An evaluation of adverse drug reactions of Bakuchi containing formulations used in the management of Shvitra (vitiligo): A retrospective, observational record-based study

Abstract

Introduction: Bakuchi (Psoralea corylifolia Linn.,); widely used, Ayurvedic classical drug with wider therapeutic utility and its constituents exhibit photosensitivity and dermatological reactions. Objective: The present review was conducted to record type, the incidence of dermatological exaggerated presentations, possible adverse drug reactions (ADRs) caused by Bakuchi containing formulations in published online, offline clinical trials conducted ITRA (Jamnagar), case reports, and published spontaneous reports of ADRs in view of their safety and efficacy. Data Source: Prospective ethically permitted clinical trials from the Ayurveda Research Database (ARD: The year (2001–2019), online published clinical researches, and spontaneous reports of ADRs. Review Methods: The data assembled from respective databases with regard to Bakuchi and its containing formulations for the management of vitiligo. Collected data were assessed for seriousness, predictability, preventability, severity, and outcome by appropriate scales. Results: After the removal of repetition/duplication, there were 20 clinical trials, out of which 7 clinical trials and 7 case studies and the rest 6 were unpublished clinical trials. Among them, 4 types of research were on internal administration, 7 on external application, 9 on the combined as external and internal administration. Five researches out of these were introduced ADRs in respective researches. There were also 3 published spontaneous ADR reports found on Bakuchi and its formulations for the management of vitiligo. Thus, total eight researches were identified thoroughly and included in the present study for the evaluation of ADRs or possible ADR or exaggerated drug response/action (retrospective observation). All reactions were classified as nonserious, definitely preventable. The predictability was found Type A in 91.42% and Type C in 8.57%. Assessment of severity showed 2.41%, 97.59% reactions in mild level 1, 2 Grades, respectively. All patients had recovered from the reaction after treatment. Conclusion: Formulations containing Bakuchi may exhibit predictable (Type A, ADR), dose-related ADRs or may lead to iatrogenic drug response.

Keywords

• adverse drug reactions
• bakuchi
• psoralea corylifolia linn
• vitiligo