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  1. Sahoo S, Barua A, Myint KT, Haq A, Abas AB, Nair NS
    PMID: 25686158 DOI: 10.1002/14651858.CD010009.pub2
    Diabetic cystoid macular oedema (CMO) is a condition which involves fluid accumulation in the inner portion of the retina. It often follows changes in retinal blood vessels which enhance the fluid to come out of vessels. Although it may be asymptomatic, symptoms are primarily painless loss of central vision, often with the complaint of seeing black spots in front of the eye.It is reported that CMO may resolve spontaneously, or fluctuate for months, before causing loss of vision. If left untreated or undiagnosed, progression of CMO may lead to permanent visual loss.It has been noted that patients with diabetic retinopathy have elevated inflammatory markers, and therefore it is likely that inflammation aids in the progression of vascular disease in these patients. Several topical non-steroidal anti-inflammatory drugs (NSAIDs) such as ketorolac 0.5%, bromfenac 0.09%, and nepafenac 0.1%, have therefore also been used topically to treat chronic diabetic CMO. Hence this review was conducted to find out the effects of topical NSAIDs in diabetic CMO.
  2. Nagraj SK, Naresh S, Srinivas K, Renjith George P, Shrestha A, Levenson D, et al.
    PMID: 25425011 DOI: 10.1002/14651858.CD010470.pub2
    BACKGROUND: The sense of taste is very much essential to the overall health of the individual. It is a necessary component to enjoying one's food, which in turn provides nutrition to an individual. Any disturbance in taste perception can hamper the quality of life in such patients by influencing their appetite, body weight and psychological well-being. Taste disorders have been treated using different modalities of treatment and there is no consensus for the best intervention. Hence this Cochrane systematic review was undertaken.

    OBJECTIVES: To assess the effects of interventions for the management of patients with taste disturbances.

    SEARCH METHODS: We searched the Cochrane Oral Health Group Trials Register (to 5 March 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2014), MEDLINE via OVID (1948 to 5 March 2014), EMBASE via OVID (1980 to 5 March 2014), CINAHL via EBSCO (1980 to 5 March 2014) and AMED via OVID (1985 to 5 March 2014). We also searched the relevant clinical trial registries and conference proceedings from the International Association of Dental Research/American Association of Dental Research (to 5 March 2014), Association for Research in Otolaryngology (to 5 March 2014), the US National Institutes of Health Trials Register (to 5 March 2014), metaRegister of Controlled Trials (mRCT) (to 5 March 2014), World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) (to 5 March 2014) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal (to 5 March 2014).

    SELECTION CRITERIA: We included all randomised controlled trials (RCTs) comparing any pharmacological agent with a control intervention or any non-pharmacological agent with a control intervention. We also included cross-over trials in the review.

    DATA COLLECTION AND ANALYSIS: Two authors independently, and in duplicate, assessed the quality of trials and extracted data. Wherever possible, we contacted study authors for additional information. We collected adverse events information from the trials.

    MAIN RESULTS: We included nine trials (seven parallel and two cross-over RCTs) with 566 participants. We assessed three trials (33.3%) as having a low risk of bias, four trials (44.5%) at high risk of bias and two trials (22.2%) as having an unclear risk of bias. We only included studies on taste disorders in this review that were either idiopathic, or resulting from zinc deficiency or chronic renal failure.Of these, eight trials with 529 people compared zinc supplements to placebo for patients with taste disorders. The participants in two trials were children and adolescents with respective mean ages of 10 and 11.2 years and the other six trials had adult participants. Out of these eight, two trials assessed the patient reported outcome for improvement in taste acuity using zinc supplements (RR 1.45, 95% CI 1.0 to 2.1; very low quality evidence). We included three trials in the meta-analysis for overall taste improvement (effect size 0.44, 95% CI 0.23 to 0.65; moderate quality evidence). Two other trials described the results as taste acuity improvement and we conducted subgroup analyses due to clinical heterogeneity. One trial described the results as taste recognition improvement for each taste sensation and we analysed this separately. We also analysed one cross-over trial separately using the first half of the results. None of the zinc trials tested taste discrimination. Only one trial tested taste discrimination using acupuncture (effect size 2.80, 95% CI -1.18 to 6.78; low quality evidence).Out of the eight trials using zinc supplementation, four reported adverse events like eczema, nausea, abdominal pain, diarrhoea, constipation, decrease in blood iron, increase in blood alkaline phosphatase, and minor increase in blood triglycerides. No adverse events were reported in the acupuncture trial.None of the included trials could be included in the meta-analysis for health-related quality of life in taste disorder patients.

    AUTHORS' CONCLUSIONS: We found very low quality evidence that was insufficient to conclude on the role of zinc supplements to improve taste perception by patients, however we found moderate quality evidence that zinc supplements improve overall taste improvement in patients with zinc deficiency/idiopathic taste disorders. We also found low quality evidence that zinc supplements improve taste acuity in zinc deficient/idiopathic taste disorders and very low quality evidence for taste recognition improvement in children with taste disorders secondary to chronic renal failure. We did not find any evidence to conclude the role of zinc supplements for improving taste discrimination, or any evidence addressing health-related quality of life due to taste disorders.We found low quality evidence that is not sufficient to conclude on the role of acupuncture for improving taste discrimination in cases of idiopathic dysgeusia (distortion of taste) and hypogeusia (reduced ability to taste). We were unable to draw any conclusions regarding the superiority of zinc supplements or acupuncture as none of the trials compared these interventions.

  3. Karanth L, Kanagasabai S, Abas AB
    Cochrane Database Syst Rev, 2017 08 04;8:CD011059.
    PMID: 28776324 DOI: 10.1002/14651858.CD011059.pub3
    BACKGROUND: Bleeding disorders are uncommon but may pose significant bleeding complications during pregnancy, labour and following delivery for both the woman and the foetus. While many bleeding disorders in women tend to improve in pregnancy, thus decreasing the haemorrhagic risk to the mother at the time of delivery, some do not correct or return quite quickly to their pre-pregnancy levels in the postpartum period. Therefore, specific measures to prevent maternal bleeding and foetal complications during childbirth, are required. The safest method of delivery to reduce morbidity and mortality in these women is controversial. This is an update of a previously published review.

    OBJECTIVES: To assess the optimal mode of delivery in women with, or carriers of, bleeding disorders.

    SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the Cochrane Pregnancy and Childbirth Group's Trials Register as well as trials registries and the reference lists of relevant articles and reviews.Date of last search of the Group's Trials Registers: 16 February 2017.

    SELECTION CRITERIA: Randomised controlled trials and all types of controlled clinical trials investigating the optimal mode of delivery in women with, or carriers of, any type of bleeding disorder during pregnancy were eligible for the review.

    DATA COLLECTION AND ANALYSIS: No trials matching the selection criteria were eligible for inclusion MAIN RESULTS: No results from randomised controlled trials were found.

    AUTHORS' CONCLUSIONS: The review did not identify any randomised controlled trials investigating the safest mode of delivery and associated maternal and foetal complications during delivery in women with, or carriers of, a bleeding disorder. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials, case studies) to decide upon the optimal mode of delivery to ensure the safety of both mother and foetus.Given the ethical considerations, the rarity of the disorders and the low incidence of both maternal and foetal complications, future randomised controlled trials to find the optimal mode of delivery in this population are unlikely to be carried out. Other high quality controlled studies (such as risk allocation designs, sequential design, and parallel cohort design) are needed to investigate the risks and benefits of natural vaginal and caesarean section in this population or extrapolation from other clinical conditions that incur a haemorrhagic risk to the baby, such as platelet alloimmunisation.

  4. Norhayati MN, Ho JJ, Azman MY
    PMID: 25803008 DOI: 10.1002/14651858.CD010089.pub2
    BACKGROUND: Acute otitis media (AOM) is one of the most common infectious diseases in children. It has been reported that 64% of infants have an episode of AOM by the age of six months and 86% by one year. Although most cases of AOM are due to bacterial infection, it is commonly triggered by a viral infection. In most children it is self limiting, but it does carry a risk of complications. Since antibiotic treatment increases the risk of antibiotic resistance, influenza vaccines might be an effective way of reducing this risk by preventing the development of AOM.

    OBJECTIVES: To assess the effectiveness of influenza vaccine in reducing the occurrence of acute otitis media (AOM) in infants and children.

    SEARCH METHODS: We searched CENTRAL (2014, Issue 6), MEDLINE (1946 to July week 1, 2014), EMBASE (2010 to July 2014), CINAHL (1981 to July 2014), LILACS (1982 to July 2014), Web of Science (1955 to July 2014) and reference lists of articles to July 2014.

    SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing influenza vaccine with placebo or no treatment in infants and children aged younger than six years old. We included children of either sex and of any ethnicity, with or without a history of recurrent AOM.

    DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies, assessed trial quality and extracted data. We performed statistical analyses using the random-effects and fixed-effect models and expressed the results as risk ratio (RR), risk difference (RD) and number needed to treat to benefit (NNTB) for dichotomous outcomes, with 95% confidence intervals (CI).

    MAIN RESULTS: We included 10 trials (six trials in high-income countries and four multicentre trials in high-, middle- and low-income countries) involving 16,707 children aged six months to six years. Eight trials recruited participants from a healthcare setting. Nine trials (and all five trials that contributed to the primary outcome) declared funding from vaccine manufacturers. Four trials reported adequate allocation concealment and nine trials reported adequate blinding of participants and personnel. Attrition was low for all trials included in the analysis.The primary outcome showed a small reduction in at least one episode of AOM over at least six months of follow-up (five trials, 4736 participants: RR 0.80, 95% CI 0.67 to 0.96; RD -0.04, 95% CI -0.07 to -0.02; NNTB 25, 95% CI 15 to 50).The subgroup analyses (i.e. number of courses, settings, seasons or types of vaccine administered) showed no differences.There was a reduction in the use of antibiotics in vaccinated children (two trials, 1223 participants: RR 0.70, 95% CI 0.59 to 0.83; RD -0.15, 95% CI -0.30 to -0.00).There was no significant difference in the utilisation of health care for the one trial that provided sufficient information to be included. The use of influenza vaccine resulted in a significant increase in fever (six trials, 10,199 participants: RR 1.15, 95% CI 1.06 to 1.24; RD 0.02, 95% CI -0.00 to 0.05) and rhinorrhoea (six trials, 10,563 children: RR 1.17, 95% CI 1.07 to 1.29; RD 0.09, 95% CI 0.01 to 0.16) but no difference in pharyngitis. No major adverse events were reported.Compared to the protocol, the review included a subgroup analysis of AOM episodes by season, and changed the types of influenza vaccine from a secondary outcome to a subgroup analysis.

    AUTHORS' CONCLUSIONS: Influenza vaccine results in a small reduction in AOM. The observed reduction with the use of antibiotics needs to be considered in the light of current recommended practices aimed at avoiding antibiotic overuse. Safety data from these trials are limited. The benefits may not justify the use of influenza vaccine without taking into account the vaccine efficacy in reducing influenza and safety data. The quality of the evidence was high to moderate. Additional research is needed.

  5. Ni H, Soe Z, Moe S
    PMID: 25234126 DOI: 10.1002/14651858.CD010509.pub2
    BACKGROUND: Bronchodilators are the mainstay for symptom relief in the management of stable chronic obstructive pulmonary disease (COPD). Aclidinium bromide is a new long-acting muscarinic antagonist (LAMA) that differs from tiotropium by its higher selectivity for M3 muscarinic receptors with a faster onset of action. However, the duration of action of aclidinium is shorter than for tiotropium. It has been approved as maintenance therapy for stable, moderate to severe COPD, but its efficacy and safety in the management of COPD is uncertain compared to other bronchodilators.
    OBJECTIVES: To assess the efficacy and safety of aclidinium bromide in stable COPD.
    SEARCH METHODS: We identified randomised controlled trials (RCT) from the Cochrane Airways Group Specialised Register of trials (CAGR), as well as www.clinicaltrials.gov, World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), US Food and Drug Administration (FDA) website and Almirall Clinical Trials Registry and Results. We contacted Forest Laboratories for any unpublished trials and checked the reference lists of identified articles for additional information. The last search was performed on 7 April 2014 for CAGR and 11 April 2014 for other sources.
    SELECTION CRITERIA: Parallel-group RCTs of aclidinium bromide compared with placebo, long-acting beta2-agonists (LABA) or LAMA in adults with stable COPD.
    DATA COLLECTION AND ANALYSIS:
    Two review authors independently selected studies, assessed the risk of bias, and extracted data. We sought missing data from the trial authors as well as manufacturers of aclidinium. We used odds ratios (OR) for dichotomous data and mean difference (MD) for continuous data, and reported both with their 95% confidence intervals (CI). We used standard methodological procedures expected by The Cochrane Collaboration. We applied the GRADE approach to summarise results and to assess the overall quality of evidence.
    MAIN RESULTS: This review included 12 multicentre RCTs randomly assigning 9547 participants with stable COPD. All the studies were industry-sponsored and had similar inclusion criteria with relatively good methodological quality. All but one study included in the meta-analysis were double-blind and scored low risk of bias. The study duration ranged from four weeks to 52 weeks. Participants were more often males, mainly Caucasians, mean age ranging from 61.7 to 65.6 years, and with a smoking history of 10 or more pack years. They had moderate to severe symptoms at randomisation; the mean post-bronchodilator forced expiratory volume in one second (FEV1) was between 46% and 57.6% of the predicted normal value, and the mean St George's Respiratory Questionnaire score (SGRQ) ranged from 45.1 to 50.4 when reported.There was no difference between aclidinium and placebo in all-cause mortality (low quality) and number of patients with exacerbations requiring a short course of oral steroids or antibiotics, or both (moderate quality). Aclidinium improved quality of life by lowering the SGRQ total score with a mean difference of -2.34 (95% CI -3.18 to -1.51; I(2) = 48%, 7 trials, 4442 participants) when compared to placebo. More patients on aclidinium achieved a clinically meaningful improvement of at least four units decrease in SGRQ total score (OR 1.49; 95% CI 1.31 to 1.70; I(2) = 34%; number needed to treat (NNT) = 10, 95% CI 8 to 15, high quality evidence) over 12 to 52 weeks than on placebo. Aclidinium also resulted in a significantly greater improvement in pre-dose FEV1 than placebo with a mean difference of 0.09 L (95% CI 0.08 to 0.10; I(2) = 39%, 9 trials, 4963 participants). No trials assessed functional capacity. Aclidinium reduced the number of patients with exacerbations requiring hospitalisation by 4 to 20 fewer per 1000 over 4 to 52 weeks (OR 0.64; 95% CI 0.46 to 0.88; I(2) = 0%, 10 trials, 5624 people; NNT = 77, 95% CI 51 to 233, high quality evidence) compared to placebo. There was no difference in non-fatal serious adverse events (moderate quality evidence) between aclidinium and placebo.Compared to tiotropium, aclidinium did not demonstrate significant differences for exacerbations requiring oral steroids or antibiotics, or both, exacerbation-related hospitalisations and non-fatal serious adverse events (very low quality evidence). Inadequate data prevented the comparison of aclidinium to formoterol or other LABAs.
    AUTHORS' CONCLUSIONS: Aclidinium is associated with improved quality of life and reduced hospitalisations due to severe exacerbations in patients with moderate to severe stable COPD compared to placebo. Overall, aclidinium did not significantly reduce mortality, serious adverse events or exacerbations requiring oral steroids or antibiotics, or both.Currently, the available data are insufficient and of very low quality in comparisons of the efficacy of aclidinium versus tiotropium. The efficacy of aclidinium versus LABAs cannot be assessed due to inaccurate data. Thus additional trials are recommended to assess the efficacy and safety of aclidinium compared to other LAMAs or LABAs.
  6. Yaacob M, Worthington HV, Deacon SA, Deery C, Walmsley AD, Robinson PG, et al.
    PMID: 24934383 DOI: 10.1002/14651858.CD002281.pub3
    Removing dental plaque may play a key role maintaining oral health. There is conflicting evidence for the relative merits of manual and powered toothbrushing in achieving this. This is an update of a Cochrane review first published in 2003, and previously updated in 2005.
  7. Moy FM, Ray A, Buckley BS, West HM
    Cochrane Database Syst Rev, 2017 06 11;6:CD009613.
    PMID: 28602020 DOI: 10.1002/14651858.CD009613.pub3
    BACKGROUND: Self-monitoring of blood glucose (SMBG) is recommended as a key component of the management plan for diabetes therapy during pregnancy. No existing systematic reviews consider the benefits/effectiveness of various techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes. The effectiveness of the various monitoring techniques is unclear.

    OBJECTIVES: To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes.

    SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016), searched reference lists of retrieved studies and contacted trial authors.

    SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM) or clinic monitoring among pregnant women with pre-existing diabetes mellitus (type 1 or type 2). Trials investigating timing and frequency of monitoring were also included. RCTs using a cluster-randomised design were eligible for inclusion but none were identified.

    DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.

    MAIN RESULTS: This review update includes at total of 10 trials (538) women (468 women with type 1 diabetes and 70 women with type 2 diabetes). The trials took place in Europe and the USA. Five of the 10 included studies were at moderate risk of bias, four studies were at low to moderate risk of bias, and one study was at high risk of bias. The trials are too small to show differences in important outcomes such as macrosomia, preterm birth, miscarriage or death of baby. Almost all the reported GRADE outcomes were assessed as being very low-quality evidence. This was due to design limitations in the studies, wide confidence intervals, small sample sizes, and few events. In addition, there was high heterogeneity for some outcomes.Various methods of glucose monitoring were compared in the trials. Neither pooled analyses nor individual trial analyses showed any clear advantages of one monitoring technique over another for primary and secondary outcomes. Many important outcomes were not reported.1. Self-monitoring versus standard care (two studies, 43 women): there was no clear difference for caesarean section (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.40 to 1.49; one study, 28 women) or glycaemic control (both very low-quality), and not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Hypertensive disorders of pregnancy, large-for-gestational age, neurosensory disability, and preterm birth were not reported in either study.2. Self-monitoring versus hospitalisation (one study, 100 women): there was no clear difference for hypertensive disorders of pregnancy (pre-eclampsia and hypertension) (RR 4.26, 95% CI 0.52 to 35.16; very low-quality: RR 0.43, 95% CI 0.08 to 2.22; very low-quality). There was no clear difference in caesarean section or preterm birth less than 37 weeks' gestation (both very low quality), and the sample size was too small to assess perinatal mortality (very low-quality). Large-for-gestational age, mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.3. Pre-prandial versus post-prandial glucose monitoring (one study, 61 women): there was no clear difference between groups for caesarean section (RR 1.45, 95% CI 0.92 to 2.28; very low-quality), large-for-gestational age (RR 1.16, 95% CI 0.73 to 1.85; very low-quality) or glycaemic control (very low-quality). The results for hypertensive disorders of pregnancy: pre-eclampsia and perinatal mortality are not meaningful because these outcomes were too rare to show differences in a small sample (all very low-quality). The study did not report the outcomes mortality or morbidity composite, neurosensory disability or preterm birth.4. Automated telemedicine monitoring versus conventional system (three studies, 84 women): there was no clear difference for caesarean section (RR 0.96, 95% CI 0.62 to 1.48; one study, 32 women; very low-quality), and mortality or morbidity composite in the one study that reported these outcomes. There were no clear differences for glycaemic control (very low-quality). No studies reported hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), neurosensory disability or preterm birth.5.CGM versus intermittent monitoring (two studies, 225 women): there was no clear difference for pre-eclampsia (RR 1.37, 95% CI 0.52 to 3.59; low-quality), caesarean section (average RR 1.00, 95% CI 0.65 to 1.54; I² = 62%; very low-quality) and large-for-gestational age (average RR 0.89, 95% CI 0.41 to 1.92; I² = 82%; very low-quality). Glycaemic control indicated by mean maternal HbA1c was lower for women in the continuous monitoring group (mean difference (MD) -0.60 %, 95% CI -0.91 to -0.29; one study, 71 women; moderate-quality). There was not enough evidence to assess perinatal mortality and there were no clear differences for preterm birth less than 37 weeks' gestation (low-quality). Mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.6. Constant CGM versus intermittent CGM (one study, 25 women): there was no clear difference between groups for caesarean section (RR 0.77, 95% CI 0.33 to 1.79; very low-quality), glycaemic control (mean blood glucose in the 3rd trimester) (MD -0.14 mmol/L, 95% CI -2.00 to 1.72; very low-quality) or preterm birth less than 37 weeks' gestation (RR 1.08, 95% CI 0.08 to 15.46; very low-quality). Other primary (hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), mortality or morbidity composite, and neurosensory disability) or GRADE outcomes (preterm birth less than 34 weeks' gestation) were not reported.

    AUTHORS' CONCLUSIONS: This review found no evidence that any glucose monitoring technique is superior to any other technique among pregnant women with pre-existing type 1 or type 2 diabetes. The evidence base for the effectiveness of monitoring techniques is weak and additional evidence from large well-designed randomised trials is required to inform choices of glucose monitoring techniques.

  8. Poirot E, Skarbinski J, Sinclair D, Kachur SP, Slutsker L, Hwang J
    PMID: 24318836 DOI: 10.1002/14651858.CD008846.pub2
    BACKGROUND: Mass drug administration (MDA), defined as the empiric administration of a therapeutic antimalarial regimen to an entire population at the same time, has been a historic component of many malaria control and elimination programmes, but is not currently recommended. With renewed interest in MDA and its role in malaria elimination, this review aims to summarize the findings from existing research studies and program experiences of MDA strategies for reducing malaria burden and transmission.

    OBJECTIVES: To assess the impact of antimalarial MDA on population asexual parasitaemia prevalence, parasitaemia incidence, gametocytaemia prevalence, anaemia prevalence, mortality and MDA-associated adverse events.

    SEARCH METHODS: We searched the Cochrane Infectious Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE+, EMBASE, to February 2013. We also searched CABS Abstracts, LILACS, reference lists, and recent conference proceedings.

    SELECTION CRITERIA: Cluster-randomized trials and non-randomized controlled studies comparing therapeutic MDA versus placebo or no MDA, and uncontrolled before-and-after studies comparing post-MDA to baseline data were selected. Studies administering intermittent preventive treatment (IPT) to sub-populations (for example, pregnant women, children or infants) were excluded.

    DATA COLLECTION AND ANALYSIS: Two authors independently reviewed studies for inclusion, extracted data and assessed risk of bias. Studies were stratified by study design and then subgrouped by endemicity, by co-administration of 8-aminoquinoline plus schizonticide drugs and by plasmodium species. The quality of evidence was assessed using the GRADE approach.

    MAIN RESULTS: Two cluster-randomized trials, eight non-randomized controlled studies and 22 uncontrolled before-and-after studies are included in this review. Twenty-two studies (29 comparisons) compared MDA to placebo or no intervention of which two comparisons were conducted in areas of low endemicity (≤5%), 12 in areas of moderate endemicity (6-39%) and 15 in areas of high endemicity (≥ 40%). Ten studies evaluated MDA plus other vector control measures. The studies used a wide variety of MDA regimens incorporating different drugs, dosages, timings and numbers of MDA rounds. Many of the studies are now more than 30 years old. Areas of low endemicity (≤5%)Within the first month post-MDA, a single uncontrolled before-and-after study conducted in 1955 on a small Taiwanese island reported a much lower prevalence of parasitaemia following a single course of chloroquine compared to baseline (1 study, very low quality evidence). This lower parasite prevalence was still present after more than 12 months (one study, very low quality evidence). In addition, one cluster-randomized trial evaluating MDA in a low endemic setting reported zero episodes of parasitaemia at baseline, and throughout five months of follow-up in both the control and intervention arms (one study, very low quality evidence). Areas of moderate endemicity (6-39%)Within the first month post-MDA, the prevalence of parasitaemia was much lower in three non-randomized controlled studies from Kenya and India in the 1950s (RR 0.03, 95% CI 0.01 to 0.08, three studies, moderate quality evidence), and in three uncontrolled before-and-after studies conducted between 1954 and 1961 (RR 0.29, 95% CI 0.17 to 0.48, three studies,low quality evidence).The longest follow-up in these settings was four to six months. At this time point, the prevalence of parasitaemia remained substantially lower than controls in the two non-randomized controlled studies (RR 0.18, 95% CI 0.10 to 0.33, two studies, low quality evidence). In contrast, the two uncontrolled before-and-after studies found mixed results: one found no difference and one found a substantially higher prevalence compared to baseline (not pooled, two studies, very low quality evidence). Areas of high endemicity (≥40%)Within the first month post-MDA, the single cluster-randomized trial from the Gambia in 1999 found no significant difference in parasite prevalence (one study, low quality evidence). However, prevalence was much lower during the MDA programmes in three non-randomized controlled studies conducted in the 1960s and 1970s (RR 0.17, 95% CI 0.11 to 0.27, three studies, moderate quality evidence), and within one month of MDA in four uncontrolled before-and-after studies (RR 0.37, 95% CI 0.28 to 0.49, four studies,low quality evidence).Four trials reported changes in prevalence beyond three months. In the Gambia, the single cluster-randomized trial found no difference at five months (one trial, moderate quality evidence). The three uncontrolled before-and-after studies had mixed findings with large studies from Palestine and Cambodia showing sustained reductions at four months and 12 months, respectively, and a small study from Malaysia showing no difference after four to six months of follow-up (three studies,low quality evidence). 8-aminoquinolines We found no studies directly comparing MDA regimens that included 8-aminoquinolines with regimens that did not. In a crude subgroup analysis with a limited number of studies, we were unable to detect any evidence of additional benefit of primaquine in moderate- and high-transmission settings. Plasmodium species In studies that reported species-specific outcomes, the same interventions resulted in a larger impact on Plasmodium falciparum compared to P. vivax.

    AUTHORS' CONCLUSIONS: MDA appears to reduce substantially the initial risk of malaria parasitaemia. However, few studies showed sustained impact beyond six months post-MDA, and those that did were conducted on small islands or in highland settings.To assess whether there is an impact of MDA on malaria transmission in the longer term requires more quasi experimental studies with the intention of elimination, especially in low- and moderate-transmission settings. These studies need to address any long-term outcomes, any potential barriers for community uptake, and contribution to the development of drug resistance.

  9. Karanth L, Jaafar SH, Kanagasabai S, Nair NS, Barua A
    PMID: 23543581 DOI: 10.1002/14651858.CD009617.pub2
    During pregnancy, a Rhesus-negative (Rh-negative) woman may develop antibodies if her fetus is Rh-positive, which can cause fetal morbidity or mortality in following pregnancies, if untreated.
  10. Ooi CP, Loke SC
    PMID: 24000051 DOI: 10.1002/14651858.CD009128.pub3
    BACKGROUND: Sweet potato (Ipomoea batatas) is among the most nutritious subtropical and tropical vegetables. It is also used in traditional medicine practices for type 2 diabetes mellitus. Research in animal and human models suggests a possible role of sweet potato in glycaemic control.

    OBJECTIVES: To assess the effects of sweet potato for type 2 diabetes mellitus.

    SEARCH METHODS: We searched several electronic databases, including The Cochrane Library (2013, Issue 1), MEDLINE, EMBASE, CINAHL, SIGLE and LILACS (all up to February 2013), combined with handsearches. No language restrictions were used.

    SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared sweet potato with a placebo or a comparator intervention, with or without pharmacological or non-pharmacological interventions.

    DATA COLLECTION AND ANALYSIS: Two authors independently selected the trials and extracted the data. We evaluated risk of bias by assessing randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias.

    MAIN RESULTS: Three RCTs met our inclusion criteria: these investigated a total of 140 participants and ranged from six weeks to five months in duration. All three studies were performed by the same trialist. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effect of sweet potato preparations with placebo on glycaemic control in type 2 diabetes mellitus. There was a statistically significant improvement in glycosylated haemoglobin A1c (HbA1c) at three to five months with 4 g/day sweet potato preparation compared to placebo (mean difference -0.3% (95% confidence interval -0.6 to -0.04); P = 0.02; 122 participants; 2 trials). No serious adverse effects were reported. Diabetic complications and morbidity, death from any cause, health-related quality of life, well-being, functional outcomes and costs were not investigated.

    AUTHORS' CONCLUSIONS: There is insufficient evidence about the use of sweet potato for type 2 diabetes mellitus. In addition to improvement in trial methodology, issues of standardization and quality control of preparations - including other varieties of sweet potato - need to be addressed. Further observational trials and RCTs evaluating the effects of sweet potato are needed to guide any recommendations in clinical practice.

  11. Swe KM, Abas AB, Bhardwaj A, Barua A, Nair NS
    PMID: 23807756 DOI: 10.1002/14651858.CD009415.pub2
    Haemoglobinopathies, inherited disorders of haemoglobin synthesis (thalassaemia) or structure (sickle cell disease), are responsible for significant morbidity and mortality throughout the world. The WHO estimates that, globally, 5% of adults are carriers of a haemoglobin condition, 2.9% are carriers of thalassaemia and 2.3% are carriers of sickle cell disease. Carriers are found worldwide as a result of migration of various ethnic groups to different regions of the world. Zinc is an easily available supplement and intervention programs have been carried out to prevent deficiency in people with thalassaemia or sickle cell anaemia. It is important to evaluate the role of zinc supplementation in the treatment of thalassaemia and sickle cell anaemia to reduce deaths due to complications.
  12. Ooi CP, Loke SC
    Cochrane Database Syst Rev, 2012 Dec 12;12:CD009361.
    PMID: 23235674 DOI: 10.1002/14651858.CD009361.pub2
    BACKGROUND: Colesevelam is a second-generation bile acid sequestrant that has effects on both blood glucose and lipid levels. It provides a promising approach to glycaemic and lipid control simultaneously.

    OBJECTIVES: To assess the effects of colesevelam for type 2 diabetes mellitus.

    SEARCH METHODS: Several electronic databases were searched, among these The Cochrane Library (Issue 1, 2012), MEDLINE, EMBASE, CINAHL, LILACS, OpenGrey and Proquest Dissertations and Theses database (all up to January 2012), combined with handsearches. No language restriction was used.

    SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared colesevelam with or without other oral hypoglycaemic agents with a placebo or a control intervention with or without oral hypoglycaemic agents.

    DATA COLLECTION AND ANALYSIS: Two review authors independently selected the trials and extracted the data. We evaluated risk of bias of trials using the parameters of randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias.

    MAIN RESULTS: Six RCTs ranging from 8 to 26 weeks investigating 1450 participants met the inclusion criteria. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effects of colesevelam with or without other antidiabetic drug treatments with placebo only (one study) or combined with antidiabetic drug treatments. Colesevelam with add-on antidiabetic agents demonstrated a statistically significant reduction in fasting blood glucose with a mean difference (MD) of -15 mg/dL (95% confidence interval (CI) -22 to - 8), P < 0.0001; 1075 participants, 4 trials, no trial with low risk of bias in all domains. There was also a reduction in glycosylated haemoglobin A1c (HbA1c) in favour of colesevelam (MD -0.5% (95% CI -0.6 to -0.4), P < 0.00001; 1315 participants, 5 trials, no trial with low risk of bias in all domains. However, the single trial comparing colesevelam to placebo only (33 participants) did not reveal a statistically significant difference between the two arms - in fact, in both arms HbA1c increased. Colesevelam with add-on antidiabetic agents demonstrated a statistical significant reduction in low-density lipoprotein (LDL)-cholesterol with a MD of -13 mg/dL (95% CI -17 to - 9), P < 0.00001; 886 participants, 4 trials, no trial with low risk of bias in all domains. Non-severe hypoglycaemic episodes were infrequently observed. No other serious adverse effects were reported. There was no documentation of complications of the disease, morbidity, mortality, health-related quality of life and costs.

    AUTHORS' CONCLUSIONS: Colesevelam added on to antidiabetic agents showed significant effects on glycaemic control. However, there is a limited number of studies with the different colesevelam/antidiabetic agent combinations. More information on the benefit-risk ratio of colesevelam treatment is necessary to assess the long-term effects, particularly in the management of cardiovascular risks as well as the reduction in micro- and macrovascular complications of type 2 diabetes mellitus. Furthermore, long-term data on health-related quality of life and all-cause mortality also need to be investigated.

  13. Tan ML, Ho JJ, Teh KH
    Cochrane Database Syst Rev, 2016 Sep 28;9:CD009398.
    PMID: 27678554 DOI: 10.1002/14651858.CD009398.pub3
    BACKGROUND: About 5% of school children have a specific learning disorder, defined as unexpected failure to acquire adequate abilities in reading, writing or mathematics that is not a result of reduced intellectual ability, inadequate teaching or social deprivation. Of these events, 80% are reading disorders. Polyunsaturated fatty acids (PUFAs), in particular, omega-3 and omega-6 fatty acids, which normally are abundant in the brain and in the retina, are important for learning. Some children with specific learning disorders have been found to be deficient in these PUFAs, and it is argued that supplementation of PUFAs may help these children improve their learning abilities.

    OBJECTIVES: 1. To assess effects on learning outcomes of supplementation of polyunsaturated fatty acids (PUFAs) for children with specific learning disorders.2. To determine whether adverse effects of supplementation of PUFAs are reported in these children.

    SEARCH METHODS: In November 2015, we searched CENTRAL, Ovid MEDLINE, Embase, PsycINFO, 10 other databases and two trials registers. We also searched the reference lists of relevant articles.

    SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing PUFAs with placebo or no treatment in children younger than 18 years with specific learning disabilities, as diagnosed in accordance with the fifth (or earlier) edition of theDiagnostic and Statistical Manual of Mental Disorders (DSM-5), or the 10th (or earlier) revision of the International Classification of Diseases (ICD-10) or equivalent criteria. We included children with coexisting developmental disorders such as attention deficit hyperactivity disorder (ADHD) or autism.

    DATA COLLECTION AND ANALYSIS: Two review authors (MLT and KHT) independently screened the titles and abstracts of articles identified by the search and eliminated all studies that did not meet the inclusion criteria. We contacted study authors to ask for missing information and clarification, when needed. We used the GRADE approach to assess the quality of evidence.

    MAIN RESULTS: Two small studies involving 116 children, mainly boys between 10 and 18 years of age, met the inclusion criteria. One study was conducted in a school setting, the other at a specialised clinic. Both studies used three months of a combination of omega-3 and omega-6 supplements as the intervention compared with placebo. Although both studies had generally low risk of bias, we judged the risk of reporting bias as unclear in one study, and as high in the other study. In addition, one of the studies was funded by industry and reported active company involvement in the study.None of the studies reported data on the primary outcomes of reading, writing, spelling and mathematics scores, as assessed by standardised tests.Evidence of low quality indicates that supplementation of PUFAs did not increase the risk of gastrointestinal disturbances (risk ratio 1.43, 95% confidence interval 0.25 to 8.15; two studies, 116 children). Investigators reported no other adverse effects.Both studies reported attention deficit hyperactivity disorder (ADHD)-related behaviour outcomes. We were unable to combine the results in a meta-analysis because one study reported findings as a continuous outcome, and the other as a dichotomous outcome. No other secondary outcomes were reported.We excluded one study because it used a cointervention (carnosine), and five other studies because they did not provide a robust diagnosis of a specific learning disorder. We identified one ongoing study and found three studies awaiting classification.

    AUTHORS' CONCLUSIONS: Evidence is insufficient to permit any conclusions about the effect of PUFAs on the learning abilities of children with specific learning disorders. Well-designed RCTs with clearly defined populations of children with specific learning disorders who have been diagnosed by standardised diagnostic criteria are needed.

  14. Jaafar SH, Lee KS, Ho JJ
    PMID: 22972095 DOI: 10.1002/14651858.CD006641.pub2
    Separate care for a new mother and infant may affect the duration of breastfeeding, breastfeeding behaviour and may have an adverse effect on neonatal and maternal outcomes.
  15. Hoe VC, Urquhart DM, Kelsall HL, Sim MR
    PMID: 22895977 DOI: 10.1002/14651858.CD008570.pub2
    BACKGROUND: Work-related upper limb and neck musculoskeletal disorders (MSDs) are one of the most common occupational disorders around the world. Although ergonomic design and training are likely to reduce the risk of workers developing work-related upper limb and neck MSDs, the evidence is unclear.

    OBJECTIVES: To assess the effects of workplace ergonomic design or training interventions, or both, for the prevention of work-related upper limb and neck MSDs in adults.

    SEARCH METHODS: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, AMED, Web of Science (Science Citation Index), SPORTDiscus, Cochrane Occupational Safety and Health Review Group Database and Cochrane Bone, Joint and Muscle Trauma Group Specialised Register to July 2010, and Physiotherapy Evidence Database, US Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health database, and International Occupational Safety and Health Information Centre database to November 2010.

    SELECTION CRITERIA: We included randomised controlled trials (RCTs) of ergonomic workplace interventions for preventing work-related upper limb and neck MSDs. We included only studies with a baseline prevalence of MSDs of the upper limb or neck, or both, of less than 25%.

    DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We included studies with relevant data that we judged to be sufficiently homogeneous regarding the intervention and outcome in the meta-analysis. We assessed the overall quality of the evidence for each comparison using the GRADE approach.

    MAIN RESULTS: We included 13 RCTs (2397 workers). Eleven studies were conducted in an office environment and two in a healthcare setting. We judged one study to have a low risk of bias. The 13 studies evaluated effectiveness of ergonomic equipment, supplementary breaks or reduced work hours, ergonomic training, a combination of ergonomic training and equipment, and patient lifting interventions for preventing work-related MSDs of the upper limb and neck in adults.Overall, there was moderate-quality evidence that arm support with alternative mouse reduced the incidence of neck/shoulder disorders (risk ratio (RR) 0.52; 95% confidence interval (CI) 0.27 to 0.99) but not the incidence of right upper limb MSDs (RR 0.73; 95% CI 0.32 to 1.66); and low-quality evidence that this intervention reduced neck/shoulder discomfort (standardised mean difference (SMD) -0.41; 95% CI -0.69 to -0.12) and right upper limb discomfort (SMD -0.34; 95% CI -0.63 to -0.06).There was also moderate-quality evidence that the incidence of neck/shoulder and right upper limb disorders were not reduced when comparing alternative mouse and conventional mouse (neck/shoulder RR 0.62; 95% CI 0.19 to 2.00; right upper limb RR 0.91; 95% CI 0.48 to 1.72), arm support and no arm support with conventional mouse (neck/shoulder RR 0.67; 95% CI 0.36 to 1.24; right upper limb RR 1.09; 95% CI 0.51 to 2.29), and alternative mouse with arm support and conventional mouse with arm support (neck/shoulder RR 0.58; 95% CI 0.30 to 1.12; right upper limb RR 0.92; 95% CI 0.36 to 2.36).There was low-quality evidence that using an alternative mouse with arm support compared to conventional mouse with arm support reduced neck/shoulder discomfort (SMD -0.39; 95% CI -0.67 to -0.10). There was low- to very low-quality evidence that other interventions were not effective in reducing work-related upper limb and neck MSDs in adults.

    AUTHORS' CONCLUSIONS: We found moderate-quality evidence to suggest that the use of arm support with alternative mouse may reduce the incidence of neck/shoulder MSDs, but not right upper limb MSDs. Moreover, we found moderate-quality evidence to suggest that the incidence of neck/shoulder and right upper limb MSDs is not reduced when comparing alternative and conventional mouse with and without arm support. However, given there were multiple comparisons made involving a number of interventions and outcomes, high-quality evidence is needed to determine the effectiveness of these interventions clearly. While we found very-low- to low-quality evidence to suggest that other ergonomic interventions do not prevent work-related MSDs of the upper limb and neck, this was limited by the paucity and heterogeneity of available studies. This review highlights the need for high-quality RCTs examining the prevention of MSDs of the upper limb and neck.

  16. Ooi CP, Yassin Z, Hamid TA
    PMID: 20166099 DOI: 10.1002/14651858.CD007845.pub2
    Momordica charantia is not only a nutritious vegetable, but is also used in traditional medical practices to treat type 2 diabetes mellitus. Experimental studies with animals and humans suggested that the vegetable has a possible role in glycaemic control.
  17. Mulimani P, Ballas SK, Abas AB, Karanth L
    Cochrane Database Syst Rev, 2016;4:CD011633.
    PMID: 27103509 DOI: 10.1002/14651858.CD011633.pub2
    Sickle cell disease is the most common single gene disorder and the commonest haemoglobinopathy found with high prevalence in many populations across the world. Management of dental complications in people with sickle cell disease requires special consideration for three main reasons. Firstly, dental and oral tissues are affected by the blood disorder resulting in several oro-facial abnormalities. Secondly, living with a haemoglobinopathy and coping with its associated serious consequences may result in individuals neglecting their oral health care. Finally, the treatment of these oral complications must be adapted to the systemic condition and special needs of these individuals, in order not to exacerbate or deteriorate their general health.Guidelines for the treatment of dental complications in this population who require special care are unclear and even unavailable in many aspects. Hence this review was undertaken to provide a basis for clinical care by investigating and analysing the existing evidence in the literature for the treatment of dental complications in people with sickle cell disease.
  18. Kumbargere Nagraj S, Prashanti E, Aggarwal H, Lingappa A, Muthu MS, Kiran Kumar Krishanappa S, et al.
    Cochrane Database Syst Rev, 2018 03 04;3:CD011930.
    PMID: 29502332 DOI: 10.1002/14651858.CD011930.pub3
    BACKGROUND: Post-extraction bleeding (PEB) is a recognised, frequently encountered complication in dental practice, which is defined as bleeding that continues beyond 8 to 12 hours after dental extraction. The incidence of post-extraction bleeding varies from 0% to 26%. If post-extraction bleeding is not managed, complications can range from soft tissue haematomas to severe blood loss. Local causes of bleeding include soft tissue and bone bleeding. Systemic causes include platelet problems, coagulation disorders or excessive fibrinolysis, and inherited or acquired problems (medication induced). There is a wide array of techniques suggested for the treatment of post-extraction bleeding, which include interventions aimed at both local and systemic causes. This is an update of a review published in June 2016.

    OBJECTIVES: To assess the effects of interventions for treating different types of post-extraction bleeding.

    SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 24 January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 12), MEDLINE Ovid (1946 to 24 January 2018), Embase Ovid (1 May 2015 to 24 January 2018) and CINAHL EBSCO (1937 to 24 January 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. We searched the reference lists of relevant systematic reviews.

    SELECTION CRITERIA: We considered randomised controlled trials (RCTs) that evaluated any intervention for treating PEB, with male or female participants of any age, regardless of type of teeth (anterior or posterior, mandibular or maxillary). Trials could compare one type of intervention with another, with placebo, or with no treatment.

    DATA COLLECTION AND ANALYSIS: Three pairs of review authors independently screened search records. We obtained full papers for potentially relevant trials. If data had been extracted, we would have followed the methods described in the Cochrane Handbook for Systematic Reviews of Interventions for the statistical analysis.

    MAIN RESULTS: We did not find any randomised controlled trial suitable for inclusion in this review.

    AUTHORS' CONCLUSIONS: We were unable to identify any reports of randomised controlled trials that evaluated the effects of different interventions for the treatment of post-extraction bleeding. In view of the lack of reliable evidence on this topic, clinicians must use their clinical experience to determine the most appropriate means of treating this condition, depending on patient-related factors. There is a need for well designed and appropriately conducted clinical trials on this topic, which conform to the CONSORT statement (www.consort-statement.org/).

  19. Lai NM, Foong SC, Foong WC, Tan K
    Cochrane Database Syst Rev, 2016 Apr 14;4:CD008313.
    PMID: 27075527 DOI: 10.1002/14651858.CD008313.pub3
    BACKGROUND: The increased birth rate of twins during recent decades and the improved prognosis of preterm infants have resulted in the need to explore measures that could optimize their growth and neurodevelopmental outcomes. It has been postulated that co-bedding simulates twins' intrauterine experiences in which co-regulatory behaviors between them are observed. These behaviors are proposed to benefit twins by reducing their stress, which may promote growth and development. However, in practice, uncertainty surrounds the benefit-risk profile of co-bedding.

    OBJECTIVES: We aimed to assess the effectiveness of co-bedding compared with separate (individual) care for stable preterm twins in the neonatal nursery in promoting growth and neurodevelopment and reducing short- and long-term morbidities, and to determine whether co-bedding is associated with significant adverse effects.As secondary objectives, we sought to evaluate effects of co-bedding via the following subgroup analyses: twin pairs with different weight ranges (very low birth weight [VLBW] < 1500 grams vs non-VLBW), twins with versus without significant growth discordance at birth, preterm versus borderline preterm twins, twins co-bedded in incubator versus cot at study entry, and twins randomized by twin pair versus neonatal unit.

    SEARCH METHODS: We used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We used keywords and medical subject headings (MeSH) to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (via PubMed), EMBASE (hosted by EBSCOHOST), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and references cited in our short-listed articles, up to February 29, 2016.

    SELECTION CRITERIA: We included randomized controlled trials with randomization by twin pair and/or by neonatal unit. We excluded cross-over studies.

    DATA COLLECTION AND ANALYSIS: We extracted data using standard methods of the CNRG. Two review authors independently assessed the relevance and risk of bias of retrieved records. We contacted the authors of included studies to request important information missing from their published papers. We expressed our results using risk ratios (RRs) and mean differences (MDs) when appropriate, along with 95% confidence intervals (95% CIs). We adjusted the unit of analysis from individual infants to twin pairs by averaging measurements for each twin pair (continuous outcomes) or by counting outcomes as positive if developed by either twin (dichotomous outcomes).

    MAIN RESULTS: Six studies met the inclusion criteria; however, only five studies provided data for analysis. Four of the six included studies were small and had significant limitations in design. As each study reported outcomes differently, data for most outcomes were effectively contributed by a single study. Study authors reported no differences between co-bedded twins and twins receiving separate care in terms of rate of weight gain (MD 0.20 grams/kg/d, 95% CI -1.60 to 2.00; one study; 18 pairs of twins; evidence of low quality); apnea, bradycardia, and desaturation (A/B/D) episodes (RR 0.85, 95% CI 0.18 to 4.05; one study; 62 pairs of twins; evidence of low quality); episodes in co-regulated states (MD 0.96, 95% CI -3.44 to 5.36; one study; three pairs of twins; evidence of very low quality); suspected or proven infection (RR 0.84, 95% CI 0.30 to 2.31; three studies; 65 pairs of twins; evidence of very low quality); length of hospital stay (MD -4.90 days, 95% CI -35.23 to 25.43; one study; three pairs of twins; evidence of very low quality); and parental satisfaction measured on a scale of 0 to 55 (MD -0.38, 95% CI -4.49 to 3.73; one study; nine pairs of twins; evidence of moderate quality). Although co-bedded twins appeared to have lower pain scores 30 seconds after heel lance on a scale of 0 to 21 (MD -0.96, 95% CI -1.68 to -0.23; two studies; 117 pairs of twins; I(2) = 75%; evidence of low quality), they had higher pain scores 90 seconds after the procedure (MD 1.00, 95% CI 0.14 to 1.86; one study; 62 pairs of twins). Substantial heterogeneity in the outcome of infant pain response after heel prick at 30 seconds post procedure and conflicting results at 30 and 90 seconds post procedure precluded clear conclusions.

    AUTHORS' CONCLUSIONS: Evidence on the benefits and harms of co-bedding for stable preterm twins was insufficient to permit recommendations for practice. Future studies must be adequately powered to detect clinically important differences in growth and neurodevelopment. Researchers should assess harms such as infection, along with medication errors and caregiver satisfaction.

  20. Kiran Kumar Krishanappa S, Prashanti E, Sumanth KN, Naresh S, Moe S, Aggarwal H, et al.
    PMID: 27231038 DOI: 10.1002/14651858.CD011784.pub2
    BACKGROUND: An oro-antral communication is an unnatural opening between the oral cavity and maxillary sinus. When it fails to close spontaneously, it remains patent and is epithelialized to develop into an oro-antral fistula. Various surgical and non-surgical techniques have been used for treating the condition. Surgical procedures include flaps, grafts and other techniques like re-implantation of third molars. Non-surgical techniques include allogenic materials and xenografts.

    OBJECTIVES: To assess the effectiveness and safety of various interventions for the treatment of oro-antral communications and fistulae due to dental procedures.

    SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (whole database, to 3 July 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2015, Issue 6), MEDLINE via OVID (1946 to 3 July 2015), EMBASE via OVID (1980 to 3 July 2015), US National Institutes of Health Trials Registry (http://clinicaltrials.gov) (whole database, to 3 July 2015) and the World Health Organization (WHO) International Clinical Trials Registry Platform (http://www.who.int/ictrp/en/) (whole database, to 3 July 2015). We also searched the reference lists of included and excluded trials for any randomised controlled trials (RCTs).

    SELECTION CRITERIA: We included RCTs evaluating any intervention for treating oro-antral communications or oro-antral fistulae due to dental procedures. We excluded quasi-RCTs and cross-over trials. We excluded studies on participants who had oro-antral communications, fistulae or both related to Caldwell-Luc procedure or surgical excision of tumours.

    DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials. Two review authors assessed trial risk of bias and extracted data independently. We estimated risk ratios (RR) for dichotomous data, with 95% confidence intervals (CI). We assessed the overall quality of the evidence using the GRADE approach.

    MAIN RESULTS: We included only one study in this review, which compared two surgical interventions: pedicled buccal fat pad flap and buccal flap for the treatment of oro-antral communications. The study involved 20 participants. The risk of bias was unclear. The relevant outcome reported in this trial was successful (complete) closure of oro-antral communication.The quality of the evidence for the primary outcome was very low. The study did not find evidence of a difference between interventions for the successful (complete) closure of an oro-antral communication (RR 1.00, 95% Cl 0.83 to 1.20) one month after the surgery. All oro-antral communications in both groups were successfully closed so there were no adverse effects due to treatment failure.We did not find trials evaluating any other intervention for treating oro-antral communications or fistulae due to dental procedures.

    AUTHORS' CONCLUSIONS: We found very low quality evidence from a single small study that compared pedicled buccal fat pad and buccal flap. The evidence was insufficient to judge whether there is a difference in the effectiveness of these interventions as all oro-antral communications in the study were successfully closed by one month after surgery. Large, well-conducted RCTs investigating different interventions for the treatment of oro-antral communications and fistulae caused by dental procedures are needed to inform clinical practice.

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