Friday, June 14, 2013

Visual Inspection with Vinegar (VIN) Based Cervical Cancer Screening Significantly Reduces Cancer Deaths

Few weeks ago Angelina Jolie made it big news by revealing her prophylactic mastectomy. Whether or not you agree with her decision of going through mastectomy just because of those silly genes, one thing you would not be able to disagree on that she prompted general public worldwide to google these exotic sounding words “BRCA1 and BRCA2” genes (now better known as “Angelina Jolie genes”) which so far used to be the part of only scientific discussions confined within the fraternity of cancer researchers. Kudos to Angelina Jolie and her celebrity power that this subject is now being discussed among women worldwide who indeed need to know about it all more than anyone else. I can’t help but believe that yesterday’s Supreme Court (US) decision to wipe patents on Angelina Jolie genes (BRCA1 and BRCA2) was also somehow got positively influenced by the debate recently initiated by Angelina Jolie’s revelation, otherwise this legal battle was ongoing in the courts for years with no conclusive outcome as it happened this yesterday. Irrespective of your quest for findings elements of right or wrong in this landmark decision, people of all walks of life, especially scientists and cancer patients have welcomed this court ruling with equal applause. I will discuss this issue later in my future postings.

Today, the topic that brought me here is very close to my heart for several reasons including a personal one. From last week’s breaking advances in the field of cancer research, I thought of picking this piece of research work, because I consider it as a big feat achieved by scientists from India, a third world country, where even a thought of having an standard cancer care infrastructure seems to be a luxury, given the dire need for general physicians and infrastructure to treat bacterial and viral diseases. This was one of the highly talked about and praised research work recently discussed at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago last week, in which over 26,000 cancer scientists and clinicians attended this meeting and thousands of research studies, small and large were reviewed by the scientific fraternity. Because ASCO is the world’s most dominant oncology specialty group, the discussions and recommendations set the standard for cancer care in the world. 

Well, a research team led by Surendra Srinivas Shastri, MD, a professor of preventive oncology at Tata Memorial Hospital (oldest and probably single dedicated cancer hospital and research center in India, a country of 1.25 billion people) in Mumbai, India, developed a simple screening technique using an inexpensive chemical agent, vinegar or acetic acid, dramatically reduced deaths related to cervical cancer in a large population of Indian women. This powerful study shows that how just “visual inspection with acetic acid or (VIA)”, conducted by non-medical personnel trained to deliver basic healthcare (paramedical staff), could cut the death rate by 31%.

One of the most important aspects of this finding lies in the fact that this strategy is highly effective and can be implemented on a broad scale in low-income countries. "There was almost no overdiagnosis, it doesn't require a laboratory, and it can be widely implemented in the lowest-resource settings, such as India," said lead study author Dr. Shastri. "If implemented at national level in India, it could prevent 22,000 cervical cancer deaths," said Dr. Shastri, who presented the findings of this large randomized trial during a plenary session at the 2013 Annual Meeting of ASCO in Chicago. He went on to say that "if taken globally to the lowest-resource countries, this method could prevent around 72,000 deaths in the developing world."

Cervical cancer is the leading cause of cancer-related mortality in women in many developing nations, where access to Pap test screening (gold standard screening method for diagnosing early stage cervical cancer) is very limited or nonexistent. Widespread Pap test screening in high-income countries has significantly reduced the incidence and subsequent death rate from cervical cancer by 80%. Unfortunately, from my own experience of talking to Indian women (I am originally from India, and keep visiting India almost every year) in my own extended family and friends, my impression is that even educated women have not heard of Pap test screening methods, let alone thinking of asking their primary care physicians to write a pathology test for this.   

Apart from lack of awareness about health issues among common people in India, "There is no cervical cancer screening program in India because it is not feasible," explained Dr. Shastri. "There is inadequate infrastructure, a lack of trained human resources, logistic difficulties, and a relatively high cost."

Therefore, the researchers looked at VIA, which is a simple visual test that can be done without laboratory support. "It consists of an application of 4% vinegar to the cervix, and the results are available in 1 minute," Dr. Shastri explained. "Paramedical workers can be trained in 4 weeks."

VIA screening method is validated
Another cancer researcher and leader in the field and also discussant for the study during the plenary session, Electra D. Paskett PhD, professor of medicine at the Ohio State University Comprehensive Cancer Center in Columbus is very enthusiastic about this pioneering study, “What is unique about this study is that it was conducted in the slums of Mumbai in an unscreened population, and participation was high and the size of the sample was large. What is essential here is the fact that both diagnostic and treatment services were available to women in both arms without any charge."

Dr. Paskett also pointed out that there are several take-home messages from this study; 1) that the VIA method has been validated, 2) it has been accepted, 3) it is inexpensive, 4) can be used in low-resource areas, and 4) can save lives.

Study Details
In this clinical trial, VIA screening technique was performed by community-based nonmedical primary health workers trained to provide basic healthcare services in regions that lack physicians and nurses. The researchers had to pass through several layers of community barriers, such as community leaders and religious leaders, before being able to speak with the women. It is noticeable that India is home to several religiously conservative communities and preventive measures in the past such as polio vaccination program had to face a lot of resistance in these communities.  "We involved the community, giving them a sense of participation, and we were able to create as sense of community ownership," Dr. Shastri said. "This ensured better participation."

Dr. Shastri and colleagues initiated this cluster randomized controlled trial in 1998 to evaluate the ability of VIA screening to reduce cervical cancer mortality. The participants were 35 to 64 years of age and had no history of cancer. The study design involved 20 clusters, with an average of 7500 eligible women in each cluster. Ten such clusters served as the screening group (n = 75,360) and 10 served as the control group (n = 76,178). From statistical point of view, this is one of the very large and powerful research studies in the history of recent clinical trials.
Primary health workers or paramedical staff did conduct 4 rounds of cancer education and VIA screening at the intervals of 24 months in each screening group. In the control group (a group of people, which was not screened by VIA, usually having such population groups are part of standard study method to conduct a scientific experiment and used as population to compare the results against), cancer education was offered once at recruitment.

Reduction in Mortality Rate
Although the researchers had planned for a 16-year study, they analyzed results at 12 years. Compliance was high, with 89% participation in screening and 79% compliance with postscreening diagnostic confirmation. The researchers note that the quality of screening performed by the primary health workers or paramedical health care workers was almost comparable to that of an experienced gynecologist.

The incidence of invasive cervical cancer was very similar in the screening and control groups (26.74 vs 27.49 per 100,000). However, for those with invasive cancer, treatment compliance was higher in the screening group than in the control group (86.34% vs. 72.29%). In the screening group, there was a 31% drop in mortality related to cervical cancer, compared with the control group (P = 0.003).

In addition to the decrease in deaths related to cervical cancer, there was also a 7% reduction in all-cause mortality (RR, 0.93; P = .41), possibly due to the fact that these patients enrolled in VIA screening program had better/timely access to medical interventions.  

On the basis of these results, the Indian health officials in the state of Maharashtra, a western province of India, where the trial was conducted, are preparing to train primary health care workers to provide VIA screening to all women 35 to 64 years of age at 24-month intervals. In addition, the Indian government is working to implement nationwide VIA screening, and is planning to reach out to other low- to moderate-income countries to share these results and offer assistance with training.

Interestingly this study was financially supported by the National Institutes of Health (NIH), USA, and Women's Cancer Initiative. Just confirms the belief that science does not care of physical boundaries, it helps humanity in general.

Take home message – while developments in state-of-art biomedical technologies are certainly needed to keep this fight alive against this dreaded disease cancer, we must not ignore the power of old fashioned scientific methods such as visual inspection with acetic acid (VIA) which can significantly reduce the death rate by cancers in the major part of the world. 

1 comment:

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