Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial

Abstract

Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) possesses anti-inflammatory effects, attributed to the main constituent andrographolide proposed as alternative in the treatment of autoimmune disease. A prospective, randomized, double blind, and placebo-controlled study in patients with rheumatoid arthritis (RA) was performed. Tablets (Paractin) made of an extract of A. paniculata (30% total andrographolides) were administered three times a day for 14 weeks, after a 2-week washout period to 60 patients with active RA. The primary outcomes were pain intensity measured using a horizontal visual analog pain scale (VAPS). In addition, ACR, EULAR, and SF36 clinical parameters were recorded. The intensity of joint pain decreased in the active vs placebo group at the end of treatment, although these differences were not statistically significant. A significant diminishing for week in tender joint -0.13 95% confidence interval (CI; -0.22 to 0.06; p = 0.001), number of swollen joints -0.15 95%CI (-0.29 to -0.02; p = 0.02), total grade of swollen joint -0.27 95%CI (-0.48 to -0.07; p = 0.010), number of tender joints -0.25 95%CI (-0.48 to -0.02; p = 0.033), total grade of swollen joints -0.27 95%CI (-0.48 to -0.07; p = 0.01), total grade of tender joints -0.47 95%CI (-0.77 to -0.17; p = 0.002) and HAQ -0.52 95%CI (-0.82 to -0.21; p < 0.001) and SF36 0.02 95%CI (0.01 to 0.02; p < 0.001) health questionnaires was observed within the group with the active drug. Moreover, it was associated to a reduction of rheumatoid factor, IgA, and C4. These findings suggest that A. paniculata could be a useful "natural complement" in the treatment of AR; however, a larger trial and a more extended period of treatment is necessary in order to corroborate these results.

Andrographolide Ameliorates Abdominal Aortic Aneurysm Progression by Inhibiting Inflammatory Cell Infiltration through Downregulation of Cytokine and Integrin Expression

“…Consistent with prior studies, no differences in body weight and appearance were noticed between Andro-and solvent-treated mice. The safety of Andro is supported by a phase II clinical study of rheumatoid arthritis patients, which revealed that A. paniculata tablets containing 30 mg of andrographolide (three times a day for 14 weeks) were well tolerated and significantly more effective in reducing symptoms and serological parameters of the disease (Burgos et al, 2009). However, higher doses of Andro (4-6 mg/kg body weight, oral administration) may cause isolated cases of allergic reactions, tiredness, headache, pruritus/rash, diarrhea, nausea, metallic taste, bitter taste, and dry tongue (Coon and Ernst, 2004).…”

Andrographolide a New Potential Drug for the Long Term Treatment of Rheumatoid Arthritis Disease

“…The effect was associated to a reduction of rheumatoid factor, IgA, and C4. The study concludes that the drug was significantly effective in reducing symptoms and serological parameters of the disease and therefore useful as natural complement in the treatment of Rheumatoid Arthritis [80].…”

“…In the literature, side effects associated with A. paniculata or andrographolide, administered in higher doses (4-6mg/kg), have caused isolated cases of allergic reactions, tiredness, headache, pruritus/rash, diarrhea, nausea, metallic taste, bitter taste, dry tongue, eyes sensitive to light, decreased short-term memory, dizziness, heartburn, tender lymph nodes, and lymphadenopathy [89]. None of these effects were observed in Rheumatoid Arthritis patients after 14 weeks of treatment [80].…”

“…Moreover, treatment with DMARDs reduces the level of IgM and IgA Figure 4. Effect of A. paniculata extract (Paractin®) on tender joints, total grade of tender joints and rheumatoid factor [80].…”

“…During all duration of this treatment, two tablets were given before meals three times a day. This dosage regimen was determined in previous preclinical and clinical trials with the pure compound and other commercially available A. paniculata extracts [80,83]. The content of these compounds was evaluated by HPLC using reference standards as described elsewhere [92].…”