AL study- traditional Chinese medicine combination Astragalus membranaceus and Ligustrum lucidum in people with advanced malignancy: research protocol for an open labelled pilot study

Abstract

Background: AL is a traditional Chinese medicine (TCM) combination commonly used as an adaptogen to improve energy levels, immunity and quality of life in those suffering from chronic diseases such as cancer. While the combination Astragalus membranaceus and Ligustrum lucidum (AL) has been investigated in China as an adjunct to standard anticancer therapies in numerous clinical studies of variable quality reported in the Chinese literature, independent assessment of its effects on safety, tolerability and efficacy are lacking. Our objectives are to determine the safety and tolerability of AL and investigate its effects on inflammation, quality of life and immunity in people with advanced malignancy in the Australian healthcare setting. Methods: The AL study is a prospectively registered, open labelled pilot multi-centre study investigating AL in people with advanced malignancy. Inclusion criteria include participants with recurrent or metastatic cancer who are not undergoing chemotherapy or palliative chemotherapy. All participants (n=25) will receive 6 capsules of AL twice daily (equivalent to 25g raw herb) for 12 weeks. Follow up consultations will monitor safety, tolerability, quality of life, immune function and adverse events. Participants will be assessed at baseline and at weeks 3, 6, 9 and 12. The primary outcome will determine the effect of AL on safety and tolerability. Secondary outcomes will include inflammation, quality of life, immune function, disease status and survival. Appropriate statistical analysis will be conducted on the pilot study data. Potential associations will be investigated where relevant. Conclusions: This study will firstly establish the safety and tolerability of this TCM combination "AL" in people with advanced malignancy in the Australian healthcare system and provide important information regarding its effect on markers that may affect survival as well as explore changes in quality of life and immune function. The impact of this research may allow the design of future studies integrating AL with standard therapy for people with advanced malignancy.

Long-Term Complete Remission of a Patient With Double-Hit Diffuse Large B-Cell Lymphoma Treated by Chemoimmunotherapy and Chinese Herbal Medicine

“…13 In the herbal granules used, the combination of Astragalus membranaceus and Ligustrum lucidum (AL) have been used for boosting immune functions and vital energy of cancer patients based on many pre-clinical and clinical research. 14 …”

“…13 In the herbal granules used, the combination of Astragalus membranaceus and Ligustrum lucidum (AL) have been used for boosting immune functions and vital energy of cancer patients based on many pre-clinical and clinical research. 14 Apart from SJZ and AL, some Chinese herbs with anticancer actions for lymphoma were added to the prescriptions for this case. Prunella vulgaris (PV) is a commonly used Chinese herb for lymphoma.…”