A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee

María Del Carmen Caamaño, Sandra García-Padilla, Miguel Ángel Duarte-Vázquez, Karla Elena González-Romero, Jorge L Rosado, María Del Carmen Caamaño, Sandra García-Padilla, Miguel Ángel Duarte-Vázquez, Karla Elena González-Romero, Jorge L Rosado

Abstract

Objective: To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis.

Methods: A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index.

Results: After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (-12.5 [-14.3, -10.7]; -9.0 [-11.4, -6.7]) and SBCG2 (-12.3 [-14.3, -10.4]; -8.9 [-10.4, -7.4]) were significantly greater than for MP (-5.0 [-7.2, -2.8]; -3.2 [-4.9, -1.5]) (P < .001).

Conclusions: Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms.

Trial registration: Clinicaltrials.gov NCT00977444.

Keywords: calcium gluconate; joint; knee; osteoarthritis therapy; sodium bicarbonate.

Conflict of interest statement

DECLARATION OF CONFLICTING INTERESTS: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This study was partially funded by Nucitec S.A. de C.V. Dr Miguel Ángel Duarte is an employee at this company and did not receive any compensation for this study. Dr Jorge L Rosado owns shares in this company. They participated in the conception and design of the study and in the revision of the final draft of the manuscript. They were not involved in the fieldwork and did not participate in the data analysis. The other authors are employed at Querétaro State University and/or Cindetec A.C. where the study and data analyses were conducted.

Figures

Figure 1.
Figure 1.
Flow of patients through the study.
Figure 2.
Figure 2.
Monthly changes in Western Ontario-McMaster University Osteoarthritis Index (WOMAC) pain index by treatment group. Mean values (±SEM) are adjusted for baseline values.
Figure 3.
Figure 3.
Monthly changes in the Lequesne functional index by treatment group. Mean values (±SEM) are adjusted for baseline values.

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