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Placebo and food cravings control: results from two randomized controlled trials

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Background: We present two studies (hereafter Study 1 and Study 2), aimed to evaluate Bach Flower Remedies (BFR) effectiveness in controlling food cravings (FC), with assessment at three different stages: baseline, 1 month after baseline and 3 months after baseline. Methods: Study 1 consisted in a double-blind placebo-controlled trial aimed to assess the specific effects of a BFR-formula and the overall effectiveness of the placebo-control on FC (n=173). Participants were assigned to BFR (n=65), Placebo (n=55) and Control group (n=53). On the other hand, Study 2 did not involve deception, and combined an implementation intention instruction with the BFR-formula, all aimed to reduce FC in overweight and obese adults while at home (n=74). Every participant received an implementation intention instruction to sip a glass of water whenever experiencing FC at home. BFR group (n=37) was instructed to sip water with BFR solution diluted in it, whereas Water group just sipped plain water (n=37). Results: Study 1 did not support specific effects for BFR; placebo seemed to be effective in controlling FC. Moreover, findings from Study 2 suggest that BFR, used at least once a day, in conjunction with implementation intention intervention, may be helpful in reducing FC in overweight and obese adults while at home. Conclusions: Results of both Studies helped us evaluate the ‘power of the placebo’ in helping individuals overcome FC in their everyday life.
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© Longhua Chinese Medicine. All rights reserved. Longhua Chin Med 2020;3:1 | http://dx.doi.org/10.21037/lcm.2020.01.01
Original Article
Placebo and food cravings control: results from two randomized
controlled trials
Boris C. Rodríguez-Martín1, Liset M. Frías-Hernández2, Juan C. O’Farril-Jiménez1,
Ángela M. Guillén-Verano1, Leticia Pastorrecio-González2, Yarai Chinea-Monzón3,
María C. O’Farril-Rodríguez3, María J. Cartalla-Gálvez3, Carlos A. Águila-Vega3, Ismaray Molina-Santos4,
Ismaray Hernández-Rodríguez1
1Department of Psychology, Universidad Central “Marta Abreu” de Las Villas, Santa Clara, Cuba; 2Department of Psychology, University of
Camagüey, Camaguey, Cuba; 3Department of Psychology, University Policlinic of Santo Domingo, Santo Domingo, Cuba; 4Department of
Psychology, Communitarian Policlinic of Quemado de Güines; Villa Clara, Cuba
Contributions: (I) Conception and design: BC Rodríguez-Martín; (II) Administrative support: BC Rodríguez-Martín; (III) Provision of study
materials or patients: All authors; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: BC Rodríguez-Martín; (VI)
Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.
Correspondence to: Boris C. Rodríguez-Martín, PhD. Department of Psychology, Universidad Central “Marta Abreu” de Las Villas, Carretera de
Camajuaní Km 5 ½, Santa Clara, Cuba. Email: borisrod@gmail.com.
Background: We present two studies (hereafter Study 1 and Study 2), aimed to evaluate Bach Flower
Remedies (BFR) effectiveness in controlling food cravings (FC), with assessment at three different stages:
baseline, 1 month after baseline and 3 months after baseline.
Methods: Study 1 consisted in a double-blind placebo-controlled trial aimed to assess the specic effects
of a BFR-formula and the overall effectiveness of the placebo-control on FC (n=173). Participants were
assigned to BFR (n=65), Placebo (n=55) and Control group (n=53). On the other hand, Study 2 did not
involve deception, and combined an implementation intention instruction with the BFR-formula, all
aimed to reduce FC in overweight and obese adults while at home (n=74). Every participant received an
implementation intention instruction to sip a glass of water whenever experiencing FC at home. BFR group
(n=37) was instructed to sip water with BFR solution diluted in it, whereas Water group just sipped plain
water (n=37).
Results: Study 1 did not support specic effects for BFR; placebo seemed to be effective in controlling
FC. Moreover, findings from Study 2 suggest that BFR, used at least once a day, in conjunction with
implementation intention intervention, may be helpful in reducing FC in overweight and obese adults while
at home.
Conclusions: Results of both Studies helped us evaluate the ‘power of the placebo’ in helping individuals
overcome FC in their everyday life.
Keywords: Food cravings (FC); Bach Flower Remedies (BFR); complementary and alternative medicine (CAM);
placebo response; obesity; implementation intentions
Received: 27 November 2019; Accepted: 07 January 2020; Published: 30 June 2020.
doi: 10.21037/lcm.2020.01.01
View this article at: http://dx.doi.org/10.21037/lcm.2020.01.01
16
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Introduction
Food cravings (FC) refer to an intense desire to eat
specific types of foods (1); this has been linked to body
mass index (BMI) and consumption of sweet, high-fat,
carbohydrate/starches and fast-food in community-dwelling
individuals (2). Although FC do not reect abnormal eating
behavior per se, very intense and frequent experiences are
associated with obesity and eating disorders such as bulimia
nervosa and binge eating disorder (3).
In this respect, FC in unsuccessful dieters or restrained
eaters have been related to a lack of control over eating, and
keeping up consuming daily planning (4), which altogether
represent a problem whenever individuals need to overcome
daily temptations by the mere use of their own willpower (5).
It seems that such individuals may need some sort of tool to
bridge the gap between intention and action.
About two decades ago, the Homeopathic Pharmacy
of Santa Clara (Cuba) began delivering a Bach Flower
Remedies (BFR)-formula which claimed helped individuals
lose weight. Many people attributed its effect to the fact
that it was easier for them to control their “anxiety to
eat”. In addition, a recent study in Brazil showed that
overweight and obese individuals did perceive benets from
an intervention with BFR on both self-control and anxiety
reduction (6).
In Cuba, we speak of “anxiety to eat” meaning FC rather
than referring to an emotion which leads to eating (7). FC
could then so be considered as a major problem among
overweight and obese Cuban adults (8). The potential of
using BFR in helping individuals with eating disorders or
obesity has been previously suggested as a helping tool
for them (9,10), but no known research up to date has yet
investigated whether BFR can truly help individuals or not
in controlling their FC.
Systematic reviews agree that BFR are essentially a
placebo (11-13); even more, a useful one (12,14-16). It is
important to highlight that although recent studies have
shown specific effects (17-22) we consider the majority of
responses to BFR in clinical practice as a broad collection of
spurious therapeutic effects (23).
In fact, it has been suggested that spirituality could be
the main dispositional predictor of the effect of BFR (24-27).
Furthermore, it has also been suggested that spirituality
predicts self-opinion about BFR whenever individuals
receive enough information about this therapy, regardless
of their dispositional optimism, or whether they have or not
already received treatment (28).
This kind of meaning response has been used to interpret
those placebo responses (29,30) in which patients respond
to a pharmacologically inert treatment (31). In some cases,
it has been observed a Goldilocks placebo effect when
individuals have chosen their own BFR-formula among
some other “correct” number of options (32).
Following the idea that there is a wide applicability for
psychological interventions to be delivered in conjunction
with complementary and alternative medicines (CAM)
approaches, as a part of an overall health maintenance
strategy (33), we hereby submit two studies which evaluate
the effectiveness of a BFR-formula in controlling FC.
Study 1 consisted in a double-blind placebo-controlled
trial aimed to assess the specific effect of the suggested
formula and the overall effectiveness of the placebo-
control in individuals with high trait FC. Beyond blinding
and randomization, we consider mandatory controlling
both Spirituality (34)—because BFR already are a kind
of a spiritualized therapy (24), and Expectancy regarding
treatment efficacy (35)—because expectancy is a given
predictive factor of placebo responses (36). As it has
been stated above, we can only attribute differential
improvements to the potential of the treatment (37) when
the active control group has reached the same expectation
of improvement (and spirituality for current studies) as the
experimental group.
Study 2 combined an implementation intention
instruction with the BFR-formula aimed to reduce FC in
overweight and obese adults while at home. Implementation
intention is an ‘if-then’ plan, which defines exactly when,
where, and how one wants to act towards one’s own goals (38).
It has been considered a useful resource for those individuals
committed to self-control of FC (39,40). In this context,
the use of replacements provide them with an alternative
action instead of suppressing or ignoring the cue (41). This
study did not involve deception, because uncertainty about
treatment allocation could also affect the response to the
intervention when compared with common clinical practice
(42,43). The suitability to combine psychological techniques
with acupressure in order to ameliorate FC had been
previously tested (44). Thus, the combination of CAM with
psychological interventions could provide proactive strategies
to reduce FC and obesity, via interventions not explicitly
oriented towards weight loss (45).
Study 1: a useful placebo
Objectives, design and hypothesis
Study 1’s main purpose was to evaluate both the specific
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effects attributed to the BFR-formula, and the overall
effectiveness of the placebo intervention in order to control
FC on individuals with frequent and intense experiences
of FC in their everyday life. Reductions in BMI were also
assessed as a secondary goal in order to provide an objective
and clinically important outcome measure.
In order to investigate on these objectives, we applied a
3×3 mixed factorial design. The within-subject factor was
“time”, with three measurement points (baseline, 1 month
later and 3 months later). The between-subject factor
was “group” with BFR group, along with Placebo group
and Control group. Participants were randomized as they
picked a number from 1 to 3 from a bowl after the baseline
assessment: 1= BFR group; 2= Placebo group; 3= Control
group.
It was hypothesized that BFR and Placebo group would
experience reductions in trait FC due to intervention.
Furthermore, it was also hypothesized that results in both
groups would eventually show a greater reduction in trait
FC, even a greater one than that of Control group, because
of the meaning associated to treatment.
Participants
The current research was approved by the Scientic Council
of the Faculty of Psychology at the Universidad Central
“Marta Abreu” de Las Villas (UCLV, Cuba); project number
33/11-12. It was conducted between January and July 2012,
and written consent was obtained from all participants. It
was carried out in accordance with The Code of Ethics of
the World Medical Association (Declaration of Helsinki)
for experiments involving humans.
There were 196 participants, recruited from a large
sample of 1,241 adults coming from a prior Study (7)
(exclusion criteria included pregnancy, lactation, elderly
population, active eating disorders, or any other diagnosed
psychopathological disorder). Advertisements sought
‘‘individuals who are experiencing strong FC in their
everyday life and would like to reduce them”.
For these individuals to be recruited, they had to
score over percentile 75 (total score 159) in the Food
Craving Questionnaire Trait—valid for Cuban adults (46).
Advertisements were posted on several family physicians’
offices billboards pertaining to the authors’ institutions
where individuals were being assessed, emphasizing the fact
that the intended intervention was not just to go on a diet
and target to reduce FC. Characteristics of the different
groups during the baseline assessment are shown in Table 1.
All participants voluntarily accepted to participate in the
study and no monetary compensation was offered to them.
Measures
Socio-demographic/anthropometric and clinical data:
Participants were asked to give out their age; gender;
height; education level; marital status and current weight.
Restrained eating was assessed using one single item
question: “Do you often restrain your food intake to reduce
or maintain your weight?” (Yes/No).
Food Cravings Questionnaire-Trait: the Spanish version
of such questionnaire (7,47) measures the intensity of
nine trait FC dimensions (see Table 2). Instructions ask
participants to reveal how frequently each given statement
“would be true for you in general”, using a 6-point scale
that ranged from 1 (never or not applicable) to 6 (always).
Spiritual Connection Questionnaire: consists of 14 items
regarding the experience of a spiritual connection with the
Universe and with other people, and the happiness such
connection brings to one-self (48). Responses were scored
on a Likert scale ranging from –3 (does not describe me at
all) to 3 (it fully describes me).
Expectancy: “At this point of time, do you expect
intervention to help you?”. Responses were scored on scale
ranging from –3 (unlikely it will help) to 3 (denitely think
it will help).
At follow-up (3 months later), an additional question
was posed in order to analyze the desire to continue with
the intervention: “Would you like to continue using this
resource?” (Yes/No/I’m not sure). Lastly, researchers also
kept a record of the number of bottles delivered to BFR
and Placebo group participants, and added the following
compliance question: “On average, how many times
a day did you take the given formula?” Answers were
ranging from 0= “never” to 6= “in accordance with the
prescription”.
Procedure
The current Study consisted of three basic stages: (I)
baseline (pre-intervention); (II) post-intervention (1 month
after baseline); and (III) follow-up (3 months after baseline).
Baseline: rst of all, the specic objectives of the Study
were explained and consent forms were given out and
then duly signed. Three trained psychologists managed
sociodemographic and clinical measures, assessed FC,
spirituality, and measured height and weight (BMI), all
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Table 1 Data from baseline assessment: ITT analysis: Study 1
Variables
Descriptive ITT Group difference
BRF (n=65) Placebo (n=55) Control (n=53) Statistics Value Sig.
Age (years), mean (95% CI) 40.40 (37.38–43.42) 37.04 (34.12–39.95) 38.89 (35.63–42.14) F (2.170) 1.242 0.291
Expectancy, mean (95% CI) 2.42 (2.17–2.67) 2.67 (2.48–2.87) 2.33 (1.98–2.69) 1.637 0.198
Spirituality, mean (95% CI) 13.72 (7.88–19.56) 17.96 (12.57–23.36) 11.21 (4.34–18.08) 1.205 0.302
BMI, n (ITT) χ2[4] 11.435 0.022
Normal weight 7 (4.0) 4 (2.3) 10 (5.8)
Overweight 38 (22.0) 33 (19.1) 38 (22.0)
Obese 20 (11.6) 18 (10.4) 5 (2.9)
Marital status, n (ITT) 1.565 0.815
Never married 17 (9.8) 15 (8.7) 19 (11.0)
Married 43 (24.9) 36 (20.8) 31 (17.9)
Divorced/widow 5 (2.9) 4 (2.3) 3 (1.7)
Health status, n (ITT) χ2[2] 3.337 0.189
Healthy/risk 43 (24.9) 43 (24.9) 42 (24.3)
Chronic illness 22 (12.7) 12 (6.9) 11 (6.4)
R-eating, n (ITT) 3.927 0.140
Yes 43 (24.9) 40 (23.1) 29 (16.8)
No 22 (12.7) 15 (8.7) 24 (35.3)
Gender, n (ITT) 19.956 0.189
Female 56 (32.4) 44 (25.4) 31 (17.9)
Male 9 (5.2) 11 (6.4) 22 (12.7)
Education, n (ITT) 1.118 0.572
Up to secondary 42 (24.3) 40 (23.1) 38 (22.0)
Higher 23 (13.3) 15 (8.7) 15 (30.6)
ANOVA, ANOVA (2.170); Married, married or in a stable relationship. ITT, intention-to-treat; BMI, body mass index; R-eating, restrained
eating.
at the physician’s office. Afterwards, participants were
randomly allocated to either BFR, Placebo or Control
group by their correspondent psychologist, and were given
out their own proper instructions (see below).
Post-intervention: 1 month later, each participant
returned to the physician’s office and his/her assigned
psychologist measured his/her weight and assessed
trait FC again. Follow-up: 3 months after baseline final
measures of weight and trait FC were taken by the assigned
psychologist. By the end of the 3rd month participants
were also asked the questions described in the following
section regarding their particular perceived difficulty to
control FC and their desire to continue using the suggested
intervention. Upon completion, participants were thanked
for their participation.
BFR formula was prepared by the Homeopathic Pharmacy
of Santa Clara. Included remedies were chosen because of
their purported action on self- control and cravings (Agrimony,
Cherry Plum, Walnut, White Chestnut and Crab Apple) (49).
Neither participants nor field researchers were aware of the
formula composition. Recommended dosage was 4 drops every
4 hours approximately taken between 7 am and 22 pm: BFR =
alcohol 10% + BFR; Placebo = alcohol 10%.
Researchers were commissioned to provide participants
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Table 2 Baseline characteristics of groups and change over time on dependent variables: Study 1
Variables Groups
Descriptive ITT: mean (95% CI) ANOVA Placebo vs. Intention
BL 1-month 3-month F (2.212) Sig.
2
p
η
FCT BFR 192.35 (187.32–197.38) 170.55 (163.11–177.99) 170.15 (161.85–178.45)
Placebo 191.72 (187.38–196.06) 165.25 (154.74–175.76) 159.80 (149.33–170.26) 12.611 0.000 0.106
Intention 184.01 (178.94–198.09) 177.03 (171.41–182.66) 177.28 (170.12–184.44)
PR BFR 26.74 (26.05–27.42) 23.86 (22.91–24.81) 23.49 (22.42–24.55)
Placebo 25.45 (24.35–26.56) 22.87 (20.02–25.72) 21.32 (19.71–22.94) 2.540 0.081 0.023
Intention 25.74 (24.89–26.59) 25.00 (24.16–25.83) 24.33 (23.35–25.34)
ER BFR 14.38 (13.52–15.25) 12.46 (11.56–13.35) 12.58 (11.65–13.51)
Placebo 13.25 (12.30–14.21) 11.85 (10.83–12.87) 11.20 (10.13–12.26) 3.459 0.033 0.032
Intention 14.13 (13.42–14.84) 13.83 (13.17–14.48) 13.75 (12.99–14.51)
CD BFR 22.05 (20.40–23.69) 18.43 (17.56–19.29) 18.60 (17.59–19.60)
Placebo 22.05 (21.30–22.81) 18.40 (17.21–19.58) 17.52 (16.27–18.77) 6.751 0.001 0.060
Intention 21.72 (20.94–22.50) 19.81 (19.02–20.59) 19.50 (18.72–20.29)
FH BFR 21.98 (21.48–22.49) 19.64 (18.76–20.53) 19.38 (18.41–20.35)
Placebo 22.20 (21.69–22.71) 18.49 (17.18–18.80) 18.30 (17.06–19.55) 9.899 0.000 0.085
Intention 21.49 (20.95–22.03) 20.67 (19.93–21.42) 19.84 (19.08–20.61)
PF BFR 29.66 (27.86–31.64) 25.93 (23.85–28.01) 26.10 (23.95–28.25)
Placebo 30.67 (29.05–32.30) 24.69 (22.69–26.68) 24.61 (22.49–26.73) 17.718 0.000 0.143
Intention 28.32 (26.21–30.43) 27.33 (25.24–29.43) 28.30 (26.38–30.22)
IE BFR 16.02 (15.51–16.52) 13.98 (13.12–14.84) 13.84 (13.00–14.68)
Placebo 15.11 (14.48–15.74) 12.74 (11.98–13.59) 12.85 (11.92–13.78) 5.635 0.004 0.050
Intention 15.11 (14.51–15.71) 14.11 (13.47–14.75) 14.24 (13.46–15.02)
LC BFR 31.32 (30.23–32.42) 27.56 (26.10–29.03) 27.56 (26.02–29.11)
Placebo 31.58 (30.59–32.57) 26.21 (24.50–27.93) 25.27 (23.32–27.21) 11.959 0.000 0.101
Intention 30.25 (29.07–31.42) 28.35 (27.24–29.47) 28.67 (27.45–29.90)
NA BFR 16.09 (14.97–17.21) 14.93 (13.71–16.16) 14.69 (13.46–15.91)
Placebo 16.80 (15.70–17.90) 15.67 (14.51–16.83) 15.21 (14.01–16.42) 5.941 0.003 0.053
Intention 15.13 (13.97–16.29) 15.81 (14.52–17.09) 15.52 (14.30–16.74)
GF BFR 14.11 (13.21–15.01) 13.72 (12.99–14.45) 13.87 (13.08–14.67)
Placebo 14.60 (13.68–15.52) 14.30 (11.87–16.74) 13.47 (12.49–14.44) 2.503 0.084 0.023
Intention 12.13 (11.27–12.99) 12.09 (11.27–12.99) 13.07 (12.24–13.90)
BMI BFR 28.79 (27.95–29.66) 28.06 (27.71–29.48) 28.64 (27.77–29.51)
Placebo 29.07 (28.11–30.04) 28.68 (27.68–29.68) 28.85 (27.80–29.92) 2.978 0.053 0.027
Intention 27.04 (26.19–27.89) 27.16 (26.32–27.99) 27.22 (26.37–28.06)
ITT, intention-to-treat; BL, baseline; BFR, Bach Flower Remedies; FCT, food cravings trait; PR, positive reinforcement; ER, emotional relief;
CD, cue-depending eating; FH, feelings of hunger; PF, preoccupation with food; IE, intentions to eat; LC, lack of control; NA, negative-
affect; GF, guilty feelings; BMI, body mass index.
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of BFR group with free bottles of the formula throughout
all 3 months intervention lasted. BFR, Placebo and their
corresponding instructions were delivered by the assigned
psychologist right after each participant’s allocation.
Psychologists were trained by the lead BFR researcher.
Participants from both groups were informed that BFR
formula would help them control their FC. On the other
hand, Control group participants were given a single
instruction which appealed to their intention to control FC:
“You will do your best to control your cravings and your
thoughts about food using your willpower” (5).
Analyses were conducted on both groups per-protocol
(PP) and intention-to-treat (ITT) samples (those who
did not take the formula at least four times a day were
considered non-compliant and were included only in the
ITT analysis). Nonetheless, just for the sake of parsimony,
PP analyses were reported only where results differed from
the ITT analysis. Data analysis was performed using the
SPSS/Windows (version 20). Changes in trait FC and BMI
were assessed using a mixed ANOVA (GLM for repeated
measures); groups were assessed as between-subject factor;
measurements were assessed as within-subject factor.
Effect sizes were calculated using partial Eta squared (
2
p
η
),
where values above 0.01; 0.06 and 0.14 were interpreted
as the effect of small, medium and large, respectively (50).
To test whether the formula had or not specific effects,
we compared BFR and Placebo groups. Thus, to test the
effectiveness of the placebo response associated to BFR
meaning, we compared Placebo and Control group. T-tests
were conducted in order to determine between-group
differences. Effect sizes were calculated using Cohen’s d,
where values above 0.2; 0.5 and 0.8 were interpreted as the
effect of small, respectively (50). Group comparisons for
nominal data were conducted using chi-square.
Results and nal discussion
Participants flow through the experiment, as well as the
reasons for exclusion, are all depicted on Figure 1A.
Baseline assessment
As may be seen on Table 1, groups did not differ in age,
spirituality, education, marital and health status, or
restrained eating. Nevertheless, there were observed
differences for gender and BMI classication. In the latter
case, the observed imbalance might be caused by many
obese participants declining to continue in the study once
they were assigned to Control group.
Although female participants were majority in each
group, there were more men in Control group. However,
it is important to point out that 13 out of 15 participants
from this group who withdrew from the study were women.
Men seem more prone than women to believing in their
“willpower” to control FC.
Along the same line, significant differences between
groups were observed for trait FC [F (2.170) =3.508,
P=0.032,
2
p
η
=0.040], although their effect size was small.
This difference was caused by participants from the Control
group who withdrew from the study, and who showed mean
values on trait FC [208.02 (179.25–188.91)] higher than
those who completed the study (see Table 2) [t (66) =4.697,
P<0.01, d=1.44]. This selective attrition has also been
observed in therapy, where individuals who do not improve
are more likely to leave the process (23).
BFR vs. Placebo
The effect of Time was signicant for the overall trait FC
and the majority of its dimensions with reductions over
time and large effect sizes [FITT (2.236) between 22.147
and 62.194, P<0.001 and
2
p
η
between 0.146 and 0.345],
with the exception of negative affect [FITT (2.236) =12.124,
P<0.001,
2
p
η
=0.093] and guilty feelings [FITT (2.236) =1.030,
P=0.359]. However, the effect size of Time on BMI could
be considered very small [FITT (2.236) =3.707, P=0.026,
2
p
η
=0.030]. Finally, PP analysis showed the largest effect
sizes for trait FC and all its dimensions [FPP (2.90) between
16.998 and 106.573, P<0.001 and
2
p
η
between 0.274 and
0.703] and BMI [FPP (2.236) =7.427, P=0.001,
2
p
η
=0.142].
Regarding time × group, results were in line with
previous findings (11-13) with absence of significant
between-group differences for most variables [FITT (2.236)
between 0.196 and 2.976, not significant (NS)] with the
exception of preoccupation with food [FITT (2.236) =3.425,
P=0.034,
2
p
η
=0.028] and lack of control over eating [FITT
(2.236) =3.177, P=0.044,
2
p
η
=0.026] where, surprisingly,
Placebo showed better results than BFR (see Table 2). These
differences disappeared with PP analysis, but displaying a
new one favorable to Placebo group for feelings of hunger
[FPP (3.297) =3.177, P=0.041,
2
p
η
=0.068] (Figure 1B). These
results may be explained by the transactional model of
placebo responding (see General discussion) (51) as well
as the likelihood that BFR might be captive of its own
meaning (30,52).
ITT and PP revealed no significant between-group
differences for desire to continue, number of bottles and
compliance. ITT analysis showed that 55% of participants
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Figure 1 CONSORT diagrams and main results. (A) CONSORT diagram showing the ow of participants through the Study 1. BFR, BFR
group; Placebo, Placebo group; Control, Control group; (B) PP baseline characteristics of BFR and Placebo groups and change over time for
feelings of hunger in Study 1; (C) CONSORT diagram showing the ow of participants through the Study 2. BFR, sips of BFR diluted in
a glass of water; water, sips of water; (D) PP baseline characteristics of groups and change over time for lack of control over eating in Study
2. CONSORT, Consolidated Standards of Reporting Trials; BFR, Bach Flower Remedies; PP, per-protocol; ITT, intention-to-treat; PLA,
Placebo; FCQ-T, Food Cravings Questionnaire-Trait.
Study 2: assessed for eligibility n=87
Excluded n=13 because did not met inclusion criteria:
(I) Normal weight: n=2
(II) Low food cravings: n=11
Assignment n=74
Withdrew n=0 Withdrew n=0
Withdrew n=0 Withdrew n=0
Analyzed
ITT n=37
PP n=31
Analyzed
ITT n=37
PP n=29
Analysis
ITT n=74
PP n= 60
3rd month
follow-up
n=74
1st month
follow-up
n=74
Assigned to BFR group n=37 Assigned to Water group n=37
Study 1: Assessed for eligibility n = 351
Excluded n = 155: score of FCQ-T < 159
Assignment n = 196
Assigned to Placebo
group n = 60
Assigned to BFR
group n = 68
Assigned to Intention
group n = 68
Withdrew n = 2 Withdrew n = 3 Withdrew n = 1
1st Month
Follow-up
n = 190
3rd Month
Follow-up
n = 173
Withdrew n = 14Withdrew n = 2Withdrew n = 1
Analysis
ITT n=173
PP n= 47
Analyzed
ITT n = 53
PP n = 0
Analyzed
ITT n = 55
PP n = 23
Analyzed
ITT n = 65
PP n = 24
Study 1: assessed for eligibility n=351
Excluded n=155: score of FCQ-T <159
Assignment n=196
Withdrew n=2 Withdrew n=3 Withdrew n=1
Withdrew n=1 Withdrew n=2 Withdrew n=14
Analyzed
ITT n=65
PP n=24
Analyzed
ITT n=55
PP n=23
Analyzed
ITT n=53
PP n=0
1st month
follow-up
n=190
3rd month
follow-up
n=173
Analysis
ITT n=173
PP n=47
Assigned to Placebo
group n=60
Assigned to BFR
group n=68
Assigned to Intention
group n=68
Baseline
Lack of control over eating
30
28
26
24
22
1st month 3rd month
IIR-BFR
IlR-Water
Baseline
Feelings of hunger
25
23
21
19
17
15
1st month 3rd month
BFR
PLA
B
D
A
C
(n=65) wished to continue with the intervention, consumed
approximately one bottle (30 mL) per month and took the
formula at least twice a day. On the other hand, PP analysis
revealed that 76% of participants (n=36) wished to continue
with the intervention and took the formula at least five
times a day.
Intention to control FC: various responses to a single
instruction
Results within Control group revealed signicant reductions
for trait FC, positive reinforcement, feelings of hunger,
intention to eat, lack of control over eating with medium
effect sizes [F (2.104) between 3.588 and 7.488, P<0.035 and
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2
p
η
between 0.065 and 0.126]. A larger and positive effect size
was observed for cue-dependent eating [F (2.104) =19.099,
P<0.001 and
2
p
η
=0.269]. Table 2 shows slight increases from
the 1st to the 3rd month of the follow-up; this could be an
indicator of will weakness to attain a certain goal by using
a mere intention instruction (38). As time passes by, an
increasing number of intervening events can reduce the
predictive validity of intentions on behavior (53).
On the other hand, it was observed a paradoxical increase
of guilty feelings with a medium effect size [F (2.104)
=4.245, P<0.020 and
2
p
η
=0.075], but not an increase of
preoccupation with food and negative affect [F (2.104) <1.3,
NS]. A parallel study showed paradoxical effects on these
FC dimensions with large effect sizes among overweight
and obese individuals after receiving the same instruction
and follow-up (5). These differences might be explained
by the inclusion of normal weight individuals in spite their
experiencing frequent and intense FC. Thus, responses to an
intention instruction to control FC seemed to be positive for
most dependent variables. Finally, slight and not signicant
increases in BMI through both follow-ups highlighted the
futility of the intention (in absence of additional resources) to
achieve weight control on most participants.
Placebo vs. Intention
Because researchers were interested on testing placebo
response, analysis was focused on time × group. ITT
analysis revealed signicant differences on most dependent
variables, with the exception of positive reinforcement,
guilty feelings and BMI (Table 2). Effect sizes were large
for preoccupation with food and medium for trait FC, cue-
dependent eating and lack of control over eating. On the
other hand, PP analysis showed significant differences for
all dependent variables [FPP (2.148) between 5.463 and
44.765, P<0.005] with large effect sizes for most variables [
2
p
η
between 0.148 and 0.377] but guilty feelings (
2
p
η
=0.107) and
BMI (
2
p
η
=0.069).
Reductions in Placebo group should be considered quite
impressive as we bear in mind lower scores for trait FC in
Control group, mainly caused by participants who withdrew
the study after baseline assessment. Results on BMI should
be analyzed with caution due to the fact that many obese
participants declined to continue in the intervention after
allocation in Control group.
Conclusions
Although BFR-formula did not show any extra effects over
Placebo formula, responses to intervention observed on
both groups showed reductions of trait FC, and had major
effects on large effect size, especially among compliant
participants. Furthermore, significant between group-
differences favorable to Placebo group were observed for
preoccupation with food and for lack of control over eating
which suggested an increased response associated with the
meaning of the intervention. Third, responses to placebo
showed highest effectiveness on trait FC, preoccupation
with food, cue-dependent eating and lack of control
over eating. Finally, response to the meaning of BFR
intervention seemed to be a suitable approach to control FC
on individuals who showed very intense and frequent FC
experiences on their everyday life.
Study 2: implementing a placebo replacement
Objectives, design and hypothesis
The objective of this study was to evaluate the effectiveness
of an implementation intention instruction using BFR in
order to reduce FC on overweight and obese individuals.
Reductions in BMI were also assessed as a secondary
objective in order to provide an objective and clinically
important outcome measure.
A mixed factorial design was applied (see Study 1),
although with BFR and Water groups as the between-
subject factor. Design did not involve deception, and
participants were informed as to what they were getting.
Participants were randomized to either BFR or control
(Water) group by allocation of a number based on arrival
sequence (even numbers were assigned to BFR group).
Firstly, it was hypothesized that both groups would
experience reductions in trait FC, because both groups
received the implementation intention instruction, as well
as direct instructions to consume water, which could reduce
stress (54) and provide relief from FC. Secondly, it was
hypothesized that those with BFR diluted into water would
have greater reduction in trait FC rather than control over
it, because of the meaning associated with treatment.
Participants
This study was conducted between February and October
2012 right after having obtained both institutional approval
and written consent from all participants; it is project
number 33/11-12. This study has been carried out in
accordance with The Code of Ethics of the World Medical
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Association (Declaration of Helsinki) for experiments
involving humans.
Participants were 74 individuals who responded to our
recruiting advertisements and who fulfilled the inclusion
criteria (see Study 1). Advertisements sought “overweight
or obese people, who are experiencing strong cravings for
food when they are at home and would like to reduce these
cravings”.
For individuals to be selected, they had to report
strong and frequent (more than once a day) FC at home.
Advertisements were posted on several family physicians’
offices billboards pertaining to the authors’ institutions,
emphasizing the fact that the intended intervention was
not just to go on a diet and that it just targeted to replace
an unhealthy snacking habit. Characteristics of BFRs
and Water groups are shown in Table 3. All participants
voluntarily accepted to participate in the study and no
compensation was offered to them.
Measures
Study 1: socio-demographic/anthropometric and clinical
data; Food Cravings Questionnaire-Trait; Spiritual
Connection Questionnaire; restrained eating; expectancy,
and desire to continue at follow-up.
At follow-up (3 months later) an additional question was
included, in order to analyze the perceived difficulty for
FC self-control: was it difcult for you to control your FC
using the assigned resource? Scores ranged from 1 (very
difcult to achieve) to 9 (very easy to achieve). Participants
were asked to keep a daily record about how many times a
day they used the assigned replacement.
Procedure and data analysis (see Study 1)
Implementation intention instructions
Both groups received the same initial instruction: “between
regular meals, if I am at home and I feel an intense desire
to eat; instead of taking a snack I will drink sips of the
replacement over a 20-minute period”. The BFR group was
instructed to sip from a glass of water with the BFR solution
diluted into it (Study 1): the recommended dosage was 4
drops per glass of water. BFR participants were informed
that BFR formula would help them control their FC. Water
group was informed that sips of water would help them
reduce their FC. All participants were instructed to follow
this program at least once a day during a 90 days period of
time; those who reported not having followed this protocol
were considered non-compliant participants.
Results and discussion
The ow of participants through the experiment, including
reasons for exclusion, is depicted on Figure 1C.
Baseline assessment
As can be seen in Table 3, groups did not differ throughout
all assessed variables. No significant differences between
groups were observed for BMI, FC trait and all its
dimensions [tITT (72) between 0.253 and 1.897 and tPP (58)
between 0.009 and 1.185; NS].
Effectiveness of the intervention
Time effect was significant for the overall FC trait with
a reduction in FC score over time [FITT (2.144) =48.826,
P<0.001 and
2
p
η
=0.404] as well as for all its dimensions [FITT
(2.144) between 10.008 and 43.837, P<0.001]. Effects were
large for lack of control over eating (
2
p
η
=0.378), feelings
of hunger (
2
p
η
=0.344), cue-dependent eating (
2
p
η
=0.342),
intention to eat (
2
p
η
=0.300), positive reinforcement (
2
p
η
=0.294), preoccupation with food (
2
p
η
=0.241) and emotional
relief (
2
p
η
=0.147). Medium to large effect sizes were observed
for negative affect (
2
p
η
=0.131) and guilty feelings (
2
p
η
=0.122).
Positive outcomes seemed to rely precisely on
intentionally programming their minds to automatically
trigger favorable responses when whichever critical
cue might be encountered (55). Provided the reported
problems related to self-control in relation to overeating,
these findings indicated that implementation intentions
may be useful translating a goal intention into action (38)
and reducing hedonic hunger (56). As a concurrent task,
focusing one’s mind on drinking sips of water could
diminish the captivating power of everyday temptations (57).
There was a significant reduction of BMI over time
with large effect size [FITT (2.144) =26.311, P<0.001 and
2
p
η
=0.268]. Both replacements appeared to be helpful for
weight reduction, perhaps as a result of a more successful
control of their FC.
Table 4 presents time × group interactions (using ITT),
where the highest score reductions were observed in the
BFR group for the FC trait, emotional relief and feelings of
hunger. Effects could be classified from small to medium,
and emotional relief showed the largest effect size (
2
p
η
=0.057). Most results were replicated when using PP
analysis except for lack of control over eating [F (2.116)
=4.023, P=0.020,
2
p
η
=0.065] where the BFR participants
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Table 3 Data from baseline and additional questions answered the follow-up: Study 2
Variables
Groups Group difference
Water (n=37) BFR (n=37) Statistics Value Sig.
Age (years), mean (95% CI) 36.30 (33.37–40.90) 37.14 (32.53–40.63) t [72] 0.314 0.717
Expectancy, mean (95% CI) 2.92 (2.66–2.90) 2.78 (2.80–3.00) 1.642 0.105
Spirituality, mean (95% CI) 7.86 (1.37–14.40) 16.08 (9.56–22.59) 1.772 0.081
Difficulty, mean (95% CI) 3.88 (3.23–4.54) 5.05 (4.40–5.72) 2.518 0.014*
Daily report, mean (95% CI) 1.55 (1.16–1.94) 1.43 (1.04–1.81) 0.448 0.656
BMI, n (ITT) χ2
corrected by
continuity[1]
3.170 0.075
Overweight 30 (40.5) 22 (29.7)
Obese 7 (9.5) 15 (20.3)
R-eating, n (ITT) 0.088 0.767
Yes 31 (41.9) 29 (39.2)
No 6 (8.1) 8 (10.8)
Health status, n (ITT) 0.319 0.572
Healthy/risk 30 (40.5) 28 (37.8)
Chronic illness 7 (9.5) 9 (12.1)
Gender, n (ITT) 0.463 0.734
Female 31 (41.9) 33 (44.6)
Male 6 (8.1) 4 (5.4)
Education, n (ITT) 0.510 0.475
Secondary 24 (32.4) 21 (28.4)
Higher 13 (17.6) 16 (21.6)
Marital status, n (ITT) χ2[2] 1.890 0.389
Never married 13 (17.6) 8 (10.8)
Married 21 (28.4) 24 (32.4)
Divorced/widow 3 (4.1) 5 (6.7)
Continue, n (ITT) 6.790 0.034
Yes 18 (24.3) 25 (33.8)
No 7 (9.4) 9 (12.7)
Insecure 12 (16.2) 3 (4.1)
*, d=0.59. Difficulty, perceived difficulty in the achievement of food cravings control; Daily report, frequency of use of the replacement;
Continue, desire to continue using the resource. ITT, intention-to-treat; BMI, body mass index; R-Eating, restrained eating.
had significantly lower scores than Water participants
(Figure 1D). BFR have been historically used by health
practitioners to correct emotional imbalances (12,58). Thus,
drinking sips of BFR diluted into water may be a useful way
for individuals to achieve emotional relief beyond eating
their desired food.
Additional questions at follow-up
Table 3 shows additional assessments on dependent
variables at follow-up. On ITT analysis both groups used
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Table 4 Baseline characteristics of groups and change over time on dependent variables
Variables Groups
Descriptive ITT: mean (95% CI) Time × group ANOVA
BL 1-month 3-month F (2.144) Sig.
2
p
η
FCT Water 158.72 (149.34–168.12) 145.48 (134.71–156.25) 138.81 (128.06–149.55) 3.673 0.028 0.049
BFR 166.40 (157.02–175.78) 139.40 (128.63–150.77) 134.70 (123.95–145.44)
PR Water 21.38 (19.62–23.13) 19.56 (18.04–21.09) 18.75 (17.22–20.29) 1.328 0.268 0.018
BFR 20.89 (19.13–22.64) 17.78 (16.25–19.31) 17.16 (15.62–18.69)
ER Water 11.49 (10.49–12.47) 11.24 (10.23–12.25) 10.78 (9.78–10.97) 4.323 0.015 0.057
BFR 12.18 (11.20–13.17) 10.40 (9.39–11.41) 9.97 (8.97–10.95)
CD Water 18.54 (17.33–19.74) 16.75 (15.43–18.07) 16.21 (14.92–17.15) 1.744 0.178 0.024
BFR 18.32 (17.21–19.52) 15.35 (14.03–16.67) 14.89 (13.59–16.18)
FH Water 20.32 (19.34–21.30) 18.32 (17.15–19.49) 18.10 (17.00–19.21) 3.405 0.036 0.045
BFR 20.62 (19.64–21.60) 16.97 (17.15–19.49) 16.45 (17.00–19.21)
PF Water 23.35 (20.97–25.72) 21.54 (19.24–23.84) 19.89 (17.56–22.22) 2.912 0.058 0.039
BFR 25.38 (23.00–27.75) 20.21 (17.91–22.51) 19.27 (17.39–22.06)
IE Water 13.16 (12.11–14.20) 11.48 (10.48–12.48) 10.83 (9.89–11.77) 0.454 0.636 0.006
BFR 13.54 (12.49–14.58) 11.24 (10.24–12.24) 10.72 (9.78–11.67)
LC Water 26.05 (24.25–27.85) 23.32 (21.81–25.26) 22.48 (20.62–24.35) 2.315 0.102 0.031
BFR 28.35 (26.55–30.14) 23.75 (21.81–25.69) 22.81 (20.94–24.67)
NA Water 13.11 (11.54–14.66) 12.37 (10.95–13.80) 11.51 (10.15–12.87) 0.908 0.405 0.012
BFR 14.59 (13.03–16.15) 12.72 (11.03–14.15) 12.29 (10.93–13.65)
GF Water 11.32 (10.17–12.47) 10.86 (9.61–12.11) 10.71 (9.05–11.38) 1.391 0.252 0.019
BFR 12.51 (11.35–13.66) 10.94 (9.69–12.20) 10.64 (9.48–11.81)
BMI Water 28.41 (27.43–29.40) 28.06 (27.01–29.10) 27.93 (26.83–29.04) 1.330 0.268 0.018
BFR 29.74 (28.75–30.73) 29.31 (28.27–30.36) 28.99 (27.89–30.09)
ITT, intention-to-treat; BL, baseline; BFR, Bach Flower Remedies; FCT, food cravings trait; PR, positive reinforcement; ER, emotional relief;
CD, cue-depending eating; FH, feelings of hunger; PF, preoccupation with food; IE, intentions to eat; LC, lack of control; NA, negative-
affect; GF, guilty feelings; BMI, body mass index.
replacement formula approximately once per day, but
Water group reported a more perceived difficulty on FC
self-control than BFR group, with a medium effect size
(see Table 5). PP analysis showed similar results (d=0.58).
Regarding participants desire to maintain in the future the
usage of the assigned replacement, answers tended to be
afrmative for both groups. However, a signicant number
of Water group individuals were hesitant about continuing
with the use of intervention habits thereinafter.
The meaning behind BFR treatment (26) as well as its
associated therapeutic ritual (59), might have contributed to
deliver better outcomes for BFR group. Thus, unconscious
activation of inhibitory control mechanisms (60) might
be the pathway through which individual’s control over
eating improves (when taking BFR). Likewise, the effect of
performing the so explained ritual consisting on diluting
BFR into water should also be considered as an explanatory
factor to observed outcomes for this particular group (59).
The current study has contributed to the understanding
(and application) of implementation intentions on everyday
life. Although the fact that a simple implementation intention
might have such effects could be striking, it is important to
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Table 5 Within-group results from baseline to 1st month and from 1st to 3rd month
Variables Groups
ITT PP
BL-1st month 1st–3rd month BL-1st month 1st–3rd month
T Sig. d T Sig. d T Sig. d T Sig. d
FCT Water 2.762 0.009 0.45 3.065 0.004 0.50 2.112 0.044 0.39 2.853 0.008 0.53
BFR 6.954 0.000 1.26 1.878 0.069 0.30 6.180 0.000 1.24 1.847 0.075 0.33
PR Water 2.528 0.016 0.44 1.888 0.067 0.31 2.159 0.040 0.34 2.169 0.039 0.30
BFR 5.512 0.000 0.90 1.563 0.127 0.25 5.213 0.000 0.94 1.430 0.163 0.26
ER Water 0.582 0.564 0.09 2.750 0.009 0.45 0.156 0.877 0.02 2.816 0.009 0.52
BFR 3.089 0.004 0.51 1.956 0.058 0.32 2.482 0.019 0.45 1.726 0.095 0.28
CD Water 3.782 0.001 0.66 2.306 0.027 0.39 3.756 0.001 0.74 2.457 0.020 0.50
BFR 4.340 0.000 0.75 1.321 0.195 0.22 3.371 0.002 0.65 1.726 0.220 0.22
FH Water 3.270 0.003 0.53 1.052 0.300 0.17 2.891 0.007 0.54 0.947 0.352 0.18
BFR 5.840 0.000 0.94 1.036 0.307 0.17 4.985 0.000 0.96 1.119 0.272 0.20
PF Water 1.510 0.140 0.24 3.053 0.004 0.50 0.951 0.350 0.18 2.451 0.021 0.46
BFR 5.041 0.000 0.83 1.844 0.243 0.23 4.417 0.000 0.75 0.727 0.473 0.13
IE Water 2.646 0.012 0.44 2.708 0.010 0.45 1.945 0.062 0.40 2.703 0.012 0.50
BFR 4.734 0.000 0.78 1.844 0.243 0.31 5.121 0.000 0.93 1.857 0.073 0.34
LC Water 3.030 0.005 0.50 2.201 0.034 0.36 1.981 0.058 0.38 2.782 0.012 0.50
BFR 6.298 0.000 1.09 1.757 0.087 0.28 6.280 0.000 1.20 1.772 0.087 0.32
NA Water 0.959 0.344 0.16 2.325 0.026 0.39 1.607 0.295 0.20 1.951 0.061 0.38
BFR 3.043 0.004 0.50 2.462 0.019 0.41 2.807 0.009 0.51 2.244 0.032 0.41
GF Water 0.793 0.433 0.13 1.560 0.128 0.06 0.628 0.535 0.11 2.383 0.024 0.45
BFR 3.154 0.003 0.53 1.186 0.243 0.19 2.421 0.022 0.45 1.134 0.162 0.26
BMI Water 3.931 0.000 0.70 1.276 0.210 0.23 3.375 0.002 0.70 0.990 0.331 0.19
BFR 4.624 0.000 0.78 3.138 0.003 0.57 4.624 0.000 0.84 3.200 0.003 0.62
ITT, intention-to-treat; PP, per-protocol; BL, baseline; BFR, Bach Flower Remedies; FCT, food cravings trait; PR, positive reinforcement;
ER, emotional relief; CD, cue-depending eating; FH, feelings of hunger; PF, preoccupation with food; IE, intentions to eat; LC, lack of
control; NA, negative-affect; GF, guilty feelings; BMI, body mass index.
highlight here that FC seem to be reduced as well whenever
individuals are distracted with carrying another task such as
working with clay (61), playing Tetris (62) or even taking a
brisk walk (63), instead of trying to suppress it (64,65).
Conclusions
To conclude, we can state that implementation intention
instruction intervention had positive effects on FC as well
as BMI. Adding BFR into water was more effective in
controlling the anticipation of relief as a result of eating,
and in controlling the lack of control over eating. All
enhanced outcomes in BFR group could be explained
by placebo mechanisms, in which meaning and rituals
pertaining treatment may contribute to obtaining better
outcomes.
General discussion
In the current paper, we analyzed the effect of BFR
both on a standalone basis and combined with an
implementation intention instruction on FC control.
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Results from both studies highlight the response to BFR
meaning. Moreover, it shows that interventions were
sufficiently appealing as most participants, with the
exception of Control group, wished to continue with their
assigned resource. These effects could be mainly attributed
to the meaning of the intervention, in view of the results
observed in Placebo group, all consistent with systematic
reviews (11-13).
Unexpected significant differences favorable to
placebo in Study 1 might suggest an increased meaning
effect (29). Taking into account BFR’s underlying
philosophy, very similar to Homeopathy (33), they could
be considered as an expanded mind/body therapy from a
health psychology point of view. As it has been previously
highlighted, some CAM could be captive of the efcacy
paradox (30).
However, transactional model of placebo responding
suggests an interesting framework for managing future
research studies, and for interpreting, current differences
between BFR and Placebo groups. For instance, BFR
effects on reducing FC could also be considered as
a placebo response, and be explained by trait reward
sensitivity factors. Prior researches have shown these last
ones to be significantly related to FC (66) and to placebo
responding (67), due to individuals responding differently
to the various aspects of the treatment (51). Whereas on
an outwardly oriented point of view, dopamine sensitive
individuals may have responded to the treatment because of
its perceived novelty, on an inward oriented one, serotonin
sensitive individuals may have responded to the suggestion
by focusing on their internal states.
Thus, the match between an individual’s biological
trait-like response system and his personal environmental
contingencies (51) may determine magnitude of the placebo
response to any identical placebo. A recent transcultural
study on Cubans and Italians showed differences in their
reward sensitivity factor (68), considering the main features
on the appetitive system (69), for both food rationing
and food-availability. Remember food restrictions were
imposed as a part of general rationing of goods among
Cubans in their everyday life, whereas this had not been a
factor for Italians.
Overall, findings indicate that BFR could be a useful
placebo in the context of controlling food related thoughts,
reducing hunger, providing relief from negative emotional
states, and promoting self-control over eating as a response
to external cues. These ndings have increasing relevance
in a context where cue-dependent eating and lack of control
over eating are better attributes of BMI among all assessed
dimensions of trait FC (8).
CAM are recommended as ethical placebos in primary
health care (69). Given proof of placebos ability to exert
neurobiological effects (70), these approaches are a feasible
way of translating the ‘power of placebo’ for improving
patient care (71,72), in the same way the use of BFR can
help individuals overcome their FC.
One of the major strengths of the study is the fact that
it encourages the application of placebo in clinical practice,
as well as implementation intentions in an everyday life.
Furthermore, participants were recruited from the general
population and results were assessed on the 3rd month of
follow-up. Last, there were conducted ITT and PP analysis.
It is important to highlight the fact that researchers used
active control conditions, and matched expectancy and
spirituality as predictors of placebo responses (37).
However, the study’s contribution should also be
considered in light of its limitations. To begin with,
although the current study included a follow-up assessment,
longer-term follow-up should be needed to be able to discern
lasting effects. Secondly, clinical and psychopathological
diagnoses were retrieved from medical records, and did
not involve further analysis for corroboration. Thirdly, our
investigation was mainly based on self-reported measures,
which may be biased due to social desirability. To end with,
it should be pointed out the unbalance observed in Study
1 during after baseline assessment for trait FC, BMI and
gender in Control group, all of which weakened favorable
changes over time among placebo participants in between-
group comparisons.
To conclude, there was no evidence that supports
specic effects for BFR on FC control beyond its meaning.
However, the intended interventions had positive effects
on trait FC and were more effective in controlling
preoccupation with food, feelings of hunger, cue-dependent
eating and lack of control over eating. Additionally, results
suggest that implementation intentions may be a useful tool
for delivering BFR in everyday life, as it is very easy to use at
home, and there is an indication that effects may last at least
in the medium term. Such interventions could be efciently
delivered through the use of different technologies (73)
as a self-help placebo intervention. Moreover, it could be
used as a complementary resource for FC control either on
interventions not explicitly oriented toward weight loss (45)
or on scalable weight loss treatment in primary care (74)
always provided there is motivational concordance between
the individual and the suggested resource (24).
Longhua Chinese Medicine, 2020Page 14 of 16
© Longhua Chinese Medicine. All rights reserved. Longhua Chin Med 2020;3:1 | http://dx.doi.org/10.21037/lcm.2020.01.01
Acknowledgments
We are truly grateful to Michael E. Hyland and Ben
Whalley for their support during the design of the study.
We are also indebted with Margot Darragh, Adrian
Meule and Isabelle Mack for their helpful comments and
suggestions on earlier versions of this paper. Finally, we
would like to thank María Inesta for language correction.
Funding: None.
Footnote
Conicts of Interest: All authors have completed the ICMJE
uniform (available at http://dx.doi.org/10.21037/lcm-2009-
006). The authors have no conicts of interest to declare.
Ethical Statement: The authors are accountable for all
aspects of the work in ensuring that questions related
to the accuracy or integrity of any part of the work are
appropriately investigated and resolved. The current
research was approved by the Scientific Council of the
Faculty of Psychology at the Universidad Central “Marta
Abreu” de Las Villas (UCLV, Cuba); project number 33/11-
12. Written consent was obtained from all participants. It
was carried out in accordance with The Code of Ethics of
the World Medical Association (Declaration of Helsinki)
for experiments involving humans.
Open Access Statement: This is an Open Access article
distributed in accordance with the Creative Commons
Attribution-NonCommercial-NoDerivs 4.0 International
License (CC BY-NC-ND 4.0), which permits the non-
commercial replication and distribution of the article with
the strict proviso that no changes or edits are made and the
original work is properly cited (including links to both the
formal publication through the relevant DOI and the license).
See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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Cite this article as: Rodríguez-Martín BC, Frías-Hernández LM,
O’Farril-Jiménez JC, Guillén-Verano AM, Pastorrecio-
González L, Chinea-Monzón Y, O’Farril-Rodríguez MC,
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Book
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El trabajo fue realizado con el objetivo de adaptar y validar un grupo de instrumentos de evaluación: Cuestionarios del Ansia por la Comida; Inventarios de Supresión de Pensamientos; Cuestionario Reducido de Control de Pensamientos; Cuestionario Habilidad para el Control de Pensamientos (versión abreviada); Cuestionario de Reacciones Emocionales y Conductuales a los Pensamientos Intrusos; Cuestionario del Ciclo del Peso; Encuesta Reducida de Valores de Schwartz; Inventario de Sugestionabilidad Reducido (IS8); Cuestionario de Conexión Espiritual; Test Abreviado de Orientación Vital (LOT6); Escala Reducida de Bienestar Subjetivo; Escala de Resiliencia de Connor-Davidson (CD-RISC)
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Background: A randomized, pilot, placebo-controlled clinical trial was conducted with the aim of evaluating the effectiveness of a cream based on Bach flower remedies (BFR) on symptoms and signs of carpal tunnel syndrome. Methods: Forty-three patients with mild to moderate carpal tunnel syndrome during their "waiting" time for surgical option were randomized into 3 parallel groups: Placebo (n = 14), blinded BFR (n = 16), and nonblinded BFR (n = 13). These groups were treated during 21 days with topical placebo or a cream based on BFR. Results: Significant improvements were observed on self-reported symptom severity and pain intensity favorable to BFR groups with large effect sizes (η(2) partial > 0.40). In addition, all signs observed during the clinical exam showed significant improvements among the groups as well as symptoms of pain, night pain, and tingling, also with large effect sizes (φ > 0.5). Finally, there were significant differences between the blinded and nonblinded BFR groups for signs and pain registered in clinical exam but not in self-reports. Conclusion: The proposed BFR cream could be an effective intervention in the management of mild and moderate carpal tunnel syndrome, reducing the severity symptoms and providing pain relief.
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The current study aimed to determine if positive opinions about BFR interacts with spirituality in adults from three Latin-American countries using a CHAID algorithm. Participants were 703 adults from Cuba (n = 319), Costa Rica (n = 252) and Chile (n = 132). Predictors: demographic data, received information, received treatment, spirituality, dispositional optimism and willingness to use a placebo intervention were measured and analyzed. A supervised classification which included a training phase (n = 423) and a test phase (n = 280) was employed. Received information about BFR, spirituality and education were selected as significant predictors of the positive opinion about BFR (>90% of correct classifications).
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