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Clinical Study of Micronized Lingzhi Mushroom in Thai HIV Patients

AddTime:2005-06-18 16:08:05  Views:  :

SUMMARY: A fine-powdered Reishi produced from a Japanese Ganoderma lucidum mushroom was administered to 10 patients with advanced HIV infection in Thailand. All but one patient had already taken antiretrovirals for two or more months before enrolling into the study and the CD4 count still remained under 200 cell/cu mm. The same antiretroviral regimens were maintained throughout the 12 weeks study period. Patients were observed every 4 weeks for clinical, CD4 and HIV viral load changes. Results indicated that micronized Reishi mushroom was well tolerated. Nevertheless, the product did not show any appreciable benefits either the clinical symptoms, the CD4 counts or the HIV viral loads. Therefore, it is desired to purify the active ingredients from the mushroom such as the terpenoids and polysaccharides including beta-D-glucan and its protein complex before additional clinical test in HIV patients is warranted.

INTRODUCTION

Acquired Immune Deficiency Syndrome (AIDS), was first reported in 1981 and has spread rapidly throughout the world 1). By the end of 1996, a total of 1,544,067 AIDS cases have been reported to the World Health Organizations 2). In addition, another 22.6 million people throughout the world have been estimated to be living with the human immunodeficiency virus (HlV), the causative agent of AIDS, approximately 92.6% from the developing countries in Africa, Asia and Latin America.

HIV infects mainly CD4+ T lymphocytes or helper T cells resulting in progressive deterioration of cell-mediated immunity in HIV-infected individuals 3). This will then lead to the development of opportunistic infections of AIDS. Currently there are no cures for AIDS. Antiretroviral remain the mainstay for the treatment of HIV infection.

   


MATERIAL AND METHODS

1. Subjects

Ten confirmed HIV-1-infected Thai patients of the Chulalongkorn University Hospital in Bangkok who met the following inclusion and exclusion criteria:

1.1 Inclusion Criteria

(1) Confirmed HIV infection
(2) Stage B (symptomatic HIV infection) or stage C (AIDS-defining illnesses) patients according to 1993 CDC Definition Criteria
(3) Age 16-65
(4) CD4 count of less than 300/cu.mm
(5) Not on any antiretrovirals or have been on antiretrovirals for at least 2 months
(6) Signed informed consent.

1.2 Exclusion Criteria

(1) Chronic diarrhea (3 or more watery stools for at least 2 weeks)
(2) Acute concurrent infection unless being treated for 2 or more months
(3) Adding, changing or initiating antiretrovirals within 2 months before enrollment into the study
(4) Allergic or intolerance to Lingzhi mushroom products. The study was approved by the Human Research Ethical Committee of the Faculty of Medicine, Chulalongkorn University.

2. Study Medication

Lingzhi mushroom product, "Micronized Lingzhi" from the Lingzhi General Institute Co. Ltd., l-9-4 Dogenzaka, Shibuya, Tokyo Japan.

3. Schedule of Administration

Micronized Lingzhi" was taken orally, 5 sachets (4 tablets per sachet) 3 times a day, 15-30 minutes before meals for 12 weeks.

4. Patient Follow-up

The patients were asked to return for follow-up at 4, 8 and 12 weeks after starting Micronized Lingzhi". Clinical examination was done and blood was drawn for laboratory tests.

5. Laboratory Investigations

At each visit (week 0, 4, 8 and 12) blood was drawn for complete blood count, CD4/CD8 count, BUN, creatinine, cholesterol, triglycerides, SGOT, SGPT and viral load study. Plasma for viral load study was stored at -80ºC freezer until being assayed. Rockets Amplicor HIV Monitor Test was used for plasma HIV RNA assay. The detection limit of the assay was 500-1000 RNA copies per milliter of plasma.

The CD4 count in the study was measured by automated flow cytometer of Becton Dickinson, FACSORT. The monoclonal antibodies used were Simultest LeucoGATE for differential WBC Count, Simultest CD3/CD4 for CD4+T-cell and Stimultest CD3/CD8 for CD8+T-cell.

The WBC count and differential WBC were done at Hospital Central Laboratory using the Coulter machine. The total lymphocyte count from the WBC count was then used to calculate the total CD4 and CD8 from %CD4 and %CD8 obtained from the flow cytometer.

DISCUSSION

Our 12 weeks study of "Micronized Lingzhi" from a Japanese supplier in 10 HIV-infected Thai patients indicated that the product was well tolerated. In this limited study, Lingzhi mushroom at the present formulation does not have appreciable benefit to HIV patients.

Although all of the patients in the present study were the far advanced patients, our previous study in relatively earlier patients also did not show any significant benefit from Lingzhi. The lack of immunostimulating effect of Lingzhi in HIV patients maybe dose-related or disease-related. Therefore, unless the active ingredients such as beta-D-glucan, beta-D-glucan peptide or their chemically modified moieties 6) are used, the crude Lingzhi extracts are inappropriate for clinical testing in HIV-infected patients.
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