CRITICAL APPRAISAL

EFFECTS OF WET-CUPPING ON BLOOD PRESSURE IN HYPERTENSIVE

PATIENTS: A RANDOMIZED CONTROLLED TRIAL

OLEH:

MOHAMMAD LUTFI
1110017007

PRODI MAGISTER KEPERAWATAN

FAKULTAS KEPERAWATAN DAN KEBIDANAN
UNIVERSITAS NAHDLATUL ULAMA SURABAYA
2017
 Worksheet Critical Appraisal
Jurnal Terapi
Judul jurnal : Effects Of Wet-Cupping On Blood Pressure In Hypertensive Patients: A
Randomized Controlled Trial
Are the results of the trial valid?
No Questions
1 Did the study address a clearly
focused issue?
HINT: A question can be
focused In terms of
The population studied
The risk factors studied
The outcomes considered
Is it clear whether the study
tried to detect a beneficial or
harmful effect?
2 Was the cohort recruited in an
acceptable way?
HINT: Look for selection bias
which might compromise the
generalisibility of the findings:
Was the cohort representative
of a defined population?
Was there something special
about the cohort?
Was everybody included who
should have been included?
3 Was the exposure accurately
measured to minimize bias?
HINT: Look for measurement or
classification bias:
Did they use subjective or
Answer Analysed
Yes This study focus determine the
efficacy of wet-cupping for high
blood pressure, and the incidence
of the procedures side effects in
the intervention group.
Yes The participants were included in
the study if they had high (grade I
or II), BP at the time of the study
(SBP 140 mmHg and/or DBP
90 mmHg). For patients with
diabetes mellitus, high BP was
defined as SBP 130 mmHg
and/or DBP 85 mmHg[10].
Patients were required to be 1965
years old, and both men and
women were included. Patients
were excluded if they had grade III
hypertension (SBP 180 mmHg
and/or DBP 110 mmHg), very
high added risk according to the
WHO hypertension management
guidelines, or secondary
hypertension, or were pregnant.
Patients who had undergone dry-
cupping, wet-cupping, or
acupuncture within the previous six
months were also excluded, as
were those who required anti-
hypertension medication dose or
type changes within the follow-up
period.
Yes After checking for eligibility,
written informed consent was
obtained, and the participants were
randomized into the treatment or
control group using block
 objective measurements?
Do the measurements truly
reflect what you want them to
(have they been validated)?
Were all the subjects classified
into exposure groups using the
same procedure
4 Was the outcome accurately
measured to minimise bias?
HINT: Look for measurement or
classification bias:
Did they use subjective or
objective measurements?
Do the measures truly reflect
what you want them to (have
they been validated)?
Has a reliable system been
established for detecting all the
cases (for measuring disease
occurrence)?
Were the measurement
methods similar in the
different groups?
Were the subjects and/or the
outcome assessor blinded to
exposure (does this matter)?
5 a. Have the authors identified
all important confounding
factors?
List the ones you think might be
important, that the author missed.
b. Have they taken account of
the confounding factors in
the design and/or analysis?
List:
HINT: Look for restriction in
design, and techniques e.g.
modelling, stratified-, regression-,
randomization method. To
preserve concealment, the
randomization was performed
using sealed opaque envelopes,
such that neither the patient nor
the observer could predict the
group to which a participant was
assigned. The randomization
process and patient enrolment into
their groups were done by the
prime investigator. Patient
confidentiality was ensured
throughout the study, and
participants were free to exit the
study whenever they desired.
Yes The present RCT was conducted in
the General Practice Department at
King Abdulaziz University
Hospital, Jeddah, Saudi Arabia,
between May 2013 and February
2014. The Declaration of Helsinki
was followed and ethical approval
was given by the Unit of
Biomedical Ethics at King
Abdulaziz University before data
collection.
This two-armed study involved an
intervention group, undergoing
wet-cupping (hijama) in addition to
conventional hypertension
treatment, and a control group
undergoing only conventional
hypertension treatment. The study
could not be blinded because
blinding was impossible for this
procedure, unlike that for dry-
cupping.
No Authors didnt tell about
confounding factors, because all
participant homogenes.
 or sensitivity analysis to correct,
control or adjust for confounding
factors
6 a. Was the follow up of subjects
complete enough?
b. Was the follow up of subjects
long enough?
HINT: Consider
The good or bad effects should
have had long enough to reveal
themselves
The persons that are lost to
follow-up may have different
outcomes than those available
for assessment
In an open or dynamic cohort,
was there anything special
about the outcome of the
people leaving, or the exposure
of the people entering the
cohort?
7 What are the results of this
study?
HINT: Consider
What are the bottom line
results?
Have they reported the rate or
the proportion between the
exposed/ unexposed, the
ratio/the rate difference?
How strong is the association
between exposure and
outcome (RR,)?
Yes During the recruitment period, 318
participants were screened to check
for the primary eligibility criteria;
180 individuals were excluded, and
58 refused to participate in the
study. The remaining 80
participants were recruited into the
study and randomized into the
intervention (40 participants) and
control (40 participants) groups.
Three participants did not attend
the 4-week follow-up session and 7
did not attend the 8-week follow-
up session. Further, 1 participants
from the intervention group and 3
from the control group were
excluded at the last follow-up
appointment because of changes in
their anti-hypertension
medications.
During the entire follow-up period,
any participant who had changed
his or her anti-hypertension
medication was excluded from the
study, as mentioned before. The
participants compliance with their
anti-hypertension medication
schedule was measured, using a
validated tool, at the beginning and
end of the study. In addition,
histories of the use of anti-
hypertensive herbal treatments or
other concomitant medications
were also obtained.
---- The results of the present study
showed a significant difference in
SBP measurements (8.4 mmHg)
between the intervention and
control groups after 4 weeks of
follow-up. After 8 weeks of
follow-up, the hijama effect had
disappeared, leaving no significant
BP difference between the
intervention and control groups.
The positive results reported in this
study are consistent with those of
 What is the absolute risk
reduction (ARR)?
8 How precise are the results?
HINT: Look for the range of
the confidence intervals, if
given
9 Do you believe the results?
HINT: Consider
Zarei et al, who also reported a
significant difference in SBP
values between the intervention
and control groups after 6 weeks of
follow-up. Therefore, hijama
produces an effect that lasts for 46
weeks.
---- At the 4-week follow-up visit, BP
measurements were repeated for
both groups. The mean SBP and
DBP after intervention in the
hijama group were significantly
different (paired t-test) from those
at baseline (P = 0.000 and 0.042,
respectively). In the control group,
there were also significant
differences (paired t-test) in the
SBP and DBP compared to those
at baseline (P = 0.016 and 0.003,
respectively). When comparing the
mean BP readings between the two
groups after 4 weeks of follow-up
(Students t-test), there was a
significant difference in SBP
values (P = 0.046) but not in DBP
values (P = 0.681). The mean
difference in SBP values between
the two groups after 4 weeks of
follow-up was 8.4 mmHg (95%
confidence interval, 16.7 to 0.1).
After 8 weeks of follow-up,
significant differences persisted
within the hijama group, for SBP
and DBP (P = 0.002 and 0.004,
respectively, compared with those
at baseline). Similar results were
also found for both SBP and DBP
in the control group (P = 0.036 and
0.022, respectively, compared with
those at baseline). When
comparing the mean BP readings
(independent Students t-test)
between the two groups, after 8
weeks of follow-up, the differences
in the SBP and DBP values were
not significantly different between
the groups (P = 0.129 and 0.881,
respectively)
Yes Desain dan metode yang digunakan
sesuai dengan penelitian yang
 Big effect is hard to ignore!
Can it be due to bias, chance
or confounding?
Are the design and methods of
this study sufficiently flawed
to make the results unreliable?
Bradford Hills criteria (e.g.
time sequence, dose-response
gradient, biological
plausibility, consistency)
10 Can the results be applied to the
local population?
HINT: Consider whether
A cohort study was the
appropriate method to answer
this question
The subjects covered in this
study could be sufficiently
different from your population
to cause concern
Your local setting is likely to
differ much from that of the
study
You can quantify the local
benefits and harms
11 Do the results of this study fit
with other available evidence?
dilakukan. Peneliti mengukur
kelompok intervensi maupun
bekam saat sebelum dan sesudah
dilakukan intervensi yang
ditunjukkan dalam jurnal. Dan
penulis sudah menjelaskan ada
beberapa peserta yang pindah
menjadi kelompok control, dan ada
juga yang tidak melakukan
intervensi. Serta dari jurnal
penelitiaan lainnya juga
menjelaskan yang sama dengan
hasil BP yang menurun.
Yes Serious side effects were not
observed in the hijama group. Most
of the mild side effects were
experienced immediately after
hijama and lasted for few hours,
but never for more than 48 h. This
excludes hijama-site pruritus,
which appeared 12 d after the
session and lasted for a few days.
So wet cupping is recommended
for patient with hypertension.
Yes This study similar with other study
about wet cupping example
Cupping is an ancient healing
method that has been practiced for
centuries in many parts of the
world. Cupping therapy can be
divided into two broad categories,
dry- and wet-cupping. Dry-
cupping is the process of using a
vacuum on different areas of the
body in order to collect blood in
that area without any incisions[5].
Wet-cupping (or hijama in Arabic)
is the process of using a vacuum at
different points on the body, along
with the use of incisions (small,
light scratches made using a
razor), to remove what was
previously termed as harmful
blood (this represents
accumulated blood that is located
just beneath the skin surface).
Although cupping remains a
popular treatment modality in
many parts of the world, its
efficacy for most diseases,
including hypertension, has not
been scientifically studied. A
recent systematic review involved
searching 15 databases, without
language restrictions, and included
all relevant trials through June
2009. Only 2 studies met the
inclusion criteria, and only one
assessed the effects of wet-
cupping. In that study, 35 patients
with acute hypertension were
included, and all patients
underwent three wet-cupping
sessions every other day on the
GV14 (Dazhui) acupuncture point;
there was no control group. After a
single wet-cupping session, acute
hypertension improved in 71% of
the patients[7]. The authors of the
systematic review concluded that
there was no strong evidence
suggesting that cupping is an
effective treatment for
hypertension, and that further
research is required[6]. A recent
randomized controlled trial (RCT)
assessed the efficacy of wet-
cupping for the treatment of
hypertension. The protocol
randomly divided 42 participants
into intervention and control
groups. After 6 weeks of follow-
up, a comparison of the mean BP
differences between the
intervention and control groups
showed a significant difference in
systolic BP (SBP), but not in
diastolic BP (DBP)[8].
Thus, further evidence is needed to
establish the efficacy of wet-
cupping for lowering high BP. The
present study investigated the
efficacy of wet-cupping in
lowering BP in hypertensive
patients, and assessed the incidence

12 What are the implications of
this study for practice?
HINT: Consider
One observational study rarely
provides sufficiently robust
evidence to recommend changes
to clinical practice or within
health policy decision making
For certain questions
observational studies provide
the only evidence
Recommendations from
observational studies are always
stronger when supported by
other evidence
of side effects among the treated
participants.
--- Wet-cupping therapy effectively
reduced SBP in hypertensive
patients for up to 4 weeks, without
any serious side effects. We
recommend the use of this
complementary treatment, in
conjunction with anti-hypertension
medications, to treat hypertension.
Additional studies are also needed
to investigate the efficacy of wet-
cupping alone, without any
concomitant anti-hypertension
medications. Moreover, additional
research on the effect of the
number of incisions and the
amount of blood collected during
the hijama procedure is needed.
We also recommend the
development of a sham wet-
cupping technique to aid future
studies.