Zoom-in on Research in Insomnia By Gil Barzilay

גיל תמונה

Zoom-in on Research in Insomnia – Lessons learned so far

Traditional Chinese Medicine (TCM) has proven very effective in treating insomnia of various etiologies. Treatment has also been researched extensively with over 200 publications of clinic, pre-clinical & case study publications.

A Cochrane review1 published in 2012 looked at randomized controlled trials (RCT=gold standard in clinical research, where people being studied are randomly allocated to one or other of the different treatments in order to avoid bias) evaluating any form of acupuncture for insomnia, who compared acupuncture with/without additional treatment against placebo or sham or no treatment or same additional treatment. 32 trials were included with 2293 participants, aged 15-98, some with medical conditions contributing to insomnia (stroke, end-stage renal disease, perimenopause, pregnancy etc.). They evaluated needle acupuncture, electroacupuncture, acupressure or magnetic acupressure. Only two studies showed highly significant improvement, but the dropout was a major bias. All trials had high risk of bias and were heterogeneous in the definition of insomnia, participant characteristics, acupoints and treatment regimen. The effect sizes were generally small with wide confidence intervals. The reviewers concluded that "due to poor methodological quality, high levels of heterogeneity and publication bias, the current evidence is not sufficiently rigorous to support or refute acupuncture for treating insomnia". As Cochrane Reviews focus first and foremost on methodology (especially design and pre-planned statistical analyses) before assessing effect size their reservation is of no surprise.

However, there is some truth in what they say. Three recently published studies highlight some of the problems.

The first study2, from Brazil, published in the prestigious journal Neuroscience Letters, included 48 elderly people who were randomized to receiving True or Placebo acupuncture. The points selected were SP-6, LI-4, ST-36, LIV-3, PC-6, and YinTang, all known to be effective in treating insomnia. The Placebo points were distant from the True points. Patients received treatment for 25 minutes, twice a week for 5 weeks (overall 10 treatments). Treatment effect was measured using the well-validated scales of Pittsburgh sleep quality index (PSQI), beck depression inventory (BDIII) and perceived stress scale (PSS), respectively, before and after the intervention. Acupuncture was highly effective for improving sleep quality (−53.23%; p<0.01), as well as depression (−48.41%; p<0.01) and stress (−25.46%; p<0.01).

The second study3, from China, published in the Journal of Traditional Chinese Medicine, was a randomized controlled study, involving 120 patients randomized equally to receive acupuncture once a day at GV20, Sishencong, BL-62, KID-6 with moxibustion at DU-20 and Sishencong vs. a Control arm that received acupuncture at HT-7, PC-6 and SP-6. As you can see, the "Control Group" received treatment at points that in some texts, and in the study above are very effective for insomnia. Not surprising then that as measured by PSQI, both groups were highly effective compared to baseline (Total Effective rate was 87.7% and 76.3% for the two groups, respectively), however, the effect on sleeping quality, time to fall asleep, sleeping disorder, and daytime function was more significant in the experimental group (P<0.05).

A third study4, from China, published last week in the prestigious Evidence-Based Complementary and Alternative Medicine, compared the efficacy of auricular, body, and abdominal acupuncture in 54 patients suffering from insomnia due to internal harassment of phlegm-heat syndrome. Body acupuncture included KID-6, Bl-62, HT-7, Yintang, Sishencong and Anmian with additional acupoints selected on the basis of syndrome differentiation ST-40, ST-44, and LI-11. Auricular were Shenmen (TF4), Occiput (AT3), Chuiqian (LO4), and Subcortex (AT4) together with Spleen (CO13), Stomach (CO4), Heart (CO15), and Liver (CO12). Acupoints were selected unilaterally at a time, alternated every other day. Abdominal Acupuncture included RN-12, RN-10, RN-6, RN-4, KID-17, ST-24, ST-26, Pinggan with Syndrome differentiation acupoints SP-15 and Xiere. Results showed that Body, auricular, and abdominal acupuncture treatments all alleviated symptoms of insomnia, depression, and anxiety, but body and auricular acupuncture had stronger therapeutic effects. Although the results are statistically meaningful, the low number of patients, divided to 3 arms with a unique statistical model, may not be sufficient to draw clear-cut conclusions about the different methodologies.

So what's next then?

More quality clinical research is warranted to further substantiate the effect of acupuncture on insomnia, as single or adjunct therapy. Research should be larger, well defined, with specific populations of specific etiologies (such as in the 3rd study), treatment protocol using an expert consensus technique, well defined controls and conducted according to the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) Guidelines.

Until then, we'll just continue to use successful & established traditional protocols…

References:

  1. Cheuk DKL, Yeung WF, Chung KF, Wong V. Acupuncture for insomnia. Cochrane Database of Systematic Reviews (2012) Issue 9. CD005472.
  2. Zuppa C, Prado CH, Wieck A., Zaparte A, Babosa A, Bauer ME Neuroscience Letters (2015) 587:35-40.
  3. Gao X, Xu C, Wang P, Ren S, Zhou Y, Yang X, Gao L. J Tradit Chin Med (2013) 15; 33(4): 428-432.
  4. Jiao Y, Han Y, Li X, Fang YG, Liu ZH, Zhou WN, Zhou JC, Wu ZC, Yang JH, Li SY, Meng FY, Xu WW Evidence-Based Complementary and Alternative Medicine (2015) http://dx.doi.org/10.1155/2015/578972

Dr. Gil Barzilay has a Diploma in Chinese Medicine (Dipl. CM, I.A.TCM) with honors from Broshim College of Integrative Medicine, Tel Aviv University.

In his past, Gil has obtained B.Sc (Hons) from Imperial College, London, a Ph.D from Oxford University in Cancer Research and an EMBO Post-Doctoral fellowship at the Weizmann Institute, specializing in Cell Death (Apoptosis) research.

 

 

This post is also available in: Hebrew

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