title: 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.
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
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00977444 September 11, 2009.
authors.affiliation: Cindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. sgarcia@cindetecresearch.org.
authors.forename: Sandra
authors.initials: S
authors.lastname: García-Padilla
authors.affiliation: Nucitec S.A. de C.V, Santiago de Querétaro, Mexico. mduarte@nucitec.com.
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Duarte-Vázquez
authors.affiliation: Cindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. kareladonai@hotmail.com.
authors.forename: Karla Elena
authors.initials: KE
authors.lastname: Gonzalez-Romero
authors.affiliation: Cindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. maria.delcarmen.caamano@uaq.mx.|Universidad Autónoma de Querétaro, Santiago de Querétaro, Mexico. maria.delcarmen.caamano@uaq.mx.
authors.forename: María del Carmen
authors.initials: Mdel C
authors.lastname: Caamaño
authors.affiliation: Cindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. jlrosado@prodigy.net.mx.|Universidad Autónoma de Querétaro, Santiago de Querétaro, Mexico. jlrosado@prodigy.net.mx.
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Rosado
mesh_terms: D000328:Adult; D002125:Calcium Gluconate / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D017693:Sodium Bicarbonate / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D017693:Sodium Bicarbonate; D002125:Calcium Gluconate