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Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis.
J Ethnopharmacol 2016; 181:1-7JE

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

This prospective, randomized, double-blinded, double-dummy, multicenter study compared the efficacy and safety of PG201 (Layla®), a new product from extracts of 12 plant sources and SKI306X (Joins®) which have been well investigated and in relatively wide usage among herbal medicine, for the treatment of patients with knee osteoarthritis.

AIM OF THE STUDY

To compare the efficacy and safety of PG201 and SKI306X in patients with knee osteoarthritis.

MATERIALS AND METHODS

A prospective, double-blinded multicenter study was conducted in 124 patients with Kellgren and Lawrence grade 2-3 knee osteoarthritis. Patients were randomly assigned to receive 600mg of PG201 (300mg, twice daily) and 600mg of SKI306X placebo (200mg, thrice daily) or 600mg of SKI306X (200mg, thrice daily) and PG201 placebo (300mg, twice daily) for 12 weeks. The primary outcome was the improvement of pain by week 8 as assessed by the 100-mm pain visual analog scale (VAS). Secondary outcomes included pain VAS improvement level at week 12, pain VAS improvement rate at weeks 8 and 12, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improvement level at weeks 8 and 12, the improvement of the quality of life (EQ-5D), overall symptom self-assessment score, and rescue medication consumption.

RESULTS

The pain VAS improvement at 8 weeks was 14.2±16.2 in the experimental group and 11.9±13.1 in control group (p=0.557), confirming that the experimental group was not inferior to the control group as lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). There was no significant difference in all secondary outcomes including pain VAS, WOMAC, EQ-5D, overall symptom self-assessment score, and rescue medication consumption. Adverse events were low and similar between the two groups.

CONCLUSIONS

The results of this study showed that PG201 significantly reduced knee pain and improved knee function and were comparable to SKI306X. PG201 can be suggested as an effective treatment of knee osteoarthritis. Trial registration ClinicalTrials.gov:NCT01768468.

Authors+Show Affiliations

Department of Orthopedic Surgery, Stem Cell & Regenerative Medicine Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea; Department of Health Sciences and Technology, SAIHST, Sungkyunkwan University, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea.Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 102 Heukseok-ro, Dongjak-gu, Seoul 06973, South Korea.Department of Orthopedic Surgery, Keimyung University Dongsan Medical Center, 56 Dalseong-ro, Jung-gu, Daegu 41931, South Korea.Department of Orthopedic Surgery, Korea University Medical Center Anam Hospital, 73 Inchon-ro, Seongbuk-gu, Seoul 02841, South Korea.Department of Orthopedic Surgery, Seoul Metropolitan Government Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul 07061, South Korea.Department of Orthopedic Surgery, Ajou University Medical Center, 164 World Cup-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16499, South Korea.Department of Orthopedic Surgery, Hanyang University Medical Center Guri Hospital, 153 Gyeongchun-ro, Guri-si, Gyeonggi-do 11923, South Korea. Electronic address: hyparkys@hanyang.ac.kr.

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26821189

Citation

Ha, Chul-Won, et al. "Prospective, Randomized, Double-blinded, Double-dummy and Multicenter Phase IV Clinical Study Comparing the Efficacy and Safety of PG201 (Layla) and SKI306X in Patients With Osteoarthritis." Journal of Ethnopharmacology, vol. 181, 2016, pp. 1-7.
Ha CW, Park YB, Min BW, et al. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016;181:1-7.
Ha, C. W., Park, Y. B., Min, B. W., Han, S. B., Lee, J. H., Won, Y. Y., & Park, Y. S. (2016). Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. Journal of Ethnopharmacology, 181, pp. 1-7. doi:10.1016/j.jep.2016.01.029.
Ha CW, et al. Prospective, Randomized, Double-blinded, Double-dummy and Multicenter Phase IV Clinical Study Comparing the Efficacy and Safety of PG201 (Layla) and SKI306X in Patients With Osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. PubMed PMID: 26821189.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. AU - Ha,Chul-Won, AU - Park,Yong-Beom, AU - Min,Byung-Woo, AU - Han,Seung-Beom, AU - Lee,Jae Hyup, AU - Won,Ye-Yeon, AU - Park,Ye-Soo, Y1 - 2016/01/25/ PY - 2015/09/14/received PY - 2016/01/15/revised PY - 2016/01/19/accepted PY - 2016/1/29/entrez PY - 2016/1/29/pubmed PY - 2016/12/15/medline KW - Analgesic KW - Arthritis KW - Clinical trials KW - Pain KW - Traditional medicine Asia & Oceania SP - 1 EP - 7 JF - Journal of ethnopharmacology JO - J Ethnopharmacol VL - 181 N2 - ETHNOPHARMACOLOGICAL RELEVANCE: This prospective, randomized, double-blinded, double-dummy, multicenter study compared the efficacy and safety of PG201 (Layla®), a new product from extracts of 12 plant sources and SKI306X (Joins®) which have been well investigated and in relatively wide usage among herbal medicine, for the treatment of patients with knee osteoarthritis. AIM OF THE STUDY: To compare the efficacy and safety of PG201 and SKI306X in patients with knee osteoarthritis. MATERIALS AND METHODS: A prospective, double-blinded multicenter study was conducted in 124 patients with Kellgren and Lawrence grade 2-3 knee osteoarthritis. Patients were randomly assigned to receive 600mg of PG201 (300mg, twice daily) and 600mg of SKI306X placebo (200mg, thrice daily) or 600mg of SKI306X (200mg, thrice daily) and PG201 placebo (300mg, twice daily) for 12 weeks. The primary outcome was the improvement of pain by week 8 as assessed by the 100-mm pain visual analog scale (VAS). Secondary outcomes included pain VAS improvement level at week 12, pain VAS improvement rate at weeks 8 and 12, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improvement level at weeks 8 and 12, the improvement of the quality of life (EQ-5D), overall symptom self-assessment score, and rescue medication consumption. RESULTS: The pain VAS improvement at 8 weeks was 14.2±16.2 in the experimental group and 11.9±13.1 in control group (p=0.557), confirming that the experimental group was not inferior to the control group as lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). There was no significant difference in all secondary outcomes including pain VAS, WOMAC, EQ-5D, overall symptom self-assessment score, and rescue medication consumption. Adverse events were low and similar between the two groups. CONCLUSIONS: The results of this study showed that PG201 significantly reduced knee pain and improved knee function and were comparable to SKI306X. PG201 can be suggested as an effective treatment of knee osteoarthritis. Trial registration ClinicalTrials.gov:NCT01768468. SN - 1872-7573 UR - https://www.unboundmedicine.com/medline/citation/26821189/Prospective_randomized_double_blinded_double_dummy_and_multicenter_phase_IV_clinical_study_comparing_the_efficacy_and_safety_of_PG201__Layla__and_SKI306X_in_patients_with_osteoarthritis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-8741(16)30029-0 DB - PRIME DP - Unbound Medicine ER -