Obesity and Diabetes are interconnected epidemics with a negative impact on health, and their prevalence continues to increase worldwide. Obesity is the 2nd leading cause of preventable death in the United States, and 5th leading cause of mortality and morbidity globally. Sustained weight loss can help reduce and prevent complications and reverse health issues including Diabetes.
Nausea is one of the most reported side effects of GLP-1s.
Glucagon-like peptide-1 receptor agonist-based medications, collectively known as GLP-1s, are revolutionizing the approach to long-term weight loss, diabetes control and health improvements beyond the scale[i] [ii] [iii] [iv] [v] including cardiovascular health[vi] [vii]. Weight loss can reach as high as 15-22% of total body weight. These medications stimulate GLP-1 (glucagon-like peptide-1) receptors, and work by mimicking the activity of GLP-1 which is a type of hormone produced by our body in response to eating. GLP-1 regulates appetite, sugar metabolism and fullness by slowing stomach emptying and activating specific centers in the brain leading to satiety.
Clinical trials on GLP-1s for Obesity and Diabetes report nausea in 15-30% of participants, however real-world use of GLP-1s indicate greater variability. Gastrointestinal side effects, namely nausea, remains the most common reason for treatment discontinuation. Nausea related to GLP-1 medication is believed to arise from direct effects on the central nervous system, mediated by GLP-1 receptors in the area postrema, a highly vascular paired structure in the medulla oblongata in the brainstem[viii]. Additionally, the effect of GLP1s on gastrointestinal (GI) function, namely delaying of gastric emptying and intestinal motility, may contribute to the occurrence of GI side effects as a whole [ix], [x]. Short-term use of anti-nausea medication has been proposed for nausea management. Other nausea relief interventions currently recommended in clinical practice include dose adjustments of the GLP-1s, and dietary changes: such as reducing the meal size, stopping to eat when feeling full, avoiding high-fat or spicy foods and moderating alcohol consumption.
“Typically, nausea is seen at the beginning of treatment, at each dose increment and will traditionally get better overtime. The challenge is that nausea is an unpleasant experience, subjectively described as an uneasy sickness to the stomach that can disrupt quality of life, sometimes leading to discontinuation of medication”, says Dr. Florencia Ziemke, MD, dABOM, a US-based Obesity Medicine expert and lead researcher evaluating Sea-Band for nausea relief in GLP1 medication users.
“Nausea is an established side effect of GLP-1 medications, which I see in clinical practice”, Dr. Ziemke says,” Prescription anti-nausea medication can present a challenge with drug interactions if a person is on other medications, plus they are not side effect free. Dietary changes alone may not be sufficient to tame the symptom.
Published Placebo-controlled trials have well established Sea-Band’s use for nausea relief, which is seen within minutes for several indications. Dr. Ziemke began evaluating Sea-Band acupressure bands for nausea relief in adults with Obesity and/or Diabetes, taking GLP-1s that presented with nausea. Participants mean age was 57, mean BMI was 35 kg/m2, 81% were White, and 72% were female. All study participants were on GLP-1 medication and experiencing nausea at the time of enrollment. As early as the one-week follow-up, 83% of participants reported a decrease in nausea symptoms, whilst 33% reported full termination of nausea. None of the participants required taking prescription oral antiemetics, nor did they report vomiting. All participants reported that they were able to tolerate foods, beverages and maintain their regular activities without interruptions nor feelings of illness. Nausea relief occurred mostly in under 5 minutes of applying Sea-Band wristbands, which is consistent with their use seen for the other approved indications.
“I feel nauseous the first few days after my injection and the Sea-Band works every time, usually within 2 minutes, never more than 3 minutes.” – Jill O., study participant
“The wristbands really helped with the nausea, especially at the beginning when I was starting my prescription. I have lost 39 lbs. (18 kg) thus far” – John C., study participant
Reasons for study discontinuation included: hospitalization for gallbladder disease, lack of insurance coverage, leaving the medical practice, and switching medications due to failed response to treatment. Study discontinuation reasons were not related to GI side-effects of GLP-1 medication. Study participant feedback highlighted that Sea-Band was conveniently portable, a comfortable elastic, washable and can be used ad libitum to improve nausea.
“Further investigations and larger scale studies are currently ongoing, including the use of our remote monitoring app for accurate tracking of symptoms and real-time monitoring.” Dr. Ziemke shares. Results of this pragmatic intervention suggest that Sea-Band provides a safe, easy to use, drug-free, and practically side-effect free, answer to tame a disruptive symptom. Additionally, Sea-Band can be used ad libitum to improve a person’s treatment journey, provide nausea relief, and importantly their day-to-day well-being.
References
[i] Davies, Melanie J., et al. “Efficacy of liraglutide for weight loss among patients with type 2 diabetes: the SCALE diabetes randomized clinical trial.” JAMA 314.7 (2015): 687-699.
[ii] Davies, Melanie, et al. “Semaglutide 2.4mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.” The Lancet 397.10278(2021):971-984.
[iii] Hales, Craig M., et al. “Prevalence of obesity and severe obesity among adults: United States, 2017-2018. NCHS Data Brief, no 360.” National Center for Health Statistics 360 (2020): 1-7.
[iv] Garvey, W. Timothy, et al. “Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomized, multicenter, placebo-controlled, phase 3 trial.” The Lancet (2023).
[v] Jastreboff, Ania M., et al. “Tirzepatide once weekly for the treatment of obesity.” New England Journal of Medicine 387.3 (2022): 205-216.
[vi] Lincoff, A. Michale, et al. “Semaglutide and cardiovascular outcomes in obesity without diabetes.” New England Journal of Medicine 389.24 (2023): 2221-2232.
[vii] Ussher, John R., and Daniel J. Drucker. “Glucagon-like peptide 1 receptor agonists: cardiovascular benefits and mechanisms of action.” Nature Reviews Cardiology 20.7 (2023): 463-474.
[viii] Kanoski SE, Hayes MR, Skibicka KP. GLP-1 and weight loss: unraveling the diverse neural circuitry. Am J Physiol Regul Integr Comp Physiol. 2016;310(10): R885–R895.
[ix] Nauck MA, Meier JJ. Management of endocrine disease: are all GLP-1 agonists equal in the treatment of type 2 diabetes? Eur J Endocrinol. 2019;181(6): R211–R234.
[x] Thazhath SS, Marathe CS, Wu T, et al. The glucagon-like peptide 1 receptor agonist exenatide inhibits small intestinal motility, flow, transit, and absorption of glucose in healthy subjects and patients with type 2 diabetes: a randomized controlled trial. Diabetes. 2016;65(1):269–275.