Drugs R D. 2003;4(2):103-9.Links
Usha PR, Naidu MU, Raju YS.
Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India. ushapingali@yahoo.com
OBJECTIVE: To evaluate the clinical efficacy and safety of a new polyherbal preparation, Immu-25, in HIV-infected patients. METHODS: 36 patients (10 female, 26 male) with a mean age of 35 +/-10 years, with confirmed HIV infection with a CD4 count <500 cells/microL, received two capsules of the test drug twice daily for 18 months in this open-label pilot study. Patients were evaluated at monthly intervals for general signs and symptoms, development of opportunistic infections, and changes in weight and performance index. Lymphocyte phenotyping and routine haematological, biochemical, hepatic and renal parameters were recorded after every 6 months of drug therapy. Viral load was evaluated before and after every 6 months of treatment. RESULTS: The polyherbal test preparation produced good symptomatic improvement within 6 months. There was an increase in mean (95% CI) weight from 58 (53-64)kg to 63 (56-69)kg, 64 (58-72)kg and 68 (62-74)kg after 6, 12 and 18 months of treatment, respectively. The incidence and severity of symptoms such as diarrhoea, fatigue, anorexia, cough and fever decreased with drug treatment. There was a decrease in the mean (95% CI) viral load from 326 438 (428 600-186 420) copies/mL to 180 495 (258 300-124 000) copies/mL and 22 069 (42 100-16 000) copies/mL after 6 and 12 months of treatment, respectively. The decrease in viral load was associated with an increase in mean (95% CI) CD4 count from a baseline of 243 (203-388) cells/microL to 336 (263-486) cells/microL after 6 months of therapy, and this continued to rise to 527 (285-767) cells/microL (p < 0.001) and 618 (362-1012) cells/microL (p < 0.001) after 12 and 18 months of treatment, respectively. With the exception of mild gastrointestinal adverse effects, the drug was well tolerated. Both patients and investigators rated the treatment as good or very good. CONCLUSION: The polyherbal drug Immu-25 showed a favourable effect in patients with HIV infection. The test drug decreased the mean viral load, which was associated with good symptomatic improvement and an increase in the mean CD4 cell count. On the basis of these data, it can be concluded that this herbal drug may have a good immunomodulatory effect and has potential as a co-therapeutic agent in the management of HIV infection. Further studies are warranted to confirm its therapeutic potential.
PMID: 12718564 [PubMed - indexed for MEDLINE]
PubMed
Tuesday, January 8, 2008
Tel Aviv University licenses cinnamon extract as HIV, flu cure
News release from Frutarom
Frutarom Industries Ltd. and Ramot at Tel Aviv University Ltd. signed an exclusive agreement to commercialize unique knowhow (patent pending) developed by Professor Michael Ovadia of Tel Aviv University, to produce an innovative extract from cinnamon with anti viral properties.
The comprehensive research performed in Professor Ovadia’s laboratory demonstrated the extract’s ability to rapidly neutralize a broad range of viruses that cause infectious diseases in both humans and animal, such as human and avian influenza, herpes (HSV-1) and human immunodeficiency virus (HIV-1). Another unique activity of this innovative extract is its ability to boost the immune system against viruses, demonstrated by the ability to serve as a vaccination agent in chicken embryos infected with Newcastle disease virus (NDV). Trials performed together with a veterinary company showed that chicken embryos can be vaccinated against the NDV virus while they are still in the egg and in so doing, significantly improve the efficiency of the vaccine’s administration, increase success rates and reduce mortality.
The agreement with Ramot gives Frutarom an exclusive global license to commercialize the knowhow in order to manufacture and market the unique natural extract, based on knowhow currently being patented. Frutarom intends to market this unique product to the nutraceutical, functional food, health food and animal feed industries and to further develop the knowhow as a drug for humans and animals as part of the Company’s unique natural product offering. Frutarom will invest in further research and development of this unique product and additional applications within Frutarom’s fields of activity. Professor Michael Ovadia will lead the research.
Frutarom will use its considerable knowhow in natural product manufacturing for the research, development and scaling up of the product’s manufacturing process in accordance with international quality standards so as to achieve industrial scale production and commercialization. Frutarom estimates that the product will be launched in about a year.
The cooperation with Ramot is part of Frutarom’s broad strategic plan to expand Frutarom’s offering of unique natural products and to strengthen Frutarom’s position and standing as a leading global supplier of natural products and functional food ingredients for tasty and healthy solutions. As part of this strategy, Frutarom invests in and cooperates with start-up companies, research institutes and universities that develop innovative and unique technologies. This supports Frutarom’s own ongoing research and development activities, carried out in-house by its R&D teams throughout the world. In the last year, Frutarom initiated several such alliances: exclusive cooperation with D-Herb, of the NGT technological incubator in Nazareth, Israel, to produce and market a unique herbal extract that is used to reduce and stabilize glucose levels in diabetecs; exclusive cooperation with Magnetika Interactive Ltd., to produce, market and sell products enriched with Omega-3 fatty acid; and exclusive cooperation with CapsiVit Biotechnology Ltd. to commercialize unique knowhow developed by the Vulcani Institute in Israel to produce a natural extract from the Capsicum annuum L. plant as a highly bio-available source of carotenoids and particularly capsanthin; and others.
Ori Yehudai, President and Chief Executive Officer of Frutarom: “The addition of this unique, innovative product to Frutarom’s varied offering of natural products will contribute to the continued realization of Frutarom’s rapid growth strategy, with emphasis on natural products intended for segments with higher than average growth rates, such as functional food, health food and nutraceuticals. Frutarom’s alliances with start-ups, research institutes and universities strengthen and expand our solid pipeline of projects and natural, innovative products that we intend to market in the coming years. Frutarom continues to work on creating additional strategic collaborations.”
Dr. Yehuda Niv, CEO of Ramot at Tel Aviv University Ltd.: “The discovery and development of this unique extract are an example of research conducted at Tel Aviv University that is both creative and leading in its field. Granting the license to Frutarom is the logical step to further develop this scientific discovery into health, biotechnology and consumer products.'' Dr. Niv added, ''Ramot fosters close relationships between Tel Aviv University researchers and industry to enable the translation of such scientific findings into novel products that will benefit the lives of people worldwide.''
As part of the cooperation, Frutarom will utilize its global reach, which includes over 5,000 international and local customers – among them leading companies in their fields – in more than 120 countries, as well as Frutarom’s sales and marketing organization and rich experience in industrial production, including extensive knowledge in scaling up production processes and commercialization
Frutarom
Frutarom is a multinational company operating in the global flavor extracts and fine ingredients markets. Frutarom has significant manufacturing and development centers on three continents and markets its products to more than 5,000 customers in over 120 countries. Frutarom’s products are intended for the food and beverage, flavor and fragrance, pharmaceutical, nutraceutical, health food, functional food, food supplement and cosmetic industries.
Frutarom operates two main divisions:
* The Flavors Division develops, manufactures and markets flavor compounds and food systems.
* The Fine Ingredients Division develops, manufactures and markets natural flavor extracts, natural functional food ingredients, natural pharma/nutraceutical extracts, essential oils and unique citrus products and aromatic chemicals.
Frutarom’s products are produced at its facilities in the USA, the UK, Switzerland, Germany, Israel, Denmark, China, and Turkey. The company’s global marketing network includes marketing departments in Israel, the USA, the UK, Switzerland, Germany, Belgium, Holland, Denmark, France, Hungary, Romania, Russia, Ukraine, Kazakhstan, Belarus, Turkey, Brazil, Mexico, China, Japan, Hong Kong, India, and Indonesia. The Company also has agents and local distributors throughout the world. Frutarom employs some 1,150 employees worldwide.
Tel Aviv University
Founded in 1963, Tel Aviv University is one of Israel’s foremost research and teaching universities. Located in Israel’s cultural, financial and industrial heartland, Tel Aviv University is at the forefront of basic and applied research in a wide variety of scientific research disciplines, including engineering, exact sciences, life sciences, medicine, social sciences, management, law, humanities and the arts.
Ramot at Tel Aviv University
Ramot is the technology transfer company of Tel Aviv University. Ramot fosters, initiates, leads, and manages the transfer of new technologies from the university laboratories to the marketplace, by performing all activities relating to the protection and commercialization of inventions and discoveries made by faculty, students and other researchers of Tel Aviv University. Ramot provides a dynamic interface connecting industry to leading edge science and innovation, offering new business opportunities in a wide variety of emerging markets.
www.ScienceBusiness.net
Frutarom Industries Ltd. and Ramot at Tel Aviv University Ltd. signed an exclusive agreement to commercialize unique knowhow (patent pending) developed by Professor Michael Ovadia of Tel Aviv University, to produce an innovative extract from cinnamon with anti viral properties.
The comprehensive research performed in Professor Ovadia’s laboratory demonstrated the extract’s ability to rapidly neutralize a broad range of viruses that cause infectious diseases in both humans and animal, such as human and avian influenza, herpes (HSV-1) and human immunodeficiency virus (HIV-1). Another unique activity of this innovative extract is its ability to boost the immune system against viruses, demonstrated by the ability to serve as a vaccination agent in chicken embryos infected with Newcastle disease virus (NDV). Trials performed together with a veterinary company showed that chicken embryos can be vaccinated against the NDV virus while they are still in the egg and in so doing, significantly improve the efficiency of the vaccine’s administration, increase success rates and reduce mortality.
The agreement with Ramot gives Frutarom an exclusive global license to commercialize the knowhow in order to manufacture and market the unique natural extract, based on knowhow currently being patented. Frutarom intends to market this unique product to the nutraceutical, functional food, health food and animal feed industries and to further develop the knowhow as a drug for humans and animals as part of the Company’s unique natural product offering. Frutarom will invest in further research and development of this unique product and additional applications within Frutarom’s fields of activity. Professor Michael Ovadia will lead the research.
Frutarom will use its considerable knowhow in natural product manufacturing for the research, development and scaling up of the product’s manufacturing process in accordance with international quality standards so as to achieve industrial scale production and commercialization. Frutarom estimates that the product will be launched in about a year.
The cooperation with Ramot is part of Frutarom’s broad strategic plan to expand Frutarom’s offering of unique natural products and to strengthen Frutarom’s position and standing as a leading global supplier of natural products and functional food ingredients for tasty and healthy solutions. As part of this strategy, Frutarom invests in and cooperates with start-up companies, research institutes and universities that develop innovative and unique technologies. This supports Frutarom’s own ongoing research and development activities, carried out in-house by its R&D teams throughout the world. In the last year, Frutarom initiated several such alliances: exclusive cooperation with D-Herb, of the NGT technological incubator in Nazareth, Israel, to produce and market a unique herbal extract that is used to reduce and stabilize glucose levels in diabetecs; exclusive cooperation with Magnetika Interactive Ltd., to produce, market and sell products enriched with Omega-3 fatty acid; and exclusive cooperation with CapsiVit Biotechnology Ltd. to commercialize unique knowhow developed by the Vulcani Institute in Israel to produce a natural extract from the Capsicum annuum L. plant as a highly bio-available source of carotenoids and particularly capsanthin; and others.
Ori Yehudai, President and Chief Executive Officer of Frutarom: “The addition of this unique, innovative product to Frutarom’s varied offering of natural products will contribute to the continued realization of Frutarom’s rapid growth strategy, with emphasis on natural products intended for segments with higher than average growth rates, such as functional food, health food and nutraceuticals. Frutarom’s alliances with start-ups, research institutes and universities strengthen and expand our solid pipeline of projects and natural, innovative products that we intend to market in the coming years. Frutarom continues to work on creating additional strategic collaborations.”
Dr. Yehuda Niv, CEO of Ramot at Tel Aviv University Ltd.: “The discovery and development of this unique extract are an example of research conducted at Tel Aviv University that is both creative and leading in its field. Granting the license to Frutarom is the logical step to further develop this scientific discovery into health, biotechnology and consumer products.'' Dr. Niv added, ''Ramot fosters close relationships between Tel Aviv University researchers and industry to enable the translation of such scientific findings into novel products that will benefit the lives of people worldwide.''
As part of the cooperation, Frutarom will utilize its global reach, which includes over 5,000 international and local customers – among them leading companies in their fields – in more than 120 countries, as well as Frutarom’s sales and marketing organization and rich experience in industrial production, including extensive knowledge in scaling up production processes and commercialization
Frutarom
Frutarom is a multinational company operating in the global flavor extracts and fine ingredients markets. Frutarom has significant manufacturing and development centers on three continents and markets its products to more than 5,000 customers in over 120 countries. Frutarom’s products are intended for the food and beverage, flavor and fragrance, pharmaceutical, nutraceutical, health food, functional food, food supplement and cosmetic industries.
Frutarom operates two main divisions:
* The Flavors Division develops, manufactures and markets flavor compounds and food systems.
* The Fine Ingredients Division develops, manufactures and markets natural flavor extracts, natural functional food ingredients, natural pharma/nutraceutical extracts, essential oils and unique citrus products and aromatic chemicals.
Frutarom’s products are produced at its facilities in the USA, the UK, Switzerland, Germany, Israel, Denmark, China, and Turkey. The company’s global marketing network includes marketing departments in Israel, the USA, the UK, Switzerland, Germany, Belgium, Holland, Denmark, France, Hungary, Romania, Russia, Ukraine, Kazakhstan, Belarus, Turkey, Brazil, Mexico, China, Japan, Hong Kong, India, and Indonesia. The Company also has agents and local distributors throughout the world. Frutarom employs some 1,150 employees worldwide.
Tel Aviv University
Founded in 1963, Tel Aviv University is one of Israel’s foremost research and teaching universities. Located in Israel’s cultural, financial and industrial heartland, Tel Aviv University is at the forefront of basic and applied research in a wide variety of scientific research disciplines, including engineering, exact sciences, life sciences, medicine, social sciences, management, law, humanities and the arts.
Ramot at Tel Aviv University
Ramot is the technology transfer company of Tel Aviv University. Ramot fosters, initiates, leads, and manages the transfer of new technologies from the university laboratories to the marketplace, by performing all activities relating to the protection and commercialization of inventions and discoveries made by faculty, students and other researchers of Tel Aviv University. Ramot provides a dynamic interface connecting industry to leading edge science and innovation, offering new business opportunities in a wide variety of emerging markets.
www.ScienceBusiness.net
Monday, January 7, 2008
Massachusetts Jury Awards $2.5. Million to Woman Who Underwent Nine Years of Unnecessary HIV Treatments
Thursday, December 13, 2007
BOSTON — A jury awarded $2.5 million in damages Wednesday to a woman who received HIV treatments for almost nine years before discovering she never actually had the virus that causes AIDS.
In her lawsuit against a doctor who treated her, Audrey Serrano said the powerful combination of drugs she took triggered a string of ailments, including depression, chronic fatigue, loss of weight and appetite and inflammation of the intestine.
Serrano, 45, said she cried after hearing the verdict in Worcester Superior Court and was gratified that the jury believed her.
"I'm going to finish my school and I am going to continue to help others," Serrano said in a telephone interview from her Fitchburg home. "I am going to find another doctor that will help me."
Serrano's attorney, David Angueira, said Dr. Kwan Lai, who treated his client at the University of Massachusetts Medical Center in Worcester's HIV clinic, repeatedly failed to order definitive tests even after monitoring of Serrano's treatment did not show the presence of HIV in her blood.
"It is one of the clearest cases of misdiagnosis that I have ever seen and it's based in part on a presumption that people who engage in certain types of conduct are more likely to have HIV and AIDS than other people without really listening to the patient," Angueira said after the verdict.
Lai testified last week that Serrano told her she had worked as a prostitute, her partner had AIDS, and that she had suffered three bouts of a type of pneumonia typically associated with those infected by the virus.
Serrano has denied she had ever been a prostitute. She confirmed that her former boyfriend tested positive for HIV/AIDS, but disputed the claim that she told the doctor that she had suffered bouts of Pneumocystis pneumonia.
Lai's attorney, Joannie Gulliford Hoban, did not return a call for comment Wednesday night.
Lai testified that she had no reason to question Serrano's original diagnosis at another clinic because Serrano convinced her she had HIV when she took her personal history, and her blood had abnormal amounts of cells used to fight infections.
Hoban argued during the trial that Lai had provided standard care to Serrano.
"Audrey's case clearly demonstrates how inadequate that procedure was," Angueira said. He said his client "is responsible for changing thousands of lives in the future."
The medical center, which was not named in the lawsuit, did not immediately return a message for comment Wednesday night. The institution has denied wrongdoing in the case.
The jury reached its verdict after two days of deliberations, Serrano's attorney said. He said the damages could total about $3.7 million including prejudgment interest.
Serrano filed the lawsuit in 2003 after she became suspicious of her diagnosis and had herself tested at another hospital.
FOX NEWS
BOSTON — A jury awarded $2.5 million in damages Wednesday to a woman who received HIV treatments for almost nine years before discovering she never actually had the virus that causes AIDS.
In her lawsuit against a doctor who treated her, Audrey Serrano said the powerful combination of drugs she took triggered a string of ailments, including depression, chronic fatigue, loss of weight and appetite and inflammation of the intestine.
Serrano, 45, said she cried after hearing the verdict in Worcester Superior Court and was gratified that the jury believed her.
"I'm going to finish my school and I am going to continue to help others," Serrano said in a telephone interview from her Fitchburg home. "I am going to find another doctor that will help me."
Serrano's attorney, David Angueira, said Dr. Kwan Lai, who treated his client at the University of Massachusetts Medical Center in Worcester's HIV clinic, repeatedly failed to order definitive tests even after monitoring of Serrano's treatment did not show the presence of HIV in her blood.
"It is one of the clearest cases of misdiagnosis that I have ever seen and it's based in part on a presumption that people who engage in certain types of conduct are more likely to have HIV and AIDS than other people without really listening to the patient," Angueira said after the verdict.
Lai testified last week that Serrano told her she had worked as a prostitute, her partner had AIDS, and that she had suffered three bouts of a type of pneumonia typically associated with those infected by the virus.
Serrano has denied she had ever been a prostitute. She confirmed that her former boyfriend tested positive for HIV/AIDS, but disputed the claim that she told the doctor that she had suffered bouts of Pneumocystis pneumonia.
Lai's attorney, Joannie Gulliford Hoban, did not return a call for comment Wednesday night.
Lai testified that she had no reason to question Serrano's original diagnosis at another clinic because Serrano convinced her she had HIV when she took her personal history, and her blood had abnormal amounts of cells used to fight infections.
Hoban argued during the trial that Lai had provided standard care to Serrano.
"Audrey's case clearly demonstrates how inadequate that procedure was," Angueira said. He said his client "is responsible for changing thousands of lives in the future."
The medical center, which was not named in the lawsuit, did not immediately return a message for comment Wednesday night. The institution has denied wrongdoing in the case.
The jury reached its verdict after two days of deliberations, Serrano's attorney said. He said the damages could total about $3.7 million including prejudgment interest.
Serrano filed the lawsuit in 2003 after she became suspicious of her diagnosis and had herself tested at another hospital.
FOX NEWS
Chinese HIV-positive man gets all clear
16:35 04/ 12/ 2007
BEIJING, December 4 (RIA Novosti) - A Chinese farmer in the northeast Jilin Province has tested HIV-negative six years after testing positive for the virus, the Xinhua news agency reported.
Wen Congcheng first tested positive for HIV in 2001 at the Chuanying District disease prevention and control center (CDC). The diagnosis was confirmed two years later at the same clinic.
However, in July this year Wen had another test at a university hospital in Jilin, which came back negative. The follow up tests made in three local hospitals also proved to be negative.
"I have no idea why the test turned out to be negative," Wen said.
Experts doubt whether the miracle result is down to drugs, while Wen said the tests might have been mixed up.
Meanwhile, People's Daily cited Lang Ying, deputy director of the CDC, as saying, "It is still early to say his negative result will last."
The only other known case was in 2003, when a British man Andrew Stimpson tested HIV negative, fourteen months after giving a positive HIV result. The case caused a sensation, but was marred by suspicions of false test results.
RedTram News
BEIJING, December 4 (RIA Novosti) - A Chinese farmer in the northeast Jilin Province has tested HIV-negative six years after testing positive for the virus, the Xinhua news agency reported.
Wen Congcheng first tested positive for HIV in 2001 at the Chuanying District disease prevention and control center (CDC). The diagnosis was confirmed two years later at the same clinic.
However, in July this year Wen had another test at a university hospital in Jilin, which came back negative. The follow up tests made in three local hospitals also proved to be negative.
"I have no idea why the test turned out to be negative," Wen said.
Experts doubt whether the miracle result is down to drugs, while Wen said the tests might have been mixed up.
Meanwhile, People's Daily cited Lang Ying, deputy director of the CDC, as saying, "It is still early to say his negative result will last."
The only other known case was in 2003, when a British man Andrew Stimpson tested HIV negative, fourteen months after giving a positive HIV result. The case caused a sensation, but was marred by suspicions of false test results.
RedTram News
Using Chinese Herbs and Acupuncture to Treat HIV/AIDS: an Analysis of 201 Cases
Being Alive; January 1994
Jin-Lin Wang, LAC, MD (China)
At the Oriental Medical Center, we began treating people with HIV/AIDS in 1986. Our approach was to use a treatment combination of Chinese herbs, specifically formulated for their antiviral and immune enhancing effects, and acupuncture. Since we began this program, we have kept records on 201 patients who were continuously treated for from six months to over five years.
The Study Groups
For the purposes of evaluation, we divided our 201 patients into two groups. The first group (Group A) used only acupuncture and Chinese herbs. The second group (Group B) added Western medicine to their treatment regimen.
The first group included 103 adults (101 men and 2 women). At the beginning of their treatment program, 11 had CD4 counts of less than 200, 63 were in the 200-500 range, and 29 had CD4 over 500.
The second group consisted of 98 adults (95 men and 3 women). In this group, 57 had initial CD4 less than 200, 32 were in the 200-500 range, and only 9 had CD4 greater than 500. As you can see, the average initial CD4 for Group A was a good deal higher than for Group B.
The Treatment Program
Treatment included both acupuncture and Chinese herbs. Acupuncture was administered once or twice a week. For those who understand such things, the basic points were: LI-4, ST-36, RE-6, Ear-Spleen. Additional points were used as individually indicated.
The Chinese herbs consisted of two basic formulas. An immune enhancer was taken twice daily (three capsules each time), and an antiviral three times daily (also three capsules each time). Additional herbs were prescribed as specific cases indicated.
Standards of Evaluation
Only twelve years have passed since the first cases of AIDS were diagnosed in 1981. We do not yet completely understand the natural progression of this disease. Some research indicates that 50% of HIV+ people will progress to AIDS within five years. Other research reports that 35% of HIV+ people can survive more than 10 years with normal CD4 counts. Thus, we believe that to evaluate the effects of a treatment, both its short term effects and long term survival must be observed.
To evaluate the short term effects of treatment, the CD4 count is used. The CD4 count is the standard used by the FDA to evaluate the effect of antiviral drugs. The CD4 count is also generally accepted internationally as an indicator of the condition of the human immune system. There is some disagreement about this; however, because of its general acceptance, we use the CD4 count as a surrogate marker.
The CD4 count fluctuates daily. We apply a classification to minimize confusion caused by fluctuations. We classify someone as Improved if CD4 count is up 50 points or more from the original level. Someone is Stable if CD4 count is plus or minus 1 to 49 points from their initial count. Finally, we call someone Decreased if CD4 drops 50 points or more from the original level.
To determine the long range value of the treatment program, we look at the three year survival rate, as well as the rate of progression to AIDS among the study subjects.
Results for Group A
Sixty-eight people (or 66% of the group) improved during the treatment program (according to the criterion noted above). At the start of the program, average CD4 count for the Improved was 435; at the end of the evaluation period, average CD4 stood at 616.
Twenty-five people in Group A were Stable, while only 10 (or 9.7% of the group) were classified as Decreased.
In Group A, 23 patients were observed for from two to five and a half years. None of these patient either progressed to AIDS or died.
Two cases from this group are good examples. One man began treatment in June of 1988 with an initial CD4 count of 317. He was treated continuously for four and a half years. During this time, his CD4 count rose to 661, and he remained free of symptoms. Another man began treatment in January of 1987 and started with a CD4 level of 300. Results were even more dramatic. After four and a half years of continuous treatment, his CD4 count increased to 710 and he stayed asymptomatic.
Results for Group B
Group B, which combined Chinese and Western treatments, began the treatment program with an average CD4 count lower than Group A. Results for this group were somewhat less successful. Only 29 people or 30% of the cases could be classified as Improved. However, 44 or some 45% remained Stable. Twenty-five patients in Group B decreased.
Thirteen cases in Group B were observed during continuous treatment of from two to four and a half years, Of this subgroup, four of the thirteen died.
Using Only Chinese Herbs and Acupuncture
We find that it is very difficult to get the CD4 count to return to normal range once it has dropped below 200. The best indication for sole use of traditional Chinese medicine is when the CD4 count is still above 300.
The Concorde study reports that AZT is not as beneficial for early HIV infection as previously believed. Our purpose with acupuncture and Chinese herbs is to slow or stop the average annual loss of T-cells and to keep the patient's immune system intact until a cure is discovered.
Some research indicates that the CD4 count will drop 70-80 points annually. Our results indicate that 66% of the 103 patients treated solely with traditional Chinese medicine showed a CD4 increase instead of a decrease. Twenty of the 103 patients whose CD4 counts were in the abnormal/low range increased into the normal range.
Combining Chinese and Western Treatments
Research demonstrates that traditional Chinese medicine may strengthen immune function and inhibit the HIV virus. Our clinical practice and results support these findings. Acupuncture and Chinese herbs have the additional advantages of cost effectiveness and general lack of side effects. However, it is our opinion that traditional Chinese medicine cannot cure HIV infection at this time. Thus, it is vital to recognize when Western medications are indicated and useful for the protection of the patient.
Because AIDS suppresses the immune system, the patient may be susceptible to infection. Western medications can prevent opportunistic infections as exemplified by the use of Bactrim to prevent PCP. We are testing Chinese herbs to prevent opportunistic infections. At this time, however, we do not have a Chinese herbal replacement for such medications as Bactrim.
The Value of Acupuncture
The mechanism of acupuncture can increase the endorphin level. Endorphins are recognized as pain relievers. Within the last three years, studies of endorphins also demonstrate that they increase T-cell count and natural killer cell activity, as well as inducing the body to form interferon.
Continuous Treatment Enhances Benefits
Our work during the past seven years indicates that there are clear benefits to the continuous use of Chinese herbs and acupuncture. When a patient seeks treatment for only a short time or on an intermittent basis, the value of the Chinese approach is diminished.
Two cases illustrate this important point. One man began treatment in April of 1987; his initial CD4 count was 430. He was treated continuously with only Chinese herbs and acupuncture for three years. At the end of this period, his CD4 had risen to 530 and his p24 antigen had gone from positive to negative. The patient chose to discontinue treatment. When he returned almost three years later, his CD4 count was only 55 and his p24 antigen was again positive.
Another man began treatment in early 1988 with a CD4 count of 443. He continued with regularly scheduled treatments for almost three and a half years. At the point that he discontinued treatment, his CD4 stood at 500. Only a year and a half later, he had an attack of shingles and returned for treatment. His CD4 count had dropped to 150.
When you compare these two cases to the ones reported in our Group A results, you can see that uninterrupted treatment seems more effective. If an HIV+ patient does choose to discontinue treatment, we strongly recommend that they check their CD4 count every three months.
www.aegis.com
Jin-Lin Wang, LAC, MD (China)
At the Oriental Medical Center, we began treating people with HIV/AIDS in 1986. Our approach was to use a treatment combination of Chinese herbs, specifically formulated for their antiviral and immune enhancing effects, and acupuncture. Since we began this program, we have kept records on 201 patients who were continuously treated for from six months to over five years.
The Study Groups
For the purposes of evaluation, we divided our 201 patients into two groups. The first group (Group A) used only acupuncture and Chinese herbs. The second group (Group B) added Western medicine to their treatment regimen.
The first group included 103 adults (101 men and 2 women). At the beginning of their treatment program, 11 had CD4 counts of less than 200, 63 were in the 200-500 range, and 29 had CD4 over 500.
The second group consisted of 98 adults (95 men and 3 women). In this group, 57 had initial CD4 less than 200, 32 were in the 200-500 range, and only 9 had CD4 greater than 500. As you can see, the average initial CD4 for Group A was a good deal higher than for Group B.
The Treatment Program
Treatment included both acupuncture and Chinese herbs. Acupuncture was administered once or twice a week. For those who understand such things, the basic points were: LI-4, ST-36, RE-6, Ear-Spleen. Additional points were used as individually indicated.
The Chinese herbs consisted of two basic formulas. An immune enhancer was taken twice daily (three capsules each time), and an antiviral three times daily (also three capsules each time). Additional herbs were prescribed as specific cases indicated.
Standards of Evaluation
Only twelve years have passed since the first cases of AIDS were diagnosed in 1981. We do not yet completely understand the natural progression of this disease. Some research indicates that 50% of HIV+ people will progress to AIDS within five years. Other research reports that 35% of HIV+ people can survive more than 10 years with normal CD4 counts. Thus, we believe that to evaluate the effects of a treatment, both its short term effects and long term survival must be observed.
To evaluate the short term effects of treatment, the CD4 count is used. The CD4 count is the standard used by the FDA to evaluate the effect of antiviral drugs. The CD4 count is also generally accepted internationally as an indicator of the condition of the human immune system. There is some disagreement about this; however, because of its general acceptance, we use the CD4 count as a surrogate marker.
The CD4 count fluctuates daily. We apply a classification to minimize confusion caused by fluctuations. We classify someone as Improved if CD4 count is up 50 points or more from the original level. Someone is Stable if CD4 count is plus or minus 1 to 49 points from their initial count. Finally, we call someone Decreased if CD4 drops 50 points or more from the original level.
To determine the long range value of the treatment program, we look at the three year survival rate, as well as the rate of progression to AIDS among the study subjects.
Results for Group A
Sixty-eight people (or 66% of the group) improved during the treatment program (according to the criterion noted above). At the start of the program, average CD4 count for the Improved was 435; at the end of the evaluation period, average CD4 stood at 616.
Twenty-five people in Group A were Stable, while only 10 (or 9.7% of the group) were classified as Decreased.
In Group A, 23 patients were observed for from two to five and a half years. None of these patient either progressed to AIDS or died.
Two cases from this group are good examples. One man began treatment in June of 1988 with an initial CD4 count of 317. He was treated continuously for four and a half years. During this time, his CD4 count rose to 661, and he remained free of symptoms. Another man began treatment in January of 1987 and started with a CD4 level of 300. Results were even more dramatic. After four and a half years of continuous treatment, his CD4 count increased to 710 and he stayed asymptomatic.
Results for Group B
Group B, which combined Chinese and Western treatments, began the treatment program with an average CD4 count lower than Group A. Results for this group were somewhat less successful. Only 29 people or 30% of the cases could be classified as Improved. However, 44 or some 45% remained Stable. Twenty-five patients in Group B decreased.
Thirteen cases in Group B were observed during continuous treatment of from two to four and a half years, Of this subgroup, four of the thirteen died.
Using Only Chinese Herbs and Acupuncture
We find that it is very difficult to get the CD4 count to return to normal range once it has dropped below 200. The best indication for sole use of traditional Chinese medicine is when the CD4 count is still above 300.
The Concorde study reports that AZT is not as beneficial for early HIV infection as previously believed. Our purpose with acupuncture and Chinese herbs is to slow or stop the average annual loss of T-cells and to keep the patient's immune system intact until a cure is discovered.
Some research indicates that the CD4 count will drop 70-80 points annually. Our results indicate that 66% of the 103 patients treated solely with traditional Chinese medicine showed a CD4 increase instead of a decrease. Twenty of the 103 patients whose CD4 counts were in the abnormal/low range increased into the normal range.
Combining Chinese and Western Treatments
Research demonstrates that traditional Chinese medicine may strengthen immune function and inhibit the HIV virus. Our clinical practice and results support these findings. Acupuncture and Chinese herbs have the additional advantages of cost effectiveness and general lack of side effects. However, it is our opinion that traditional Chinese medicine cannot cure HIV infection at this time. Thus, it is vital to recognize when Western medications are indicated and useful for the protection of the patient.
Because AIDS suppresses the immune system, the patient may be susceptible to infection. Western medications can prevent opportunistic infections as exemplified by the use of Bactrim to prevent PCP. We are testing Chinese herbs to prevent opportunistic infections. At this time, however, we do not have a Chinese herbal replacement for such medications as Bactrim.
The Value of Acupuncture
The mechanism of acupuncture can increase the endorphin level. Endorphins are recognized as pain relievers. Within the last three years, studies of endorphins also demonstrate that they increase T-cell count and natural killer cell activity, as well as inducing the body to form interferon.
Continuous Treatment Enhances Benefits
Our work during the past seven years indicates that there are clear benefits to the continuous use of Chinese herbs and acupuncture. When a patient seeks treatment for only a short time or on an intermittent basis, the value of the Chinese approach is diminished.
Two cases illustrate this important point. One man began treatment in April of 1987; his initial CD4 count was 430. He was treated continuously with only Chinese herbs and acupuncture for three years. At the end of this period, his CD4 had risen to 530 and his p24 antigen had gone from positive to negative. The patient chose to discontinue treatment. When he returned almost three years later, his CD4 count was only 55 and his p24 antigen was again positive.
Another man began treatment in early 1988 with a CD4 count of 443. He continued with regularly scheduled treatments for almost three and a half years. At the point that he discontinued treatment, his CD4 stood at 500. Only a year and a half later, he had an attack of shingles and returned for treatment. His CD4 count had dropped to 150.
When you compare these two cases to the ones reported in our Group A results, you can see that uninterrupted treatment seems more effective. If an HIV+ patient does choose to discontinue treatment, we strongly recommend that they check their CD4 count every three months.
www.aegis.com
AIDS Patients Face Downside of Living Longer
By JANE GROSS
Published: January 6, 2008
CHICAGO — John Holloway received a diagnosis of AIDS nearly two decades ago, when the disease was a speedy death sentence and treatment a distant dream.
John Holloway, 59, survived AIDS but has more health problems than his 84-year-old father.
Dominga Montanez, 58, says she has new health problems that are worse than having AIDS.
Yet at 59 he is alive, thanks to a cocktail of drugs that changed the course of an epidemic. But with longevity has come a host of unexpected medical conditions, which challenge the prevailing view of AIDS as a manageable, chronic disease.
Mr. Holloway, who lives in a housing complex designed for the frail elderly, suffers from complex health problems usually associated with advanced age: chronic obstructive pulmonary disease, diabetes, kidney failure, a bleeding ulcer, severe depression, rectal cancer and the lingering effects of a broken hip.
Those illnesses, more severe than his 84-year-old father’s, are not what Mr. Holloway expected when lifesaving antiretroviral drugs became the standard of care in the mid-1990s.
The drugs gave Mr. Holloway back his future.
But at what cost?
That is the question, heretical to some, that is now being voiced by scientists, doctors and patients encountering a constellation of ailments showing up prematurely or in disproportionate numbers among the first wave of AIDS survivors to reach late middle age.
There have been only small, inconclusive studies on the causes of aging-related health problems among AIDS patients.
Without definitive research, which has just begun, that second wave of suffering could be a coincidence, although it is hard to find anyone who thinks so.
Instead, experts are coming to believe that the immune system and organs of long-term survivors took an irreversible beating before the advent of lifesaving drugs and that those very drugs then produced additional complications because of their toxicity — a one-two punch.
“The sum total of illnesses can become overwhelming,” said Charles A. Emlet, an associate professor at the University of Washington at Tacoma and a leading H.I.V. and aging researcher, who sees new collaborations between specialists that will improve care.
“AIDS is a very serious disease, but longtime survivors have come to grips with it,” Dr. Emlet continued, explaining that while some patients experienced unpleasant side effects from the antiretrovirals, a vast majority found a cocktail they could tolerate. “Then all of a sudden they are bombarded with a whole new round of insults, which complicate their medical regime and have the potential of being life threatening. That undermines their sense of stability and makes it much more difficult to adjust.”
The graying of the AIDS epidemic has increased interest in the connection between AIDS and cardiovascular disease, certain cancers, diabetes, osteoporosis and depression. The number of people 50 and older living with H.I.V., the virus that causes AIDS, has increased 77 percent from 2001 to 2005, according to the federal Centers for Disease Control, and they now represent more than a quarter of all cases in the United States.
The most comprehensive research has come from the AIDS Community Research Initiative of America, which has studied 1,000 long-term survivors in New York City, and the Multi-Site AIDS Cohort Study, financed by the National Institutes of Health, which has followed 2,000 subjects nationwide for the past 25 years.
The Acria study, published in 2006, examined psychological, not medical, issues and found unusual rates of depression and isolation among older people with AIDS.
The Multi-Site AIDS Cohort Study, or MACS, will directly examine the intersection of AIDS and aging over the next five years. Dr. John Phair, a principal investigator for the study, which has health data from both infected and uninfected men, said “prolonged survival” coupled with the “naturally occurring health issues” of old age raised pressing research questions: “Which health issues are a direct result of aging, which are a direct result of H.I.V. and what role do H.I.V. meds play?”
The MACS investigators, and other researchers, defend the slow pace of research as a function of numbers. The first generation of AIDS patients, in the mid-1980s, had no effective treatments for a decade, and died in overwhelming numbers, leaving few survivors to study.
Those survivors, like Mr. Holloway, gaunt from chemotherapy and radiation and mostly housebound, lurch from crisis to crisis. Mr. Holloway says his adjustment strategy is simple: “Deal with it.” Still he notes, ruefully, that his father has no medical complaints other than arthritis, failing eyesight and slight hearing loss.
“I look at how gracefully he’s aged, and I wish I understood what was happening to my body,” Mr. Holloway said during a recent home visit from his case manager at the Howard Brown Health Center here, a gay, lesbian and transgender organization. The case manager, Lisa Katona, could soothe but not inform him. “Nobody’s sure what causes what,” Ms. Katona told Mr. Holloway. “You folks are the first to go through this and we’re learning as we go.”
Mr. Holloway is uncomplaining even in the face of pneumonia and a 40-pound weight loss, both associated with his cancer treatment. Has the cost been too high? He says it has not, “considering the alternatives.”
Halfway across the country, Jeff, 56-year-old New Yorker who was found to have AIDS in 1987, said he asks himself that question often.
Jeff, who asked that he not be fully identified, has had one hip replacement because of a condition called avascular necrosis, the death of cells from inadequate blood supply, and needs another to avoid a wheelchair. Many experts think that avascular necrosis is caused by the steroids many early AIDS sufferers took for pneumonia.
“The virus is under control, and I should be in a state of ecstasy,” he said, “but I can’t even tie my own shoe laces and get up and down the subway stairs. ”
His bones are spongy from osteoporosis, a disorder that afflicts many postmenopausal women but rarely middle-aged men, except some with AIDS. No research has explained the unusual incidence.
In addition, Jeff has Parkinson’s disease, which is causing tremors and memory lapses.
He is in an AIDS support group at SAGE, a social service agency for older gay men and lesbians. His fellow group members also say they find the illnesses associated with age more taxing than the H.I.V. infection. One 69-year-old member of the group, for example, has had several heart attacks and triple bypass surgery, and his doctor predicts that heart disease is more likely to kill him than AIDS.
Cardiovascular disease and diabetes are associated with a condition called lipodystrophy, which redistributes fat, leaving the face and lower extremities wasted, the belly distended and the back humped. In addition, lipodystrophy raises cholesterol levels and causes glucose intolerance, which is especially dangerous to black people, who are already predisposed to heart disease and diabetes.
At Rivington House, a residence for AIDS patients on the Lower East Side of Manhattan, Dr. Sheree Starrett, the medical director, said that neither heart disease nor diabetes was “terribly hard to treat, except that every time you add more meds there is more chance of something else going wrong.”
Statins, for instance, which are the drug of choice for high cholesterol, are bad for people with abnormal liver function, also a greater risk among blacks. Many AIDS patients have end-stage liver disease, either from intravenous drug use or alcohol abuse. Among Dr. Starrett’s AIDS patients is 58-year-old Dominga Montanez, whose first husband died of AIDS and whose second husband is also infected.
“My liver is acting up, my diabetes is out of control and I fractured my spine” because of osteoporosis, Ms. Montanez said. “To me, the new things are worse than the AIDS.”
There are no data that compare the incidence, age of onset and cause of geriatric diseases in the general population with the long-term survivors of H.I.V. infection. But physicians and researchers say that they do not see people in their mid-50s, absent AIDS, with hip replacements associated with vascular necrosis, heart disease or diabetes related to lipodystrophy, or osteoporosis without the usual risk factors.
“All we can do right now is make inferences from thing to thing to thing,” said Dr. Tom Barrett, medical director of Howard Brown. “They might have gotten some of these diseases anyway. But the rates and the timing, and the association with certain drugs, makes everyone feel this is a different problem.”
One theory about why research on AIDS and aging has barely begun is “the rapid increase in numbers,” Dr. Emlet said. The federal disease centers’ most recent surveillance data, from 33 states that meet certain reporting criteria, showed that the number of people 50 and older with AIDS or H.I.V. infection was 115,871 in 2005, nearly double the 64,445 in 2001.
Another is the routine exclusion of older people from drug trials by big pharmaceutical companies. The studies are designed to measure safety and efficacy but generally not long-term side effects.
Those explanations do not satisfy Larry Kramer, founder of several AIDS advocacy groups. Mr. Kramer, 73 and a long-term survivor, said he had always suspected “it was only a matter of time before stuff like this happened” given the potency of the antiretroviral drugs. “How long will the human body be able to tolerate that constant bombardment?” he asked. “Well, we are now seeing that many bodies can’t. Once again, just as we thought we were out of the woods, sort of, we have good reason again to be really scared.”
The lack of research also limits a patient’s care. Dr. Barrett says the incidence of osteoporosis warrants routine screening. Medicare, Medicaid and private insurers, however, will not cover bone density tests for middle-aged men.
Marty Weinstein, 55 and infected since 1982, has had a pacemaker installed, has been found to have osteoporosis, and has been treated for anal cancer and medicated for severe depression — all in the last year. He also has cognitive deficits.
A former professor of psychology in Chicago, he presses his doctors about cause and effect. Sometimes they offer a hypothesis, he said, but never a certain explanation.
“I know the first concern was keeping us alive,” Mr. Weinstein said. “But now that so many people are going to live longer lives, how are we going to get them through this emotionally and physically?”
New York Times
Published: January 6, 2008
CHICAGO — John Holloway received a diagnosis of AIDS nearly two decades ago, when the disease was a speedy death sentence and treatment a distant dream.
John Holloway, 59, survived AIDS but has more health problems than his 84-year-old father.
Dominga Montanez, 58, says she has new health problems that are worse than having AIDS.
Yet at 59 he is alive, thanks to a cocktail of drugs that changed the course of an epidemic. But with longevity has come a host of unexpected medical conditions, which challenge the prevailing view of AIDS as a manageable, chronic disease.
Mr. Holloway, who lives in a housing complex designed for the frail elderly, suffers from complex health problems usually associated with advanced age: chronic obstructive pulmonary disease, diabetes, kidney failure, a bleeding ulcer, severe depression, rectal cancer and the lingering effects of a broken hip.
Those illnesses, more severe than his 84-year-old father’s, are not what Mr. Holloway expected when lifesaving antiretroviral drugs became the standard of care in the mid-1990s.
The drugs gave Mr. Holloway back his future.
But at what cost?
That is the question, heretical to some, that is now being voiced by scientists, doctors and patients encountering a constellation of ailments showing up prematurely or in disproportionate numbers among the first wave of AIDS survivors to reach late middle age.
There have been only small, inconclusive studies on the causes of aging-related health problems among AIDS patients.
Without definitive research, which has just begun, that second wave of suffering could be a coincidence, although it is hard to find anyone who thinks so.
Instead, experts are coming to believe that the immune system and organs of long-term survivors took an irreversible beating before the advent of lifesaving drugs and that those very drugs then produced additional complications because of their toxicity — a one-two punch.
“The sum total of illnesses can become overwhelming,” said Charles A. Emlet, an associate professor at the University of Washington at Tacoma and a leading H.I.V. and aging researcher, who sees new collaborations between specialists that will improve care.
“AIDS is a very serious disease, but longtime survivors have come to grips with it,” Dr. Emlet continued, explaining that while some patients experienced unpleasant side effects from the antiretrovirals, a vast majority found a cocktail they could tolerate. “Then all of a sudden they are bombarded with a whole new round of insults, which complicate their medical regime and have the potential of being life threatening. That undermines their sense of stability and makes it much more difficult to adjust.”
The graying of the AIDS epidemic has increased interest in the connection between AIDS and cardiovascular disease, certain cancers, diabetes, osteoporosis and depression. The number of people 50 and older living with H.I.V., the virus that causes AIDS, has increased 77 percent from 2001 to 2005, according to the federal Centers for Disease Control, and they now represent more than a quarter of all cases in the United States.
The most comprehensive research has come from the AIDS Community Research Initiative of America, which has studied 1,000 long-term survivors in New York City, and the Multi-Site AIDS Cohort Study, financed by the National Institutes of Health, which has followed 2,000 subjects nationwide for the past 25 years.
The Acria study, published in 2006, examined psychological, not medical, issues and found unusual rates of depression and isolation among older people with AIDS.
The Multi-Site AIDS Cohort Study, or MACS, will directly examine the intersection of AIDS and aging over the next five years. Dr. John Phair, a principal investigator for the study, which has health data from both infected and uninfected men, said “prolonged survival” coupled with the “naturally occurring health issues” of old age raised pressing research questions: “Which health issues are a direct result of aging, which are a direct result of H.I.V. and what role do H.I.V. meds play?”
The MACS investigators, and other researchers, defend the slow pace of research as a function of numbers. The first generation of AIDS patients, in the mid-1980s, had no effective treatments for a decade, and died in overwhelming numbers, leaving few survivors to study.
Those survivors, like Mr. Holloway, gaunt from chemotherapy and radiation and mostly housebound, lurch from crisis to crisis. Mr. Holloway says his adjustment strategy is simple: “Deal with it.” Still he notes, ruefully, that his father has no medical complaints other than arthritis, failing eyesight and slight hearing loss.
“I look at how gracefully he’s aged, and I wish I understood what was happening to my body,” Mr. Holloway said during a recent home visit from his case manager at the Howard Brown Health Center here, a gay, lesbian and transgender organization. The case manager, Lisa Katona, could soothe but not inform him. “Nobody’s sure what causes what,” Ms. Katona told Mr. Holloway. “You folks are the first to go through this and we’re learning as we go.”
Mr. Holloway is uncomplaining even in the face of pneumonia and a 40-pound weight loss, both associated with his cancer treatment. Has the cost been too high? He says it has not, “considering the alternatives.”
Halfway across the country, Jeff, 56-year-old New Yorker who was found to have AIDS in 1987, said he asks himself that question often.
Jeff, who asked that he not be fully identified, has had one hip replacement because of a condition called avascular necrosis, the death of cells from inadequate blood supply, and needs another to avoid a wheelchair. Many experts think that avascular necrosis is caused by the steroids many early AIDS sufferers took for pneumonia.
“The virus is under control, and I should be in a state of ecstasy,” he said, “but I can’t even tie my own shoe laces and get up and down the subway stairs. ”
His bones are spongy from osteoporosis, a disorder that afflicts many postmenopausal women but rarely middle-aged men, except some with AIDS. No research has explained the unusual incidence.
In addition, Jeff has Parkinson’s disease, which is causing tremors and memory lapses.
He is in an AIDS support group at SAGE, a social service agency for older gay men and lesbians. His fellow group members also say they find the illnesses associated with age more taxing than the H.I.V. infection. One 69-year-old member of the group, for example, has had several heart attacks and triple bypass surgery, and his doctor predicts that heart disease is more likely to kill him than AIDS.
Cardiovascular disease and diabetes are associated with a condition called lipodystrophy, which redistributes fat, leaving the face and lower extremities wasted, the belly distended and the back humped. In addition, lipodystrophy raises cholesterol levels and causes glucose intolerance, which is especially dangerous to black people, who are already predisposed to heart disease and diabetes.
At Rivington House, a residence for AIDS patients on the Lower East Side of Manhattan, Dr. Sheree Starrett, the medical director, said that neither heart disease nor diabetes was “terribly hard to treat, except that every time you add more meds there is more chance of something else going wrong.”
Statins, for instance, which are the drug of choice for high cholesterol, are bad for people with abnormal liver function, also a greater risk among blacks. Many AIDS patients have end-stage liver disease, either from intravenous drug use or alcohol abuse. Among Dr. Starrett’s AIDS patients is 58-year-old Dominga Montanez, whose first husband died of AIDS and whose second husband is also infected.
“My liver is acting up, my diabetes is out of control and I fractured my spine” because of osteoporosis, Ms. Montanez said. “To me, the new things are worse than the AIDS.”
There are no data that compare the incidence, age of onset and cause of geriatric diseases in the general population with the long-term survivors of H.I.V. infection. But physicians and researchers say that they do not see people in their mid-50s, absent AIDS, with hip replacements associated with vascular necrosis, heart disease or diabetes related to lipodystrophy, or osteoporosis without the usual risk factors.
“All we can do right now is make inferences from thing to thing to thing,” said Dr. Tom Barrett, medical director of Howard Brown. “They might have gotten some of these diseases anyway. But the rates and the timing, and the association with certain drugs, makes everyone feel this is a different problem.”
One theory about why research on AIDS and aging has barely begun is “the rapid increase in numbers,” Dr. Emlet said. The federal disease centers’ most recent surveillance data, from 33 states that meet certain reporting criteria, showed that the number of people 50 and older with AIDS or H.I.V. infection was 115,871 in 2005, nearly double the 64,445 in 2001.
Another is the routine exclusion of older people from drug trials by big pharmaceutical companies. The studies are designed to measure safety and efficacy but generally not long-term side effects.
Those explanations do not satisfy Larry Kramer, founder of several AIDS advocacy groups. Mr. Kramer, 73 and a long-term survivor, said he had always suspected “it was only a matter of time before stuff like this happened” given the potency of the antiretroviral drugs. “How long will the human body be able to tolerate that constant bombardment?” he asked. “Well, we are now seeing that many bodies can’t. Once again, just as we thought we were out of the woods, sort of, we have good reason again to be really scared.”
The lack of research also limits a patient’s care. Dr. Barrett says the incidence of osteoporosis warrants routine screening. Medicare, Medicaid and private insurers, however, will not cover bone density tests for middle-aged men.
Marty Weinstein, 55 and infected since 1982, has had a pacemaker installed, has been found to have osteoporosis, and has been treated for anal cancer and medicated for severe depression — all in the last year. He also has cognitive deficits.
A former professor of psychology in Chicago, he presses his doctors about cause and effect. Sometimes they offer a hypothesis, he said, but never a certain explanation.
“I know the first concern was keeping us alive,” Mr. Weinstein said. “But now that so many people are going to live longer lives, how are we going to get them through this emotionally and physically?”
New York Times
Wednesday, January 2, 2008
International Team Studies South African Plant for HIV/AIDS
CAM at the NIH: Focus on Complementary and Alternative Medicine
Volume XIV, Number 4: Fall 2007
International Team Studies South African Plant for HIV/AIDS
"It's just overwhelming. It feels like anything you do is a drop in a huge, huge bucket. But, you drop a drop, and it causes a ripple, and that causes a lot of change. Sometimes you have to be a drop, because that's all you've got."
So Kathleen Goggin, Ph.D., describes part of what draws her to co-lead a groundbreaking study of an African traditional medicine. A plant called Sutherlandia is being examined for its potential to help patients with HIV infection. The study is being cosponsored by NCCAM and NIH's Office of AIDS Research, Office of Dietary Supplements, and Fogarty International Center.
According to the joint United Nations program on HIV/AIDS, or UNAIDS, about 33.2 million people worldwide have HIV infection. AIDS is among the leading causes of death worldwide.
A group of contributors to the Sutherlandia study met in September 2007. Courtesy of Kathleen Goggin
A group of contributors to the Sutherlandia study met in September 2007 in Pietermaritzburg, KwaZulu-Natal, South Africa. Left to right: Douglas Wilson, James Syce, Kevin Rudeen, Laurie Ben-yair, Tilly Pillay, Makhosi Msomi, Thulani Hlongwa, Baba Shange, Baba Thabethe, Elliot Makhathini, Bill Folk, Makhosi Xaba, Deborah Hayes, and Makhosi Dlamini. The photo’s setting is a shop for supplies for traditional inyanga healing.
Courtesy of Kathleen Goggin
South Africa is one of the countries that have been hardest hit by HIV/AIDS. While changes in South Africa have been taking place (including a new national strategic plan for AIDS) to help prevent transmission of the virus and to treat those who are infected, the challenges are large in scale. UNAIDS states that in South Africa by the end of 2006:
* About 5½ million people (or one in nine) were living with HIV infection. Almost one-quarter million of them were children under 15 years old.
* More than 360,000 people were taking antiretroviral therapy (ART).
* For every person in South Africa who begins taking ART, three more become infected with HIV.
Could a Plant Be Helpful?
Lessertia frutescens. William Curtis (1792), courtesy of the Missouri Botanical Garden
Lessertia frutescens (Sutherlandia)
William Curtis (1792), courtesy of the Missouri Botanical Garden
Working to create a ripple in the pandemic's bucket are an international team of Western-trained clinicians and researchers from both the United States and South Africa (see box below) as well as South African traditional healers. The plant they are studying, Sutherlandia, is a member of the pea family, uniquely native to South Africa, and wild-growing in places there. Its scientific name is Lessertia frutescens; some of its popular names are Insisa, Unwele, Phetola, and cancer bush.
Walk into any South African traditional medicine market, and there it is—alongside the other herbs, barks, pieces of wood, animal bones and teeth, and other products sold and traded for medicinal purposes. Sutherlandia is used to make traditional medicine believed to be helpful for many health problems—such as infections (including HIV), inflammation, depression, cancer, and stress effects—and as a wellness tonic. It is also available in South African drugstores and in some other countries such as the United States, where it is sold as a dietary supplement.
This randomized, placebo-controlled study is looking at Sutherlandia's safety in a group of 124 volunteers who are at an early stage of HIV infection and do not qualify for government-sponsored ART. The researchers will also collect data that could shed light on the plant's usefulness in treating some of the symptoms of HIV infection. The participants who receive Sutherlandia will take by mouth a preparation made from ground leaves and specially formulated for the study. The study will be conducted at Edendale Hospital, a large county hospital located in Pietermaritzburg, KwaZulu-Natal, South Africa, and affiliated with the Nelson R. Mandela School of Medicine.
Jack Killen, M.D., Acting Deputy Director of NCCAM and Director of NCCAM's Office of International Health Research, said, "Many people are using this plant in South Africa, where it originated, and where traditional healers are commonly the first and/or the only medical care option." He added, "Not much is known yet about Sutherlandia scientifically, including whether and how it works.We hope to learn a good deal from this study about Sutherlandia specifically and about the best practices for rigorous research on traditional medicines more generally."
Centers That Study Traditional/Indigenous Therapies
The Sutherlandia study is a key project of one of NCCAM's Centers for International Research on CAM: The International Center for Indigenous Phytotherapy Studies (TICIPS) on HIV/AIDS, Secondary Infections, and Immune Modulation. This center is a partnership between many institutions:
South Africa
University of the Western Cape
University of Cape Town
University of KwaZulu-Natal
Medical Research Council of South Africa
United States
University of Missouri, Columbia
University of Missouri, Kansas City
Missouri Botanical Garden
Georgetown University
University of Texas Medical Branch at Galveston
TICIPS also plans to study African wormwood (Artemisia afra), another traditional South African medicine, for its potential usefulness against tuberculosis and cervical cancer.
Dr. Bill Folk (left) and Dr. Quinton Johnson. Copyright University of Missouri School of Medicine.
Dr. Bill Folk (left)
and Dr. Quinton Johnson
© University of Missouri
School of Medicine
TICIPS and Study Leaders
Key personnel include William Folk, Ph.D., principal investigator and TICIPS co-director, who is professor of biochemistry at the University of Missouri, Columbia, and associate dean for research at its school of medicine. Quinton Johnson, Ph.D., is TICIPS co-director and director of the South African Herbal Science and Medicine Institute at the University of the Western Cape. Co-leaders of the Sutherlandia study are Kathleen Goggin, Ph.D., associate professor of psychology at the University of Missouri, Kansas City, and Douglas Wilson, M.B.Ch.B., F.C.P., head of the Department of Medicine at Edendale Hospital. Nceba Gqaleni, Ph.D., is the Department of Science and Technology/National Research Foundation Research Chair on Indigenous Health Care Systems, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal. James Syce, Ph.D., is professor of pharmacy at the University of the Western Cape.
NCCAM's international centers are designed to examine complementary, alternative, and traditional medical therapies in the environments where they originated and have the longest tradition of use. In South Africa, that environment is "one of the most botanically diverse and rich regions in the world," says Dr. Folk. South Africa has over 20,000 indigenous species of plants, several thousand of which are used for health purposes by traditional healers.
A Traditional System That Millions Rely Upon
South African traditional medicine dates back to ancient times. It has been recognized by the South African government as a key part of that country's health care system. It is estimated that in South Africa, there are about 200,000 traditional healers, and about 80 percent of the population (which numbers about 48 million, with 18 languages and many cultures) uses these healers for their primary health care.
African traditional medicine is too complex to describe fully in this article, but a few of its aspects include:
* The approach is holistic, focusing on the whole person rather than on particular organs or disorders.
* Body, spirit, and environment are all taken into consideration.
* Many traditional healers use rituals, herbs and other naturally derived medicines, divination (obtaining information through what is believed to be supernatural means), offerings, faith healing, and purgative approaches such as enemas and incisions.
* The different types of traditional healers include inyangas, who are especially skilled in natural medicines; sangomas, spiritualists who counsel and heal through communication with ancestral spirits; traditional birth attendants; and traditional surgeons.
Western medicine is also available in South Africa, including at Edendale Hospital, but it can be challenging to obtain for many reasons, including distance (close to 50 percent of South Africa's population lives in nonurban areas) and a shortage of Western-trained doctors, nurses, and other health staff. In the district of Mount Frere, for example, there is one Western doctor for every 30,000 residents.
A Carefully Designed Research Collaboration
Traditional healers in South Africa are collaborating in research with allopathic team members at every stage of the Sutherlandia study—from developing the research questions through analyzing, interpreting, and sharing the results. This reflects not only a level of commitment but the use of, and training in, a research strategy called community-based participatory research.
Dr. Goggin says, "The traditional health providers are helping us in so many ways. They have helped give legitimacy to the study. They partnered with us in translation and in developing outcome measures. They will be helping us with patient retention. Above all, they are willing to try. For 1,000 years, people have taken things from their traditional and indigenous medicine—stolen [them] and walked away. Our colleagues are trusting that we are not going to do that and we will work hand in hand." The study is designed to ensure compliance with U.S. and South African regulations on the conduct of research, financial disclosure, conflict of interest, and international property rights.
Adapting for Culture
Dr. Goggin recalls a key aspect of the study in which all the members of the team, as well as additional groups of traditional healers, offered their expertise to adapt tools for the study.
They were going to need quantifiable outcome measures—including for perceived stress, symptoms of depression, and quality of life, all of which have cultural associations. The U.S. researchers began with some standard scales and the 10 "good practice" steps developed by the International Society for Pharmacoeconomics and Outcomes Research. How would these translate in the context of Zulu South Africa?
Dr. Goggin says, "We did focus groups with traditional healers who are culturally Zulu and speak isiZulu. Many also speak English, but isiZulu is their primary language and the one they use when treating clients and seeing patients. They helped us to figure out what our measures should be."
She continues, "There was no easy translation for any of the items on the depression measure, for example. There's no single word for depression in isiZulu. So, when we talked about the concept of depression, we asked, 'When someone is having a lot of worries and stress and is not feeling well, what is that called?' They came to consensus on a term, umoya uphansi.
"Then we asked, 'What would those people look like and be like?' And they came up with every single symptom of depression. We used the CES-D [one of the screening tests for depression, developed by the Center for Epidemiologic Studies, National Institute of Mental Health], which does not include an item on sexual dysfunction. The traditional healers added sexual dysfunction on their own."
When it came to a term for quality of life, the traditional healers agreed on izinga/iqophelo lempilo, which Dr. Goggin says means "spirit of life… It's very, very close to our concept, but they don't think of quality of life as a thing. It's something that somebody strives for at all times. Everyone would want 'quality of life.'"
There were many steps by the team members to review and revise questionnaires to be used in the study. For example, the versions of isiZulu spoken in two cities that are 45 minutes apart, Pietermaritzburg and Durban, turned out to be significantly different.
The Experience So Far
Dr. Goggin and her colleagues learned from talking to traditional healers, she says, that "Sutherlandia is a powerful part of their muthis [or mutis, traditional medicine formulas], and they use it often. They don't use Sutherlandia on its own, but in combinations with other herbs. It is believed to have an impact on gastrointestinal distress, especially in reducing nausea and increasing appetite. That may be true, at least from some of the early studies that have been done in animals and in our previous phase I study [on safety in healthy adults]. With increased eating, one often sees an increase in mood and in quality of life."
Although Sutherlandia is widely used, Dr. Folk says, previously there was no solid research evidence of its safety and effectiveness, including in HIV/AIDS. He notes there is some preliminary scientific evidence that this herb can help treat infections, such as bronchitis or the common cold—and also some laboratory evidence that Sutherlandia has "significant interactions" with ART drugs (in other words, taking them together could alter the effectiveness or side effects of ART).
Dr. Folk says that he has found it particularly rewarding so far "to assist in the development of the collaboration in research between traditional healers and physicians, which will undoubtedly improve care." Dr. Goggin appreciates "having had the opportunity to work with and learn from my colleagues in South Africa and being part of this historic trial." She adds that she finds South Africa to be "an amazing place. People there are generally just the most warm, open, and inviting people you'll ever meet."
Is Sutherlandia Safe?
The TICIPS team first carried out a small, randomized, double-blind, placebo-controlled safety study of Sutherlandia in a group of 25 healthy volunteers. Dr. Quinton Johnson and his colleagues found it to be well tolerated, with no clinically significant differences in side effects seen between the group who received the Sutherlandia and the group who received a placebo, except that the Sutherlandia group showed indications of an increase in appetite. They noted that in an earlier study in vervet monkeys, Sutherlandia was given at nine times a typical dose and no adverse effects occurred. They suggested that Sutherlandia's potential benefits might be attributed to one or more of the following ingredients: D-pinitol (a simple sugar often found in legumes), GABA (gabba-amino butyric acid, an amino acid and a neurotransmitter), and L-canavanine (an amino acid).
There is very limited information about Sutherlandia's safety and side effects in the peer-reviewed literature. However, among the common points in two evidence-based reviews are that:
* Sutherlandia has a long history in Africa of apparently safe use.
* Its known side effects include mild diarrhea, dry mouth, increased urination, and (in people who have wasting and weakness from disease) dizziness.
* There are indications that Sutherlandia interacts with ART.
* The safety of the ingredient L-canavanine is a controversial area. It may have an association with lupus and a lupus-like syndrome—a concern that appears to be based largely on a case report, and some laboratory and animal studies, on L-canavanine in another legume plant, alfalfa (Medicago sativa). One of the reviews cites a South African reference reporting rare instances of birth defects and induction of abortion from L-canavanine. In short, the safety of L-canavanine is controversial—more high-quality studies are needed.
* Very little is known scientifically about the safety of D-pinitol and GABA.
Sources
Babb DA, Pemba L, Seatlanyane P, et al. Use of traditional medicine by HIV-infected individuals in South Africa in the era of antiretroviral therapy. Psychology, Health and Medicine. 2007;12(3):314-320.
Bottom Line Monograph: Alfalfa. Natural Standard database. Accessed at http://www.naturalstandard.com on October 9, 2007.
GABA (Gamma-Aminobutyric Acid). Natural Medicines Comprehensive Database. Accessed at http://www.naturaldatabase.com on October 9, 2007.
Giarelli E, Jacobs LA. Traditional healing and HIV-AIDS in KwaZulu-Natal, South Africa. American Journal of Nursing. 2003;103(10):36-46.
Goggin K., Mbhele AL, Makhathini ME, et al. The translation and cultural adaptation of patient-reported outcome measures: a report from the field. 2007. [Unpublished manuscript]
Goggin K, Pinston M, Gqaleni N, et al. The role of South African traditional health practitioners in HIV/AIDS prevention and treatment. 2007 [in press]. In Pope C, White R, Malow R (Eds.) Globalization of HIV/AIDS: An Interdisciplinary Reader. New York: Routledge.
Johnson Q, Syce J, Nell H, et al. A randomized, double-blind, placebo-controlled trial of Lessertia frutescens in healthy adults. PloS Clinical Trials. 2007;2(4)e6.
Mills E, Cooper C, Seely D, et al. African herbal medicines in the treatment of HIV: Hypoxis and Sutherlandia: An overview of evidence and pharmacology. Nutrition Journal. 2005;4(19):1-6.
Morris K. Treating HIV in South Africa: a tale of two systems. Lancet. 2001;357:1190.
Ngubane H. Aspects of clinical practice and traditional organization of indigenous healers in South Africa. Social Science and Medicine. Part B, Medical Anthropology. 1981;15B:361-365.
Puckree R, Mkhize M, Mgobhozi Z, et al. African traditional healers: what health care professionals need to know. International Journal of Rehabilitation Research. 2002;25:247-251.
UNAIDS. AIDS epidemic update: December 2007. Accessed at http://data.unaids.org/pub/EpiSlides/2007/2007_epiupdate_en.pdf on December 4, 2007.
UNAIDS. Uniting the world against AIDS: South Africa. June 2007. Accessed at http://www.unaids.org/en/CountryResponses/Countries/south_africa.asp on October 12, 2007.
Advancing Global Health
In its Strategic Plan for 2005–2009, NCCAM describes its interest in:
* Advancing the understanding of traditional/indigenous medical systems (which may also be used as CAM) through multidisciplinary collaborative studies
* Contributing to the preservation of irreplaceable and valuable knowledge about them
* Enhancing understanding of how best to integrate them with "conventional" medical interventions.
Go to nccam.nih.gov/about/plans/2005/ to view NCCAM's
Strategic Plan.
CAM at the NIH
Volume XIV, Number 4: Fall 2007
International Team Studies South African Plant for HIV/AIDS
"It's just overwhelming. It feels like anything you do is a drop in a huge, huge bucket. But, you drop a drop, and it causes a ripple, and that causes a lot of change. Sometimes you have to be a drop, because that's all you've got."
So Kathleen Goggin, Ph.D., describes part of what draws her to co-lead a groundbreaking study of an African traditional medicine. A plant called Sutherlandia is being examined for its potential to help patients with HIV infection. The study is being cosponsored by NCCAM and NIH's Office of AIDS Research, Office of Dietary Supplements, and Fogarty International Center.
According to the joint United Nations program on HIV/AIDS, or UNAIDS, about 33.2 million people worldwide have HIV infection. AIDS is among the leading causes of death worldwide.
A group of contributors to the Sutherlandia study met in September 2007. Courtesy of Kathleen Goggin
A group of contributors to the Sutherlandia study met in September 2007 in Pietermaritzburg, KwaZulu-Natal, South Africa. Left to right: Douglas Wilson, James Syce, Kevin Rudeen, Laurie Ben-yair, Tilly Pillay, Makhosi Msomi, Thulani Hlongwa, Baba Shange, Baba Thabethe, Elliot Makhathini, Bill Folk, Makhosi Xaba, Deborah Hayes, and Makhosi Dlamini. The photo’s setting is a shop for supplies for traditional inyanga healing.
Courtesy of Kathleen Goggin
South Africa is one of the countries that have been hardest hit by HIV/AIDS. While changes in South Africa have been taking place (including a new national strategic plan for AIDS) to help prevent transmission of the virus and to treat those who are infected, the challenges are large in scale. UNAIDS states that in South Africa by the end of 2006:
* About 5½ million people (or one in nine) were living with HIV infection. Almost one-quarter million of them were children under 15 years old.
* More than 360,000 people were taking antiretroviral therapy (ART).
* For every person in South Africa who begins taking ART, three more become infected with HIV.
Could a Plant Be Helpful?
Lessertia frutescens. William Curtis (1792), courtesy of the Missouri Botanical Garden
Lessertia frutescens (Sutherlandia)
William Curtis (1792), courtesy of the Missouri Botanical Garden
Working to create a ripple in the pandemic's bucket are an international team of Western-trained clinicians and researchers from both the United States and South Africa (see box below) as well as South African traditional healers. The plant they are studying, Sutherlandia, is a member of the pea family, uniquely native to South Africa, and wild-growing in places there. Its scientific name is Lessertia frutescens; some of its popular names are Insisa, Unwele, Phetola, and cancer bush.
Walk into any South African traditional medicine market, and there it is—alongside the other herbs, barks, pieces of wood, animal bones and teeth, and other products sold and traded for medicinal purposes. Sutherlandia is used to make traditional medicine believed to be helpful for many health problems—such as infections (including HIV), inflammation, depression, cancer, and stress effects—and as a wellness tonic. It is also available in South African drugstores and in some other countries such as the United States, where it is sold as a dietary supplement.
This randomized, placebo-controlled study is looking at Sutherlandia's safety in a group of 124 volunteers who are at an early stage of HIV infection and do not qualify for government-sponsored ART. The researchers will also collect data that could shed light on the plant's usefulness in treating some of the symptoms of HIV infection. The participants who receive Sutherlandia will take by mouth a preparation made from ground leaves and specially formulated for the study. The study will be conducted at Edendale Hospital, a large county hospital located in Pietermaritzburg, KwaZulu-Natal, South Africa, and affiliated with the Nelson R. Mandela School of Medicine.
Jack Killen, M.D., Acting Deputy Director of NCCAM and Director of NCCAM's Office of International Health Research, said, "Many people are using this plant in South Africa, where it originated, and where traditional healers are commonly the first and/or the only medical care option." He added, "Not much is known yet about Sutherlandia scientifically, including whether and how it works.We hope to learn a good deal from this study about Sutherlandia specifically and about the best practices for rigorous research on traditional medicines more generally."
Centers That Study Traditional/Indigenous Therapies
The Sutherlandia study is a key project of one of NCCAM's Centers for International Research on CAM: The International Center for Indigenous Phytotherapy Studies (TICIPS) on HIV/AIDS, Secondary Infections, and Immune Modulation. This center is a partnership between many institutions:
South Africa
University of the Western Cape
University of Cape Town
University of KwaZulu-Natal
Medical Research Council of South Africa
United States
University of Missouri, Columbia
University of Missouri, Kansas City
Missouri Botanical Garden
Georgetown University
University of Texas Medical Branch at Galveston
TICIPS also plans to study African wormwood (Artemisia afra), another traditional South African medicine, for its potential usefulness against tuberculosis and cervical cancer.
Dr. Bill Folk (left) and Dr. Quinton Johnson. Copyright University of Missouri School of Medicine.
Dr. Bill Folk (left)
and Dr. Quinton Johnson
© University of Missouri
School of Medicine
TICIPS and Study Leaders
Key personnel include William Folk, Ph.D., principal investigator and TICIPS co-director, who is professor of biochemistry at the University of Missouri, Columbia, and associate dean for research at its school of medicine. Quinton Johnson, Ph.D., is TICIPS co-director and director of the South African Herbal Science and Medicine Institute at the University of the Western Cape. Co-leaders of the Sutherlandia study are Kathleen Goggin, Ph.D., associate professor of psychology at the University of Missouri, Kansas City, and Douglas Wilson, M.B.Ch.B., F.C.P., head of the Department of Medicine at Edendale Hospital. Nceba Gqaleni, Ph.D., is the Department of Science and Technology/National Research Foundation Research Chair on Indigenous Health Care Systems, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal. James Syce, Ph.D., is professor of pharmacy at the University of the Western Cape.
NCCAM's international centers are designed to examine complementary, alternative, and traditional medical therapies in the environments where they originated and have the longest tradition of use. In South Africa, that environment is "one of the most botanically diverse and rich regions in the world," says Dr. Folk. South Africa has over 20,000 indigenous species of plants, several thousand of which are used for health purposes by traditional healers.
A Traditional System That Millions Rely Upon
South African traditional medicine dates back to ancient times. It has been recognized by the South African government as a key part of that country's health care system. It is estimated that in South Africa, there are about 200,000 traditional healers, and about 80 percent of the population (which numbers about 48 million, with 18 languages and many cultures) uses these healers for their primary health care.
African traditional medicine is too complex to describe fully in this article, but a few of its aspects include:
* The approach is holistic, focusing on the whole person rather than on particular organs or disorders.
* Body, spirit, and environment are all taken into consideration.
* Many traditional healers use rituals, herbs and other naturally derived medicines, divination (obtaining information through what is believed to be supernatural means), offerings, faith healing, and purgative approaches such as enemas and incisions.
* The different types of traditional healers include inyangas, who are especially skilled in natural medicines; sangomas, spiritualists who counsel and heal through communication with ancestral spirits; traditional birth attendants; and traditional surgeons.
Western medicine is also available in South Africa, including at Edendale Hospital, but it can be challenging to obtain for many reasons, including distance (close to 50 percent of South Africa's population lives in nonurban areas) and a shortage of Western-trained doctors, nurses, and other health staff. In the district of Mount Frere, for example, there is one Western doctor for every 30,000 residents.
A Carefully Designed Research Collaboration
Traditional healers in South Africa are collaborating in research with allopathic team members at every stage of the Sutherlandia study—from developing the research questions through analyzing, interpreting, and sharing the results. This reflects not only a level of commitment but the use of, and training in, a research strategy called community-based participatory research.
Dr. Goggin says, "The traditional health providers are helping us in so many ways. They have helped give legitimacy to the study. They partnered with us in translation and in developing outcome measures. They will be helping us with patient retention. Above all, they are willing to try. For 1,000 years, people have taken things from their traditional and indigenous medicine—stolen [them] and walked away. Our colleagues are trusting that we are not going to do that and we will work hand in hand." The study is designed to ensure compliance with U.S. and South African regulations on the conduct of research, financial disclosure, conflict of interest, and international property rights.
Adapting for Culture
Dr. Goggin recalls a key aspect of the study in which all the members of the team, as well as additional groups of traditional healers, offered their expertise to adapt tools for the study.
They were going to need quantifiable outcome measures—including for perceived stress, symptoms of depression, and quality of life, all of which have cultural associations. The U.S. researchers began with some standard scales and the 10 "good practice" steps developed by the International Society for Pharmacoeconomics and Outcomes Research. How would these translate in the context of Zulu South Africa?
Dr. Goggin says, "We did focus groups with traditional healers who are culturally Zulu and speak isiZulu. Many also speak English, but isiZulu is their primary language and the one they use when treating clients and seeing patients. They helped us to figure out what our measures should be."
She continues, "There was no easy translation for any of the items on the depression measure, for example. There's no single word for depression in isiZulu. So, when we talked about the concept of depression, we asked, 'When someone is having a lot of worries and stress and is not feeling well, what is that called?' They came to consensus on a term, umoya uphansi.
"Then we asked, 'What would those people look like and be like?' And they came up with every single symptom of depression. We used the CES-D [one of the screening tests for depression, developed by the Center for Epidemiologic Studies, National Institute of Mental Health], which does not include an item on sexual dysfunction. The traditional healers added sexual dysfunction on their own."
When it came to a term for quality of life, the traditional healers agreed on izinga/iqophelo lempilo, which Dr. Goggin says means "spirit of life… It's very, very close to our concept, but they don't think of quality of life as a thing. It's something that somebody strives for at all times. Everyone would want 'quality of life.'"
There were many steps by the team members to review and revise questionnaires to be used in the study. For example, the versions of isiZulu spoken in two cities that are 45 minutes apart, Pietermaritzburg and Durban, turned out to be significantly different.
The Experience So Far
Dr. Goggin and her colleagues learned from talking to traditional healers, she says, that "Sutherlandia is a powerful part of their muthis [or mutis, traditional medicine formulas], and they use it often. They don't use Sutherlandia on its own, but in combinations with other herbs. It is believed to have an impact on gastrointestinal distress, especially in reducing nausea and increasing appetite. That may be true, at least from some of the early studies that have been done in animals and in our previous phase I study [on safety in healthy adults]. With increased eating, one often sees an increase in mood and in quality of life."
Although Sutherlandia is widely used, Dr. Folk says, previously there was no solid research evidence of its safety and effectiveness, including in HIV/AIDS. He notes there is some preliminary scientific evidence that this herb can help treat infections, such as bronchitis or the common cold—and also some laboratory evidence that Sutherlandia has "significant interactions" with ART drugs (in other words, taking them together could alter the effectiveness or side effects of ART).
Dr. Folk says that he has found it particularly rewarding so far "to assist in the development of the collaboration in research between traditional healers and physicians, which will undoubtedly improve care." Dr. Goggin appreciates "having had the opportunity to work with and learn from my colleagues in South Africa and being part of this historic trial." She adds that she finds South Africa to be "an amazing place. People there are generally just the most warm, open, and inviting people you'll ever meet."
Is Sutherlandia Safe?
The TICIPS team first carried out a small, randomized, double-blind, placebo-controlled safety study of Sutherlandia in a group of 25 healthy volunteers. Dr. Quinton Johnson and his colleagues found it to be well tolerated, with no clinically significant differences in side effects seen between the group who received the Sutherlandia and the group who received a placebo, except that the Sutherlandia group showed indications of an increase in appetite. They noted that in an earlier study in vervet monkeys, Sutherlandia was given at nine times a typical dose and no adverse effects occurred. They suggested that Sutherlandia's potential benefits might be attributed to one or more of the following ingredients: D-pinitol (a simple sugar often found in legumes), GABA (gabba-amino butyric acid, an amino acid and a neurotransmitter), and L-canavanine (an amino acid).
There is very limited information about Sutherlandia's safety and side effects in the peer-reviewed literature. However, among the common points in two evidence-based reviews are that:
* Sutherlandia has a long history in Africa of apparently safe use.
* Its known side effects include mild diarrhea, dry mouth, increased urination, and (in people who have wasting and weakness from disease) dizziness.
* There are indications that Sutherlandia interacts with ART.
* The safety of the ingredient L-canavanine is a controversial area. It may have an association with lupus and a lupus-like syndrome—a concern that appears to be based largely on a case report, and some laboratory and animal studies, on L-canavanine in another legume plant, alfalfa (Medicago sativa). One of the reviews cites a South African reference reporting rare instances of birth defects and induction of abortion from L-canavanine. In short, the safety of L-canavanine is controversial—more high-quality studies are needed.
* Very little is known scientifically about the safety of D-pinitol and GABA.
Sources
Babb DA, Pemba L, Seatlanyane P, et al. Use of traditional medicine by HIV-infected individuals in South Africa in the era of antiretroviral therapy. Psychology, Health and Medicine. 2007;12(3):314-320.
Bottom Line Monograph: Alfalfa. Natural Standard database. Accessed at http://www.naturalstandard.com on October 9, 2007.
GABA (Gamma-Aminobutyric Acid). Natural Medicines Comprehensive Database. Accessed at http://www.naturaldatabase.com on October 9, 2007.
Giarelli E, Jacobs LA. Traditional healing and HIV-AIDS in KwaZulu-Natal, South Africa. American Journal of Nursing. 2003;103(10):36-46.
Goggin K., Mbhele AL, Makhathini ME, et al. The translation and cultural adaptation of patient-reported outcome measures: a report from the field. 2007. [Unpublished manuscript]
Goggin K, Pinston M, Gqaleni N, et al. The role of South African traditional health practitioners in HIV/AIDS prevention and treatment. 2007 [in press]. In Pope C, White R, Malow R (Eds.) Globalization of HIV/AIDS: An Interdisciplinary Reader. New York: Routledge.
Johnson Q, Syce J, Nell H, et al. A randomized, double-blind, placebo-controlled trial of Lessertia frutescens in healthy adults. PloS Clinical Trials. 2007;2(4)e6.
Mills E, Cooper C, Seely D, et al. African herbal medicines in the treatment of HIV: Hypoxis and Sutherlandia: An overview of evidence and pharmacology. Nutrition Journal. 2005;4(19):1-6.
Morris K. Treating HIV in South Africa: a tale of two systems. Lancet. 2001;357:1190.
Ngubane H. Aspects of clinical practice and traditional organization of indigenous healers in South Africa. Social Science and Medicine. Part B, Medical Anthropology. 1981;15B:361-365.
Puckree R, Mkhize M, Mgobhozi Z, et al. African traditional healers: what health care professionals need to know. International Journal of Rehabilitation Research. 2002;25:247-251.
UNAIDS. AIDS epidemic update: December 2007. Accessed at http://data.unaids.org/pub/EpiSlides/2007/2007_epiupdate_en.pdf on December 4, 2007.
UNAIDS. Uniting the world against AIDS: South Africa. June 2007. Accessed at http://www.unaids.org/en/CountryResponses/Countries/south_africa.asp on October 12, 2007.
Advancing Global Health
In its Strategic Plan for 2005–2009, NCCAM describes its interest in:
* Advancing the understanding of traditional/indigenous medical systems (which may also be used as CAM) through multidisciplinary collaborative studies
* Contributing to the preservation of irreplaceable and valuable knowledge about them
* Enhancing understanding of how best to integrate them with "conventional" medical interventions.
Go to nccam.nih.gov/about/plans/2005/ to view NCCAM's
Strategic Plan.
CAM at the NIH
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