), and 8 months (IQR, 1-10) for secukinumab, adalimumab, etanercept, and infliximab, respectively. The main reason for drug discontinuation was loss of efficacy (26%), inadequate funding (14.3%), loss to follow-up (10.4%), adverse events (4.5%), and patients' request (1.3%).
CONCLUSION: Our study shows ustekinumab has the best long-term drug survival among biologics in Malaysian patients with psoriasis in real-life setting. Further study is required to evaluate the long-term drug survival for newer biologics.
METHODOLOGY: This study was designed as a parallel, double blind, randomized controlled trial where symptomatic mature permanent teeth with carious pulp exposure meeting the inclusion criteria were randomly treated with full pulpotomy using one of 3 calcium silicate-based materials (ProRoot MTA, Biodentine and TotalFill). Full pulpotomy was performed, and haemostasis was achieved via a cotton pellet moistened with 2.5% NaOCl. A 3-mm layer of the calcium silicate-based material was randomly placed as the pulpotomy agent through a block randomization process followed by a resin-based composite restoration. Postoperative periapical radiograph was taken. Clinical and radiographic evaluation were completed after 6 months and 1 year. The patient and evaluator were blinded to the type of materials used. Pain levels were scored preoperatively and 7 days after treatment. Effect of potential prognosis factors including gender, age, diagnosis, bleeding time and type of caries were also analysed.
RESULTS: One hundred and sixty-four teeth in 146 patients received full pulpotomy and were randomly assigned to either the tested or control material through block randomization technique (50 MTA, 50 Biodentine and 64 TotalFill). The age ranged from 10 to 70 years. The diagnosis was irreversible pulpitis in 112 teeth (72%) and reversible pulpitis in 28 teeth (28%). The majority of patients presented with severe pain, during the first week 96.9% reported complete relief of pain or mild pain. Four cases had immediate failure. At 6 months the overall success rate was 92.2%, over 1 year 156/164 teeth attended follow-up with 12 failures (2 restorative failures and 10 endodontic failures), the overall success of pulpotomy at 1 year was 92.3% (144/156); 91.8% in MTA, 93.3% in Biodentine and 91.9% in TotalFill with no significant difference amongst the groups and no side effects observed. No significant association was evident between outcome and the investigated variables.
CONCLUSIONS: The 1-year success rate of full pulpotomy did not differ significantly between Biodentine pulpotomy, TotalFill pulpotomy, and MTA pulpotomy. The study was registered with clinical trials; registration number (NCT04345263).
MATERIALS AND METHODS: Four online databases (PubMed, ScienceDirect, Scopus, and Web of Science) were searched using different MeSH terms and Boolean Operators to retrieve the articles (until June 2021), followed by a hand-search of the reference list of the included articles. All full-text, original studies in English that evaluated SDF staining and at least one SDF modification/alternative were included.
RESULTS: Among the assessed studies, nine studies explored the stain-minimization effect of potassium iodide (KI) post-application following SDF treatment. Among these, eight concluded that KI application after SDF treatment significantly reduced tooth staining, while one showed marginal staining following glass ionomer restoration of the SDF-treated dentine. Additionally, one study applied potassium fluoride (KF) and silver nitrate (AgNO3 ) concurrently to mitigate SDF-mediated staining. One study compared SDF staining with polyethylene glycol (PEG)-coated nanoparticles containing sodium fluoride (NaF), and another used nanosilver fluoride (NSF) for staining comparison with SDF.
CONCLUSIONS: Within the limitations of this study, the addition of different materials to SDF has proven to be a beneficial strategy for overcoming tooth staining associated with SDF. Future studies are warranted, particularly clinical trials, to validate these findings.
CLINICAL SIGNIFICANCE: SDF-mediated tooth staining is a serious concern that limits its clinical use. A review of various strategies to overcome this problem will help clinicians enhance its clinical use and patient acceptance.