Marske Cynthia, Bernard Natasha, Palacios Alison, Wheeler Cary, Preiss Ben, Brown Mackenzie, Bhattacharya Saveri, Klapstein Gloria
College of Osteopathic Medicine, Touro University California , Vallejo, CA.
J Altern Complement Med. 2018 Apr;24(4):395-402. doi: 10.1089/acm.2017.0178. Epub 2018 Jan 3.
This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms.
This study was an 8-week prospective, single center feasibility study.
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.
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.
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.
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.
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.
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。
本研究为一项为期8周的前瞻性单中心可行性研究。
2006年至2009年期间，从加利福尼亚州的索拉诺县、索诺马县和康特拉科斯塔县招募了40名受试者。受试者年龄在18至65岁之间，符合美国风湿病学会（ACR）1990年纤维肌痛标准。
本研究有三个治疗组：仅加巴喷丁组（900毫克/天）、仅骨病手法治疗（OMM）组以及加巴喷丁加OMM联合治疗组。OMM治疗由高年级医学生进行，每次30分钟，每周一次。试验持续8周，包括6周的治疗以及初始和最终访视。
主要观察指标包括面部表情疼痛评分量表（WBF）、临床总体健康印象（CGI）、纤维肌痛影响问卷（FIQ）以及压痛点数量。
29名受试者完成了试验；8名受试者仅接受加巴喷丁治疗，11名患者仅接受OMM治疗，10名患者接受加巴喷丁加OMM联合治疗。基于WBF，仅接受OMM治疗的受试者和接受OMM与加巴喷丁联合治疗的受试者显示出临床改善（分别为p < 0.01和p = 0.03），而仅加巴喷丁组的变化不显著。仅OMM组是唯一在CGI量表上有显著下降的组（p < 0.01）。FIQ或压痛点数量未观察到统计学上的显著变化。各组之间的差异无统计学意义。在样本量较小的可行性研究中，这是可以预期的。
本初步研究表明，OMM治疗和加巴喷丁对与纤维肌痛相关的疼痛及其他体质和躯体症状是安全且临床有效的治疗方法。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。
