The purpose of this study was to perform a 9-month pilot Internet randomised controlled trial (RCT) of cherry extract and diet modification in gout in order to examine the feasibility of an Internet study and produce effect estimates. 84 individuals with physician-confirmed gout were randomly assigned to either cherry extract 3,600 mg/d or dietitian-assisted diet adjustment for gout after obtaining online informed permission in response to Internet ads, social media, or clinic brochures. All research results were gathered through the use of the Internet and phone calls.The primary goal was to determine the feasibility of an Internet research, with secondary goals of obtaining impact estimates for gout flares, functional capacity measured with the Health Assessment Questionnaire (HAQ), and adverse events (AEs) for future studies. Overall completion rates for most study procedures up to 6 months were greater than 80% for the 84 individuals randomised, and similar for the two active comparators. Gout flares and HAQ scores improved in the cherry extract and diet modification groups at 9 months compared to baseline: gout flares per month, 0.22 vs 0.36 and 0.28 versus 0.31; proportion with any gout flare, 56 percent versus 98 percent and 65 percent versus 98 percent; and mean standard deviation HAQ score, respectively, 0.28 0.54 vs 0.55 0.68 and 0.23 0.40 versus 0.48 0.61. At 9 months, the percentages of AEs and gastrointestinal symptoms/AEs in the cherry extract and diet change groups were 3% against 0% and 28% versus 27%, respectively.
For nonpharmacological gout therapies, an Internet gout RCT is conceivable. A big Internet RCT of cherry extract versus placebo is required to test hypotheses.
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