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reference
Rudrappa GH, Murthy M, Saklecha S, Kumar Kare S, Gupta A, Basu I. Rapid pain relief in exercise-induced acute musculoskeletal pain by turmeric-boswellia formulation: a randomized, placebo-controlled, double-blind, multicenter study.medicine.2022;101(35):e30144.
Study objective
To determine whether dietary supplementation with the plant extracts curcumin andBoswelliacan be used for acute pain relief in diseases of the musculoskeletal system
Key to take away
A turmeric andBoswelliaDietary supplements effectively reduced pain intensity and relieved acute musculoskeletal pain.
design
Double-blind, randomized and placebo-controlled model conducted in multiple centers.
Participant
The study involved 232 healthy participants (aged 18 to 65 years) who suffered from an acute musculoskeletal injury. Randomization was carried out in a 1:1 ratio between men and women.
Inclusion criteria consisted of the following injuries diagnosed within 24 hours of study entry (all did not require hospitalization): “stress-related musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful, uncomplicated, acute, soft injuries.” Tissue injury of the upper or lower extremity, including acute injury to ligaments, tendons or muscles (including Grade 1 sprain or strain).”
Interventions
Researchers assessed pain intensity every 30 minutes for 6 hours after oral administration of a single dose of either the intervention or placebo. The three conditions during the 6 hours were: rest, movement or pressure.
The intervention group received two 500 mg soft gels, each containing sesame oil-based curcuminoids (266 mg) and acetylketo-boswellic acid (10 mg) (Rhuleave-K™). The placebo capsules consisted of maltodextrin based on polysorbate-80, propylene glycol and polyethylene glycol-400.
Evaluated study parameters
The researchers used several pain scales to assess the pain. They obtained data using the NRS (numeric pain rating scale), PRS (pain relief scale), and MPQ (short form of the McGill Pain Questionnaire). They measured the onset of analgesia with stopwatches.
Primary outcome
Changes in “pain intensity difference” 6 hours after intervention/placebo at rest
Key findings
NRS in turmericBoswellia (TBF) group showed significant improvement over placebo after 6 hours. The area under the curve (AUC) differed by:
- 95,39 % im Ruhezustand (P≤0,0001)
- 93,52 % mit Bewegung (P≤0,0001)
- 93,28 % mit Druck (P≤0,0001)
Onset of analgesia
- Spürbare Schmerzlinderung (PPR): 99,1 % hatten in der TBF-Gruppe eine Linderung gegenüber 10,4 % in der Placebo-Gruppe (P=0.0001).
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Significant pain relief (MPR): 95.7% experienced relief in the TBF group versus 1.7% in the placebo group (P=0.0001).
PRS scale
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Complete pain relief at 6 hours (TOTPAR6) at rest, with exercise and with pressure all showed significant improvement with TBF (P=0.0001).
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Limited mean time to maximum pain relief: 194 minutes at rest, 197.7 minutes with exercise, 194.2 minutes with pressure (P=0.0001 for each)
McGill Pain Questionnaire
- Signifikante Reduzierung der affektiven, sensorischen und gesamten Domänen im Vergleich zu den Werten vor und nach der Behandlung (P=0,0001)
transparency
Arjuna Natural Private Ltd of India provided the Rhuleave-K™ capsules and a placebo.
Implications and limitations for practice
BoswelliaTree resin extract, also known as Indian frankincense, and turmeric have been used in traditional Ayurvedic medicine for thousands of years. Both herbal medicines are touted for joint rejuvenation and their many other anti-inflammatory health benefits. Each can be taken orally or applied topically. Curcumin, one of the active ingredients in turmeric, has been shown to alleviate obesity, metabolic syndrome, diabetes, depression and fatty liver disease.1
In recent years, turmeric andBoswelliaDietary supplements have become popular for relieving chronic pain and discomfort, primarily due to their reliable anti-inflammatory effects. TheImplications foracuteHowever, applications are less well studied1The aim of this clinical study was to provide information about their use in acute situations, particularly for injury-related musculoskeletal pain.
Recent research shows a possible synergistic effect between turmeric and boswellia in treating inflammation and pain associated with osteoarthritis.
Turmeric (and its active ingredient curcumin) is widely known for its anti-inflammatory effects. Fewer studies focus onBoswellia, as it is less available and less popular than turmeric. However, research has shown that long-term use ofBoswelliafor patients with osteoarthritis is safe and effective.2Recent research shows a possible synergistic effect between turmeric andBoswelliafor the treatment of inflammation and pain in osteoarthritis.3
The study reviewed here was placebo-controlled, randomized, and double-blind and was conducted by researchers at multiple centers in India. The design, intervention and randomization used sound procedures. The study uses multiple pain scales to obtain a variety of data points, leading to a more rigorous conclusion. However, it should be noted that the data collected is subjective. The researchers did not collect objective measures such as functional changes (improved activity level or range of motion of the affected joint). There was no comparison to an over-the-counter analgesic, such as a nonsteroidal anti-inflammatory drug (NSAID), or to other prescription medications.
The study used a product called Rhuleave-K™, manufactured by Arjuna Natural Private Ltd. developed and manufactured in India. Extraction of turmeric rhizomes andBoswellia serrataGum resin used a proprietary technology. It is unknown whether this technology is used by other companies.
Previous randomized control trials have demonstrated the effectiveness of other curcumin andBoswelliaPain relief formulations with fewer gastrointestinal side effects than NSAIDs.4The dosage was selected for the healthy participants of this particular study, but dosage adjustments for special populations such as the elderly or those with liver or kidney impairment were not mentioned. Turmeric is generally considered safe at a dose of 500 mg twice daily.5However, mentioning specific populations may allow for better clinical application.
The study did not report any side effects that participants may have suffered. A literature review found that excessive intake of curcumin can cause various negative effects, including on the liver, kidney, cardiac system, blood, and immune system.6Although these side effects are rare and usually occur when consumed in excess, they must be taken into account. The researchers also did not discuss bioavailability and absorption, which could be considered outside the context of this study.
As an intervention for acute musculoskeletal pain in urgent situations, a turmeric andBoswelliaAddition looks promising. The implications are large because of the opportunity to avoid opioids or NSAIDs, which have a more dangerous safety profile, in high-risk populations. Further research is needed to determine effectiveness outside of healthy populations and to investigate side effects before clinical conclusions can be made.