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              Prescribing Patterns, Safety and Effect of Suk Sai-Yad Thai Traditional
              Medicine Formula on Patients’ Quality of Life

              Apakorn Boontham , Preecha Nootim , Piyameth Dilokthornsakul ‡,§,¶
                                             †
                              *,†
              * Master of Pharmacy Program in Community Pharmacy, Faculty of Pharmaceutical Sciences, Naresuan University,
              Tha Pho Sub-District, Mueang Phitsanulok District, Phitsanulok 65000, Thailand.
              † Thai Traditional and Integrated Medicine Hospital, Department of Thai Traditional and Alternative Medicine, Khlong
               Maha Nak Sub-District, Pom Prap Sattru Phai District, Bangkok 10100, Thailand
              ‡ Center for Medical and Health Technology Assessment (CM-HTA), Department of Pharmaceutical Care, Faculty of
               Pharmacy, Chiang Mai University, Suthep Sub-District, Mueang Chiang Mai District, Chiang Mai 50200, Thailand
              § Center of Pharmaceutical Outcomes Research, Department of Pharmacy Practice, Faculty of Pharmaceutical
               Sciences, Naresuan University, Tha Pho Sub-District, Mueang Phitsanulok District, Phitsanulok 65000, Thailand
              ¶ Corresponding author:  piyamethd@nu.ac.th

                                                Abstract
                   Suk Sai-Yad formula is a Thai traditional medicine (TTM) formula containing cannabis recorded in the Royal
              Scripture of King Narai’s Traditional Medicine. This formula containing 15.38% of cannabis leaves is recommended
              by the Department of Thai Traditional and Alternative Medicine and the Thai Traditional Medicinal Council for the
              treatment of patients with insomnia and loss of appetite. In the past, although cannabis was used as an ingredient in
              TTM remedies for a long time, when cannabis was classified as a schedule 5 narcotic under Thailand’s Narcotics
              Act B.E. 2522 (1979), medical use of cannabis-containing TTM preparations became illegal. Moreover, research
              and scientific evidence on its efficacy, safety, and patterns of use was also limited. This study aimed to determine
              prescribing patterns, adverse events, and quality of life of patients receiving Suk Sai-Yad formula. Therefore, a
              retrospective cohort study using a patient record review was conducted on patients visiting the Medical Cannabis
              Clinic at the Thai Traditional and Integrated Medicine Hospital for at least two visits from October 2019 to Decem-
              ber 2020 and having follow-up treatment every month. A total of 138 patients (61.59% males and mean age 56.81
              ± 15.51 years) participated in the study. The formula was prescribed for insomnia (87.68%), headache (7.97%),
              and other indications (4.35%) including loss of appetite, numbness and Parkinson’s disease. The initial doses were
              0.5–2.0 g/day and the most prescribed initial dosage regimen was 1 g once a day (52.90%). Common maintenance
              doses prescribed were 2.0 g/day (44.18%) and 1.0 g/day (40.70%). Fifteen patients discontinued medication because
              of drug ineffectiveness. Researchers observed 31 adverse events in 23 patients, namely gastrointestinal irritation
              (7.97%), dizziness/headache (5.79%), dry mouth and dry throat (4.34%). Sixteen patients (11.59%) discontinued
              medication because of adverse effects. The quality of life measured using the EQ-5D-5L self-assessed questionnaire
              indicated that the average utility was 0.95 ± 0.11 at treatment initiation and 0.98 ± 0.05 (p < 0.001) after 3-month
              treatment. In conclusion, it was found that despite a few non-serious adverse effects, Suk Sai-Yad formula is a safe
              and effective alternative medication that can improve the quality of life for patients with insomnia.

                   Key words:  Suk Sai-Yad formula, cannabis, prescribing patterns, adverse events, quality of life
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