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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

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.
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Fig3: 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.

Mentions: Baseline values and unadjusted and adjusted mean changes of the Lequesne functional index subscales and global scores at different time points until 18 months are shown in Table 3. After 12 months of treatment, patients in both groups showed a significant improvement in all score subscales, for SBCG1 and SBCG2 groups, there was a 74% and 69% reduction in pain, 74% and 71% improvement in maximum walking distance and 65% and 56% improvement in the daily activities subscale, respectively. Figure 3 shows the changes in Lequesne´s functional Index along the study period. During the first 3 months of intervention the Lequesne´s functional index score decreased substantially and from month 4 to month 12 the improvement was maintained. After intervention period there was a reduction in the Lequene´s total score of about 68% and 69% with SBCG1 and SBCG2 groups, respectively, compared with baseline values. There was no difference within treatments during intervention and post-intervention period.Table 3


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)

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

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

Fig3: 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.
Mentions: Baseline values and unadjusted and adjusted mean changes of the Lequesne functional index subscales and global scores at different time points until 18 months are shown in Table 3. After 12 months of treatment, patients in both groups showed a significant improvement in all score subscales, for SBCG1 and SBCG2 groups, there was a 74% and 69% reduction in pain, 74% and 71% improvement in maximum walking distance and 65% and 56% improvement in the daily activities subscale, respectively. Figure 3 shows the changes in Lequesne´s functional Index along the study period. During the first 3 months of intervention the Lequesne´s functional index score decreased substantially and from month 4 to month 12 the improvement was maintained. After intervention period there was a reduction in the Lequene´s total score of about 68% and 69% with SBCG1 and SBCG2 groups, respectively, compared with baseline values. There was no difference within treatments during intervention and post-intervention period.Table 3

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