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- Turmeric (Curcuma longa)
- Meriva®
- Osteoarthritis
| Date:
07-29-2011 | HC#
031163-429
|
Re: Turmeric Complex with Phosphatidylcholine Safe and Effective as Adjunct in Mild to Moderate Osteoarthritis
Belcaro G, Cesarone MR, Dugall M, et al. Efficacy and safety
of Meriva®, a curcumin-phosphatidylcholine complex, during extended
administration in osteoarthritis patients. Altern
Med Rev. 2010;15(4):337-344.
Turmeric
(Curcuma longa) root has a long
history of use for treating inflammation and arthritis.1 Within the
compounds isolated from turmeric root, curcumin has been extensively investigated
and shown to be effective in treating inflammation, in part, by suppressing the
expression and function of a series of cellular agents (enzymes, cytokines,
transcription factors) associated to this condition.1,2 Despite this
and evidence of other bioactivity, the clinical exploitation of curcumin has lagged
behind because of poor bioavailability.1 The researchers in this two-armed
study have addressed curcumin's potential in alleviating osteoarthritis (OA)
symptoms, capitalizing on the improved bioavailability of curcuminoids formulated
with phospholipids, as in Meriva® (Indena S.p.A.; Milan, Italy).
The
researchers recruited 100 patients with x-ray diagnosed OA in either or both
knees. The patients included had mild to moderate pain, were not fully
responding to non-steroidal anti-inflammatory drugs (NSAIDs), and were allowed
to use NSAIDs, analgesics, and other treatments throughout the study. Patients who
were under medical treatment for cardiovascular disease or diabetes, or had a
body mass index >25, were excluded, as were those who were suffering from a
severe metabolic disorder, had undergone surgery or arthroscopy in the 3 months
prior to the study, or had oncologic or severe bone or joint conditions.
Patients unable to walk were also excluded from the study. In addition, female
patients breastfeeding, pregnant, or planning on a pregnancy were not included.
The researchers split the 100 patients into 2 study groups; group A, the
control group, used the best available treatment according to their doctor and
specialist's directives. Group B, the treatment group, received the best
available treatment along with Meriva.
While
Meriva was developed by Indena S.p.A., it was made for this study by Sigmar
Italia S.p.A., Almè, Italy. The treatment was 1,000 mg
daily in the form of two 500 mg pills consumed after morning and evening meals
for 8 months. This regimen corresponded to an overall intake of 200 mg of
curcuminoids per day. The composition of each pill was 20% curcuminoid mixture
(75% curcumin, 15% demethoxycurcumin, and 10% bisdemethoxycurcumin), 40%
phosphatidylcholine, and 40% microcrystalline cellulose. No use of placebo is
mentioned in the control group.
The
symptoms and severity of OA were measured in various ways at the beginning and
end of the study. Patients' functionality was assessed using the Karnofsky
Performance Scale Index and patients answered the Western
Ontario and McMaster Universities (WOMAC) questionnaire for
symptom evaluation. Also, patients were asked to conduct a treadmill test, in
which patients' ability to walk without pain at 3 km/hour at a 10% inclination
for as long as possible was evaluated. The researchers also required the
patients to document their use of other drugs during the study, as well as certain
quality of life indicators like time off of work or hospitalization due to OA.
Lastly, the patients' blood was collected, and oxidative stress was measured in
Carr units, in addition to a set of inflammatory markers that included erythrocyte
sedimentation rate (ESR), interleukin-1β (IL-1β), IL-6, soluble CD40 ligand (sCD40L),
and soluble vascular cell adhesion molecule-1 (sVCAM-1).
From
the 100 total patients enrolled in the study, 11 dropped out due to logistical
conflicts, leaving a final n=44 for the control group and n=45 in the treatment
group. The treatment group's Karnofsky Performance Scale Index was
significantly improved after 8 months from 73.3 at baseline to 92.2 (P<0.05).
No difference in the index was observed in the control group. The overall WOMAC
score in the treatment group significantly improved by decreasing from 80.6 to
33.3 (P<0.05). The WOMAC scores for the treatment group's pain dropped
significantly from 16.6 to 7.3 (P<0.05) at the study's conclusion. In
addition, the WOMAC scores for stiffness were significantly reduced from 7.4 to
3.2 (P<0.05). The WOMAC scores for physical function also improved
significantly in the treatment group from baseline to the end of the study by
decreasing from 56.6 to 22.8 (P<0.05). The scores for emotional and social
function were also significantly improved, 33.9 vs. 10.2 and 24.4 vs. 10.3 from
baseline to endpoint, respectively (P<0.05 for both). No significant
differences were seen in any of the control group's WOMAC scores at the end of
the study, and all treatment scores were improved significantly compare to
control (P<0.05).
At
the end of the study, the researchers also report a significant 3.87-fold
improvement in the treatment group's treadmill test results over the control
group (P<0.05 compared to baseline and controls). Also, the treatment group's
inflammation markers ESR, IL-1β, IL-6, sCD40L, and sVCAM-1 were significantly
reduced (P<0.05 for all), while no significant difference in these markers was
observed in the control group. A notable result reported in the treatment group
was the 63% reduction in the use of NSAIDs (e.g., celecoxib) and
doctor-recommended painkillers (e.g., acetaminophen) as compared with a 12%
reduction in the control group (P<0.05). The researchers also report
significant reductions in gastrointestinal complaints, distal edema, and
hospital services related to OA in the treatment group vs. the control group at
the end of the study (P<0.05 for each). The reported percentages for all of
these changes differed from the presumed mean decreases in the text and the given
median decreases in Table 8.
The
authors conclude that the association of Meriva to conventional
anti-inflammatory therapy improves the management of a multitude of symptoms and
lifestyle indicators associated with OA. The authors mention that a dosage of 1
g Meriva/day (corresponding to 200 mg/day curcuminoids and ca.150 mg/day
curcumin) is much less than the 10 g/day or even larger doses of unformulated
curcumin used in other pre-clinical or clinical studies on curcumin.
This
study confirms the beneficial effect of Meriva evidenced in a previous smaller
and shorter study.3 Of notable interest is the documentation of a positive
effect of Meriva on OA at a low daily dosage of curcumin. This
observation supports the dramatic increase in bioavailability of curcumin from
Meriva observed in a previous animal study.4 Another additional important
result of this study is the significant decrease of NSAID and analgesic usage
by patients also taking Meriva, along with an associated significant reduction in
gastrointestinal adverse effects and costs. The decrease of various
inflammatory markers, especially IL-1β, IL-6, suggests a generalized
downregulation of the inflammatory status.
One
weakness of this study is the absence of a placebo pill for the control group;
thus, any placebo effect is not accounted for or addressed. Despite this
problem, the study furthers the knowledge of curcumin use via Meriva as an adjuvant
for OA treatment. Furthermore, the observed benefits provide a basis for
the study of Meriva as a stand-alone agent in future comparative studies with
NSAIDs for the treatment of OA, at least in its milder form.
—Amy C.
Keller, PhD
References
1Blumenthal M, Goldberg
A, Brinckmann J, eds. Herbal Medicine:
Expanded Commission E Monographs. Austin, TX: American
Botanical Council; Newton, MA: Integrative Medicine Communications;
2000.
2Lantz RC, Chen GJ,
Solyom AM, Jolad SD, Timmermann BN. The effect of turmeric extracts on
inflammatory mediator production. Phytomedicine.
June 15, 2005;12(6-7):445-452.
3Belcaro G, Cesarone
MR, Dugall M, Pellegrini L, Ledda A, Grossi MG, Togni S, Appendino G.
Product-evaluation registry of Meriva®, a curcumin-phosphatidylcholine complex,
for the complementary management of osteoarthritis. Panminerva Med. 2010; 52 (2 Suppl 1): 55-62.
4Marczylo TH, Verschoyle
RD, Cooke DN, Morazzoni P, Steward WP, Gescher AJ. Comparison of systemic
availability of curcumin with that of curcumin formulated with
phosphatidylcholine. Cancer Chemother
Pharmacol. 2007;60(2):171-177.
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