Govt approves TB supplement ahead of pending trial results, experts raise concerns

The government has opted to introduce Energy Dense Nutritional Supplementation (EDNS)—a sachet containing sweetened peanut paste, milk powder, and oil—for 12 lakh underweight TB patients over two months, instead of providing food. This decision comes before the results of a trial to assess EDNS’s effectiveness have been released. Experts have raised concerns about the premature rollout, warning that it could commercialize the intervention and ultimately become more expensive than simply supplying food to the patients.

The largest trial demonstrating the effectiveness of nutritional support for underweight TB patients, published in The Lancet in September of last year, recommended offering a monthly 10 kg food basket (containing rice, pulses, milk powder, and oil) along with multivitamins for six months to help these patients gain weight and reduce mortality. The trial, known as RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status), was funded by ICMR, involved 2,800 patients, and was conducted between August 2019 and January 2021.

RATIONS trial estimated monthly cost of the food basket at Rs 1,100 per patient at 2019 prices. However, govt estimate of Rs 1,040 crore to provide EDNS to 12 lakh patients for two months works out to roughly Rs 4,300 per patient per month. Moreover, EDNS is only for 2 months though nutritional support was recommended for six months.

EDNS was being considered as an intervention for TB well before RATIONS trial results were published.

A small study on the acceptability of EDNS, involving 102 patients, was done between Sept 2018 and Feb 2019 by the same authors who did the efficacy trial later. It was published in Sept 2020. However, with RATIONS trials conclusively proving how effective distributing a food basket is in improving TB cure rates and reducing mortality, it has come as a surprise to many TB experts that govt has pushed ahead with EDNS.

According to clinical trial registration website, the efficacy trial with 329 participants, with 167 in intervention arm (given EDNS) and 162 in control arm (only given dietary advice), was funded by ICMR. It started in Jan 2020 and was completed in Feb 2023. “Though results of the main trial have not yet been published in a peer reviewed journal, they have been presented to experts and have been accepted for presentation during Union World Congress on Lung health,” said Dr Anand Krishnan, of Centre for Community Medicine in AIIMS Delhi, who is one of the study authors.Dr Veena Shatrugna, former deputy director of National Institute of Nutrition, told TOI “The message of improving home diets in TB patients is not possible if such a programme is launched. It will be a fertile ground for the food processing industry to provide EDNS.”There was no response from health ministry, ICMR or TB division to queries sent to them.

(With TOI inputs)