Abstract
BackgroundA 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.MethodsA 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.ResultsAfter 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 treatmentConclusionA 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 registrationClinicaltrials.gov NCT00977444 September 11, 2009.
Highlights
A novel therapeutic management of osteoarthritis (OA) of the knee was assessed
Besides surgery, which is recommended for severe cases, there are a wide variety of OA therapies commonly used: Non-pharmacological treatments are mainly aimed to unload the joint, such as García-Padilla et al BMC Musculoskeletal Disorders (2015) 16:114 weight loss or the use of lateral wedge insoles for medial OA of the knee; and pharmacological therapies which include analgesics, nonsteroidal anti-inflammatory drugs (NSAIDS), opioids, hyaluronic acid (HA) or corticosteroid injections and various drugs purported as diseasemodifying osteoarthritis drugs (DMOADs) [3]
HA injections may lead to increase medial co-contraction and accelerate joint deterioration [7]. Corticosteroid injections, they have not demonstrated to change the functionality of the knee, they are associated with reductions in knee pain over 2 weeks, these clinical improvements disappear by 4 weeks [8] and it is unsafe to inject it more than 4 times per year [9]
Summary
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. Besides surgery, which is recommended for severe cases, there are a wide variety of OA therapies commonly used: Non-pharmacological treatments are mainly aimed to unload the joint, such as García-Padilla et al BMC Musculoskeletal Disorders (2015) 16:114 weight loss or the use of lateral wedge insoles for medial OA of the knee; and pharmacological therapies which include analgesics, nonsteroidal anti-inflammatory drugs (NSAIDS), opioids, hyaluronic acid (HA) or corticosteroid injections and various drugs purported as diseasemodifying osteoarthritis drugs (DMOADs) [3]. According to a recent review of knee OA therapeutic responses, HA injections, corticosteroids injections and opioids have demonstrated the highest effect of the recommended treatments [4]. None of these interventions have demonstrated to halt the disease progression. Therapies appear to be misdirected and a different approach should be used to evaluate different alternatives
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