Objectives To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson’s disease. Design Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial. Setting The speech and language therapy interventions were delivered in outpatient or home settings between 26 September 2016 and 16 March 2020. Participants 388 people with Parkinson’s disease and dysarthria. Interventions Participants were randomly assigned to one of three groups (1:1:1): 130 to Lee Silverman voice treatment (LSVT LOUD), 129 to NHS speech and language therapy, and 129 to no speech and language therapy. LSVT LOUD consisted of four, face-to-face or remote, 50 min sessions each week delivered over four weeks. Home based practice activities were set for up to 5-10 mins daily on treatment days and 15 mins twice daily on non-treatment days. Dosage for the NHS speech and language therapy was determined by the local therapist in response to the participants’ needs (estimated from prior research that NHS speech and language therapy participants would receive an average of one session per week over six to eight weeks). Local practices for NHS speech and language therapy were accepted, except for those within the LSVT LOUD protocol. Analyses were based on the intention to treat principle. Main outcome measures The primary outcome was total score at three months of self-reported voice handicap index. Results People who received LSVT LOUD reported lower voice handicap index scores at three months after randomisation than those who did not receive speech and language therapy (−8.0 points (99% confidence interval −13.3 to −2.6); P<0.001). No evidence suggests a difference in voice handicap index scores between NHS speech and language therapy and no speech and language therapy (1.7 points (−3.8 to 7.1); P=0.43). Patients in the LSVT LOUD group also reported lower voice handicap index scores than did those randomised to NHS speech and language therapy (−9.6 points (−14.9 to −4.4); P<0.001). 93 adverse events (predominately vocal strain) were reported in the LSVT LOUD group, 46 in the NHS speech and language therapy group, and none in the no speech and language therapy group. No serious adverse events were recorded. Conclusions LSVT LOUD was more effective at reducing the participant reported impact of voice problems than was no speech and language therapy and NHS speech and language therapy. NHS speech and language therapy showed no evidence of benefit compared with no speech and language therapy. Trial registration ISRCTN registry [ISRCTN12421382][1]. All requests for access to PD COMM data should be submitted to the corresponding author for consideration by the current investigator. Access to anonymised patient level data with a data dictionary may be granted following review, no earlier than six months after this publication with no end date. Proposals for data access will need to describe how the data will be used. Transfer of data will be by a secure method and only after approval by the Trial investigator team. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN12421382

中文翻译：

---

Lee Silverman 语音治疗与 NHS 言语和语言治疗与对照治疗帕金森病患者的构音障碍 (PD COMM)：实用、英国、多中心、三臂、平行组、非盲、随机对照试验


目的 评估两种言语和语言治疗方法与不使用言语和语言治疗方法治疗帕金森病患者构音障碍的临床效果。设计务实、英国、多中心、三臂、平行组、非盲、随机对照试验。地点 2016 年 9 月 26 日至 2020 年 3 月 16 日期间，言语和语言治疗干预在门诊或家庭环境中进行。参与者包括 388 名帕金森病和构音障碍患者。干预措施 参与者被随机分配到三组中的一组 (1:1:1)：130 人接受 Lee Silverman 语音治疗 (LSVT LOUD)，129 人接受 NHS 言语和语言治疗，129 人接受无言语和语言治疗。 LSVT LOUD 包括四次面对面或远程课程，每周 50 分钟，为期四个星期。治疗日每天在家练习活动最多 5-10 分钟，非治疗日每天两次每次 15 分钟。 NHS 言语和语言治疗的剂量由当地治疗师根据参与者的需求确定（根据之前的研究估计，NHS 言语和语言治疗参与者在六到八周内平均每周接受一次疗程）。 NHS 言语和语言治疗的当地实践已被接受，但 LSVT LOUD 协议范围内的实践除外。分析基于意向治疗原则。主要结果指标 主要结果是三个月自我报告的声音障碍指数的总分。结果 接受 LSVT LOUD 治疗的患者在随机分组后三个月时报告的声音障碍指数得分低于未接受言语和语言治疗的患者（−8.0 分（99% 置信区间 -13.3 至 -2.6）；P<0.001）。 没有证据表明 NHS 言语和语言治疗与未接受言语和语言治疗之间的声音障碍指数评分存在差异（1.7 分（-3.8 至 7.1）；P=0.43）。 LSVT LOUD 组患者的声音障碍指数评分也低于随机接受 NHS 言语和语言治疗的患者（−9.6 分（−14.9 至 −4.4）；P<0.001）。 LSVT LOUD 组报告了 93 例不良事件（主要是声带紧张），NHS 言语和语言治疗组报告了 46 例不良事件，无言语和语言治疗组报告了 46 例不良事件。没有记录到严重的不良事件。结论 LSVT LOUD 在减少参与者报告的声音问题影响方面比无言语和语言治疗以及 NHS 言语和语言治疗更有效。 NHS 言语和语言治疗没有显示出与不进行言语和语言治疗相比有任何益处的证据。试用注册 ISRCTN 注册表 [ISRCTN12421382][1]。所有访问 PD COMM 数据的请求均应提交给相应作者，以供当前研究者考虑。经过审查后，可以授予通过数据字典访问匿名患者级别数据的权限，不得早于本发布后六个月，且没有结束日期。数据访问提案需要描述数据的使用方式。数据传输将通过安全方法进行，并且仅在试验研究者团队批准后进行。 [1]：/外部引用？link_type=ISRCTN&access_num=ISRCTN12421382