Adjuvant Immunotherapy Improves Tuberculosis Outcomes

Jim Kling

November 02, 2010

November 2, 2010 (Vancouver, Canada) — Tuberculosis patients receiving the immunomodulator tinocordin (Tinospora cordifolia, also called Guduchi) in addition to standard therapy showed significant radiologic and clinical improvement, compared with standard therapy alone, according to research presented here at CHEST 2010: American College of Chest Physicians Annual Meeting.

Immunomodulators have been studied in tuberculosis treatment, but have returned mixed results. Guduchi is a herb that grows in India that has been shown to have some immunomodulatory properties. "There were some good experimental results that prompted me to test [tinocordin, a Guduchi extract]," lead investigator and presenter Pramod Sood, MD, senior consultant in intensive care at the Dayanand Medical College in Ludhiana, India, told Medscape Medical News.

The team conducted a prospective randomized controlled trial using a Guduchi preparation called tinocordin. The study involved 100 patients with sputum-positive pulmonary tuberculosis admitted to a tertiary care teaching hospital between January 1999 and April 2000. One group was randomized to receive antitubercular drugs, including rifampicin, isoniazid, ethambutol, and pyrazinamide. The other group received the same antitubercular treatment plus 500 mg tinocordin 3 times per day for the first 2 months of treatment.

The researchers followed patients at 15, 30, and 60 days, assessing them for clinical improvement, weight gain, radiologic improvement, hematologic parameters, sputum conversion, and adverse effects. Patient outcomes were deemed satisfactory after 2 months if they achieved sputum conversion, clinical improvement of greater than 80%, and radiologic improvement greater than 50%.

At 15, 30, and 60 days, clinical improvement was 23%, 48%, and 73%, respectively, in the study group, and 16%, 31%, and 57%, respectively, in the control group. The differences were statistically significant.

In the study group, mean radiologic improvement at 30 days was 26.1% and at 60 days was 55.5%; in the control group, it was 23.24% at 30 days and 46.96% at 60 days (P < .05 at 60 days).

Sputum conversion at 15, 30, and 60 days was achieved by 46%, 74%, and 90% of the study group, respectively; it was achieved by 22%, 58%, and 76% of the control group, respectively (P < .001).

At 2 months, 69.56% of patients in study group had a satisfactory response, compared with 30.61% of the control group. Adverse effects (11%) included constipation (2.17%), rash and itching (4.34%), and increased frequency of micturation (4.34%).

"Tinocordin can be used as an adjuvant immunomodulator along with antitubercular drugs safely in the treatment of tuberculosis," the researchers write in their abstract.

"It offers some potentially exciting information, but it was only done at 1 site, and it needs to be repeated in a larger trial at multiple sites. If we can incorporate something that's fairly low cost, has few side effects, and can improve treatment — particularly the fact that it causes sputum to clear more quickly so patients become less infectious — that could be a big deal," Sandra Willsie, DO, who moderated the session, told Medscape Medical News. Dr. Willsie is medical director at PRA International, which has its corporate headquarters in Raleigh, North Carolina.

The study did not receive commercial support. Dr. Sood and Dr. Willsie have disclosed no relevant financial relationships.

CHEST 2010: American College of Chest Physicians Annual Meeting: Abstract 10463. Presented November 1, 2010.