This planned study is based on a randomized, placebo-controlled cross-over design.
Boswellic acids, the triterpenes found in the gum resins of Boswellia serrata (family: Burseraceae), are traditionally used in the Indian Ayurvedic medicine system as antioxidants and anti-inflammatory agents for treating conditions such as rheumatoid arthritis, chronic bronchitis, asthma, and chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease). The β-configured pentacyclic triterpenic acids in B. serrata include 3-acetyl-11-keto-β-boswellic acid (AKBBA), 11-keto-β-boswellic acid (KBBA), β-boswellic acid (BBA), and 3-acetyl-β-boswellic acid (ABBA). These compounds, which constitute approximately 14% of the lipophilic fractions of the B. serrata extract, are the major active components. Boswellia serrata is marketed as a food supplement in accordance with EU Directive 2002/46/EC. Several clinical studies have examined the efficacy of B. serrata in chronic pain conditions.
The data suggest a clinical analgesic efficacy, without, however, allowing conclusions about the underlying mechanisms. These have not yet been investigated in a human experimental pain model. The aim of the study is to investigate the influence of Boswellia serrata in peripheral and central sensitization, as well as descending inhibitory pathways by Quantitative Sensory Testing (QST). These findings are of great relevance for a better understanding of clinical efficacy.
The 'Capsaicin Pain Model' is a validated method for inducing short-term peripheral and central sensitization. As a non-invasive human pain model, it is therefore well suited for investigating the analgesic and anti-hyperalgesic effects of drugs.
Furthermore, the influence of Boswellia serrata on mood (depression, anxiety), sleep quality and psychological well-being will be investigated by using the psychological questionnaires Becks-Depression-Inventory, Becks-Anxiety-Inventory, Pittsburgh Sleep Quality Index and World Health Organization Well-Being Index (BDI-II, BAI, PSQI and WHO5) as secondary target variables.
Age: ≥18 years
Not pregnant or breastfeeding
No renal or liver insufficiency
No neurological/dermatological/cardiovascular diseases
No chronic pain and/or use of analgesics
Crossover
Boswellia serrata extract
Dietary supplementBoswellia Serrata 1x day (600mg)
Placebo
Other interventionPlacebo 1x/day
Change in spontaneous pain intensity
is measured on a visual analogue scale (0 means no pain and 10 means the worst imaginable pain)
Change in Allodynia
Starting from the center of the capsaicin application, a von Frey filament (128 mN) is applied to the skin in four radial lines at 5 mm intervals, first from the outside to the inside, followed by a measurement from the inside to the outside. The distance at which a sharp unpleasant sensation first occurre or cease is determined. The eight measurements are averaged. A low score means a worse outcome, a higher score a better outcome.
Change in Hyperalgesia
When testing temporal summation, the perceived pain intensity of a single pinprick stimulus iscompared to a sequence of 10 pinprick stimuli of the same force repeated at a rate of 1/s (256 mN). A train of pinprick stimuli will be given within a small area of 1 cm² approximately 5 cm proximal to the middle of the capsaicin stimulation area. The subject will be asked to give a pain rating representing the pain at the end of the train using a numerical rating scale (0-100). The wind-up ratio (WUR) will be calculated as the mean pain rating of three trains divided by the mean pain rating for the single stimuli. A low score means good outcome, a higher score a worse outcome (0-100).
Change in heat detection threshold
The skin will be heated with a TSA-II Neuro Sensory Analyzer (Medoc Ltd. Advanced Medical Systems, Ramat Yishai, Israel). The proband is instructed to stop the heating via a stop button once he noticed the increase in temperature (heat detection threshold). Each measurement will be performed three times, and the results will be averaged. Measured in degrees C° A low score means worse outcome, a higher score a good outcome.
Change in heat pain threshold
measured in degrees C°
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