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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.

García-Padilla S, Duarte-Vázquez MA, Gonzalez-Romero KE, Caamaño Mdel C, Rosado JL - BMC Musculoskelet Disord (2015)

Bottom Line: 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.Both SBCG interventions were well tolerated after 12 months of treatment 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.

View Article: PubMed Central - PubMed

Affiliation: Cindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. sgarcia@cindetecresearch.org.

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.

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Related in: MedlinePlus

Flow of patients through the study.
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Related In: Results  -  Collection

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Fig1: Flow of patients through the study.

Mentions: A total of 123 patients were initially screened for the study between December 2007 and February 2008, 50 did not meet the inclusion criteria or refused to participate. A total of 74 subjects were randomly assigned to one of the two treatment groups, one refused to receive the allocated intervention, 21 refused to continue at some point during the trial due to personal reasons and 1 due to a rash that according with the physician should not continue with the treatment. Thus, 51 patients finished the intervention and follow up period (Figure 1).Figure 1


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.

García-Padilla S, Duarte-Vázquez MA, Gonzalez-Romero KE, Caamaño Mdel C, Rosado JL - BMC Musculoskelet Disord (2015)

Flow of patients through the study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4493958&req=5

Fig1: Flow of patients through the study.
Mentions: A total of 123 patients were initially screened for the study between December 2007 and February 2008, 50 did not meet the inclusion criteria or refused to participate. A total of 74 subjects were randomly assigned to one of the two treatment groups, one refused to receive the allocated intervention, 21 refused to continue at some point during the trial due to personal reasons and 1 due to a rash that according with the physician should not continue with the treatment. Thus, 51 patients finished the intervention and follow up period (Figure 1).Figure 1

Bottom Line: 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.Both SBCG interventions were well tolerated after 12 months of treatment 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.

View Article: PubMed Central - PubMed

Affiliation: Cindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. sgarcia@cindetecresearch.org.

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.

Show MeSH
Related in: MedlinePlus