Effects of Supplementation With Iron Syrup or Iron-Containing Multiple Micronutrient Powders on Neural Indices of Cognitive Functioning in Bangladeshi Children

Abstract Objectives Micronutrients, especially iron, play a critical role in the developing infant brain. Yet, the causal effects of iron supplementation on neurocognitive functioning in a low-income anemic population of children have not been examined. This study sought to evaluate the effects of supplementation with iron syrup and iron-containing multiple micronutrient powders (MNPs) in Bangladeshi children on habituation to familiar sounds, a marker for healthy memory development, using auditory event-related brain potentials (ERPs). Methods This study was nested within the Benefits and Risks of Iron Supplementation in Children (BRISC) trial, a double blinded double dummy randomized controlled trial (RCT). At 8 months of age, 3300 children were randomized to receive 3 months of 1) iron syrup + placebo MNPs, or 2) MNPs (containing iron, retinol, zinc, and Vitamin C) + placebo iron syrup, or 3) placebo iron syrup and placebo MNPs. ERPs in response to an auditory roving oddball paradigm were measured in a random subset of 441 children at 3 months post-intervention (11 months of age) and 595 children after a further 9 months follow-up (20 months of age). ERP measures indexing aspects of habituation included the [deviant minus standard] difference waveform amplitude, N2 waveform amplitude, and the difference in deviant-evoked ERP amplitudes between the first and second half of the paradigm. Intention-to-treat analyses on ERP outcomes using linear models were used at 11 and 20 months of age separately. Results Baseline characteristics were balanced between treatment groups. Overall prevalence of anemia was 43.7% and iron deficiency was 28.4%. Intention-to-treat analyses indicated no significant treatment effects of iron or MNPs on the difference waveform amplitude at 11 months of age [mean difference (MD, 95% CI) iron vs placebo 0.24 (–1.03, 1.51); MNP vs placebo 0.59 (–0.70, 1.88)] and 20 months of age [(MD, 95% CI) iron vs placebo 0.50 (–0.62, 1.63); MNP vs placebo 0.24 (–0.89, 1.38)]. There were no differences by treatment arm for the other ERP measures. Conclusions Results from a rigorous prospectively powered sub-study of an RCT in an iron deficient population indicated no significant effects of supplementation with iron or MNPs on neural indices of habituation. Funding Sources NHMRC and The University of Melbourne.

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Mirror therapy for phantom limb and stump pain: a randomized controlled clinical trial in landmine amputees in Cambodia

Scandinavian Journal of Pain ◽

10.1515/sjpain-2018-0042 ◽

2018 ◽

Vol 18 (4) ◽

pp. 603-610 ◽

Cited By ~ 4

Author(s):

Ha Sam Ol ◽

Yang Van Heng ◽

Lena Danielsson ◽

Hans Husum

Keyword(s):

Low Income ◽

Controlled Trial ◽

Phantom Limb Pain ◽

Phantom Limb ◽

Controlled Clinical Trial ◽

Mirror Therapy ◽

Randomized Controlled ◽

Stump Pain ◽

The Difference ◽

Therapy Interventions

Abstract Background and aims The aim of the study was to examine the effect of mirror and tactile therapy on phantom and stump pain in patients with traumatic amputations, with particular reference to amputees in low-income communities. Methods The study was conducted with an open, randomized, semi-crossover case-control design in rural Cambodia. A study sample of 45 landmine victims with trans-tibial amputations was allocated to three treatment arms; mirror therapy, tactile therapy, and combined mirror-and-tactile therapy. Non-responders from the mono-therapy interventions were crossed over to the alternative intervention. The intervention consisted of 5 min of treatment every morning and evening for 4 weeks. Endpoint estimates of phantom limb pain (PLP), stump pain, and physical function were registered 3 months after the treatment. Results All three interventions were associated with more that 50% reduction in visual analogue scale (VAS)-rated PLP and stump pain. Combined mirror-tactile treatment had a significantly better effect on PLP and stump pain than mirror or tactile therapy alone. The difference between the three treatment arms were however slight, and hardly of clinical relevance. After treatment, the reduction of pain remained unchanged for an observation period of 3 months. Conclusions The study documents that a 4-week treatment period with mirror and/or tactile therapy significantly reduces PLP and stump pain after trans-tibial amputations. Implications The article reports for the first time a randomized controlled trial of mirror therapy in a homogenous sample of persons with traumatic amputations. The findings are of special relevance to amputees in low-resource communities.

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The Effect of Lactobacillus plantarum 299v on Iron Status and Physical Performance in Female Iron-Deficient Athletes: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu12051279 ◽

2020 ◽

Vol 12 (5) ◽

pp. 1279

Author(s):

Ulrika Axling ◽

Gunilla Önning ◽

Maile A. Combs ◽

Alemtsehay Bogale ◽

Magnus Högström ◽

...

Keyword(s):

Lactobacillus Plantarum ◽

Physical Performance ◽

Female Athletes ◽

Mood State ◽

Iron Status ◽

Controlled Trial ◽

Iron Stores ◽

Iron Deficient ◽

The Difference ◽

The Impact

Iron is an essential micronutrient for oxygen transport and mitochondrial metabolism and is critical for physical performance. Compromised iron stores are more commonly found among athletes, and females are especially at risk. Iron deficiency is generally treated using oral iron supplements. However, only a small proportion of ingested iron is absorbed, necessitating higher intakes, which may result in adverse side effects, reduced compliance, and inefficient repletion of iron stores. The probiotic strain Lactobacillus plantarum 299v (Lp299v) significantly increases intestinal iron absorption in meal studies. The present study was conducted to explore the effects of 20 mg of iron with or without Lp299v on iron status, mood state, and physical performance. Fifty-three healthy non-anemic female athletes with low iron stores (ferritin < 30 μg/L) were randomized, and 39 completed the study. Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone (13.6 vs. 8.2 µg/L), but the difference between the groups was not significant (p = 0.056). The mean reticulocyte hemoglobin content increased after intake of Lp299v compared to control (1.5 vs. 0.82 pg) after 12 weeks, but the difference between the group was not significant (p = 0.083). The Profile of Mood States (POMS) questionnaire showed increased vigor with Lp299v vs. iron alone after 12 weeks (3.5 vs. 0.1, p = 0.015). No conclusive effects on physical performance were observed. In conclusion, Lp299v, together with 20 mg of iron, could result in a more substantial and rapid improvement in iron status and improved vigor compared to 20 mg of iron alone. A larger clinical trial is needed to further explore these findings as well as the impact of Lp299v on physical performance.

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Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/201592 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 2

Author(s):

Tsuyoshi Miyaoka ◽

Motohide Furuya ◽

Jun Horiguchi ◽

Rei Wake ◽

Sadayuki Hashioka ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Efficacy And Safety ◽

Treatment Resistant ◽

Double Blind ◽

Double Blind Placebo ◽

Intention To Treat ◽

The Difference ◽

The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

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Normal Growth of Healthy Infants Born from HIV+ Mothers Fed a Reduced Protein Infant Formula Containing the Prebiotics Galacto-Oligosaccharides and Fructo-Oligosaccharides: A Randomized Controlled Trial

Clinical Medicine Insights Pediatrics ◽

10.4137/cmped.s17841 ◽

2015 ◽

Vol 9 ◽

pp. CMPed.S17841

Author(s):

Hugo Da Costa Ribeiro Júnior ◽

Tereza Cristina Medrado Ribeiro ◽

Angela Peixoto De Mattos ◽

Mariana Pontes ◽

Roseli Oselka Saccardo Sarni ◽

...

Keyword(s):

Weight Gain ◽

Infant Formula ◽

Controlled Trial ◽

Normal Growth ◽

Daily Weight Gain ◽

Term Infants ◽

Intention To Treat ◽

Formula Group ◽

The Difference ◽

Breast Fed

Objective The aim of the current study was to evaluate the safety of a new reduced protein (2.1 g/100 kcal) infant formula containing 4 g/L of 90% galacto-oligosaccharides (GOS) and 10% fructo-oligosaccharides (FOS). Methods Healthy term infants from Brazil were enrolled. Those born to human immunodeficiency virus (HIV)-positive mothers were randomized to a test ( n = 65) or control ( n = 63) formula group. Infants born to HIV-negative mothers were either exclusively breast-fed ( n = 79) or received a mixed diet (breast milk and test formula, n = 65). Between 2 weeks and 4 months of age, infants were exclusively fed according to their assigned group. Anthropometric measurements were taken at baseline, 1, 2, 3, 4, 6, 8, 10, and 12 months. Digestive tolerance was evaluated during the first 4 months. The primary outcome was mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups. Results Data from all infants ( N = 272) were used in the intention-to-treat (ITT) analysis and data from 230 infants were used in the per-protocol (PP) analysis. The difference in mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups was 1.257 g/day (onesided 95% confidence interval [CI]: -0.705 to inf, P < 0.001) in the PP analysis, showing that the lower bound of the 95% CI was above the -3.0 g/day non-inferiority margin. Results were similar in the ITT analysis. Symptoms of digestive tolerance and frequency of adverse events were similar in the two groups. Conclusions The formula containing 2.1 g/100 kcal protein and GOS and FOS was safe and tolerated well.

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Supervised training in primary care units but not spontaneous physical activity lowered cardiovascular risk in Brazilian low-income patients: a controlled trial

10.21203/rs.2.11959/v1 ◽

2019 ◽

Author(s):

Amana M. Lima ◽

André O. Werneck ◽

Edilson Cyrino ◽

Paulo Farinatti

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Total Cholesterol ◽

Body Mass ◽

Low Income ◽

Controlled Trial ◽

Intention To Treat ◽

Spontaneous Physical Activity ◽

Public Health Strategies

Abstract Background: Public health strategies to increase physical activity in low-income communities may reduce cardiovascular risk in these populations. This controlled trial compared the cardiovascular risk estimated by the Framingham Risk Score (FRS) over 12 months in formally active (FA), declared active (DA), and physically inactive (PI) patients attended by the ‘Family Health Strategy’ in low-income communities at Rio de Janeiro City, Brazil (known as ‘favelas’). Methods: Patients were matched for age and assigned into three groups: a) FA (supervised training, n=53; 60.5±7.7 yrs); b) DA (self-reported, n=43; 57.0±11.2 yrs); c) PI (n=48; 57.0±10.7 yrs). FA performed twice a week a 50-min exercise circuit including strength and aerobic exercises, complemented with 30-min brisk walking on the third day, whereas DA declared to perform spontaneous physical activity twice a week. Comparisons were adjusted by sex, chronological age, body mass index, and use of anti-hypertensive/statin medications. Results: At baseline, groups were similar in regards to body mass, body mass index, triglycerides, and LDL-C, as well to FRS and most of its components (age, blood pressure, hypertension prevalence, smoking, HDL-C, and total cholesterol; P>0.05). However, diabetes prevalence was 10-15% lower in DA vs. FA and PI (P<0.05). Intention-to-treat analysis showed significant reductions after intervention (P<0.05) in FA for total cholesterol (~10%), LDL-C (~15%), triglycerides (~10%), systolic blood pressure (~8%), and diastolic blood pressure (~9%). In DA, only LDL-C decreased (~10%, P < 0.05). Significant increases were found in PI (P<0.05) for total cholesterol (~15%), LDL-C (~12%), triglycerides (~15%), and systolic blood pressure (~5%). FRS lowered 35% in FA (intention-to-treat, P<0.05), remained stable in DA (P>0.05), and increased by 20% in PI (P<0.05). Conclusions: A supervised multi-modal exercise training developed at primary care health units reduced the cardiovascular risk in adults living in very low-income communities. The risk remained stable in patients practicing spontaneous physical activity and increased among individuals who remained physically inactive. These promising results should be considered within public health strategies to prevent cardiovascular disease in communities with limited resources. Trial registration: TCTR20181221002 (registered December 21, 2018; retrospectively registered).

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Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial

Endoscopy ◽

10.1055/a-0767-6529 ◽

2019 ◽

Vol 51 (05) ◽

pp. 427-435 ◽

Cited By ~ 1

Author(s):

Xin Shi ◽

Hui Luo ◽

Bo Ning ◽

Xiangping Wang ◽

Qin Tao ◽

...

Keyword(s):

Controlled Trial ◽

Controlled Study ◽

Duodenal Papilla ◽

Intention To Treat ◽

Randomized Controlled ◽

Percentage Points ◽

Major Duodenal Papilla ◽

Examination Time ◽

Transparent Cap ◽

The Difference

Abstract Background Cap-assisted esophagogastroduodenoscopy (CA-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for examination of the major duodenal papilla (MDP). However, it remains unclear whether CA-EGD is noninferior to standard duodenoscopy for MDP examination. The aim of this study was to compare the efficacies of the two methods for complete examination of the MDP. Methods This prospective, noninferior, randomized controlled study was conducted at two endoscopy centers. Consecutive patients who underwent endoscopic retrograde cholangiopancreatography were randomized (1:1) to undergo CA-EGD or standard duodenoscopy for MDP examination. The primary outcome was complete examination of the MDP, defined as visualization of the upper end, opening, and lower end of the papilla. Secondary outcomes included endoscopic findings and the time taken for the MDP examination. Results The study was terminated for futility after the interim analysis. A total of 171 patients were randomly allocated to CA-EGD (n = 85) or standard duodenoscopy (n = 86). The baseline characteristics were comparable between the two groups. Complete examination of the MDP was achieved in 58/85 patients (68.2 %) in the CA-EGD group and in 74/86 (86.0 %) in standard duodenoscopy group. The difference in proportions was – 17.81 percentage points (95 % confidence interval [CI] –28.14 to –7.48) by intention-to-treat analysis and – 18.22 percentage points (95 %CI –28.34 to –8.10) by per-protocol analysis, both of which were significantly lower than the noninferiority margin of –5 %, and therefore the noninferiority of CA-EGD could not be confirmed. Examination time was significantly longer with CA-EGD (69.5 [SD 46.4] vs. 33.0 [SD 28.9] seconds; P < 0.001). Conclusions Although complete examination of the MDP can be achieved by CA-EGD in most patients, it could not replace duodenoscopy as the standard method for examination of the MDP.

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Supervised training in primary care units but not self-directed physical activity lowered cardiovascular risk in Brazilian low-income patients: a controlled trial

BMC Public Health ◽

10.1186/s12889-019-7716-y ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Amana M. Lima ◽

André O. Werneck ◽

Edilson Cyrino ◽

Paulo Farinatti

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Total Cholesterol ◽

Body Mass ◽

Low Income ◽

Controlled Trial ◽

Intention To Treat ◽

Supervised Training ◽

Public Health Strategies

Abstract Background Public health strategies to increase physical activity in low-income communities may reduce cardiovascular risk in these populations. This controlled trial compared the cardiovascular risk estimated by the Framingham Risk Score (FRS) over 12 months in formally active (FA), declared active (DA), and physically inactive (PI) patients attended by the ‘Family Health Strategy’ in low-income communities at Rio de Janeiro City, Brazil (known as ‘favelas’). Methods Patients were matched for age and assigned into three groups: a) FA (supervised training, n = 53; 60.5 ± 7.7 yrs); b) DA (self-reported, n = 43; 57.0 ± 11.2 yrs); c) PI (n = 48; 57.0 ± 10.7 yrs). FA performed twice a week a 50-min exercise circuit including strength and aerobic exercises, complemented with 30-min brisk walking on the third day, whereas DA declared to perform self-directed physical activity twice a week. Comparisons were adjusted by sex, chronological age, body mass index, and use of anti-hypertensive/statin medications. Results At baseline, groups were similar in regards to body mass, body mass index, triglycerides, and LDL-C, as well to FRS and most of its components (age, blood pressure, hypertension prevalence, smoking, HDL-C, and total cholesterol; P > 0.05). However, diabetes prevalence was 10–15% lower in DA vs. FA and PI (P < 0.05). Intention-to-treat analysis showed significant reductions after intervention (P < 0.05) in FA for total cholesterol (~ 10%), LDL-C (~ 15%), triglycerides (~ 10%), systolic blood pressure (~ 8%), and diastolic blood pressure (~ 9%). In DA, only LDL-C decreased (~ 10%, P < 0.05). Significant increases were found in PI (P < 0.05) for total cholesterol (~ 15%), LDL-C (~ 12%), triglycerides (~ 15%), and systolic blood pressure (~ 5%). FRS lowered 35% in FA (intention-to-treat, P < 0.05), remained stable in DA (P > 0.05), and increased by 20% in PI (P < 0.05). Conclusions A supervised multi-modal exercise training developed at primary care health units reduced the cardiovascular risk in adults living in very low-income communities. The risk remained stable in patients practicing self-directed physical activity and increased among individuals who remained physically inactive. These promising results should be considered within public health strategies to prevent cardiovascular disease in communities with limited resources. Trial registration TCTR20181221002 (retrospectively registered). Registered December 21, 2018.

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Comprehensive Anaemia Programme And Personalized Therapies (CAPPT): Protocol For A Cluster-Randomised Controlled Trial Testing The Effect Women’s Groups, Home Counselling And Iron Supplementation On Haemoglobin In Pregnancy In Southern Nepal

10.21203/rs.3.rs-557765/v1 ◽

2021 ◽

Author(s):

Naomi M Saville ◽

Chandani Kharel ◽

Joanna Morrison ◽

Helen A. Harris-Fry ◽

Philip James ◽

...

Keyword(s):

Cluster Size ◽

Home Visiting ◽

Iron Supplementation ◽

Controlled Trial ◽

Haemoglobin Concentration ◽

Cluster Randomised Controlled Trial ◽

Individual Level ◽

Intention To Treat ◽

Anaemia In Pregnancy ◽

In Pregnancy

Abstract BackgroundAnaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes.Methods This non-blinded cluster-randomized controlled trial in the plains of Nepal has two study arms: 1) Control: routine antenatal care (ANC); 2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants: Women in 54 non-contiguous clusters (mean 2582; range 1299-4865 population) in Southern Kapilbastu district are eligible if they consent to menstrual monitoring, are resident, married, aged 13-49 years and able to respond to questions. After 1-2 missed menses and a positive pregnancy test, consenting women <20 weeks’ gestation, who plan to reside locally for most of the pregnancy, enrol into trial follow-up. Interventions comprise two home-counselling visits (at 12-21- and 22-26-weeks’ gestation) with iron folic acid (IFA) supplement dosage tailored to women’s haemoglobin concentration, plus monthly PLA women’s group meetings using a dialogical problem-solving approach to engage pregnant women and their families. Home visits and PLA meetings will be facilitated by auxiliary nurse midwives.Hypothesis: Haemoglobin of women at 30±2 weeks’ gestation is ≥0.4 g/dL higher in the intervention arm than in the control. A sample of 842 women (421 per arm, average 15.6 per cluster) will provide 88% power, assuming SD 1.2, ICC 0.09 and CV of cluster size 0.27.Outcomes are captured at 30±2 weeks gestation. Primary outcome: Haemoglobin concentration (g/dL). Secondary outcomes: Anaemia prevalence (%), mid-upper arm circumference (cm), Mean Probability of micronutrient Adequacy (MPA) and number of ANC visits at a health facility.Indicators to assess pathways to impact include number of IFA tablets consumed during pregnancy, intake of energy (kcal/d) and dietary iron (mg/d), a score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator.Costs and cost-effectiveness of the intervention will be estimated from a provider perspective. Using constrained randomisation we allocated clusters to study arms, ensuring similarity with respect to cluster size, ethnicity, religion and distance to a health facility. Analysis is by intention-to-treat at the individual level, using mixed-effects regression.Discussion: Findings will inform Nepal government policy on approaches to increase adherence to IFA, improve diets and reduce anaemia in pregnancy.Trial registration: ISRCTN 12272130.

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Supervised training in primary care units but not self-directed physical activity lowered cardiovascular risk in Brazilian low-income patients: a controlled trial

10.21203/rs.2.11959/v2 ◽

2019 ◽

Author(s):

Amana M. Lima ◽

André O. Werneck ◽

Edilson Cyrino ◽

Paulo Farinatti

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Total Cholesterol ◽

Body Mass ◽

Low Income ◽

Controlled Trial ◽

Intention To Treat ◽

Supervised Training ◽

Public Health Strategies

Abstract Background: Public health strategies to increase physical activity in low-income communities may reduce cardiovascular risk in these populations. This controlled trial compared the cardiovascular risk estimated by the Framingham Risk Score (FRS) over 12 months in formally active (FA), declared active (DA), and physically inactive (PI) patients attended by the ‘Family Health Strategy’ in low-income communities at Rio de Janeiro City, Brazil (known as ‘favelas’). Methods: Patients were matched for age and assigned into three groups: a) FA (supervised training, n=53; 60.5±7.7 yrs); b) DA (self-reported, n=43; 57.0±11.2 yrs); c) PI (n=48; 57.0±10.7 yrs). FA performed twice a week a 50-min exercise circuit including strength and aerobic exercises, complemented with 30-min brisk walking on the third day, whereas DA declared to perform self-directed physical activity twice a week. Comparisons were adjusted by sex, chronological age, body mass index, and use of anti-hypertensive/statin medications. Results: At baseline, groups were similar in regards to body mass, body mass index, triglycerides, and LDL-C, as well to FRS and most of its components (age, blood pressure, hypertension prevalence, smoking, HDL-C, and total cholesterol; P>0.05). However, diabetes prevalence was 10-15% lower in DA vs. FA and PI (P<0.05). Intention-to-treat analysis showed significant reductions after intervention (P<0.05) in FA for total cholesterol (~10%), LDL-C (~15%), triglycerides (~10%), systolic blood pressure (~8%), and diastolic blood pressure (~9%). In DA, only LDL-C decreased (~10%, P < 0.05). Significant increases were found in PI (P<0.05) for total cholesterol (~15%), LDL-C (~12%), triglycerides (~15%), and systolic blood pressure (~5%). FRS lowered 35% in FA (intention-to-treat, P<0.05), remained stable in DA (P>0.05), and increased by 20% in PI (P<0.05). Conclusions: A supervised multi-modal exercise training developed at primary care health units reduced the cardiovascular risk in adults living in very low-income communities. The risk remained stable in patients practicing self-directed physical activity and increased among individuals who remained physically inactive. These promising results should be considered within public health strategies to prevent cardiovascular disease in communities with limited resources.

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Outcomes and safety of concomitant topiramate or metformin for antipsychotics-induced obesity: A randomized controlled trial

10.21203/rs.3.rs-47407/v1 ◽

2020 ◽

Author(s):

Congjie Wang ◽

Wenjie Shi ◽

Jianyang Xu ◽

Chengbing Huang ◽

Jiannan Zhu

Keyword(s):

Missing Values ◽

Controlled Trial ◽

Intention To Treat ◽

Waist Hip Ratio ◽

Reduced Body ◽

Significant Difference ◽

The Difference ◽

The Impact ◽

Baseline Bmi

Abstract BackgroundAlthough some data exist describing the use of topiramate in patients with antipsychotic-induced obesity, direct comparision with metformin is limited. The purpose of this study was to explore the effectiveness and safety of concomitant topiramate on antipsychotic-induced obesity and compare with metformin.Methods62 stabilized outpatients with antipsychotic-induced obesity were randomized to 16-week treatment group of topiramate or metformin. The patients’ weight, body mass index (BMI), waist-hip ratio and side effects were assessed and compared. Intention-to-treat and completer analyses were performed. Meanwhile, Covariance analysis was conducted to control the impact of the significant difference in BMI when comparison between the two groups.ResultsTwo groups had comparable characteristics though the difference in baseline BMI was significant. Intention-to-treat analyses: The random missing values were replaced using the last observation carried forward method when intention-to-treat analyses. Compared with the baseline, the weight, BMI and waist-hip ratio with topiramate markedly decreased at each follow-up, whereas, only waist-hip ratio with metformin significantly decreased at 4-week. Compared with metformin,only weight and BMI with topiramate significantly decreased at 4-week, and all weight, BMI and waist-hip ratio at week 8–16 also remarkably declined. Completer analyses: Compared with the baseline, the weight, BMI and waist-hip ratio with topiramate at week 4–16 markedly decreased, whereas, only waist-hip ratio with metformin significantly decreased at 4-week. Compared with metformin, all BMI with topiramate markedly decreased at week 4–16, moreover weigh and waist-hip ratio also notably lowered at 8-week. No significant differences in adverse events were found between the two groups.ConclusionsTopiramate, similar to metformin in reducing obesity as previously reported, also significantly reduced body weight, BMI and waist-hip ratio in patients with antipsychotic-induced obesity and demonstrated well tolerance in psychiatric patients.The trial was registered at http://www.chictr.org.cn, and the number was ChiCTR-IPR-17013122.

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