Chaos in cervical high-risk HPV testing in China and related recommendations

       A revolutionary advance in cervical cancer screening is the combination of HPV testing with cytology. Depending on the results of both, there are different follow-up tests. However, in China, informal HPV testing, interpretation, and treatment are causing a series of chaos in the current OB/GYN clinics, which are briefly summarized as follows: 1. Some hospitals, after testing patients for HPV and TCT, recommend that patients be tested for “cellular DNA”. 2.  2. After finding that the patient’s cervix is positive for high-risk HPV (cytology is normal), the patient is recommended to use interferon, traditional Chinese medicine, and even so-called imported messy drugs. 3. Intentionally or unintentionally exaggerating the harm of simple HPV positivity, psychologically forcing the patient to accept drugs and physical therapy that have no positive effect. 4. “positive” to lure patients into treatment.  5. Using the fact that the cervical HPV remains positive after “treatment” as evidence for conical hysterectomy.  6. With commercial interests at heart, many businesses use the gimmick that their instruments can detect and type all high-risk HPV and explain the meaning of a positive test on the report card.  …… Before understanding why I call the above phenomenon “chaos”, let’s understand the formal screening program.  China does not have its own screening guidelines based on national conditions and epidemiological data, and has pretty much copied the US protocol. The latest screening guidelines proposed by the United States in 2013 include the following points; 1. The starting age for screening is 21 years old (after having sex), but before the age of 30, only cytology is done, not HPV testing. 31 years old, the best screening program is cytology + HPV testing.  2. For those with normal cytology and negative HPV, the screening interval section is extended to 5 years (used to be 3 years) 3. For those with normal cytology and positive HPV, colposcopy is performed immediately for those with HPV type 16 and 18. For those who are not 16 or 18, just review once a year.  The U.S. Food and Drug Administration (FDA) does not allow HPV testing methods (technologies) that are not clinically validated to be used in clinical practice. Typing for HPV is also limited to checking for 16 and 18; typing for other types of HPV is not allowed.  The development of the above protocol in the United States is influenced by the following factors. Cervical cancer is not the first gynecologic tumor in the United States; they are more concerned with endometrial and breast cancer. That’s why the Americans specify: no HPV screening before age 30; 5-year interval for those who are negative.  Cervical cancer screening in the U.S. is paid for by the government. One of the elements of Obama’s health care reform is to reduce health care spending. With the need to strike a balance between “disease detection” and “economic spending,” the U.S. has had to consider health economics, or “money issues,” when screening for cervical cancer. That’s why the 2013 revised program is a clear “money saver.  Colposcopy in the United States is done by a doctor. It is not as easy to get a doctor in the US as it is in China; there is a waiting list for appointments and it is expensive (it is really not that hard or expensive to get a doctor in China!). . So unlike the 2006 protocol (where colposcopy could be done for simple HPV positivity), the decision to do colposcopy is made after HPV typing to find out if you are positive for types 16 and 18. The main purpose is to reduce the number of colposcopies and the government saves money.  Now, let me explain each of the aforementioned points of confusion: 1. The recommended guidelines in China only recommend cytology and HPV testing, but not “cellular DNA” testing. It may be that “cellular DNA testing” is effective on its own, but bundling it with TCT and HPV is not recommended by any institution in the world. That’s why our hospital rejects this technique.  2. Again, there is no effective drug for simple HPV positivity to turn negative.  3. The rate of HPV infection in the normal population is about 20%. If so many women “can develop cervical cancer” in the future, then HPV infection is plague, smallpox? So don’t be afraid, just review it regularly.  4. Doctors who let patients take HPV tests several times a year are either ignorant or unscrupulous.  5, in order to 1080 yuan surgery cost, to high-risk HPV positive patients to “cone cut” doctor, conscience is greatly bad.  6. The FDA only approves the testing of HPV types 16 and 18, and does not allow the typing of other high-risk HPV types. In addition, the FDA only recommended instruments from four companies for clinical HPV testing because the technology of these companies has been validated in 40-50,000 women. The great Chinese CFDA has no such recommendation (because there is no national database), so the companies are allowed to market unvalidated methods with great enthusiasm. When some technologies claim to be able to type all HPV, you can ask: “Does this typing make sense? Is there any clinically validated information?” .  I would like to add a few comments about the use of US screening programs in China based on the Chinese context: One third of the new cervical cancer cases detected worldwide each year are in China. The age of these populations is trending younger. This year, my department has treated two patients (27 and 31 years old) who were already pregnant to full term with cervical cancer, both were primiparous and not early stage cancers. These are just two cases I have encountered in my 25 years of practice. In China, the cost of cytology plus HPV testing is around $540, a cost that is all paid for by yourself. So it’s not necessarily limited to after age 30. I am in favor of the old way of getting screened for cervical cancer if you have been sexually active for more than 3 years. Since it is paid for by the individual, the most sensitive cytology + HPV test is chosen. The disadvantage is that a positive result can cause psychological stress to some people. The key is whether the doctor can explain to the patient patiently and objectively.  In the case of normal cytology and positive HPV, there is no need for further typing and then colposcopy in China. The patient has already spent over $500 for the test, there is no need to save $40 or $50 instead of getting a colposcopy. My opinion is that colposcopy should be done for all positive HPV cases.  The life of a doctor is a continuous learning process. I hope that our Chinese Society of Gynecologic Oncology can recommend our own screening guidelines and techniques to the majority of physicians in the context of China. I often hear some famous people “interpreting” the various guidelines in the U.S. on various occasions, but rarely do I see someone who can describe how to apply them in the Chinese context. We are impressed by the rigor of the American approach, but we should also be aware of the American intentions. It is not even possible to copy Marxist theory, let alone a practical guide.