An Evidenced-Based Nursing presented to the

Institute of Health Sciences and Nursing

Far Eastern University-Manila

In Partial Fulfillment of the Requirements for the course:

NCM 117- CARE OF CLIENTS WITH MALADAPTIVE
PATTERNS OF BEHAVIOR

Deypalan, Judiel
Domingo Lucky Leu

Mrs. Maria Cecilia Penalosa

Clinical Instructor / Preceptor
April 2023
 A. Clinical question: Knee joint pain: Do the extracts of Scutellaria
baicalensis and Acacia catechu (UP446) , a natural dietary supplement,
are more effective as an alternative treatment for pain and increasing the
overall mobility of joints than naproxen (NSAID)?.

B. Citation:
(1) Arjmandi, B. H., Ormsbee, L. T., Elam, M. L., Campbell, S. C.,
Rahnama, N., Payton, M. E., Brummel-Smith, K., & Daggy, B. P. (2014). A
Combination of Scutellaria Baicalensis and Acacia Catechu Extracts for
Short-Term Symptomatic Relief of Joint Discomfort Associated with
Osteoarthritis of the Knee. Journal of Medicinal Food, 17(6), 707–713.
https://doi.org/10.1089/jmf.2013.0010

(2) Burnett BP, Jia Q, Zhao Y, et al..: A medicinal extract of Scultellaria

baicalensis and Acacia catechu acts as a dual inhibitor of cyclooxygenase
and 5-lipoxygenase to reduce inflammation. J Med Food
2007;10:442–451. Link, Google Scholar

(3) Lee YC, Hyun E, Yimam M, Brownell L, Jia Q: Acute and 26-week
repeated oral dose toxicity study of UP446, a combination of Scutellaria
extract and Acacia extract in rats. Food Nutr Sci 2013;4:14–27. Crossref,
Google Scholar

(4) Sampalis JS, Brownell LA: A randomized, double blind, placebo and
active comparator controlled pilot study of UP446, a novel dual pathway
inhibitor anti-inflammatory agent of botanical origin. Nutr J 2012;11:21.
Crossref, Medline, Google Scholar

C. Study Characteristics:

Patient Intervention Comparison Outcome

There were a total The participants The study is Respondents who

of 252 were randomly compared to the took UP446 for
participants who assigned using a NSAID naproxen, one week
responded to the pregenerated which was given maintained the
phone screening randomization list daily for one week same level of
for eligibility; 100 to receive either to alleviate joint activity,
were excluded, 15 UP446 pain and determined by
could not be (500mg/day) or discomfort. self-reported
reached, and 85 naproxen participation in
had at least one (400mg/day) for 1 moderate
exclusion met. week in a activities.
The 137 double-blind
respondents left manner where the
to undergo drugs were
laboratory indistinguishable.
screening and 53
of them dropped.
Overall, 84
participants have
been randomly
assigned to
administer either
UP466 or
naproxen.

The study of Arjmandi et al. (2014) demonstrated that extracts of

Scutellaria Baicalensis and Acacia Catechu, also known as UP446 and a natural
dietary supplement, are more effective than naproxen (NSAID) for relieving knee
joint pain. In addition, participants were given tests such as the 6-minute walk
and range of motion at the beginning and end of the study. According to the
results, after one week of intervention, individuals taking UP446 maintained the
same level of activity and increased their range of motion, allowing them to
perform ADLs without experiencing discomfort. However, those who took
naproxen were hardly able to engage in their usual activities and were unable to
alleviate knee joint discomfort.

a. Does the study focus on the significant problem in clinical practice?

Yes, because naproxen and other nonsteroidal anti-inflammatory drugs

(NSAIDs) are typically used for immediate pain relief. However, moderate
use of this class of drugs may impact other organs and cause additional
pain. While there is a second medication that is a natural dietary
supplement which is the UP446 that can alleviate pain and help a person
to perform ADLs.

D. Methodology / Design
a. Methodology

Arjmandi et al. (2014) identified an alternative to naproxen (NSAIDs) for

immediate pain alleviation in the form of UP446, a natural dietary
supplement. The study intends to determine which is more effective and
can positively increase individuals range of motion after relieving their
knee joint pain. The researchers were able to gather a total of 84
participants who met the inclusion criteria, and they were randomly
divided into two groups: (45) respondents received UP446 and (39)
received naproxen. However, in naproxen participants, four (4) of them
dropped out due to scheduling conflicts, and one participant experienced
headaches and dizziness, leaving a total of (34) naproxen recipients. The
researchers have provided two (2) tests, such as the 6-minute walking
test (6MWT) and the range of motion test, from baseline to final day, to
help determine more effective knee joint pain medication and improve
their range of motion. The researchers evaluated the pain, stiffness, and
difficulty of performing ADLs using the WOMAC scale, a measurement of
pain and function specific to the lower extremities on a scale from 0 (mild)
to 4 (severe). Throughout the one-week trial, the Western Ontario and
McMaster Universities Arthritis Index (WOMAC) scale was completed
once every two days. SAS v9.2 was used to conduct all statistical
analyses, and analyses of variance (ANOVA) were used to assess the
effects of treatment and time.

b. Design

An experimental design for individuals with knee joint pain or related to

osteoarthritis were randomly assigned to receive either UP446 or
naproxen (NSAIDs) based on a pregenerated randomization. They will
take the medication every day for a week. On the baseline and final test
day, each respondent underwent basic anthropometric (height, weight,
body mass index), vital sign, blood draw, physical activity, range of motion
(ROM), and 6 minute walk test (6MWT) assessments to determine if
there is an relief of pain and improve range of motion after one week of
medication.

c. Setting
 Using flyers, radio, and online listings, the researchers target individuals
with knee joint pain and osteoarthritis (OA) in Tallahassee, Florida and
nearby areas.

d. Data Sources

There were a total of 252 respondents who responded to the phone

screening for eligibility, with 100 excluded, 15 unreachable, and 85 having
at least one exclusion met. The 137 respondents are currently
undergoing laboratory testing, and 53 dropped out. The remaining 84
participants who met the inclusion criteria were randomized to receive
either UP446 or naproxen (NSAIDs) to determine which drug medication
is more effective for knee joint discomfort and range of motion
improvement, thus improving their ability to perform ADLs.

e. Has the original study been replicated?

No other studies replicated of the study conducted by Arjmandi, B. H.,

Ormsbee, L. T., Elam, M. L., Campbell, S. C., Rahnama, N., Payton, M.
E., Brummel-Smith, K., & Daggy, B. P. (2014). They were the first authors
to prove that Scutellaria Baicalensis and Acacia Catechu (UP446) is
better to naproxen based on the results after a week of intervention in
which the individual taking UP446 experienced pain relief and was able to
increase their range of motion without feeling any discomfort, whereas
the individual taking naproxen (NSAIDs) had difficulty performing
range-of-motion exercises and still complained of knee pain.

f. What were the risk and benefit of nursing actions / interventions tested in the
study

The risk associated with the nursing intervention made by the

researchers is that the medication given, particularly UP446, a natural
dietary supplement for which the acute effects have not yet been studied,
and individuals may give them further discomfort, as well as naproxen, for
which individuals taking NSAIDs moderately can experience immediate
adverse effects. The benefit of the study is that the researchers proved
that administering UP446 gave respondents with pain alleviation and was
able to perform ADLs without any discomfort.

E. Results of the Study

 According to the results of Arjmandi et al. (2014), all respondents
take baseline values, including their demographic profile and assessment
of vital signs, before randomly receiving either UP446 or naproxen. The
respondents were female and male adults between the ages of 60 and 63
who had knee joint discomfort or osteoarthritis (OA). Using the WOMAC
pain scale, the researchers were able to determine that UP446
substantially reduced pain (P=0.009) after one week of medication,
whereas naproxen had no effect. Based on baseline and final data, both
medication-treated groups were able to reduce stiffness (UP446,
P=0.0021; naproxen, P=0.0081). Based on the range of motion test and
6MWT, the UP446 group improved their range of motion and duration of
walking after a week of intervention by 6% (P=0.36), whereas the
naproxen group decreased by 0.1%. In addition, after a week of
intervention, the UP446 group, especially the male respondents, were
able to perform their ADLs without any pain and discomfort.

F. Author’s Conclusion / Recommendation

a. What contribution to the client’s health status does the nursing

action/intervention make?

According to the author, “Similar to that of naproxen, UP446 is capable of

reducing perceived joint pain and stiffness while also improving joint
flexibility.” Which can greatly improve the client's health status because
not only does it reduce pain, it also offers improvement in joint flexibility
that can be of benefit to the client as this can help to the patient’s daily
activities.

b. What overall contribution to nursing knowledge does the study make?

This study can be a great contribution in nursing knowledge and nursing

research as the author states that “Whether or not the supplement offers
improvements in mobility will require further investigation and future
studies should include multiple doses of UP446 with the addition of a
placebo group, and duration of study of up to 3 months with periodic
measures.” This gives way for a new study to be born and can further
support the effect of UP446 when it comes to treating knee pain or knee
osteoarthritis.
 G. Applicability

a. Does the study provide a direct enough answer to your critical question in
terms of type of patients, interventions, and outcome?

Yes, the study's findings indicated that UP446 was more effective than
NSAIDs at lowering pain and improving joint flexibility, which answers our
clinical question.

b. Is it feasible to carry out the nursing action in the real world?

Yes, it is possible to carry out this type of medication in the real world in
some certain types of patients. Such as patients with known allergy
towards NSAID or patients that have some problems with medication
adherence towards modern medicine.

H. Reviewer’s Conclusion / Commentary

To summarize, the UP446 group experienced a significant decrease in

perceived pain, time dependently and stiffness was significantly reduced
by both treatments and a significant increase in mean ROM over time
were found in the UP446 group. Which led the researchers to conclude
that based on what the findings suggested, UP446 is more effective in
reducing the physical symptoms associated with knee OA.

I. Evaluating Nursing Care Practices

a. Safety

The competence of nurses to guarantee patient safety depends on their

vigilant nature, autonomy and observation skills. When it comes to the
safety of UP446 medication, UP446 has been extensively tested in
animals(3) and was used in a randomized clinical trial.

b. Competence of the care provider

We nurses guarantee that the UP446 medication will be beneficial and

safe to the patient before administering by checking if the patient has any
allergic reactions to the said medicine and will record any changes to the
 patient and discontinue immediately if the patient shows negative
symptoms

c. Acceptability

To assist people with knee pain or possible osteoarthritis regain their

mobility and do their activities of daily living efficiently. We nursing
researchers guarantee that the UP446 is safe to use and it was also
mentioned in several studies(2) inside the main journal that UP446 has
been shown to be effective and safe.

d. Effectiveness

Whereas the study demonstrates the efficacy of various pharmaceutical

therapies, this study and other studies mentioned suggested that UP446
is definitely effective when it comes to treating pain and improving joint
flexibility and no known side effects were noted through the use of the
medication.

e. Appropriateness

This study confirms that UP446 is medical food formulation composed of

a concentrated (>90% purity) combination of the two botanical extracts
Scutellaria baicalensis and Acacia catechu, known as flavocoxid, has
been shown to be safe and effective in alleviating joint discomfort,
reducing stiffness, and improving mobility. The content of flavonoids in
the dietary supplement UP446 is approximately 85:15 Free-B-ring
flavonoids to flavans. The Free-B-ring flavonoids are of Scutellaria origin
and the flavans of Acacia origin. Flavocoxid is not available to the public
without a prescription. Thus, UP446 has been developed for use as a
dietary supplement.

f. Efficiency

The efficacy of such proprietary blends is largely attributed to the

inhibition of COX-2 and lipoxygenase (LOX) activities,15,18 both of which
regulate the generation of proinflammatory molecules. The previous
studies lasted for 4–12 weeks and did not examine whether the extracts
had any effect in periods of less than 1 month. In the present study, we
investigated the short-term effects of a proprietary dietary supplement
known as UP446 for the alleviation of pain associated with OA and for the
improvement of knee joint mobility. In terms of safety, UP446 has been
extensively tested in animals19 and used in a randomized clinical trial. In
this study cited at the main journal showed that(4) UP446 has beneficial
effects for knee OA-associated symptoms, analogous to that of naproxen.