scholarly journals Effect of vitamin B6 supplementation, in combination with magnesium, on severe stress and magnesium status: secondary analysis from an RCT

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Lionel Noah ◽  
Gisèle Pickering ◽  
Claude Dubray ◽  
Andre Mazur ◽  
Simon Hitier ◽  
...  
Keyword(s):  
General Population ◽  
Vitamin B6 ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Subscale Score ◽  
Normal Range ◽  
Parallel Group ◽  
Stress Score ◽  
Randomised Controlled ◽  
The Relationship

AbstractIntroductionEvidence from a recent randomised controlled trial1 suggests that in severely stressed subjects with low magnesemia, supplementation with magnesium (Mg) in combination with vitamin B6 (B6) provides greater benefits than Mg alone. B6 was reported to facilitate Mg absorption and its cellular uptake and to exert synergistic effect with Mg. The current secondary analysis explored the relationship between Mg-B6 combination and erythrocyte Mg concentration, used as a biomarker of body Mg status.Material and MethodsAn 8-week, Phase IV, controlled, single-blinded, parallel-group trial (EudraCT Number 2015-003749-24) stratified by sex was conducted in adults (n = 264) with a Depression Anxiety Stress Scales - stress subscale score (DASS-42SS) > 18 and serum Mg of 0.5–0.85mmol/L, randomised 1:1 to daily oral Mg-B6 (Magne B6®, Mg 300 mg; B6 30mg) or oral Mg alone (Magnespasmyl®, Mg 300mg). Outcomes were stress score, serum Mg (mmol/L), erythrocytes Mg (mmol/L), and serum B6 (nmol/L) from baseline to Week4 and Week8. Data are given as mean(SD) values.Results & DiscussionBaseline characteristics. Baseline magnesemia was 0.80(0.04) for both groups. Erythrocyte Mg concentration for the lower quintile of the studied population (n = 53) was 0.73–1.62, below the normal range of 1.65–2.65 in general population. The mean stress score in this subgroup was higher [29.5(6.3)], but not significantly different from that in other quintiles [lowest value: 26.1(7.6)]. Baseline B6 serum level for the lower B6 quintile (5–23), below the normal range for general population, was suggestive of possible B6 deficiency.Treatment effects. Both treatments increased slightly but not significantly erythrocyte Mg level from baseline to Week8 [1.84(0.03) to 1.86(0.03), and 1.86(0.03) to 188(0.03), respectively for Mg + B6 and Mg groups]. Significant changes were observed in subjects with low erythrocyte Mg level at baseline (< 1.6), namely an increase of + 0.13(0.04–0.22) for Mg + B6 and + 0.17(0.08–0.25) for Mg groups, but with no difference between treatments. Moreover, Mg + B6 supplementation led to a significant change (p < 0.0001) in serum B6 level between baseline and Wk8 [55.9(4.8) to 370.9(11.3)], as compared to Mg alone [51.9(4.8) to 51.5(11.3)].In conclusion, both treatments significantly increased erythrocyte Mg in subjects with low Mg status. B6 supplementation did not lead to further increase in erythrocyte Mg level. We have previously shown that severely stressed population benefits from B6 supplementation in combination with Mg, however, the mechanism of the interaction between Mg and B6 remains to be elucidated.1Sponsored by Sanofi

scholarly journals Nortriptyline for pain in knee osteoarthritis in general practice: a double blind randomised controlled trial

2021 ◽  
pp. BJGP.2020.0797
Author(s):  
Ben Hudson ◽  
Jonathan A Williman ◽  
Lisa K Stamp ◽  
John S Alchin ◽  
Gary J Hooper ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Subscale Score ◽  
Womac Pain ◽  
Double Blind ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Osteoarthritis (OA) of the knee is a common cause of chronic pain. The currently available analgesics have limited efficacy and may be poorly tolerated. Aim: To investigate the analgesic efficacy of nortriptyline in people with knee OA. Design and setting: A two-arm parallel-group 1:1 double blind randomised placebo-controlled trial. Participants were recruited from orthopaedic outpatient clinics, primary care, and by public advertising. Method: Adults with knee OA and with pain rated as >20 points on the 50 point Western Ontario and McMaster University (WOMAC) pain sub-scale were randomised to receive either nortriptyline or identical placebo for 14 weeks. Primary outcome was knee pain at 14 weeks measured using the WOMAC pain sub-scale. Secondary outcomes included function, stiffness, non-steroidal anti-inflammatory drug, opioid and/or paracetamol use, participant global assessment, and adverse effects at 14 weeks. Results: Of the 205 randomised participants, 201 (98%) completed follow-up at 14 weeks. The baseline-adjusted mean WOMAC pain subscale score at week 14 was 6.15 points lower (95% CI -0.26 to 12.6, p = 0.06) in the nortriptyline vs. the placebo arm. Differences in secondary outcomes generally favoured the nortriptyline arm, but were small and unlikely to be clinically relevant. Dry mouth (87% vs. 51%, p < 0.001), constipation (69% vs. 30%, p < 0.001), and sweating (31% vs. 21%, p = 0.033) were all more commonly reported by participants taking nortriptyline. Conclusion: This study suggests nortriptyline does not significantly reduce pain in people with knee OA. Adverse effect profile was as expected.

scholarly journals How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043444
Author(s):  
Martine Rostadmo ◽  
Siri Lunde Strømme ◽  
Magne Nylenna ◽  
Pal Gulbrandsen ◽  
Erlend Hem ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
First Language ◽  
Review Article ◽  
Scientific Article ◽  
Potential Range ◽  
Parallel Group ◽  
The Difference ◽  
Randomised Controlled ◽  
Primary Care Medicine

IntroductionEnglish is the lingua franca of science. How well doctors understand English is therefore crucial for their understanding of scientific articles. However, only 5% of the world’s population have English as their first language.MethodsObjectives: To compare doctors’ comprehension of a scientific article when read in their first language (Norwegian) versus their second language (English). Our hypothesis was that doctors reading the article in Norwegian would comprehend the content better than those reading it in English.Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical review article in either Norwegian or English, before completing a questionnaire about the content of the article.Setting: Conference in primary care medicine in Norway, 2018.Participants: 130 native Norwegian-speaking doctors, 71 women and 59 men. One participant withdrew before responding to the questionnaire and was excluded from the analyses.Interventions: Participants were randomly assigned to read a review article in either Norwegian (n=64) or English (n=66). Reading time was limited to 7 min followed by 7 min to answer a questionnaire.Main outcome measures: Total score on questions related to the article content (potential range −9 to 20).ResultsDoctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared with 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% CI 0.03 to 2.62; p=0.046). Age was independently associated with total score, with decreased comprehension with increasing age.ConclusionThe difference in comprehension between the group who read in Norwegian and the group who read in English was statistically significant but modest, suggesting that the language gap in academia is possible to overcome.

scholarly journals Social Influence and Uptake of Couples HIV Testing and Counselling in KwaZulu-Natal, South Africa

2021 ◽  
Author(s):  
Matthew J. Johnson ◽  
Lynae A. Darbes ◽  
Victoria Hosegood ◽  
Mallory O. Johnson ◽  
Katherine Fritz ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Peer Support ◽  
Social Influences ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Sub Saharan Africa ◽  
Survival Models ◽  
Hiv Testing And Counselling ◽  
Randomised Controlled ◽  
Support Score

AbstractSocial influences may create a barrier to couples HIV testing and counselling (CHTC) uptake in sub-Saharan Africa. This secondary analysis of data collected in the ‘Uthando Lwethu’ randomised controlled trial used discrete-time survival models to evaluate the association between within-couple average ‘peer support’ score and uptake of CHTC by the end of nine months’ follow-up. Peer support was conceptualised by self-rated strength of agreement with two statements describing friendships outside of the primary partnership. Eighty-eight couples (26.9%) took up CHTC. Results tended towards a dichotomous trend in models adjusted only for trial arm, with uptake significantly less likely amongst couples in the higher of four peer support score categories (OR 0.34, 95% CI 0.18, 0.68 [7–10 points]; OR 0.53, 95% CI 0.28, 0.99 [≥ 11 points]). A similar trend remained in the final multivariable model, but was no longer significant (AOR 0.59, 95% CI 0.25, 1.42 [7–10 points]; AOR 0.88, 95% CI 0.36, 2.10 [≥ 11 points]). Accounting for social influences in the design of couples-focused interventions may increase their success.

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M. Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract Background As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study. Methods The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline. Discussion Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers. Trial registration Unique identification number in ISRCTN registry: ISRCTN10201482. Date registered: 12 May 2020

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