Rossini M, Di Munno O, Valentini G, Bianchi G, Biasi G, Cacace E, Malesci D, La Montagna G, Viapiana O, Adami S
Rheumatology Unit, University of Verona, Italy.
Clin Exp Rheumatol. 2007 Mar-Apr;25(2):182-8.
Fibromyalgia (FMS) is a chronic syndrome characterized by widespread pain, troubled sleep, disturbed mood, and fatigue. Several analgesic strategies have been evaluated but the results are moderate and inconsistent. Antidepressant agents are now considered the treatment of choice in most patients. It has been recently suggested that FMS may be associated with metabolic alterations including a deficit of carnitine. In this multicenter randomized clinical trial we evaluated the efficacy of acetyl L-carnitine (LAC) in patients with overt FMS.
One hundred and two patients meeting the American College of Rheumatology criteria for FMS were randomized into the study. The treatment consisted of 2 capsules/day of 500 mg LAC or placebo plus one intramuscular (i.m.) injection of either 500 mg LAC or placebo for 2 weeks. During the following 8 weeks the patients took 3 capsules daily containing either 500 mg LAC or placebo. The patients were seen during treatment after 2 (visit 3), 6 (visit 4) and 10 weeks (visit 5). The patients were also visited 4 weeks after treatment discontinuation (follow-up visit). Outcome measures included the number of positive tender points, the sum of pain threshold (kg/cm2 or "total myalgic score"), the Short Form 36 (SF36), a 100 mm visual analog scale (VAS) for self-perceived stiffness, fatigue, tiredness on awakening, sleep, work status, depression, and muscular-skeletal pain, and the Hamilton depression scale.
The "total myalgic score" and the number of positive tender points declined significantly and equally in both groups until the 6th week of treatment. At the 10th week both parameters remained unchanged in the placebo group but they continued to improve in the LAC group with a statistically significant between-group difference. Most VAS scores significantly improved in both groups. A statistically significant between-group difference was observed for depression and musculo-skeletal pain. Significantly larger improvements in SF36 questionnaire were observed in LAC than in placebo group for most parameters. Treatment was well-tolerated.
Although this experience deserves further studies, these results indicate that LAC may be of benefit in patients with FMS, providing improvement in pain as well as the general and mental health of these patients.
纤维肌痛（FMS）是一种慢性综合征，其特征为广泛疼痛、睡眠障碍、情绪紊乱和疲劳。已对多种镇痛策略进行了评估，但结果一般且不一致。目前，抗抑郁药被认为是大多数患者的首选治疗方法。最近有人提出，FMS可能与包括肉碱缺乏在内的代谢改变有关。在这项多中心随机临床试验中，我们评估了乙酰左旋肉碱（LAC）对明显患有FMS患者的疗效。
102名符合美国风湿病学会FMS标准的患者被随机纳入该研究。治疗方案为每天服用2粒500毫克的LAC胶囊或安慰剂，外加一次500毫克LAC或安慰剂的肌肉注射，持续2周。在接下来的8周内，患者每天服用3粒含500毫克LAC或安慰剂的胶囊。在治疗期间，分别于2周（访视3）、6周（访视4）和10周（访视5）对患者进行检查。在治疗停止4周后（随访访视）也对患者进行检查。疗效指标包括阳性压痛点数量、疼痛阈值总和（千克/平方厘米或“总肌痛评分”）、简短健康调查问卷（SF36）、用于自我感知僵硬、疲劳、睡醒时疲倦、睡眠、工作状态、抑郁和肌肉骨骼疼痛的100毫米视觉模拟量表（VAS），以及汉密尔顿抑郁量表。
在治疗的第6周前，两组的“总肌痛评分”和阳性压痛点数量均显著且同等程度下降。在第10周时，安慰剂组的这两个参数保持不变，但LAC组继续改善，两组间差异有统计学意义。两组的大多数VAS评分均显著改善。在抑郁和肌肉骨骼疼痛方面观察到两组间有统计学意义的差异。在SF36问卷中，LAC组在大多数参数上的改善明显大于安慰剂组。治疗耐受性良好。
尽管这一经验值得进一步研究，但这些结果表明，LAC可能对FMS患者有益，可改善这些患者的疼痛以及总体健康和心理健康状况。
