Ziemke Florencia, Belarj Soufiane, Esguerra Jem, Reyes Anita, Istfan Nawfal
Evexia Medical, Jupiter, FL, USA.
BellaVida Family Practice, Royal Palm Beach, FL, USA.
Obes Pillars. 2025 May 8;15:100178. doi: 10.1016/j.obpill.2025.100178. eCollection 2025 Sep.
Nausea is one of the most reported side effect of GLP-1 receptor agonists (GLP-1a). Current recommendations fall short in taming the symptoms, include antiemetic medication, behavior changes, GLP-1a dose adjustment, and often cause a disruption to treatment. Sea-Band® is a drug-free, class II FDA-cleared medical device for relief of nausea in motion sickness, morning sickness, chemotherapy and anesthesia induced nausea. The device is a set of soft, elastic, reusable acupressure wristbands (ACW) with a skin-facing plastic button worn below the wrist crease applying pressure at acupoint pericardium 6. We hypothesized that ACW was an effective tool for GLP-1a associated nausea.
This was a one-arm, open-label, non-randomized, prospective interventional study evaluating the antiemetic effect of ACW in non-pregnant adults on GLP-1as with nausea. GLP-1a were semaglutide or tirzepatide. Exclusion criteria were patients on GLP-1a without nausea, recent use of antiemetic medications, other nausea-related conditions, history of gastroparesis, and uncontrolled gastroesophageal reflux disease. Patients were shown how to properly place and use ACW at the onset of nausea and were followed weekly for 4 weeks. Follow-ups assessed frequency of nausea, ACW use frequency and duration, and change in nausea.
359 episodes of nausea were recorded amongst 31 adult participants over 4 weeks. Adults, mean age 55, mean BMI 34, mean HbA1c 5.9 %, reported nausea over 80 % of the time on a weekly basis. ACW were used in all recorded episodes of nausea. Medication doses were kept stable throughout the duration of this study. Nausea relief was achieved within 5 min in one third of episodes, and in over 5 min but under 20 min in the remainder of the episodes. A logistic regression model was used to evaluate the likelihood of nausea relief. A consistent rate of nausea relief over 80 % was observed during the study period, adjusting for the correlation between reduced nausea episodes and reduced episodes.
Although not a controlled trial, this pilot, proof of concept, pragmatic study suggests that ACW may offer a safe, self-administered, reusable, and drug-free option for managing GLP-1a associated nausea.ACW's nausea reducing effect was seen in over 80 % of episodes, and remained consistent throughout the study period. One third of participants experienced relief within 5 min of wearing ACW in the first three weeks. Given the relatively small sample size of the population, further large-scale investigations are justified. Nausea is common in day-to-day real-world use of GLP-1as, and our results suggest that using ACW may provide a first-line therapeutic intervention used ad libitum to tame a disruptive symptom, improve day-to-day well-being, and positively impact a person's treatment journey on GLP-1a.
恶心是胰高血糖素样肽-1受体激动剂（GLP-1a）最常报告的副作用之一。目前的建议在缓解症状方面效果不佳，包括使用止吐药物、改变行为、调整GLP-1a剂量，且常常会导致治疗中断。Sea-Band®是一种经美国食品药品监督管理局（FDA）批准的II类无药物医疗器械，用于缓解晕动病、妊娠呕吐、化疗及麻醉引起的恶心。该装置是一组柔软、有弹性、可重复使用的指压式腕带（ACW），带有一个面向皮肤的塑料按钮，佩戴在手腕横纹下方，对心包经6穴位施加压力。我们假设ACW是治疗GLP-1a相关恶心的有效工具。
这是一项单臂、开放标签、非随机、前瞻性干预研究，评估ACW对有恶心症状的非妊娠成年GLP-1a使用者的止吐效果。GLP-1a为司美格鲁肽或替尔泊肽。排除标准为无恶心症状的GLP-1a使用者、近期使用过止吐药物、患有其他与恶心相关的疾病、有胃轻瘫病史以及未控制的胃食管反流病患者。在恶心发作时向患者展示如何正确佩戴和使用ACW，并每周随访4周。随访评估恶心频率、ACW使用频率和时长以及恶心变化情况。
在4周内，31名成年参与者共记录到359次恶心发作。平均年龄55岁、平均体重指数（BMI）为34、平均糖化血红蛋白（HbA1c）为5.9%的成年参与者报告，每周超过80%的时间有恶心症状。在所有记录的恶心发作中均使用了ACW。在本研究期间，药物剂量保持稳定。三分之一的发作在5分钟内恶心缓解，其余发作在5分钟以上但在20分钟内缓解。使用逻辑回归模型评估恶心缓解的可能性。在研究期间，观察到恶心缓解率持续超过80%，同时对减少的恶心发作次数和减少的发作之间的相关性进行了校正。
尽管这不是一项对照试验，但这项初步的概念验证性实用研究表明，ACW可能为管理GLP-1a相关恶心提供一种安全、可自行给药、可重复使用且无药物的选择。超过80%的发作中观察到ACW的恶心缓解效果，且在整个研究期间保持一致。前三周，三分之一的参与者在佩戴ACW后5分钟内症状缓解。鉴于研究人群样本量相对较小，有必要进行进一步的大规模调查。在GLP-1a的日常实际使用中，恶心很常见，我们的结果表明，使用ACW可能提供一种一线治疗干预措施，可随意用于缓解这种干扰性症状、改善日常健康状况，并对个人的GLP-1a治疗过程产生积极影响。
