Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Bangkok Post - March 13, 2002
Anjira Assavanonda
The trial would be spearheaded by Dr Oraphan Methadilokkul, chief of the Office of Occupational and Environmental Medicine at the hospital, who earlier carried out a study on hundreds of patients who have taken V-1 Immunitor at Ban Bangpakong clinic and Wat Phra Baat Nam Phu. Most patients reportedly got better after receiving the product while only 10% got worse.
V-1 Immunitor was registered as a food supplement with the Food and Drug Administration, but its inventor Vichai Jirathitikal, wants it upgraded.
Dr Oraphan said the patients who got better were generally younger, had short-term infection of not more than one year, never received anti-retroviral drugs and were mostly women.
Since the study proved positive, it was necessary to continue the trial into the next phase, which would prove if V-1 caused the improvement.
Dr Oraphan said she was planning two trial projects under the placebo control method. One of the projects would involve 100 volunteers who were asymptomatic HIV-positive. The volunteers must meet criteria such as having CD4 count at more than 450, with CD4/CD8 ratio not less than 0.5, having low level of viral load, and aged between 20-50.
This trial would be conducted at Rajavithi hospital and would take one year to complete. Dr Oraphan said the hospital director was reluctant to permit the trial but finally allowed it to proceed.
The other trial was expected in 20 symptomatic HIV sufferers who have the symptoms of cachexia, but not yet experienced opportunistic infections such as tuberculosis, or brain and lung infections.
However, since this trial was involved with symptomatic patients, she was concerned it would not pass the hospital's ethic panel, and therefore planned to move the trial to other hospitals such as Police hospital or Bamrat Naradura hospital.
Dr Oraphan explained that in both trials, half of the volunteers would receive V-1, while the other half would receive placebo unknowingly. This double-blind study was to prove whether the patients could get better treatment from V-1.
As president of the Society of Thai Occupational and Environmental Medicine, Dr Oraphan yesterday organised a seminar on V-1 Immunitor to present various studies about the substances.
Tasanee Lakhanapichonchat, of Thammasat University's Faculty of Social Science, who conducted a study on 1,200 patients at Ban Bangpakong clinic between August and September, was also surprised at the positive results.
She said 49% of the interviewees felt they could eat better after receiving V-1, 43% said they gained hope and spiritual strength, 35% gained weight, another 35% could work, 24% feel fresher, while 17% said skin rashes were relieved or even vanished.
V-1 immunitor became controversial after its inventor started to distribute the product to HIV/Aids patients last year. Its opponents argued the manufacturer exaggerated the product's efficacy since there was no scientific evidence to clearly prove that V-1 could cure HIV/Aids.
The Medical Council ruled against the product, causing dissatisfaction among V-1 supporters.
Dr Dwip Kitayaporn, professor in Epidemiology at Mahidol University, said he did not believe V-1 had any beneficial effect.
He also warned that Dr Oraphan's trial on humans would breach medical ethics if it was conducted without approval of the Public Health Ministry's ethics panel.
"Before any trials, a researcher should have a prior study in animals to prove safety of the substance," said Dr Dwip.
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