HIV
People living with HIV (PLWH) are common users of so-called alternative medicine (SCAM). The main objective of this study was to study the frequency and patterns of SCAM natural products use in a large cohort of PLWH and to identify potential drug–drug interactions (DDIs) and the impact on their antiretroviral treatment (ART) adherence and efficacy.
This was a cross-sectional multicenter survey including 420 PLWH from different Spanish hospitals. Participants completed a face-to-face questionnaire on SCAM consumption and different sociodemographic and clinical data were collected. DDIs between SCAM and ART were identified and classified according to the Liverpool University Database and patient factors related to SCAM consumption were assessed.
In total, 420 participants were included (82.6% male, mean age 47 years); 209 patients (49.8%) were taking at least one SCAM. The most consumed SCAM were:
- green, black and red tea (n=146, 25.4%),
- ginger (n=26, 4.5%),
- fish oil (n=25, 4.4%),
- cannabis (n=24, 4.2%).
An ART based on integrase inhibitors was the only factor independently associated with SCAM consumption (OR 1.54, 95% CI 1.04 to 2.26). 50 potential SCAM–ART interactions in 43 (20.6%) patients taking SCAM were identified, being clinically significant in 80% of the cases. SCAM products most frequently involved with a potential significant DDI were supplements containing divalent cations (n=11) and garlic (n=7). No differences in ART efficacy and adherence were observed between patients with and without SCAM consumption.
The authors concluded that almost 50% of patients were taking at least one SCAM product and its use was associated with an integrase inhibitor based ART. One out of every six patients was at risk of presenting with an interaction between a SCAM and their ART, confirming the need to review continuously the use of SCAM as part of the medication review process.
So, the authors found that half of all PLWHs use some form of SCAM (whether I would classify tea as a SCAM is a different question). They also point out that this might put many PLWHs at risk. What I don’t understand is why they do not take the next logical step and ask what the benefits of the SCAMs for PLWHs are.
Allow me to answer this question: they are zero or very close to zero!
And this means that SCAMs generate a risk for PLWHs without creating any meaningful benefit. In other words the risk-benefit balance fails to be positive.
I think that this is an important point which needs to be stressed clearly in the conclusions. Therefore, I suggest to re-formulate them as follows:
Almost 50% of patients were taking at least one SCAM product. One out of every six patients was at risk of presenting with an interaction between a SCAM and their ART. The SCAMs used convey no appreciatable benefit. Therefore, SCAM use fails to generate more good than harm. It follows that responsible healthcare professionals should discurage SCAM use.
This retrospective cohort study investigated the effect of reflexology on immunological parameters of people living with HIV (PLWH). All patients who received at least one reflexology treatment were included and compared with the group of PLWH who were not treated with reflexology. Measured parameters included CD4 count, CD4%, CD8 count, CD8%, CD4/CD8 ratio, and HIV viral load (VL). Changes in these parameters before and after the treatment were compared with changes in two consecutive measurements in the control group.
In total, 74 patients who received reflexology treatments were matched by age and sex to 144 controls. There was a male predominance of 86% in both groups. Patients in the control group were slightly older, with a median age of 45 versus 43 in the treatment group (p = 0.022). The median baseline CD4 count (730 vs. 795, p = 0.187) and CD8 count (890 vs. 832, p = 0.32) did not differ between the groups. Baseline CD4% tended to be lower in the treatment group (34% vs. 36%, p = 0.058), CD8% was higher in the treatment group (40% vs. 38%, p = 0.03), and the
CD4/CD8 ratio was lower in the treatment group (0.8 vs. 1, p = 0.002).
After therapy, there was a significantly higher increase in CD4, CD4%, and CD4/CD8 in the treatment group (p = 0.006, 0.0004, <0.001, respectively), whereas CD8% decreased significantly and CD8 tended to decrease in the treatment group (p < 0.001, 0.054, respectively).
The authors concluded that reflexology showed a positive impact on the immunological parameters of PLWH.
Who on earth conceives such a study?
Who funds such offensive rubbish?
Who publishes it?
We may well ask these questions, because the paper is pure nonsense!
The authors are very clear about their conviction that the observed differences were caused by the reflexology treatment. They don’t even discuss other options. Yet, there are several plausible explanations that have nothing to do with reflexology.
The patients in the control group originate from the hospital’s register from the time before reflexology had been introduced in the standard care package. Thus these patients differ in numerous ways from those of the experimental group. To name just one possibility, these patients were treated at a time when the treatment of PLWH was less sophicticated and thus had worse outcomes.
The two patient groups are clearly not comparable! This is also shown by the data published in the paper. So why compare them?
The only sensible conclusion of this paper is in my view:
In an effort to prove that their SCAM works, enthusiasts without research expertise often go to great lengths. As a result they mislead us all and do a great disservice to science and medicine.
The ‘best homeopathy doctor in Delhi‘ is so ‘marvellous’ that he and his colleagues offer homeopathic treatment for HIV/AIDS:
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Antiretroviral Therapy (ART) is recommended for each and every case of AIDS where CD4 count goes less than 350. Aura Homeopathy does not offer cure for AIDS. However, several research and clinical studies done by various Research centre including few from CCRH (Central Council for Research in Homeopathy, Govt. of India), have prove the supportive role of homeopathic medicines. Homeopathy medicine only relief symptoms but also reduced frequency of opportunistic infections, increase appetite, weight, and sense of well being, etc. At Aura Homeopathy, we apply classical homeopathy protocols on HIV/AIDS patients, as a part of our Clinical trial and Research projects. The results were very encouraging.
At Aura Homeopathy, we have seen an increase in the CD4 count in number of patients, after using Aura homeopathy medicines. Dr.Abhishek recommend’s Homeopathy as supporting line of therapy for all HIV patients.
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When I read this I wanted to be sick; but instead I did something a little more sensible: I conducted a quick Medline search for ‘homeopathy, AIDS’.
It returned 30 articles. Of these, there were just 4 that presented anything remotely resembling data. Here are their abstracts:
Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.
Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even “cure” and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.
This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.
2nd paper (I am a co-author of this one)
The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM’s popularity, the paucity of clinical trials and their low methodological quality are concerning.
3rd paper (author is our old friend Dana Ullman!)
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.
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.
A total of five controlled clinical trials were identified. A double-blinded, placebo-controlled study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects with persistent generalized lymphadenopathy (stage III) in whom individualized single-remedy 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.
The first study was conducted by the Regional Research Institute for Homeopathy in Mumbai, India, under the Central Council for Research in Homeopathy, 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.
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.
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.
In 1996, [name removed] was convicted on charges of conspiracy and introducing an unapproved drug into interstate commerce and the 2nd U.S. Circuit Court of Appeals upheld the conviction. [Name removed]’s company, Writers and Researchers Inc. sold a drug called 714X to individuals and physicians, promoting it as a nontoxic therapy for AIDS, cancer, and other chronic diseases. The Food and Drug Administration (FDA) warned [name removed] that his marketing was illegal because the product had not been proven safe and effective for use in treating disease. [Name removed] argued that the product was a homeopathic drug, revealed by FDA tests to contain 94 percent water, and a mixture of nitrate, ammonium, camphor, chloride, ethanol, and sodium. The courts found that 714X was subject to FDA scrutiny because it was touted as a cure for cancer and AIDS.
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So, what does this collective evidence tell us?
I think it makes it abundantly clear that there is no good reason to suggest that HIV/AIDS patients can be helped in any way by homeopathy. On the contrary, homeopathy might distract them from essential conventional care and it would needlessly harm their bank balance. It follows that claims to the contrary are bogus, unethical, reckless, and possibly even criminal.
In the realm of homeopathy there is no shortage of irresponsible claims. I am therefore used to a lot – but this new proclamation takes the biscuit, particularly as it currently is being disseminated in various forms worldwide. It is so outrageously unethical that I decided to reproduce it here [in a slightly shortened version]:
“Homeopathy has given rise to a new hope to patients suffering from dreaded HIV, tuberculosis and the deadly blood disease Hemophilia. In a pioneering two-year long study, city-based homeopath Dr Rajesh Shah has developed a new medicine for AIDS patients, sourced from human immunodeficiency virus (HIV) itself.
The drug has been tested on humans for safety and efficacy and the results are encouraging, said Dr Shah. Larger studies with and without concomitant conventional ART (Antiretroviral therapy) can throw more light in future on the scope of this new medicine, he said. Dr Shah’s scientific paper for debate has just been published in Indian Journal of Research in Homeopathy…
The drug resulted in improvement of blood count (CD4 cells) of HIV patients, which is a very positive and hopeful sign, he said and expressed the hope that this will encourage an advanced research into the subject. Sourcing of medicines from various virus and bacteria has been a practise in the homeopathy stream long before the prevailing vaccines came into existence, said Dr Shah, who is also organising secretary of Global Homeopathy Foundation (GHF)…
Dr Shah, who has been campaigning for the integration of homeopathy and allopathic treatments, said this combination has proven to be useful for several challenging diseases. He teamed up with noted virologist Dr Abhay Chowdhury and his team at the premier Haffkine Institute and developed a drug sourced from TB germs of MDR-TB patients.”
So, where is the study? It is not on Medline, but I found it on the journal’s website. This is what the abstract tells us:
“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.”
In other words, the study had not even a control group. This means that the observed ‘effects’ are most likely just the normal fluctuations one would expect without any clinical significance whatsoever.
The homeopathic Ebola cure was bad enough, I thought, but, considering the global importance of AIDS, the homeopathic HIV treatment is clearly worse.
Massage is an agreeable and pleasant treatment. It comes in various guises and, according to many patients’ experience, it relaxes both the mind and the body. But does it have therapeutic effects which go beyond such alleged benefits?
There is a considerable amount of research to test whether massage is effective for some conditions, including depression. In most instances, the evidence fails to be entirely convincing. Our own systematic review of massage for depression, for instance, concluded that there is currently a lack of evidence.
This was ~5 years ago – but now a new trial has emerged. It was aimed at determining whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. Subjects were randomized into one of three groups to receive either Swedish massage (the type that is best researched amongst the many massage-variations that exist), or touch, or no such interventions. The treatment period lasted for eight weeks. Patients had to be at least 16 years of age, HIV-positive, suffering from a major depressive disorder, and on a stable neuropsychiatric, analgesic, and antiretroviral regimen for > 30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were taking antidepressants, and all subjects were judged to be medically stable.
Patients in the Swedish massage and touch groups visited the massage therapist for one hour twice per week. In the touch group, a massage therapist placed both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects.
The primary and secondary outcome measures were the Hamilton Rating Scale for Depression score and the Beck Depression Inventory. The results showed that, compared to no intervention and/or touch, massage significantly reduced the severity of depression at week 4, 6 and 8.
The authors’ conclusion is clear: The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal “dose” of massage, and mechanisms by which massage exerts its antidepressant effects remain to be determined.
Clinical trials of massage therapy encounter formidable problems. No obvious funding source exists, and the expertise to conduct research is minimal within the realm of massage therapy. More importantly, it is difficult to find solutions to the many methodological issues involved in designing rigorous trials of massage therapy.
One such issue is the question of an adequate control intervention which might enable to blind patients and thus account for the effects of placebo, compassion, attention etc. The authors of the present trial have elegantly solved it by creating a type of sham treatment which consisted of mere touch. However, this will only work well, if patients can be made to believe that the sham-intervention was a real treatment, and if somehow the massage therapist is prevented to influence the patients through verbal or non-verbal communications. In the current trial, patients were not blinded, and therefore patients’ expectations may have played a role in influencing the results.
Despite this drawback, the study is one of the more rigorous investigations of massage therapy to date. Its findings offer hope to those patients who suffer from depression and who are desperate for an effective and foremost safe treatment to ease their symptoms.
My conclusion: the question whether massage alleviates depression is intriguing and well worth further study.
