Preliminary Efficacy and Safety of Oral Suspension SH, Combination of Five Chinese Medicinal Herbs, in People Living with HIV/AIDS ; the Phase I/II Study
Mayura Kusum MD*, Virat Klinbuayaem MD**, Malee Bunjob Msc in Pharm***, Somchai Sangkitporn MD****
Affiliation : * Department of Medical Sciences, Ministry of Public Health ** Sanpatong Hospital, Sanpatong District, Chiang Mai *** Medicinal Plant Research Institute, Department of Medical Sciences **** National Institute of Health, Department of Medical Sciences
Objective : To evaluate the preliminary efficacy and safety of the mixture of drug extracts from 5 Chinese
medicinal herbs (SH), in the treatment of Human Immunodeficiency Virus (HIV) infection among people
living with HIV/AIDS (PLWHA).
Design : Open-label study.
Setting : Sanpatong Hospital, Chiang Mai, Thailand.
Subjects : HIV-1 infected adults with a CD4 cell count of more than 200 cell/mm3 and HIV-1 RNA > 20,000
copies/ml.
Materials and Methods : Patients received an oral suspension of SH, a combination of 5 Chinese medicinal
herbs namely Glycyrrhiza glaba L., Artemisia capillaris Thumb., Morus alba L., Astragalus membrana-
ceus(Fisch.) Bge., Carthamus tinctorius L., 5 g or 30 ml, in 3 divided doses after meals, plus sulfamethozaxole/
trimethoprim, 400/80 mg tablet, once daily after breakfast for 12 weeks. During the treatment and the follow
up period, the absolute CD4 cell count and the plasma HIV-1 RNA were monitored. Adverse events were
observed.
Results : Of the 28 enrolled patients, the number of positive response patients with reduction of plasma HIV-
1 RNA more than 0.5 log during the treatment and follow up period were 4-10 (14.2-35.7%) while the
number of negative response patients who had plasma HIV-1 RNA rising at least 0.5 log were 2-4 (0-14.2%).
The means viral load at week 0 (baseline), 12 and 20 were 4.94, 4.83 and 4.76 log copies/ml, which were
slightly declined. Whilst, the mean absolute CD4 cell count of week 0 (baseline), 4, 8, 12, and 20 fluctuated
within the baseline, range of 382.1, 404.2, 359.4, 404.1, 360.2 cell/mm3, respectively. All subjects had good
compliance without any serious adverse events.
Conclusion : Under the condition used, SH drug therapy is safe. Satisfactory positive response, by decreased
viral load of more than 0.5 log, was found in 14%-35% of HIV-positive patients. However, the immunologic
response, an increase of CD4 cell count was not clearly demonstrated. The clinical benefit of SH needs more
thorough scientific support before being prescribed as adjunctive therapy for treating PLWHA.
Keywords : Efficacy, Safety, SH, Chinese medicinal herbs, People living with HIV/AIDS
