RCT: Synergistic botanical pain relief comparable to paracetamol

By Nikki Hancocks contact

- Last updated on GMT

getty | kieferpix
getty | kieferpix

Related tags: botanical, pain relief, Curcumin, boswellia

A synergistic botanical formula of curcumin, frankincense and black sesame oil can provide pain relief with efficacy and speed comparable to paracetamol, according to a new RCT.

Curcumin is one of the most extensively studied​ natural compounds, especially for relieving pain and inflammation. It has demonstrated ability to exert a broad spectrum of biological activity for modulating inflammatory signalling pathways. The analgesic activity of B. serrata extract​ also has been identified in several studies, particularly its positive effect on joint tenderness in cases of osteoarthritis. It, too, has exhibited abilities to raise the pain threshold in comparison to placebos.

Rhuleave-K, from Indian manufacturer Arjuna Natural, is a liquid formula comprising turmeric (Curcuma longa​) and frankincense (resinous extract of Boswellia serrata​), combined in a black sesame oil base.

Arjuna argues black sesame oil acts not only as an effective carrier, helping to disperse and dissolve fat-soluble compounds into the body, but in traditional Ayurvedic practice sesame oil is used for its warming, penetrative, and anti-inflammatory properties​.

In the current study, published in Medicine​, Rhuleave-K’s efficacy was tested in a randomised, active, controlled, open-label study involving 88 healthy subjects (18 to 65 years of age) with acute musculoskeletal pain.

Participants were randomised to receive 1,000mg per day of Rhuleave-K or 1,000mg of acetaminophen (Paracetamol).

All subjects were instructed to take study medication for a treatment period of 7 days. There were a total of three visits and/or follow ups: screening, randomisation (visit 1, baseline or day 1), follow up (visit 2 or day 3) and end of study visit (visit 3 or day 7).

The researchers found that treatment with the botanical formula resulted in average magnitude of pain relief comparable to the Paracetamol - 66% of subjects in the treatment group reported positive response in pain relief (≥50% max TOTPAR; total pain relief) after six hours, compared to 73% of control.

73% of subjects on treatment were considered positive responders, compared to 80% in the control group. The average time of onset of analgesia was 1 hour for the treatment group, versus 0.83 hour for control.

At the end of day 3 and 7, there was significant improvement in the pain condition of treatment group and was comparable to control.

Both the groups were equal in providing sensory pain relief, but the treatment was 8.57 times significantly better than acetaminophen in reducing the unpleasantness and emotional aspects (affective domain) involved with acute pain.

The report concludes the botanical treatment is "as effective as acetaminophen in reducing the pain and it reduces the unpleasantness due to pain significantly better than acetaminophen".

It adds: "Since in this study, treatment (Rhuleave-K) demonstrated similar activities as of acetaminophen (paracetamol), a new study should be planned comparing treatment against placebo."

Previous research

At cellular and molecular levels, curcumin has been shown to regulate a number of signalling pathways, including the eicosanoid pathway involving COX-2. Regulation of COX and LOX enzymes by curcumin​ may be the key mechanism for its beneficial effects in preventing various inflammatory diseases. 

During the pain and inflammatory process, 5-lipoxygenase (5-LOX) pathway is also involved, which generates leukotrienes (LTs), namely LTB4 and cysteinyl LTs. B. serrata​ extract–derived boswellic acids are specific, non-redox inhibitors of 5-LOX, and 3-O​-acetyl-11-keto-β-boswellic acid (AKBA) possesses the most potent 5-LOX inhibitory activity​. 

In a 90-day, double-blind, randomized, placebo-controlled study​ B. serrata​ extract was evaluated for its efficacy and safety in the treatment of osteoarthritis of the knee. The extract at 100 and 250 mg daily dose conferred clinically and statistically significant improvements in pain scores and physical function scores in osteoarthritis patients.

The synergistic effects of curcumin and boswellic acid have been previously reported in humans. In a randomised, double blind, placebo controlled study​, 12-week use of curcumin or its combination with boswellic acid reduced pain-related symptoms in patients with osteoarthritis. Curcumin in combination with boswellic acid was more effective and it was concluded that combining C. longa​ and B. serrata​ extracts increases the efficacy of treatment presumably due to synergistic effects of curcumin and boswellic acid.

In ancient times, oils and extracts from sesame seed have been used in various purposes including food, salve, and medicine. The Assyrians community used sesame oil as food and medicine, whereas it was a popular ingredient of massage in Ayurvedic medicine, and as a sacred oil in rituals.

Sage Charaka quotes that there is no medication which excels sesame oil in curing vatika diseases because of its penetrating property through the subtle channels of the body, and its warming properties. When sesame is processed with other herbs, it has been found​ to be more powerful therapeutically.

Source: Medicine

Rudrappa, G.H., et al 

"Efficacy of high-dissolution turmeric-sesame formulation for pain relief in adult subjects with acute musculoskeletal pain compared to acetaminophen"  

doi: 10.1097/MD.0000000000020373

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