© 2019 The Cochrane Collaboration. Background: Macrolide antibiotics (macrolides) are among the most commonly prescribed antibiotics worldwide and are used for a wide range of infections. However, macrolides also expose people to the risk of adverse events. The current understanding of adverse events is mostly derived from observational studies, which are subject to bias because it is hard to distinguish events caused by antibiotics from events caused by the diseases being treated. Because adverse events are treatment-specific, rather than disease-specific, it is possible to increase the number of adverse events available for analysis by combining randomised controlled trials (RCTs) of the same treatment across different diseases. Objectives: To quantify the incidences of reported adverse events in people taking macrolide antibiotics compared to placebo for any indication. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which includes the Cochrane Acute Respiratory Infections Group Specialised Register (2018, Issue 4); MEDLINE (Ovid, from 1946 to 8 May 2018); Embase (from 2010 to 8 May 2018); CINAHL (from 1981 to 8 May 2018); LILACS (from 1982 to 8 May 2018); and Web of Science (from 1955 to 8 May 2018). We searched clinical trial registries for current and completed trials (9 May 2018) and checked the reference lists of included studies and of previous Cochrane Reviews on macrolides. Selection criteria: We included RCTs that compared a macrolide antibiotic to placebo for any indication. We included trials using any of the four most commonly used macrolide antibiotics: azithromycin, clarithromycin, erythromycin, or roxithromycin. Macrolides could be administered by any route. Concomitant medications were permitted provided they were equally available to both treatment and comparison groups. Data collection and analysis: Two review authors independently extracted and collected data. We assessed the risk of bias of all included studies and the quality of evidence for each outcome of interest. We analysed specific adverse events, deaths, and subsequent carriage of macrolide-resistant bacteria separately. The study participant was the unit of analysis for each adverse event. Any specific adverse events that occurred in 5% or more of any group were reported. We undertook a meta-analysis when three or more included studies reported a specific adverse event. Main results: We included 183 studies with a total of 252,886 participants (range 40 to 190,238). The indications for macrolide antibiotics varied greatly, with most studies using macrolides for the treatment or prevention of either acute respiratory tract infections, cardiovascular diseases, chronic respiratory diseases, gastrointestinal conditions, or urogynaecological problems. Most trials were conducted in secondary care settings. Azithromycin and erythromycin were more commonly studied than clarithromycin and roxithromycin. Most studies (89%) reported some adverse events or at least stated that no adverse events were observed. Gastrointestinal adverse events were the most commonly reported type of adverse event. Compared to placebo, macrolides caused more diarrhoea (odds ratio (OR) 1.70, 95% confidence interval (CI) 1.34 to 2.16; low-quality evidence); more abdominal pain (OR 1.66, 95% CI 1.22 to 2.26; low-quality evidence); and more nausea (OR 1.61, 95% CI 1.37 to 1.90; moderate-quality evidence). Vomiting (OR 1.27, 95% CI 1.04 to 1.56; moderate-quality evidence) and gastrointestinal disorders not otherwise specified (NOS) (OR 2.16, 95% CI 1.56 to 3.00; moderate-quality evidence) were also reported more often in participants taking macrolides compared to placebo. The number of additional people (absolute difference in risk) who experienced adverse events from macrolides was: gastrointestinal disorders NOS 85/1000; diarrhoea 72/1000; abdominal pain 62/1000; nausea 47/1000; and vomiting 23/1000. The number needed to treat for an additional harmful outcome (NNTH) ranged from 12 (95% CI 8 to 23) for gastrointestinal disorders NOS to 17 (9 to 47) for abdominal pain; 19 (12 to 33) for diarrhoea; 19 (13 to 30) for nausea; and 45 (22 to 295) for vomiting. There was no clear consistent difference in gastrointestinal adverse events between different types of macrolides or route of administration. Taste disturbances were reported more often by participants taking macrolide antibiotics, although there were wide confidence intervals and moderate heterogeneity (OR 4.95, 95% CI 1.64 to 14.93; I2 = 46%; low-quality evidence). Compared with participants taking placebo, those taking macrolides experienced hearing loss more often, however only four studies reported this outcome (OR 1.30, 95% CI 1.00 to 1.70; I2 = 0%; low-quality evidence). We did not find any evidence that macrolides caused more cardiac disorders (OR 0.87, 95% CI 0.54 to 1.40; very low-quality evidence); hepatobiliary disorders (OR 1.04, 95% CI 0.27 to 4.09; very low-quality evidence); or changes in liver enzymes (OR 1.56, 95% CI 0.73 to 3.37; very low-quality evidence) compared to placebo. We did not find any evidence that appetite loss, dizziness, headache, respiratory symptoms, blood infections, skin and soft tissue infections, itching, or rashes were reported more often by participants treated with macrolides compared to placebo. Macrolides caused less cough (OR 0.57, 95% CI 0.40 to 0.80; moderate-quality evidence) and fewer respiratory tract infections (OR 0.70, 95% CI 0.62 to 0.80; moderate-quality evidence) compared to placebo, probably because these are not adverse events, but rather characteristics of the indications for the antibiotics. Less fever (OR 0.73, 95% 0.54 to 1.00; moderate-quality evidence) was also reported by participants taking macrolides compared to placebo, although these findings were non-significant. There was no increase in mortality in participants taking macrolides compared with placebo (OR 0.96, 95% 0.87 to 1.06; I2 = 11%; low-quality evidence). Only 24 studies (13%) provided useful data on macrolide-resistant bacteria. Macrolide-resistant bacteria were more commonly identified among participants immediately after exposure to the antibiotic. However, differences in resistance thereafter were inconsistent. Pharmaceutical companies supplied the trial medication or funding, or both, for 91 trials. Authors' conclusions: The macrolides as a group clearly increased rates of gastrointestinal adverse events. Most trials made at least some statement about adverse events, such as "none were observed". However, few trials clearly listed adverse events as outcomes, reported on the methods used for eliciting adverse events, or even detailed the numbers of people who experienced adverse events in both the intervention and placebo group. This was especially true for the adverse event of bacterial resistance.

/pdf/adverse-events-in-people-taking-macrolide-antibiotics-versus-apvsdqqzz4.pdf

Adverse events in people taking macrolide antibiotics versus placebo for any indication.

© 2020 Indian Journal of Anaesthesia | Published by Wolters Kluwer Medknow Pradeep A Dongare, S Bala Bhaskar1, S S Harsoor2, Rakesh Garg3, Sudheesh Kannan4, Umesh Goneppanavar5, Zulfiqar Ali6, Ramachandran Gopinath7, Jayashree Sood8, Kalaivani Mani9, Pradeep Bhatia10, Priyanka Rohatgi11, Rekha Das12, Santu Ghosh13, Subramanyam S Mahankali14, Sukhminder Jit Singh Bajwa15, Sunanda Gupta16, Sunil T Pandya17, Venkatesh H Keshavan18, Muralidhar Joshi19, Naveen Malhotra20

Perioperative fasting and feeding in adults, obstetric, paediatric and bariatric population: Practice Guidelines from the Indian Society of Anaesthesiologists.

Background There is an unmet need for in-service training of health providers for essential new-born care. This study evaluated the ability of a multi-modal training workshop on new-born care to improve the knowledge and skills of health providers. Methods This was an intervention based pre-and post-study on 54 students who attended a two-day workshop on essential new-born care. The teaching used self-directed learning, demonstration, videos, webinars, podcasts, group discussion, role-play and individual feedback. Knowledge was assessed by a set of 25 peer-reviewed multiple-choice questions (MCQs), both pre-and post-test and skills by 3 peer-reviewed and validated objective structured clinical examination (OSCE) stations in the post-test period. Follow-up assessment after 10 months was also done for 30 students. Results There was a significant improvement in the knowledge scores on MCQs after the workshop [16.65 ± 1.84 vs 12 ± 2.98, mean difference 4.65, 95%CI (3.85 to 5.44); p value  Conclusion An essential new-born care workshop using multi-modal teaching methods resulted in an improvement in knowledge and skill scores among a diverse mix of nurses and doctors. This model of learning was acceptable and can be adapted for future training of health providers. There is a need for regular refresher training to maintain knowledge and skills.

Evaluation of a multimodal teaching method on essential newborn care among health providers at a tertiary care hospital

Background
Both the self inflating bag and the T-piece resuscitator are recommended for neonatal resuscitation, but many health care workers are unfamiliar with using the latter. A prospective, comparative, observational study was done to determine the ease and effectiveness of training of health care personnel in the two devices using infant training manikins.

Comparison of training in neonatal resuscitation using self inflating bag and T-piece resuscitator.

Survival of premature and low birth weight infants has markedly improved during the last few decades.Nutrition is believed to playa fundamental role inoptimizing the growth and development of theseinfants both during their period of hospital stay andpost discharge. Feeding of low birth weight babiesis a very challenging issue as trials dealing withvarious aspects are lacking. There is need forinformation on the choice of milk for a preterm inhospital and post discharge, fortification, dilemmasregarding when to initiate feeds, progression andfrequency of feeds and lastly management of feedintolerance. The purpose of this review is to highlightthe paucity of evidence in certain areas of LBWfeeding and suggest important areas of futureresearch.

Research issues in low birth weight feeding

We evaluated the effectiveness of teaching at a neonatal resuscitation programme (NRP) workshop held for 35 medical personnel (including postgraduate trainee doctors, general duty medical officers, nursing officers and probationer nurses) using a one-group pretest-posttest design. None of the participants had any formal exposure to the NRP guidelines. A pre-workshop test of 20 multiple-choice questions was administered to all the participants. At the end of the workshop, the same 20 questions were administered and the two scores compared using t-test for paired data on SPSS statistical software. The mean pre-workshop score was 9.03 (SD 2.66) which improved to a mean of 15.53 (SD 1.93) post-workshop. This improvement was highly significant with p < 0.0001 (two-tailed) and the 95% confidence interval being -7.41 to -5.59. Subgroup analysis revealed that nursing officers and probationer nurses showed highly significant improvement in the post-workshop scores while trainee doctors doing Medicine, Pediatrics and the general duty medical officers showed statistically significant improvement in the post-workshop scores. This study shows that a medical workshop is an effective means of imparting knowledge to a mixed group of medical personnel.

Effectiveness of Teaching of Neonatal Resuscitation Programme at a Workshop for a Mixed Population of Medical Personnel

Background
To study the promotility effects of low dose erythromycin on gastric emptying time in a population of normal low birth weight (LBW) neonates on breast feeds with or without nutritional supplements and human milk fortifier (HMF).

Effect of Erythromycin on Gastric Emptying Time of Low Birth Weight Babies.

Wegener's granulomatosis, characterized by multisystem granulomatous inflammation and necrotising vasculitis, is rarely seen in children and, to date, there are less than 100 cases reported in the world literature in children under 15 years of age. No published Indian report is available. We report a case of a 13-year old boy who presented with typical features, had a rapid course and succumbed due to massive pulmonary hemorrhage.

Wegener's Granulomatosis with Fungal Lung Infection in a Child.

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Effectiveness of Teaching of Neonatal Resuscitation Programme at a Workshop for a Mixed Population of Medical Personnel

Effect of Erythromycin on Gastric Emptying Time of Low Birth Weight Babies.

Wegener's Granulomatosis with Fungal Lung Infection in a Child.