Forum

Notifications
Clear all

Thoughts and Questions Related to Untested Medicine

11 Posts
8 Users
0 Likes
1,054 Views
(@amin-sadig)
Posts: 37
Eminent Member
Topic starter
 

There are conflicting studies on the effects of acupuncture especially proving efficacy against a placebo. While it is currently approved for pain treatments the current services provided go much farther. I have had a growing interest in the field, and found that electroacupuncture is currently being done in the US. while it is not approved by insurance companies, people can have electroacupuncture sessions were electrodes are placed into meridians and then low current and voltage are applied between the inserted needles.
There is minimal or conflicting evidence that shows that this treatment has any effects whatsoever and there are some risks involved since you are inserting needles and an electric current into the body. While this is not as egregious as the antifreeze elixir mentioned in the lecture, long term side effects as well as simply being scammed do not seem to be an issue in the FDA's eyes. Should electroacupuncture stimulators be FDA regulated? (note the stimulators are essentially the same used on circuit boards)
Should electroacupuncture be allowed before more conclusive evidence is presented? While I personally believe in acupuncture, my question lies with regulator justification that can be used for such a device.

 
Posted : 28/01/2018 4:23 pm
 zbw2
(@zbw2)
Posts: 47
Eminent Member
 

considering the immediate risks of both acupuncture and transcutaneous electrical nerve stimulation are well documented and are minimal when performed by an experienced practitioner, and electroacupuncture is a combination of the two practices, i don't believe it should be banned. many drugs and devices on the market do not have documentation of their respective long term effects, yet remain on the shelves.

I am not sure what you mean about being scammed.

 
Posted : 28/01/2018 5:25 pm
 cs22
(@cs22)
Posts: 27
Eminent Member
 

Currently, there is a major issue involving the overuse of opioid painkillers in pain management. So much so that the FDA has released guidelines for doctors to explore the use of chiropractic methods and acupuncture as alternative treatments:
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM557071.pdf

The FDA has also approved an electroacupuncture system in 2014 to help eliminated opioid withdrawal symptoms:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585271.htm

From these two sources it seems that the FDA sees potential in the methods as a way to help combat opioid addiction, which currently is a major epidemic in the US. The FDA may feel that the potential benefits outweigh the current lack of long term clinical data. I would agree with this sentiment as the low voltages used pose a very small risk to the patient.

 
Posted : 28/01/2018 5:27 pm
(@amin-sadig)
Posts: 37
Eminent Member
Topic starter
 

For clarification purposes.
The scamming that I was referring to is with regards to the fact that many of the treatment options available with acupuncture and electroacupuncture are not proven to be statistically significantly different than placebo acupuncture or sham acupuncture. Also, while EA and acupuncture are approved for certain patients like cancer patients during chemotherapy, Acupuncture clinics also have a plethora of other therapies that anyone can get for things ranging from weight loss to face lifting and increased range of motion to reduced muscle stiffness. Not all of these applications have been proven but are currently done. From an objective standpoint, is this much different than the made up elixirs of the past (so long as they are not made of something that can harm the body obviously) such as the cancer curing bottle of water? Should they be used only for things that are proven empirically with the current testing schemes or not?

 
Posted : 28/01/2018 5:38 pm
(@es338)
Posts: 42
Eminent Member
 

Acupuncture needles are regulated by the FDA, being classified as a Class II device. If the manufacturers of acupuncture needles claim treatments with their devices, then I believe the FDA would regulate the "therapy" or service differently than what is currently being done. Depending on the 510(k) submission, how a company legally markets their devices is done with incredible consideration in their promoting content. Acupuncture is considered a non-pharmacological approach for an alternative to opioid drugs. Below is a link to a FDA presentation about approaches taken/considered in resolving the opioid epidemic in the U.S..

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5580

https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/anestheticandanalgesicdrugproductsadvisorycommittee/ucm501048.pdf

 
Posted : 28/01/2018 6:13 pm
 zbw2
(@zbw2)
Posts: 47
Eminent Member
 

While some research states that belief may be a contributing factor in the effectiveness of acupuncture, the NIH acknowledges that "Acupuncture may help ease types of pain that are often chronic such as low-back pain, neck pain, and osteoarthritis/knee pain". therefore, while the efficacy of acupuncture has not been "proven", the evidence supporting it is strong enough that it does differentiate it from silver bullet elixirs and other treatments of the sort. Also, since the risks of acupuncture, when performed with sterile equipment by skilled practitioners, are relatively low there is little reason to disallow the practice. I would argue the same for electro-acupuncture.

https://nccih.nih.gov/health/acupuncture/introduction#hed3

 
Posted : 04/02/2018 11:46 am
(@msc52njit-edu)
Posts: 78
Trusted Member
 

I think that if a practice or device is believed to be used for medical benefits then it must be regulated and tested by the FDA. In this scenario the electro-acupuncture device should be governed as it is a device that if not used properly could inflict harm on the user. It should be regulated and tested to ensure that no major complications can arise when used and that it will not cause any side effects for the user. I would have to say that more studies should be concluded before electro-acupuncture is used as it is still uncertain with this new device if there are any long term malignant problems. The use of stabbing one self with needles is already dangerous and although acupuncturists are mostly professionals who are exact in their needle locations, you still do not know if electrical stimulation around these certain points can cause damage and what type of damage it could cause. There must be testing to ensure the right needle is used and that the right current is used, with regulations on the power of the electro-acupuncture device.

 
Posted : 10/02/2018 1:19 pm
 cs22
(@cs22)
Posts: 27
Eminent Member
 

In response to the questionable services provided by acupuncturists in addition to their regular service, I feel this is acceptable provided that their primary service is FDA approved and they are properly licensed. The extra income from their secondary services, provided these services are not harmful, help keep the business open and financially stable. Many of these products are mainly just placebos and pose no significant risk to the consumer.

 
Posted : 11/02/2018 4:24 pm
(@alexandrabuga)
Posts: 149
Estimable Member
 

Reading this discussion about FDA regulation and example of acupuncture made me think of whole body cryotherapy. I myself have actually done a few cryotherapy sessions and reading this was curious to see what the FDA had approved. Interestingly enough the FDA has actually posted info regarding whole body cryotherapy (WBC) on their website.

“Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved WBC devices as safe and effective to treat medical conditions,” says Aron Yustein, M.D., a medical officer in the FDA’s Center for Devices and Radiological Health. “That is not the case.”
In fact, not a single WBC device has been cleared or approved by the agency in support of these claims.
Nevertheless, a quick Internet search for the term “whole body cryotherapy” turns up a wealth of websites extolling the praises of WBC for a number of serious illnesses and conditions, including:
• Asthma
• Alzheimer’s
• Anxiety
• Chronic pain
• Depression
• Fibromyalgia
• Insomnia
• Migraines
• Multiple sclerosis
• Osteoarthritis
• Rheumatoid Arthritis
• Weight Loss
Those who sell WBC machines and facilities that operate them may also claim that WBC can improve blood circulation, increase metabolism, improve recovery and soreness after workouts, and relieve joint and body pain.
“Given a growing interest from consumers in whole body cryotherapy, the FDA has informally reviewed the medical literature available on this subject,” Yustein says. “We found very little evidence about its safety or effectiveness in treating the conditions for which it is being promoted.”
It goes on to state the people should consult their doctors before doing WBC. It will be interesting to see if in the future these WBC machines become FDA regulated/approved.

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm508739.htm

 
Posted : 06/05/2018 11:22 am
 Josh
(@orleron)
Posts: 95
Trusted Member Admin
 

test Spiral Medical Development test post

Spiral Medical Development
www.spiralmeddev.com

 
Posted : 30/09/2018 11:10 am
(@jr377)
Posts: 79
Trusted Member
 

Well this is an interesting point. Acupuncture has been done for centuries, so safety doesn't seem to be a concern. However, the needles have been known if migrate if left in the body. Whether or not it is effective is also still in doubt. There would need to be more studies for the FDA to decide whether or not to allow it's continued practice or not. I do agree with zbw2 in that there are many products that aren't regulated. Are gym supplements FDA approved? They aren't but are still sold on a wide market. While I wouldn't suggest going to do these alternative medicines I don't know of a way for the FDA to restrict it's use. It may be grandfathered into new regulations already or it might just be a part of such a large market that it may be impossible. The only thing I think can happen is for the FDA to really push for people to be careful about using any of this.

 
Posted : 02/02/2019 11:50 am
Share: