Patten Scott B, Metz Luanne M
Department of Community Health Sciences, University of Calgary MS Clinic, Alberta, Canada.
Int J Psychiatry Med. 2002;32(2):155-65. doi: 10.2190/2G2N-WE19-NM47-JNY8.
Two recent randomized double-blind placebo controlled clinical trials of interferon beta-1a in multiple sclerosis have obtained hopelessness ratings using the Beck Hopelessness Scale (BHS). One of these studies, the PRISMS trial, evaluated interferon beta-1a in relapsing remitting multiple sclerosis (RRMS). Another, the SPECTRIMS trial, evaluated the same medication in secondary progressive (SP) MS. The objective of this analysis was to compare levels of hopelessness in persons with RRMS and SPMS, and to describe changes over time in the clinical trial participants.
Raw data from each clinical trial was obtained from the sponsor of the trials (Serono). Median BHS ratings, and the proportions at or above the BHS cut-point of 10 were calculated over a two (PRISMS) or three (SPECTRIMS) year period.
The analysis included n = 532 clinical trial participants. Ratings of hopelessness were higher in SPMS clinical trial participants (SPECTRIMS) than in the RRMS group (PRISMS) at baseline (Fisher's exact test, p = 0.0035). Furthermore, ratings of hopelessness were higher during follow-up than at baseline, in the SPMS group (McNemar's exact probability,p = 0.0015), but not in the RRMS group (McNemar's exact probability,p = 0.65). Depression was strongly associated with hopelessness in both RRMS (z = 4.13, p < 0.001) and SPMS (z = 5.24, p < 0.001).
Hopelessness is associated with SPMS, and may increase over time in this group. Hopelessness may influence suicide risk in people with MS and may potentially have an impact on coping and quality of life. Additional research is necessary to define the clinical implications of hopelessness in persons with this condition.
最近两项关于干扰素β-1a治疗多发性硬化症的随机双盲安慰剂对照临床试验使用贝克绝望量表(BHS)获得了绝望评分。其中一项研究,即PRISMS试验,评估了干扰素β-1a在复发缓解型多发性硬化症(RRMS)中的作用。另一项研究,即SPECTRIMS试验,评估了同一药物在继发进展型(SP)多发性硬化症中的作用。本分析的目的是比较RRMS和SPMS患者的绝望水平,并描述临床试验参与者随时间的变化情况。
从试验主办方(雪兰诺公司)获得每项临床试验的原始数据。在两年(PRISMS试验)或三年(SPECTRIMS试验)期间计算BHS评分中位数以及达到或高于BHS临界值10的比例。
该分析纳入了n = 532名临床试验参与者。在基线时,SPMS临床试验参与者(SPECTRIMS试验)的绝望评分高于RRMS组(PRISMS试验)(Fisher精确检验,p = 0.0035)。此外,在随访期间,SPMS组的绝望评分高于基线水平(McNemar精确概率,p = 0.0015),而RRMS组则不然(McNemar精确概率,p = 0.65)。在RRMS(z = 4.13,p < 0.001)和SPMS(z = 5.24,p < 0.001)中,抑郁都与绝望密切相关。
绝望与SPMS相关,并且在该组中可能随时间增加。绝望可能影响MS患者的自杀风险,并可能对应对方式和生活质量产生潜在影响。需要进一步研究来确定绝望在这种疾病患者中的临床意义。