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

Andrew Pipingas³  Avni Sali¹  David J White²  Marni Kras³  Erin Fogg³  Con Stough³  Andrew Scholey³  David A Camfield³  Katherine H M Cox³  Jerome Sarris³ 

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

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

Others  :  823770
DOI  :  10.1186/1475-2891-11-110

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

【 摘 要 】

Background

While 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.

Methods

Semi-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.

Results

Of 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.

Conclusion

This 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 registration

Prior to commencement this trial was registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au webcite) ACTRN12611000092998

【 授权许可】

   
2012 Sarris et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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