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Exploring the Effectiveness of External Use of Bach Flower Remedies on Carpal Tunnel Syndrome: A Pilot Study

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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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Original Article
Exploring the Effectiveness of External Use of
Bach Flower Remedies on Carpal Tunnel
Syndrome: A Pilot Study
Saira R. Rivas-Sua
´rez, MD
1,2
, Jaime A
´guila-Va
´zquez, MD
2
,
Ba
´rbara Sua
´rez-Rodrı
´guez, MD
2
,La
´zaro Va
´zquez-Leo
´n, MD
2
,
Margarita Casanova-Giral, MD
2
, Roberto Morales-Morales, MD
2
,
and Boris C. Rodrı
´guez-Martı
´n, PhD
3
Abstract
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 ¼14), blinded BFR (n ¼16), and nonblinded BFR (n ¼13). 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 (Z
2partial
> 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 (j> 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.
Keywords
carpal tunnel syndrome, Bach flower remedies, complementary and alternative medicine
Received June 1, 2015. Received revised September 12, 2015. Accepted for publication September 14, 2015.
Bach flower remedies (BFR) is a complementary therapy that
deserves further scientific investigation. Edward Bach was a
physician who used highly diluted preparations mainly from
many derivatives species of wildflowers in order to help indi-
viduals recover their health. This topic had been very contro-
versial, but it could be supported by the new knowledge
about nanoparticles and its effects on living systems
1-4
rather
than some ‘‘unknown healing energy.’
Although BFR has showed potentialities for pain manage-
ment,
5
there is no evidence of its specific action beyond the pla-
cebo effect.
6-8
However, recent data suggest that some BFR
could have specific effects on inflammation,
9
cardiovascular
risk factors,
10
spiritual well-being,
11
and unwanted intrusive
thoughts.
12
In clinical practice, classical selection of the remedy is
mostly guided by individuals’ mood or their personality
traits,
13
but beyond this individualized treatment, there are
anecdotic experiences of pain relief among patients with carpal
tunnel syndrome (CTS) using a cream based on a BFR combi-
nation.
14
Placebo analgesia pathways are well documented,
15-17
and it could result in support for the use of BFR as an ethical
self-help placebo.
18-20
However, uncertainty about treatment allocation in rando-
mized clinical trials could affect both treatment and placebo
response.
21,22
On the other hand, in clinical practice patients
tend to believe that they receive an ‘‘active’’ treatment, even
when they are using a placebo intervention.
21,23
As can be sug-
gested, belief is an amazing healing device,
24
which acts on
behavior as a self-fulfilling prophecy.
25
As it has been stated,
the contexts involved in randomized clinical trials and clinical
practice are quite different.
26
Because of this, our study
included a third group in which patients received the interven-
tion as is usual in clinical practice.
1
Medical University ‘‘Serafı
´n Ruı
´zdeZa
´rate Ruı
´z’’ of Villa Clara, Santa Clara,
Cuba
2
University Hospital ‘‘Arnaldo Milia
´n Castro,’’ Santa Clara, Cuba
3
Central University ‘‘Marta Abreu’’ of Las Villas, Santa Clara, Cuba
Corresponding Author:
Saira R. Rivas-Sua
´rez, MD, Medical University ‘‘Serafı
´n Ruı
´zdeZa
´rate Ruı
´z’’ of
Villa Clara, Road of Aqueduct and Beltway, Santa Clara 50100, Cuba.
Email: sairars@ucm.vcl.sld.cu
Journal of Evidence-Based
Complementary & Alternative Medicine
2017, Vol. 22(1) 18-24
ªThe Author(s) 2015
Reprints and permission:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/2156587215610705
journals.sagepub.com/home/cam
CTS is a frequent entrapment neuropathy.
27-30
Primary fea-
tures of CTS include pain in the hand, unpleasant tingling, pain
or numbness in the distal distribution of the median nerve
(thumb, index, middle finger, and the radial side of the ring fin-
ger), and a reduction of grip strength and function of the
affected hand.
27
Surgical and nonsurgical treatments have been
suggested for CTS.
31,32
Surgery is usually considered for
patients with an experience of conservative treatment failure
and those who have severe CTS, while nonsurgical treatments
are usually prescribed as an initial option for the patients who
suffer from nonconstant symptoms of mild to moderate CTS.
32
Multiple alternative nonsurgical techniques have been
trialed.
30
Complementary and alternative medicine can play
an important role as new conservative treatments for CTS.
33-35
Researchers suggest new formats to manage CTS, in order to
improve cost-effectiveness using topic treatment applica-
tions.
35,36
The topical use of BFR might be a useful resource
to many individuals with CTS with the purpose of achieving
pain relief. Compared with other alternatives, it is cheap, easy
to apply, and entails only a minimal contact with the patients.
The aim of the current pilot study was to evaluate the effective-
ness of a cream based on BFR on symptoms and signs of CTS.
With the additional aim of assessing the magnitude of the effect
caused by the certainness of receiving an intervention, we intro-
duced a nonblinded BFR group as is usual in clinical practice.
Methods
Participants
The design consisted of pilot therapeutic interventions in 43 outpati-
ents who were aged between 20 and 89 (mean ¼50.90; standard
deviation ¼13.97), with 93%being females (n ¼40). Each individual
had been previously diagnosed with CTS (from mild to moderated
degree), according to clinical and electrographic criteria. The patients
were referred to the Orthopaedic and Rheumatology Services at Uni-
versity Hospital ‘‘Arnaldo Milia´n Castro’’ with signs and symptoms of
CTS for more than 3 months duration. In those with bilateral symp-
toms, the arm with the most severe symptoms was chosen, and treat-
ment of this arm was randomized.
Every patient had already been treated for symptoms of the CTS
without improvements and they were referred to surgical option after
been treated conservatively. Physicians invited patients to participate
in this study during their ‘‘waiting’’ time for surgical option. The inter-
vention involved outpatients who were randomly allocated into
3 groups: 2 blinded groups as is usual in double-blind controlled trials,
which were Placebo (n ¼14) and BFR (n ¼16); and 1 nonblinded
group, which also received BFR (n ¼13) as is usual in clinical
practice.
Patients with neurological symptoms and signs suggestive of
widespread peripheral neuropathy (such as sensory symptoms in the
lower limbs and depressed or absent tendon reflexes) were excluded
from the study. The patients were not receiving treatment with non-
steroidal anti-inflammatory drugs (NSAID), neither were they sub-
dued to local treatments at least a week before.
The flow of participants through the experiment, including reasons
for exclusion, is depicted in Figure 1.
Measures
Physician’s Report of Signs and Symptoms. Clinical exam was
employed in order to detect signs of Tinel, Durcan, and Phalen as well
as a set of core symptoms (see Table 1). The physician reported the
presence or absence of each sign and symptom using a binary code
of classification (0 ¼No or Absence; 1 ¼Yes or Presence).
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) diagram showing the flow of participants through the study. BFRb, blinded
BFR; BFRnb, nonblinded BFR.
Rivas-Sua
´rez et al 19
Patient’s Self-Report of Symptom Severity and Daily Pain Intensity.
Symptom Severity Scale (SSS) was assessed using the 11 items corre-
sponding to the 11-item subscale of symptom severity from the Boston
Carpal Tunnel Syndrome Questionnaire,
37
which is a disease-specific
questionnaire referring to a typical 24-hour period in the past 2 weeks.
Visual Analogue Scale of Pain Intensity (VAS) is a daily self-report
based on the visual analogue scale.
38,39
The scale was presented as a
10-cm line, anchored by verbal descriptors that follow a Likert-type
scale interval, 0 ¼‘‘no pain’’ to 10 ¼‘worst imaginable pain.’’ The
patients were asked to report their pain intensity every day. Weekly
means were calculated during the baseline period (1 week prior to
treatment) and during the treatment since the first to third weeks.
Procedure
The current pilot study was approved by the Scientific Council of the
University Hospital ‘‘Arnaldo Milia´n Castro’’ and its medical ethics
committee (No. 211/2011) prior to starting the study. Patients gave
written informed consent prior to assessment and intervention.
The study consisted of 2 basic stages: (1) Baseline (pre-interven-
tion) and (2) postintervention (21 days after baseline).
1. Baseline: First, the objectives of the study were explained and
consent forms were signed prior to assessment. A specialist in
orthopedics and another specialist in rheumatology performed
the clinical exam and diagnosed symptoms and signs. Three
general practitioners were in charge to collect self-reports for
both SSS and VAS. Then, patients were randomly allocated
either to the placebo or the BFR group by their corresponding
general practitioner and given their instructions (see below).
2. Postintervention: 21 days later, the participant returned to the
physician’s office and the assigned general practitioner col-
lected self-reports while both the orthopedic specialist and
rheumatologist repeated the clinical exam.
BFR used in the current study were provided by Healing
Herbs Ltd and prepared in the Homeopathic Pharmacy (Santa
Clara, Villa Clara, Cuba), based on solid petrolatum. The
personal of this pharmacy created a code to identify creams
in order to blind both participants and researchers; the code was
revealed to researchers once the project was over.
Five BFR (Ulmus procera [pain relief], Ornithogalum umbellatum
[recovering after trauma], Verbena officinalis [reduce inflammation],
Clematis vitalba [reduce numbness and tingling], and Carpinus betu-
lus [strength recovery]) were combined into a single formula (100 mL
of each remedy from the stock bottle per 100 mL of solid petrolatum).
Solid petrolatum was used as the placebo control. Each cream was
numbered and its content was unknown to physicians or patients,
except for the nonblinded BFR group. All the containers were identi-
cal in shape, color, and size.
Those patients allocated to the blinded groups were told that they
would receive either BFR or placebo during their ‘‘waitlist’’ period,
whereas those patients allocated to the nonblinded group were told
that the will receive a BFR cream. Patients were asked to apply the
cream on the affected area every morning and night, over 21 days.
Statistical Analysis
Data analyses were performed using SPSS for Windows (version
20.0). A mixed ANOVA design (GLM for repeated measures) was
used. The within-subject factor was ‘‘Time,’’ referring to the mean
of the dependent variables throughout the baseline (BL) to the end
of the ‘‘waiting’’ period (21 days). The between-subject factor was
‘‘Group,’’ referred to the blinded groups and the nonblinded group.
The analysis of the interaction Time Group was considered the main
outcome analysis for the current study. Effect sizes were expressed
with Z
2partial
whereby values of 0.01, 0.06, and 0.14 were defined as
small, medium, and large, respectively.
40
Regarding the physician’s report of signs and symptoms, we con-
ducted both global and specific analyses. Global analyses were per-
formed creating 2 new variables named sum of symptoms and sum
of signs (see Table 2), respectively, which were analyzed using the
aforementioned mixed ANOVA.
On the other hand, specific between-group analyses of signs and
symptoms were performed using the w
2
test. We additionally created
a new variable named difference by subtracting values at the 21st day
Table 1. Report of Signs and Symptoms During the Baseline Period.
Positive Reports PLA BFRb BFRnb
w
2
(2) Sig. j
Freq. %Presence/Absence
Pain 43 100 14/0 16/0 13/0
Night pain 42 97.7 13/1 16/0 13/0 2.121 .346 0.22
Pain after Exercise 39 90.7 14/0 12/4 13/0 7.444 .024 0.41
Pain Hand & Fingers 28 65.1 10/4 11/5 7/6 1.066 .587 0.15
Tingling sensation 42 97.7 13/1 16/0 13/0 2.121 .346 0.22
Numbness 18 41.9 2/12 11/5 11/2 14.878 .001 0.58
Burning 19 44.2 6/8 9/7 4/9 1.903 .386 0.21
Valleix 23 53.5 10/4 11/5 2/11 10.896 .004 0.53
Temperature sensitivity 19 44.2 7/7 10/6 2/11 6.471 .034 0.39
Swelling sensation 32 74.4 12/2 12/4 8/5 2.074 .355 0.20
Thenar atrophy 10 23.3 14/0 11/5 5/8 6.499 .039 0.38
Weakness 31 72.1 13/1 14/2 4/9 15.922 .000 0.61
Tinel 39 90.7 14/0 14/2 11/2 2.200 .333 0.22
Phalen 41 95.3 13/1 15/1 13/0 0.992 .631 0.14
Durcan 41 95.3 14/0 14/2 13/0 3.540 .170 0.28
Abbreviations: PLA, placebo group; BFR, Bach flower remedies; BFRb, blinded BFR group; BFRnb, nonblinded BFR group.
20 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
of treatment from baseline, with only 3 possible outcome values, 1, 0,
and 1, which indicate worsening,no changes, and recovering,
respectively. Effect sizes were calculated with j, where values of
0.1, 0.3, and 0.5 were defined as small, medium, and large effects,
respectively.
41
All statistical tests are reported 2-tailed, and Pvalues
marked as ns refer to P> .05.
Results
Baseline Period
Groups did not differ in gender (w
2
[2] ¼2.140, P¼.343), age,
SSS, sum of signs, and sum of symptoms (F[2, 40] between
0.474 and 2.008, P> .005). As can be seen in Table 1, signs of
Tinel, Phalen, and Durcan as well as a considerable number of
symptoms did not show significant between-group differences.
However, significant differences with large effect sizes (j>
0.5) were reported for pain, reported as dull or aching discom-
fort, in the hand, forearm, or upper arm; numbness; and weak-
ness of hand and fingers. Numbness showed more positive
reports among participants included in the BFR groups than
those in the placebo group. On the other hand, participants
included in the blinded groups reported more pain, reported
as dull or aching discomfort, in the hand, forearm, or upper arm
and weakness than those included in the nonblinded group.
Effectiveness of the Intervention
The effect of Time was significant for the all assessed variables
(F
SSS-PSigns-PSymptoms
[1, 40] between 68.990 and 110.595, P<
.001, Z
2partial
>0.60;F
VAS
[3, 120] ¼65.142, P< .001,
Z
2partial
> 0.62). However, as can be derived from Table 2,
researchers were more interested in the effect of Time Group
where there were significant differences favorable to BFR groups
over placebo with very large effect sizes (Z
2partial
>0.5).
The effect of Group brings support to the above-mentioned
changes favorable to the BFR groups (F[2, 40] between 7.081
and 16.126, P< .001, Z
2partial
> 0.25). Table 3 displays the post
hoc analyses in which BFR groups were grouped into the same
subset of effects. It is important to highlight that the nonblinded
BFR group differed from placebo for all analyses.
Regarding the effectiveness of the intervention on each spe-
cific sign, results were also favorable to BFR groups as can be
seen in Table 2. Furthermore, there were also significant differ-
ences between both BFR groups for Phalen with large effect
Table 2. Baseline Characteristics of the Groups and Change Over Time on Dependent Variables.
PLA,
Mean +SD
BFRb,
Mean +SD
BFRnb,
Mean +SD
Statistics Effect Size,
Z
2partial
Fdf Sig.
SSS-BL 2.98 +0.50 3.07 +0.35 3.25 +0.29 21.771 2,40 .000 0.52
SSS-final 2.84 +0.50 1.69 +0.89 1.43 +0.59
PSigns-BL 2.92 +0.26 2.68 +0.79 2.84 +0.37 21.681 2,40 .000 0.52
PSigns-final 2.85 +0.53 1.37 +1.20 0.38 +0.86
PSymptoms-BL 8.14 +1.46 8.56 +2.12 7.30 +1.25 7.901 2,40 .001 0.28
PSymptoms-final 7.00 +1.88 3.75 +3.54 2.69 +1.97
VAS of pain BL 8.00 +1.83 8.43 +1.49 8.15 +0.89 13.762 6,120 .000 0.40
VAS of pain week 1 7.86 +1.85 7.17 +1.33 6.74 +1.27
VAS of pain week 2 7.77 +1.51 5.88 +1.44 5.36 +1.49
VAS of pain week 3 7.57 +1.75 3.95 +2.74 1.91 +2.48
Recovered/Equal/Worsened w
2
df Sig. j
Pain 0/14/0 7/9/0 12/1/0 23.291 2 .000 0.73
Night pain 1/13/0 10/6/0 12/1/0 20.484 2 .000 0.69
Pain after exercise 2/12/0 6/10/0 0/13/0 6.916 2 .031 0.40
Pain hand and fingers 1/12/1 4/12/0 6/7/0 7.064 4 .133 0.13
Tingling sensation 1/13/1 11/5/0 10/3/0 20.642 4 .000 0.69
Numbness 1/13/0 3/13/0 6/7/0 6.038 2 .049 0.37
Burning 2/11/1 7/8/1 4/9/0 4.010 4 .405 0.35
Valleix 3/10/1 8/7/1 4/9/0 8.348 4 .080 0.44
Temperature sensitivity 3/10/1 8/8/0 1/12/0 8.832 4 .065 0.45
Swelling sensation 3/11/0 7/9/0 7/6/0 3.153 2 .207 0.27
Thenar atrophy 0/14/0 1/15/0 0/13/0 1.178 2 .422 0.20
Weakness 5/9/0 7/9/0 1/12/0 4.717 2 .095 0.33
Tinel 0/14/0 9/7/0 10/3/0 17.677 2 .000 0.64
Phalen 1/12/1 6/10/0 12/1/0 21.452 4 .000 0.76
Durcan 1/13/0 6/10/0 10/3/0 13.775 2 .001 0.56
Abbreviations: PLA, placebo group; SD, standard deviation; BFR, Bach flower remedies; BFRb, blinded BFR group; BFRnb, nonblinded BFR group; SSS, Symptom
Severity Scale; VAS, Visual Analogue Scale; BL, baseline period; PSigns, sum of signs; PSymptoms, sum of symptoms.
Note: Bold values are those values with effect sizes higher than medium.
Rivas-Sua
´rez et al 21
size (w
2
[1] ¼9.151, P¼.002, j¼0.56) and for Durcan with
medium effect size (w
2
[1] ¼4.507, P¼.034, j¼0.39).
Pain, night pain, and tingling were those symptoms in which
a large number of individuals from BFR groups were reported
as recovered with large effect sizes over the placebo group
(Table 2). In addition, BFR groups differed on pain relief with
a large effect size favorable to the nonblinded group (w
2
(1) ¼
7.486, P¼.006, j¼0.51). Finally, although worsening of
symptoms was scarcely reported among both blinded groups
these reports were not observed among nonblinded individuals.
The observed differences between blinded and nonblinded
BFR groups for signs of Phalen and Durcan and for symptom
of pain were an interesting finding because these improvements
were diagnosed by physicians. On the other hand, both blinded
and nonblinded BFR groups tended to be grouped into the same
subset of effect when patients’ self-reports of symptom severity
and weekly mean values of the daily report of pain intensity
were analyzed.
Finally, significantly less number of patients needed surgery
among BFR groups (blinded n¼7 and nonblinded n¼1) when
compared with the placebo group (n ¼13) with a large effect
size (w
2
[2] ¼19.831, P< .001, j¼0.68). Furthermore, there
was significant difference between both BFR groups favorable
to the nonblinded group but with medium effect size (w
2
[1] ¼
4.668, P¼.031, j¼0.40).
Discussion
The current research, performed with the aim of evaluating the
effectiveness of a BFR cream on symptoms and signs of CTS
showed interesting results that, although encouraging, should
be discussed with caution.
The observed therapeutic outcomes that were favorable to
the BFR groups over placebo in reducing signs, symptom
severity, and pain as well as a less number of patients who
needed surgery provide evidence that topical use of BFR might
be an effective complementary treatment for CTS.
Multiples alternative nonsurgical treatments have been
trailed in CTS. Oral steroids for a short period is efficacious
after a month, but the long-term efficacy of oral steroid treat-
ment remains uncertain.
42
Steroid and procaine injections are
effective in CTS regarding short-term (for 2 months) and
long-term outcomes compared with placebo injections,
reducing the symptoms of CTS.
43
However, the use of steroids
is contraindicated for some patients.
With regard to the topical treatment for CTS, few studies
were found. A clinical trial evaluating EMLA cream (lidocaine
2.5%plus prilocaine 2.5%) had some beneficial effects after 4
weeks of treatment.
36
Some studies evaluated herbal prepara-
tions in the management of CTS such as linseed oil.
35
The current results also support the idea that BFR may exert
some biological effects,
9,10
specifically on numbness indepen-
dent of whether a group was blinded or not. The controversial
effects of high dilution could be clarified with the understand-
ing of nanoparticles,
44
its features,
45
and the biological effect
found in the field of homeopathy.
2,46
It is almost well estab-
lished that there are certain differences between those comple-
mentary and alternative medicine modalities, but some
researchers point to the existence of derivate from biological
synthesis of metallic nanoparticles in plant extracts, bacteria,
algae, and fungus,
47
and the rapid sunlight-induced efficient
biogenic synthesis of nanoparticles
48
could be due to the effect
of the ‘‘sun method’’ in the preparation process of BFR.
49
It
might mean that the nonexistent particles in BFR would be just
a misconception.
It was interesting to note that the placebo group did not show
substantial improvements taking into account that the placebo
effect on pain
50
or hand surgery
51
as well other symptoms of
CTS has been reported in previous studies. Possibly the context
of the study itself could explain the lack of placebo effect.
26
In
our study, we offered an alternative treatment while patients
were waiting for the surgical option (the ‘‘real’’ treatment).
Maybe the perception of treatment as ‘‘something to do’ in the
meanwhile and not as the main option impaired the mechanism
of placebo response. However, this idea should be tested in
future studies.
Results among nonblinded patients also deserve to be ana-
lyzed because they reported the greatest outcomes because sig-
nificant differences observed with blinded BFR on signs and
pain could be mainly attributed to the clinical exam rather than
patients’ self-reports. This finding suggests that doctors
involved tended to overestimate the effect of the treatment
when they believe they have prescribe the right treatment.
In fact, a previous study using BFR provides indicators that
users tended to underestimate its effects. Hyland and colleagues
found that after a self-help treatment with BFR only 54%of the
participants perceived improvements but the rates increased to
83%when they reported symptoms improvements.
20
In addition, results of the nonblinded group support the idea
that regular clinical practice (in which uncertainty because
allocation does not exist) exerts a context effect that tends to
improve the healing properties of the assessed interventions.
52
The study’s contribution should be considered in light of its
main limitation, which was the small sample size. However,
sample size apparently seems an obstacle when results favor
BFR over placebo. For example, the study of Pintov and col-
leagues,
53
which reported 12 and 11 children in the BFR and
placebo group, respectively, has been cited in recent systematic
reviews as an evidence of nonspecific effects.
6-8
On the other
Table 3. Results From Post Hoc Analyses: HSD Tukey.
SSS PSings PSymptoms VAS of Pain
S1 S2 S1 S2 S1 S2 S1 S2
BFRnb 2.34 1.61 5.00 5.54
BFRb 2.38 2.03 6.15 6.15 6.36
PLA 2.91 2.89 7.57 7.80
Sig. .964 1.000 .167 1.000 .192 .089 .251 1.000
Abbreviations: PLA, placebo group; BFR, Bach flower remedies; BFRb, blinded
BFR group; BFRnb, nonblinded BFR group; SSS, Symptom Severity Scale; VAS,
Visual Analogue Scale; PSigns, sum of signs; PSymptoms, sum of symptoms.
22 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
hand, positive results against placebo from an interesting sub-
group into the study of Halberstein and colleagues,
49
with 22
and 17 participants in the BFR and placebo groups, respec-
tively, are scarcely mentioned.
As it has been stated, many valuable studies might have
been missed due to the publication bias known in this area.
54
Fortunately, there is new evidence that supports the idea that
BFR may have specific effects.
9-12
This study was also limited due to consideration of short-
term effects. Further research is recommended to determine the
long-term outcomes and comparison of BFR creams with other
conservative managements of CTS.
To conclude, the BFR cream could be an effective interven-
tion in the management of mild and moderate carpal tunnel
syndrome, reducing the severity symptoms and providing pain
relief.
Author Contributions
SRRS was the leader of the project, performed data analysis, and
drafted the manuscript. JAV, BSR, RMM, LVL, and MCG collabo-
rated in recruiting and assessing patients as well as providing critical
revisions to the manuscript. BCRM performed data analysis and
drafted the manuscript. All authors have approved the final version
of the manuscript.
Declaration of Conflicting Interests
The authors declared the following potential conflicts of interest with
respect to the research, authorship, and/or publication of this article:
SRRS and BCRM are coordinators of GCBach (www.gcbach.com),
a research group that promotes the scientific study of BFR. BCRM
is also author of books regarding the topic. The rest of authors do not
declare any conflicts of interest.
Funding
The authors received no financial support for the research, authorship,
and/or publication of this article.
Ethical Approval
Approval of Institutional Ethics Committee (No. 211/2011) and the
Scientific Council of the University Hospital ‘‘Arnaldo Milia´n Cas-
tro’’ was obtained before the initiation of the project, and the proce-
dures followed were in accordance with the ethical international
standards for human health research. Informed consent was obtained
from each individual before the screening study.
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24 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
... [14] A pilot study showed that Bach flower remedies cream was effective in the management of mild-to-moderate CTS, reducing symptom severity and providing pain relief. [15] A study showed that homoeopathic medicines might be comparable to antidepressants and superior to placebo in depression; [16] patients with anxiety and depressive disorder who chose to consult general practitioners prescribing homoeopathy reported less use of psychotropic drugs and were marginally more likely to experience clinical improvement. [17] The database on studies of homoeopathy and placebo in psychiatry is limited; however, studies show some benefit of homoeopathic treatment for patients with self-reported depression. ...
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This case report focuses on 50-year-old woman who was diagnosed with dysthymia and carpal tunnel syndrome (CTS). After reviewing her detailed history, she was prescribed homoeopathic medicine Natrum Carb considering the grief after death of her middle daughter, suppression of emotions since her childhood and her characteristic mental state of desiring to be alone and weeping when alone; her characteristic physical generals and dispositional qualities were also considered. After taking homoeopathic medicine, significant improvement occurred in her subjective symptoms such as paraesthesia as well as in the objective CTS-related signs such as the Tinel sign and Phalen test. Her anger, weeping spells, sleep disturbances and sadness were ameliorated as well. Homoeopathic medicine was found to be effective in relieving CTS and dysthymia in this case. Further research is needed to prove the efficacy of this treatment method in this disease.
... A randomized placebo-controlled trial, which aimed to assess the efficacy of a Bach floral-based cream in signs and symptoms of carpal tunnel syndrome, concluded that could be an effective intervention in the management of this mild and moderate syndrome, reducing symptoms of severity, providing pain relief (12) . ...
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Objectives: to assess the effects of floral therapy in the face of factors that boost pain in the parturition process and its results in the duration of labor. Methods: this is a randomized, controlled and triple-blind clinical trial. We selected 164 pregnant women with gestational age ≥37 weeks, cervical dilation ≥4 cm, randomly divided into floral therapy and placebo group. Results: the Five Flower floral essence proved to be effective, considering the factors that boost pain in labor. Experimental Group did not show an increase in contractions, unlike Control Group, which presented an increase of one contraction for mothers in active phase and amniorrhexis. The Five Flower essence proved to be effective in reducing labor time by 1:30h from the beginning of the intervention at birth. Conclusions: floral therapy proved to be effective in pain management, reflecting positively in its brevity, qualifying its outcome.
... 9 Systematic reviews of clinical studies have not found significant differences between the effects of BFR and those of a placebo. [10][11][12] However, later studies showed that BFR can have beneficial effects on anxiety (formula composed of Impatiens, Cherry Plum, White Chestnut, and Beech), 13 sleep (Bach Rescue Remedy), 14 unwanted intrusive thoughts (White Chestnut), 15 pain (formula composed of Elm, Star of Bethlehem, Vervain, Clematis, and Hornbeam), 16 stress-fear-tension in labor (Bach Rescue Remedy), 17 and vital parameters (Bach Rescue Remedy) 18,19 when compared with a placebo. ...
Article
Objective: The aim of this study was to compare the efficacy of flower therapy for the treatment of anxiety in overweight or obese adults with that of a placebo. The authors examined improvement in sleep patterns, reduction in binge eating, and change in resting heart rate (RHR). Design: This was a randomized, double-blind, placebo-controlled clinical trial with a parallel-group design and two arms. Setting/Location: Clinical Research Unit, Medical School, São Paulo State University, Botucatu, SP, Brazil. Subjects: The study included 40 participants in the placebo group and 41 in the intervention group. Participants were of both genders, from 20 to 59 years of age, overweight or obese, with moderate to high anxiety. Interventions: The participants were divided into two random groups: one group was treated with Bach flower remedies (BFR) (bottles containing 30 mL of 30% hydro-brandy solution with two drops each of Impatiens, White Chestnut, Cherry Plum, Chicory, Crab Apple, and Pine), and the other group was given a placebo (same solution without BFR). The patients were instructed to orally ingest the solution by placing four drops directly in the mouth four times a day for 4 weeks. Outcome measures : The primary outcome was anxiety (State-Trait Anxiety Inventory [STAI]). Secondary outcomes were sleep (Pittsburgh Sleep Quality Index [PSQI]), binge eating (Binge Eating Scale [BES]), and RHR (electrocardiogram). Results: Multivariate analysis showed significant reductions in scores for the following variables in the intervention group when compared with the placebo group: STAI (β = -0.190; p < 0.001), PSQI (β = -0.160; p = 0.027), BES (β = -0.226; p = 0.001), and RHR (β = -0.07; p = 0.003). Conclusions: The anxiety symptoms, binge eating, and RHRs of the individuals treated with flower therapy decreased, and their sleep patterns improved when compared with those treated with the placebo. Registered at the Brazilian Registry of Clinical Trials (no. RBR-47-kfxh).
... Systematic reviews agree that BFR are essentially a placebo (11)(12)(13); even more, a useful one (12,(14)(15)(16). It is important to highlight that although recent studies have shown specific effects (17)(18)(19)(20)(21)(22) we consider the majority of responses to BFR in clinical practice as a broad collection of spurious therapeutic effects (23). ...
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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.
... The clinical use is based on seven disharmonized stages in which the florals reestablish equilibrium. Some clinical evidence has been provided in the case of attention deficit hyperactivity, 144 several psychological problems and pain, 145 and external use in the treatment of carpal tunnel syndrome, 146 with relative good acceptance in Latin American countries. 147 Musicotherapy. ...
... Como alternativa à terapia alopática no tratamento do comportamento ansioso dos indivíduos com sobrepeso ou obesidade e seus efeitos colaterais indesejados, propõe-se a terapia floral como uma estratégia integrativa e complementar em saúde. Apesar da literatura apresentar poucos ensaios clínicos com terapia floral (8)(9)(10) , a experiência dos participantes nesse tipo de estudo não foi encontrada. ...
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Objective: To understand the experience from the perspective of the participant of a clinical research, which had as intervention the flower therapy for anxiety of individuals with overweight and obesity. Method: qualitative study, developed by semi-structured interview with 42 participants from a clinical research and data submitted to content analysis. Results: after analysis, five thematic categories emerged: seeking natural alternatives to aid in control of anxiety and obesity; perceiving the benefits of flower therapy in itself and in family and professional relationships; recognizing flower therapy as source of tranquility and self-knowledge; perceiving changes in sleep quality; acquiring self-control and guidance on food and relational needs. Final considerations: the participants showed the intention of seeking natural alternatives to aid the control of anxiety and obesity, employing complementary therapies to strengthen their health. Consequently, participants reported self-control in feeding and in family and professional relationships.
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The objective of this article was to map the use of Bach flower remedies in adult health care. The studies reported that the following flower essences were used: Impatiens, Cherry Plum, White Chestnut, and Beech. When applied in 4 diluted drops, they helped reducing anxiety, depression, fear, and pain.
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La terapia floral o flores de Bach, se popularizó en la década de los 30’ gracias al médico homeópata Edward Bach. Este artículo tiene por objetivo revelar información científica basada en evidencias sobre la eficacia de la terapia floral mediante una revisión de literatura en diferentes bases bibliográficas.
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Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain ( P=0.79) and bruising ( P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.
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SUMMARY Expectations of pain relief drive placebo analgesia. Understanding how expectations of improvement trigger distinct biological systems to shape therapeutic analgesic outcomes has been the focus of recent pharmacologic and neuroimaging studies in the field of pain. Recent findings indicate that placebo effects can imitate the actions of real painkillers and promote the endogenous release of opioids and nonopioids in humans. Social support and observational learning also contribute to placebo analgesic effects. Distinct psychological traits can modulate expectations of analgesia, which facilitate brain pain control mechanisms involved in pain reduction. Many studies have highlighted the importance and clinical relevance of these responses. Gaining deeper understanding of these pain modulatory mechanisms has important implications for personalizing patient pain management.
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Nanotechnology is now regarded as a distinct field of research in modern science and technology with multifaceted areas including biomedical applications. Among the various approaches currently available for the generation of metallic nanoparticles, biogenic synthesis is of increasing demand for the purpose of green nanotechnology. Among various natural sources, plant materials are the most readily available template-directing matrix offering cost-effectiveness, eco-friendliness, and easy handling. Moreover, the inherent pharmacological potentials of these medicinal plant extracts offer added biomedical implementations of the synthesized metal nanoparticles. A robust practical method for eco-friendly synthesis of silver nanoparticles using aqueous leaf extract of Ocimum sanctum (Tulsi) as both reducing and capping agent, under the influence of direct sunlight has been developed without applying any other chemical additives. The nanoparticles were characterized with the help of UV-visible spectrophotometer and transmission electron microscopy (TEM). The prepared silver nanoparticles exhibited considerable antibacterial activity. The effects were more pronounced on non-endospore-forming Gram-positive bacteria viz., Staphylococcus aureus, Staphylococcus epidermidis, and Listeria monocytogenes than endospore-forming species Bacillus subtilis. The nanoparticles also showed prominent activity on Gram-negative human pathogenic Salmonella typhimurium, Escherichia coli, Pseudomonas aeruginosa, and plant pathogenic Pantoea ananatis. A bactericidal mode of action was observed for both Gram-positive and Gram-negative bacteria by the nanoparticles. We have developed a very simple, efficient, and practical method for the synthesis of silver nanoparticles using aqueous leaf extract of O. sanctum under the influence of direct sunlight. The biosynthesis of silver nanoparticles making use of such a traditionally important medicinal plant without applying any other chemical additives, thus offers a cost-effective and environmentally benign route for their large-scale commercial production. The nanoparticles dispersed in the mother solution showed promising antibacterial efficacy. Graphical Abstract Sunlight-induced rapid and efficient biogenic synthesis of silver nanoparticles using aqueous leaf extract of Ocimum sanctum Linn. with enhanced antibacterial activity.
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Some physicians have incorporated some forms of complementary and alternative medicine (CAM) or related medicinal products in their clinical practices, suggesting that an unconventional treatment approach might be seen as an integration rather than as an alternative to standard medical practice. Among the various CAMs, homeopathy enjoys growing popularity with the lay population, but it is not acknowledged by academia or included in medical guidelines. The major problem is to establish the effectiveness of this clinical approach using the strict criteria of evidence-based medicine. This issue of the Journal of Medicine and the Person collects contributions from some of the most prestigious centers and research groups working in the field of homeopathy and integrative medicine. These contributions are not specialized information but are of general interest, focusing on this discipline as one of the emerging fields of personalized medical treatment.
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INTRODUCTION: Carpal tunnel syndrome is a neuropathy caused by compression of the median nerve within the carpal tunnel. However, the severity of symptoms and signs does not often correlate well with the extent of nerve damage.
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Introduction: No term has probably been as misused and has caused so much confusion as the term 'placebo'. Its effects have strengthened medical treatments throughout history without receiving due recognition. Understood as events attributable to the significance acquired by an intervention in a given therapeutic context, it takes on a new dimension, detaching from the prevailing tautological definitions. Objective: Analyze the challenges posed by this theoretical stand, as well as its potential for research and clinical practice. Method: An analysis is conducted of the limitations of its use in randomized clinical trials, among them the efficacyparadox paradox. A contrast is made of evidence of its effectiveness generated in various contexts. A description is provided of placebos available in clinical practice and situations of use, as well as doctors' and patients' opinions. Its effect is presented from a biopsychosocial perspective, within the framework of Lifestyle Medicine. An outline is provided of the factors preventing alternative medicines from being «better than a placebo». Finally, its place in clinical practice is identified and exemplified. Conclusions: The placebo effect should be understood as an effect from the context, structured on the basis of the individual significance assigned to the intervention by a specific culture and historical development, which is significant for a large number of diseases, through the activation and modification of psychological and physiological variables. Conceived of as an Optimal Healing Environment, it acquires the «active principle» required to act by itself (when the alternative is doing nothing), or strengthen the effect of conventional treatments.
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Multiple studies have demonstrated that traditional homeopathic manufacturing reagents and processes can generate remedy source and silica nanoparticles (NPs). Homeopathically-made NPs would initiate adaptive changes in an organism as a complex adaptive system (CAS) or network. Adaptive changes would emerge from several different endogenous amplification processes that respond to exogenous danger or threat signals that manufactured nanomaterials convey, including (1) stochastic resonance (SR) in sensory neural systems and (2) time-dependent sensitization (TDS)/oscillation. SR is nonlinear coherent amplification of a weak signal by the superposition of a larger magnitude white noise containing within it the same frequencies of the weak signal. TDS is progressive response magnitude amplification and oscillatory reversal in response direction to a given low dose at physiological limits with the passage of time.