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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

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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Fig4: 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.

Mentions: Joint space narrowing, within the knee joint during treatment with intra-articular administration of SBCG1 and SBCG2 is shown in Figure 4. After the 12 month-period of treatment there was a significant decrease in joint-space width of −0.37 (95% CI: −0.64, −0.10) mm in SBCG1 group, and there was no significant change in SBCG2 group: 0.15 (−0.33, 0.63) mm. The mean joint space change of SBCG2 was significantly higher than SBCG1 group after 4 and 18 months.Figure 4


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)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig4: 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.
Mentions: Joint space narrowing, within the knee joint during treatment with intra-articular administration of SBCG1 and SBCG2 is shown in Figure 4. After the 12 month-period of treatment there was a significant decrease in joint-space width of −0.37 (95% CI: −0.64, −0.10) mm in SBCG1 group, and there was no significant change in SBCG2 group: 0.15 (−0.33, 0.63) mm. The mean joint space change of SBCG2 was significantly higher than SBCG1 group after 4 and 18 months.Figure 4

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