Most overweight people don’t know where to begin and can do with a little help to get them started. A new pill may help them in this journey of self-determination and health improvement. It’s rather simple to use. Ingest it, keep it in the stomach where it swells up and cuts down your appetite.
The Central Drug Standard Control Organisation (CDSCO) recently approved a medical weight-loss device — the Allurion Swallowable Capsule — which its US makers believe to be a cutting edge step, combining technology with Pavlovian conditioning, to bring about behavioural change to tackle obesity. The US-based Allurion Technologies Inc has developed a non-endoscopic, non-surgical intervention in the form of a swallowable pill. Now this inflates like a balloon inside the stomach upon being filled with water. Its polyurethane-membrane expands and when it reaches full capacity, degrades itself and is ultimately excreted at the end of four months. The resultant fullness in the stomach is aimed at controlling feelings of hunger, ultimately training the individual in portion control. The device is also accompanied by a weighing scale and a smartphone application that enables weight loss tracking and communication between the patient and their care team, which may include nutritionists, physicians and psychologists. The results can last a lifetime. By the time the balloon passes, you’ve developed new food preferences, adjusted to smaller portion sizes, and developed a new understanding of your body which leads to longer and sustained results.
How does tech regulate biochemical mechanism?
Weight loss depends on the hormones, leptin and ghrelin, which regulate feelings of satiety and hunger. Leptin is a hormone, made by fat cells, that decreases your appetite while ghrelin is a hormone that increases appetite, and also plays a role in body weight. With the water-filled balloon occupying space in the stomach, a feeling of fullness remains, which is coupled with food portion control aided by the application nudges. With hunger going down, the balloon regulates and delays the emptying of the stomach, which prevents insulin spikes that come with dumping of the high carbohydrate food.
What has studies shown so far when it comes to device safety, efficacy and adverse events?
A key study on the safety and efficacy of the device has been a multi-centre (19 centres, located in Europe and West Asia), prospective, non-randomised, open-label study of 1,770 patients, published in August 2020, which recorded 14.2 per cent of total body weight loss (TBWL).
Sixty-three patients (3.6 per cent) did not complete the programme and had the balloon removed before four months due to intolerance or other adverse events. Of these, 11 (0.6 per cent) empty balloons were vomitted after being ingested, and 52 (2.9 per cent) patients had intolerance requiring balloon removal. Eleven (0.6 per cent) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Apart from measuring TBWL, BMI loss and percent excess weight loss, the study also measured change in laboratory values of triglycerides, Low Density Lipoprotein (LDL), which are cholesterol indicators, and HbA1c (percentage), which is a diabetes indicator, among patients following the Allurion regimen. The study reported improvement in metabolic indicators, which then spurred another study on the role of Allurion swallowable balloon in Type 2 diabetes (T2D) and prediabetes treatment, comprising 226 patients at five diabetes centres.
The study reported that after four months of treatment, there was a reduction by 1.5 percent in HbA1c level among T2D patients and 1.1 percent reduction among pre-diabetics. A study was also conducted to look at the efficacy of sequential the Allurion balloon treatment, which meant that after three months of the first balloon treatment, a second balloon was inserted, the whole process taking upto a year. According to the company, two sequential balloon treatments resulted in an average TBWL of 22.8 per cent against the 14.4 percent after a single balloon treatment, and not a single adverse event was reported. A study is also going on in the USA to compare sequential balloon treatment against a control arm receiving only exercise and diet. To see the efficacy in maintaining the weight lost over a prolonged period, a 16-month follow up of 509 patients have shown that 95 per cent of the subjects sustained a weight loss at 16 months.
What are the pros and cons you need to know about?
Dr Mohit Bhandari, an Indore-based bariatric and endoscopic surgeon and who spearheaded a small trial in India prior to CDSCO approval, says that of the patients who need bariatric surgery, only one per cent goes ahead with it owing to the fear of the knife and hesitation over surgical scars. Dr Ram Chhutani, chief medical officer and founding partner of Allurion, adds that sometimes surgical interventions come with a risk of developing additional infections or post-surgery weight gain. This can be avoidable with the balloon device. And if overweight patients pursue multiple Elipse balloon treatments in a series, they will just be spending 20 minutes as an OPD patient.
Can the scope of the pill be extended in other body conditions?
While the studies conducted so far have established that weight loss can be maintained over a sustained period of 16 months, further studies are going on to see if it can be extended to two years. “Our next endeavour or challenge is to show whether similar control over diabetes can be sustained over a long-term period as well. We do not have that data yet. But our hypothesis is that if we can sustain weight-loss, there is no reason why we should not be able to sustain that improvement in HbA1c. There are other mechanisms at work as well, hormonal mechanisms related to the balloon when it comes to improvement of diabetes,” says Dr Chhutani.
However, he adds that while there may be sustained improvement in HbA1c, but not to the extent of the sustained weight loss Allurion has achieved, the same can be significantly tackled through diabetes medication. Dr Chhutani also adds that the future scope could include the effect on women facing obesity-induced infertility or those suffering from non-alcoholic fatty liver disease.
How feasible is this in the Indian context?
The CDSCO nod requires that this method can be an option for those aged above 16 years of age and those with a Body Mass Index (BMI) over 27. Given the co-morbidities associated with obesity, (the latest NFHS showed an increase from 21 per cent to 24 percent among women and 19 per cent to 23 percent in men between 2016 and 2021), Dr Bhandari stresses that it becomes a viable alternative. However, the company has also been marketing the device as a go-to device to resort to for weight loss before “major life events” such as “weddings”. Founder and CEO of Allurion, Dr Shantanu Gaur, is quick to defend that the company is “agnostic”, and is administering it only through doctors to prevent misuse. The regimen — including the device and the back-end technology — is expected to cost around Rs 3.5 lakh. But in case of widespread use in India, it could become cheaper in the future. In comparison, bariatric surgery may cost upto Rs 5-6 lakh.
However, Allurion is only partially covered under insurance at present unlike bariatric surgery, and remains absent from state and Central Government schemes. According to Dr Bhandari, the device is expected to be covered under the Central Government Health Scheme in the near future.
Additionally, with food habits, demographic and socio-cultural profile, along with genetic factors affecting obesity, the large-scale study of 1,700 patients did not include any centre from India. However, Dr Chhutani clarifies that the Middle-Eastern centres included in the study cover the profile similar to that of Indians, thus being a surrogate. Additionally, Dr Bhandari headed a study, comprising 150 patients in India as part of the CDSCO approval process.