Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial

Chopra, Arvind; Saluja, Manjit; Tillu, Girish; Sarmukkaddam, S; Venugopalan, Anuradha; Narsimulu, G; Handa, Rohini; Sumantran, Venil N.; Raut, Atul; Bichile, Lata; Joshi, Kalpana; Patwardhan, Bhushan

doi:10.1093/rheumatology/kes414

Cited by 89 publications

(70 citation statements)

References 23 publications

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“…A comparison of Ayurvedic formulations (extracts of Tinospora cordifolia , Zingiber officinale , Emblica officinalis and Boswellia serrata ), glucosamine sulfate 2 g daily and celecoxib 200 mg daily in 440 Indian patients with knee OA over a 24‐week period showed that pain relief was within the equivalence range. However, seven patients using Ayurvedic intervention were withdrawn due to increased serum glutamic pyruvic transaminase, which normalized when the intervention was stopped 24. These findings indicate that safety assessments of alternative medications are warranted, together with a definition of bioequivalence of efficacy in clinical studies.…”

Section: Discussionmentioning

confidence: 97%

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

et al. 2015

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AimTo compare the efficacy, tolerability and safety of celecoxib, naproxen and placebo in Asian patients with osteoarthritis (OA) of the knee.MethodPatients of Asian descent with knee OA, aged ≥ 45 years, in a flare state with a functional capacity classification of I–III, received celecoxib 200 mg once daily, naproxen 500 mg twice daily or placebo, for 6 weeks. The change in Patient's Assessment of Arthritis Pain (week 6 vs. baseline) was the primary endpoint. Secondary endpoints, including Patient's and Physician's Global Assessments of Arthritis, Western Ontario and McMaster Universities OA Index (WOMAC), use of complementary and alternative medicines, incidence of treatment‐emergent adverse events (TEAEs) and measurements of upper gastrointestinal tolerability, were also assessed.ResultsThree hundred and sixty‐seven patients were randomized: 145 to celecoxib, 144 to naproxen and 78 to placebo. Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline in visual analogue scale score [standard error] −37.1 [2.0] for celecoxib and −37.5 [2.0] for naproxen). Patient's and Physician's Global Assessment of Arthritis, WOMAC scores, Pain Satisfaction Scale and Patient Health Questionnaire‐9 showed statistically significant improvement in active treatment groups versus placebo, with the exception of naproxen WOMAC scores. Treatment‐related TEAEs occurred in 19 (13%), 34 (24%) and six (8%) patients in the celecoxib, naproxen and placebo groups, respectively.ConclusionCelecoxib and naproxen were comparable in their effects to reduce the signs and symptoms of knee OA in Asian patients. Celecoxib was shown to be safe and well tolerated in this patient population.

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Section: Discussionmentioning

confidence: 97%

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

et al. 2015

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“…[21] As one of the ingredient in polyherbal formulation, Boswellia serrata significantly reduced knee pain and improved knee function which were equivalent to glucosamine and celecoxib in a 6-month controlled study of knee OA. [22] In another ayurvedic study, a formulation (containing Curcuma longa and Boswellia serrata extracts) at 500 mg administered twice a day demonstrated to be more effective compared to celecoxib 100 mg twice a day for symptom scoring and clinical examination with good safety in OA patients. [23] In the present study, Boswellia serrata also has demonstrated a significant analgesic activity when compared to placebo even when administered as a single dose with good safety and tolerability.…”

Section: Discussionmentioning

confidence: 99%

A randomized, double blind, placebo controlled, cross over study to evaluate the analgesic activity of Boswellia serrata in healthy volunteers using mechanical pain model

et al. 2014

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Objective:Experimental pain models in human healthy volunteers are advantageous for early evaluation of analgesics. All efforts to develop nonsteroidal anti-inflammatory drugs (NSAIDs) which are devoid of gastrointestinal and cardiovascular system effects are still far from achieving a breakthrough. Hence we evaluated the analgesic activity of an ayurvedic drug, Boswellia serrata by using validated human pain models which has shown its analgesic activity both in-vitro and preclinical studies to evaluate the analgesic activity of single oral dose (125 mg, 2 capsules) of Boswellia serrata compared to placebo using mechanical pain model in healthy human subjects.Materials and Methods:After taking written informed consent, twelve healthy subjects were randomized (1:1) to receive single oral dose of Boswellia serrata (Shallaki®) 125 mg, 2 capsules or identical placebo in a crossover design. Mechanical pain was assessed using Ugo basile analgesymeter (by Randall Selitto test) at baseline and at 1 hr, 2 hrs and 3 hrs after test drug administration. Pain Threshold force and time and Pain Tolerance force and time were evaluated. Statistical analysis was done by paired t-test.Results:Twelve healthy volunteers have completed the study. Mean percentage change from baseline in Pain Threshold force and time with Boswellia serrata when compared to placebo had significantly increased [Force: 9.7 ± 11.0 vs 2.9 ± 3.4 (P = 0.05) and time: 9.7 ± 10.7 vs 2.8 ± 3.4 (P = 0.04)] at third hr. Mean Percentage change from baseline in Pain Tolerance force and time with Boswellia serrata when compared to placebo had significantly (P ≤ 0.01) increased at 1 hr, 2 hrs and 3 hrs.Conclusion:In the present study, Boswellia serrata significantly increased the Pain Threshold and Pain Tolerance force and time compared to placebo. Both study medications were well tolerated. Further multiple dose studies may be needed to establish the analgesic efficacy of the drug.

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“…For continuous outcomes with no standard deviation reported, we calculated standard deviations (SD), if possible, from standard errors (SEM), P values, or CIs. For four studies we converted the VAS data from a 10 cm scale to a 100 mm scale (Chopra 2013; Gupta 2011; Kuptniratsaikul 2011; Piscoya 2001), and for three studies we converted SEM to SD (Huber 1991; Maheu 2013; Piscoya 2001). …”

Section: Methodsmentioning

confidence: 99%

Oral herbal therapies for treating osteoarthritis

Cameron

Chrubasik

2014

Cochrane Database of Systematic Reviews

104

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Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial

Abstract: Clinical Drug Trial Registry-India, www.ctri.nic.in, CTRI/2008/091/000063.

Cited by 89 publications

References 23 publications

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

A randomized, double blind, placebo controlled, cross over study to evaluate the analgesic activity of Boswellia serrata in healthy volunteers using mechanical pain model

Oral herbal therapies for treating osteoarthritis

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