Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis

Background Elagolix is effective and safe for treating menorrhagia in women with uterine fibroid. However, it is reported to be associated with hypoestrogenism that can be alleviated by adding estradiol/norethindrone acetate. This systematic review and meta-analysis aimed to determine the effectiveness of elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid by comparing: elagolix versus placebo and elagolix versus estradiol/norethindrone acetate. Methodology The Cochrane Central Register of Controlled Trials (CENTRAL 2021, Issue 3 of 12), MEDLINE databases (1980 to December week 1, 2020), and trial registries for relevant randomized clinical trials were used. All randomized clinical trials were reviewed and evaluated. Random effects models were used to estimate the dichotomous outcomes and mean differences with 95% confidence intervals. Data for risk of bias, heterogeneity, sensitivity, reporting bias and quality of evidence were assessed. Results Four randomized controlled trials with 1949 premenopausal women from 323 locations were included. Elagolix improved menstrual blood loss of less than 80 ml (RR 4.81, 95% CI 2.45 to 9.45; four trials, 869 participants; moderate quality evidence) or more than 50% reduction from baseline (RR 4.87, 95% CI 2.55 to 9.31; four trials, 869 participants; moderate quality evidence) compared to placebo. There was no difference in menstrual blood loss of less than 80 ml (RR 1.08, 95% CI 1.00 to 1.16; five trials, 1365 participants; moderate quality evidence) or more than 50% reduction from baseline between the elagolix (RR 1.08, 95% CI 1.01 to 1.15; five trials, 1365 participants; high quality evidence) and elagolix with estradiol/norethindrone acetate. In both comparisons, elagolix has reduced the mean percentage change in uterine and fibroid volume, improved symptoms, and health-related quality of life. More patients had hot flush, and bone mineral density loss in the elagolix treatment compared to both placebo and elagolix with estradiol/norethindrone acetate. Conclusions Elagolix appeared to be effective in reducing heavy menstrual bleeding caused by uterine fibroid and combination with estradiol/norethindrone acetate was able to alleviate the hypoestrogenism side effects in premenopausal women. Review registration PROSPERO CDR 42021233898.

Efficacy and Safety of Acupuncture Combined with Herbal Medicine in Treating Gouty Arthritis: Meta-Analysis of Randomized Controlled Trials

Background. Gouty arthritis is a common metabolic disease caused by long-term purine metabolism and elevated serum uric acid. In recent years, the incidence of gouty arthritis has been increasing year by year. As an effective method for treating gouty arthritis, acupuncture combined with herbal medicine has been widely used in clinical practice. However, the evidence for the treatment needs to be evaluated through systematic review and meta-analysis. Methods. The Cochrane Library, PubMed, Web of Science, EMBASE, China CBM database, Clinical Trials, CNKI, China Wanfang database, and VIP information database were searched from the establishment of each database to March 2021. Randomized controlled trials (RCTs) were included in the study, and the therapeutic effects of acupuncture combined with herbal medicine versus conventional therapy, or acupuncture combined with herbal medicine versus anti-inflammatory drugs, or acupuncture combined with herbal medicine versus acupuncture/herbal medicine alone were compared in the subjects with gouty arthritis. Two authors screened all references, assessed the risk of bias, and independently extracted the data. The binary outcome was summarized using 95% confidence intervals (CIs) and risk ratios (RRs). The overall quality of the evidence was assessed with hierarchy, and meta-analysis was performed with a random-effects model. Results. A total of 14 randomized controlled trials (1,065 participants, 540 treatment groups, and 525 control groups) with treatment courses of 5 to 21 days were included. Acupuncture combined with herbal medicine and acupuncture was compared in three trials, acupuncture combined with herbal medicine and conventional therapy was compared in 14 of them, and acupuncture combined with herbal medicine and anti-inflammatory drugs was compared in 8 of them. The clinical efficacy (clinical symptoms, serological tests, and visual analogue scale (VAS) results) was significantly improved in the acupuncture combined with herbal medicine treatment group ( P = 0.0005 , 95% CI 0.03 to 0.13; 687 participants; 8 trials), and the efficacy in reducing uric acid was also better ( P < 0.00001 ; 95% CI −102.89, −68.37; 100 participants; 2 trials; evidence with moderate quality). The effect of acupuncture combined with herbal medicine was better than that of acupuncture alone (RR 1.22, 95%CI 1.06 to 1.41; 139 participants; 3 trials), the effect of acupuncture combined with herbal medicine was better than that of herbal medicine alone (RR 1.31 95%CI 1.08 to 1.57, 100 participants, 2 trials, evidence with moderate quality), and the effect of acupuncture combined with herbal medicine was better than that of colchicine (P = 0.02, RR 1.14 95%CI 1.02 to 1.27, 2 trials, evidence with moderate quality). The incidence of adverse events was considerably different between the two groups, and the acupuncture combined with herbal medicine group was significantly superior to the control group in terms of adverse events ( P < 0.00001 ; 95% CI (0.08 to 0.32)). Conclusions. The efficacy of acupuncture combined with herbal medicine was better than conventional drug therapy in treating gouty arthritis. The study results must be interpreted with caution due to the high or unclear risk of bias of the trials included in the study. PROSPERO registration number: CRD42020202544. INPLASY registration number: 202090006.

Spinal manipulative therapy and acupuncture for chronic low back pain: a systematic review and meta-analysis of RCTs

Background Spinal manipulation therapy (SMT) and acupuncture are commonly used for low back pain (LBP) among complementary and alternative therapies. However, it remains unclear which of the two therapies is more effective for LBP. Therefore, the purpose of this meta-analysis was to evaluate the effectiveness of SMT and acupuncture on LBP. Methods Four electronic databases were searched for randomized controlled trials (all years until July 2021), including PubMed, Embase, Web of Science, and Cochrane Library. Two reviewers independently abstracted data, assessed risk of bias, and rated the quality of evidence. The primary outcome was pain; secondary outcomes included functional status and adverse events. Review Manager 5.3 software and Stata 12.0 were used for all statistical analyses. Results 9 RCTs with a total of 714 participants were identified, who were on average middle aged (39-60 years) without signs of radiating pain. These trials included patients with mild to moderate pain. Overall, moderate quality of evidence suggested that SMT had better effects for pain relief (MD: 0.32, 95%CI: 0.09 to 0.55, I2=34%) and similar effects in function (MD: 0.24, 95%CI: -0.45 to 0.94, I2=21%) when compared to acupuncture. Moderate quality of evidence showed SMT reduced pain better than acupuncture at month 2 (MD: 0.61, 95%CI: 0.08 to 1.14, I2=0%) and at month 12 (MD: 1.02, 95%CI: 0.28 to 1.75, I2=42%). In addition, Low quality of evidence showed SMT may provide better improvement in pain at month 3 (MD: 0.74, 95%CI: 0.09 to 1.39, I2=42%) and in function at month 4 (MD: 3.50, 95%CI: 0.71 to 6.29). Adverse events associated with SMT and acupuncture were rare and mild. Conclusions SMT showed better effects than acupuncture for chronic low back pain, while SMT and acupuncture had similar effects in functional improvement. Although SMT and acupuncture were tolerable and safe, patients should be informed about the potential risks of adverse events before starting therapy.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

Main Recommendations 1 ESGE recommends the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) over percutaneous transhepatic biliary drainage (PTBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) in malignant distal biliary obstruction when local expertise is available.Strong recommendation, moderate quality evidence. 2 ESGE suggests EUS-BD with hepaticogastrostomy only for malignant inoperable hilar biliary obstruction with a dilated left hepatic duct when inadequately drained by ERCP and/or PTBD in high volume expert centers.Weak recommendation, moderate quality evidence. 3 ESGE recommends that EUS-guided pancreatic duct (PD) drainage should only be considered in symptomatic patients with an obstructed PD when retrograde endoscopic intervention fails or is not possible.Strong recommendation, low quality evidence. 4 ESGE recommends rendezvous EUS techniques over transmural PD drainage in patients with favorable anatomy owing to its lower rate of adverse events.Strong recommendation, low quality evidence. 5 ESGE recommends that, in patients at high surgical risk, EUS-guided gallbladder drainage (GBD) should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions in EUS-GBD.Strong recommendation, high quality of evidence. 6 ESGE recommends EUS-guided gastroenterostomy (EUS-GE), in an expert setting, for malignant gastric outlet obstruction, as an alternative to enteral stenting or surgery.Strong recommendation, low quality evidence. 7 ESGE recommends that EUS-GE may be considered in the management of afferent loop syndrome, especially in the setting of malignancy or in poor surgical candidates. Strong recommendation, low quality evidence. 8 ESGE suggests that endoscopic ultrasound-directed transgastric ERCP (EDGE) can be offered, in expert centers, to patients with a Roux-en-Y gastric bypass following multidisciplinary decision-making, with the aim of overcoming the invasiveness of laparoscopy-assisted ERCP and the limitations of enteroscopy-assisted ERCP.Weak recommendation, low quality evidence.

Thermal Protection of Newborns: The World Health Organization Guidelines Need to Include Clear and Feasible Options for Low-Resource Settings

Backgorund: Hypothermia in babies may increase mortality, directly or indirectly, by potentiating the effect of the other morbidities. Guidelines published by The World health organization (WHO) on newborn health (2015) may be inadequate to address the issue in a low-resource setting. To be relevant in such a context, they should be user-friendly for the trainers of health workers (HW) who may be responsible for interpreting the recommendations and training the HW. Text: According to earlier guidelines (2013), ‘No randomized or quasi-randomized trial that evaluated the impact of keeping infants warm after discharge (hospital births) or after 24 hours (home births) was identified’. However, kangaroo mother care (KMC), a strong recommendation with moderate-quality evidence, and thermal protection are inseparable, as the most crucial component of KMC is skin-to-skin contact, which keeps a baby warm. A HW may be surprised when the guidelines or the basis change and, the move comes at a time when the earlier guidelines (1993) are just finding roots in patient care practices. Current guidelines are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, where randomized trials assume more importance. The guidelines recommend the following methods to keep infants warm after birth: KMC (strong recommendation, moderate-quality evidence), intermittent KMC (strong recommendation, moderate-quality evidence), and radiant warmers or incubators (strong recommendation, very low-quality evidence). The divergence between the evidence and the recommendations may be difficult for the HW to comprehend. Conclusions: The guidelines for postnatal care need to be revisited and revised so that clear and feasible options for keeping infants warm in low-resource settings are offered. Besides KMC, warm rooms, heated mattresses, plastic wraps and Styrofoam boxes may be suggested. What is already known about this subject? • In the absence of a randomized or quasi-randomized trial that evaluated the impact of keeping infants warm, there are fewer options in a low-resource setting. • They include Kangaroo mother care and incubators/radiant warmers. What does this study add? • Options that may not have been supported by randomized trials but have consistent results may be suggested. • They include warm rooms, heated mattresses, plastic wraps and Styrofoam boxes. • In future revisions, the level of evidence should be paired with the recommendations. How might this impact on clinical practice or future developments? The health worker may choose the most feasible option at home or at a facility.

Management and follow-up of gallbladder polyps: updated joint guidelines between the ESGAR, EAES, EFISDS and ESGE

Main recommendations Primary investigation of polypoid lesions of the gallbladder should be with abdominal ultrasound. Routine use of other imaging modalities is not recommended presently, but further research is needed. In centres with appropriate expertise and resources, alternative imaging modalities (such as contrast-enhanced and endoscopic ultrasound) may be useful to aid decision-making in difficult cases. Strong recommendation, low–moderate quality evidence. Cholecystectomy is recommended in patients with polypoid lesions of the gallbladder measuring 10 mm or more, providing the patient is fit for, and accepts, surgery. Multidisciplinary discussion may be employed to assess perceived individual risk of malignancy. Strong recommendation, low-quality evidence. Cholecystectomy is suggested for patients with a polypoid lesion and symptoms potentially attributable to the gallbladder if no alternative cause for the patient’s symptoms is demonstrated and the patient is fit for, and accepts, surgery. The patient should be counselled regarding the benefit of cholecystectomy versus the risk of persistent symptoms. Strong recommendation, low-quality evidence. If the patient has a 6–9 mm polypoid lesion of the gallbladder and one or more risk factors for malignancy, cholecystectomy is recommended if the patient is fit for, and accepts, surgery. These risk factors are as follows: age more than 60 years, history of primary sclerosing cholangitis (PSC), Asian ethnicity, sessile polypoid lesion (including focal gallbladder wall thickening > 4 mm). Strong recommendation, low–moderate quality evidence. If the patient has either no risk factors for malignancy and a gallbladder polypoid lesion of 6–9 mm, or risk factors for malignancy and a gallbladder polypoid lesion 5 mm or less, follow-up ultrasound of the gallbladder is recommended at 6 months, 1 year and 2 years. Follow-up should be discontinued after 2 years in the absence of growth. Moderate strength recommendation, moderate-quality evidence. If the patient has no risk factors for malignancy, and a gallbladder polypoid lesion of 5 mm or less, follow-up is not required. Strong recommendation, moderate-quality evidence. If during follow-up the gallbladder polypoid lesion grows to 10 mm, then cholecystectomy is advised. If the polypoid lesion grows by 2 mm or more within the 2-year follow-up period, then the current size of the polypoid lesion should be considered along with patient risk factors. Multidisciplinary discussion may be employed to decide whether continuation of monitoring, or cholecystectomy, is necessary. Moderate strength recommendation, moderate-quality evidence. If during follow-up the gallbladder polypoid lesion disappears, then monitoring can be discontinued. Strong recommendation, moderate-quality evidence. Source and scope These guidelines are an update of the 2017 recommendations developed between the European Society of Gastrointestinal and Abdominal Radiology (ESGAR), European Association for Endoscopic Surgery and other Interventional Techniques (EAES), International Society of Digestive Surgery–European Federation (EFISDS) and European Society of Gastrointestinal Endoscopy (ESGE). A targeted literature search was performed to discover recent evidence concerning the management and follow-up of gallbladder polyps. The changes within these updated guidelines were formulated after consideration of the latest evidence by a group of international experts. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Key Point • These recommendations update the 2017 European guidelines regarding the management and follow-up of gallbladder polyps.

Vocational interventions to help adults with long-term health conditions or disabilities gain and maintain paid work: an overview of systematic reviews

ObjectiveTo conduct an overview of systematic reviews to examine the effectiveness of vocational interventions to help adults with long-term health conditions or disability gain and maintain new paid work and to analyse the spread and quality of evidence in this area.MethodsWe pre-published our protocol in PROSPERO (CRD42019132448). We searched Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, Proquest Dissertations and Theses database, NICE and Business Source Complete from inception to 21 August 2020. We included any systematic reviews of clinical trials on vocational interventions for adults with long-term health conditions or disability who were not in work or had recently gained work. We excluded reviews of vocational interventions for employed people on sick leave. Two researchers identified, critically appraised,using A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2, and extracted data from included reviews. We used Grading of Recommendations Assessment, Development and Evaluation to evaluate strength of evidence underpinning overview findings.ResultsWe identified 26 reviews (5 high-quality and 21 critically low to moderate quality) that focused on vocational interventions for acquired brain injury, autism, intellectual disability, multiple sclerosis, mental health conditions, spinal cord injury and general disability populations. We identified moderate quality evidence that people with moderate to severe mental health conditions who participate in supported employment, particularly individual placement and support, are more likely to gain competitive employment compared with people who receive traditional vocational services (risk ratio 2.07; 95% CI 1.82 to 2.35; 27 studies, 6651 participants). We found only very low-quality to low-quality evidence on vocational intervention for people with any other health condition. We found little to no data on employer or employee satisfaction with work outcomes or the cost effectiveness of interventions.ConclusionGiven the importance placed on work opportunities for people with long-term health conditions or disability, there is urgent need for more high-quality research on vocational interventions for this population.Prospero registration numberCRD42019132448.

Airway Complications in Intubated Versus Laryngeal Mask Airway–Managed Dentistry: A Meta-Analysis

Objective: Serious airway complications can occur with inadequate airway management during general anesthesia (GA). This meta-analysis investigated randomized controlled trials that compared perioperative technique failures and airway complications, including hypoxia, during GA for dentistry using endotracheal intubation or a laryngeal mask airway (LMA) for airway management. Methods: A systematic search of electronic databases and gray literature was completed. Independent reviewers assessed eligibility, performed data extraction, completed risk of bias assessment, and judged the quality of results through Grading of Recommendations, Assessment, Development, and Evaluation. Risk ratios (RRs) for airway complications, with 95% CIs, were calculated. Heterogeneity was quantified using the I2 statistic. Sensitivity and age-subgroup analyses were explored. Results: Six trials were deemed eligible from a total of 9076 identified reports. The airway management intervention for these trials was LMA. Technique failures or effect differences in airway complications were not detected except for postoperative hypoxia, where LMA use had a decreased risk (RR, 0.22; 95% CI, 0.06-0.77; I2 = 0%; moderate quality). A similar effect was seen in the pediatric analysis (RR, 0.10; 95% CI, 0.01-0.84; I2 = 0%; moderate quality). Additionally, LMA use reduced pediatric sore throat risk (RR, 0.08; 95% CI, 0.04-0.15; I2 = 0%; moderate quality). Conclusion: Use of an LMA in dentistry may have the potential to reduce the risk of postoperative hypoxia, particularly in pediatric patients, although further study is required.

Pregnancy-related complications and perinatal outcomes following progesterone supplementation before 20 weeks of pregnancy in spontaneously achieved singleton pregnancies: a systematic review and meta-analysis

Background Progesterone supplementation is widely performed in women with threatened miscarriage or a history of recurrent miscarriage; however, the effects of early progesterone supplementation on pregnancy-related complications and perinatal outcomes in later gestational weeks remain unknown. Methods Ovid MEDLINE, the Cochrane Library, Embase and ClinicalTrials.gov were searched until April 3rd, 2021. Randomized controlled trials regarding spontaneously achieved singleton pregnancies who were treated with progestogen before 20 weeks of pregnancy and were compared with those women in unexposed control groups were selected for inclusion. We performed pairwise meta-analyses with the random-effects model. The risk of bias was assessed according to the Cochrane Collaboration tool. The primary outcomes included preeclampsia (PE), and gestational diabetes mellitus (GDM), with the results presented as odds ratios (ORs) with 95% confidence intervals (CIs). Results We identified nine eligible studies involving 6439 participants. The pooled OR of subsequent PE following early progestogen supplementation was 0.64 (95% CI 0.42–0.98, moderate quality of evidence). A lower OR for PE was observed in the progestogen group when the subgroup analysis was performed in the vaginal subgroup (OR 0.62, 95%CI 0.40–0.96). There was insufficient evidence of a difference in the rate of GDM between pregnant women with early progestogen supplementation and unexposed pregnant women (OR 1.02, 95% CI 0.79–1.32, low quality of evidence). The pooled OR of low birth weight (LBW) following oral dydrogesterone was 0.57 (95% CI 0.34–0.95, moderate quality of evidence). The results were affected by a single study and the total sample size of enrolled women did not reach the required information size. Conclusion Use of vaginal micronized progesterone (Utrogestan) in spontaneously achieved singleton pregnancies with threatened miscarriage before 20 weeks of pregnancy may reduce the risk of PE in later gestational weeks. Among spontaneously achieved singleton pregnancies with threatened miscarriage or a history of recurrent miscarriage, use of oral dydrogesterone before 20 weeks of pregnancy may result in a lower risk of LBW in later gestational weeks. However, the available data were not sufficient to reach definitive conclusions, which highlighted the need for future studies.

The association between whole body vibration exposure and spine degeneration on imaging: A systematic review

BACKGROUND: Low frequency vibrations from motorized vehicles and heavy equipment have been associated with musculoskeletal disorders. Spine degeneration on diagnostic imaging provides direct and objective measures of the possible effects of such exposures on the spine. OBJECTIVE: The objective of this systematic review was to evaluate the association of exposure to whole-body vibration (WBV) with spine degeneration on imaging. METHODS: We conducted electronic searches in MEDLINE, CINAHL, EMBASE, and Web of Science to July 2021. Two reviewers independently screened search results, assessed quality, and extracted data. Studies evaluating the exposure to WBV and lumbar spine degeneration on imaging were included. RESULTS: Fifteen studies (16 manuscripts) were included. Seven studies including a meta-demonstrated moderate quality evidence of no association between WBV and disc degeneration. There was also moderate quality evidence of no association between WBV and disc height narrowing and osteophytes. Overall, there was low level evidence of no association between WBV and other degenerations findings. CONCLUSIONS: There was moderate to low quality evidence suggesting no association between WBV exposures with spine degeneration on imaging. The results of this study currently do not support assertion that motorized vehicle and WBV exposure accelerates degeneration and causes structural damage to the spine.