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

View Article: PubMed Central - PubMed

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

No MeSH data available.


Flow of patients through the study.
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f1-10.1177_1179544116688899: Flow of patients through the study.

Mentions: Of the 161 patients who were screened for the study, 111 met the inclusion criteria and agreed to participate. Participants were randomly assigned to one of the 3 study medications. During the 3-month study, 1 refused to receive the allocated intervention, 9 refused to continue due to personal reasons, 1 developed rashes and stopped the treatment according to the physician’s recommendation, and 4 patients had protocol violations. Thus, 97 patients were included in the “per-protocol” data set analyses (Figure 1).


A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee
Flow of patients through the study.
© Copyright Policy - open-acces
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5385469&req=5

f1-10.1177_1179544116688899: Flow of patients through the study.
Mentions: Of the 161 patients who were screened for the study, 111 met the inclusion criteria and agreed to participate. Participants were randomly assigned to one of the 3 study medications. During the 3-month study, 1 refused to receive the allocated intervention, 9 refused to continue due to personal reasons, 1 developed rashes and stopped the treatment according to the physician’s recommendation, and 4 patients had protocol violations. Thus, 97 patients were included in the “per-protocol” data set analyses (Figure 1).

View Article: PubMed Central - PubMed

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

No MeSH data available.