BACKGROUNDHIV-infected people and AIDS patients often seek complementary therapies including herbal medicines due to reasons such as unsatisfactory effects, high cost, non-availability, or adverse effects of conventional medicines.OBJECTIVESTo assess beneficial effects and risks of herbal medicines in patients with HIV infection and AIDS.SEARCH STRATEGYElectronic searches included the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, LILACS, Science Citation Index, the Chinese Biomedical Database, TCMLARS; plus CISCOM, AMED, and NAPRALERT; combined with manual searches. The search ended in December 2004.SELECTION CRITERIARandomized clinical trials on herbal medicines compared with no intervention, placebo, or antiretroviral drugs in patients with HIV infection, HIV-related disease, or AIDS. The outcomes included mortality, HIV disease progression, new AIDS-defining event, CD4 cell counts, viral load, psychological status, quality of life, and adverse effects.DATA COLLECTION AND ANALYSISTwo authors extracted data independently and assessed the methodological quality of trials according to randomization, allocation concealment, double blinding, and drop-out.MAIN RESULTSNine randomized placebo-controlled trials involving 499 individuals with HIV infection and AIDS met the inclusion criteria. Methodological quality of trials was assessed as adequate in five full publications and unclear in other trials. Eight different herbal medicines were tested.A compound of Chinese herbs (IGM-1) showed significantly better effect than placebo in improvement of health-related quality of life in 30 symptomatic HIV-infected patients (WMD 0.66, 95% CI 0.05 to 1.27). IGM-1 appeared not to affect overall health perception, symptom severity, CD4 count, anxiety or depression (Burack 1996a). An herbal formulation of 35 Chinese herbs did not affect CD4 cell counts, viral load, AIDS events, symptoms, psychosocial measure, or quality of life (Weber 1999). There was no statistical difference between SPV30 and placebo in new AIDS-defining events, CD4 cell counts, or viral load (Durant 1998) although an earlier pilot trial showed positive effect of SPV30 on CD4 cell count (Durant 1997). Combined treatment of Chinese herbal compound SH and antiretroviral agents showed increased antiviral benefit compared with antiretrovirals alone (Sangkitporn 2004). SP-303 appeared to reduce stool weight (p = 0.008) and abnormal stool frequency (p = 0.04) in 51 patients with AIDS and diarrhoea (Holodniy 1999). Qiankunning appeared not to affect HIV-1 RNA levels (Shi 2003), Curcumin ineffective in reducing viral load or improving CD4 cell counts (Hellinger 1996), and Capsaicin ineffective in relieving pain associated with HIV-related peripheral neuropathy (Paice 2000). The occurrence of adverse effects was higher in the 35 Chinese herbs preparation (19/24) than in placebo (11/29) (79% versus 38%, p = 0.003) (Weber 1999). Qiankunning was associated with stomach discomfort and diarrhoea (Shi 2003).AUTHORS' CONCLUSIONSThere is insufficient evidence to support the use of herbal medicines in HIV-infected individuals and AIDS patients. Potential beneficial effects need to be confirmed in large, rigorous trials.