Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee

Abstract

BackgroundExtracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial was to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives were to assess effects on the signs and symptoms of this disorder.MethodsIndividuals greater than 50 years of age with OA of the hip or knee were eligible for trial entry. A total of 40 patients were enrolled in 3 cohorts and were treated with escalating chicory doses of 600 mg/day, 1200 mg/day and 1800 mg/day for 1 month. The ratio of active treatment to placebo was 5:3 in cohorts 1 and 2 (8 patients) each and 16:8 in cohort 3 (24 patients). Safety evaluations included measurement of vital signs and routine lab tests at baseline and the end of the treatment period. Efficacy evaluations at baseline and final visits included self-assessment questionnaires and measurement of the 25-foot walking time.ResultsIn the highest dose cohort, 18 patients who completed treatment per protocol were analyzed for efficacy. In this group, 13 patients showed at least 20% improvement in the defined response domains of pain, stiffness and global assessment: 9 of 10 (90%) patients randomized to active treatment with chicory and 4 of 8 (50%) patients randomized to placebo (P = 0.06). In general, the treatment was well-tolerated. Only one patient who was treated with the highest dose of chicory had to discontinue treatment due to an adverse event.ConclusionsThe results of this pilot study suggest that a proprietary bioactive extract of chicory root has a potential role in the management of OA and merits further investigation. Clinicaltrials.gov identifier: NCT 01010919.

Medical Plant Extracts for Treating Knee Osteoarthritis: a Snapshot of Recent Clinical Trials and Their Biological Background

“…Of the studies in our survey, four studies were performed without running a placebo group [12,14,16,17] and five trials did not include an active comparator [15,[18][19][20][21], clearly limiting the informative value of the studies. The particular importance of control groups for trials on OA has been underscored by a systematic review and meta-analysis involving 193 placebo (16,364 patients) and 14 untreated control groups (1167 patients) from RCTs, showing that the overall effect size (95 % CI) for pain relief was 0.51 (0.46 to 0.55) for placebo, and 0.03 (−0.13 to 0.18) for untreated controls [65].…”

“…Ninety percent of the patients randomized to active treatment with chicory and 50 % of the patients randomized to placebo showed 20 % improvement in pain, stiffness, and global assessment. Olsen et al concluded that the investigated proprietary chicory root extract was beneficial for the management of OA and deserves further investigation [19].…”

“…The safety and tolerability of a proprietary bioactive extract of chicory root was determined in patients with OA in a phase-1, placebo-controlled, double-blinded, dose-escalating RCT [19]. Forty patients, enrolled in 3 cohorts, were given escalating daily chicory doses of 600, 1200, and 1800 mg or an equal dose of placebo for 1 month.…”

“…Finally, 11 clinical trials investigating a total of 7 different plant extracts were selected and are reviewed in the following section [12][13][14][15][16][17][18][19][20][21][22]. Key parameters of the trials are summarized in Table 1.…”

Evaluation of the Antifungal Effect of Chicory Extracts on Candida Glabrata and Candida Krusei in a Laboratory Environment

“…10,11 In a study, the chicory extract's anti-inflammation features were evaluated and the important role of chicory in osteoarthritis was clarified. 12 The antibacterial features of this plant were also realized in different studies. [13][14][15][16] The antibacterial and antioxidation activities of the chicory plant have been proven before, but limited studies were performed on the antifungal features of this plant.…”