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Auricular acupressure as assistant in primary insomnia management: a randomized single-blind controlled clinical trial

耳穴按压辅助治疗原发性失眠的随机单盲临床对照试验

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Abstract

Objective

To observe the efficacy and safety of dexzopiclone plus auricular acupressure in intervening primary insomnia.

Methods

A total of 72 participants who met the inclusion criteria were enrolled in a randomized controlled trial, with 36 cases allocated to a treatment group and 36 cases allocated to a control group. Both groups were given dexzopiclone as the routine treatment. Patients in the treatment group were given auricular acupressure with Wang Bu Liu Xing (Semen Vaccariae) seeds at the auricular acupoints related to sleep and emotion based on meridian theory, whereas for patients in the control group, the medical plasters with Wang Bu Liu Xing (Semen Vaccariae) seeds were only gently stuck to acupoints unrelated to sleep without stimulation. Patients in both groups were required to visit the hospital once a week for replacing the seeds and plasters. The course of intervention lasted for 8 weeks and the patients were followed up for another 4 weeks. Pittsburgh sleep quality index (PSQI) and Karolinska sleep diary (KSD) were used to evaluate the outcomes. Meanwhile, adverse effects were monitored and recorded.

Results

In the enrolled 72 cases, 4 patients (one in the treatment group and three in the control group) reported thirst and a bitter taste, and one case in the control group reported nausea and vomiting. At last, 3 cases in the control group dropped out for adverse reactions, and 69 cases completed the clinical trial. After 8 weeks of treatment, the global scores of PSQI in both treatment and control groups decreased significantly compared with the baseline (both P<0.001). Furthermore, the global score of PSQI in the treatment group was lower than that in the control group (P<0.01). The global scores of PSQI in both groups at the follow-up were significantly different from the baseline (both P<0.001), but insignificantly different compared with the post-treatment results (both P>0.05). According to KSD, both treatment protocols could prolong the total sleep time, shorten sleep-onset latency, improve sleep efficacy and sleep quality significantly, and the changes in the treatment group were more significant. The total effective rate was 88.9% in the treatment group, higher than 81.8% in the control group, though the difference was statistically insignificant (P>0.05).

Conclusion

Dexzopiclone plus auricular acupressure is effective and safe for patients with primary insomnia both in short and long terms, and it is more effective than monotherapy of dexzopiclone.

概要

目的

观察右佐匹克隆联合耳穴按压干预原发性失眠症的有效性及安全性。

方法

将符合入组标准的 72例受试者随机分为两组, 治疗组36例, 对照组各36例。两组均接受右佐匹克隆作为基础治疗。治疗组在此基础 上根据经络理论选用与睡眠、情绪相关的耳穴以王不留行籽按压, 对照组则只在与睡眠无关的耳穴上轻轻贴上王 不留行籽, 不予以按压。所有患者被要求1周来院更换1次耳贴。治疗共持续8周, 随访4周。采用匹兹堡睡眠质量 指数(PSQI)和卡罗林斯卡睡眠日志(KSD)评价临床疗效, 同时观察并记录不良反应。

结果

招募的72例受试者中, 4例(治疗组1例, 对照组3例)报告口干、口苦, 1例(对照组)报告恶心呕吐。最终, 对照组3例因不良反应退出临床试 验, 共69例完成临床研究。经8周治疗, 对照组与治疗组PSQI评分均明显下降, 治疗前后评分均具有统计学差异 (均P<0.001), 且治疗组PSQI总分下降较对照组更明显(P<0.01)。随访时与治疗前相比, 两组PSQI总分均有统计学 差异(均P<0.001), 但与治疗刚结束时相比, 差异均无统计学意义(均P>0.05)。根据KSD, 提示两种治疗方案均能 显著延长睡眠总时间, 缩短睡眠潜伏期和提高睡眠质量及睡眠效率, 且治疗组效果更显著。治疗组总有效率 88.9%, 高于对照组的81.8%, 但组间差异无统计学意义(P>0.05)。

结论

耳穴按压联合右佐匹克隆是治疗原发性 失眠的有效、安全方法, 近期、远期疗效佳, 且疗效优于单独应用右佐匹克隆。

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References

  1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev, 2002, 6(2): 97–111.

    Article  PubMed  Google Scholar 

  2. Liang ZT, Zhang XP, An YL. An overview of the study of primary insomnia in Chinese and Western medicine. Xinjiang Zhongyiyao, 2013, 31(1): 72–76.

    Google Scholar 

  3. Hall–Porter JM, Curry T, Walsh JK. Pharmacologic treatment of primary insomnia. Sleep Med Clin, 2010, 5(4): 609–625.

    Article  Google Scholar 

  4. Hillman DR, Murphy AS, Pezzullo L. The economic cost of sleep disorders. Sleep, 2006, 29(3): 299–305.

    Article  PubMed  Google Scholar 

  5. National Institutes of Health State. National Institutes of Health State of the Science Conference statement manifestations and management of chronic insomnia in adult. Sleep, 2005, 28(9): 1049–1057.

    Article  Google Scholar 

  6. Fernandez C, Maradeix V, Gimenez F, Thuillier A, Farinotti R. Pharmacokinetics of zopiclone and its enantiomers in Caucasian young healthy volunteers. Drug Metab Dispos, 1993, 21(6): 1125–1128.

    PubMed  CAS  Google Scholar 

  7. Garland SN, Gehrman P, Barg FK, Xie SX, Mao JJ. Choosing Options for Insomnia in Cancer Effectively (CHOICE): design of a patient centered comparative effectiveness trial of acupuncture and cognitive behavior therapy for insomnia. Contemp Clin Trials, 2016, 47: 349–355.

    Article  PubMed  Google Scholar 

  8. Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiat Serv, 2005, 56(3): 332–343.

    Article  Google Scholar 

  9. Morin CM, Benca R. Chronic insomnia. Lancet, 2012, 379(9821): 1129–1141.

    Article  PubMed  Google Scholar 

  10. Hughes CM, McCullough CA, Bradbury I, Boyde C, Hume D, Yuan J, Quinn F, McDonough SM. Acupuncture and reflexology for insomnia: a feasibility study. Acupunct Med, 2009, 27(4): 163–168.

    Article  PubMed  Google Scholar 

  11. Yeung WF, Chung KF, Poon MK, Ho YY, Zhang SP, Zhang ZJ, Ziea TC, Wong T. Acupressure, reflexology, and auricular acupressure for insomnia: a systematic review of randomized controlled trials. Sleep Med, 2012, 13(8): 971–984.

    Article  PubMed  Google Scholar 

  12. Li MK, Lee TF, Suen KP. Complementary effects of auricular acupressure in relieving constipation symptoms and promoting disease–specific health–related quality of life: a randomized placebo–controlled trial. Complem Ther Med, 2014, 22(2): 266–277.

    Article  CAS  Google Scholar 

  13. Yang GG, Liu YJ, Liu YL. Clinical observation of insomnia treated by auricular acupressure combined with estazolam. Xiandai Zhongxiyi Jiehe Zazhi, 2014, 23(35): 3949–3950.

    Google Scholar 

  14. Hou NN. Clinical observation on treating insomnia by auricular–plaster therapy. Zhongyi Linchuang Yanjiu, 2017, 9(2): 89–92.

    Google Scholar 

  15. Sjoling M, Rolleri M, Englund E. Auricular acupuncture versus sham acupuncture in the treatment of women who have insomnia. J Altern Complem Med, 2008, 14(1): 39–46.

    Article  Google Scholar 

  16. World Health Organization. International Statistical Classification of Diseases and Related Health Problems. 10th Revision. Geneva: World Health Organization, 1992.

    Google Scholar 

  17. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th Edition. Arlington: American Psychiatric Association, 2013.

    Book  Google Scholar 

  18. Chinese Society of Psychiatry. Chinese Classification of Mental Disorders. 3rd Edition. Jinan: Shandong Science and Technology Press, 2001.

    Google Scholar 

  19. Chen XJ. Internal Medicine of Traditional Chinese Medicine. Shanghai: Shanghai Scientific & Technical Publishers, 2004.

    Google Scholar 

  20. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res, 1989, 28(2): 193–213.

    Article  PubMed  CAS  Google Scholar 

  21. Akerstedt T, Hume K, Minors D, Waterhouse J. The meaning of good sleep: a longitudinal study of polysomnography and subjective sleep quality. J Sleep Res, 1994, 3(3): 152–158.

    Article  PubMed  CAS  Google Scholar 

  22. Keklund G, Akerstedt T. Objective components of individual differences in subjective sleep quality. J Sleep Res, 1997, 6(4): 217–220.

    Article  PubMed  CAS  Google Scholar 

  23. Mellinger GD, Balter MB, Uhlenhuth EH. Insomnia and its treatment: prevalence and correlates. Arch Gen Psychiatry, 1985, 42(3): 225–232.

    Article  PubMed  CAS  Google Scholar 

  24. Buysse DJ. Insomnia. JAMA, 2013, 309(7): 706–716.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  25. Hung CM, Li YC, Chen HJ, Lu K, Liang CL, Liliang PC, Tsai YD, Wang KW. Risk of dementia in patients with primary insomnia: a nationwide population–based case–control study. BMC Psychiatry, 2018, 18(1): 38.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Lichstein KL. Insomnia identity. Behav Res Ther, 2017, 97: 230–241.

    Article  PubMed  Google Scholar 

  27. Lee HH, Chen YC, Chen JJ, Lo SH, Guo YL, Hu HY. Insomnia and the risk of atrial fibrillation: a populationbased cohort study. Acta Cardiologica Sinica, 2017, 33(2): 165–172.

    PubMed  PubMed Central  Google Scholar 

  28. Gulyani S, Salas RE, Gamaldo CE. Sleep medicine pharmacotherapeutics overview: today, tomorrow, and the future (Part 1: insomnia and circadian rhythm disorders). Chest, 2012, 142(6): 1659–1668.

    Article  PubMed  CAS  Google Scholar 

  29. Xie ZZ, Chen F, Li WA, Geng X, Li C, Meng X, Feng Y, Liu W, Yu F. A review of sleep disorders and melatonin. Neurol Res, 2017, 39(6): 559–565.

    Article  PubMed  CAS  Google Scholar 

  30. Cunnington D, Junge MF, Fernando AT. Insomnia: prevalence, consequences and effective treatment. Med J Aust, 2013, 199(8): S36–S40.

    Google Scholar 

  31. Yang YT, Huang QF, Jia YF, Liu J, Ma XP. Current situation and analysis of clinical application of auricular acupoint sticking therapy. J Acupunct Tuina Sci, 2016, 14(2): 141–148.

    Article  Google Scholar 

  32. Huang YH, Gu LH, Gao YQ, Zhuo YH, Sun XH, Nie HM. Therapeutic observation of auricular point sticking with magnetic bead for insomnia in hepatocirrhosis. Shanghai Zhenjiu Zazhi, 2015, 34(6): 503–504.

    Google Scholar 

  33. Cai XM, Zhang XP, Tang X. Observation on clinical effect of auricular acupoint sticking plus music therapy for post–stroke insomnia. J Acupunct Tuina Sci, 2015, 13(4): 227–231.

    Article  Google Scholar 

  34. Wang Y, Li P, Wen QQ, Liu L, Chen XL, Wei QR, Yue ZH. Advances in studies on acupuncture treatment of primary insomnia. Shanghai Zhenjiu Zazhi, 2016, 35(7): 768–772.

    Google Scholar 

  35. Mc–Geeney BE. Acupuncture is all placebo and here is why. Headache, 2015, 55(3): 465–469.

    Article  Google Scholar 

  36. Linde K, Niemann K, Schneider A, Meissner K. How large are the nonspecific effects of acupuncture? A meta–analysis of randomized controlled trials. BMC Med, 2010, 8: 75.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Solomon S. Acupuncture for Headache. It’s still all placebo. Headache, 2017, 57(1): 143–146.

    PubMed  Google Scholar 

  38. He W, Wang X, Shi H, Shang H, Li L, Jing X, Zhu B. Auricular acupuncture and vagal regulation. Evid Based Complement Alternat Med, 2012, 2012: 786839.

    PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

This work was supported by Scientific Project of National Science & Technology Pillar Program During the Eleventh Five-year Plan Period (国家“十一五”科技支撑 计划项目, No. 2007BAI10B01-027); Shanghai Municipal Commission of Health and Family Planning, Scientific and Technological Innovation Project of TCM: Mobile Internet-based Insomnia Rehabilitation Prevention (Chronic Disease Management) Guidance Platform [上海 市卫生和计划生育委员会中医药科技创新项目——基 于移动互联网的失眠症“治未病”康复预防(慢病管理) 指导平台, No. ZYKC20161016].

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Zhao, Fy., Zhao, Yx., Yan, Hx. et al. Auricular acupressure as assistant in primary insomnia management: a randomized single-blind controlled clinical trial. J. Acupunct. Tuina. Sci. 17, 49–55 (2019). https://doi.org/10.1007/s11726-019-1092-0

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