A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee: The MOZArT trial

Carlos Lozada, Eve del Rio, Donald P. Reitberg, Robert A. Smith, Charles B. Kahn, Roland W. Moskowitz

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction Osteoarthritis of the knee is a prevalent and painful condition increasing with age. The aim of this, the first well-controlled randomized controlled trial, was to evaluate the efficacy and safety of co-administered Traumeel1 (Tr14) and Zeel1 (Ze14) in patients with knee osteoarthritis (OA) experiencing moderate-to-severe pain. Methods This was a double-blind, multi-center, randomized, saline-controlled trial. Eligible patients meeting the American College of Rheumatology criteria for knee OA were randomized to 3, weekly intra-articular Tr14/Ze14 (n = 119) or saline (n = 113) injections. Primary efficacy endpoint was knee pain change from baseline (day 1) to end-of-study visit (day 99), as measured by the WOMAC Pain Subscore. Secondary endpoints included measures of WOMAC OA Index total and subscores, 50-foot walk test, and patient (PGA) and physician (PhGA) global assessments. Safety was assessed by vital signs, treated knee examinations, adverse events (AEs), and concomitant medications use. Effect sizes were calculated post hoc for consistency with published meta-analyses of standard-of-care treatments. Results 232 patients were randomized with no significant baseline differences. For the primary endpoint Tr14/Ze14 was significantly superior to saline (−32.0 vs. −25.5; p = 0.0383, 95% CI for difference: −12.40, −0.35). WOMAC and 50-foot walk pain measures showed statistically significant efficacy for pain relief over study days 15–99 (except Day 29). Safety profile showed no serious adverse events related to the treatment. PhGA indicated significant improvement for Tr14/Ze14 on Days 29, 71 and Day 85. Conclusion In this study, intra-articular Tr14/Ze14 provided significant pain relief compared to saline-control throughout the observation period. Treatment effect sizes were clinically relevant, since these were comparable to those reported for standard-of-care treatments. The safety profile was benign.

Original languageEnglish (US)
Pages (from-to)54-63
Number of pages10
JournalEuropean Journal of Integrative Medicine
Volume13
DOIs
StatePublished - Aug 1 2017

Fingerprint

Intra-Articular Injections
Knee Osteoarthritis
Safety
Pain
Standard of Care
Knee
Therapeutics
Randomized Controlled Trials
Joints
Prostaglandins A
Vital Signs
Osteoarthritis
Meta-Analysis
Observation
Physicians
Injections

Keywords

  • Homeopathic medicinal product
  • Intra-articular injections
  • Knee joint
  • Osteoarthritis of the knee
  • Pain
  • Randomized controlled trial
  • Tr14
  • Traumeel
  • WOMAC
  • Ze14
  • Zeel

ASJC Scopus subject areas

  • Complementary and alternative medicine

Cite this

A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee : The MOZArT trial. / Lozada, Carlos; del Rio, Eve; Reitberg, Donald P.; Smith, Robert A.; Kahn, Charles B.; Moskowitz, Roland W.

In: European Journal of Integrative Medicine, Vol. 13, 01.08.2017, p. 54-63.

Research output: Contribution to journalArticle

@article{c7d330c7f5014c8dabf2e9abbef11eb3,
title = "A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee: The MOZArT trial",
abstract = "Introduction Osteoarthritis of the knee is a prevalent and painful condition increasing with age. The aim of this, the first well-controlled randomized controlled trial, was to evaluate the efficacy and safety of co-administered Traumeel1 (Tr14) and Zeel1 (Ze14) in patients with knee osteoarthritis (OA) experiencing moderate-to-severe pain. Methods This was a double-blind, multi-center, randomized, saline-controlled trial. Eligible patients meeting the American College of Rheumatology criteria for knee OA were randomized to 3, weekly intra-articular Tr14/Ze14 (n = 119) or saline (n = 113) injections. Primary efficacy endpoint was knee pain change from baseline (day 1) to end-of-study visit (day 99), as measured by the WOMAC Pain Subscore. Secondary endpoints included measures of WOMAC OA Index total and subscores, 50-foot walk test, and patient (PGA) and physician (PhGA) global assessments. Safety was assessed by vital signs, treated knee examinations, adverse events (AEs), and concomitant medications use. Effect sizes were calculated post hoc for consistency with published meta-analyses of standard-of-care treatments. Results 232 patients were randomized with no significant baseline differences. For the primary endpoint Tr14/Ze14 was significantly superior to saline (−32.0 vs. −25.5; p = 0.0383, 95{\%} CI for difference: −12.40, −0.35). WOMAC and 50-foot walk pain measures showed statistically significant efficacy for pain relief over study days 15–99 (except Day 29). Safety profile showed no serious adverse events related to the treatment. PhGA indicated significant improvement for Tr14/Ze14 on Days 29, 71 and Day 85. Conclusion In this study, intra-articular Tr14/Ze14 provided significant pain relief compared to saline-control throughout the observation period. Treatment effect sizes were clinically relevant, since these were comparable to those reported for standard-of-care treatments. The safety profile was benign.",
keywords = "Homeopathic medicinal product, Intra-articular injections, Knee joint, Osteoarthritis of the knee, Pain, Randomized controlled trial, Tr14, Traumeel, WOMAC, Ze14, Zeel",
author = "Carlos Lozada and {del Rio}, Eve and Reitberg, {Donald P.} and Smith, {Robert A.} and Kahn, {Charles B.} and Moskowitz, {Roland W.}",
year = "2017",
month = "8",
day = "1",
doi = "10.1016/j.eujim.2017.07.005",
language = "English (US)",
volume = "13",
pages = "54--63",
journal = "European Journal of Integrative Medicine",
issn = "1876-3820",
publisher = "Elsevier GmbH",

}

TY - JOUR

T1 - A double-blind, randomized, saline-controlled study of the efficacy and safety of co-administered intra-articular injections of Tr14 and Ze14 for treatment of painful osteoarthritis of the knee

T2 - The MOZArT trial

AU - Lozada, Carlos

AU - del Rio, Eve

AU - Reitberg, Donald P.

AU - Smith, Robert A.

AU - Kahn, Charles B.

AU - Moskowitz, Roland W.

PY - 2017/8/1

Y1 - 2017/8/1

N2 - Introduction Osteoarthritis of the knee is a prevalent and painful condition increasing with age. The aim of this, the first well-controlled randomized controlled trial, was to evaluate the efficacy and safety of co-administered Traumeel1 (Tr14) and Zeel1 (Ze14) in patients with knee osteoarthritis (OA) experiencing moderate-to-severe pain. Methods This was a double-blind, multi-center, randomized, saline-controlled trial. Eligible patients meeting the American College of Rheumatology criteria for knee OA were randomized to 3, weekly intra-articular Tr14/Ze14 (n = 119) or saline (n = 113) injections. Primary efficacy endpoint was knee pain change from baseline (day 1) to end-of-study visit (day 99), as measured by the WOMAC Pain Subscore. Secondary endpoints included measures of WOMAC OA Index total and subscores, 50-foot walk test, and patient (PGA) and physician (PhGA) global assessments. Safety was assessed by vital signs, treated knee examinations, adverse events (AEs), and concomitant medications use. Effect sizes were calculated post hoc for consistency with published meta-analyses of standard-of-care treatments. Results 232 patients were randomized with no significant baseline differences. For the primary endpoint Tr14/Ze14 was significantly superior to saline (−32.0 vs. −25.5; p = 0.0383, 95% CI for difference: −12.40, −0.35). WOMAC and 50-foot walk pain measures showed statistically significant efficacy for pain relief over study days 15–99 (except Day 29). Safety profile showed no serious adverse events related to the treatment. PhGA indicated significant improvement for Tr14/Ze14 on Days 29, 71 and Day 85. Conclusion In this study, intra-articular Tr14/Ze14 provided significant pain relief compared to saline-control throughout the observation period. Treatment effect sizes were clinically relevant, since these were comparable to those reported for standard-of-care treatments. The safety profile was benign.

AB - Introduction Osteoarthritis of the knee is a prevalent and painful condition increasing with age. The aim of this, the first well-controlled randomized controlled trial, was to evaluate the efficacy and safety of co-administered Traumeel1 (Tr14) and Zeel1 (Ze14) in patients with knee osteoarthritis (OA) experiencing moderate-to-severe pain. Methods This was a double-blind, multi-center, randomized, saline-controlled trial. Eligible patients meeting the American College of Rheumatology criteria for knee OA were randomized to 3, weekly intra-articular Tr14/Ze14 (n = 119) or saline (n = 113) injections. Primary efficacy endpoint was knee pain change from baseline (day 1) to end-of-study visit (day 99), as measured by the WOMAC Pain Subscore. Secondary endpoints included measures of WOMAC OA Index total and subscores, 50-foot walk test, and patient (PGA) and physician (PhGA) global assessments. Safety was assessed by vital signs, treated knee examinations, adverse events (AEs), and concomitant medications use. Effect sizes were calculated post hoc for consistency with published meta-analyses of standard-of-care treatments. Results 232 patients were randomized with no significant baseline differences. For the primary endpoint Tr14/Ze14 was significantly superior to saline (−32.0 vs. −25.5; p = 0.0383, 95% CI for difference: −12.40, −0.35). WOMAC and 50-foot walk pain measures showed statistically significant efficacy for pain relief over study days 15–99 (except Day 29). Safety profile showed no serious adverse events related to the treatment. PhGA indicated significant improvement for Tr14/Ze14 on Days 29, 71 and Day 85. Conclusion In this study, intra-articular Tr14/Ze14 provided significant pain relief compared to saline-control throughout the observation period. Treatment effect sizes were clinically relevant, since these were comparable to those reported for standard-of-care treatments. The safety profile was benign.

KW - Homeopathic medicinal product

KW - Intra-articular injections

KW - Knee joint

KW - Osteoarthritis of the knee

KW - Pain

KW - Randomized controlled trial

KW - Tr14

KW - Traumeel

KW - WOMAC

KW - Ze14

KW - Zeel

UR - http://www.scopus.com/inward/record.url?scp=85026852047&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85026852047&partnerID=8YFLogxK

U2 - 10.1016/j.eujim.2017.07.005

DO - 10.1016/j.eujim.2017.07.005

M3 - Article

AN - SCOPUS:85026852047

VL - 13

SP - 54

EP - 63

JO - European Journal of Integrative Medicine

JF - European Journal of Integrative Medicine

SN - 1876-3820

ER -