A randomized, double-blind placebo-controlled study of intranasal standardized cinnamon bark extract for seasonal allergic rhinitis.

OBJECTIVES: The aim of the study was to assess the safety and efficacy of a nasal spray containing a polyphenol-rich standardized extract of cinnamon bark (Cinnamomum zeylanicum) (IND02) for the treatment of seasonal allergic rhinitis (SAR). METHODS: This study was a randomized, double-blind, placebo-controlled study conducted in otherwise healthy men and women, aged between 18 and 75 years old, who were experiencing acute SAR symptoms. Participants were randomized in a 1:1 ratio to a nasal spray containing either IND02 (100 µg/100 µL) or matching placebo in each nostril, twice a day, for seven days. RESULTS: The outcome measures were the rhinoconjunctivitis quality of life questionnaire (RQLQ), the total daily symptom score comprising of day-time nasal, day-time eye, and night-time nasal symptom scores, the Work Productivity and Activities Impairment (WPAI:SHP), the Pittsburgh Sleep Quality Index (PSQI), the Perceived Stress Scale (PSS) and laboratory clinical parameters. RESULTS: The IND02 group showed a statistically and clinically significant reduction in total RQLQ and the sub-domains; activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function. There was a significant reduction in the total daily symptom score and sub-domains of total day-time nasal, total day-time eye and total night-time nasal symptoms scores, and total work impairment and regular activity impairment in the IND02 group compared with the placebo group after treatment. The laboratory clinical parameters remained within healthy normal reference range. CONCLUSION: The use of a nasal spray of a standardized extract of cinnamon bark (IND02) over seven days reduced symptom severity and improved quality of life, work productivity and regular daily activities in participants experiencing SAR.

A double-blind randomized placebo controlled study assessing safety, tolerability and efficacy of palmitoylethanolamide for symptoms of knee osteoarthritis.

BACKGROUND: The aim of the study was to assess the safety, tolerability and efficacy of palmitoylethanolamide (PEA) when dosed at 300 mg and 600 mg per day on symptoms of knee osteoarthritis. METHODS: This was a single site, comparative, double-blind placebo controlled study in adults with mild to moderate knee osteoarthritis with 111 participants randomized to receive 300 mg PEA, 600 mg PEA or placebo each day, in divided doses b.i.d, for 8 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes were the Numerical Rating Scales (NRS) for pain, the Depression Anxiety Stress Scale (DASS), the Perceived Stress Scale (PSS), the Pittsburg Sleep Quality Index (PSQI), the Short Form Health Survey (SF-36), the use of rescue pain medication and clinical safety assessment. RESULTS: There was a significant reduction in the total WOMAC score in the 300 mg PEA (p = 0.0372) and the 600 mg PEA (p = 0.0012) groups, the WOMAC pain score (300 mg PEA, p = 0.0074; 600 mg PEA, p = < 0.001), the WOMAC stiffness score (PEA 300 mg, p < 0.0490; 600 mg PEA, p = 0.001) and in the WOMAC function score in the 600 mg PEA group (p = 0.033) compared to placebo. The NRS pain evaluations for "worst pain" and "least pain" were significantly reduced in the 300 mg PEA group (p < 0.001, p = 0.005) and the 600 mg PEA group (p < 0.001, p < 0.001) compared to placebo. There was a significant reduction in anxiety (DASS) in both active treatment groups (300 mg PEA, p = 0.042; 600 mg PEA group (p = 0.043) compared to placebo. There were no changes in the clinical markers and the product was well tolerated. CONCLUSIONS: The study demonstrated that palmitoylethanolamide may be a novel treatment for attenuating pain and reducing other associated symptoms of knee osteoarthritis. Further studies on the pharmacological basis of this anti-inflammatory effect are now required.