Effect of Tomato (Solanum lycopersicum) Extract in Patients with Primary Insomnia: A Double-blind Randomized Study.
- 2023-08
- Central nervous system agents in medicinal chemistry 23(2)
- Parvin Dehnavi
- Hassan Rakhshandeh
- Elham Bakhtiari
- Hadi Asadpour
- Seyed Mostafa Moshirian Farahi
- Fatemeh Forouzanfar
- PubMed: 37475550
- DOI: 10.2174/1871524923666230720155754
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 70
- Population
- 70 patients with primary insomnia (50 females, 20 males)
- Methods
- Randomized, placebo-controlled; 2 weeks of tomato capsules or placebo nightly; ISI and PSQI questionnaires before and after intervention
- Blinding
- Double-blind
- Duration
- 2 weeks
- Funding
- Unclear
Objective
Insomnia is a condition that causes sleep problems, and many people suffer from it. Patients with this disorder have difficulty with beginning or continuation of sleep, so they are exhausted all day long, and their performance reduces. This study was designed to assess the efficacy of capsules that contain tomato extract in patients with primary insomnia.Methods
In this study, 70 patients with primary insomnia were assigned to 2 groups randomly: intervention and control. The intervention group used to take tomato capsules every night for 2 weeks, and the placebo one used to take placebo capsules every night for 2 weeks. All patients used to fill out Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after the intervention. ISI and PSQI results were analyzed separately on SPSS software.Results
A total of 70 patients (35 in the intervention group and 35 in the control group), including 50 females and 20 males, were studied. Female to male ratio and the rate of unemployment were significantly higher in the intervention group (in both cases P < 0.001), but there was no significant difference between the intervention and control groups in other characteristics (Age, marital status, weight, height, education; in all cases P > 0.05). At the end of the study, the amount of actual sleep had increased, and the delay in falling asleep decreased in both groups; the two groups at the end of the study were not significantly different in terms of these two variables (P > 0.05). The ISI score in both groups decreased significantly at the end of the study, and the PSQI score in both groups decreased significantly at the end of the study (In both cases, P < 0.05). The absolute value of ISI score change in the intervention group was significantly higher than the control group (P < 0.001); But the absolute value of PSQI score change was not significantly different between the two groups (P = 0.102). Most importantly, the improvement of both ISI and PSQI scores in the intervention group was significantly better than the control group (P > 0.05).Conclusion
This study showed that tomato capsules have sleep-inducing effects, although there was no significant difference in the amount of actual sleep, and the delay in falling sleep in the intervention group compared to the control group.Research Insights
the absolute value of PSQI score change was not significantly different between the two groups (P = 0.102)
- Effect
- Neutral
- Effect size
- Small
the amount of actual sleep had increased, and the delay in falling asleep decreased in both groups; the two groups at the end of the study were not significantly different in terms of these two variables (P > 0.05)
- Effect
- Neutral
- Effect size
- Small
The absolute value of ISI score change in the intervention group was significantly higher than the control group (P < 0.001)
- Effect
- Beneficial
- Effect size
- Moderate
the amount of actual sleep had increased, and the delay in falling asleep decreased in both groups; the two groups at the end of the study were not significantly different in terms of these two variables (P > 0.05)
- Effect
- Neutral
- Effect size
- Small