Participant experiences from chronic administration of a multivitamin versus placebo on subjective health and wellbeing: a double-blind qualitative analysis of a randomised controlled trial

Nutrition Journal

Research

Erin Fogg¹  Con Stough¹  Andrew Scholey¹  David A Camfield¹  Katherine H M Cox¹  Marni Kras¹  Andrew Pipingas¹  David J White²  Jerome Sarris³  Avni Sali⁴ 

[1] Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia;Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia;Brain and Psychological Sciences Research Centre, Swinburne University of Technology, Hawthorn, Australia;Department of Psychiatry, The University of Melbourne, Melbourne, Australia;Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia;National Institute of Integrative Medicine, Hawthorn, Australia;

关键词: Multivitamin;    Mood;    Energy;    Cognition;    Adverse reactions;    Qualitative;   

DOI  :  10.1186/1475-2891-11-110

 received in 2012-08-07, accepted in 2012-11-30,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundWhile many randomised controlled trials have been conducted on multivitamins, to our knowledge no qualitative research exploring the subjective experience of taking a multivitamin during a clinical trial has been reported.MethodsSemi-structured and open-ended written questions were incorporated into a 16-week double-blind, randomised, placebo-controlled, parallel groups trial of once-daily multivitamin administration. At the final study visit (week 16), three open-ended questions were posed to elucidate any positive, negative or unusual experiences from taking either the multivitamin or matched placebo. Qualitative thematic analysis was undertaken by researchers who were blind as to treatment condition of participants, and triangulation (independent analysis from three researchers) was employed to ensure methodological rigour. Participant’s experiences were categorised as “positive” or “negative” and a Chi Square analysis was then applied to each of the experiential themes, to compare experiences between the multivitamin and placebo groups, (subdividing the groups by gender). Usual experiences were categorised and discussed separately.ResultsOf the 182 participants enrolled, 116 completed the study and qualitative data were available from 114 participants. Thematic analysis revealed significant effects in favour of the multivitamin over placebo for participants experiencing increased energy levels (p=.022) and enhanced mood (p=.027). The beneficial effect on energy levels was particularly evident among female participants. A trend was found for participants reporting better sleep in the multivitamin over placebo. The multivitamin and placebo groups did not significantly differ in perceived positive or negative effects in areas relating to other aspects of mental function or physical health. No significant negative effects were revealed, although there was a non-significant trend for more people in the multivitamin group having minor digestive complaints.ConclusionThis represents the first documented qualitative investigation of participants’ experience of chronic administration of a multivitamin. Results uncovered a range of subjective beneficial effects that are consistent with quantitative data from previously published randomised controlled trials examining the effects of multivitamins and B vitamin complexes on mood and well-being.Trial registrationPrior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au) ACTRN12611000092998

【 授权许可】

Unknown   
© Sarris et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.