Issue:
118
Page: 38-40
Turmeric and Boswellia Formulation Found to Be More Effective in Treatment of Osteoarthritis than Turmeric Supplement Alone
by Shari Henson
HerbalGram.
2018; American Botanical Council
Reviewed: Haroyan A, Mukuchyan V, Mkrtchyan N, et
al. Efficacy and safety of curcumin and its combination with boswellic acid in
osteoarthritis: a comparative, randomized, double-blind, placebo-controlled
study. BMC Complement Altern Med. 2018;18(1):7.
doi: 10.1186/s12906-017-2062-z.
Symptoms of osteoarthritis (OA),
including pain, morning stiffness, joint swelling, limited range of motion, and
decreased physical function, typically are treated with nonsteroidal
anti-inflammatory drugs (NSAIDs) and cortisone. Although those drugs help
manage pain and inflammation, they are associated with adverse effects, drug
interactions, and are contraindicated in certain populations. Curcumin, a
component of turmeric (Curcuma longa, Zingiberaceae) root and rhizome,
has been reported to be a potent anti-inflammatory agent. The boswellic acids
found in boswellia (Boswellia serrata, Burseraceae) possess
anti-inflammatory and anti-arthritic properties.
The primary objective of this
randomized, double-blind, placebo-controlled study was to compare the efficacy
of curcumin, a combination of boswellic acid and curcumin, and placebo in
treating OA by assessing their effects on joint pain, morning stiffness, and
limitations of physical function. The secondary objective was to investigate
the safety of the treatments.
The study was conducted between
September 2014 and May 2016 and included 201 patients (40-77 years of age) from
the Erebuni Medical Center in Yerevan, Armenia, who had been diagnosed with
degenerative hypertrophic OA of the knee.
The active treatments were Curamin and
CuraMed (both from EuroPharma USA; Green Bay, Wisconsin). Each 500-mg Curamin
capsule contained 350 mg BCM-95 (Arjuna Natural Ltd.; Kerala, India) and 150 mg
boswellia gum resin extract (BosPure; DolCas Biotech, LLC; Landing, New Jersey)
consisting of 75% total organic and boswellic acids, including 10% 3-O-acetyl-11-keto-boswellic
acid. Each 500 mg placebo capsule contained maltodextrin, calcium phosphate,
gelatin, magnesium stearate, silica dioxide, FD&C yellow 5, FD&C yellow
6, and titanium dioxide. Each 750-mg capsule of the curcumin supplement
CuraMed* contained 552-578 mg of BCM-95, a dry turmeric extract with 500 mg
curcuminoids and 49-52 mg essential oil from turmeric rhizome. Excipients
(120-149 mg) included phosphatidylcholine, medium-chain triglycerides,
glycerol, gelatin, and yellow beeswax.
The patients were randomly assigned to
the Curamin (n = 67), CuraMed (n = 66), or placebo group (n = 68), and were
instructed to take one capsule three times daily for 12 weeks. No significant
differences in demographic and other measured characteristics were observed
among the patients at baseline. The mean age was 56.2 years, the average body
mass index was 29 kg/m2, and 93% of the patients were female.
In the Curamin group, dropouts during
the study included two patients who did not return, one who lost interest
because of lack of improvement, one who was injured, and one who reported
nausea and vomiting. In the CuraMed group, dropouts included three patients who
did not return, one who was unable to attend the study visits, one who lost
interest because of lack of improvement, and three who did not trust the
medication. In the placebo group, three patients did not return, three lost
interest because of lack of improvement, and three reported adverse effects
(weight gain, stomach pain, dyspepsia, rash, and itching).
During the study visits at baseline,
four weeks, and 12 weeks, the patients underwent radiography and sonography,
completed the Western Ontario and McMaster Universities Osteoarthritis (WOMAC)
index and physical performance measures (PPM) tests, and provided blood
samples.
After four weeks of treatment,
significant decreases were seen in total WOMAC index scores in all groups (P
< .05 for all). The scores gradually decreased in the Curamin and CuraMed
groups until the end of the study. However, in the placebo group, no
significant changes were seen at 12 weeks. At the end of the study, the
improvements in the CuraMed (P < .001) were 3.6-fold and Curamin (P
< .001) 2.7-fold greater than the improvement seen in the placebo group (P
= .154).
Statistically
significant pain relief was observed in all groups, as reported on the WOMAC
index. In the placebo group, the pain index decreased significantly after four
weeks of treatment (P < .01); however, after 12 weeks, the change was
not significant (P > 0.05). Significant decreases in pain were seen
in the Curamin and CuraMed groups (P < 0.001 for both) after 12 weeks
of treatment.
The significant
decrease in pain reported in the placebo group after four weeks is similar to
results from other studies that have reported placebo effects of OA treatments;
meta-analyses have indicated that more than 50% of OA study subjects respond
positively to placebo treatment.1,2 Placebo effects can be
influenced by the strength of the active treatment, the severity of disease at
baseline, the route of medication delivery, and the study’s sample size.1
After 12 weeks of
treatment, patients in the Curamin and CuraMed groups reported significantly
less difficulty in moving their knees and less stiffness compared with baseline
(P < .05 for both groups). In the placebo group, significant
improvement was seen only after four weeks (P < .05) of treatment.
Differences in changes during the study between the Curamin and placebo groups,
and between the CuraMed and placebo groups, were not significant at any time
point.
Among the PPM tests
was the chair stand test. The maximum number of chair stand repetitions in 30
seconds increased significantly during the study in the Curamin and CuraMed
groups (P < .001 for both). Significant differences between the Curamin
and placebo groups (P < .05) and between the CuraMed and placebo
groups (P < .01) were observed, with greater improvements in the
Curamin and CuraMed groups. A timed walking test (40-m walking speed) revealed
significantly increased walking speeds from baseline to week 12 only in the
Curamin (P < .001) and CuraMed (P < .01) groups. Comparing
the changes from baseline among the groups revealed significant differences
between the CuraMed and placebo groups (P < .05) and between the
Curamin and placebo groups (P < .01), with faster speeds reported in
the active treatment groups.
In a separate
walking test, patients were timed as they rose from a chair, walked three
meters, turned around, walked back to the chair, and sat down. They wore
regular footwear and used a walking aid if needed. The time to complete this
task significantly decreased only in the Curamin (P < .001) and
CuraMed (P < .05) groups. Comparing the changes from baseline to the
end of the study revealed greater improvement in the Curamin group compared
with the placebo group (P < .01); improvements in the CuraMed and
placebo groups were not significantly different (P > .05).
The time required
to go up and down a flight of stairs significantly decreased by week 12 only in
the Curamin (P < .001) and CuraMed (P < .01) groups.
Comparing the changes from baseline to the end of the study revealed greater
improvement in the Curamin group compared with the placebo group (P <
.01); improvements in the CuraMed and placebo groups were not significantly
different.
Inflammation
markers (i.e., erythrocyte sedimentation rate index and C-reactive protein
levels) significantly increased (P < .05) in all groups compared with
baseline, but were still within normal ranges, with no significant differences
seen among the groups.
Adverse effects
were observed in 13 of the 201 patients: four in the placebo group, two in the
Curamin group, and seven in the CuraMed group. None of these effects were
serious. The types and frequency of adverse effects were similar in all groups
and were not considered related to the treatment.
Compared with
placebo, Curamin significantly improved the patients’ performance on all
physical performance tests and factors of the WOMAC index, and patients treated
with CuraMed saw improvements in two physical performance tests and in the
WOMAC joint pain index. These results suggest that “these plant extracts are
more effective in combination,” wrote the authors, possibly because “boswellic
acid may increase the bioavailability of curcumin. However, to our knowledge,
there is no published study demonstrating the effect of boswellic acid on the
bioavailability of curcuminoids.”
In this study, the 12-week use of
curcumin complex (BCM-95) or its combination with boswellic acids reduced
pain-related symptoms in patients with OA. The authors conclude that the
combination of curcumin and boswellia extracts “increases the efficacy of
treatment of OA, presumably due to synergistic effects of curcumin and
boswellic acid.”
—Shari Henson
* In the journal article, the authors
list two different amounts of curcuminoids for the “500 mg CuraMed” capsules.
In the abstract, they state that each capsule contains “333 mg curcuminoids,”
whereas each capsule is later described as containing “500 mg curcuminoids.”
Company representatives clarified that a 750-mg CuraMed capsule was used that
contains 500 mg curcuminoids.
References
- Zhang
W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its
determinants in osteoarthritis: meta-analysis of randomized controlled trials. Ann
Rheum Dis. 2008;6712):1716-1723.
- Zou
K, Wong J, Abdullah N, et al. Examination of overall treatment effect and the
proportion attributable to contextual effect in osteoarthritis: meta-analysis
of randomized controlled trials. Ann Rheum Dis. 2016;75(11):1964-1970.
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