Study of Effectiveness and Safety of Cannabis-Containing and Non-Cannabis Ya Sukkhasaiyat Formulas in Patients with Insomnia

Abstract

Introduction and objective: Sleep is a fundamental need for human health and well-being. Maintaining a good and high-quality sleep cycle is essential as insufficient sleep or sleep disorders can adversely affect both physical and mental health. Currently, many people have problems with insomnia. The Thai Traditional and Integrative Medicine Hospital provides treatment for patients with insomnia using herbal medicine for relieving the symptom. There are herbal remedies for relieving insomnia, including those containing cannabis and those without. The researchers are interested in studying the comparative effectiveness and safety of cannabis-containing Ya Sukkhasaiyat and non-cannabis Ya Sukkhasaiyat formulas (CCYS and NCYS) in patients with insomnia. To provide information for further research and development on the use of Ya Sukkhasaiyat in patients with insomnia in the future. The objectives of this study were to (1) evaluate the effectiveness of CCYS and NCYS sleep quality, (2) assess the severity and safety of adverse reactions to Ya Sukkhasaiyat in insomnia patients, and (3) evaluate satisfaction of using Ya Sukkhasaiyat for insomnia.

Method: This research, using an experimental study double-blinded randomized control design, was conducted on patients with chronic insomnia or difficulty sleeping, who were receiving treatment at the Thai Traditional and Integrative Medicine hospital, with a total of 84 participants. By assessing sleep quality using the Pittsburgh Sleep Quality Index, data were collected and then analyzed using descriptive statistics, independent t-test, and paired t-test.

Results: When comparing composite scores of sleep quality of the participants before and after treatment, the CCYS group had mean scores of 10.45 ± 3.79 and 5.91 ± 2.72, respectively, while the NCYS group’s mean scores were 10.49 ± 3.15 and 6.68 ± 1.75, respectively. In both groups the post-treatment scores significantly reduced (p < 0.05), but there was no significant difference between the groups (p > 0.05). Based on the assessment of adverse drug reactions, both groups had mild adverse symptoms including epigastric burning from using the formulas. As for quality of life, the ESAS assessments of pain, tiredness/fatigue, nausea, depression, anxiety, drowsiness, anorexia, physical/mental discomfort, shortness of breath, other symptoms, showed a significant decrease in ESAS scores (p < 0.05).

Discussion: Regarding patient satisfaction after treatment, the CCYS group had significantly increased satisfaction with their sleep, but the increase was not significant in the NCYS group (p < 0.05). However, between the two groups, their satisfaction levels were not significantly different (p > 0.05). Based on the comparison of sleep satisfaction levels, it can be explained that the CCYS group had significantly different sleep satisfaction scores before and after treatment regarding sleeping more soundly, not waking up during the night, and better sleep quality, etc. The higher satisfaction level might result from the effect of the cannabis contained in the medication as cannabis has an important compound called delta-9-tetrahydrocannabinol (THC), which helps induce relaxation, euphoria, and sleep. However, when considering the sleep satisfaction scores before and after treatment in the NCYS group, the satisfaction rating increased post-treatment, but not significantly. Based on the satisfaction scores of both formulas, it was found that the participants had higher sleep satisfaction scores after receiving the two herbal medicine formulas. That was because both formulas contain the same 11 herbal ingredients, and according to herbal drug information, the herbs other than cannabis that have sleep-inducing properties are, for example, long pepper, neem, ginger and nutmeg.

Conclusion and recommendation: The results of this study have shown that both Ya Sukkhasaiyat formulas are significantly effective and safe in treating patients with insomnia. The efficacies in both study groups are not significantly different. If more research on this matter is promoted, it can help solve public health problems and reduce chronic diseases caused by insomnia. To ensure safety, future studies should investigate the effects of active compounds in the formulas, potentially in collaboration with external organizations. This would provide a systematic scientific evidence to support their use.