Auricular Acupressure on Specific Points for Hemodialysis Patients with Insomnia: A Pilot Randomized Controlled Trial

<div><p>Objectives</p><p>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.</p><p>Methods</p><p>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.</p><p>Results</p><p>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, <i>P</i> = 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.</p><p>Conclusion</p><p>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.</p><p>Trial Registration</p><p>Chinese Clinical Trial Registry <a href="http://www.chictr.org/cn/proj/show.aspx?proj=2863" target="_blank">ChiCTR-TRC-12002272</a>.</p></div

Flow chart of participants enrollment, assignment and follow-up.

<p>Flow chart of participants enrollment, assignment and follow-up.</p

Baseline Characteristic of Participants

<p>Abbreviations: TCO2: Total carbon dioxide content, PTH: Parathyroid hormone, KT/V: urea clearance index</p><p>Baseline Characteristic of Participants</p

Change of PSQI global scores in two groups.

<p>Change of PSQI global scores in two groups.</p

Auricular acupoints.

<p>a: Auricular acupoints used in treatment and control group. b: Codes for the acupoints used.</p

Numbers of participants taking hypnotic or hypnotic free.

<p>Before treatment between two groups (χ2 = 0.77, <i>P</i> = 0.38). After treatment between two groups (χ2 = 9.63, <i>P</i> < 0.01). End of follow-up between two groups (χ2 = 4.59, <i>P</i> = 0.03).</p