To evaluate the additional effect and safety of peloidotherapy to usual care at short- and middle-term in patients with rheumatoid arthritis (RA). RA patients were recruited in the medical ecology and hydroclimatology department of Istanbul Medical Faculty and were randomized into two parallel groups. Peloidotherapy group was treated with heated mudpack (41–42 °C) on painful and active joints (5 days/week, during 2 weeks) + usual care. Control group received usual care alone. Randomization was performed by using a computer-generated table of random numbers and was blinded. The sequence was concealed until interventions were assigned. The investigator was blinded. The assessments were done before and after the intervention, 1 month and 3 months after the completion of treatment. The main criterion was the number of patients with low disease activity (DAS 28 ≤ 3.2) at the end of follow-up. Other judgment criteria were pain (VAS), patient’s global assessment (VAS), physician’s global assessment (VAS), Health Assessment Questionnaire (HAQ), Disease Activity Score (DAS 28), CRP, and ESR. Fifty-six patients were recruited and analyzed: 29 in peloidotherapy group and 27 in the control group between 11/2011 and 02/2012. At the third month, 9/29 patients were with low disease activity in peloidotherapy group and 4/27 in the control group (p = 0.15). There was a statistically significant improvement in favor of peloidotherapy group for HAQ during all follow-up period (0.25 vs 0.63, p = 0.007 at the end of the treatment, 0.29 vs 0.68 p = 0.007 at the 1st month and 0.30 vs 0.59, p = 0.040 at the 3^rd month). Pain (35vs50, p = 0.028), patient’s global assessment (37vs53, p = 0.028), physician’s global assessment (33vs48, p = 0.030), and DAS28 (3.76vs4.58, p = 0.049) improved significantly more in peloidotherapy group at the 3^rd month. There were no between group differences for ESR and CRP. There were no important adverse events. There is no significant improvement for the main criteria so we can’t conclude that peloidotherapy has additional effect over usual care. But most of the other judgment criteria improved more in the peloidotherapy group than in the control group and peloidotherapy was well tolerated. A trial with higher statistical power is necessary to if we want to reveal the effects on disease activity and confirm the short and middle term efficiency of this treatment modality on pain and quality of life.

评估类风湿性关节炎 (RA) 患者短期和中期对常规治疗的治疗效果和安全性。在伊斯坦布尔医学院的医学生态学和水文气候学系招募 RA 患者，并将其随机分为两个平行组。Peloidotherapy 组在疼痛和活动关节（5 天/周，2 周内）+常规护理上使用加热泥巴（41-42°C）进行治疗。对照组单独接受常规护理。随机化是通过使用计算机生成的随机数表进行的，并且是不知情的。该序列被隐藏，直到分配干预。调查员被蒙蔽了双眼。在干预前后、治疗完成后1个月和3个月进行评估。主要标准是随访结束时疾病活动度低（DAS 28 ≤ 3.2）的患者数量。其他判断标准为疼痛（VAS）、患者总体评估（VAS）、医生总体评估（VAS）、健康评估问卷（HAQ）、疾病活动评分（DAS 28）、CRP和ESR。招募并分析了 56 名患者：2011 年 11 月至 2012 年 2 月期间，治疗组 29 名，对照组 27 名。在第 3 个月时，治疗组 9/29 患者的疾病活动度较低，对照组为 4/27（2011 年 11 月 2 日至 2012 年 2 月 11 日至 2012 年 2 月 1 日，治疗组有 29 人，对照组有 27 人。在第 3 个月时，治疗组 9/29 患者的疾病活动度较低，对照组为 4/27（2011 年 11 月 2 日至 2012 年 2 月 11 日至 2012 年 2 月 1 日，治疗组有 29 人，对照组有 27 人。在第 3 个月时，治疗组 9/29 患者的疾病活动度较低，对照组为 4/27（p  = 0.15）。在所有随访期间，骨盆治疗组的 HAQ 有统计学意义的显着改善（ 治疗结束时0.25 对 0.63，p = 0.007， 第 1 个月时0.29 对 0.68 p = 0.007 和 0.30 对 0.59，p  = 0.040在3^次月）。疼痛 (35vs50, p = 0.028)、患者的总体评估 (37vs53, p = 0.028)、医生的总体评估 (33vs48, p = 0.030) 和 DAS28 (3.76vs4.58, p = 0.049) 在 peloid 治疗组中显着改善3^次月。ESR 和 CRP 没有组间差异。没有重要的不良事件。主要标准没有显着改善，因此我们不能得出结论，peloidotherapy 比常规护理有额外的效果。但大多数其他判断标准在 peloidotherapy 组中比对照组有更好的改善，并且 peloidotherapy 的耐受性良好。如果我们想揭示对疾病活动的影响并确认这种治疗方式对疼痛和生活质量的短期和中期效率，则需要具有更高统计功效的试验。