Post Marketing Efficacy and Safety Study of BOHECO Peace (Full Spectrum Hemp Leaf Extract Based Ayurvedic Proprietary Medicine) for the Management of Pain

Abstract

Introduction: The use of Cannabis leaf-based medicines is being developed at an exponential rate with more and more studies and research carried out to assess the efficacy of the drug in various illnesses including management of pain. Materials and Methods: 50 patients who had been on the full spectrum cannabis leaf based ayurvedic proprietary medicine manufactured by Bombay Hemp Company, Mumbai, India for pain were selected for the study. Separate structured multiple-choice questionnaires were used for the assessment of safety and efficacy of BOHECO’s PEACE manufactured by BOHECO. Results: In Overall effect of management of Pain, out of 50 participants, 47 responses were received in which, 3 patients (6.4%) reported complete remission of the pain, 28 patients (59.5%) reported marked improvement, 15 patients (31.9%) were getting moderate Improvement and one patient (2.1%) reported mild improvement. Out of 15 patients who reported adverse events, most reported AEs were dry mouth in 12 patients which is a common response of the body to Cannabis leaf-based medicine, mild euphoria in 3 patients, somnolence in 2 patients, sedation in 2 patients and anxiety in 1 patient. The mild AEs reported were self-limiting without any medical intervention. Conclusion: Full Spectrum Hemp leaf extract based Ayurvedic proprietary medicine sold under the brand name BOHECO PEACE used for the management of pain has been observed to be effective and safe for long term use. It is observed to have reduced chronic pain with no serious adverse reactions at prescribed doses.