Acm.2013.0125 Sorghum HIV
Acm.2013.0125 Sorghum HIV
Acm.2013.0125 Sorghum HIV
Abstract
Objectives: The purpose of this study was to evaluate a traditional herbal preparation, Jobelyn, for its effects
on anemia and CD4 + T-cell counts in human immunodeficiency virus–positive (HIV + ) patients in Nigeria.
Design: An open-label pilot study involving 10 confirmed (HIV + ) patients who were not receiving antiretroviral
therapy (ARVT) was performed, in which the patients consumed Jobelyn for 8 weeks, at a dose of 500 mg twice
daily. The pilot study was followed by a controlled trial involving 51 patients, all confirmed HIV + , where the
patients with CD4 + T-cell counts below 350 cells/lL were receiving ARVT. The eight patients with baseline
CD4 + T-cell counts above 350 cells/lL received Jobelyn. The remaining patients who all received ARVT were
randomized to ARVT alone versus ARVT + Jobelyn for 12 weeks.
Results: Patients receiving ARVT showed a statistically significant improvement in their CD4 + T-cell counts
across the 12-week study period ( p < 0.01). Patients receiving ARVT + Jobelyn showed a faster improvement,
reaching a high level of statistical significance compared to baseline already at 6 weeks ( p < 0.001), and remained
highly significant at 12 weeks ( p < 0.001).
Conclusions: This is the first controlled study conducted to evaluate efficacy of Jobelyn on immune status in
HIV + patients. The data suggest that consumption of Jobelyn contributed to improved hemoglobin levels and
increased CD4 + T-cell counts in Nigerian HIV + patients. Further studies are needed to examine similar effects
in other populations, and to elaborate on the underlying mechanisms, specifically, whether the consumption of
Jobelyn supported multiple aspects of bone marrow function.
1
Department of Pathology, 68 Nigerian Army Reference Hospital, Yaba, Lagos, Nigeria.
2
NIS Labs, Klamath Falls, OR.
3
Health Forever International, Ikeja, Lagos, Nigeria.
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54 AYUBA ET AL.
The quantification of these five polyphenol marker compounds was evaluated by the highly sensitive LC/MS-MS methodology, and their
structures were confirmed by CAD-MS/MS analysis. The testing was performed by Brunswick Laboratories, Norton, MA.
in antiviral immune defense actions, and up-regulating of the pilot studies were performed on patients with HIV in Lagos,
production of antiviral chemokines.10 Nigeria. An initial pilot study involved 10 HIV + patients
Jobelyn’s effects on anemia3–6 lead to the speculation who also suffered from anemic conditions. A subsequent
whether the effect on red blood cell production as well as controlled study continued to evaluate the effects of CD4 +
production of other cell types may be positively affected. T-cell counts in HIV + patients, some of whom also received
Limited use in uncontrolled trials in antiretroviral-naı̈ve HIV- antiretroviral treatment. The controlled study aimed at
infected subjects as well as patients on highly active anti- evaluating the role (if any) of Jobelyn in the management of
retroviral therapy (HAART) has suggested some improve- HIV in the presence or absence of HAART.
ment in several hematological parameters and quality of life.11
HAART uses a combination of reverse transcriptase inhibitors Methods
and protease inhibitors and is the current standard drug
treatment of HIV/acquired immune deficiency syndrome Nutritional supplement
(AIDS). Appropriate and consistent use of HAART can help The consumable nutritional supplement Jobelyn was
reduce viral load and allow for some immune system recon- grown, harvested, and manufactured by Health Forever
stitution, including an increase in CD4 + T-cell counts. How- Products, Ikeja, Lagos, Nigeria, using seed stock from a re-
ever, even with heavy subsidy, HAART is neither accessible cently domesticated variant of West African Sorghum bicolor.
nor affordable to a majority of people living with HIV/AIDS One lot was used for the open-label pilot study, and a second
in third-world countries. Use of HAART is also limited by lot was used for the controlled trial. Both lots had similar
potential toxicity and side-effects, as well as development of chemistry profiles showing a very high content of polyphe-
resistant strains of HIV. Only patients whose biologic profiles nols, particularly apigeninidin, which was present at ap-
fit the eligibility criteria are typically treated with HAART. proximately 4% of the dry weight of the botanical material
These limitations emphasize the need for continued search for (Table 1). This level is consistent with other lots tested for
viable alternatives or adjuncts to HAART. immune-modulating activities.10
Increasing use of Jobelyn by many HIV + patients and
people with anemia justifies further evaluation of its efficacy
Trial 1
for support of production of lymphocytes and red blood cells
in people with bone marrow suppression. This study was Ten patients (4 men and 6 women, age range 23–49 years)
therefore designed to address these questions. Two clinical with confirmed HIV + , a reduced number of CD4 + T
Vol. no. Gender Age ARVT JOB Week 0 Week 4 Week 8 Week 0 Week 4 Week 8
Trial 2
Based on these pilot data, a controlled trial was performed
at the Clinical Research Division of the Military Hospital,
Ikoyi, Lagos, Nigeria. Fifty-one patients (28 men and 23
women, age range 18–67 years) were enrolled in the study
upon written informed consent, as approved by the Ikoyi
Military Hospital Institutional Review Board. Potential study
participants were regular patients of Dr. Ayuba, and invited FIG. 1. The changes in CD4 + T-cell counts from Trial 2 (a
to participate, by use of written informed consent. All study controlled study with 51 HIV + patients, where HIV + status
was confirmed by electrophoresis) are shown as the group
participants who at the time of screening had CD4 + T-cell
average – standard error of the mean. Improvements were
counts below 350 cells/lL were treated with ARVT, which seen for all three groups: Eight patients who started the
consisted of nevirapine (200 mg), lamivudine (150 mg), and study with CD4 + T-cell numbers higher than 350 cell/lL,
stavudine (40 mg) twice daily. All 51 patients who partici- and were not eligible for antiretroviral therapy (ARVT)
pated in this clinical trial were monitored for CD4 + T-cell consumed Jobelyn ( JOB) for 12 weeks. Improvement
counts at baseline, 6, and 12 weeks. Eight patients who at the reached statistical significance at 12 weeks ( p < 0.01). Forty-
time of screening had a CD4 + T-cell count at 350 or higher three patients with baseline CD4 + T-cell counts lower than
were ineligible for ARVT, and received Jobelyn for the same 350 cells/lL were eligible for ARVT, and were randomized
duration of 12 weeks. The remaining 43 patients were ran- to either ARVT alone or ARVT and Jobelyn. There was no
domized into two groups, where one group of 16 people was statistical significance in the CD4 + T-cell counts at baseline
between these two groups. The group receiving ARVT
only treated with ARVT, and the other group of 27 people
alone showed the expected improvement in CD4 + T-cell
was treated with ARVT and also consumed Jobelyn daily for counts, which reached statistical significance already at 6
12 weeks. There was no significant difference in the baseline weeks ( p < 0.01), and continued to improve at 12 weeks
CD4 + T-cell counts between these two groups. Data were ( p < 0.001). The group that received ARVT and also con-
analyzed using ‘‘within-subject’’ analysis using the paired sumed Jobelyn showed a more robust improvement, which
two-tailed t-test, as well as ‘‘between-groups’’ analysis, using reached a high level of significance already at 6 weeks, and
the unpaired two-tailed t-test. remained highly significant at 12 weeks ( p < 0.001). Data
analysis utilized the within-subject two-tailed paired t-test
Results to compare each person’s changes for week 6 and week 12
compared to baseline values, and also the between-groups
Trial 1 unpaired t-test to compare the data for the ARVT + JOB +
and the ARVT + JOB- groups at 12 weeks. Levels of statis-
A statistically significant increase in CD4 + T lymphocytes tical significance are indicated by asterisks: **for p < 0.01,
( p < 0.01) and hemoglobin ( p < 0.001) was observed within 4 and ***for p < 0.001.
weeks, using the paired two-tailed t-test. Among the 10 par-
ticipants, everyone showed an improvement in both CD4 + T- ARVT + Jobelyn was significantly higher than the group re-
cell count and in hemoglobin levels (Table 2). All 10 patients ceiving ARVT alone, both at 6 and 12 weeks ( p < 0.001).
had hemoglobin levels below normal for their gender at Within the study population of 51 people, only 3 patients
baseline. All of them showed an improvement in hemoglobin had lower CD4 + T-cell counts after the 12-week study than at
levels. After 8 weeks of consuming Jobelyn, all 10 patients had study baseline; all 3 patients received ARVT, and 2 of them also
hemoglobin levels near the lower normal range. consumed Jobelyn. These three people experienced concurrent
infections (tuberculosis, pneumonia) during the study. Patients’
Trial 2 appetite and weight increased and there was improvement in
Among the 51 patients participating in this controlled trial, their general well-being. The maculopapular skin rash of three
43 patients had baseline CD4 + T-cell counts at or below 350 of the patients who had herpes zoster remitted.
cells/lL, and received ARVT. The third group of patients (i.e., those eight people who
As expected, people on ARVT showed a statistically sig- received Jobelyn only, since they were not eligible for ARVT
nificant improvement in their CD4 + T-cell counts across the due to a higher CD4 + T-cell count at baseline) also showed
12-week study period (n = 16, p < 0.01) (Fig. 1). However, an improvement during the weeks of Jobelyn consumption
patients receiving ARVT + Jobelyn showed a more robust (Fig. 1). This improvement was statistically significant from
improvement, which reached a high level of statistical sig- baseline after 12 weeks ( p < 0.01).
nificance compared to baseline already at 6 weeks (n = 27,
Discussion
p < 0.001), and remained highly significant at 12 weeks
( p < 0.001) (Fig. 1). Analysis comparing the two groups The core result presented here is the improvement in
showed that the CD4 + T-cell counts in the group receiving CD4 + T-cell numbers over time in the two groups that
56 AYUBA ET AL.