Ren Wan-wen, Zhou Zhi-ying, Xu Mi-mi, Long Sen, Tang Guang-zheng, Mao Hong-jing, Chen Shu-lin
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Feb;36(2):166-71.
To evaluate clinical effect and safety of floating needle therapy and duloxetine in treating patients with persistent somatoform pain disorder (PSPD).
Totally 108 PSPD patients were randomly assigned to the floating needle treatment group, the duloxetine treatment group, and the placebo treatment group, 36 in each group. Patients in the floating needle treatment group received floating needle therapy and placebo. Those in the duloxetine treatment group received duloxetine and simulated floating needle therapy. Those in the placebo treatment group received the placebo and simulated floating needle therapy. All treatment lasted for six weeks. Efficacy and adverse reactions were evaluated using Simple McGill pain scale (SF-MPQ) and Treatment Emergent Symptom Scale (TESS) before treatment and immediately after treatment, as well as at the end of 1st, 2nd, 4th, and 6th week of treatment, respectively. Hamilton Depression Scale (HAMD, 17 items), Hamilton Anxiety Scale (HAMA) were assessed before treatment and at the end of 1st, 2nd, 4th, and 6th week of treatment, respectively. Patients in the floating needle treatment group and the duloxetine treatment group with the total reducing score rate of SF-MPQ in Pain Rating index (PRI) ≥ 50% after 6 weeks' treatment were involved in the follow-up study.
(1) Compared with the same group before treatment, SF-MPQ score, HAMD score and HAMA total scores all decreased in all the three groups at the end of 1st, 2nd, 4th, and 6th week of treatment (P < 0.05, P < 0.01). Besides , each item of SF-MPQ significantly decreased immediately after treatment in the floating needle treatment group (P < 0.01). Compared with the placebo treatment group, SF-MPQ, HAMD, and HAMA total score in the floating needle treatment group significantly decreased after 1, 2, 4, and 6 weeks of treatment (P < 0.05, P < 0.01). SF-MPQ score, HAMD score and HAMA total score in the duloxetine treatment group also significantly decreased after 2, 4, and 6 weeks of treatment (P < 0.05, P < 0.01). (2) There were 3 patients (8.3%) who had adverse reactions in the floating needle treatment group, 17 (50.0%) in the duloxetine treatment group, and 7 (21.2%) in the placebo treatment group. Compared with the placebo treatment group, the incidence of adverse reaction increased in the duloxetine treatment group (χ² = 6.04, P < 0.05). Besides, it was higher in the duloxetine treatment group than in the floating needle treatment group (χ² = 14.9, P < 0.05). (3) There were 19 patients in the floating needle treatment group and 17 patients in the duloxetine treatment group involved in the follow-up study. Compared with 6 weeks after treatment, no significant difference was observed at 3 and 6 months after treatment in the score of SF-MPQ, HAMD, and HAMA in the floating needle treatment group and the duloxetine treatment group. No significant difference was observed between the two groups (P > 0.05). There were 5 patients (29.4%) who had adverse reactions in the duloxetine treatment group, and no adverse reactions were observed in the floating needle treatment group. The adverse reaction rate was significantly different between the two groups (χ² = 4.26, P < 0.05).
Floating needle therapy and duloxetine were effective in treatment of patients with PSPD. However, floating needle therapy could relieve pain more rapidly than duloxetine, with obviously less adverse reactions.
评价浮针疗法与度洛西汀治疗持续性躯体形式疼痛障碍（PSPD）患者的临床疗效及安全性。
将108例PSPD患者随机分为浮针治疗组、度洛西汀治疗组和安慰剂治疗组，每组36例。浮针治疗组患者接受浮针疗法及安慰剂。度洛西汀治疗组患者接受度洛西汀及模拟浮针疗法。安慰剂治疗组患者接受安慰剂及模拟浮针疗法。所有治疗均持续6周。分别在治疗前、治疗结束即刻以及治疗第1、2、4、6周结束时，使用简化麦吉尔疼痛量表（SF-MPQ）和治疗中出现的症状量表（TESS）评估疗效及不良反应。分别在治疗前以及治疗第1、2、4、6周结束时评估汉密尔顿抑郁量表（HAMD，17项）、汉密尔顿焦虑量表（HAMA）。浮针治疗组和度洛西汀治疗组中治疗6周后疼痛评定指数（PRI）中SF-MPQ总分减分率≥50%的患者纳入随访研究。
（1）与治疗前同组相比，三组在治疗第1、2、4、6周结束时SF-MPQ评分、HAMD评分及HAMA总分均降低（P<0.05,P<0.01）。此外，浮针治疗组治疗结束后即刻SF-MPQ各条目均显著降低（P<0.01）。与安慰剂治疗组相比，浮针治疗组在治疗1、2、4、6周后SF-MPQ、HAMD及HAMA总分显著降低（P<0.05,P<0.01）。度洛西汀治疗组在治疗2、4、6周后SF-MPQ评分、HAMD评分及HAMA总分也显著降低（P<0.05,P<0.01）。（2）浮针治疗组有3例患者（8.3%）出现不良反应，度洛西汀治疗组有17例（50.0%），安慰剂治疗组有7例（21.2%）。与安慰剂治疗组相比，度洛西汀治疗组不良反应发生率增加（χ²=6.04,P<0.05）。此外，度洛西汀治疗组高于浮针治疗组（χ²=14.9,P<0.05）。（3）浮针治疗组有19例患者、度洛西汀治疗组有17例患者纳入随访研究。与治疗6周后相比，浮针治疗组和度洛西汀治疗组在治疗3个月和6个月时SF-MPQ、HAMD及HAMA评分无显著差异。两组间无显著差异（P>0.05）。度洛西汀治疗组有5例患者（29.4%）出现不良反应，浮针治疗组未观察到不良反应。两组不良反应发生率差异有统计学意义（χ²=4.26,P<0.05）。
浮针疗法与度洛西汀治疗PSPD患者均有效。然而，浮针疗法比度洛西汀能更快缓解疼痛，且不良反应明显更少。
