Most overweight people don’t know where to start and can do with a little help to get them started. A new pill can help them on this journey of self-determination and better health. It is rather simple to use. Ingest it, keep it in the stomach where it swells and suppresses the appetite.
The Central Drug Standard Control Organization (CDSCO) recently approved a weight-loss medical device – the Allurion swallow capsule – that its US manufacturers consider a breakthrough step, combining technology with Pavlovian conditioning, to bring about a change in behavior to fight obesity. The American company Allurion Technologies Inc has developed a non-endoscopic and non-surgical intervention in the form of a swallowing pill. Now it inflates like a balloon inside the stomach when it is filled with water. Its polyurethane membrane expands and when it reaches its full capacity, degrades and is finally excreted after four months. The resulting fullness in the stomach aims to control feelings of hunger, ultimately training the individual to control portions. The device also comes with a scale and a smartphone app that enables weight loss tracking and communication between the patient and their healthcare team, which may include nutritionists, doctors and psychologists. The results can last a lifetime. By the time the ball passes, you’ve developed new food preferences, adjusted to smaller portions, and developed a new understanding of your body that leads to longer, lasting results.
How does technology regulate the biochemical mechanism?
Weight loss depends on the hormones leptin and ghrelin, which regulate feelings of fullness and hunger. Leptin is a hormone, made by fat cells, which decreases appetite while ghrelin is a hormone which increases appetite and also plays a role in body weight. With the water-filled balloon taking up space in the stomach, a feeling of fullness remains, which is coupled with food portion control aided by the application nudges. When hunger subsides, the balloon regulates and delays the emptying of the stomach, preventing the insulin spikes that accompany the emptying of carbohydrate-rich foods.
What have the studies shown so far regarding the safety, effectiveness and adverse effects of the devices?
A key study on the safety and efficacy of the device was a multicenter (19 centers, located in Europe and West Asia), prospective, non-randomized, open-label study involving 1,770 patients, published in August 2020, which recorded 14.2% total body weight loss (TBWL).
Sixty-three patients (3.6 percent) did not complete the program and had the balloon removed before four months due to intolerance or other adverse events. Of these, 11 empty balloons (0.6%) vomited after being ingested and 52 patients (2.9%) presented with intolerance requiring removal of the balloon. Eleven (0.6%) balloons deflated earlier. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier ball design. In addition to measuring TBWL, BMI loss, and percent excess weight loss, the study also measured changes in laboratory values of triglycerides, low-density lipoproteins (LDL), which are indicators cholesterol, and HbA1c (percentage), which is an indicator of diabetes, in patients. following the Allurion diet. The study reported improvement in metabolic indicators, which then stimulated another study of the role of the Allurion swallowable balloon in the treatment of type 2 diabetes (T2DM) and prediabetes, including 226 patients at five centers diabetes.
The study reported that after four months of treatment, there was a 1.5% reduction in HbA1c levels in patients with T2D and 1.1% in prediabetics. A study was also conducted to examine the effectiveness of the Allurion sequential balloon treatment, meaning that after three months of the first balloon treatment, a second balloon was inserted, with the whole process taking up to a year . According to the company, two sequential balloon treatments resulted in an average TBWL of 22.8% compared to 14.4% after a single balloon treatment, and no adverse events were reported. A study is also underway in the United States to compare sequential balloon therapy to a control arm receiving only exercise and diet. To see the effectiveness of maintaining lost weight over an extended period, a 16-month follow-up of 509 patients showed that 95% of subjects experienced weight loss at 16 months.
What are the pros and cons you need to know?
Dr. Mohit Bhandari, an Indore-based bariatric and endoscopic surgeon who led a small trial in India before CDSCO approval, says that among patients who need bariatric surgery, only one percent pursue it due to fear of the knife and hesitation over surgical scars. Dr. Ram Chhutani, chief medical officer and founding partner of Allurion, adds that sometimes surgical procedures carry a risk of developing additional infections or gaining weight after surgery. This can be avoided with the balloon device. And if overweight patients continue several Elipse balloon treatments in a series, they will only spend 20 minutes as an OPD patient.
Can the scope of the pill be extended to other bodily conditions?
While studies conducted so far have established that weight loss can be sustained over a sustained period of 16 months, further studies are underway to see if it can be extended to two years. “Our next effort or challenge is to show whether similar diabetes control can also be maintained over a long-term period. We don’t have that data yet. But our hypothesis is that if we can sustain weight loss, there’s no reason we shouldn’t be able to sustain that HbA1c improvement. There are also other mechanisms at work, hormonal mechanisms related to the ball when it comes to improving diabetes,” says Dr. Chhutani.
However, he adds that while there may be a lasting improvement in HbA1c, but not to the extent of the sustained weight loss that Allurion achieved, the same can be significantly resolved with medication. against diabetes. Dr Chhutani also adds that future scope could include the effect on women facing obesity-induced infertility or those with non-alcoholic fatty liver disease.
How feasible is this in the Indian context?
The CDSCO Wink requires that this method may be an option for people over the age of 16 and those with a body mass index (BMI) greater than 27. Given the comorbidities associated with obesity, ( the latest NFHS showed an increase of 21-24% in women and 19-23% in men between 2016 and 2021), Dr. Bhandari points out that this is becoming a viable alternative. However, the company also marketed the device as a go-to device for losing weight before “major life events” such as “weddings.” Allurion founder and CEO Dr. Shantanu Gaur is quick to defend that the company is “agnostic” and only administers it through doctors to prevent abuse. The scheme – including the device and back-end technology – is expected to cost around Rs 3.5 lakh. But in case of widespread use in India, it might become cheaper in the future. In comparison, bariatric surgery can cost up to Rs 5-6 lakh.
However, Allurion is currently only partially covered by insurance, unlike bariatric surgery, and remains absent from state and central government plans. According to Dr Bhandari, the device is expected to be covered by the central government health scheme in the near future.
Additionally, with dietary habits, demographic and socio-cultural profile, as well as genetic factors affecting obesity, the large-scale study of 1,700 patients did not include any Indian center. However, Dr. Chhutani clarifies that the Middle Eastern centers included in the study cover the similar profile as Indians, thus being a surrogate. Additionally, Dr. Bhandari led a study involving 150 patients in India as part of the CDSCO approval process.