Benefits
Breathing-related quality of life improved versus placebo
In a 56-day double-blind trial of 200 mg/day in 36 randomized adults with mild to moderate asthma (29 completed), the asthma quality-of-life questionnaire, the primary outcome, improved more than placebo on all four domains, and emotional function (p=.0305) and symptom scores (p=.0002) separated from placebo by day 14. The trial was small and funded by the manufacturer.
Lung function: peak flow rose more than placebo, FEV1 unchanged
In the same 56-day trial, peak expiratory flow rose 90.0 L/min from baseline on the blend versus 43.9 L/min on placebo (p=0.019), so the placebo group gained about half as much on its own. FEV1, the standard spirometry measure, did not differ between groups (+0.05 L versus −0.03 L, p=0.41).
Lung function and walking distance in pollution-sensitive adults
A 42-day study, two of whose three authors work for the seller, randomized 105 healthy adults who reported air-pollution sensitivity to 200 mg/day, the blend plus licorice extract, or placebo (87 completed). The poster reports better FEV1, FVC and six-minute walk results than placebo, but placebo FEV1 was already lower at baseline, and the study exists only as a conference abstract and poster.
Upper respiratory symptom and well-being scores in pollution-sensitive adults
In the same abstract-only study, Wisconsin Upper Respiratory Symptom Survey scores fell by about 40% from baseline on 200 mg/day while placebo scores worsened, and well-being scores (PGWBI) improved more than placebo, according to the authors' poster. These are self-reported questionnaires in a seller-authored study not published in full or peer reviewed.
Cytokine markers shifted (IFN-γ up, IL-4 down)
In the published 56-day trial, serum IFN-γ rose (22.0 versus 15.4 pg/ml, p=0.0014) and IL-4 fell (1.09 versus 1.44 pg/ml, p=0.0497) compared with placebo. These are laboratory markers measured in 29 people, not measures of infections or illness. The abstract-only pollution study reported similar marker changes but no difference from placebo in CD4+ or CD8+ cells.
5-LOX inhibition in laboratory testing
In a cell-free enzyme assay, the 1:1 blend inhibited 5-lipoxygenase at a lower concentration (IC50 11.6 µg/ml) than its Boswellia extract (14.8 µg/ml) or Bengal quince extract (22.1 µg/ml) alone, and it lowered 5-LOX protein in cultured human monocytes. 5-LOX activity has not been measured in people taking the blend, so this lab result does not show an effect in the body.
Mechanism of action
5-Lipoxygenase (5-LOX) inhibition
AKBA and related boswellic acids inhibit 5-lipoxygenase, the enzyme that makes leukotrienes, in laboratory assays, and leukotrienes contribute to airway inflammation. A pharmacology review notes, however, that boswellic acids failed to block leukotriene formation in human whole blood and that plasma AKBA levels after oral intake are far below the concentrations active in the lab, so this mechanism is uncertain in people.
Boswellia plus Bengal quince activity in the lab
In an isolated-enzyme assay the 1:1 combination inhibited 5-LOX at a lower concentration (mean IC50 11.6 µg/ml) than the Boswellia gum resin extract (14.8 µg/ml, p=0.0135) or the Aegle marmelos fruit extract (22.1 µg/ml, p<0.0001) on its own. The difference was seen only in vitro, and no human study of this blend has measured 5-LOX activity or leukotriene levels.
Th1/Th2 cytokine balance shift
In the published trial, IFN-γ (a Th1 cytokine) rose and IL-4 (a Th2 cytokine) fell compared with placebo, a shift away from the Th2 pattern linked with allergic airway inflammation. Whether that shift changes airway responsiveness was not measured, and the cytokine and symptom changes, recorded in the same 29 completers, cannot show that one caused the other.
IL-8 and T-cell markers in the pollution-sensitivity study
The conference poster of the 105-person pollution-sensitivity study reports lower serum IL-8, a chemokine that recruits neutrophils, on the blend than on placebo. CD4+ cell percentage rose from baseline in the supplement groups but did not differ from placebo, and CD8+ cells did not change. These data have not been published in full.
Clinical trials
Randomized, double-blind, placebo-controlled, single-center trial in India of the LI13109F Boswellia serrata gum resin plus Aegle marmelos fruit blend that the paper identifies as AlvioLife, registered as CTRI/2016/10/007393. Funded by the manufacturer, Laila Nutraceuticals, with one author based at its research center. The primary outcome was the Asthma Quality of Life Questionnaire; lung function and serum cytokines were secondary outcomes (Yugandhar et al. 2018, Phytother Res).
36 adults with mild to moderate asthma randomized (18 per arm); 29 completed (16 supplement, 13 placebo). 56-day intervention.
All four quality-of-life domains improved more than placebo at day 56, and emotional function (p=.0305) and symptom scores (p=.0002) separated from placebo by day 14. Peak expiratory flow rose 90.0 L/min from baseline versus 43.9 L/min on placebo (p=0.019). FEV1 did not differ between groups (+0.05 L versus −0.03 L, p=0.41). Serum IFN-γ rose (p=.0014) and IL-4 fell (p=.0497) versus placebo. Minor stomach upset, mild fever and weakness occurred in both groups, with no serious adverse events. Small, maker-funded, with uneven dropout.