Table 1: Summary of randomized clinical studies of TCM for treating HIV infections and AIDS.

Study
(country)
DesignParticipants ( )TreatmentControlOutcome measuresMain findings

Burack et al. 1996
(US) [13]
Parallel, two arms,
Double-blind trial
Symptomatic patients infected with HIV with decreased CD4 cells (30)Chinese herbal preparation (IGM-1) for 12 weeksPlaceboSymptoms, CD4 cell counts, qulity of life, adverse effectsOverall life satisfaction improved in patients treated with herbs, no difference in CD4 count and symptom severity

Sangkitporn et al. 2005 (Thailand) [14]Muticentre, double-blind, placebo-controlled trialAdults with HIV-1 infection (60)Chinese herbal compound (SH) plus ZDV and ddC for 24 weeksPlacebo plus ZDV and ddc for 24 weeksHIV RNA, CD4 counts, adverse effectsSignificant decrease in HIV RNA levels in SH group than placebo without serious adverse events

Shi and Peng 2003
(China) [15]
Parallel, two arms,
Double-blind trial
Adult patients infected with HIV and AIDS (36)Qiankunning (extracts from 14 herbs) for 7 monthsPlaceboCD4 cell counts, viral loads, adverse effectsSignificant decrease in HIV RNA levels in herb group than placebo. Use of herbs was related to gastroenterological adverse effects.

Wang et al. 2006
(China) [16]
Parallel, double-blind, placebo-controlled trialPatients infected with HIV and AIDS (72)Chinese herbal preparation ZY-4 for 6 monthsPlaceboCD4 cell counts, viral loads, symptom, body weight, adverse effectsSignificant increase of CD4 counts in ZY-4, but not significant difference on symptoms, weight or viral load between groups

Weber et al. 1999
(Switzerland) [17]
Parallel, two arms,
Double-blind trial
Adults infected with HIV with decreased CD4 cells (68)Chinese herbs (35 herbs) for 6 monthsPlaceboAIDS event, CD4 cell counts, viral load, quality of life, adverse effectsNo positive findings for the outcome and herbs associated with adverse effects

Wang et al. 2008
(China) [18]
Parallel, two arms, placebo-controlled
Double-blind
trial
adults infected with HIV, received HAART therapy for 0.5–1 year (100)Chinese herbal preparation Aining Granule (AG) plus d4T, ddI and NVP for 11 monthsplacebo plus d4T, ddI and NVP for 11 monthsSymptoms, CD4 cell counts, viral loads, CD8, IL-2, IL-4, IFN- , adverse effectsSignificant decrease of CD4 counts in placebo group, improvement of symptoms of anepithymia, diarrhea and nausea, but not significant difference on viral load, CD8, IL-2,4 between groups

Jiang et al. 2009
(China) [19]
Parallel, two arms,
controlled
open label trial
Patients who are HIV infection and AIDS with oral candidiasis symptoms (80)Chinese herbal preparation XiaoMi Granule (XMG) plus Nystatin for external use for 2 weeksNystatin for 2 weeksSymptoms of oral candidiasis, adverse effectsSignificant improvement of symptoms of oral candidiasis in herb group, no adverse event was found

Jiang et al. 2011
(China) [20]
Parallel,
double-blind, double dummy trial
Patients who are HIV infection and AIDS with leukopenia symptoms (116)Chinese herbal preparation Jingyuankang Capsule (JC) plus AZT, ddI, NVP and analogue Leucogen Tablets for 6 monthsLeucogen Tablets plus AZT, ddI, NVP and analogue JCPeripheral leukocytes, adverse effectsSignificant increase of peripheral leukocytes without serious adverse events

Xu et al. 2011
(China) [21]
Parallel, double-blind, double dummy trialPatients with AIDS and diarrhea (158)Chinese herbal preparation Xielikang Capsule (XC) plus analogue loperamide for 14 daysLoperamide plus analogue XC for 14 daysSymptoms of diarrhea, adverse effectsImprovement of symptom of diarrhea in herb group

Xie et al. 2008
(China) [22]
Parallel, two arms, placebo-controlled
Single-blind trial
Patients infected with HIV and AIDS with CD4 250–600 cells/mm3 without HAART therapy (102)Aikang Capsule (AC) for 6 months Placebo for 6 monthsCD4 cell countsNo significant difference between groups.

Shao 2008
(China) [23]
Parallel, two arms, placebo-controlled
Double-blind trial
Patients infected with HIV and AIDS
Without HAART therapy (176)
Tangcao Tablets (TT) for 6 monthsPlacebo for 6 monthsCD4 cell counts, viral loads, symptom, body weight, adverse effectsSignificant increase of CD4 counts, CD4/CD8 and weight in herb group, significant decrease of viral load in placebo group, improvement of symptoms in herb group.