Background: Astragalus membranaceus and Ligustrum lucidum (AL) has been widely used in traditional Chinese medicine in adjunct to standard anti-cancer therapies.
Aim: Investigate the safety and tolerability of AL and effect on inflammation, QOL and immune function in patients with advance malignancies.
Method: This open-label prospective observational pilot study (ACTRN 12615001203549)1 recruited patients with recurrent or metastatic malignancies not on chemotherapy to receive 6 capsules twice daily of AL (Zhenqi Fuzheng Capsules, Gansu Fuzheng Pharmaceuticals, equivalent to 25 g of native drug) for 12 weeks. Patients were assessed at weeks 3, 6, 9 and 12 for safety and tolerability. Secondary outcomes included changes in inflammatory and immunological markers, QOL (FACT-G, FACT-F and GHQ scores) and disease progression.
Results: Of the 25 patients enrolled, 96% had stage IV disease. 17(68%) patients completed 12 weeks; 47% of these patients continued further. Physician’s assessment found 84% had tolerated the treatment well after 12 weeks. Lack of therapeutic effect was the reason for cessation in 80%; 4 ceased due to adverse events (AE). 75% had proven disease progression at week 12. 89.1% of AEs were grade 1 or 2 and majority were gastrointestinal (52.5%). Three developed venous thromboembolism and one with known liver metastases developed hepatic derangement. Tumour markers overall remained stable over 12 weeks while 5 had downtrending markers. Neutrophil-to-Lymphocyte ratio was unchanged ((mean ± SEM) 3.4 ± 0.4 baseline, 5.0 ± 1.6 week 12). Regulatory T cells, measuring immunological response, did not change (4.6 ± 0.7 baseline, 4.1 ± 0.6 week 12). No significant differences were found in QOL scores in FACT-G (-5.1 ±6.8), FACT-F (-1.7 ± 6.5) or GHQ (0.1±1.7).
Conclusion: AL was well tolerated and most AEs were mild with no significant impact on inflammatory or tumour markers or disease progression. QOL remained stable. This pilot study could inform an RCT.