Our clinical data further support existing in vitro and in vivo evidence of the safety of Undaria and Spirulina (Belay 2002; Beppu et al. 2009; Chung et al. 2010; Kim et al. 2010a, b). Our sample size was too small to make any generalizations about efficacy, but the two subjects followed for at least a year showed either improvement or stability. For the subject who remained stable, her life events during that time included unemployment, family losses, and homelessness, all thought to contribute to social stresses associated with declining health.
No previous studies have been conducted using seaweed supplements in people with HIV, but there have been a few clinical trials conducted using Undaria sp./Alaria sp. that support algae as nontoxic and potentially health-enhancing for humans. Hata and colleagues reported improvements in the blood pressure of 18 elderly Japanese patients receiving 3.3 g day−1 additional Undaria (Hata et al. 2001). Similarly, an 8-week study investigating the impact of consuming 4 or 6 g day−1 of Undaria in 27 men and women reported a significant decrease in systolic blood pressure (Teas et al. 2009a). Irhimeh compared the impact of 75% Undaria fucoidan (3 g day−1) on clotting time in a randomized single-blinded placebo-controlled (guar gum) trial in 20 healthy volunteers followed for 12 days (Irhimeh et al. 2009), and the trial reported normal clinical parameters.
Clinical data also are available for the closely related Alaria esculenta. In 30 healthy postmenopausal women who consumed placebo (maltodextrin) or 5 g day−1Alaria for 8 weeks in conjunction with a soy supplement, there was a significant improvement in estrogen, phytoestrogen, and insulin-like growth factor metabolism, but no impact on thyroid function was observed (Teas et al. 2007, 2009b, 2011).
A clinical trial of 20 people with type 2 diabetes given half Undaria sp. and half Laminaria japonica supplement for 4 weeks improved glycemic control, lowered blood lipids, and increased serum antioxidant activities (Kim et al. 2008). Evidence that fucoidan has specific antiviral properties comes from two clinical trials. In the first, 21 patients with herpes infection consumed an Undaria high fucoidan supplement and reported increased rates of healing and decreased reactivation of viral symptoms (Cooper et al. 2002).
Perhaps of the most relevance to this study, Araya and colleagues conducted a trial using fucoidan in 13 patients with human T-lymphotropic virus type 1-associated neurological disease. Subjects were given 6 g day−1 fucoidan and followed for 6–13 months. Outcome variables were inhibition of cell-to-cell transmission of HTLV-1 in vitro and a 42% decrease in proviral serum concentration. The only toxicity observed was that four patients experienced diarrhea while on fucoidan which resolved when fucoidan treatment ceased. No effect was observed on the host immune cells.
Several studies have included Spirulina supplements to improve immune function in children with HIV (Simpore et al. 2005, 2007), and it has been determined that a minimum dose of 10 g day−1 was needed for children (Simpore et al. 2007). As our study only provided 5 g day−1 for adults, we almost certainly did not give enough Spirulina to properly test its effectiveness against HIV or its immune-enhancing properties in people with HIV. On the other hand, the dose (5 g day−1) of seaweed and the combined dose of seaweed plus Spirulina may have been synergistic and adequate to achieve stability of immune response and viral load. More research is needed before a therapeutic dose can be established, especially for Spirulina.
In studies that have used the MOS-HIV questionnaire, the same magnitude of differences (7% in general health and 5% in mental health) distinguished people with an AIDS-defining health event and those who remained free of opportunistic infection (Wu et al. 1997). Although we did not collect information on comorbidities, based on comments of participants, part of their perceived quality of life improvements were related to getting sick less often, and for subject 7, absence of esophageal reflux when taking the algae supplements.
Drug development is driven nearly exclusively by financial backing of pharmaceutical industry interests; the corollary is that a food that can be purchased in a grocery store has no patentable possibilities. Additionally, there are cultural values associated with algae that give it high value in some countries, notably Japan and Korea, but low value in other countries like the USA and Europe. Our intention had been to include 12 subjects in each treatment arm. However, our study was limited by lack of physician interest. Only one physician we approached had any real interest in nontoxic natural alternatives for her patients with HIV who showed signs of failing health but who did not yet qualify for ARV. When she left the community health clinic, none of her colleagues had any interest in non-pharmaceutical therapies. In the absence of such collaboration, we can only conclude that algal supplementation appeared to be safe and improved the quality of life of the subjects with HIV who did participate in our study, but there may be strong physician resistance to non-pharmaceutical alternatives for patients in resource-rich countries.
Dietary algae may offer immediate support for people with HIV who do not have access to ARV as well as provide new options for future drug development. Additionally, maintaining stable health indicators, especially for people with HIV who have declining health, may be a desirable objective leading to prolongation of the time between HIV infection and AIDS-defining illnesses. Based on our findings and those from other clinical trials using Undaria sp. as well as in vitro and in vivo evidence of nontoxicity, we propose that dietary Undaria and the combination of Undaria and Spirulina are safe to use in a phase III randomized placebo-controlled clinical trial to test for efficacy against HIV/AIDS and its associated opportunistic infections.