Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial

Sandra García-Padilla, Miguel Angel Duarte-Vázquez, Karla Elena Gonzalez-Romero, María del Carmen Caamaño, Jorge L Rosado, Sandra García-Padilla, Miguel Angel Duarte-Vázquez, Karla Elena Gonzalez-Romero, María del Carmen Caamaño, Jorge L Rosado

Abstract

Background: A novel therapeutic management of osteoarthritis (OA) of the knee was assessed. The study aimed to evaluate the effect of monthly sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate injections on OA of the knee; as well as the efficacy and safety of both SBCG interventions in the long term.

Methods: A double-blind parallel-group clinical trial with 74 knee OA patients was performed during 12 months, both SBCG interventions were followed-up for another 6mo after intervention. The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC), the Lequesne's functional index and joint-space width changes from serial radiographs.

Results: After 12 months, group SBCG1 decreased -14.8 (95% CI:-14.2, -17.0) and group SBCG2 decreased -14.6 (-16.9, -12.4) in the global WOMAC score, the mean changes represent 80% and 82% lessened pain, respectively. In the Lequesne Functional Index scale, SBCG1 decreased -11.9 (-10.4, -14.2) and SBCG2 decreased -11.9 (-13.8, -10.0), representing 66 and 69% of improvement. Both mean scores were maintained after intervention discontinued. SBCG2 improved the knees' joint space width more than SBCG1 at 3 and 18 months. Both SBCG interventions were well tolerated after 12 months of treatment

Conclusion: A solution of sodium bicarbonate and calcium gluconate is effective on reducing the symptoms associated with OA. Its beneficial effect is maintained for one year of continuous monthly administration and at least for 6 months after the administration is discontinued. When the dose of calcium gluconate is increased, it prevents further narrowing of joint-space.

Trial registration: Clinicaltrials.gov NCT00977444 September 11, 2009.

Figures

Figure 1
Figure 1
Flow of patients through the study.
Figure 2
Figure 2
Monthly changes in WOMAC pain index by treatment group. Means (±SEM) are adjusted for baseline values. All post-treatment measurements were significantly different from baseline value. There were no significant differences between treatments.
Figure 3
Figure 3
Monthly changes in Lequesne´s functional index by treatment group. Means (±SEM) are adjusted for baseline values. All post-treatment measurements were significantly different from baseline value. There were no significant differences between treatments.
Figure 4
Figure 4
Joint space width changes in patients completing the intervention and 6 months follow-up. Errors bars represent SEM. *Different to baseline value in Paired T-test (p < 0.05). ƗSignificantly different from SBCG2 in a Generalized Estimating Equation model that considered the correlation between both knees from each subject, and also considered the baseline evaluation values as a covariate.

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