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LETTER TO EDITOR
Year : 2010  |  Volume : 42  |  Issue : 1  |  Page : 57
 

Use of Tinospora cordifolia in HIV infection


Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry - 605006, India

Date of Web Publication12-Apr-2010

Correspondence Address:
Shahid Akhtar
Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry - 605006
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0253-7613.62402

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How to cite this article:
Akhtar S. Use of Tinospora cordifolia in HIV infection. Indian J Pharmacol 2010;42:57

How to cite this URL:
Akhtar S. Use of Tinospora cordifolia in HIV infection. Indian J Pharmacol [serial online] 2010 [cited 2020 Feb 25];42:57. Available from: http://www.ijp-online.com/text.asp?2010/42/1/57/62402


Sir,

With reference to the research article entitled 'Immunomodulatory effect of Tinospora cordifolia extract (TCE) in Human immunodeficiency virus positive patients' [1] published in the May - June 2008 issue of Indian Journal of Pharmacology, there are some issues that need to be clarified by the authors. The baseline parameters of placebo and TCE groups indicate that some patients with CD4 count < 200 / µL were included in the study (289.5 ± 200.3 in TCE group and 282.9 ± 214.1 in placebo group). This is in contrast to the guidelines for initiation of highly active anti retroviral therapy (HAART) in HIV positive patients as laid down by the National AIDS Control Organization (NACO) and the Centre for Disease Control (CDC), Atlanta. [2],[3] Advanced HIV infection, as indicated by these low levels of CD4 counts, can rapidly progress to full blown AIDS or encourage opportunistic infections. The use of placebo as control in this trial also goes against the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.

Paragraph 29 states -A placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances:

  • Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or
  • Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.
All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review." [4]

In this trial, the patients were placed either on placebo or TCE. A more reasonable approach could have been placing the patients on HAART and using TCE as an add-on therapy.

The authors observe a significant decrease in the eosinophil count in the TCE group, which has been attributed to the immunomodulatory effects of the extract. There was a significant fall in the Hb% in the TCE treatment group. Was it an adverse drug reaction to TCE? The authors have not established the causality in the case of the death of a single patient in the TCE group. The statistical analysis using Kruskal Wallis test is also inappropriate for this kind of data. As compared to the placebo, TCE failed to demonstrate any significant advantage. Yet, at the end of the trial, the patients were offered treatment with TCE instead of being referred to an ART center.

 
 » References Top

1.Kalikar MV, Thawani VR, Varadpande UK, Sontakke SD, Singh RP, Khiyani RK. Immunomodulatory effect of Tinospora cordifolia extract in human immuno-deficiency virus positive patients. Indian J Pharmacol 2008;20:107-10.  Back to cited text no. 1      
2.Antiretroviral Therapy Guidelines for HIV infected Adults and Adolescents including Post-exposure. Available from: http://www.nacoonline.org/Quick_Links/Publication/.../Antiretroviral_Therapy_Guidelines_for_HIV_infected/htm . [last cited on 2008 Sep 30].  Back to cited text no. 2      
3.Guidelines for using antiretroviral agents among HIV-infected adults and adolescents recommendations of the panel on clinical practices for treatment of HIV. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5107a1.htm . [last cited on 2008 Sep 30].  Back to cited text no. 3      
4.World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects. Available at http://www.wma.net/e/policy/b3.htm. [last cited on 2008 Sep 30].  Back to cited text no. 4      



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