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In people with bone and soft tissue injuries of the wrist, hand and/or fingers, do feedback-guided exercises performed on a tablet touchscreen hasten return to work, reduce healthcare usage and improve clinical recovery more than a home exercise program prescribed on paper? Randomised, parallel-group trial with concealed allocation, assessor blinding and intention-to-treat analysis. Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers. Participants in the experimental and control groups received the same in-patient physiotherapy and occupational therapy. Participants in the experimental group received a home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression. Participants in the control group were prescribed an evidence-based home exercise program on paper. The primary outcome was the time taken to return to work. Secondary outcomes included: healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation. Compared with the control group, the experimental group: returned to work sooner (MD –18 days, 95% CI –33 to –3); required fewer physiotherapy sessions (MD –7.4, 95% CI –13.1 to –1.6), rehabilitation consultations (MD –1.9, 95% CI –3.6 to 0.3) and plastic surgery consultations (MD –3.6, 95% CI –6.3 to –0.9); and had better short-term recovery of functional ability and pinch strength. In people with bone and soft-tissue injuries of the wrist, hand and/or fingers, prescribing a feedback-guided home exercise program using a tablet-based application instead of a conventional program on paper hastened return to work and improved the short-term recovery of functional ability and pinch strength, while reducing the number of required healthcare appointments. ACTRN12619000344190 [ABSTRACT FROM AUTHOR]

Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

Objective: The beneficial effects of antiseptics in the treatment of periodontitis are still controversial. The goal of this randomized split-mouth study was to evaluate the clinical and microbiologic results of a unique subgingival irrigation of 10% povidone-iodine in addition to a full-mouth scaling and root planing for the treatment of chronic periodontitis. Method and Materials: Twenty patients with chronic periodontitis took part in this investigation. In each patient, four initially untreated pockets > 4 mm were randomly selected for one subgingival irrigation. After a one-session full-mouth treatment with scaling and root planing (SRP), two pockets of a split mouth received one unique irrigation with 10 mL 0.9% NaCl solution (control group, CG). Two pockets on the other side received 10 mL of povidone-iodine 10% (test group, PIG). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), Plaque Index (PI), Gingival Index (GI), probing pocket depth (PPD), and clinical attachment level (CAL) parameters were assessed at baseline and after 1, 3, and 6 months (M). Bacterial samplings with sterile paper points were taken at M0 and after M1, M3, and M6. These samplings were separately cultured under aerobic and anaerobic conditions before CFU evaluation. Results: Pl, GI, PPD, and CAL were significantly improved in both groups after 6 months. The major difference was seen between M0 and M3 (P<.001). No significant differences were seen between the groups, except for deep pockets (> 6 mm) where a statistical difference was observed in favor of PIG after 6 months; in these subgroups the mean probing reduction was 2.68 ± 0.37 mm for CG versus 3.93 ±0.23 mm in PIG (P<.001). No significant differences were seen between CG and PIG regarding the microbiologic results after 6 months. Conclusion: One single irrigation of 10% povidone-iodine associated with full-mouth SRP would bring a small additional benefit in deep pockets. More studies are needed to yield additional results. [ABSTRACT FROM AUTHOR]

Objective: Arginine-containing toothpastes are a promising new treatment for dentin hypersensitivity (DH), which afflicts a considerable number of patients. However, there have to date been only individual studies. We aim to present an overview of the clinical evidence in order to determine trends and establish firmer conclusions regarding the use of arginine-containing toothpastes for management of DH. Method and Materials: A protocol was developed based on the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0), including: search strategy, selection criteria, data extraction, and risk of bias assessment. We searched electronic databases (up to October 2012) without language limitation, and reference lists of relevant papers for randomized controlled trials that assessed the efficacy of arginine-containing toothpastes for DH treatment. Data extraction and domain-based risk of bias assessment were independently performed by two reviewers. The meta-analysis was performed in STATA (version 12.0). The GRADE analysis was conducted in GRADE profiler (version 3.6). Results: Fourteen randomized controlled studies with different risk of bias were included in the meta-analysis, all evaluated by tactile and air blast assessment. The mean differences and standard deviations for each treatment group were pooled for analysis using a random-effect model. We found that arginine-containing toothpastes had better overall effects in comparison with placebo toothpastes (P < .05), potassium salt-containing toothpastes (P < .05), and strontium-containing toothpastes (P < .05). The GRADE analysis showed that quality of the evidence was moderate when arginine-containing toothpastes were compared to placebo and potassium salt-containing toothpastes, and quality of the evidence was low with comparison to strontium-containing toothpastes. Conclusion: Current available clinical evidence suggests that arginine-containing toothpastes are associated with the reduction of DH compared to both placebo and positive control toothpastes. However, there are limitations to the current studies, and more well-designed trials are needed to confirm the efficacy. [ABSTRACT FROM AUTHOR]

Aim The aim of this systematic review was to evaluate the efficacy of anti-plaque chemical formulations for managing gingivitis, in 6-month, home-use, randomised clinical trials ( RCTs). Material and Methods A protocol was designed, including inclusion and exclusion criteria to identify RCTs assessing gingival and/or bleeding indices. Electronic and hand-searches identified relevant papers, which were screened and evaluated for inclusion. Full-papers were retrieved and relevant information was extracted (also plaque indices), including quality and risk of bias. Mean treatment effects were calculated to obtain weighted mean differences ( WMD) and 95% confidence intervals. Results After the process of screening and selection, 87 articles with 133 comparisons, were included in the review. The additional effects of the tested products were statistically significant in terms of Löe & Silness gingival index (46 comparisons, WMD −0.217), modified gingival index ( n = 23, −0.415), gingivitis severity index ( n = 26, −14.939%) or bleeding index ( n = 23, −7.626%), with significant heterogeneity. For plaque, additional effects were found for Turesky (66 studies, WMD −0.475), Silness & Löe ( n = 26, −0.109), and plaque severity ( n = 12, −23.4%) indices, with significant heterogeneity. Conclusion Within the limitations of the present study, formulations with specific agents for chemical plaque control provide statistically significant improvements in terms of gingival, bleeding and plaque indices. [ABSTRACT FROM AUTHOR]

Objective To compare the costs of inpatient (usual care) with outpatient (intervention) care for cervical priming for induction of labour in women with healthy, low-risk pregnancies who are being induced for prolonged pregnancies or for social reasons. Methods Data from a randomised controlled trial at two hospitals in South Australia were matched with hospital financial data. A cost analysis comparing women randomised to inpatient care with those randomised to outpatient care was performed, with an additional analysis focusing on those who received the intervention. Results Overall, 48% of women randomised into the trial did not receive the intervention. Women randomised to outpatient care had an overall cost saving of $319 per woman (95% CI -$104 to $742) as compared with women randomised to usual care. When restricted to women who actually received the intervention, in-hospital cost savings of $433 (95% CI -$282 to $1148) were demonstrated in the outpatient group. However, these savings were partially offset by the cost of an outpatient priming clinic, reducing the overall cost savings to $156 per woman. Conclusions Overall cost savings were not statistically significant in women who were randomised to or received the intervention. However, the trend in cost savings favoured outpatient priming. What is known about the topic? Induction of labour is a common obstetric intervention. For women with low-risk, prolonged pregnancies who require cervical priming there has been increased interest in whether this period of waiting for the cervix to 'ripen' can be achieved at home. Outpatient priming has been reported to reduce hospital costs and improve maternal satisfaction. However, few studies have actually examined the cost of outpatient priming for induction of labour. What does this paper add? This is the first paper in Australia to both assess the full cost of outpatient cervical priming and to compare it with usual (inpatient) care. This is the first costing paper from a randomised controlled trial directly comparing inpatient and outpatient priming with prostaglandin E[sub 2]. What are the implications for practitioners? For women with prolonged, low-risk pregnancies, a program of outpatient cervical priming can potentially reduce in-hospital costs and free up labour ward beds by avoiding an additional overnight hospitalisation. [ABSTRACT FROM AUTHOR]

Aim To report the evidence on the effect of mechanical and/or chemical plaque control in the simultaneous management of gingivitis and caries. Material and Methods A protocol was designed to identify randomized ( RCTs) and controlled ( CCTs) clinical trials, cohort studies and prospective case series ( PCS), with at least 6 months of follow-up, reporting on plaque, gingivitis and caries. Relevant information was extracted from full papers, including quality and risk of bias. Meta-analyses were performed whenever possible. Results After the screening of 1,373 titles, 15 RCTs, 10 CCTs and 2 PCS were included. Low to moderate evidence support that combined professional and self-performed mechanical plaque control significantly reduces standardized plaque index [ n = 4; weighted mean difference ( WMD) = 1.294; 95% CI (0.445; 2.144); p = 0.003] and gingivitis scores [ n = 4; WMD = 1.728; 95% CI (0.631; 2.825); p = 0.002]. The addition of fluoride to mechanical plaque control is relevant for caries management [ n = 5; WMD = 1.159; 95% CI (0.145; 2.172); p = 0.025] while chlorhexidine rinses are relevant for gingivitis. Conclusion Mechanical plaque control procedures are effective in reducing plaque and gingivitis. The addition of fluoride to mechanical plaque control is significant for caries management. Chlorhexidine rinse has a positive effect on gingivitis and inconclusive role in caries. [ABSTRACT FROM AUTHOR]

Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

Objective: Non-pharmacological therapies (NPTs) have received increasing attention from researchers as a category of treatment to improve cognitive impairment in patients with dementia because of their fewer side effects. In this study, photobiomodulation (PBM), enriched environment (EE), exercise therapy (ET), computerized cognitive training (CCT), and cognitive stimulation therapy (CST) were selected to compare the effects of NPTs that improve dementia by quantifying information from randomized controlled trials (RCTs). Methods: We did a systematic review and network meta-analysis. We searched PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure Database, Wan Fang Database, Chinese Biomedical Literature Database, Web of Science, and VIP Database from the time of database creation to 1 August 2022. Two investigators independently screened the literature, extracted information, and assessed the RCTs' quality with the Cochrane Collaboration Network Risk of Bias 2.0. Network meta-analysis was performed using R language (X64 version 4.1.3) and STATA 17.0. Results: We identified 1,268 citations and of these included 38 trials comprising 3,412 participants. For improving dementia, the results of the network metaanalysis showed that compared with the control group (CON), PBM (SMD = 0.90, 95% CI: 0.43-1.37), EE (SMD = 0.71, 95% CI: 0.02-1.41), ET (SMD = 0.42, 95% CI: 0.16-0.68), and CST (SMD = 0.36, 95% CI: 0.11-0.62) were significantly different (P < 0.05); There was no significant difference in CCT (SMD = 0.41, 95% CI: 0.07-0.88) (P > 0.05). The ranked results showed that PBM has more potential to be the best intervention (P = 0.90). In addition, there was a significant difference between PBM and CST in improving cognitive function (SMD = 0.54, 95% CI: 0.00; 1.08, P < 0.05). Conclusion: In this study, NPTs have excellent potential to improve cognition in people with dementia, and PBM may have more significant benefits in improving cognition than the other four NPTs. [ABSTRACT FROM AUTHOR]

Objective: A multicriteria decision analysis (MCDA) model was used to evaluate the benefits and risks of traditional Chinese medicine preparations of sinomenine alone or in combination with conventional drugs in the treatment of rheumatoid arthritis (RA) and to provide a basis for the rational clinical application of sinomenine. Methods: A study search was performed using six major databases, and Review Manager 5.3 was used for data analysis. Then, an MCDA model evaluation system was established for the treatment of RA with sinomenine preparations, and the benefit values, risk values, and total benefit-risk values of sinomenine preparations alone or in combination with conventional drugs were calculated using Hiview 3.2 software. Finally, Monte Carlo simulations were performed using Crystal Ball embedded in Excel software to calculate the 95% confidence intervals (95% CI), and the probability of the differences between the 2 drug regimens was determined to optimize the evaluation results. Results: Forty-four randomized controlled trials (RCTs) were included. Quantitative assessment of the MCDA model showed that the sinomenine preparation alone offered less benefits than when combined with conventional drugs with a benefit difference of 20 (95% CI 3.06, 35.71). However, the risk of the combination was significantly lower with a risk difference of 13(95% CI -10.26, 27.52). The total value of the benefit-risk of sinomenine alone and in combination with conventional drugs was 46 and 53 at 60% and 40% of the benefit-risk ratio of the two dosing regimens, respectively, with a difference of 7 (95% CI -4.26, 22.12). The probability that the comprehensive score of the combined regimen is greater than that of sinomenine alone is 90.1%, and the evaluation was steady. Conclusion: The benefit-risk of the combined application regimen of sinomenine is greater than that of sinomenine alone. [ABSTRACT FROM AUTHOR]

Context: Both balance training and selected interventions meant to target sensory structures (STARS) have been shown to be effective at restoring deficits associated with chronic ankle instability (CAI). Clinicians often use multiple treatment modalities in patients with CAI. However, evidence for combined intervention effectiveness in CAI patients remains limited. Objective: To determine if augmenting a balance-training protocol with STARS (BTS) results in greater improvements than balance training (BT) alone in those with CAI. Design: Randomized-controlled trial. Setting: Research laboratory. Patients: 24 CAI participants (age 21.3 ± 2.0 y; height 169.8 ± 12.9 cm; mass 72.5 ± 22.2 kg) were randomized into 2 groups: BT and BTS. Interventions: Participants completed a 4-week progression-based balance-training protocol consisting of 3 20-min sessions per week. The experimental group also received a 5-min set of STARS treatments consisting of calf stretching, plantar massage, ankle joint mobilizations, and ankle joint traction before each balance-training session. Main Outcome Measures: Outcomes included self-assessed disability, Star Excursion Balance Test reach distance, and time-to-boundary calculated from static balance trials. All outcomes were assessed before, and 24-hours and 1-week after protocol completion. Self-assessed disability was also captured 1-month after the intervention. Results: No significant group differences were identified (P > .10). Both groups demonstrated improvements in all outcome categories after the interventions (P < .10), many of which were retained at 1-week posttest (P < .10). Although 90% CIs include zero, effect sizes favor BTS. Similarly, only the BTS group exceeded the minimal detectable change for time-to-boundary outcomes. Conclusions: While statistically no more effective, exceeding minimal detectable change scores and favorable effect sizes suggest that a 4-week progressive BTS program may be more effective at improving self-assessed disability and postural control in CAI patients than balance training in isolation. [ABSTRACT FROM AUTHOR]

Background Melasma is a common facial skin disorder seen in women. Manual acupuncture (MA) is widely used alone or in combination with conventional treatments for melasma in China. Objectives To assess the effectiveness and safety of MA for melasma, and explore the range of treatments applied. Methods Six databases were searched systematically for randomised controlled trials (RCTs) on acupuncture for melasma in women up to November 2014. RevMan software was used for data analysis. The Cochrane tool of Risk of Bias was used to assess the methodological quality of the RCTs. Results Eight RCTs involving 587 women were included. Seven studies used the encircling needling method, four studies used the quick needling method and four studies used intensive needle manipulations. Five studies provided individualised acupuncture treatments. Points used with highest frequency were SP6, ST36 and SP10. MA was compared with oral tranexamic acid, vitamin C and E, vitamin C and tamoxifen, topical 20% azelaic acid, hydroquinone, vitamin A and no treatment. Studies were too heterogeneous to conduct a meta-analysis. For global outcome measures, seven trials showed that MA groups were significantly better than the conventional treatments either with a better cure rate or with a better combined cure rate and markedly effective rate, and one trial did not (MA vs vitamin A). No acupuncture-related adverse events were reported. Conclusions MA appeared to be beneficial and safe for women with melasma, but insufficient evidence was found to reach conclusions. The encircling needling method, the quick needling method, intensive needle manipulations and individualised points ' selection were widely used. Well-designed trials are required. [ABSTRACT FROM AUTHOR]

Background: As yet there is no firm evidence about the types of intervention that can reduce emergency room revisits. However, the literature on emergency room revisits suggests patient difficulties with managing their health problems and treatments after discharge may play a role. Objectives: We carried out a randomized trial of an emergency department-based nursing intervention, but results showed no reduction in revisits (primary outcome). This paper describes the secondary outcomes of the trial: patient perceptions of continuity of care, illness perceptions, self-care capacities, psychological symptoms and medication adherence 30 days after emergency room discharge. Design: Randomized, controlled trial. Settings: The trial was conducted in the emergency department of a tertiary cardiac hospital in Montreal, Canada between November 2007 and March 2010. Participants: The study involved 203 patients, including 108 in the experimental group and 95 in the control group. Methods: The intervention included one nurse patient encounter before discharge and two phone calls in the 10 days after discharge. Participants provided data 30 days post-discharge on secondary outcomes potentially related to emergency department revisits. Results: Although, as previously reported, the intervention had no impact on the primary outcome of emergency department revisits, the present study demonstrated a significant positive effect on patients’ perceived continuity of care (p = .033), self-care capacities (p = .037), anxiety (p = .007) and depressive symptoms (p = .043), and the illness perceptions treatment control subscale (p = .037). No differences were found for other illness perception subscales or medication adherence (all p’s > .05). Conclusion: Although the intervention did not influence emergency department revisits it did improve secondary outcomes, suggesting pathways for future research. [ABSTRACT FROM AUTHOR]

This study compared self-report logbooks of exercise performance to objective measures of performance to determine the accuracy of and patterns of misreporting in self-report logbooks in people with Parkinson's disease. Fifteen participants from the intervention arm of a randomized control trial were prescribed a minimally supervised, 12-week, home-based upper limb exergame program (ACTRN 12614001048673). The exergame system provided an objective electronic measure of adherence for comparison with self-report logbooks. Logbooks showed excellent to good accuracy of overall reported adherence to prescribed sessions (Intraclass correlation (ICC) = 0.83) and games (ICC 0.71). Logbooks were also a good to fair representation of weekly adherence across participants for both sessions (ICC 0.66) and games (ICC 0.56). Individual participant ICCs ranged from minimal to perfect agreement between logbooks and electronic records (ICC sessions range: −0.02 to 1; games range: −0.24 to 0.99). The pattern of logbook reporting suggested some participants were biasing entries to match prescribed exercise. Self-report logbooks may provide an accurate measure of overall adherence. However, the accuracy of individual logbooks was highly variable indicating caution is needed in using self-report measures to assess individual adherence in intervention studies and for clinical decision making. Clinical Trial Registration: Registered in Australia and New Zealand Clinical Trials Registry (): Registration number: ACTRN12614001048673. Adherence to prescribed unsupervised exercise is usually self-reported. Self-reported logbooks gave a good to excellent indication of exercise adherence overall when compared to electronically captured records for a group of participants with mild to moderate Parkinson's disease. There were high levels of variability in the accuracy of individual logbooks with a tendency to record prescribed rather than actual exercise. Logbooks may be accurate to monitor group adherence, but caution is required when using them to assess an individual's adherence to an exercise prescription. [ABSTRACT FROM AUTHOR]

Objective To assess the effectiveness of acupuncture combined with selective serotonin reuptake inhibitors (SSRIs) for patients with depression in hospital using a pragmatic randomised controlled trial. Methods 76 patients with depression were randomly divided into two groups (randomisation ratio 2:1 for treatment and control groups (CGs), respectively) and 71 patients completed the study. The 45 patients in the treatment group (TG) underwent acupuncture and received an SSRI and the 26 patients in the CG received an SSRI only. The 17-item Hamilton Depression Rating Scale (HDRS-17) was used to quantitatively assess patients after 1, 2, 4 and 6 weeks of treatment. Results The mean (SD) baseline total HDRS scores were 22.2 (0.60) and 22.1 (0.33) in the TG and CG, respectively. After the first week of treatment the HDRS score for the TG was reduced to 15.6 (0.81), significantly different from the score of 18.3 (0.55) for the CG, p<0.05. This significant difference was maintained to the end of the 6-week treatment period, when HDRS scores had fallen to 6.3 (0.49) and 8.2 (0.35) for the TG and CG, respectively. Conclusions Acupuncture combined with an SSRI showed a statistically significant benefit for patients with depression in hospital over the 6-week period compared with SSRIs alone. This reduction in symptoms started in the first week and continued throughout the 6 weeks of treatment. [ABSTRACT FROM AUTHOR]

Background Vascular mild cognitive impairment (VMCI) is the most common type of vascular cognitive impairment induced by cerebrovascular disease. No effective medicines are currently available for VMCI. Objective To assess the effectiveness and safety of acupuncture for VMCI. Methods Seven electronic databases were searched for randomised controlled trials which investigated the effects of acupuncture compared with no treatment, placebo or conventional therapies on cognitive function or other clinical outcomes in patients with VMCI. The quality of the trials selected was evaluated according to the 'risk of bias' assessment provided by the Cochrane Handbook for Systematic Reviews of Interventions. RevMan V.5.1 software was employed for data analysis. Results Twelve trials with 691 participants were included. The methodological quality of all included trials was unclear and/or they had a high risk of bias. Meta-analysis showed acupuncture in conjunction with other therapies could significantly improve Mini-Mental State Examination scores (mean difference 1.99, 95% CI 1.09 to 2.88, random model, p<0.0001, 6 trials). No included trials mentioned any adverse events of the treatment. Conclusions The current clinical evidence is not of sufficient quality for wider application of acupuncture to be recommended for the treatment of VMCI, and further large, rigorously designed trials are warranted. [ABSTRACT FROM AUTHOR]

Ready‐to‐use therapeutic foods (RUTF) used to treat children with severe acute malnutrition (SAM) are costly, and the prescribed dosage has not been optimized. The MANGO trial, implemented by Action Contre la Faim in Burkina Faso, proved the non‐inferiority of a reduced RUTF dosage in community‐based treatment of uncomplicated SAM. We performed a cost‐minimization analysis to assess the economic impact of transitioning from the standard to the reduced RUTF dose. We used a decision‐analytic model to simulate a cohort of 399 children/arm, aged 6–59 months and receiving SAM treatment. We adopted a societal perspective: direct medical costs (drugs, materials and staff time), non‐medical costs (caregiver expenses) and indirect costs (productivity loss) in 2017 international US dollar were included. Data were collected through interviews with 35 caregivers and 20 informants selected through deliberate sampling and the review trial financial documents. The overall treatment cost for 399 children/arm was $36,550 with the standard and $30,411 with the reduced dose, leading to $6,140 (16.8%) in cost savings ($15.43 saved/child treated). The cost/consultation was $11.6 and $9.6 in the standard and reduced arms, respectively, with RUTF accounting for 56.2% and 47.0% of the total. The savings/child treated was $11.4 in a scenario simulating the Burkinabè routine SAM treatment outside clinical trial settings. The reduced RUTF dose tested in the MANGO trial resulted in significant cost savings for SAM treatment. These results are useful for decision makers to estimate potential economic gains from an optimized SAM treatment protocol in Burkina Faso and similar contexts. [ABSTRACT FROM AUTHOR]

Background: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design: Feasibility double-blind randomised placebo-controlled clinical trial. Methods: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions: It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration: HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884. [ABSTRACT FROM AUTHOR]

Objectives: Acute coronary syndrome (ACS) is an acute disease with high mortality. Although early percutaneous coronary intervention (PCI) is proved to be the practical approach in treating ACS, the incidence of cardiovascular events is still far from satisfactory. The combination of Suxiao Jiuxin Pill (SJP) and Western medicine is one conventional approach in the treatment of ACS. Many elementary and clinical trials have proved the efficacy and safety in the improvement of cardiocerebral vascular conditions. The aim of this project is to evaluate the safety and efficacy of SJP on ACS with early PCI patients. Trial Design: This is a multicenter randomized, double-blind placebo-controlled trial. Trial registration: ChiCTR-TRC-13003053. Settings: Hospitals. Subjects: A total of 200 ACS with early PCI patients were randomly divided into SJP group (n = 100) and placebo group (n = 100). Interventions: The SJP group was treated with routine treatment and SJP (taking eight SJP pills orally each time, three times per day). The placebo group was treated with routine treatment along with equal amounts of SJP placebo. The course of treatment was 6 months and a follow-up visit at 12 months. Outcome Measures: Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC). Results: The SJP group had a relatively low incidence of MACE than the placebo (p < 0.05, odds ratio: 1.916, 95% confidence interval [0.999–3.674]). LVEF was significantly higher in the SJP group than the placebo group on the 360-day follow-up (p < 0.01). SJP had a significant increase score in the SAQ subscale of physical limitation, angina frequency, and treatment satisfaction (p < 0.05). There is no significant difference in the cTNI and CRP level between the two groups. The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo (p < 0.05). The numbers of adverse events between the two groups were not statistically different (p > 0.05). Conclusions: SJP is associated with a reduction in MACE, and an improvement of heart function and quality of life in ACS patients with early PCI, and is probably safe to use. [ABSTRACT FROM AUTHOR]

Background: When nonoperative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporary pain reduction but no healing. Platelet-rich plasma (PRP) has proven to be a safe therapeutic option in the treatment of tendon, muscle, bone, and cartilage injuries. Purpose: To determine the effectiveness of PRP as compared with corticosteroid injections for chronic plantar fasciitis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with chronic plantar fasciitis were allocated to have steroid injection or PRP. The primary outcome measure was the Foot Function Index (FFI) Pain score. Secondary outcome measures were function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF). All outcomes were measured at baseline and at 4, 12, and 26 weeks and 1 year after the procedure. Results: Of the 115 patients, 63 were allocated to the PRP group, of which 46 (73%) completed the study, and 52 were allocated to the control group (corticosteroid injection), of which 36 (69%) completed the study. In the control group, FFI Pain scores decreased quickly and then remained stable during follow-up. In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group. After adjusting for baseline differences, the PRP group showed significantly lower pain scores at the 1-year follow-up than the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of patients with at least 25% improvement (FFI Pain score) between baseline and 12-month follow-up differed significantly between the groups. Of the 46 patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20 (55.6%) of the 36 in the control group showed such an improvement (P =.003). The PRP group showed significantly lower FFI Disability scores than the control group (mean difference, 12.0; 95% CI, 2.3-21.6). Conclusion: Treatment of patients with chronic plantar fasciitis with PRP seems to reduce pain and increase function more as compared with the effect of corticosteroid injection. Registration: NCT00758641 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

The article discusses the study of examining whether depression intervention in older adults in primary care modifies the increased risk of death associated with it or not. It reveals the result that patients with major depression in intervention practices experiences no risk as compared with those who are not depressed. It is also concluded that those suffering from major depression in primary care experiences 24 percent less chances of death than those with major depression in usual care.

A summary of the article "Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial," by Simon Stewart et al. is presented. The changes in systolic and diastolic blood pressure according to individual blood pressure target at randomisation are recorded. In the study, 8.8% more participants in the intervention group achieved individualised blood pressure control.

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Background: Electropalatography (EPG) records details of the location and timing of tongue contacts with the hard palate during speech. It has been effective in treating articulation disorders that have failed to respond to conventional therapy approaches but, until now, its use with children and adolescents with intellectual/learning disabilities and speech disorders has been limited. Aims: To evaluate the usefulness of EPG in the treatment of speech production difficulties in children and adolescents with Down syndrome (DS) aged 8–18 years. Methods & Procedures: A total of 27 children with DS were assessed on a range of cognitive and speech and language measures and underwent additional EPG assessment. Participants were randomly allocated to one of three age‐matched groups receiving either EPG therapy, EPG‐informed conventional therapy or 'treatment as usual' over a 12‐week period. The speech of all children was assessed before therapy using the Diagnostic Evaluation of Articulation and Phonology (DEAP) and reassessed immediately post‐ and 3 and 6 months post‐intervention to measure percentage consonants correct (PCC). EPG recordings were made of the DEAP assessment items at all time points. Per cent intelligibility was also calculated using the Children's Speech Intelligibility Measure (CSIM). Outcomes & Results: Gains in accuracy of production immediately post‐therapy, as measured by PCC, were seen for all groups. Reassessment at 3 and 6 months post‐therapy revealed that those who had received therapy based directly on EPG visual feedback were more likely to maintain and improve on these gains compared with the other groups. Statistical testing showed significant differences between groups in DEAP scores across time points, although the majority did not survive post‐hoc evaluation. Intelligibility across time points, as measured by CSIM, was also highly variable within and between the three groups, but despite significant correlations between DEAP and CSIM at all time points, no statistically significant group differences emerged. Conclusions & Implications: EPG was an effective intervention tool for improving speech production in many participants. This may be because it capitalizes on the relative strength of visual over auditory processing in this client group. The findings would seem to warrant an increased focus on addressing speech production difficulties in current therapy. [ABSTRACT FROM AUTHOR]

Objective: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. Design: Multi-centre, randomized controlled, feasibility study. Setting: Three multiple sclerosis out-patient centres. Participants: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4–6.5). Interventions: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy (n = 45; intervention) or a sheet of exercises (n = 45; active comparator). Outcome measures: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. Results: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40%–63% and 53%–71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (Intervention-80.4(33.91)m, Comparator-70.6(31.20)m) and no change over time (at six-month Intervention-81.6(32.75)m, Comparator-74.8(36.16)m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8(17.4)m in two-minute walk test between groups, 76 participants/group would be required (80% power, P > 0.05) for a future randomized controlled trial. Conclusion: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants. [ABSTRACT FROM AUTHOR]

Objective: To determine the short-term effects of supplying hospital inpatients with earplugs and eye masks, preparatory to a full-scale trial. Design: A single-centre, open-label, two-arm, parallel group, randomized-controlled trial. Setting: A total of 13 medical and surgical wards in a large teaching hospital in the United Kingdom. Participants: Everyone admitted to hospital aged 18 years or older, who stayed overnight and had the mental capacity and sufficient understanding of English to give consent, the ability to complete the study questionnaire and the ability to use earplugs and eye masks unaided was considered. Interventions: The intervention group was provided with earplugs and eye masks for use the following night, and the control group received standard care. Main measures: Sleep quality assessed using the SleepSure questionnaire after the first night of using the intervention, use of earplugs and eye masks, number of falls throughout their inpatient stay, use of zopiclone during inpatient stay, length of stay and recruitment rate. Results: A total of 1600 patients were admitted; out of which, 626 (39%) were eligible and 206 (13% total, 33% eligible) recruited (intervention group, 109). The intervention group's mean sleep quality score was 6.33 (95% confidence interval (CI): 5.89–6.77), compared with 5.09 (95% CI: 4.66–5.52) in the control group (p < 0.001). There were no differences in use of zopiclone, falls or length of stay between the groups. Of the intervention group, 91 (86%) reported using the earplugs and/or eye masks. Conclusions: The intervention seems feasible, and effective, but trial eligibility rate and rate of recruitment into the study were limited. [ABSTRACT FROM AUTHOR]

Objective: Aim of this trial was to compare efficacy of activated platelet-rich plasma against hyaluronic acid as intra-articular injections to people with osteoarthritis of the knee. Design: Phase-2 randomized controlled trial, with blind patients and outcome assessors. Setting: Outpatient rehabilitation service; years 2011-2013. Subjects: Patients with knee osteoarthritis grades 2-3 at magnetic resonance imaging (MRI) were included after consent and randomized. Target sample size was 25 patients per group. Interventions: Patients received three activated platelet-rich plasma (intervention group) or hyaluronic acid (controls) intra-articular injections at 4-week intervals. Main measures: Main outcome measure was proportion of patients with >1 grade improvement at six months from last injection, as assessed by a radiologist blind to study group. Patients were evaluated over time clinically and with functional scales (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm, Tegner, American Knee Society Score (AKSS), Lequesne, visual analogue scale (VAS) for pain). Results: Overall, 30 patients were randomized to intervention and 28 to control group. For primary outcome, 28 patients (29 knees) in the intervention and 22 (25 knees) in the control group were available. Patients with at least 1 grade improvement at repeat MRI were 14 (48.3%) in the intervention and 2 (8%) in the control group (P < 0.003). Improvement in symptoms and functional scales was consistently higher in the intervention group. No side-effects were observed in either group. Conclusion: Activated platelet-rich plasma reduces articular damage as evident at MRI, as soon as six months after treatment; it reduces pain and improves patient's function and overall quality of life. [ABSTRACT FROM AUTHOR]

ABSTRACT Background As many delirium manifestations (e.g., hallucinations or fears) are linked to patients' experiences and personality traits, it is suggested that interventions should be tailored to optimize its management. The inclusion of family members, as part of an intervention, has recently emerged as a solution to developing individualised patient care, but has never been assessed in post-cardiac surgery intensive care unit where almost half of patients will present with delirium. Aims To assess the feasibility, acceptability and preliminary efficacy of an nursing intervention involving family caregivers ( FC) in delirium management following cardiac surgery. Design A randomized pilot study. Methods A total of 30 patient/ FC dyads were recruited and randomized to usual care ( n = 14) or intervention ( n = 16). The intervention was based on the Human Caring Theory, a mentoring model, and sources informing self-efficacy. It comprised seven planned encounters spread over 3 days between an intervention nurse and the FC, each including a 30-min visit at the patient's bedside. During this bedside visit, the FC used delirium management strategies, e.g. reorient the person with delirium. The primary indicator of acceptability was to obtain consent from 75% of approached FCs. The preliminary effect of the intervention on patient outcomes was assessed on (1) delirium severity using the Delirium Index, (2) occurrence of complications, such as falls, (3) length of postoperative hospital stay and (4) psycho-functional recovery using the Sickness Impact Profile. The preliminary effect on FC outcomes was assessed on FC anxiety and self-efficacy. Data were analysed using descriptive statistics, ANCOVAs and logistic regressions. Results The primary indicator of obtaining consent from FC was achieved (77%). Of the 14 dyads, thirteen (93%) dyads received all seven encounters planned in the experimental intervention. Intervention group patients presented better psycho-functional recovery scores when compared with control group patients ( p = 0·01). Mean delirium severity scores showed similar trajectories on days 1, 2 and 3 in both groups. Conclusion The mentoring intervention was acceptable and feasible and shows promising results in improving patients and FC outcomes. Relevance to clinical practice Nurses should involve, if willing, FC to participate in activities that optimise patient well-being FC to use recognized delirium management strategies like reorientation and reassurance. [ABSTRACT FROM AUTHOR]

Background: Orlistat is a lipase inhibitor which reduced absorption of dietary fat by ~30% thereby inducing a weight loss; however, side effects occur as a consequence of increased colonic fat content. To test the hypothesis that most gastrointestinal side events induced by treatment with orlistat could be prevented/ameliorated by concomitant use of natural dietary components, flaxseed fiber (FF) and/or dairy calcium (Ca), binding liquid fats to more solid complexes. Methods: A randomized controlled dietary intervention study. Thirty-eight obese adults completed a 1-week run-in period, where all participants were treated with orlistat (60 mg t.i.d) and were hereafter randomized to 12 weeks dietary supplementation with/without 5 g FF (FF+/FF-) and/or 1200 mg dairy calcium (Ca+/Ca-) in conjunction with orlistat. All feces were collected for 3 days, and diet was recorded for 5 days, during run-in and week 4. The primary end-point, gastrointestinal symptoms, was assessed biweekly. At baseline and after 12 weeks, cardiometabolic risk markers and anthropometrics were evaluated as secondary end-points. Results: Both FF and Ca increased fecal fat excretion (P = 0.02 and P = 0.04, respectively). Although fecal fat excretion increased by ~100% in the FF+/Ca + group, and only by ~12% in the FF-/Ca + group, no interaction between FF and Ca was present, suggesting an additive effect. The fecal fat excretion was ~10 g/d higher with FF and Ca (~25 g/d) compared to fecal fat excretion with orlistat alone (~15 g/d). Mean ratings of severity of diarrhea tended to increase with Ca (P = 0.03) but not with FF. No other gastrointestinal symptoms, or a composite score of symptoms, were affected by the dietary supplements. Body weight was reduced in all groups but did not differ between groups, whereas waist circumference was most reduced in the FF+/Ca + group. No effects of dietary supplements on cardiometabolic risk factors were observed, except a slight increase in diastolic blood pressure (P = 0.03) with FF, but not Ca. Conclusions: Our results do not support an improvement in orlistat-induced gastrointestinal side effects by concomitant use of FF and Ca. However, fecal fat excretion was increased with both FF and Ca in the absence of a worsening of symptoms, warranting further studies powered to detect potential additive weight loss effects. Trial registration: Ethical Committee of the Capital Region of Denmark reg. no. H-1-2010-110, 02-11-2010 database no. NCT01320228, 21-03-2011. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

Objectives To compared outcomes of regional nerve blocks with those of standard analgesics after hip fracture. Design Multisite randomized controlled trial from April 2009 to March 2013. Setting Three New York hospitals. Participants Individuals with hip fracture (N = 161). Intervention Participants were randomized to receive an ultrasound-guided, single-injection, femoral nerve block administered by emergency physicians at emergency department ( ED) admission followed by placement of a continuous fascia iliaca block by anesthesiologists within 24 hours (n = 79) or conventional analgesics (n = 82). Measurements Pain (0-10 scale), distance walked on Postoperative Day ( POD) 3, walking ability 6 weeks after discharge, opioid side effects. Results Pain scores 2 hours after ED presentation favored the intervention group over controls (3.5 vs 5.3, P = .002). Pain scores on POD 3 were significantly better for the intervention than the control group for pain at rest (2.9 vs 3.8, P = .005), with transfers out of bed (4.7 vs 5.9, P = .005), and with walking (4.1 vs 4.8, P = .002). Intervention participants walked significantly further than controls in 2 minutes on POD 3 (170.6 feet, 95% confidence interval ( CI) = 109.3-232 vs 100.0 feet, 95% CI = 65.1-134.9; P = .04). At 6 weeks, intervention participants reported better walking and stair climbing ability (mean Functional Independence Measure locomotion score of 10.3 (95% CI = 9.6-11.0) vs 9.1 (95% CI = 8.2-10.0), P = .04). Intervention participants were significantly less likely to report opioid side effects (3% vs 12.4%, P = .03) and required 33% to 40% fewer parenteral morphine sulfate equivalents. Conclusion Femoral nerve blocks performed by emergency physicians followed by continuous fascia iliaca blocks placed by anesthesiologists are feasible and result in superior outcomes. [ABSTRACT FROM AUTHOR]

Background: Children with intellectual and developmental disabilities (IDD) experience heightened attention difficulties which have been linked to poorer cognitive, academic and social outcomes. Although, increasing research has focused on the potential of computerised cognitive training in reducing attention problems, limited studies have assessed whether this intervention could be utilised for those with IDD. This study aimed to assess the efficacy of a computerised attention training programme in children with IDD. Methods: In a double-blind randomised controlled trial, children (n = 76; IQ < 75) aged 4–11 years were assigned to an adaptive attention training condition or a nonadaptive control condition. Both conditions were completed at home over a 5-week period and consisted of 25 sessions, each of 20-min duration. Outcome measures (baseline, posttraining and 3-month follow-up) assessed core attention skills (selective attention, sustained attention and attentional control) and inattentive/hyperactive behaviour. Results: Children in the attention training condition showed greater improvement in selective attention performance compared to children in the control condition (SMD = 0.24, 95% CI 0.02, 0.45). These improvements were maintained 3 months after training had ceased (SMD = 0.26, 95% CI 0.04, 0.48). The attention training programme was not effective in promoting improvements in sustained attention, attentional control or inattentive/ hyperactive behaviours. Conclusions: The findings suggest that attention training may enhance some aspects of attention (selective attention) in children with IDD, but the small to medium effect sizes indicate that further refinement of the training programme is needed to promote larger, more global improvements. [ABSTRACT FROM AUTHOR]

Objectives Mental ill-health has become a large health problem and it is important for caregivers to provide effective treatment alternatives. REGASSA is a randomized controlled study performed in primary care to study the effects of 12 weeks of Internet-based cognitive behaviour therapy ( ICBT) and physical exercise ( PE) compared with treatment as usual ( TAU) in patients with mild-to-moderate mental ill-health. The present study aimed to examine the results of these treatment alternatives on psychological functioning, stress, and sleep disturbances. Methods The study comprised 879 patients with mental ill-health taking part in the REGASSA study. Data were collected by Interactive Voice Response ( IVR), a computerized, automated telephone technique. The treatments were compared at baseline, twice during treatment, at the end of treatment and at three follow-ups after treatment. Measures used were the Outcome Questionnaire-45, the short versions of the Perceived Stress Scale, and the Karolinska Sleep Questionnaire. Results Linear mixed models showed that the patients in ICBT and PE had better results than in TAU on psychological functioning and sleep disturbances, p < .001 , with weak-to-moderate effect sizes. On stress there were no differences; all groups made improvements. Women had stronger effects than men. More patients recovered on psychological functioning ( OQ-45) in ICBT and PE than in TAU. Conclusions Internet-based cognitive behaviour therapy and PE proved to be effective treatment alternatives for patients with mild-to-moderate mental ill-health in improving psychological functioning, stress, and sleep disturbances and could be useful alternatives in primary care. Practitioner points Internet-based cognitive behaviour therapy and physical exercise proved to be effective treatment alternatives for mental ill-health patients in primary care., Automated techniques (Interactive Voice Response) could be useful for following treatment course in large groups of patients in the health care., It is important to use measures that capture different aspects of patients' health problems., The recruitment of participants was based on patients' interest and inclusion criteria which may have affect the generalizability. [ABSTRACT FROM AUTHOR]

The objective of this study was to evaluate the efficacy of psychological treatments for depression in pre-adolescent children, a disorder affecting 1-2 % of children in this age range. A systematic review of studies of psychological interventions to treat depressive disorder in pre-adolescent children (aged up to 12-years-old) was carried out. The primary outcome was level of depressive symptoms. Studies were found using Medline, PsycINFO, EMBASE and Web of Knowledge databases and selected on several criteria. Only randomised controlled trials were included. Where individual studies covered a broader age range (usually including adolescents up to age 18 years), authors of those studies were contacted and requested to provide individual patient level data for those aged 12 years and younger. 2822 abstracts were reviewed, and from these 124 full text articles were reviewed, yielding 7 studies for which we were able to access appropriate data for this review. 5 of these studies evaluated cognitive behaviour therapy (CBT). Combined results from these studies suggest that there is a lack of evidence that CBT is better than no treatment [standard mean difference −0.342 (95 % confidence interval −0.961, 0.278)], although the number of participants included in the trials was relatively small. The evidence for efficacy of family therapy and psychodynamic therapy is even more limited. The very limited number of participants in randomised controlled trials means that there is inconclusive evidence for the psychological treatment of depression in children aged 12 years and below. Given the prevalence and significant impact of this disorder, there is an urgent need to establish the effectiveness or otherwise of psychological intervention. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Objectives To test a new cognitive behavioral therapy for insomnia ( CBT-I) program designed for use by nonclinicians. Design Randomized controlled trial. Setting Department of Veterans Affairs healthcare system. Participants Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159). Intervention Nonclinician 'sleep coaches' delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education. Measurements Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency ( SOL-D), wake after sleep onset ( WASO-D), total wake time ( TWT-D), and sleep efficiency ( SE-D); Pittsburgh Sleep Quality Index ( PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index ( ISI), depressive symptoms (Patient Health Questionnaire-9 ( PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 ( SF-12v2)). Results Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2. Conclusion Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia. [ABSTRACT FROM AUTHOR]

Background: It has become common practice to incorporate balance tasks into the training program for athletes who want to improve performance and prevent injuries, in rehabilitation programs, and in fall prevention programs for the elderly. However, it is still unclear whether incorporating balance tasks into a training program increases performance only in these specific tasks or if it affects balance in a more general way. Objectives: The objective of this systematic literature review and meta-analysis was to determine to what extent the training of balance tasks can improve performance in non-trained balance tasks. Data Sources: A systematic literature search was performed in the online databases EMBASE, PubMed, SPORTDiscus and Web of Science. Articles related to balance training and testing in healthy populations published between January 1985 and March 2015 were considered. Study Eligibility Criteria: A total of 3093 articles were systematically evaluated. Randomized controlled trials were included that (i) used only balance tasks during the training, (ii) used at least two balance tests before and after training, and (iii) tested performance in the trained balance tasks and at least one non-trained balance task. Six studies with a total of 102 subjects met these criteria and were included into the meta-analysis. Study Appraisal and Synthesis Methods: The quality of the studies was evaluated by means of the Physiotherapy Evidence Database (PEDro) scale. A random effect model was used to calculate the between-subject standardized mean differences (SMD) in order to quantify the effect of balance training on various kinds of balance measures relative to controls. The tested balance tasks in each study were classified into tasks that had been trained and tasks that had not been trained. For further analyses, the non-trained balance tasks were subdivided into tasks with similar or non-similar body position and similar or non-similar balance perturbation direction compared to the trained task. Results: The effect of balance training on the performance of the trained balance tasks reached an SMD of 0.79 [95 % confidence interval (CI) 0.48-1.10], indicating a high effect in favor for the trained task, with no notable heterogeneity ( I = 0 %). The SMD in non-trained categories reached values between −0.07 (95 % CI −0.53 to 0.38) and 0.18 (95 % CI −0.27 to 0.64), with non-notable to moderate heterogeneity ( I = 0-32 %), indicating no effect of the balance training on the respective non-trained balance tasks. Limitations: With six studies, the number of studies included in this meta-analysis is rather low. It remains unclear how the limited number of studies with considerable methodological diversity affects the outcome of the SMD calculations and thus the general outcome of the meta-analysis. Conclusion: In healthy populations, balance training can improve the performance in trained tasks, but may have only minor or no effects on non-trained tasks. Consequently, therapists and coaches should identify exactly those tasks that need improvement, and use these tasks in the training program and as a part of the test battery that evaluates the efficacy of the training program. Generic balance tasks-such as one-leg stance-may have little value as overall balance measures or when assessing the efficacy of specific training interventions. [ABSTRACT FROM AUTHOR]

Background Relapse is common in alcohol-dependent individuals and can be triggered by alcohol-related cues in the environment. It has been suggested that these individuals develop cognitive biases, in which cues automatically capture attention and elicit an approach action tendency that promotes alcohol seeking. The study aim was to examine whether cognitive bias modification ( CBM) training targeting approach bias could be delivered during residential alcohol detoxification and improve treatment outcomes. Methods Using a 2-group parallel-block (ratio 1:1) randomized controlled trial with allocation concealed to the outcome assessor, 83 alcohol-dependent inpatients received either 4 sessions of CBM training where participants were implicitly trained to make avoidance movements in response to pictures of alcoholic beverages and approach movements in response to pictures of nonalcoholic beverages, or 4 sessions of sham training (controls) delivered over 4 consecutive days during the 7-day detoxification program. The primary outcome measure was continuous abstinence at 2 weeks postdischarge. Secondary outcomes included time to relapse, frequency and quantity of alcohol consumption, and craving. Outcomes were assessed in a telephonic follow-up interview. Results Seventy-one (85%) participants were successfully followed up, of whom 61 completed all 4 training sessions. With an intention-to-treat approach, there was a trend for higher abstinence rates in the CBM group relative to controls (69 vs. 47%, p = 0.07); however, a per-protocol analysis revealed significantly higher abstinence rates among participants completing 4 sessions of CBM relative to controls (75 vs. 45%, p = 0.02). Craving score, time to relapse, mean drinking days, and mean standard drinks per drinking day did not differ significantly between the groups. Conclusions This is the first trial demonstrating the feasibility of CBM delivered during alcohol detoxification and supports earlier research suggesting it may be a useful, low-cost adjunctive treatment to improve treatment outcomes for alcohol-dependent patients. [ABSTRACT FROM AUTHOR]

Introduction: Depression is common in patients with coronary heart disease, and together these conditions significantly affect health outcomes. Impaired social support is also considered an important predictor of coronary heart disease prognosis and, as there is a complex interplay between social isolation and depression, interventions to address both may be required. This review aimed to assess the effectiveness of psychosocial interventions addressing both depression and social support for people with coronary heart disease and depression. Methods: PRISMA guidelines were used to search major health databases to identify randomised controlled trials that evaluated psychosocial interventions compared with usual care in patients with coronary heart disease and depression; the primary outcome was depressive symptoms and secondary outcomes were mortality (all-cause and cardiac), myocardial infarction, revascularisation, anxiety, social support and quality of life. Data, when suitable, were pooled using a random-effects meta-analysis model. Results: Five studies (n=1358 participants) were eligible and included. The psychosocial intervention group had significantly lower levels of depressive symptoms (standardised mean difference (SMD) –0.15, 95% confidence interval (CI) −0.27 to −0.03; P=0.02) and higher levels of social support (SMD 0.17; 95% CI 0.04 to 0.30; P=0.01) but no differences were found for mortality (all-cause and cardiac), myocardial infarction, revascularisation, anxiety or quality of life. Conclusions: Psychosocial interventions for patients with coronary heart disease and depression result in modest reductions in depressive symptoms and improvements in social support. However, caution is warranted in view of the small number of studies included in the review and potential heterogeneity in outcomes and in differences in treatment. [ABSTRACT FROM AUTHOR]

Objectives. To determine the effect of sodium (Na) reduction on occurrence of headaches. Methods. In the Trial of Nonpharmacologic Interventions in the Elderly, 975 men and woman (aged 60-80 years) with hypertension were randomized to a Na-reduction intervention or control group and were followed for up to 36 months. The study was conducted between 1992 and 1995 at 4 clinical centers (Johns Hopkins University, Wake Forest University School of Medicine, Robert Wood Johnson Medical School, and the University of Tennessee). Results. Mean difference in Na excretion between the Na-reduction intervention and control group was significant at each follow-up visit (P < .001) with an average difference of 38.8 millimoles per 24 hours. The occurrence of headaches was significantly lower in the Na-reduction intervention group (10.5%) compared with control (14.3%) with a hazard ratio of 0.59 (95% confidence interval = 0.40, 0.88; P = .009). The risk of headaches was significantly associated with average level of Na excretion during follow-up, independent of most recent blood pressure. The relationship appeared to be nonlinear with a spline relationship and a knot at 150 millimoles per 24 hours. Conclusions. Reduced sodium intake, currently recommended for blood pressure control,may also reduce the occurrence of headaches in older persons with hypertension. [ABSTRACT FROM AUTHOR]

Objective. To define the optimal biologic agent for systemic JIA (sJIA) based on safety and efficacy data from a randomized controlled trial (RCT). Methods. Through a systematic literature search, sJIA RCTs evaluating biologic agents were identified. The primary efficacy outcome was defined as a 30% improvement according to the modified American College of Rheumatology Paediatric 30 response criteria (JIA ACR30). The primary safety outcome was defined as serious adverse events (SAEs). Outcomes were analysed by pairwise and network meta-analyses. The quality of evidence between biologic agents was assessed by applying the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Results. From the 493 citations originally identified, 5 RCTs were eligible for inclusion--one each for anakinra, canakinumab and tocilizumab and two for rilonacept: all vs placebo. While all were effective, the network meta-analysis indicated with low-quality evidence (due to indirect comparison and inconsist-ency) that rilonacept-treated patients were less likely to respond than those treated with canakinumab [odds ratio (OR) 0.10 (95% CI 0.02, 0.38), P = 0.001] or tocilizumab [OR 0.12 (95% CI 0.03, 0.44), P = 0.001]. Risks of SAEs were similar among the biologic agents (supported by very low-quality evidence) and not different from placebo. Conclusion. Despite heterogeneous eligibility criteria and study designs across the five studies and different modified JIA ACR30 criteria, this meta-analysis of short-term RCTs presents empirical evidence that canakinumab and tocilizumab are more effective than rilonacept. Biologic agents in sJIA seem safe and comparable with respect to SAE risk in the short term. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Randomized clinical trial. BACKGROUND: The recommended initial management strategy for patients with low back pain and signs of nerve root compression is conservative treatment, but there is little evidence to guide the most appropriate management strategy. Preliminary research suggests that a treatment protocol of mechanical traction and extension- oriented exercises may be effective, particularly in a specific subgroup of patients. OBJECTIVE: To examine the effectiveness of mechanical traction in patients with lumbar nerve root compression and within a predefined subgroup. METHODS: One hundred twenty patients with low back pain with nerve root compression were recruited from physical therapy clinics. Using predefined subgrouping criteria, patients were stratified at baseline and randomized to receive an extension-oriented treatment approach with or without the addition of mechanical traction. During a 6-week period, patients received up to 12 treatment visits. Primary outcomes of pain and disability were collected at 6 weeks, 6 months, and 1 year by assessors blinded to group allocation. Outcomes were examined using linear mixed- model analyses examining change over time by treatment and the interaction between treatment and subgrouping status. RESULTS: The mean ± SD age of participants was 41.1 ± 11.3 years, median duration of symptoms was 62 days, and 57% were male. No significant differences in disability or pain outcomes were noted between treatment groups at any time point, nor was any interaction found between subgroup status and treatment. CONCLUSION: Patients with lumbar nerve root compression presenting for physical therapy can expect significant changes in disability and pain over a 6-week treatment period. There is no evidence that mechanical lumbar traction in combination with an extension-oriented treatment is superior to extension-oriented exercises alone in the management of these patients or within a predefined subgroup of patients. The study protocol was registered with ClinicalTrials.gov (NCT00942227). [ABSTRACT FROM AUTHOR]

Objective Evaluate the immediate and cumulative optical whitening efficacy of a blue covarine toothpaste. Materials and Methods 180 bovine tooth specimens with similar shade (Δ E < 3.5) were staining of different beverage: black tea(BT), green tea (GT), red wine (RW), orange soda (OS), and brazilian açai juice (AJ), and then submitted to tooth brushing with a blue covarine toothpaste (Op) or a control abrasive toothpaste (Ab). The whitening effect was evaluated at baseline (B), after staining (S), after 1 day (1D) and 7 days of cumulative use of toothpastes (7D). The color shade chances were assessment by Vita Easyshade reflectance spectroscope and the data of CIELab color coordinates (L*, a*, and b*), color difference (Δ E) and the whiteness index optimized (WIO), were analyzed by two-way mixed analysis of variance (ANOVA) for repeated measures and Bonferroni-corrected t-tests (α = 0.05). Results The analysis showed statistically significant differences before and after staining by colored beverages ( p < 0.05), but no differences were found due to the action of toothpaste ( p > 0.05), in the CIELab coordinates, Δ E and WIO index. Conclusions The use of toothpastes (Op or Ab) reduced the dental staining caused by different colored beverage, but the whitening effect of blue covarine toothpaste could not be confirmed ( p > 0.05). [ABSTRACT FROM AUTHOR]

Objectives To evaluate the efficacy of nonpharmacological care-delivery interventions (staff training, care-delivery models, changes to the environment) to reduce and manage agitation and aggression in nursing home and assisted living residents. Design Three bibliographic databases, references of systematic reviews, ClincalTrials.gov, and the International Controlled Trials Registry Platform were systematically searched for randomized controlled trials reporting behavioral outcomes for nonpharmacological care-delivery interventions in nursing homes and assisted living facilities. Five investigators independently assessed study eligibility, extracted data, rated risk of bias, and graded strength of evidence. Inclusion was limited to studies with low to moderate risk of bias. Setting Nursing homes and assisted living facilities. Participants Facility caregiving staff. Measurements Agitation, aggression, antipsychotic and other psychotropic use, general behavior. Results Nineteen unique studies met entry criteria, addressing several categories of facility caregiver training interventions: dementia care mapping ( DCM; n = 3), person-centered care ( PCC; n = 3), clinical protocols to reduce the use of antipsychotic and other psychotropic drugs (n = 3), and emotion-oriented care (n = 2). Eleven additional studies evaluated other unique interventions. Results were pooled for the effect of each type of intervention on agitation and aggression: DCM (standardized mean difference −0.12, 95% confidence interval ( CI) = −0.66 to 0.42), PCC (standardized mean difference −0.15, 95% CI = −0.67 to 0.38), and protocols to reduce antipsychotic and other psychotropic use (Cohen-Mansfield Agitation Inventory mean difference −4.5, 95% C = −38.84 to 29.93). Strength of evidence was generally insufficient to draw conclusions regarding efficacy or comparative effectiveness. Conclusion Evidence was insufficient regarding the efficacy of nonpharmacological care-delivery interventions to reduce agitation or aggression in nursing home and assisted living facility residents with dementia. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the effect of structured physical activity on respiratory outcomes in community-dwelling elderly adults with mobility limitations. Design Multicenter, randomized trial of physical activity vs health education, with respiratory variables prespecified as tertiary outcomes over an intervention period of 24-42 months. Physical activity included walking (goal of 150 min/week) and strength, flexibility, and balance training. Health education included workshops on topics relevant to older adults and upper extremity stretching exercises. Setting Lifestyle Interventions and Independence in Elders ( LIFE) Study. Participants Community-dwelling persons aged 70-89 with Short Physical Performance Battery scores less than 10 (N = 1,635). Measurements Dyspnea severity (defined as moderate to severe according to a Borg index >2 immediately after a 400-m walk), forced expiratory volume in 1 second ( FEV1) (

The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40–98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate–emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants’ adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0–M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1–max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9–35.6%) reported both PrEP and condom use; 11.7% (7.2–18.9%) reported condom-use only, and 16.7% (10.8–29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2–68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3–79.4%) and 69.3% (58.3–75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4–max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM. [ABSTRACT FROM PUBLISHER]

This systematic review was to identify available evidence on the effectiveness of tocolysis in inhibiting preterm delivery for women with threatened extremely preterm birth, multiple gestations, and growth-restricted babies, and their infants' outcomes. A comprehensive search using MEDLINE, Embase, the Cochrane Library, CINAHL, POPLINE and the WHO Global Health Library databases was conducted on 14 February 2014. For selection criteria, randomized controlled trials and non-randomized studies that compared tocolysis treatment to placebo or no treatment were considered. Selection of eligible studies, critical appraisal of the included studies, data collection, meta-analyses, and assessment of evidence quality were performed in accordance with the Cochrane Collaboration's guidance and validated assessment criteria. The search identified seven studies for extremely preterm birth, in which three were randomized controlled trials (RCTs) and four were non-randomized studies (non-RCTs). There were no eligible studies identified for women with multiple pregnancy and growth-restricted fetuses. Meta-analyses indicated no significant difference was found for the relative effectiveness of tocolytics versus placebo for prolonging pregnancy in women with extremely preterm birth (RR 1.04, 95 % CI 0.83 to 1.31) or reducing the rate of perinatal deaths (RR 2.22, 95 % CI 0.26 to 19.24). In summary, there is no evidence to draw conclusions on the effectiveness of tocolytic therapy for women with threatened extremely preterm birth, multiple gestations, and growth-restricted babies. [ABSTRACT FROM AUTHOR]

Objective. There has been no attempt to date to synthesize the available evidence for the efficacy of ginger for treating primary dysmenorrhea. This systematic review evaluates the current evidence for the effectiveness of ginger for treating primary dysmenorrhea. Methods. Literature searches were conducted using 12 electronic databases including PubMed, EMBASE, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were: "ginger" or "Zingiber officinale" and "dysmenorrhea" and "pain." Studies using ginger as a treatment of primary dysmenorrhea were considered for inclusion. The major outcome of primary dysmenorrhea was assessed using a pain visual analogue score (PVAS). Results. Initial searches yielded 29 articles. Of these original results, seven met specific selection criteria. Four of the RCTs compared the therapeutic efficacy of ginger with a placebo during the first 3-4 days of the menstrual cycle and were included in the meta analysis. The meta-analysis of these data showed a significant effect of ginger in reducing PVAS in subjects having primary dysmenorrhea (risk ratio, 21.85; 95% CI of 22.87, 20.84, P=0.0003). Six RCTs out of 7 exhibited low to moderate of risk of bias. Conclusion. Collectively these RCTs provide suggestive evidence for the effectiveness of 750-2000 mg ginger powder during the first 3-4 days of menstrual cycle for primary dysmenorrhea. [ABSTRACT FROM AUTHOR]