PMID- 32453288 OWN - NLM STAT- MEDLINE DCOM- 20210322 LR - 20240229 IS - 1536-7355 (Electronic) IS - 1076-1608 (Print) IS - 1076-1608 (Linking) VI - 26 IP - 4 DP - 2020 Jun TI - A Randomized Internet-Based Pilot Feasibility and Planning Study of Cherry Extract and Diet Modification in Gout. PG - 147-156 LID - 10.1097/RHU.0000000000001004 [doi] AB - OBJECTIVE: The aim of this study was to conduct a 9-month pilot Internet randomized controlled trial (RCT) of cherry extract and diet modification in gout to assess the feasibility of an Internet study and obtain effect estimates. METHODS: After providing online informed consent in response to Internet advertisements and social media or clinic flyers, 84 people with physician-confirmed gout were randomized to either cherry extract 3,600 mg/d (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via Internet and phone calls. The primary objective was the feasibility of an Internet study, and secondary objectives were to obtain effect estimates for gout flares, functional ability assessed with the Health Assessment Questionnaire (HAQ), and adverse events (AEs) for future trials. RESULTS: Of the 84 people randomized, overall completion rates were more than 80% for most study procedures up to 6 months and similar for the 2 active comparators. Improvements were seen in gout flares and HAQ scores in cherry extract and diet modification groups at 9 months compared with baseline: gout flares per month, 0.22 versus 0.36 (p = 0.049) and 0.28 versus 0.31 (p = 0.76); proportion with any gout flare, 56% versus 98% (p < 0.0001) and 65% versus 98% (p = 0.0002); and mean +/- standard deviation HAQ score, 0.28 +/- 0.54 versus 0.55 +/- 0.68 (p = 0.001) and 0.23 +/- 0.40 versus 0.48 +/- 0.61 (p = 0.06), respectively. Any AEs and gastrointestinal symptoms/AEs at 9 months in cherry extract and diet modification groups were 3% versus 0% and 28% versus 27%, respectively. CONCLUSIONS: An Internet gout RCT is feasible for nonpharmacological gout treatments. A hypothesis-testing, large Internet RCT of cherry extract versus placebo is needed. FAU - Singh, Jasvinder A AU - Singh JA AD - From the Medicine Service, VA Medical Center, Birmingham, AL. AD - Division of Clinical Immunology and Rheumatology. AD - Department of Epidemiology, School of Public Health. FAU - Green, Candace AU - Green C AD - Division of Clinical Immunology and Rheumatology. FAU - Morgan, Sarah AU - Morgan S AD - Division of Clinical Immunology and Rheumatology. FAU - Willig, Amanda L AU - Willig AL AD - Division of Infectious Diseases, Department of Medicine at School of Medicine. FAU - Darnell, Betty AU - Darnell B AD - Department of Nutrition. FAU - Saag, Kenneth G AU - Saag KG AD - Division of Clinical Immunology and Rheumatology. FAU - Weiss, Rick AU - Weiss R AD - Viocare, Princeton, NJ. FAU - Cutter, Gary AU - Cutter G AD - Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL. FAU - McGwin, Gerald AU - McGwin G AD - Department of Epidemiology, School of Public Health. LA - eng GR - UL1 TR001417/TR/NCATS NIH HHS/United States GR - UL1 TR003096/TR/NCATS NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - J Clin Rheumatol JT - Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases JID - 9518034 RN - 0 (Capsules) RN - 0 (Plant Extracts) SB - IM MH - Capsules MH - *Diagnostic Self Evaluation MH - Diet Therapy/*methods MH - Feasibility Studies MH - Female MH - *Functional Status MH - Gout/diagnosis/diet therapy/*therapy MH - Humans MH - Internet-Based Intervention MH - Male MH - Middle Aged MH - Phytotherapy/methods MH - *Plant Extracts/administration & dosage/adverse effects MH - *Prunus domestica MH - Symptom Assessment/methods MH - Symptom Flare Up MH - Treatment Outcome PMC - PMC8664374 MID - NIHMS1752304 COIS- Financial Conflict: JAS has received consultant fees from Crealta/Horizon, Fidia, UBM LLC, Medscape, WebMD, the National Institutes of Health and the American College of Rheumatology. JAS is a member of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS served as a member of the American College of Rheumatology's (ACR) Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee and the co-chair of the ACR Criteria and Response Criteria subcommittee. JAS is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 36 companies. SM has no relevant disclosures. RW is the owner and CEO of Viocare, a company that markets online dietary assessment tools. KGS has received research grants from Amgen, Ironwood/AstraZeneca, Horizon, Merck, SOBI, and Takeda pharmaceuticals and consultant fees from Abbott, Amgen, Ironwood/AstraZeneca, Bayer, BMS, Horizon, Lilly, Merck, Pfizer, Radius, Roche/Genentech, SOBI, and Takeda pharmaceuticals. Other authors have no relevant disclosures. EDAT- 2020/05/27 06:00 MHDA- 2021/03/23 06:00 PMCR- 2021/12/10 CRDT- 2020/05/27 06:00 PHST- 2020/05/27 06:00 [entrez] PHST- 2020/05/27 06:00 [pubmed] PHST- 2021/03/23 06:00 [medline] PHST- 2021/12/10 00:00 [pmc-release] AID - 00124743-202006000-00006 [pii] AID - 10.1097/RHU.0000000000001004 [doi] PST - ppublish SO - J Clin Rheumatol. 2020 Jun;26(4):147-156. doi: 10.1097/RHU.0000000000001004.