Stimulated by Li et al 2020,[1] and Yu et al 2020.[2]
EA – electroacupuncture
key to acronyms
PSQI – Pittsburgh Sleep Quality Index
PMI – perimenopausal insomnia
MA – manual acupuncture
CBT-I – cognitive behaviour therapy for insomnia
MSKCC – Memorial Sloan Kettering Cancer Centre
ISI – Insomnia Severity Index
I am starting the year with a focus on sleep. There have been a couple of small trials out that appeared in my searches at the very end of 2020. They both involved EA and used the PSQI as the primary outcome, so it seems appropriate to group them together here.
perimenopausal insomnia
The first is a sham controlled study (n=84) with 2 parallel arms in patients with perimenopausal insomnia (PMI), and it comes from Shanghai. 18 sessions were performed over 8 weeks – 3 per week for 4 weeks followed by 2 per week for 2 weeks and once per week for the last 2 weeks. The acupuncture protocol was semi-standardised using mostly manual acupuncture (MA) with EA applied to two midline points on the head (GV20–yintang). Interestingly they refer to yintang as GV29 in this paper, which I don’t recall seeing before. Yintang does lie on the GV meridian but is between numbers 24 and 25. EA was applied for 30 minutes at 2.5Hz and 4–5mA, which seems quite intense, but we are not told the pulse width, and that can make quite a difference. MA was applied at GV24, CV6, CV4, and bilaterally at anmian (an extra point on the mastoid), SP6 and HT7. Additional points were allowed depending on the TCM syndrome diagnosis, and these included GV4 and BL23, or KI3 and KI7. So, I make that a total of 14 or 15 needles with two of them connected to EA.
The sham acupuncture utilised the Streitberger non-penetrating needle and used the same points including dummy EA (no current).
The PSQI is a questionnaire with 10 questions including a total of 19 separate items. The scoring is quite complex, with multiple items feeding into 7 component scores of 0–3, making a total score from 0–21, with higher scores indicating lower sleep quality. A score of 5 or greater is the threshold indicating sleep problems, and previous researchers have used a change in PSQI score of 3 to represent a minimal clinically important change.[3]
The EA/MA group performed significantly better than sham from week 8 onwards (18 sessions) but was not significantly better after 4 weeks (12 sessions). The drop in PSQI was 4.4 at week 20 in the EA/MA group and 0.76 in the sham group.
heroin use disorder
The second study is slightly smaller (n=50) but used a 2-arm crossover design, which means it had more statistical power than the first study discussed. This was based in Taiwan and the population was adults receiving methadone maintenance treatment for heroin use disorder. The interventions tested were both active treatments, and both involved acupressure to the auricular point shenmen. The EA group received additional EA applied to LI4 and ST36 bilaterally as well as the acupressure. Treatment was performed twice weekly for 4 weeks followed by a 3-week washout period, and then another 4 weeks of the alternate treatment.
The PSQI data was presented as percentage improvement in component scores in this study, which makes comparison with the first study more difficult, but fortunately the total score was included at the bottom of one of the tables. There was a baseline difference in PSQI score of over 2 points, but this did not quite reach significance, and the drop in PSQI over the whole study in each group was less than 2 points. Indeed the mean total score in group A did not reach as low as the baseline mean in group B. The total PSQI score reduction in group A was 1.67 and in group B it was 1.45, but the distribution of the drop across the different interventions was such that a significantly greater effect was attributed to the EA component
I guess there are two key differences between the trials that might account for the much larger change in PSQI in the former: the population, and the total number of sessions.
Sleep, or lack thereof, has come up on the blog previously (May 2019), when a trial from the Memorial Sloan Kettering Cancer Centre (MSKCC) found that cognitive behaviour therapy (for insomnia) was slightly superior to acupuncture: CBT-I pips acupuncture in insomnia. The primary outcome in this trial was the Insomnia Severity Index (ISI), but the PSQI was used as a secondary outcome. In the acupuncture group, which received 10 treatments over 8 weeks, the drop in PQSI was 4.62 at 20 weeks. The CBT-I group experienced a drop of 5.84 at 20 weeks.[4]
PSQI versus ISI
It is interesting to note that whilst the baseline PSQI score in the MSKCC population sample was just over 1 point higher than the perimenopausal population sample of Li et al, the baseline ISI was 4 points higher. The ISI is a 7-item questionnaire with a total score range from 0 to 28, which is just 33% more than the PSQI total of 21. Something doesn’t quite add up there, but when you look at the outcome measures in detail, they are quite different, and whilst the drop in ISI was considerably larger in the MSKCC population sample, the final score reached about the same level as the acupuncture group in perimenopausal population sample of Li et al.
I suppose there is a clue in the titles. The PSQI is about sleep quality and the ISI is about insomnia, so they may have differing sensitivities across a range of sleep disorders.
So, what should we take away from this? Be careful choosing your primary outcome measure if you are a researcher and do lots of treatment sessions when using acupuncture to treat patients with sleep problems.
References
1 Li S, Wang Z, Wu H, et al. Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial. Nat Sci Sleep 2020;12:1201–13. doi:10.2147/NSS.S282315
2 Yu K-C, Wei H-T, Chang S-C, et al. The Efficacy of Combined Electroacupuncture and Auricular Pressure on Sleep Quality in Patients Receiving Methadone Maintenance Treatment. Am J Addict Published Online First: 30 December 2020. doi:10.1111/ajad.13134
3 Hughes CM, McCullough CA, Bradbury I, et al. Acupuncture and reflexology for insomnia: a feasibility study. Acupunct Med J Br Med Acupunct Soc 2009;27:163–8. doi:10.1136/aim.2009.000760
4 Garland SN, Xie SX, DuHamel K, et al. Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial. J Natl Cancer Inst Published Online First: April 2019. doi:10.1093/jnci/djz050
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