From the Medicine Service, VA Medical Center, Birmingham, AL.
Division of Clinical Immunology and Rheumatology.
J Clin Rheumatol. 2020 Jun;26(4):147-156. doi: 10.1097/RHU.0000000000001004.
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.
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.
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.
An Internet gout RCT is feasible for nonpharmacological gout treatments. A hypothesis-testing, large Internet RCT of cherry extract versus placebo is needed.
本研究旨在开展为期 9 个月的樱桃提取物与痛风饮食改良的互联网随机对照试验（RCT），以评估互联网研究的可行性并获得疗效预估。
通过对互联网广告、社交媒体或诊所传单做出在线知情同意后，84 名经医生确诊的痛风患者被随机分配至樱桃提取物 3600mg/d 组（n=41）或营养师辅助痛风饮食改良组（n=43）。所有研究结果均通过互联网和电话收集。主要目标是评估互联网研究的可行性，次要目标是获得痛风发作、健康评估问卷（HAQ）评估的功能能力以及未来试验的不良事件（AE）的疗效预估。
84 名随机患者中，大多数研究程序的总体完成率在 6 个月时超过 80%，两种活性对照药物的完成率也相似。与基线相比，樱桃提取物和饮食改良组在 9 个月时的痛风发作和 HAQ 评分均有所改善：每月痛风发作次数分别为 0.22 与 0.36（p=0.049）和 0.28 与 0.31（p=0.76）；任何痛风发作的比例分别为 56%与 98%（p<0.0001）和 65%与 98%（p=0.0002）；HAQ 评分均值分别为 0.28±0.54 与 0.55±0.68（p=0.001）和 0.23±0.40 与 0.48±0.61（p=0.06）。樱桃提取物和饮食改良组在 9 个月时的任何 AE 和胃肠道症状/AE 分别为 3%与 0%和 28%与 27%。
互联网痛风 RCT 对于非药物性痛风治疗是可行的。需要开展一项关于樱桃提取物与安慰剂的互联网大型 RCT 以验证假设。
