CLINICAL

Article TRIALS

Clinical Trials
2020, Vol. 17(5) 545–551
Ó The Author(s) 2020
Double-blinding of an acupuncture Article reuse guidelines:
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randomized controlled trial optimized DOI: 10.1177/1740774520934910
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Alana D Steffen1, Larisa A Burke2, Heather A Pauls2, Marie L Suarez3,

Yingwei Yao4, William H Kobak5, Miho Takayama6, Hiroyoshi Yajima6,
Ted J Kaptchuk7, Nobuari Takakura6, Diana J Wilkie4 and Judith M
Schlaeger3

Abstract
Background: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, con-
ceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to imple-
ment and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of
acupuncture for the treatment of vulvodynia.
Methods: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software’s
randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding
assessments are conducted multiple times to identify possible correlates of unblinding.
Results: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acu-
puncturist blinding assessments.
Discussion: Our approach to blinding and blinding assessment has the potential to improve our understanding of
unblinding over time in the presence of possible clinical improvement.

Keywords
Acupuncture, randomization, blinding, randomized controlled trial, Research Electronic Data Capture, clinical transla-
tional science, vulvodynia, double-blind sham acupuncture

Background
The efficacy of acupuncture is difficult to demonstrate
in the absence of a double-blind milieu. We are cur-
rently testing a double-blind treatment protocol for the
treatment of vulvodynia. Vulvodynia is a chronic pain
condition characterized by vulvar pain and painful sex-
ual intercourse (dyspareunia) and has no consistently
effective treatments.1 We provide details of our proce-
dures to achieve an internally valid, double-blind acu-
puncture efficacy trial with careful attention to blinding
of the treatment condition, concealment of treatment
allocation, and measurement of blinding success.
Acupuncture experiments have a range of methodo-
logical challenges. Most are performed unblinded or
single-blinded (subject blind, acupuncturist unblind)
and use a range of control conditions including no acu-
puncture conditions, which may vary in intensity
1
Department of Health Systems Science, College of Nursing, University
of Illinois at Chicago, Chicago, IL, USA
2
Office of Research Facilitation, College of Nursing, University of Illinois
at Chicago, Chicago, IL, USA
3
Department of Women, Children and Family Health Science, College of
Nursing, University of Illinois at Chicago, Chicago, IL, USA
4
Department of Biobehavioral Nursing Science, College of Nursing,
University of Florida, Gainesville, FL, USA
5
Department of Obstetrics and Gynecology, College of Medicine,
University of Illinois at Chicago, Chicago, IL, USA
6
Department of Acupuncture and Moxibustion, Faculty of Health
Sciences, Tokyo Ariake University of Medical and Health Sciences,
Tokyo, Japan
7
Program in Placebo Studies, Beth Israel Deaconess Medical Center,
Harvard Medical School, Boston, MA, USA
Corresponding author:
Judith M Schlaeger, Department of Women, Children and Family Health
Science, College of Nursing, University of Illinois at Chicago, 845 S.
Damen (M/C 802), Ste.856, Chicago, IL 60612, USA.
Email: jschlaeg@uic.edu
546
Figure 1. A set of double-blind acupuncture needles (DBNs).
(e.g. physical therapy, usual care, no other care, or
attention control), or sham acupuncture using a variety
of methods. Evidence shows stronger effects for acu-
puncture compared to no acupuncture,2 yet these
designs do not establish that the therapeutic effect is
more than a placebo or expectancy effect, a common
criticism of acupuncture experiments.3–5 Sham acu-
puncture control conditions may use shallow needle
insertion at non-acupuncture points or non-penetrating
needles, but have shown more similar results to thera-
peutic acupuncture, possibly because needling or skin
stimulation at the alternative sites has some therapeutic
effect.2 Others have argued that acupuncture in single-
blind controlled studies is less effective than routine
clinical care due to the use of a base unit that hides nee-
dle penetration.6 We have developed a rigorous test of
acupuncture for reduction of the pain and dyspareunia
of vulvodynia using penetrating (verum) and placebo
needles that are identical in appearance and are
designed to feel the same to subjects and acupunctur-
ists, that is, double-blind needles (Figure 1). The valid-
ity of these double-blind needles has been supported in
multiple studies, in single-use applications,7–12 but this
is the first study to use this methodology in a multi-nee-
dle, multi-session experiment. Our study is designed to
test the efficacy of the standardized vulvodynia acu-
puncture protocol beyond placebo effect and, seconda-
rily, to learn about correlates of blinding.
Treatment allocation in the context of a randomized
trial is the process of assigning subjects to either a treat-
ment or control condition and the allocation sequence
Clinical Trials 17(5)
is the randomized order of each subject assignment.
Selection bias may occur when research staff create
conditions that influence which subjects are enrolled
and the sequence of their assignment to a treatment
arm. To prevent this bias, methodologists recommend
that subjects are randomized after enrollment and that
the allocation sequence is concealed from staff.13 In a
double-blind placebo controlled trial, the blinding and
concealment of treatment allocation can occur through
the same process and both are critical to the integrity
of the study. In accordance with the consolidated stan-
dards of reporting trials (CONSORT),14 we present
our process for blinding and treatment allocation as
well as the level of blinding for persons involved in this
research. These details have rarely been reported in
methodology sections of published RCTs.14–16
While it is accepted that double-blinding is ideal in
an experimental design, the measurement of blinding
success is controversial.17–19 For many conditions and
therapies, blinding to treatment arm may be con-
founded with treatment efficacy. As a subject improves,
the subject and clinician may correctly assume the sub-
ject received an active treatment. Measurement of
blinding success was part of the CONSORT checklist
but was removed in the 2010 revision due to this
dilemma.14,19 Our study dually tests an acupuncture
treatment protocol and the use of double-blind needles
in a multi-session trial. Therefore, we have taken a dis-
covery approach to understanding blinding success
through a multi-pronged assessment for subjects and
acupuncturists that will allow us to learn about possible
correlates of unblinding. We present an overview of our
protocol, methods to conceal treatment allocation and
maintain a double-blind protocol, and our approach to
measuring the success of blinding.
Methods
Study overview
Our study was designed to achieve equipoise for all
non-specific effects of our treatment protocol. All 80
subjects expected to complete the study are acupunc-
ture naı̈ve at time of enrollment. Subjects randomized
1:1 to either penetrating or placebo needles, receive a
13-needle, twice-weekly, 10-session, 5-week acupunc-
ture treatment protocol. Subjects and acupuncturists
are instructed to speak only if safety is compromised in
an attempt to remove the therapeutic effects of their
relationship. A research associate monitors the fidelity
of the acupuncture treatment protocol at all treatment
sessions. Data collection and management are facili-
tated using the Research Electronic Data Capture
(REDCap), hosted at the University of Illinois at
Chicago.20,21 This study was approved by the
University of Illinois at Chicago Institutional Review
Board. Successful completion of our research will allow
Steffen et al.
Figure 2. Needle package contents for each subject.
us to study the methodology of double-blinding in a
multi-session multi-needle efficacy trial and to test the
efficacy of an acupuncture protocol for the treatment
of vulvodynia pain.
Randomization protocol
We developed our randomization and blinding proce-
dures to support the internal validity of our study. The
on-site statistician oversees the labeling of needle
packages, which arrive from the manufacturer in Japan
tagged with the treatment arm identifier (1 or 2;
Figure 2). The statistician removes the tag and labels
the packet with a unique code, described below.
Randomization is implemented using the REDCap
randomization module for its ability to manage strati-
fied randomization and because we could adapt it to
mask group allocation. We chose to randomize within
strata defined by diagnostic subtype, generalized vulvo-
dynia, and provoked vestibulodynia, due to its prog-
nostic importance.22 We wanted to achieve complete
masking of group allocation to ensure that our clinical
and research staff did not observe patterns across sub-
jects that might unblind them. For example, if staff
were aware of group allocation (e.g. treatment arm 1),
they might notice that subjects in that arm seem to
improve compared to the other arm and deduce it is
547
the penetrating needle arm. If this occurs, staff have
the potential to introduce an expectancy bias in their
interactions with future subjects assigned to arm 1.
Therefore, we went beyond masking that arm 1 might
be the penetrating needle arm, thus preventing staff
from ascertaining any treatment arm identifiers
entirely.
The REDCap randomization module executes a
user-defined randomization model. It requires the proj-
ect statistician to upload an allocation sequence devel-
oped using other software and generates assignments
accordingly with the click of a button. Typically, in a
randomized controlled trial, subjects are assigned to
two or three groups, but since we adapted the module
to mask allocation, we created 176 ‘‘groups,’’ one for
each possible subject accounting for attrition and
unknown strata proportions. Instead of REDCap
assigning one of the two treatment arms, we had it
assign one of the 176 ‘‘groups’’ which represent unique
codes for each individual enrolled. We called this code
a randomization identifier (ID) that is linked to the
treatment arm in a spreadsheet stored outside of
the REDCap system. This randomization ID serves as
the study ID for the remainder of the study.
We developed the allocation sequence using Stata23
with permuted blocks of consistent size including twice
as many potential assignments than our target sample
548 Clinical Trials 17(5)

Table 1. Master worksheet sample for randomization allocation schedule.

Generated by Stata Manually addeda

Arm Block Random number Sequence number Generalized subtype Randomization ID

2 1 0.0238564 1 1 140
1 1 0.1413895 2 1 173
1 1 0.1841138 3 1 116
2 1 0.971364 4 1 145
2 2 0.0461595 1 1 180
1 2 0.4007082 2 1 136
2 2 0.7773784 3 1 141
1 2 0.9007107 4 1 115
2 43 0.2526355 1 0 183
1 43 0.3804519 2 0 134
2 43 0.6840113 3 0 104
1 43 0.9718139 4 0 150
1 44 0.1008327 1 0 133
2 44 0.5935789 2 0 179
2 44 0.754083 3 0 160
1 44 0.8610591 4 0 181

REDCap: Research Electronic Data Capture.

Two arm 1 and two arm 2 assignments were randomly shuffled within each block by creating a column with random numbers, then sorting the
random number from smallest to largest within each block. Half of the blocks were assigned to each diagnostic subtype. A randomization ID was
inputted to be linked to each treatment arm assignment.
a
Columns used for REDCap allocation template.

size. After copying this sequence into a spreadsheet, we
added a diagnostic subtype indicator in equal propor-
tions and a randomly ordered list of IDs. This master
worksheet, which included treatment arm allocations (1
and 2), was saved in a secure location with access
restricted to the two study statisticians. An example of
this master worksheet is shown in Table 1. We used the
diagnostic subtype and ID columns from our master
worksheet to set up the randomization module in
REDCap. We used ID instead of the treatment arm
indicator, which functioned as desired because we set
up 176 ‘‘groups.’’ Thus, when a staff person randomizes
a subject, the ID code is revealed rather than the treat-
ment arm. The staff selects the needle package with the
matching code, which contains the subject’s needles for
their full course of acupuncture.
By design, the principal investigator, research staff,
and acupuncturists are blinded to any treatment arm
identifier, and allocation of assignment is concealed.
The statistician is aware of a treatment arm identifier
(1 or 2) but blinded to its meaning. Our off-site statisti-
cian is the only person not blinded to treatment arm.
Consequently, he manages communication with study
subjects following completion of the study (e.g. emails
to inform the subject about treatment received and to
offer free acupuncture sessions to those receiving
placebo).
Measurement of blinding success
Both subjects and acupuncturists are asked to guess the
type of needles used without a ‘‘don’t know’’ option
and to rate their confidence on a 0–10 scale. Subjects
answer these questions twice, after their first and after
their final acupuncture session via a self-administered
survey using a tablet computer. The first assessment
allows us to examine subjects’ blinding before sustained
treatment effects are evident. The second assessment,
after 10 acupuncture sessions, will allow us to examine
the association of treatment effects with beliefs about
treatment received.
Our approach for the assessment of acupuncturist
blinding capitalizes on our 10-session protocol. We use
multiple acupuncturists to administer the study treat-
ments. Due to the logistics of scheduling 10 sessions per
subject, multiple acupuncturists may treat each subject
over the 5-week course of treatment. Acupuncturists
are asked the blinding questions after the subjects’ 1st
and 10th sessions and each time they see a subject for
the first time.
Statistical analyses
Once data collection is completed, statistical methods
will be used to assess blinding. We will compute a
weighted guess score coding a correct guess as + 1 and
an incorrect guess as 21, which will be multiplied by
the confidence rating yielding a possible range of 210
to + 10, where 0 indicates no confidence in the guess
regardless of its accuracy. For subject responses, we will
calculate a separate blinding index for each treatment
arm using Bang’s method, adapted for our guess score,
which yields a value from 21 interpreted as opposite
guessing (100% incorrect guesses) to + 1, which is
complete unblinding (100% correct guessing).24 Bang’s
Blinding Index is a descriptive measure that can be
Steffen et al. 549

Table 2. Possible predictors of unblinding for exploratory analyses.

Variable Description

Treatment arm Penetrating versus non-penetrating placebo needles

Session number Session 1–10 of treatment protocol that is associated with the guess, treated as categorical
fixed effect
Recent pain rating Patient’s worst pain in the past 24 h. For 10th session, this rating will be indicative
treatment response.a
Acupuncturist’s experience Years of experience
Protocol experience Number of treatments acupuncturist provided within the study in total
Session # of Number of sessions acupuncturist has treated the subjecta
acupuncturist–subject pair
Body mass index Acupuncturist may note difference with needle insertion if subject has low versus higher
body fat.
Month Months of data collection over the duration of the studya
Adverse events Subject feeling like they will ‘‘pass out’’ or the treatment is too strong
a
Time-varying measures that will be tested as average and deviation scores as appropriate.

compared with findings from other literature reviews
published using this approach.25,26 Mixed effect linear
regression models will be used to understand correlates
of the guess score measure for subjects and acupunctur-
ists in separate analyses.27 Our data will contain multi-
ple records per subject, and random coefficients will be
used to account for respondents’ influence on their
repeated measurements over time. Treatment arm by
time interactions will be a key predictor in our model-
ing. Other candidate variables for these analyses are
shown in Table 2.
Results
We are currently 22 months into our data collection
period and have screened 238 women and enrolled and
randomized 58 to participate in the study. We have
completed the protocol with 48 subjects and 9 drop-
outs. We employ six part-time acupuncturists. The
results presented below include the lessons learned from
our randomization approach, our adherence to the
blinding measurement protocol, and the current num-
bers of blinding assessments associated with the 48 sub-
jects who have completed the study.
Randomization
Our randomization model was designed to assign sub-
jects stratified by two diagnostic subtypes of vulvody-
nia. This function has been implemented without issue.
So far, one randomization-related problem arose on
one occasion during the study period. The REDCap
system was unavailable when a new subject entered the
study and needed to be randomized. Our solution was
to randomly choose a needle package so that treatment
could be initiated as usual. Afterwards, the statistician
reassigned the package chosen to the next randomiza-
tion identifier in the sequence once REDCap was back
online and reallocated the original packet number for
future use. This required careful documentation and
correction to the master worksheet. A backup plan was
also made should this problem recur. In our study, the
outage and our workaround for randomization was
more easily corrected than if we had used REDCap to
assign the treatment arm directly. It should be noted
that the randomization sequence in REDCap cannot
be edited once the module is set up and in production.
Blinding assessments
We examined the blinding assessment data for missing
values to judge adherence with our protocol for the 48
subjects who completed the protocol. We recognized in
the early months of enrollment that the collection of
the blinding assessment after the first session was over-
looked for several subjects. In contrast, no blinding
assessment was missing from the 10th session.
Assessing the circumstances, we determined that all
missing assessments were not filled out due to the com-
plexity of intake tasks to be completed at the first visit.
The research specialist self-corrected and developed a
reminder system so that the questions were asked routi-
nely. We assume these missing assessments are consis-
tent with the missing at random mechanism because
they are associated with a procedural error in the first
months of data collection. Consequently, we will esti-
mate our mixed effect models using full-information
maximum likelihood, which will utilize all available
data and produce less biased than complete case
analysis.28,29
At present, we have 39 (81%) subjects with two
blinding assessments and 9 (19%) with one. Our acu-
puncturist assessments were collected following the
appropriate acupuncture sessions: 1st, 10th, and every
session when an acupuncturist treated a subject for the
first time. These data were collected with 94% adher-
ence to the protocol. For the same 48 subjects described
above, we have 206 assessments distributed across the
10 sessions as shown in Figure 3.
550 Clinical Trials 17(5)

50
45

Number of Assessments
40
35
30
25
20
15
10
5
0
1 2 3 4 5 6 7 8 9 10
Acupuncture Visit

Figure 3. Number of acupuncturist blinding assessments by visit (48 subjects, 9 acupuncturists, 206 assessments).

Discussion acupuncture studies. In addition to our primary aim, to

The methods described here reflect a team effort to
carefully design and implement a rigorous and intern-
ally valid acupuncture double-blind RCT. Although we
encountered minor issues along the way, we are confi-
dent that our study will be useful in testing the efficacy
of our acupuncture protocol for the relief of vulvody-
nia pain compared to a valid placebo condition. Our
use of the REDCap randomization module to assign a
unique randomization code has worked well to conceal
the allocation schedule and mask treatment arms from
staff. These procedural steps have been easy to imple-
ment and work reliably. We believe that we have cre-
ated the best conditions to maintain blinding to
treatment allocation and group assignment, but to
achieve acupuncture double-blinding and to success-
fully measure it, over a 10-session, 5-week treatment
may be difficult. Statistical approaches to quantify the
degree of unblinding have been developed and
used.18,24,25,30–33 Other researchers have used methods
for analysis and interpretation when blinding has been
breached.34,35 Our approach is to discover if there are
limits to blinding that occur over time, with experience,
and with symptom relief.
We recognize some limitations in our approach. Our
research specialist, though blind to condition, is not
asked blinding questions. Anecdotally, she has observed
situations that are potentially unblinding (e.g. redden-
ing of the skin at the needle insertion site, more pain
reaction with needle insertion, needles that fall over
after placement). These situations are infrequent and do
not occur consistently with the same subjects or acu-
puncturists. Time will tell if they lead to unblinding due
to experience.
In sum, the methods employed here and lessons
learned may be helpful to others in developing rigorous
evaluate efficacy for the treatment of vulvodynia pain,
this study has promise for adding to our understanding
about acupuncturists’ blinding with non-penetrating
placebo needles. It will also provide a longitudinal
opportunity to look at subject blinding before and after
a clinical effect may occur.
Acknowledgements
ClinicalTrials.gov Identifier: NCT03364127.
Declaration of conflicting interests
The author(s) declared the following potential conflicts of
interest with respect to the research, authorship, and/or publi-
cation of this article: N.T. and the Educational Foundation of
Hanada Gakuen possess a US patent 6575992B1, a Canadian
patent CA 2339223, a Korean patent 0478177, a Taiwanese
patent 150135, a Chinese patent ZL00800894.9 (Title: Safe nee-
dle, placebo needle and needle set for double-blinding), and
two Japanese patents 4061397 (Title: Placebo needle, and nee-
dle set for double-blinding) and 4315353 (Title: Safe needle) on
the needles described in this manuscript. N.T. is a salaried
employee of the Educational Foundation of Hanada Gakuen.
Drs. Y.Y., J.M.S., and A.D.S. report grants from the National
Institutes of Health, National Institute of Nursing Research.
Dr. D.J.W. reports grants from the National Institutes of
Health, National Cancer Institute and ownership of eNursing
llc, a company with no ownership of tools used in this study.
No other author has any competing interests.
Funding
The author(s) disclosed receipt of the following financial sup-
port for the research, authorship, and/or publication of this
article: This publication was made possible by the grant num-
ber R01 HD091210 from the National Institutes of Health,
National Institute of Child Health and Human Development
(NICHD). Its contents are solely the responsibility of the
Steffen et al.
authors and do not necessarily represent the official views of
the NICHD. The final peer-reviewed manuscript is subject to
the National Institutes of Health Public Access Policy.
ORCID iD
Judith M Schlaeger https://orcid.org/0000-0002-3754-6176
References
1. Bornstein J, Goldstein AT, Stockdale CK, et al. 2015
ISSVD, ISSWSH, and IPPS consensus terminology and
classification of persistent vulvar pain and vulvodynia. J
Sex Med 2016; 13(4): 607–612.
2. Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture
for chronic pain: update of an individual patient data
meta-analysis. J Pain 2018; 19(5): 455–474.
3. Bausell R, Lao L, Bergman S, et al. Is acupuncture ana-
lygesia an expectancy effect? Eval Health Prof 2005; 28:
9–26.
4. McGeeney BE. Acupuncture is all placebo and here is
why. Headache 2015; 55(3): 465–469.
5. Colquhoun D and Novella SP. Acupuncture is theatrical
placebo. Anesth Analg 2013; 116(6): 1360–1363.
6. Kim TH, Lee MS, Alraek T, et al. Acupuncture in sham
device controlled trials may not be as effective as acu-
puncture in the real world: a preliminary network meta-
analysis of studies of acupuncture for hot flashes in
menopausal women. Acupunct Med 2020; 38(1): 37–44.
7. Takakura N and Yajima H. A double-blind placebo nee-
dle for acupuncture research. BMC Complement Altern
Med 2007; 7: 31.
8. Takakura N, Takayama M, Kawase A, et al. Double-
blind acupuncture needle: a potential tool to investigate
the nature of pain and pleasure. ISRN Pain 2013; 2013:
825751.
9. Takakura N, Takayama M, Kawase A, et al. Double-
blind acupuncture needling: does patient reaction reveal
needle authenticity? Med Acupunct 2008; 20(3): 169–174.
10. Takakura N, Takayama M, Kawase A, et al. Double
blinding with a new placebo needle: a validation study on
participant blinding. Acupunct Med 2011; 29(3): 203–207.
11. Takakura N and Yajima H. A placebo acupuncture nee-
dle with potential for double blinding: a validation study.
Acupunct Med 2008; 26(4): 224–230.
12. Takakura N and Yajima H. Analgesic effect of acupunc-
ture needle penetration: a double-blind crossover study.
Open Med 2009; 3(2): e54–e61.
13. Altman DG and Schulz KF. Statistics notes: concealing
treatment allocation in randomised trials. BMJ 2001;
323(7310): 446–447.
14. Moher D, Hopewell S, Schulz KF, et al. CONSORT
2010 explanation and elaboration: updated guidelines for
reporting parallel group randomised trials. BMJ 2010;
340: c869.
15. Polit DF. Blinding during the analysis of research data.
Int J Nurs Stud 2011; 48(5): 636–641.
16. Polit DF, Gillespie BM and Griffin R. Deliberate ignor-
ance: a systematic review of blinding in nursing clinical
trials. Nurs Res 2011; 60(1): 9–16.
551
17. Sackett DL. Commentary: measuring the success of
blinding in RCTs: don’t, must, can’t or needn’t? Int J
Epidemiol 2007; 36(3): 664–665.
18. Kolahi J, Bang H and Park J. Towards a proposal for
assessment of blinding success in clinical trials: up-to-date
review. Community Dent Oral Epidemiol 2009; 37(6):
477–484.
19. Schulz KF, Altman DG, Moher D, et al. CONSORT
2010 changes and testing blindness in RCTs. Lancet 2010;
375(9721): 1144–1146.
20. Harris PA, Taylor R, Minor BL, et al. The REDCap con-
sortium: building an international community of software
platform partners. J Biomed Inform 2019; 95: 103208.
21. Harris PA, Taylor R, Thielke R, et al. Research electronic
data capture (REDCap): a metadata-driven methodology
and workflow process for providing translational
research informatics support. J Biomed Inform 2009;
42(2): 377–381.
22. Harlow BL and Stewart EG. A population-based assess-
ment of chronic unexplained vulvar pain: have we under-
estimated the prevalence of vulvodynia? J Am Med
Womens Assoc 2003; 58(2): 82–88.
23. Stata statistical software: release 15 (computer program).
College Station, TX: StataCorp, 2017.
24. Bang HJ, Ni LY and Davis CE. Assessment of blinding
in clinical trials. Control Clin Trials 2004; 25(2): 143–156.
25. Moroz A, Freed B, Tiedemann L, et al. Blinding mea-
sured: a systematic review of randomized controlled trials
of acupuncture. Evid Based Complement Alternat Med
2013; 2013: 708251.
26. Freed B, Assall OP, Panagiotakis G, et al. Assessing
blinding in trials of psychiatric disorders: a meta-analysis
based on blinding index. Psychiatry Res 2014; 219(2):
241–247.
27. Hedeker D and Gibbons RD. Longitudinal data analysis.
Hoboken, NJ: John Wiley & Sons, 2006.
28. Enders CK. Applied missing data analysis. New York:
Guilford Press, 2010.
29. Graham JW. Missing data analysis: making it work in the
real world. Annu Rev Psychol 2009; 60: 549–576.
30. Bang H. Random guess and wishful thinking are the best
blinding scenarios. Contemp Clin Trials Commun 2016; 3:
117–121.
31. Bang H and Park JJ. Blinding in clinical trials: a practical
approach. J Altern Complement Med 2013; 19(4):
367–369.
32. Bang HJ, Ni LY and Davis CE. Assessment of blinding
may be inappropriate after the trial: response to Hen-
neicke-von-Zepelin and Harri Hemili’s comment. Con-
temp Clin Trials 2005; 26(4): 514–515.
33. Park J, Bang H and Cañette I. Blinding in clinical trials,
time to do it better. Complement Ther Med 2008; 16(3):
121–123.
34. Arandjelović O. A new framework for interpreting the
outcomes of imperfectly blinded controlled clinical trials.
PLoS ONE 2012; 7(12): e48984.
35. Chow SC and Shao J. Analysis of clinical data with brea-
ched blindness. Stat Med 2004; 23(8): 1185–1193.