Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study

J Ethnopharmacol. 2016 Aug 2:189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16.

Abstract

Ethnopharmacology relevance: A previous study indicated non-inferiority of GCSB-5 to celecoxib regarding efficacy and safety in treating OA; however, the gastrointestinal (GI) safety data was limited to 12 weeks. Accordingly, a longer term study with a larger number of patients was necessary to establish the GI safety of GCSB-5.

Aim of study: The primary goal was to determine the safety and efficacy of 24-week use of GCSB-5. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS).

Method: This was a 24-week, multicenter, single-arm phase IV Study for the safety and efficacy of GCSB-5. A total of 761 patients were enrolled and 756 patients received at least one dose of GCSB-5. Among them, 629 patients (82.7%) completed the 24 week follow up. The primary goal was to determine the safety and efficacy of GCSB-5 for 24 weeks. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS).

Results: The incidence of GI disorders of GCSB-5 was 23.7%. The annual rate of perforation, ulcer obstruction, or bleeding (PUB) incidence was 0.0%. The drop-out rate due to GI disorders following GCSB-5 use was 4.8%. Compared to celecoxib data from CLASS, the incidence of GI disorders (23.7% vs. 31.4%, p<0.001), annual rate of PUB and gastroduodenal ulcers (0.0% vs 2.2%, p=0.004), and drop-out rate due to GI disorders following GCSB-5 use were significantly low (4.8% vs 8.7%, p<0.001). Efficacy was proven by significant improvements in Western Ontario McMaster Questionnaire (WOMAC) scale, Korean Knee Score (KKS), 100-mm pain visual analogue scale (VAS), and physician's global assessments of patient's response to therapy (PGART).

Conclusions: The safety and efficacy profile of GCSB-5 are comparable to celecoxib. These results indicate GCSB-5 is safe for a long-term treatment of knee OA patients.

Trial registration: ClinicalTrials.gov (NCT01604239).

Keywords: GCSB-5; GI safety; Herbal medicine; Osteoarthritis; Shinbaro.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Antirheumatic Agents / adverse effects
  • Antirheumatic Agents / therapeutic use*
  • Celecoxib / adverse effects
  • Celecoxib / therapeutic use*
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Gastrointestinal Diseases / epidemiology
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Osteoarthritis, Knee / diagnosis
  • Osteoarthritis, Knee / drug therapy*
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Republic of Korea / epidemiology
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Antirheumatic Agents
  • Plant Extracts
  • shinbaro
  • Celecoxib

Associated data

  • ClinicalTrials.gov/NCT01604239