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Figure 2. Risk of Bias Summary
a Yellow: unclear; green: low risk of bias; red: high risk of bias. the wake-promoting rate and found that people in the treatment
Zhang—Acupuncture for Patients in Coma After TBI
a remained, and 466 trials were excluded due to the
predetermined eligibility criteria. On the basis of a review of
the full texts, the research team excluded 48 trials. The
reasons and the processes for selecting the relevant studies
are documented in Figure 1. 47
A final total of 24 publications fit the inclusion criteria. 19-42
All of the 24 RCTs originated in China and were published in
Chinese. The sizes of the trials varied between 30 and 100
participants, and participants underwent acupuncture with
different acupoints. Characteristics of all included trials
aiming to arouse patients in a coma and relevant information
related to treatments are shown in Table 1.
Most trials chose a set of acupoints, such as Shuigou
(GV-26), Neiguan (PC-6), and Baihui (GV-20) as their main
points; only 1 trial assessed the effects of specific points on
41
Yongquan (KI-1) for arousing patients in a coma who had
brain trauma. Twenty-three studies directly compared
acupuncture plus conventional treatment against
conventional treatment. One study evaluated the effects of
40
acupuncture combined with hyperbaric oxygen therapy
versus hyperbaric oxygen therapy alone.
Quality
The current research team’s judgments about risk of bias
for each domain are summarized in Figure 2, and the quality
of these studies was low. Only 12 trials provided detailed
accounts of how they generated randomized
sequences. 20,22,23,25,26,32,33,37,39-41,42 The allocation concealment
across trials was identified only in 10 studies, with high
risk. 20,22,25,26,32,33,37,39,41,42
The current research team judged that the risk of
performance bias in all trials was low because no need existed
to blind the patients or the persons providing the acupuncture.
No trial reported sufficient details about assessor blinding;
thus, the judgment about detection bias was unclear.
Only one of the 24 trials reported drop-out data and
40
used intention-to-treat principles. None of trials have shown
possible adverse effects with use of acupuncture to arouse
unconscious patients. Therefore, the attrition bias for the
other trials was considered to be at high risk. With regard to
selective-reporting bias, the research team judged that
expected outcomes were stated in all trials.
Efficacy
Glasgow Outcome Score. Only one study reported
19
posttreatment GOS with significant differences between
acupuncture intervention and control (MD, 1.00; 95% CI
[0.60 to 1.40]; P < .01). Sixteen studies 21,24-35,37,39,41 reported
that the number of subjects with normal GOS, the results of
which yielded a highly significant RR, demonstrating efficacy
between acupuncture intervention and control (RR; 1.95;
95% CI [1.64 to 2.31]; P < .01; I² = 0%) (Figure 3).
Wake-promoting Rates. Seven studies 20,32,33,37-39,42 reported
group had significantly differences compared with the control
group (RR, 1.48; 95%; CI [1.19 to 1.83]; P < .01; I² = 52%).
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