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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 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.
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Fig2: 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.

Mentions: Baseline and unadjusted as well as adjusted mean changes of the WOMAC subscales and global scores at different time points until 18 months are shown in Table 2. At the end of the intervention, patients in SBCG1 and SBCG2 groups, showed a significant improvement compared with their baseline values in all WOMAC subscales: 81% and 77% in pain, 92% and 79% in stiffness and 90% and 81% in physical functioning, respectively. The changes in WOMAC total score along the period of treatment are shown in Figure 2. The mean score that decreased at 12 months was maintained 6 months after treatment suspension. There was no difference within treatments during intervention or during post-treatment period.Table 2


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

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

Fig2: 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.
Mentions: Baseline and unadjusted as well as adjusted mean changes of the WOMAC subscales and global scores at different time points until 18 months are shown in Table 2. At the end of the intervention, patients in SBCG1 and SBCG2 groups, showed a significant improvement compared with their baseline values in all WOMAC subscales: 81% and 77% in pain, 92% and 79% in stiffness and 90% and 81% in physical functioning, respectively. The changes in WOMAC total score along the period of treatment are shown in Figure 2. The mean score that decreased at 12 months was maintained 6 months after treatment suspension. There was no difference within treatments during intervention or during post-treatment period.Table 2

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