Phyllanthus niruri Linn increase infiltrating lymphocyte and apoptosis of rectosigmoid cancer patients: A Phase II Clinical Trial

Background: Phyllanthus niruri Linn ( PNL) extract has potential cytotoxic effects on colorectal cancer in both in vitro and in vivo studies, but this has never been reported in human subjects. The purpose of this study is to elaborate whether PNL extract also has cytotoxic effects on human colorectal cancer. Method: A one-group pre- and post-test analysis was conducted on 15 patients with non-obstructive operable rectosigmoid cancer without neo-adjuvant chemotherapy or chemoradiation. Before commencing treatment using PNL extract (100 mg Stimuno), all patients underwent rectoscopy biopsy. Stimuno treatment was given for at least 14 days and later patients underwent rectal resection. Specimens from biopsy and rectosigmoid resection were managed by the Department of Anatomical Pathology, Faculty of Medicine, Gajahmada University, Yogyakarta, for evaluating the diagnosis, infiltrating lymphocyte, apoptosis index, perforin, and granzyme-B and caspase-3 expression. A paired t-test was done to evaluate the significant increase in measured variables, and a linear regression analysis was also done to evaluate the role of individual variables. Result: Infiltrating lymphocyte; expression of perforin, granzyme-B, and caspase-3; and apoptosis index significantly (p = 0.000) improved after the treatment using PNL extract. After conducting the linear regression analysis, we found that the only variable that significantly correlated with apoptosis was infiltrating lymphocyte. Conclusion: Use of PNL extract increased the apoptosis index of colorectal cancer through an increase in infiltrating lymphocyte.