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. Author manuscript; available in PMC: 2013 Jun 4.
Published in final edited form as: Am J Gastroenterol. 2012 Apr 10;107(6):835–848. doi: 10.1038/ajg.2012.66

Table 2.

Risk of bias summary*

Adequate
sequence
generation
Allocation
concealment
Patient
blinding
Incomplete
outcome data
addressed
Free of
selective
reporting
Baseline
compara-
bility a
ITT b
An (2010) (33) Yes [Yes] No [Unclear]C Yes Unclear No
Anastasi (1999) (34) [Yes] [Yes] Yes d Yes Yes Yes No
Chen (2009) (36) [No] e [No] No [Unclear]f Yes Yes No
Chen (2011) (35) Yes [Yes] No [Yes] Yes Yes No
Forbes (2005) (37) Yes [Yes] Yes g Yes Yes Yes Yes
Lembo (2009) (38) Yes Yes Yes h Yes Yes Yes Yes
Li (2009) (39) [No] e [No] No [Unclear]C Yes Yes No
Liu (1997) (40) [Unclear]i [Unclear] No [Unclear]C Yes Unclear No
Liu (2010) (41) [Unclear]i [No] No [Unclear]j Yes Unclear No
Lowe (2000) (42) [Yes] [Yes] Uncleark UnclearC Yes Yes Unclear
Reynolds (2008) (43) [Yes] [Yes] No Yes No Yes Yes
Schneider (2006) (44) [Yes] Yes Yes h Yes Yes Yes No
Shi (2010) (45) [Yes] [Yes] No Yes Yes Yes Yes
Sun (2011) (46) [Yes] [No] No Yes Yes Yes No
Xiong (2008) (47) [Yes] [No] No [Unclear]C Yes Unclear No
Xue (2009) (48) [Unclear]i [Unclear] No Yes Yes Yes No
Zeng (2010) (49) Yes [Yes] No Yes Yes Yes No
*

We followed the Cochrane Handbook criteria (28) for making judgments about the risk of bias for each of the 6 domains in the Cochrane Risk of Bias tool. Additional data obtained from RCT authors is enclosed in brackets to allow such data to be differentiated from the data included only in the publications.

a

For the baseline comparability criterion to score “Yes”, a comparison of the symptom scores between the treatment and control group(s) at baseline needed to be reported.

b

For the ITT criterion to score “Yes”, an intention-to-treat analysis needed to be reported.

C

In these trials, the authors did not report the numbers of drop-outs in their publication, and did not have records of the numbers of drop-outs to provide during the telephone interviews.

d

For the sham control, penetrating needles were superficially inserted at nonpoints which were 2-3 cm away from the true points, and placebo moxibustion was performed above the same sham points without generating a heat sensation.

e

The authors of these trials confirmed in telephone interviews that a few patients were non-randomly assigned to achieve identical sized treatment groups.

f

For this trial, the authors endeavored to maintain equal group sizes, by eliminating participants who withdrew during the trial and replacing them with new patients, and the number of such replacements was not recorded by the author.

g

For the sham control, acupuncture needles were inserted at areas on the body that do not correspond to acupuncture points and are deemed to have no therapeutic value. The points and needling technique were varied somewhat each week, as was also done in the true acupuncture group, who received individualized point selection.

h

For the sham control in these trials, the Streitberger placebo needle was used, which has been previously validated as a sufficiently credible sham (29). The Streitberger needles were placed close to the genuine acupuncture points in both trials. In both trials, the participants were acupuncture naïve.

i

This criterion was scored as “Unclear” because the authors of these 3 trials were unable to explain how equal sample sizes were achieved.

j

For this trial, the authors reported no drop-outs, which would be unusual in a 4 week trial of 300 participants.

k

The sham control used in this trial was judged to have been potentially detectable as a fake treatment by the trial participants. The sham procedure involved tapping a blunt needle on the skin and then taping the needle in place. Although this procedure was described as “validated”, we are unaware of a validation study for this procedure. Also, in the trial report there was no description of whether or not the patients were required to have never previously used acupuncture, and there were no reported tests for checking the success of the blinding.