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Kusum et al conducted a Phase I/II study to evaluate the preliminary efficacy and safety of a mixture of Chinese herbal extracts for treatment of HIV infection among people living with HIV/AIDS (PLWHA).  The Chinese herbal extract used was a preparation of the "SH drug," which itself was a herbal preparation composed of 5 Chinese medicinal plants extracts developed by the Kunming Institute of Botany in Kunming, China.  SH has been used as a tonic solution among Chinese people and PLWA for more than 10 years.  SH consists of extracts from the following herbs: Glycyrrhiza glaba L., Artemisia capillaris Thumb., Morus alba L., Astragalus membranaceus, and Carthamus tinctorius L.

Details of the study

• Of the 90 subjects screened, 28 met the criteria and were enrolled in the study.  22 subjects were female; the mean age was 34.
• Inclusion criteria: 18 years old or older; HIV-1 mRNA load of 20,000 copies/ml or CD4 count not lower than 200 cell/ml; no prior AIDS-defining illness.
• Exclusion criteria: pregnancy, breast-feeding, unwilling to avoid pregnancy for the duration of the trial, allergy to sulfamethoxazole/trimetroprim (SMX/TMP), and having conventional anti-HIV-1 mediation within 6 months of entry or planning to have it during the study
• Subjects were prescribed 12 weeks of SH suspension 5 grams or 30ml orally in 3 divided doses after meals plus a tablet of SMX/TMP 400/80 mg once daily after breakfast for the prophylaxis of pneumocystis carrinii pneumonia
• After the treatment period, subjects were followed up until 20 weeks (a prospective study), disease progression was observed (by means of CD4 and viral mRNA counts) and adverse event were reported by patients.
• Analysis of Data was done as follows:
• Viral mRNA load was measured at 0 (baseline) 2,4,6,8,10,12 and 20 weeks.  Mean mRNA loads were 4.94 (baseline), 4.79, 4.78, 4.76, 4.66, 4.82, 4.83, and 4.76, respectively.  The graph below shows the reduction of viral load compared to baseline over the treatment period.  For example, at week 2, the change from baseline (4.94) was 4.94 - 4.79 = -0.15

• The above numbers are the means of viral mRNA loads.  The researchers also analyzed the data in a different way, looking at the absolute decreases of each patient.  The patients were put into three categories based on their mRNA changes: 1)more negative that -0.5,  2)  -0.5 to +0.5, and 3) greater than +0.5 log units.  Changes in mRNA were assessed at each clinic visit (2,3,6 etc weeks) and placed into these categories. 
• The majority of patients were in the 2) category, while the portion of subjects in the 1) category ranged between 14% - 35% at different times during the trial.  This is important because a 0.5 log unit decrease defines a significant effect.  See the critique section.
• The CD4 counts of week 0, 4, 8, 12, and 20 fluctuated within the baseline of 382.1 - 404.2, which was no significant change. 
• Study Conclusion: the herbal treatment of AIDS is "safe in terms of adverse reactions and side effects...The present result challenged and warranted further clinical trials of SH drugs in a larger number of HIV infected subjects in conjunction with other antiretroviral agents for a longer treatment period."
• Critique