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- Turmeric (Curcuma longa, Zingiberaceae)
- Curcumin
- Boswellia (Boswellia serrata, Burseraceae)
- Osteoarthritis
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Date:
03-15-2018 | HC# 021831-588
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Re: Combining Curcumin and Boswellic Acid Is More Effective in the Treatment of Osteoarthritis than Curcumin Alone
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. January 9, 2018;18(1):7.
doi: 10.1186/s12906-017-2062-z.
The
symptoms of osteoarthritis (OA), including pain, morning stiffness, joint
swelling, limited range of motion, decreased physical function, and restriction
of social activities, are treated with analgesic, nonsteroidal
anti-inflammatory drugs (NSAIDs), and cortisone. Although those drugs manage
the pain and inflammation, they are associated with adverse effects, drug
interactions, and contraindications. Curcumin, a component of turmeric (Curcuma longa, Zingiberaceae), has been
reported to be a potent anti-inflammatory agent. The boswellic acids found in boswellia
(Boswellia serrata, Burseraceae)
possess anti-inflammatory and antiarthritic properties. The primary objective
of the comparative, randomized, double-blind, placebo-controlled study reported
here was to compare the efficacy of curcumin, a combination of boswellic acid
and curcumin, and placebo in treating degenerative joint disease 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, which used Curamin® and CuraMed® (both donated by EuroPharma
USA, Inc.; Green Bay, Wisconsin), was conducted between September 2014 and May
2016. The study included 201 males and females aged 40 to 77 years who had been
diagnosed with degenerative hypertrophic OA of the knee and were patients at
Erebuni Medical Center in Yerevan, Armenia. Each 500-mg capsule of the curcumin
supplement CuraMed contained 552-578 mg of BCM-95® (DolCas Biotech,
LLC; Landing, New Jersey), a dry turmeric extract with 500 mg curcuminoids and
49-52 mg volatile oil from turmeric rhizome. Inactive excipients (120-149 mg)
included phosphatidylcholine, medium-chain triglycerides, glycerol, gelatin,
and yellow beeswax. Each 500-mg Curamin capsule contained 350 mg BCM-95 and 150
mg boswellia gum resin extract consisting of 75% boswellic acids and 10%
3-O-acetyl-11-keto-boswellic acid. Each 500-mg placebo capsule (donated by
EuroPharma USA, Inc.) contained maltodextrin, calcium phosphate, gelatin,
magnesium stearate, silica dioxide, FD&C yellow 5, FD&C yellow 6, and
titanium dioxide.
The
patients were randomly assigned to the Curamin (n = 67), CuraMed (n = 66), or placebo
group (n = 68). The patients were instructed to take 1 capsule 3 times daily
for 12 weeks. No significant differences in demographic or 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 females.
In
the Curamin group, dropouts during the study included 2 patients who did not
respond, 1 who lost interest because of lack of improvement, 1 who was injured,
and 1 who reported nausea and vomiting. In the placebo group, 3 patients did
not respond, 3 lost interest because of lack of improvement, and 3 reported
adverse effects (weight gain, stomach pain, dyspepsia, rash, and itching). In
the CuraMed group, dropouts included 3 patients who did not respond, 1 who was
unable to attend the study visits, 1 who lost interest because of lack of
improvement, and 3 who did not trust the medication.
During
the study visits at baseline, after 4 weeks, and after 12 weeks, the patients
underwent radiography and sonography, completed the Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC) and physical performance
measures (PPM) tests, and provided blood samples. The text stated labs differently
than the corresponding table, so it is unclear at which visits each of these
tests were done.
After
4 weeks of treatment, significant decreases were seen in total WOMAC scores in
all groups (P < 0.05 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 group (P < 0.001) were 3.6-fold greater, and in
the Curamin group (P < 0.001), 2.7-fold greater, than the improvement seen
in the placebo group (P = 0.154).
Statistically
significant pain relief was observed in all groups, as reported on the WOMAC.
In the placebo group, the pain index decreased significantly after 4 weeks of
treatment (P < 0.01); 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 4 weeks is
similar to results from other studies that report placebo effects of OA
treatments; meta-analyses have indicated that more than 50% of study patients
with OA 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 < 0.05 for both groups). In the placebo group, significant
improvement was seen only after 4 weeks (P < 0.05) of treatment. Differences
in changes during the study between the Curamin and placebo groups and between
the CuraMed and placebo groups were not significant.
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 < 0.001 for both). Significant differences
between the Curamin and placebo groups (P < 0.05) and between the CuraMed
and placebo groups (P < 0.01) 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 < 0.001) and CuraMed (P < 0.01) groups. Comparing the changes
from baseline among the groups revealed significant differences between the
CuraMed and placebo groups (P < 0.05) and between the Curamin and placebo
groups (P < 0.01), with faster speeds reported in the active treatment
groups.
Patients
were timed as they rose from a chair, walked 3 meters, turned around, walked
back to the chair, and sat down. They wore regular footwear and used a walking
aid if needed. The time significantly decreased only in the Curamin (P < 0.001)
and CuraMed (P < 0.05) 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 < 0.01); improvements in the CuraMed and placebo groups
were not significantly different (P > 0.05). The time required to go up and
down a flight of stairs significantly decreased by week 12 only in the Curamin
(P < 0.001) and CuraMed (P < 0.01) 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 < 0.01); improvements in the
CuraMed and placebo groups were not significantly different. Blood levels of inflammation
markers significantly increased (P < 0.05) in all groups compared with
baseline, with no significant differences seen among the groups.
Adverse
effects were observed in 13 of the 201 patients as follows: 4 in the placebo
group, 2 in the Curamin group, and 7 in the CuraMed group. None of those
effects were serious. The types and frequency of adverse effects were similar
in all groups and were not related to the treatment.
Compared
with placebo, Curamin significantly improved the patients' performance on all
physical tests and on the factors of the WOMAC. Patients treated with CuraMed
saw improvements in 2 physical performance tests and in the WOMAC joint pain
index. These results suggest that "these plant extracts are more effective
in combination," write the authors, possibly because boswellic acid
increases 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 a curcumin
complex or its combination with boswellic acids reduced pain-related symptoms
in patients with OA. The authors conclude that the combination of curcumin and boswellia
extract "increases the efficacy of treatment of OA presumably due to
synergistic effects of curcumin and boswellic acid."
This
study was supported in part by EuroPharma USA, Inc.
―Shari Henson
References
1Zhang W, Robertson J,
Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in
osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008;67(12):1716-1723.
2Zou K, Wong J,
Abdullah N, et al. Examination of overall treatment effect and the proportion
attributable to contextual effect in osteoarthritis: meta-analysis of randomised
controlled trials. Ann Rheum Dis.
2016;75(11):1964-1970.
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