Abstract：
OBJECTIVE: Fibromyalgia (FM) is characterised by a form of debilitating pain that is unresponsive to standard analgesics. The aim of this study was to evaluate the efficacy of supplementing ongoing pregabalin (PGB) and duloxetine (DLX) treatment with palmitoylethanolamide (PEA) and acetyl-L-carnitine (ALC) for 24 weeks in FM patients.
METHODS: After undergoing three months of stable treatment with DLX+PGB, FM patients were randomised to continue the same treatment (Group 1) or to add PEA 600 mg b.i.d + ALC 500 mg b.i.d. (Group 2) for a further 12 weeks. Every two weeks throughout the study, cumulative disease severity was estimated using the Widespread Pain Index (WPI) as the primary outcome measure; the secondary outcomes were the fortnightly scores of the patient-completed revised Fibromyalgia Impact Questionnaire (FIQR) and the modified Fibromyalgia Assessment Status (FASmod) questionnaire. All three measures were expressed as time-integrated area under the curve (AUC) values.
RESULTS: One hundred and thirty (91.5%) of the initial 142 FM patients completed the study: 68 patients in Group 1 and 62 in Group 2. Twenty-four weeks after randomisation, the Group 2 patients showed additional significant improvements in all three outcome measures. Although there was some fluctuation in both groups during the study period, the AUC values of the WPI scores steadily decreased in Group 2 (p=0.048), which also showed better outcomes in terms of the AUC values of the FIQR (p=0.033) and FASmod scores (p=0.017).
CONCLUSIONS: This is the first randomised controlled study demonstrating the effectiveness of the adding on therapy of PEA+ALC to DLX+PGB in FM patients.
METHODS: After undergoing three months of stable treatment with DLX+PGB, FM patients were randomised to continue the same treatment (Group 1) or to add PEA 600 mg b.i.d + ALC 500 mg b.i.d. (Group 2) for a further 12 weeks. Every two weeks throughout the study, cumulative disease severity was estimated using the Widespread Pain Index (WPI) as the primary outcome measure; the secondary outcomes were the fortnightly scores of the patient-completed revised Fibromyalgia Impact Questionnaire (FIQR) and the modified Fibromyalgia Assessment Status (FASmod) questionnaire. All three measures were expressed as time-integrated area under the curve (AUC) values.
RESULTS: One hundred and thirty (91.5%) of the initial 142 FM patients completed the study: 68 patients in Group 1 and 62 in Group 2. Twenty-four weeks after randomisation, the Group 2 patients showed additional significant improvements in all three outcome measures. Although there was some fluctuation in both groups during the study period, the AUC values of the WPI scores steadily decreased in Group 2 (p=0.048), which also showed better outcomes in terms of the AUC values of the FIQR (p=0.033) and FASmod scores (p=0.017).
CONCLUSIONS: This is the first randomised controlled study demonstrating the effectiveness of the adding on therapy of PEA+ALC to DLX+PGB in FM patients.
摘要：
目的：纤维肌痛（FM）的特征是一种对标准镇痛药无反应的衰弱性疼痛。这项研究的目的是评估在FM患者中使用棕榈酰乙醇胺（PEA）和乙酰-L-肉碱（ALC）补充正在进行的普瑞巴林（PGB）和度洛西汀（DLX）治疗24周的疗效。
方法：接受DLX+PGB稳定治疗3个月后，FM患者被随机分配以继续相同的治疗（第1组）或添加PEA600mgb.i.d.ALC500mgb.i.d.（第2组），再持续12周。在整个研究过程中每两周，累积疾病严重程度采用广泛疼痛指数(WPI)作为主要结局指标;次要结局是患者完成的修订纤维肌痛影响问卷(FIQR)和修订纤维肌痛评估状态(FASmod)问卷的每两周评分.所有三个测量值表示为时间积分曲线下面积(AUC)值。
结果：最初的142例FM患者中有一百三十例（91.5％）完成了研究：第1组68例，第2组62例。随机化24周后,第2组患者在3项结局指标中均有显著改善.尽管在研究期间两组都有一些波动，第2组WPI评分的AUC值稳步下降（p=0.048），在FIQR（p=0.033）和FASmod评分（p=0.017）的AUC值方面也显示出更好的结果。
结论：这是第一项随机对照研究，证明了在FM患者中添加PEAALC治疗DLXPGB的有效性。
方法：接受DLX+PGB稳定治疗3个月后，FM患者被随机分配以继续相同的治疗（第1组）或添加PEA600mgb.i.d.ALC500mgb.i.d.（第2组），再持续12周。在整个研究过程中每两周，累积疾病严重程度采用广泛疼痛指数(WPI)作为主要结局指标;次要结局是患者完成的修订纤维肌痛影响问卷(FIQR)和修订纤维肌痛评估状态(FASmod)问卷的每两周评分.所有三个测量值表示为时间积分曲线下面积(AUC)值。
结果：最初的142例FM患者中有一百三十例（91.5％）完成了研究：第1组68例，第2组62例。随机化24周后,第2组患者在3项结局指标中均有显著改善.尽管在研究期间两组都有一些波动，第2组WPI评分的AUC值稳步下降（p=0.048），在FIQR（p=0.033）和FASmod评分（p=0.017）的AUC值方面也显示出更好的结果。
结论：这是第一项随机对照研究，证明了在FM患者中添加PEAALC治疗DLXPGB的有效性。
