Research - HIV
Clinical trial for evaluation of a Human Immunodeficiency Virus nosode in the treatment for Human Immunodeficiency Virus-Infected individuals
Rajesh Shah
Director & Head, Research & Development, Mumbai, Maharashtra, India
Abstract
Introduction: Identifying the need for strengthening of the immune system, the investigator has developed new Human Immunodeficiency Virus (HIV) nosode and evaluated its effect on HIV positive individuals through a clinical trial.
Methods: Standardized and the scientific method of HIV nosode preparation has been described and documented. Thirty-seven HIV-infected persons were registered for the trial, and ten participants were dropped out from the study, so the effect of HIV nosode 30C and 50C, was concluded on 27 participants under the trial.
Results: Out of 27 participants, 7 (25.93%) showed a sustained reduction in the viral load from 12 to 24 weeks. Similarly 9 participants (33.33%) showed an increase in the CD4+ count by 20% altogether in 12 th and 24 th week. Significant weight gain was observed at week 12 (P = 0.0206). 63% and 55% showed an overall increase in either appetite or weight. The viral load increased from baseline to 24 week through 12 week in which the increase was not statistically significant (P > 0.05). 52% (14 of 27) participants have shown either stability or improvement in CD4% at the end of 24 weeks, of which 37% participants have shown improvement (1.54-48.35%) in CD4+ count and 15% had stable CD4+ percentage count until week 24 week. 16 out of 27 participants had a decrease (1.8-46.43%) in CD8 count. None of the adverse events led to discontinuation of study.
Conclusion: The study results revealed improvement in immunological parameters, treatment satisfaction, reported by an increase in weight, relief in symptoms, and an improvement in health status, which opens up possibilities for future studies.
Source Indian Journal of Research in Homeopathy
Link to Full Article
A Qualitative Systematic Review of the Homeopathic Outcome Studies in Patients with HIV/AIDS
Subhranil Saha, Malay Mundle, Shubhamoy Ghosh, Munmun Koley, Sk. Intaj Hossain
Clinical Research Unit (Siliguri), Central Council for Research in Homeopathy, India
2Medical College, Kolkata, Government of West Bengal, India
3M. B. H. Medical College & Hospital, Government of West Bengal, India
ABSTRACT
Background and aims: Systematic reviews of high-quality randomized controlled trials (RCTs) are crucial in evidence-based medicine (EBM). The aim of the present review was to investigate whether there is enough evidence on the efficacy of homeopathy in individuals with HIV/AIDS based on clinical trials.
Methods: The present is a criteria-based systematic review of cumulative research, and assessment of the methodological quality of published studies. The quality of the trials was evaluated using a list of validated and predefined criteria, and their outcomes were interpreted based on their quality. The main outcome measure was the methodological quality of the studies in terms of the threats to external, internal, construct, and statistical conclusion validity.
Results: Among the 6 clinical outcome studies located, 3 were open-label, non-randomized, non-controlled trials, 2 were RCTs, and one was a single-set replication study. The trials were too few in number, and did not exhibit very high quality. The results showed a positive trend regardless of the quality of the trials, or the variety of homeopathic treatment used. The results of the present review may be complicated by publication bias.
Conclusion: The currently available evidences do not suffice to infer definitive conclusions. Therefore, further evaluation of homeopathic treatment by means of appropriate RCTs with high methodological quality is required.
Source : Int J High Dilution Res 2013; 12(42):02-12
Link to Full Article
Homeopathy in HIV infection: a trial report of double-blind placebo controlled study
DP Rastogi1*, VP Singh1, V Singh2, SK Dey2 and K Rao2
1Central Council for Research in Homoeopathy, JNBCHA. Bhavan, 61-65, Institutional Area, D-Block, Janakpuri, New Delhi-110 058, India; and
2Regional Research Institute for Homoeopathy, Irla Lane, Vile Parle (West), Mumbai-400 056, India
Abstract
Objective: This study was aimed to evaluate the immuno-modulator role of homeopathic
remedies in Human Immunodefciency Virus (HIV) infection.
Methodology: A randomised double blind clinical trial was conducted to compare the effect of homeopathic remedies with placebo, on CD4‡ve T-lymphocytes in HIV infected individuals, conforming to Centres for Disease Control (CDC) stage II & III. 100 HIV‡+ve individuals between 18±50 y (71% males) were included in the study. 50 cases conformed to CDC stage II Asymptomatic HIV infection, and 50 cases to CDC stage III
Persistent Generalised Lymphadenopathy (PGL). Cases were stratifed according to their clinical status and CD4‡+ve lymphocyte counts. The randomisation charts were prepared much before the start of the trial by randomly assigning placebo and verum codes to registration numbers from 1 to 50. A single individualised homeopathic remedy was prescribed in each case and was followed up at intervals of 15 d to one month. A six months study was performed for each registered case. Assessment of progress was made by evaluation of CD4‡+ve lymphocyte counts, which was the prospectively-defned main outcome measure of the study; the results were compared with the base line immune status.
Results: In PGL, a statistically signifcant difference was observed in CD4‡+ve T-lymphocyte
counts between pre and post trial levels in verum group (P<0.01). In the placebo group a similar comparison yielded non-signifcant results. (P=ˆ0.91). Analysis of change in the pre and post trial counts of CD4‡+ve cells between groups was also statistically signifcant (Pˆ0.04). In asymptomatic HIV infection, differences in absolute CD4+‡ve lymphocyte counts between pre and post trial levels were not signifcant. Analysis of changes in pre and post trial CD4 levels of placebo and verum groups for combined strata of asymptomatic
and PGL groups was also not signifcant.
Conclusion: The study suggests a possible role of homeopathic treatment in HIV infection in symptomatic phase, as evidenced by a statistically signifcant elevation of base line immune status in persistent generalised lymphadenopathy
Source : British Homeopathic Journal (1999) 88, 49±57
Link to Full Study
Controlled Clinical Trials Evaluating the Homeopathic Treatment of People with Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome
DANA ULLMAN, M.P.H.
ABSTRACT
Context: Homeopathic medicine developed significant popularity in the nineteenth century
in the United States and Europe as a result of its successes treating the infectious disease epidemics
during that era. Homeopathic medicine is a medical system that is specifically oriented
to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune
and defense system rather than directly attacking the microbial agents.
Objectives: To review the literature referenced in MEDLINE™ and in nonindexed homeopathic
journals for placebo-controlled clinical trials using homeopathic medicines to treat people
with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different
theoretical and methodological approach to treating people with the viral infection.
Findings: A total of five controlled clinical trials were identified. A double-blinded, placebocontrolled
study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects
with persistent generalized lymphadenopathy (stage III) in whom individualized singleremedy
homeopathic treatment was provided. A separate body of preliminary research was
conducted using homeopathic doses of growth factors. Two randomized double-blinded,
placebo-controlled studies were conducted with a total of 77 people with AIDS who used only
natural therapies over a 8–16-week period. Two other studies were conducted over a 2.5-year
period with 27 subjects in an open-label format.
Settings: The first study was conducted by the Regional Research Institute for Homoeopathy
in Mumbai, India, under the Central Council for Research in Homoeopathy, with the approval
of the Ministry of Health and Family Welfare, Government of India. The second body of studies
was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.
Results: The first study found no statistically significant improvement in CD4 T-lymphocytes,
but did find statistically significant pretest and post-test results in subjects with stage III AIDS,
in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific
physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements
in lymphocyte counts and functions and reductions in HIV viral loads.
Conclusions: As a result of the growing number of people with drug-resistant HIV infection
taking structured treatment interruptions, homeopathic medicine may play a useful role as an
adjunctive and/or alternative therapy.
Source : THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 9, Number 1, 2003, pp. 133–141
Link to Full Article
Rajesh Shah
Director & Head, Research & Development, Mumbai, Maharashtra, India
Abstract
Introduction: Identifying the need for strengthening of the immune system, the investigator has developed new Human Immunodeficiency Virus (HIV) nosode and evaluated its effect on HIV positive individuals through a clinical trial.
Methods: Standardized and the scientific method of HIV nosode preparation has been described and documented. Thirty-seven HIV-infected persons were registered for the trial, and ten participants were dropped out from the study, so the effect of HIV nosode 30C and 50C, was concluded on 27 participants under the trial.
Results: Out of 27 participants, 7 (25.93%) showed a sustained reduction in the viral load from 12 to 24 weeks. Similarly 9 participants (33.33%) showed an increase in the CD4+ count by 20% altogether in 12 th and 24 th week. Significant weight gain was observed at week 12 (P = 0.0206). 63% and 55% showed an overall increase in either appetite or weight. The viral load increased from baseline to 24 week through 12 week in which the increase was not statistically significant (P > 0.05). 52% (14 of 27) participants have shown either stability or improvement in CD4% at the end of 24 weeks, of which 37% participants have shown improvement (1.54-48.35%) in CD4+ count and 15% had stable CD4+ percentage count until week 24 week. 16 out of 27 participants had a decrease (1.8-46.43%) in CD8 count. None of the adverse events led to discontinuation of study.
Conclusion: The study results revealed improvement in immunological parameters, treatment satisfaction, reported by an increase in weight, relief in symptoms, and an improvement in health status, which opens up possibilities for future studies.
Source Indian Journal of Research in Homeopathy
Link to Full Article
A Qualitative Systematic Review of the Homeopathic Outcome Studies in Patients with HIV/AIDS
Subhranil Saha, Malay Mundle, Shubhamoy Ghosh, Munmun Koley, Sk. Intaj Hossain
Clinical Research Unit (Siliguri), Central Council for Research in Homeopathy, India
2Medical College, Kolkata, Government of West Bengal, India
3M. B. H. Medical College & Hospital, Government of West Bengal, India
ABSTRACT
Background and aims: Systematic reviews of high-quality randomized controlled trials (RCTs) are crucial in evidence-based medicine (EBM). The aim of the present review was to investigate whether there is enough evidence on the efficacy of homeopathy in individuals with HIV/AIDS based on clinical trials.
Methods: The present is a criteria-based systematic review of cumulative research, and assessment of the methodological quality of published studies. The quality of the trials was evaluated using a list of validated and predefined criteria, and their outcomes were interpreted based on their quality. The main outcome measure was the methodological quality of the studies in terms of the threats to external, internal, construct, and statistical conclusion validity.
Results: Among the 6 clinical outcome studies located, 3 were open-label, non-randomized, non-controlled trials, 2 were RCTs, and one was a single-set replication study. The trials were too few in number, and did not exhibit very high quality. The results showed a positive trend regardless of the quality of the trials, or the variety of homeopathic treatment used. The results of the present review may be complicated by publication bias.
Conclusion: The currently available evidences do not suffice to infer definitive conclusions. Therefore, further evaluation of homeopathic treatment by means of appropriate RCTs with high methodological quality is required.
Source : Int J High Dilution Res 2013; 12(42):02-12
Link to Full Article
Homeopathy in HIV infection: a trial report of double-blind placebo controlled study
DP Rastogi1*, VP Singh1, V Singh2, SK Dey2 and K Rao2
1Central Council for Research in Homoeopathy, JNBCHA. Bhavan, 61-65, Institutional Area, D-Block, Janakpuri, New Delhi-110 058, India; and
2Regional Research Institute for Homoeopathy, Irla Lane, Vile Parle (West), Mumbai-400 056, India
Abstract
Objective: This study was aimed to evaluate the immuno-modulator role of homeopathic
remedies in Human Immunodefciency Virus (HIV) infection.
Methodology: A randomised double blind clinical trial was conducted to compare the effect of homeopathic remedies with placebo, on CD4‡ve T-lymphocytes in HIV infected individuals, conforming to Centres for Disease Control (CDC) stage II & III. 100 HIV‡+ve individuals between 18±50 y (71% males) were included in the study. 50 cases conformed to CDC stage II Asymptomatic HIV infection, and 50 cases to CDC stage III
Persistent Generalised Lymphadenopathy (PGL). Cases were stratifed according to their clinical status and CD4‡+ve lymphocyte counts. The randomisation charts were prepared much before the start of the trial by randomly assigning placebo and verum codes to registration numbers from 1 to 50. A single individualised homeopathic remedy was prescribed in each case and was followed up at intervals of 15 d to one month. A six months study was performed for each registered case. Assessment of progress was made by evaluation of CD4‡+ve lymphocyte counts, which was the prospectively-defned main outcome measure of the study; the results were compared with the base line immune status.
Results: In PGL, a statistically signifcant difference was observed in CD4‡+ve T-lymphocyte
counts between pre and post trial levels in verum group (P<0.01). In the placebo group a similar comparison yielded non-signifcant results. (P=ˆ0.91). Analysis of change in the pre and post trial counts of CD4‡+ve cells between groups was also statistically signifcant (Pˆ0.04). In asymptomatic HIV infection, differences in absolute CD4+‡ve lymphocyte counts between pre and post trial levels were not signifcant. Analysis of changes in pre and post trial CD4 levels of placebo and verum groups for combined strata of asymptomatic
and PGL groups was also not signifcant.
Conclusion: The study suggests a possible role of homeopathic treatment in HIV infection in symptomatic phase, as evidenced by a statistically signifcant elevation of base line immune status in persistent generalised lymphadenopathy
Source : British Homeopathic Journal (1999) 88, 49±57
Link to Full Study
Controlled Clinical Trials Evaluating the Homeopathic Treatment of People with Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome
DANA ULLMAN, M.P.H.
ABSTRACT
Context: Homeopathic medicine developed significant popularity in the nineteenth century
in the United States and Europe as a result of its successes treating the infectious disease epidemics
during that era. Homeopathic medicine is a medical system that is specifically oriented
to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune
and defense system rather than directly attacking the microbial agents.
Objectives: To review the literature referenced in MEDLINE™ and in nonindexed homeopathic
journals for placebo-controlled clinical trials using homeopathic medicines to treat people
with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different
theoretical and methodological approach to treating people with the viral infection.
Findings: A total of five controlled clinical trials were identified. A double-blinded, placebocontrolled
study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects
with persistent generalized lymphadenopathy (stage III) in whom individualized singleremedy
homeopathic treatment was provided. A separate body of preliminary research was
conducted using homeopathic doses of growth factors. Two randomized double-blinded,
placebo-controlled studies were conducted with a total of 77 people with AIDS who used only
natural therapies over a 8–16-week period. Two other studies were conducted over a 2.5-year
period with 27 subjects in an open-label format.
Settings: The first study was conducted by the Regional Research Institute for Homoeopathy
in Mumbai, India, under the Central Council for Research in Homoeopathy, with the approval
of the Ministry of Health and Family Welfare, Government of India. The second body of studies
was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.
Results: The first study found no statistically significant improvement in CD4 T-lymphocytes,
but did find statistically significant pretest and post-test results in subjects with stage III AIDS,
in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific
physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements
in lymphocyte counts and functions and reductions in HIV viral loads.
Conclusions: As a result of the growing number of people with drug-resistant HIV infection
taking structured treatment interruptions, homeopathic medicine may play a useful role as an
adjunctive and/or alternative therapy.
Source : THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 9, Number 1, 2003, pp. 133–141
Link to Full Article