Forsyth L M, Preuss H G, MacDowell A L, Chiazze L, Birkmayer G D, Bellanti J A
Department of Pediatrics, Georgetown University School of Medicine, Washington, D.C., USA.
Ann Allergy Asthma Immunol. 1999 Feb;82(2):185-91. doi: 10.1016/S1081-1206(10)62595-1.
Chronic fatigue syndrome (CFS) is a disorder of unknown etiology, consisting of prolonged, debilitating fatigue, and a multitude of symptoms including neurocognitive dysfunction, flu-like symptoms, myalgia, weakness, arthralgia, low-grade fever, sore throat, headache, sleep disturbances, and swelling and tenderness of lymph nodes. No effective treatment for CFS is known.
The purpose of the study was to evaluate the efficacy of the reduced form of nicotinamide adenine dinucleotide (NADH) i.e., ENADA the stabilized oral absorbable form, in a randomized, double-blind, placebo-controlled crossover study in patients with CFS. Nicotinamide adenine dinucleotide is known to trigger energy production through ATP generation which may form the basis of its potential effects.
Twenty-six eligible patients who fulfilled the Center for Disease Control and Prevention criteria for CFS completed the study. Medical history, physical examination, laboratory studies, and questionnaire were obtained at baseline, 4, 8, and 12 weeks. Subjects were randomly assigned to receive either 10 mg of NADH or placebo for a 4-week period. Following a 4-week washout period, subjects were crossed to the alternate regimen for a final 4-week period.
No severe adverse effects were observed related to the study drug. Within this cohort of 26 patients, 8 of 26 (31%) responded favorably to NADH in contrast to 2 of 26 (8%) to placebo. Based upon these encouraging results we have decided to conduct an open-label study in a larger cohort of patients.
Collectively, the results of this pilot study indicate that NADH may be a valuable adjunctive therapy in the management of the chronic fatigue syndrome and suggest that further clinical trials be performed to establish its efficacy in this clinically perplexing disorder.
慢性疲劳综合征（CFS）是一种病因不明的疾病，其特征为长期使人衰弱的疲劳，以及包括神经认知功能障碍、流感样症状、肌痛、虚弱、关节痛、低热、喉咙痛、头痛、睡眠障碍以及淋巴结肿大和压痛等多种症状。目前尚无针对CFS的有效治疗方法。
本研究旨在通过一项随机、双盲、安慰剂对照的交叉研究，评估还原型烟酰胺腺嘌呤二核苷酸（NADH）即稳定的口服可吸收形式ENADA对慢性疲劳综合征患者的疗效。已知烟酰胺腺嘌呤二核苷酸通过生成三磷酸腺苷（ATP）来触发能量产生，这可能是其潜在作用的基础。
26名符合美国疾病控制与预防中心慢性疲劳综合征标准的合格患者完成了该研究。在基线、第4、8和12周时获取病史、体格检查、实验室检查和问卷调查结果。受试者被随机分配接受10毫克NADH或安慰剂，为期4周。经过4周的洗脱期后，受试者交叉接受替代治疗方案，为期最后4周。
未观察到与研究药物相关的严重不良反应。在这26名患者中，26人中有8人（31%）对NADH反应良好，而对安慰剂反应良好的为26人中有2人（8%）。基于这些令人鼓舞的结果，我们决定在更大的患者队列中进行一项开放标签研究。
总体而言，这项初步研究的结果表明，NADH可能是慢性疲劳综合征管理中有价值的辅助治疗方法，并建议进行进一步的临床试验以确定其在这种临床复杂疾病中的疗效。
