Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

Cynthia Marske, Natasha Bernard, Alison Palacios, Cary Wheeler, Ben Preiss, Mackenzie Brown, Saveri Bhattacharya, Gloria Klapstein
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引用次数: 13

Abstract

Objectives: This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms.

Design: This study was an 8-week prospective, single center feasibility study.

Setting and subjects: Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia.

Interventions: This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits.

Outcome measures: Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points.

Results: Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p < 0.01 and p = 0.03, respectively), while the change among the gabapentin-only group was nonsignificant. The OMM only group was the only group to experience a significant decline in CGI scale (p < 0.01). No statistically significant changes were observed with the FIQ or number of tender points. No differences across groups were statistically significant. This is to be expected in a feasibility study with a small sample size.

Conclusions: This pilot study suggests that OMM treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

加巴喷丁与整骨疗法手法治疗纤维肌痛:一项初步研究。
目的:本初步研究比较了三种治疗方法在减轻疼痛和改善纤维肌痛症状方面的安全性和有效性。设计:本研究为为期8周的前瞻性单中心可行性研究。环境和受试者:2006-2009年从加州索拉诺、索诺玛和康特拉科斯塔县招募了40名受试者。受试者年龄18-65岁,符合美国风湿病学会(ACR) 1990年纤维肌痛标准。干预措施:本研究有三个治疗组:加巴喷丁单独治疗(900毫克/天),整骨疗法(OMM)单独治疗,加巴喷丁加OMM联合治疗。OMM治疗由高级医学生进行,每次30分钟,每周一次。试验持续8周,其中包括6周治疗加上初次和最后一次就诊。结果测量:主要结果测量包括Wong-Baker FACES疼痛评定量表(WBF)、临床总体健康印象(CGI)、纤维肌痛影响问卷(FIQ)和压痛点数量。结果:29名受试者完成试验;8例患者只接受加巴喷丁治疗,11例患者只接受OMM治疗,10例患者接受加巴喷丁加OMM治疗。单独接受OMM和联合接受OMM和加巴喷丁治疗的受试者显示出基于WBF的临床改善(p)结论:本初步研究表明OMM和加巴喷丁治疗与纤维肌痛相关的疼痛和其他体质和躯体症状是安全且临床有效的。需要使用新的ACR 2010纤维肌痛标准进行更大规模的试验来证实这些发现。
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