Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy.
BACKGROUND
The clinical effectiveness of complementary and alternative medicines (CAMs) is widely debated because of a lack of clinical trials. The internet may provide an effective and economical approach for undertaking randomised controlled trials (RCTs) of low-risk interventions. We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT (Consolidated Standards of Reporting Trials) statement quality checklist for reporting of RCTs. A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks.


METHODS
People aged > or =18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms. The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months. The primary outcome measure was the performance of the trial according to the revised CONSORT statement.


RESULTS
147 people were randomised into the trial. The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial. Recruitment of the required number of participants was completed in 19 months. Sixty-five percent (96/147) completed the entire 3 months of the trial. The trial was low cost and demonstrated that in an intention to treat analysis, probiotics did not improve well-being or bowel symptoms.


CONCLUSIONS
The internet-based RCT proved to be a successful and economical method for examining this CAM intervention. Recruitment, adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost. Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and are an appropriate method for studying low-risk interventions.


BACKGROUND
ISRCTN36133252.
Brophy
Sinead
S
School of Medicine, Swansea University, Swansea, Wales SA2 8PP, UK. s.brophy@swansea.ac.uk
Burrows
Claire L
CL
Brooks
Caroline
C
Gravenor
Michael B
MB
Siebert
Stefan
S
Allen
Stephen J
SJ
D000328:Adult; D000529:Complementary Therapies / Q000379:methods / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020407:Internet / Q000592:standards*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D025242:Spondylarthropathies / Q000178:diet therapy* / Q000453:epidemiology