{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T17:01:49Z","timestamp":1757610109143,"version":"3.44.0"},"reference-count":29,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,3]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n<jats:p>In 2024, the Indian National Leprosy Eradication Program released Revised Treatment Guidelines for management of paucibacillary (PB) leprosy, introducing clofazimine into the existing PB multidrug therapy (PB-MDT). This treatment simplification has a dubious scientific basis and serious long-term implications. Notably, this policy shift is derived from WHO guidelines (2018), which issued only a conditional recommendation for uniform-MDT, relying on very low-quality evidence to support the change. We reviewed the studies cited in support and found multiple methodological shortcomings, including insufficient samples, lack of blinding, and unvalidated outcome measures. This significantly undermines the justification for incorporating clofazimine into PB-MDT. Leaving these limitations unaddressed could lead to unintended consequences, including increased drug resistance, higher treatment costs, and adverse drug effects, further complicating disease management. Such a fundamental policy revision should be preceded by rigorous, field-level research, preferably a multicentric, triple-blind superiority trial, alongside establishing surveillance for clofazimine resistance.<\/jats:p>","DOI":"10.4269\/ajtmh.25-0131","type":"journal-article","created":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T11:34:49Z","timestamp":1750764889000},"page":"494-497","source":"Crossref","is-referenced-by-count":0,"title":["Programmatic Addition of Clofazimine to Multidrug Therapy for Paucibacillary Leprosy in India: A One-Size-Fits-All Approach in Absence of Sound Clinical Evidence"],"prefix":"10.4269","volume":"113","author":[{"given":"Akshita","family":"Jain","sequence":"first","affiliation":[{"name":"North DMC Medical College & Hindu Rao Hospital, Guru Gobind Singh Indraprastha University, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soumit","family":"Sharma","sequence":"additional","affiliation":[{"name":"North DMC Medical College & Hindu Rao Hospital, Guru Gobind Singh Indraprastha University, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vishal","family":"Gupta","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anwita","family":"Khaitan","sequence":"additional","affiliation":[{"name":"Department of Community Medicine, All India Institute of Medical Sciences\u2014Central Armed Police Forces Institute of Medical Sciences, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"year":"2023","key":"b1","article-title":"Leprosy (Hansen\u2019s disease)"},{"year":"2024","key":"b2","article-title":"National Leprosy Eradication Program"},{"year":"2024","key":"b3"},{"year":"2023","key":"b4","article-title":"Ministry of Health and Family Welfare"},{"year":"2018","key":"b5","article-title":"WHO Guidelines for the Diagnosis, Treatment, and Prevention of Leprosy"},{"key":"b6","series-title":"Indian J Med Res","first-page":"525","article-title":"International open trial of uniform multidrug therapy regimen for leprosy patients: Findings & implications for national leprosy programs","volume":"144","author":"Manickam","year":"2016"},{"key":"b7","series-title":"Trop Med Int Health","first-page":"594","article-title":"International open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients: Rationale, design, and preliminary results","volume":"13","author":"Kroger","year":"2008"},{"key":"b8","series-title":"Indian J Lepr","first-page":"311","article-title":"Chemotherapy trial in paucibacillary leprosy using clofazimine","volume":"71","author":"Katoch","year":"1999"},{"key":"b9","series-title":"Mem Inst Oswaldo Cruz","first-page":"74","article-title":"Brazilian clinical trial of uniform multidrug therapy for leprosy patients: The correlation between clinical disease types and adverse effects","volume":"107","author":"de S\u00e1 Gon\u00e7alves","year":"2012"},{"key":"b10","series-title":"Lepr Rev","first-page":"143","article-title":"Comparative study of uniform-MDT and WHO MDT in pauci and multibacillary leprosy patients over 24 months of observation","volume":"80","author":"Rao","year":"2009"},{"article-title":"Center Mum on Availability, Requirement of Key Leprosy Drug","year":"2022","author":"Jayanth","key":"b11"},{"article-title":"Is There a TB Drugs Shortage in India? | Explained","year":"2023","author":"Prasad","key":"b12"},{"key":"b13","series-title":"Lepr Rev","first-page":"14","article-title":"The INFIR Cohort Study: Investigating prediction, detection, and pathogenesis of neuropathy and reactions in leprosy. Methods and baseline results of a cohort of multibacillary leprosy patients in North India","volume":"76","author":"Van Brakel","year":"2005"},{"year":"1982","key":"b14","article-title":"Chemotherapy of Leprosy for Control Programs: Report of a WHO Study Group"},{"year":"1997","key":"b15","article-title":"Seventh Report"},{"year":"2023","key":"b16","article-title":"Weekly Epidemiological Record\u20148 September 2023"},{"key":"b17","series-title":"Lep Rev","first-page":"255","article-title":"Changing proportions of paucibacillary leprosy cases in global leprosy case notification","volume":"91","author":"Butlin","year":"2020"},{"key":"b18","series-title":"Lepr Rev","first-page":"310","article-title":"Risk factors for the development of clinical leprosy among contacts, and their relevance for targeted interventions","volume":"75","author":"Moet","year":"2004"},{"key":"b19","series-title":"World Health Organ Tech Rep Ser","first-page":"1","article-title":"Chemotherapy of leprosy for control programs","volume":"675","year":"1982"},{"year":"2023","key":"b20","article-title":"National Guidelines for Surveillance of Antimicrobial Resistance in Leprosy"},{"key":"b21","series-title":"RRTM","first-page":"75","article-title":"Global surveillance system to monitor the development of drug resistance in Mycobacterium leprae","volume":"6","author":"Matsuoka","year":"2015"},{"key":"b22","series-title":"Int J Res Dermatol","first-page":"110","article-title":"Effect of clofazimine on nerve function impairment in paucibacillary leprosy patients","volume":"5","author":"Poulkar","year":"2019"},{"year":"1994","key":"b23","article-title":"Risk of Relapse in Leprosy"},{"key":"b24","series-title":"Indian J Dermatol Venereol Leprol","first-page":"126","article-title":"Relapse in leprosy","volume":"75","author":"Kaimal","year":"2009"},{"key":"b25","series-title":"Biomed Res Int","first-page":"705804","article-title":"WHO multidrug therapy for leprosy: Epidemiology of default in treatment in Agra district, Uttar Pradesh, India","volume":"2015","author":"Kumar","year":"2015"},{"key":"b26","series-title":"Int J Lepr Other Mycobact Dis","first-page":"19","article-title":"Relapses in paucibacillary leprosy after MDT\u2014A clinical study","volume":"58","author":"Grugni","year":"1990"},{"year":"2004","series-title":"Multidrug Therapy Against Leprosy: Development and Implementation over the Past 25 Years","author":"Lechat","key":"b27"},{"key":"b28","series-title":"Lepr Rev","first-page":"2","article-title":"Uniform MDT (U-MDT) regimen for all leprosy patients\u2014Another example of wishful thinking","volume":"74","author":"Ji","year":"2003"},{"key":"b29","series-title":"PLoS Negl Trop Dis","first-page":"e0007671","article-title":"Three drugs are unnecessary for treating paucibacillary leprosy\u2014A critique of the WHO guidelines","volume":"13","author":"Lockwood","year":"2019"}],"container-title":["The American Journal of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/113\/3\/article-p494.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/113\/3\/article-p494.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/113\/3\/article-p494.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T13:13:55Z","timestamp":1756905235000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/113\/3\/article-p494.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,3]]},"references-count":29,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.25-0131","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"type":"print","value":"0002-9637"},{"type":"electronic","value":"1476-1645"}],"subject":[],"published":{"date-parts":[[2025,9,3]]}}}