Fioravanti A, Bacaro G, Giannitti C, Tenti S, Cheleschi S, Gui Delli G M, Pascarelli N A, Galeazzi M
Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Policlinico "Le Scotte," Viale Bracci 1, 53100, Siena, Italy,
Int J Biometeorol. 2015 Sep;59(9):1333-43. doi: 10.1007/s00484-014-0943-0. Epub 2014 Dec 17.
The objective of this prospective parallel randomized single-blind study was to assess that a cycle of mud-bath therapy (MBT) provides any benefits over usual treatment in patients with bilateral knee osteoarthritis (OA). Patients with symptomatic primary bilateral knee OA, according to ACR criteria, were included in the study and randomized to one of two groups: one group received a cycle of MBT at spa center of Chianciano Terme (Italy) in addition to the usual treatment, and one group continued their regular care routine alone. Clinical assessments were performed 7 days before enrollment (screening visit), at the time of enrollment (basal time), after 2 weeks, and after 3, 6, 9, and 12 months after the beginning of the study. All assessments were conducted by two researchers blinded to treatment allocation. The primary efficacy outcomes were the global pain score evaluated by Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore for physical function (W-TPFS). Of the 235 patients screened, 103 met the inclusion criteria: 53 patients were included in the MBT group and 50 in the control group. In the group of patients treated with MBT, we observed a statistically significant (p < 0.001) reduction of VAS and W-TPFS score at the end of the treatment; this improvement was significant (p < 0.05) also at 3 months of follow-up. The control group did not show significant differences between baseline time and all other times. The differences between one group were significant for both primary parameters already from the 15th day and persisted up to the 9th month. This beneficial effect was confirmed by the significant reduction of symptomatic drug consumption. Tolerability of MBT seemed to be good, with light and transitory side effects. Our results confirm that a cycle of MBT added to usual treatment provides a beneficial effect on the painful symptoms and functional capacities in patients with knee OA that lasts over time. Mud-bath therapy can represent a useful backup to pharmacologic treatment of knee OA or a valid alternative for patients who do not tolerate pharmacological treatments.
这项前瞻性平行随机单盲研究的目的是评估一个疗程的泥浴疗法（MBT）相较于常规治疗，能否为双侧膝关节骨关节炎（OA）患者带来更多益处。根据美国风湿病学会（ACR）标准，有症状的原发性双侧膝关节OA患者被纳入本研究，并随机分为两组：一组除接受常规治疗外，还在意大利基安恰诺泰尔梅的温泉中心接受一个疗程的MBT；另一组仅继续其常规护理。在入组前7天（筛查访视）、入组时（基线时间）、2周后以及研究开始后的3、6、9和12个月进行临床评估。所有评估均由两名对治疗分配不知情的研究人员进行。主要疗效指标为采用视觉模拟量表（VAS）评估的总体疼痛评分以及西安大略和麦克马斯特大学骨关节炎指数（WOMAC）身体功能子评分（W-TPFS）。在筛查的235例患者中，103例符合纳入标准：53例患者被纳入MBT组，50例被纳入对照组。在接受MBT治疗的患者组中，我们观察到治疗结束时VAS和W-TPFS评分有统计学显著降低（p < 0.001）；在随访3个月时，这种改善也具有显著性（p < 0.05）。对照组在基线时间与所有其他时间之间未显示出显著差异。两组之间的差异在第15天就已在两个主要参数上表现显著，并持续到第9个月。症状性药物消耗的显著减少证实了这种有益效果。MBT的耐受性似乎良好，副作用轻微且短暂。我们的结果证实，在常规治疗基础上加用一个疗程的MBT，对膝关节OA患者的疼痛症状和功能能力有持续的有益影响。泥浴疗法可以成为膝关节OA药物治疗的有用辅助手段，或者是不耐受药物治疗患者的有效替代方案。
