The clinical study, conducted by researchers at India's Krishna Institute of Medical Sciences, Dr Vithalrao Vikhe Patil Foundation, and City Care Accident Hospital, also reported that the participants did not experience any of the gastric side effects sometimes associated with the use of NSAIDs.
BCM-95 — also called Curcugreen — has been granted a GRAS (generally recognised as safe) status by the US FDA, and has been used in over 50 scientific studies globally. It is also the subject of 50 patents.
As the world's fourth leading cause of disability, osteoarthritis of the knee is a major cause for concern, especially among adults aged 40 and older. A growing ageing population in many APAC countries has also resulted in a higher prevalence of osteoarthritis.
With this in mind, the researchers behind the randomised, open-label, parallel-arm study recruited 139 knee osteoarthritis patients aged 38 to 65. Over the course of 28 days, they were given either 500mg of BCM-95 three times daily, or 50mg of diclofenac (under the trade name Voltaren) twice daily.
They underwent an assessment at baseline, then after seven, 14 and 28 days, with the main outcome measure being pain severity, using a visual analogue scale score on the 14th and 28th days.
Among its secondary outcome measures, the study included Knee Injury and Osteoarthritis Outcome Score (KOOS) on the 14th and 28th days and anti-flatulent effects on the seventh day, as well as anti-ulcer and weight reduction effects.
The researchers reported that within two weeks of treatment, the study subjects supplemented with BCM-95 began experiencing less pain and a lower degree of joint stiffness, as well as improved daily living functions, recreational sporting activity, and overall quality of life.
These effects were similar to those seen in the subjects who were taking Voltaren, and were attributed to curcumin's ability to suppress certain pro-inflammatory cytokines and their release mediators.
The participants in the intervention group also reported an anti-ulcerative effect of BCM-95, along with a significant reduction in the incidence of flatulence, a common side effect of certain types of NSAIDs.
These findings were consistent with pre-clinical rat studies that had demonstrated the gastro-protective properties of curcumin, which is known for its anti-inflammatory effects.
In addition, they did not need heartburn drugs — such as H2 blockers — which are often prescribed together with NSAIDs; 28% of the participants in the control group required H2 blockers.
Furthermore, those in the intervention group experienced some weight loss after 28 days of treatment, and fewer adverse effects than those in the control group (13% versus 38%).
Placebo for better proof
The researchers said one of the study's limitations was its open-label design that lacked a placebo group.
They added that the short treatment duration may not have been enough to properly assess the long-term efficacy of BCM-95 on the prevention of disease progression in osteoarthritic patients.
As such, a long-term study on curcumin's anti-osteoarthritis effects is warranted, using objective measurement of pain as opposed to the current study's subjective measurement.
In conclusion, the study's authors wrote: "Our findings suggest that curcumin three times daily has similar efficacy to but a better safety profile than diclofenac two times daily among patients with knee osteoarthritis.
"The study results (also) suggest that curcumin with increased bioavailability — such as BCM-95 — can be a good alternative treatment option in patients with knee osteoarthritis (and) who are intolerant of the side effects of NSAIDs."
According to Arjuna Natural, this was the first study in which curcumin therapy had found a significant positive connection to osteoarthritic care.
Joint MD Benny Antony said in a media release: "BCM-95 curcumin could be a favourable alternative for people seeking relief from osteoarthritis symptoms, especially those who are intolerant of the side effects of standard over-the-counter drugs.
"The beneficial results obtained in the study are highly likely due to the combination of curcuminoids and essential oil of turmeric present in our proprietary curcumin formulation with increased curcumin bioavailability.
"The permeability of curcumin is increased by the turmerone-rich essential oil complex, incurring a seven-fold enhancement of plasma curcumin levels, proven to yield statistically significant clinical benefits."
Source: BioMed Central
"Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study"
Authors: Dhaneshwar Shep, et al.