Feasibility and Effect of Electroacupuncture on Cognitive Function Domains in Patients with Mild Cognitive Impairment: A Pilot Exploratory Randomized Controlled Trial

Although Electroacupuncture (EA) has been reported to be potentially effective for cognitive disorders, there is limited information about which domains of cognitive function can be improved by EA treatment. Sixty patients with MCI were randomly assigned (1:1:1) to groups to receive 24 sessions over 12 weeks of EA, sham EA, or usual care. In the EA group, electric stimulation was applied at bilateral PC6 and HT7. Various cognitive tests included in the Seoul Neuropsychological Screening Battery II (SNSB-II) were performed at baseline and post-treatment to explore effects of EA on five cognitive domains: attention, language, visuospatial function, memory, and frontal/executive function. Among 60 randomized participants (63.7 ± 7.1 years, 89.7% females), 45 (75%) completed the study. Of the five cognitive function domains of SNSB-II, the T score of visuospatial function showed a tendency to be higher in the EA group than in the usual care group at post-treatment assessment (mean difference: 10.16 (95% CI, 1.14, 19.18), Cohen’s d = 0.72, p = 0.0283). According to the results of this pilot study, the estimated effect size of EA on the visuospatial function of MCI patients compared to usual care was medium. Large-scale clinical trials are needed to confirm effects of EA on cognitive functions.

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Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

10.2196/preprints.36480 ◽

2022 ◽

Author(s):

Maryam Zahid ◽

Ume Sughra

Keyword(s):

Nutritional Status ◽

Usual Care ◽

Usual Care Group ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

Randomized Controlled ◽

Nutritional Status Of Children ◽

Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

Acupuncture in Medicine ◽

10.1136/aim.25.4.121 ◽

2007 ◽

Vol 25 (4) ◽

pp. 121-129 ◽

Cited By ~ 6

Author(s):

Stephanie L Prady ◽

Kate Thomas ◽

Lisa Esmonde ◽

Simon Crouch ◽

Hugh MacPherson

Keyword(s):

Back Pain ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Bodily Pain ◽

Care Group ◽

Long Term Outcomes ◽

Short Term Treatment ◽

Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

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Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2012-010261 ◽

2013 ◽

Vol 31 (1) ◽

pp. 31-38 ◽

Cited By ~ 36

Author(s):

Jorge Vas ◽

José Manuel Aranda-Regules ◽

Manuela Modesto ◽

María Ramos-Monserrat ◽

Mercedes Barón ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Primary Healthcare ◽

Primary Outcome ◽

Controlled Trial ◽

Acupuncture Point ◽

Care Group ◽

Moxibustion Group ◽

Vertex Presentation ◽

Randomised Controlled

Objective To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. Methods This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33–35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. Results In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. Conclusions Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. Trial Registration Current Controlled Trials ISRCTN10634508.

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Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial

Clinical Rehabilitation ◽

10.1177/0269215516661751 ◽

2016 ◽

Vol 31 (7) ◽

pp. 891-903 ◽

Cited By ~ 7

Author(s):

AJ Turton ◽

P Cunningham ◽

F van Wijck ◽

HJM Smartt ◽

CA Rogers ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Usual Care Group ◽

Controlled Trial ◽

Care Group ◽

Reach To Grasp ◽

Arm Pain ◽

Home Based ◽

Wolf Motor Function Test ◽

Randomised Controlled

Objective: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. Design: single-blind parallel group RCT. Participants: Residual arm deficit less than 12 months post-stroke. Interventions: Reach-to-Grasp training in 14 one-hour therapist’s visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Control: Usual care. Main Measures: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Results: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. Conclusions: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

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Treating anxiety and depression in young adults: A randomised controlled trial comparing clinician-guided versus self-guided Internet-delivered cognitive behavioural therapy

Australian & New Zealand Journal of Psychiatry ◽

10.1177/0004867417738055 ◽

2017 ◽

Vol 52 (7) ◽

pp. 668-679 ◽

Cited By ~ 14

Author(s):

Blake F Dear ◽

Vincent J Fogliati ◽

Rhiannon Fogliati ◽

Bareena Johnson ◽

Olivia Boyle ◽

...

Keyword(s):

Young Adults ◽

Cognitive Behaviour Therapy ◽

Large Scale ◽

Satisfaction With Life ◽

Controlled Trial ◽

Post Treatment ◽

Anxiety And Depression ◽

Behaviour Therapy ◽

Advantages And Disadvantages ◽

Cognitive Behaviour

Background: Internet-delivered cognitive behaviour therapy may increase access by young adults to evidence-based treatments for anxiety and depression. Objective: The aim of this study was to compare the efficacy of an Internet-delivered cognitive behaviour therapy intervention designed for adults aged 18–24 years, when delivered in clinician-guided versus self-guided formats. Design: The intervention, the Mood Mechanic Course, is a transdiagnostic treatment that simultaneously targets symptoms of anxiety and depression using cognitive and behavioural skills. The brief intervention comprised four lessons, delivered over 5 weeks. Following a brief telephone interview, young adults ( n = 191) with symptoms of anxiety and depression were randomly allocated to either (1) clinician-guided treatment ( n = 96) or (2) self-guided treatment ( n = 95). Results: At post treatment, large reductions (average improvement; clinician guided vs self-guided) were observed in symptoms of anxiety (44% vs 35%) and depression (40% vs 31%) in both groups. Significant improvements were also observed in general psychological distress (33% vs 29%), satisfaction with life (18% vs 15%) and disability (36% vs 29%). No marked or consistent differences in clinical outcomes emerged between conditions at post-treatment, at 3-month or 12-month follow-up. Satisfaction was high with both treatment formats, but slightly higher for clinician-guided treatment. Conclusion: These results indicate the potential of carefully developed Internet-delivered cognitive behaviour therapy interventions for young adults with anxiety and depression provided in either self or therapist-guided format. Further large-scale research is required to determine the short- and long-term advantages and disadvantages of different models of support.

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Acupuncture versus Usual Care for Postoperative Nausea and Vomiting in Children after Tonsillectomy/Adenoidectomy: A Pragmatic, Multicentre, Double-Blinded, Randomised Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2014-010738 ◽

2015 ◽

Vol 33 (3) ◽

pp. 196-203 ◽

Cited By ~ 21

Author(s):

Ingrid Liodden ◽

Leiv Sandvik ◽

Berit Taraldsen Valeberg ◽

Einar Borud ◽

Arne Johan Norheim

Keyword(s):

Usual Care ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Randomised Trial ◽

Postoperative Nausea And Vomiting ◽

Nausea And Vomiting ◽

Care Group ◽

Placebo Effects ◽

Expectancy Effects ◽

Double Blinded

Objectives To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. Methods A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012–2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1–11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5–45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. Results This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. Conclusions The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. Trial Registration Number ClinicalTrials.gov NCT01729052.

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Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial

BMJ ◽

10.1136/bmj.k3760 ◽

2018 ◽

pp. k3760 ◽

Cited By ~ 25

Author(s):

Nerys M Astbury ◽

Paul Aveyard ◽

Alecia Nickless ◽

Kathryn Hood ◽

Kate Corfield ◽

...

Keyword(s):

Weight Loss ◽

Usual Care ◽

Usual Care Group ◽

Practice Nurse ◽

Controlled Trial ◽

Care Group ◽

Metabolic Risk ◽

Behavioural Support ◽

Total Diet ◽

Randomised Controlled

Abstract Objective To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting. Design Pragmatic, two arm, parallel group, open label, individually randomised controlled trial. Setting 10 primary care practices in Oxfordshire, UK. Participants 278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months. Interventions The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction. Main outcome measures The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded. Results Participants in the TDR group lost more weight (−10.7 kg) than those in the usual care group (−3.1 kg): adjusted mean difference −7.2 kg (95% confidence interval −9.4 to −4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity. Conclusions Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease. Trial registration International Standard Randomised Controlled Trials No ISRCTN75092026 .

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MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2017-017540 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017540 ◽

Cited By ~ 22

Author(s):

Karla Santo ◽

Clara K Chow ◽

Aravinda Thiagalingam ◽

Kris Rogers ◽

John Chalmers ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Medication Adherence ◽

Randomised Controlled Trial ◽

Usual Care ◽

Usual Care Group ◽

Controlled Trial ◽

Care Group ◽

Randomised Controlled ◽

Medication Reminder

IntroductionThe growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.Methods and analysisRandomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.Ethics and disseminationEthical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.Trial registration numberACTRN12616000661471; Pre-results

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Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-020-05571-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Zeenat Fatima Chatha ◽

Usman Rashid ◽

Sharon Olsen ◽

Fakhar ud Din ◽

Amjad Khan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

People Living With Hiv ◽

Post Intervention ◽

Randomized Controlled ◽

Cell Counts ◽

Cd4 Cell

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

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Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand

BMJ ◽

10.1136/bmj.m3797 ◽

2020 ◽

pp. m3797 ◽

Cited By ~ 1

Author(s):

Justin S White ◽

Christopher Lowenstein ◽

Nucharee Srivirojana ◽

Aree Jampaklay ◽

William H Dow

Keyword(s):

Usual Care ◽

Text Messaging ◽

Controlled Trial ◽

Cluster Randomized Trial ◽

Monetary Incentive ◽

Care Group ◽

Smoking Abstinence ◽

Open Label ◽

Intention To Treat ◽

Cluster Randomized

Abstract Objective To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country. Design Parallel group, open label, assessor blinded, cluster randomized controlled trial. Setting Large industrial workplaces in metropolitan Bangkok, Thailand. Participants Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies). Interventions Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40). Main outcome measures The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers. Results Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval −2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; −3.2 points, −6.6 to −0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other. Conclusions Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings. Trial registration ClinicalTrials.gov ( NCT02421224 ).

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