Lissoni P, Rovelli F, Brivio F, et al. A randomized study of chemotherapy versus biochemotherapy with chemotherapy plus Aloe arborescens in patients with metastatic cancer. In Vivo. 2009;23(1):171-175.
Randomized, open clinical trial
Two hundred forty patients with metastatic bronchial or gastric solid tumors who had not previously undergone chemotherapy: Participants were not considered likely to tolerate intensive chemotherapy due to advanced age, concomitant illness, or poor health as measured by Karnofsky score.
Study Parameters Assessed
Patients were randomized to receive chemotherapy alone (several regimens were used depending on the tumor type involved) or the same chemotherapy regimens combined with Aloe arborescens 10 mL 3 times daily starting 6 days prior to beginning chemotherapy. The aloe extract was made by macerating aloe leaf in honey at a 3:5 ratio then adding 40 mL of 40% ethanol. All subjects underwent at least 3 cycles of chemotherapy. Both treatment groups were well matched at baseline.
Three-year survival rate was significantly better in the chemotherapy-plus-aloe group at 19% compared to 5% for the chemotherapy alone group (P<.01). Survival advantages were better regardless of tumor type. Mean lymphocyte counts after chemotherapy were also significantly higher in the chemotherapy-plus-aloe group compared with the chemotherapy alone group (P<.05). Participants in the aloe groups had significantly less chemotherapy-associated asthenia and/or fatigue compared with the group that did not receive aloe (26% affected vs 46% respectively; P<.01). Patients treated with vinorelbine had significantly less constipation when concomitantly treated with aloe compared with those not so treated (18% vs 71%, P<.01). No toxicity from aloe was detected.
Efficacy of chemotherapy as measured by survival can be improved by combination with natural immunomodulating agents. This has been reported previously with many such agents, though perhaps most convincingly for high-dose melatonin and extracts of Trametes versicolor (cloud mushroom or yun zhi). Aloe gel products appear to be extremely safe additions to this growing armamentarium. Though 19% survival at 3 years is dismal, it is almost 4 times greater than the 5% survival reported for chemotherapy alone. Patients with metastatic solid tumors are obviously very difficult to treat, and aloe is not a miracle cure for these patients.
The use of a crude aloe extract was intriguing. Some will consider this a limitation, preferring highly refined, drug-like herbal extracts. Others will see it as a benefit, retaining the complexity of a larger range of presumed synergistic compounds in the original herb. This type of extract is additionally quite palatable and soothing to take.
This trial suffered from several methodological flaws that weaken its conclusions. The lack of a placebo control was unfortunate, introducing the possibility that results were skewed by knowledge of the participants and study practitioners of who was receiving aloe treatment. The inclusion of multiple tumor types in some ways makes it difficult to assess the efficacy of the treatment for any particular cancer due to insufficient sample size, though overall efficacy appears good regardless. The results cannot as yet be generalized to patients with good general health prior to chemotherapy or to patients undergoing high-dose, rigorous chemotherapy protocols.