Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial.
Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial.
复制标题
手部骨关节炎：研究含雌激素治疗的疼痛效应（HOPE-e）：一项可行性随机安慰剂对照试验方案。
DOI：
10.1186/s40814-021-00869-1
复制
发表时间：
2021-06-24
影响因子：
1.7
通讯作者：
Watt FE
中科院分区：
文献类型：
--
作者：
Marian IR;Goff M;Williams JAE;Gulati M;Chester-Jones M;Francis A;Watson M;Vincent TL;Woollacott S;Mackworth-Young C;Glover V;Furniss D;Gardiner M;Lamb SE;Vincent K;Barber VS;Black J;Dutton SJ;Watt FE
手骨关节炎（OA）是一种常见的疾病，导致疼痛，僵硬和生活质量下降。妇女发病率较高，特别是在绝经年龄前后。虽然性激素和OA之间的关系已经在体外研究，在流行病学研究和激素替代疗法（HRT）的临床试验，这项研究是第一个调查的影响，含雌激素治疗的绝经后妇女手疼痛症状手OA的随机研究设计。这是一项双盲安慰剂对照干预的可行性研究，以1：1的比例随机分配至0.45 mg结合雌激素和20 mg醋酸巴多昔芬（Duavive）或安慰剂。目标人群为患有症状性手部OA的绝经后女性，旨在招募60-90名研究参与者。主要目的是评估未来完全把握度随机对照试验（RCT）的可行性。受试者将服用研究药物24周，并在随机化后随访28周。用于确定可行性的主要结局是合格受试者识别率和途径;合格受试者的招募、随机化和保留率;研究药物依从性;以及意外揭盲的可能性。次要结果包括手部疼痛、功能、外观和更年期症状的测量。研究结束问卷和焦点小组将有助于完善完整研究的最终方案。确定症状性手部OA的新治疗方法是公认的研究优先事项。这项研究将帮助我们了解是否有足够的感兴趣和合格的个人在这个目标人群谁会考虑HRT为他们的手症状。它将提供关于HRT对该人群手部疼痛和其他临床相关结局影响的概念验证RCT数据。该研究将获得关于完整RCT的可行性以及如何最好地运行该RCT的宝贵信息。研究结果将发表在同行评审期刊上，并在相关会议上发表。ISRCTN 12196200于2019年1月15日注册。在线版本包含补充材料，可通过10.1186/s40814-021-00869-1获得。
Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design. This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60–90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study. Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference. ISRCTN12196200 registered on 15 January 2019. The online version contains supplementary material available at 10.1186/s40814-021-00869-1.