Review Of Randomized Controlled Trials Research Articles

THERAPEUTIC TARGETING OF BRAIN ARACHIDONIC ACID CASCADE IN BIPOLAR DISORDER BY LOW DOSE ASPIRIN AND CELECOXIB

Studies in unanesthetized rats suggest that mood stabilizers approved for treating bipolar disorder downregulate brain arachidonic acid (AA) metabolism. AA plays a role in neurotransmission and neuroinflammation, among other processes. Other drugs that reduce brain AA metabolism may add to mood stabilizer action. We reviewed randomized controlled trials (RCTs) and population studies to examine whether celecoxib, a selective cyclooxygenase (COX)-2 inhibitor, and acetylsalicylate (aspirin), a COX-1 and COX-2 inhibitor and acetylator, were useful in bipolar disorder patients on mood stabilizers. COX-1 and COX-2 metabolize AA to bioactive eicosanoids. Celecoxib significantly enhanced mood stabilizer efficacy in two 6-week RCTs involving 86 manic bipolar inpatients, and in one 8-week RCT on 49 patients with treatment-resistant bipolar depression. With regard to aspirin, a Dutch pharmacoepidemiological study involving 5145 subjects taking lithium reported symptom reduction with added chronic low dose 30-80 mg/day aspirin, while a Danish study on 321,350 subjects taking chronic 75-150 mg/day aspirin found fewer manic episodes than in subjects not on aspirin. Finally, a recent 6-week RCT using low-dose aspirin and/or minocycline showed a specific positive effect of aspirin. Efficacy of both celecoxib and aspirin as adjuncts to mood stabilizers in the treatment of bipolar disorder is consistent with the AA hypothesis for mood stabilizer action in that disorder.

A Systematic Review of Music Therapy for Psychosocial Outcomes of Substance Use Clients

The objective of this study is to systematically review randomized controlled trials (RCTs) and quasi-experiments that assess how music therapy affects the psychosocial outcomes of clients who are being treated for substance use concerns. This review includes all RCTs and quasi-experiments published in English-language peer-reviewed journals since 2006 that assess music therapy interventions for substance use. A search of bibliographic databases returned a list of 195 potential studies, which was narrowed to 14 for analysis. Current research supports the possibility that music therapy is an expressive intervention that can reduce depressive symptoms, as well as increase motivation for treatment and readiness to change patterns of substance use. Despite an increase in quantitative research on this topic in the last 10 years, an overall paucity of quantitative studies and lack of long-term research suggest that more primary studies are still needed before any conclusions can be made about the efficacy of music therapy for treating substance use.

Randomized Controlled Trials of Headache Treatments in Pregnancy: A Systematic Review.

Headaches affect 88% of reproductive-aged women. Yet data are limited addressing treatment of headache in pregnancy. While many women experience improvement in pregnancy, primary and secondary headaches can develop. Consequently, pregnancy is a time when headache diagnosis can influence maternal and fetal interventions. This study was aimed to summarize existing randomized control trials (RCTs) addressing headache treatment in pregnancy. We searched PubMed, CINAHL, EMBASE, ClinicalTrials.gov, Cochrane Library, CINAHL, and SCOPUS from January 1, 1970 through June 31, 2019. Studies were eligible if they were English-language RCTs addressing treatment of headache in pregnancy. Conference abstracts and studies investigating postpartum headache were excluded. Three authors reviewed English-language RCTs addressing treatment of antepartum headache. To be included, all authors agreed each article to meet the following criteria: predefined control group, participants underwent randomization, and treatment of headache occurred in the antepartum period. If inclusion criteria were met no exclusions were made. Our systematic review registration number was CRD42019135874. A total of 193 studies were reviewed. Of the three that met inclusion criteria all were small, with follow-up designed to measure pain reduction and showed statistical significance. Our systematic review of RCTs evaluating treatment of headache in pregnancy revealed only three studies. This paucity of data limits treatment, puts women at risk for worsening headache disorders, and delays diagnosis placing both the mother and fetus at risk for complications.

Effects of mind-body exercises for osteoporosis in older adults: Protocol for systematic review and Bayesian network meta-analysis of randomized controlled trials.

background:Osteoporosis is an important cause of bone fractures and even a cause of threaten to the lives of elderly people. Mind-body exercises are beneficial interventions for improving flexibility, controlling body balance, and reducing pain. To assess the effect of mind-body exercise on osteoporosis in aging people, we will perform this systematic review.Methods:Randomized controlled trials (RCTs) which carried out about mind-body exercise for osteoporosis will be included. Web of Science, PubMed, Science Direct, Medline, Cochrane Library, China National Knowledge Infrastructure, and Wanfang will be searched from inception to January 2020. The outcomes will include bone mineral density (BMD), bone mineral content (BMC), body balance, function of lower extremity, pain, fearing level, and quality of life. Trial reporting quality will be assessed by 2 reviewers independently and Review Manager 5.3 software will be used for meta-analysis. Trial registration is under PROSPERO (CRD42020165385).Results:Based on the current evidence, the potential rank of the efficacy and safety of mind-body exercises for BMD, BMC, body balance, function of lower extremity, pain, fearing level and quality of life will be assessed, and a prioritization regimen will be summarized.Conclusions:Evidence from this systematic review could be useful for patients, clinical practitioners, and guideline-makers to select an optimum proposal of mild-body exercises for older adults with osteoporosis.

Efficacy and safety of methotrexate in the management of inflammatory bowel disease: A systematic review and meta-analysis of randomized, controlled trials

BackgroundThe therapeutic role of methotrexate (MTX) for management of inflammatory bowel disease (IBD) remains unclear. MethodsWe systematically reviewed randomized, controlled trials (RCTs) of MTX for induction and maintenance of remission in IBD until January 2020 in accordance with PROSPERO protocol (#CRD42018115047). Relative risk (RR) of maintenance of remission, induction of remission, endoscopic disease activity, and adverse events were combined in a meta-analysis. FindingsMTX monotherapy was not superior to placebo for induction of clinical remission in Crohn's disease (CD). However, MTX was superior to placebo in maintaining clinical remission of CD. Concomitant therapy with MTX and the TNF inhibitor infliximab (IFX) was not superior to IFX monotherapy in CD. In ulcerative colitis (UC), MTX monotherapy was not superior to placebo neither for induction of clinical remission, nor for maintenance of clinical remission. MTX did not result in superior endoscopic outcomes during induction or maintenance therapy compared with placebo. Regarding adverse events (AEs), our meta-analysis on CD studies showed a significantly higher risk of AEs when comparing MTX versus placebo in studies investigating induction of remission, but not in maintenance of remission. In UC, no such differences in AEs between MTX or placebo were observed. InterpretationCurrent data support the efficacy of parenteral MTX monotherapy for maintenance of clinical remission in CD. MTX is not confirmed to be effective for treatment of UC or for induction of remission in CD. No evidence supports concomitant MTX to improve efficacy of IFX (no other biologics investigated).

Effects of physical activities on dementia-related biomarkers: A systematic review of randomized controlled trials.

IntroductionPhysical activities (PA) may lead to improved cognition in mild cognitive impairment (MCI), Alzheimer's disease (AD), and dementia. The mechanisms mediating potential PA effects are unknown. Assessment of PA effects on relevant biomarkers may provide insights into mechanisms underlying potential PA effects on cognition.MethodsWe systematically reviewed randomized controlled trials (RCTs) that studied PA effects on biomarkers in MCI, AD, and dementia populations. We examined whether biological mechanisms were hypothesized to explain associations among PA, biomarkers, and cognitive functions. We used the PubMed database and searched for RCTs with PA until October 31, 2019.ResultsOf 653 studies examining changes in biomarkers in PA trials, 18 studies met inclusion criteria for the present review. Some studies found favorable effects of PA on neurotrophic and inflammatory biomarkers. AD pathological markers were rarely investigated, with inconclusive results. Most studies were relatively small in sample size, of limited duration, and not all studies compared the changes in biomarkers between the control and experimental groups.DiscussionThere is only limited use of potentially informative biomarkers in PA trials for MCI, AD, and dementia. Most studies did not examine the role of biomarkers to study associations between PA and cognitive functions in their analyses. Several potential biomarkers remain uninvestigated. Careful use of biomarkers may clarify mechanisms underlying PA effects on cognition. Our review serves as a useful resource for developing future PA RCTs aimed at improving cognitive functions in MCI, AD, and dementias.

The diode laser as coadyuvant therapy in the non-surgical conventional treatment of peri-implant mucositis: A systematic review and meta-analysis

BackgroundThe present study systematically reviewed randomized controlled trials (RCT) to investigate the effect of diode laser therapy in the management of peri-implant mucositis. Material and MethodsThe electronic databases were searched until January 2020. Outcome measures were bleeding on probing (BOP), plaque index (PI) and probing depth (PD). The addressed PICO question was: Is the diode laser therapy effective reducing the signs of inflammation as an adjunctive element in the non-surgical treatment of peri-implant mucositis?. ResultsEight randomized clinical trials (RCTs) were included in the systematic review for qualitative synthesis and three in the meta-analysis for quantitative synthesis. All studies included in the quantitative synthesis have low risk of bias according to the Cochrane collaborations’ tool. Diode laser as coadyuvant therapy significantly reduced plaque index (SMD: -1.24; -0.47/-1.53) but not in bleeding on probing (SMD: -0.84; -0.31/-1.53) or probing pocket depth (SMD: -1.36; -0.28/-1.69). Non-statistically significant reductions in peri-implant bleeding on probing and in probing pocket depth were also observed in the test groups of most studies included in the meta-analysis. ConclusionsThe results should be interpreted cautiously due to the great heterogeneity in the methodology of the studies included in the systematic review. However the meta-analysis suggests that the use of diode lasers, as an adjunct in conventional non-surgical treatment of peri-implant mucositis, is promising in reducing the clinical signs of peri-implant mucositis, especially reducing the perii-implant plaque index. Key words:Peri-implant diseases, peri-implant mucositis, laser therapy, diode laser.

Can Active Video Games Improve Physical Activity in Adolescents? A Review of RCT.

Children and adolescents are not meeting the required federal physical activity (PA) guidelines established by the United States Department of Health and Human Services. It is critical that a regular pattern of PA is established in their youth to ensure ongoing PA into adulthood. However, many programs implemented during adolescence have shown limited effects, stressing the need for more innovative approaches to generate more interest and maintenance of PA behavior in this age group. Active video games (AVGs) or exergaming may prove to be an innovate process to improve PA in children and adolescents. A literature review was conducted to explore if active video games or exergaming could be an effective intervention to improve physical activity in adolescents. Active video games, also called “exergames”, are a category of video games that require movement or physical exertion to play the game. The methodology consisted of searching Academic Search Premier, CINAHL, The Cochrane Library, ERIC, PubMed, and Web of Science databases. Inclusion criteria involved only youth aged 12 to 19 years, randomized controlled trials (RCTs), and studies within the last 12 years. The following search terms were used: exergaming or active video games; physical activity or exercise; adolescents or youth; RCT or randomized clinical trial. The outcome indicates that exergaming or active video games can be an effective tool to improve PA in adolescents that will be more acceptable and sustainable than many conventional approaches.

An overview of systematic reviews of complementary and alternative therapies for infantile colic

BackgroundInfantile colic is a distressing condition characterised by excessive crying in the first few months of life. The aim of this research was to update the synthesis of evidence of complementary and alternative medicine (CAM) research literature on infantile colic and establish what evidence is currently available.MethodsMedline, Embase and AMED (via Ovid), Web of Science and Central via Cochrane library were searched from their inception to September 2018. Google Scholar and OpenGrey were searched for grey literature and PROSPERO for ongoing reviews. Published systematic reviews that included randomised controlled trials (RCTs) of infants aged up to 1 year, diagnosed with infantile colic using standard diagnostic criteria, were eligible. Reviews of RCTs that assessed the effectiveness of any individual CAM therapy were included. Three reviewers were involved in data extraction and quality assessment using the AMSTAR-2 scale and risk of bias using the ROBIS tool.ResultsSixteen systematic reviews were identified. Probiotics, fennel extract and spinal manipulation show promise to alleviate symptoms of colic, although some concerns remain. Acupuncture and soy are currently not recommended. The majority of the reviews were assessed as having high or unclear risk of bias and low confidence in the findings.ConclusionThere is clearly a need for larger and more methodologically sound RCTs to be conducted on the effectiveness of some CAM therapies for IC. Particular focus on probiotics in non-breastfed infants is pertinent.Systematic review registrationPROSPERO: CRD42018092966.

Probiotics for glycemic control in patients with type 2 diabetes mellitus: protocol for a systematic review

BackgroundType 2 diabetes mellitus (T2DM) is a major public health problem worldwide. It is characterized by the increased concentration of glucose in the blood and leads to damage of the body system, especially blood vessels and nerves. Lifestyle modification is often combined with anti-diabetic therapy as the standard of care for T2DM to maintain the proper blood glucose and to prevent long-term diabetic complications. The role of probiotics in improving glycemic control has been investigated in several randomized controlled trials (RCTs). Previous systematic reviews and meta-analyses, including different sets of trials have concluded an overall beneficial effect of probiotics in patients with T2DM. At least two RCTs with a longer treatment duration have been published since the publication of existing reviews.MethodsWe will conduct a systematic review of RCTs that evaluated the effectiveness and safety of probiotics for glycemic control in T2DM patients. Primary outcomes are fasting blood glucose and glycosylated hemoglobin (A1c). Secondary outcomes are plasma insulin, blood lipid profile, adverse events, and cost associated with the intervention and hospital visits. We will search PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, and trial registries. Two reviewers will independently screen titles and abstracts, review full texts, extract information, and assess the risk of bias. We will summarize the results both qualitatively and statistically. We will use random-effects model for meta-analysis.DiscussionThis systematic review aims to examine whether probiotics are effective and safe for glycemic control in T2DM patients. Evidence generated from this review will inform clinical and public health practice and future research.Systematic review registrationCRD42019121682

Perspectives on the Use of Ninjin'yoeito in Modern Medicine: A Review of Randomized Controlled Trials.

Background Ninjin'yoeito (NYT), a traditional Japanese (Kampo) medicine that originates from China, has been used to treat qi and blood deficiency based on its original concept. Kampo medicine has been widely used to treat many conditions and disorders combined with western medicine or Kampo medicine alone in modern situation. Aims We reviewed randomized controlled trials (RCTs) of NYT and discussed various standpoints regarding its use in modern situation. Methods We searched PubMed, Cochrane Library, and Evidence Reports of Kampo Treatment (EKAT) for articles written in English, and Ichushi, J-Stage, and EKAT for those written in Japanese. Articles published before January 1, 2019, were retrieved using the keywords “ninjinyoeito” and “ninjin'yoeito,” and RCTs were selected from these extracted articles. Result Of 734 articles, 13 were RCTs, 46 were non-RCTs or studies of other designs, 15 were case reports, and 36 were experimental studies using NYT. NYT was evaluated for its use as a treatment for cancer and related conditions, refractory blood diseases and conditions, and otorhinolaryngologic symptom in 13 RCTs. Based on the use of Kampo medicine in modern situation called as Yasui's classification, 10 of 13 RCTs were categorized as “the side effects of Western medicinal treatment are mitigated when combined with Kampo treatment” and the remaining 3 were categorized as “treatment effect of Kampo medicine is increased in combination with standard Western medicinal treatment.” Conclusion. Several studies demonstrated the efficacy of NYT in refractory diseases and other conditions, and the accompanied side effects of treatment with western medicine.

Evaluating the quality of conduct of systematic reviews on the application of transcranial magnetic stimulation (TMS) for aphasia rehabilitation post-stroke

ABSTRACT Background Noninvasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) are used to facilitate the recovery of language in stroke patients with aphasia. Although rTMS is a promising therapeutic method, further investigations are needed to expand the knowledge base about the use of the technique in stroke-induced aphasia. Aims To evaluate the quality of conduct of systematic reviews of randomized controlled trials (RCTs) of interventions on the application of rTMS for aphasia rehabilitation post-stroke using the AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) instrument. Methods & Procedures A search was performed of databases specific to systematic reviews. Four systematic reviews met the inclusion criteria. All aspects regarding the conduct of each individual systematic review was critically appraised using the AMSTAR 2 instrument. Outcomes & Results The overall confidence ratings based on weaknesses in critical domains identified by the AMSTAR 2 was low for one systematic review and critically low for the remaining three. Conclusions The quality of conduct of published systematic reviews of RCTs on the application of rTMS for aphasia rehabilitation post-stroke is low. The evidence for the effectiveness of rTMS on language recovery post-stroke remains inconclusive. The findings underscore the need for methodologically rigor trials on the applicability of TMS as an intervention approach for aphasia. Published guidelines to provide reliable and replicable results are urgently needed.

Interventions for Dietary Sodium Restriction Among Patients with Heart Failure: A Mismatch in the Evidence and Intervention Design (OR22-05-19)

ObjectivesDietary sodium restriction guidelines are controversial due to a lack of studies assessing their effect on heart failure outcomes. An important aspect of this problem is the effectiveness of behavioral nutrition interventions to reduce patients’ sodium intake. We systematically reviewed randomized controlled trials (RCTs) of sodium restricted diets and descriptive studies relating mediators of behavior to successful adherence to sodium restricted diets in patients with heart failure. MethodsWe queried PubMed, CINAHL, and Cochrane databases with relevant search terms for studies published in English January 2000-December 2018. Included were RCTs of interventions for heart failure patients, with sodium restriction as a primary or secondary outcome, and quantitative and qualitative descriptive studies of adherence to sodium restricted diets. Included studies may or may not have reported clinical outcomes (health events, quality of life, etc.). Reviewers noted setting, methods, and outcomes as well as theoretical mediators of dietary behavior change in included studies. We then compared behavioral mediators addressed by the RCTs and behavioral mediators identified in the descriptive studies. ResultsOf 638 studies identified, 445 were excluded by title. 2 reviewers assessed 60 abstracts and included 36 studies in this analysis: 10 RCTs and 26 descriptive studies. 6 of 10 intervention RCTs were successful, but no interventions achieved the recommended 1500 mg/day sodium intake (mean for all studies 3271 mg/day). Interventions that reduced sodium intake were behaviorally focused, were delivered by an RN and/or RD, and included individual feedback and counseling. RCTs intervened only through knowledge, skills, and social support. Behavioral mediators identified in descriptive studies included perceived risk, perceived benefits, outcome expectations, cultural norms, social norms, social support, taste preferences, determinism, self-efficacy, knowledge, skills, and habits. These were not included in the RCTs, which signifies a mismatch between evidence-based moderators of behavior and intervention designs. ConclusionsRCTs have been unable to achieve the recommended goal of 1500 mg/day of sodium. More effective interventions should consider evidence-based mediators, rather than focusing on knowledge and skills. Funding SourcesDr. Burgermaster received funding from NHLBI T32 training grant.

Animal-assisted therapy for schizophrenia and related disorders: A systematic review

Animal-assisted therapy (AAT) is increasingly researched as a potential treatment for physical and mental illness, including schizophrenia. The aim of the current paper is to systematically review randomised controlled trials (RCTs) to assess the effectiveness of AAT for schizophrenia and related disorders. We searched PubMed, PsycINFO, CINAHL, EMBASE, The Cochrane Library, CAB Abstracts, and Web of Science for RCTs of AAT for schizophrenia and related disorders. Primary outcomes were mental state and behaviour, clinical global response, and quality of life and wellbeing. Studies were eligible if they were RCTs that had compared AAT, or other animal-assisted intervention, to any control group using any participants with a clinical diagnosis of schizophrenia (or related disorder), regardless of age, gender, setting, or severity and duration of illness. Seven studies were identified for the review. Meta-analysis was not possible due to heterogeneity of studies, including marked differences in outcome measures and interventions. Five out of seven studies included symptoms as an outcome measure, with one reporting improvements in negative symptoms and one study reporting improvements in positive and emotional symptoms. The remaining studies reported no significant effects of AAT. Three studies included quality of life as an outcome measure but did not find any significant effects. Two studies did, however, report improvements in various measures of self-view. The use of AAT for schizophrenia remains inconclusive and there is currently not enough evidence to draw any firm conclusions due to heterogeneity of studies, risk of bias, and small samples. Rigorous, large-scale RCTs are needed to assess the true impact of AAT on schizophrenia.

Sa1945 – Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Systematic Review of Randomized-Controlled Trials

Sa1945 – Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Systematic Review of Randomized-Controlled Trials

Yoga for symptom management in oncology: A review of the evidence base and future directions for research.

Because yoga is increasingly recognized as a complementary approach to cancer symptom management, patients/survivors and providers need to understand its potential benefits and limitations both during and after treatment. The authors reviewed randomized controlled trials (RCTs) of yoga conducted at these points in the cancer continuum (N=29; n=13 during treatment, n=12 post-treatment, and n=4 with mixed samples). Findings both during and after treatment demonstrated the efficacy of yoga to improve overall quality of life (QOL), with improvement in subdomains of QOL varying across studies. Fatigue was the most commonly measured outcome, and most RCTs conducted during or after cancer treatment reported improvements in fatigue. Results also suggested that yoga can improve stress/distress during treatment and post-treatment disturbances in sleep and cognition. Several RCTs provided evidence that yoga may improve biomarkers of stress, inflammation, and immune function. Outcomes with limited or mixed findings (eg, anxiety, depression, pain, cancer-specific symptoms, such as lymphedema) and positive psychological outcomes (such as benefit-finding and life satisfaction) warrant further study. Important future directions for yoga research in oncology include: enrolling participants with cancer types other than breast, standardizing self-report assessments, increasing the use of active control groups and objective measures, and addressing the heterogeneity of yoga interventions, which vary in type, key components (movement, meditation, breathing), dose, and delivery mode.

Network meta-analysis of randomised trials of pharmacological, psychotherapeutic, exercise and collaborative care interventions for depressive symptoms in patients with coronary artery disease: hybrid systematic review of systematic reviews protocol

BackgroundDepression is common in patients with coronary artery disease (CAD) and is associated with poorer outcomes and higher costs. Several randomised controlled trials (RCTs) targeting depression, of various modalities (including pharmacological, psychotherapeutic and other approaches), have been conducted and summarised in pairwise meta-analytic reviews. However, no study has considered the cumulative evidence within a network, which can provide valuable indirect comparisons and information about the relative efficacy of interventions. Therefore, we will adopt a review of review methodology to develop a network meta-analysis (NMA) of depression interventions for depression in CAD.MethodsWe will search relevant databases from inception for systematic reviews of RCTs of depression treatments for people with CAD, supplementing this with comprehensive searches for recent or ongoing studies. We will extract data from and summarise characteristics of individual RCTs, including participants, study characteristics, outcome measures and adverse events. Cochrane risk of bias ratings will also be extracted or if not present will be conducted by the authors.RCTs that compare depression treatments (grouped as pharmacological, psychotherapeutic, combined pharmacological/psychotherapeutic, exercise, collaborative care) to placebo, usual care, waitlist control or attention controls, or directly in head-to-head comparisons, will be included. Primary outcomes will be the change in depressive symptoms (summarised with a standardised mean difference) and treatment acceptability (treatment discontinuation: % of people who withdrew). Secondary outcomes will include change in 6-month depression outcomes, health-related quality of life (HRQoL), mortality, cardiovascular morbidity, health services use and adverse events. Secondary analyses will form further networks with individual anti-depressants and psychotherapies.We will use frequentist, random effects multivariate network meta-analysis to synthesise the evidence for depression intervention and to achieve a ranking of treatments, using Stata. Rankograms and surface under the cumulative ranking curves will be used for treatment ranking. Local and global methods will evaluate consistency. GRADE will be used to assess evidence quality for primary outcomes.DiscussionThe present review will address uncertainties about the evidence in terms of depression management in CAD and may allow for a ranking of treatments, including providing important information for future research efforts.Systematic review registrationPROSPERO CRD42018108293

Health effects of micronutrient fortified dairy products and cereal food for children and adolescents: A systematic review.

IntroductionMicronutrient (MN) deficiencies cause a considerable burden of disease for children in many countries. Dairy products or cereals are an important food component during adolescence. Fortification of dairy products or cereals with MN may be an effective strategy to overcome MN deficiencies, but their specific impact on health in this age group is poorly documented.MethodsWe performed a systematic review and meta-analysis (registration number CRD42016039554) to assess the impact of MN fortified dairy products and cereal food on the health of children and adolescents (aged 5–15 years) compared with non-fortified food. We reviewed randomised controlled trials (RCT) using electronic databases (MEDLINE, EMBASE, Cochrane library; latest search: January 2018), reference list screening and citation searches. Three pairs of reviewers assessed 2048 studies for eligibility and extracted data. We assessed the risk of bias and applied GRADE to rate quality of evidence.ResultsWe included 24 RCT (often multi MN fortification) with 30 pair-wise comparisons mainly from low- and middle income countries. A very small and non-significant increase of haemoglobin values emerged (0.09 g/dl [95%-CI: -0.01 to 0.18]; 13 RCT with iron fortification; very low quality of evidence). No significant difference was found on anaemia risk (risk ratio 0.87 [95%-CI: 0.76 to 1.01]; 12 RCT; very low quality), but a significant difference in iron deficiency anaemia favouring fortified food was found (risk ratio 0.38 [95%-CI: 0.18 to 0.81]; 5 RCT; very low quality). Similar effects were seen for fortified dairy products and cereals and different fortification strategies (mono- vs. dual- vs. multi-MN). Follow-up periods were often short and the impact on anthropometric measures was weak (low quality of evidence) Very low quality of evidence emerged for the improvement of cognitive performance, functional measures and morbidity.ConclusionsFortification of dairy products and cereal food had only marginal health effects in our sample population from 5–15 years. Further evidence is needed to better understand the health impact of fortified dairy products and cereals in this age group.Systematic review registrationThe study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 26 May 2016 (registration number CRD42016039554).

Control Groups in RCTs of Psychoeducational Palliative Care Interventions: A Systematic Review (S830)

1.Explain the purpose of a control group that is neither usual care nor no-treatment.2.Describe the current practice using control groups that are neither usual care nor no-treatment in RCTs of psychoeducational palliative care interventions.3.Compare the explanations of the active intervention and the more-than-usual-care control in trial reports of RCTs of psychoeducational palliative care interventions. In randomized controlled trials (RCTs) an active intervention’s efficacy is determined relative to a control condition; thus the control condition’s design is as important as the intervention’s. In RCTs of psychoeducational palliative care interventions, researchers often use a control condition that is neither usual care nor no-treatment, but little is known about the extent of research practices in designing such control conditions. Therefore, this study examined: 1) the current research practice using control conditions that are neither usual care nor no-treatment controls in RCTs of psychoeducational palliative care interventions, and 2) the rationale and completeness of the description of those control conditions in trail reports. PubMed, Embase, PsychINFO, and Web of Science were searched. The final sample included nine trial reports. For quality assessment, a modified Delphi list was used. The descriptions of both the active interventions and the control conditions were assessed using a modified version of Schulz et al's Intervention Taxonomy checklist. Four trials used attention controls designed to be equivalent to the structure of the active interventions. An additional four trials used a control condition with some aspects of attention control, but neither the amount nor the intensity of attention were similar to the intervention. Only three trial reports stated the rationale for choice of control conditions. Most reports contained delivery mode, materials, duration, frequency, and sequence of both the intervention and control conditions; but none described the qualifications or training required to deliver the control condition. Only one report mentioned the fidelity monitoring method, and no report included fidelity monitoring data. Our review of RCTs in psychoeducational palliative care interventions calls for researchers’ attention to appropriate selection, design, conduct and report of control conditions.

Effectiveness of core stability exercises in patients with chronic non-specific low back pain: A review of randomized controlled trials

Individual studies have shown that core stability exercise (CSE) program is effective at improving pain and function in patients with chronic nonspecific low back pain (LBP) and the use of this intervention has become increasingly popular. However, there is still a further need for systematic review to infer the precise efficacy of CSEs for chronic nonspecific LBP (CNLBP). The aim of this study was to systematically review randomized controlled trials (RCTs) evaluating the effectiveness of CSEs in patients with CNLBP. A systematic review of RCTs was done using published articles. Recognized databases such as CINAHL, AMED, MEDLINE, PEDro, and The Cochrane Library were used to search for RCTs published between 2010 and 2015 in which pain and disability were evaluated as outcomes. Methodological quality was assessed using the PEDro scale. Six studies met the criteria for this review. The included studies randomised participants into two different exercise groups. All studies had PEDro scores of >5/10. Five out of the six studies showed benefits of CSEs over other intervention or control for pain and disability while the other study shows both CSEs and traditional trunk exercises to be effective. The result of this review supports the effectiveness of CSEs at improving pain and disability in patients with CNLBP. Further studies with robust methodology are warranted to assess the longterm effects of this intervention in patients with CNLBP.