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热浴与运动作为附加治疗对常规护理治疗抑郁症的效果和可行性:一项随机对照的初步研究。

Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study.

机构信息

European Institute for Physical Therapy and Balneology, Freiburg, Germany.

University of Freiburg, Faculty of Medicine, Freiburg, Germany.

出版信息

BMC Psychiatry. 2020 Nov 11;20(1):536. doi: 10.1186/s12888-020-02941-1.

Abstract

BACKGROUND

Limitations of current therapy of depression highlight the need for an immediately available, easily implementable add-on treatment option with high acceptance from patients. Hyperthermic baths (HTB) are a form of balneotherapy with head-out-of-water-immersion in a hot pool or tub at 40 °C for 15-20 min. A prior study suggests that HTB added to usual depression care can have antidepressant effects.

METHOD

Single-site, open-label randomised controlled 8-week parallel-group pilot study at a university outpatient clinic. 45 medically stable outpatients with moderate depression as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥ 18 and a score ≥ 2 on item 1 (Depressed Mood) were recruited. They were randomised to twice weekly HTB (n = 22) or a physical exercise program (PEP) of moderate intensity (n = 23). Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) and per-protocol (PP) principle.

RESULTS

Forty-five patients (HTB n = 22; PEP n = 23) were analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference after 2 weeks was 4.3 points in the HAM-D score in favor of HTB (p < 0.001). Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). Per protocol analysis only showed superiority of HTB as a trend (p = 0.068). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was higher than in other trials investigating exercise in depression. Due to the high number of dropouts the effect in the ITT-analysis may be overestimated.

CONCLUSIONS

HTB added to usual care may be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depression severity after 2 weeks; it is also suitable for persons who have problems performing exercise training.

TRIAL REGISTRATION

German Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

摘要

背景

目前抑郁症治疗的局限性突出表明,需要一种能够立即获得、易于实施、且患者接受度高的附加治疗选择。热浴疗法(HTB)是一种浸浴疗法,患者头露出水面浸入 40°C 的热水池中或浴盆中 15-20 分钟。先前的研究表明,HTB 联合常规抑郁症治疗可产生抗抑郁作用。

方法

在一所大学门诊诊所进行的单中心、开放标签、随机对照 8 周平行分组试验研究。招募了 45 名经 17 项汉密尔顿抑郁量表(HAM-D)评分≥18 分和第 1 项(抑郁情绪)评分≥2 分的中度抑郁症的医学稳定门诊患者。他们被随机分配到每周两次的 HTB(n=22)或中等强度的身体锻炼计划(PEP)(n=23)。主要观察指标是从基线(T0)到第 2 周(T1)时 HAM-D 总分的变化。进行线性回归分析,根据基线值进行调整,以估计意向治疗(ITT)和方案(PP)原则的干预效果。

结果

根据 ITT(平均年龄 48.4 岁,标准差 11.3,平均 HAM-D 评分 21.7,标准差 3.2)分析了 45 名患者(HTB n=22;PEP n=23)。经过 2 周的调整后,HTB 组 HAM-D 评分的平均差值为 4.3 分(p<0.001)。HTB 组的干预和随访依从性要好得多(2 名退出,13 名退出)。仅在 PP 分析中显示 HTB 有优势趋势(p=0.068)。没有与治疗相关的严重不良事件。主要限制:PEP 组(23 名中有 13 名)的脱落人数高于其他研究中评估运动治疗抑郁症的试验。由于脱落人数较多,ITT 分析中的效果可能被高估。

结论

HTB 联合常规治疗可能是一种快速起效、安全且易于获得的方法,可在 2 周后导致抑郁症严重程度的临床相关改善;它也适用于那些有运动训练问题的人。

试验注册

德国临床试验注册处(DRKS),注册号 DRKS00011013(注册日期 2016-09-19),在研究开始之前。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a61/7661265/83a955bb2ab9/12888_2020_2941_Fig1_HTML.jpg

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