Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial

Chuan Zou, Lihong Yang, Yuchi Wu, Guobin Su, Shuhui Chen, Xinfeng Guo, Xiuqing Wu, Xusheng Liu, Qizhan Lin, Chuan Zou, Lihong Yang, Yuchi Wu, Guobin Su, Shuhui Chen, Xinfeng Guo, Xiuqing Wu, Xusheng Liu, Qizhan Lin

Abstract

Objectives: To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA) on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD) patients with insomnia.

Methods: Sixty three (63) eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32), or sham AA (SAA) group received AA on points irrelevant to insomnia treatment (n=31) for eight weeks. All participants were followed up for 12 weeks after treatments. The primary outcome was clinical response at eight weeks after randomization, defined as a reduction of Pittsburgh Sleep Quality Index (PSQI) global score by 3 points and more.

Results: Fifty-eight (58) participants completed the trial and five dropped out. Twenty participants in AA group (62.5%) and ten in SAA group (32.3%) responded to the eight-week interventions (χ2 = 5.77, P = 0.02). PSQI global score declined 3.75 ± 4.36 (95%CI -5.32, -2.18) and 2.26 ± 3.89 (95%CI -3.68, -0.83) in AA group and SAA group respectively. Three participants died during the follow-up period. No evidence supported their deaths were related to the AA intervention. No other adverse event was observed.

Conclusion: Feasibility and logistics of patient recruitment, randomization procedure, blinding approach, interventions application and outcome assessment had been tested in this pilot trial. The preliminary data appeared to show a favorable result on AA treatment. A full-scale trial is warranted.

Trial registration: Chinese Clinical Trial Registry ChiCTR-TRC-12002272.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow chart of participants enrollment,…
Fig 1. Flow chart of participants enrollment, assignment and follow-up.
Fig 2. Auricular acupoints.
Fig 2. Auricular acupoints.
a: Auricular acupoints used in treatment and control group. b: Codes for the acupoints used.
Fig 3. Change of PSQI global scores…
Fig 3. Change of PSQI global scores in two groups.
Fig 4. Numbers of participants taking hypnotic…
Fig 4. Numbers of participants taking hypnotic or hypnotic free.
Before treatment between two groups (χ2 = 0.77, P = 0.38). After treatment between two groups (χ2 = 9.63, P < 0.01). End of follow-up between two groups (χ2 = 4.59, P = 0.03).

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