Abstract
Objectives
Insomnia and sleep disorders are common and can be severe amongst patients with cancer, especially during chemotherapy. The aim of this study was to evaluate the efficacy of lettuce seed syrup in breast cancer patients who suffer from insomnia or disordered sleep.
Methods
This pilot study was a double-blinded randomized controlled clinical trial conducted in Shoha-e-Tajrish Hospital (Tehran, Iran) from September 2018 to June 2019. 50 adult patients with breast cancer with insomnia or sleep disorders were enrolled. Participants were randomly allocated to lettuce seed syrup (5 mL twice daily), or placebo syrup at the same dose for four weeks. The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate sleep quality before and after the intervention.
Results
Compared to placebo, the mean of the total PSQI score decreased significantly in participants who received lettuce seed syrup (p=0.014). In addition, there were statistically significant reductions in the mean scores of subject quality sleep (p=0.002), sleep duration (p=0.038), habitual sleep efficacy (p=0.029) and sleep disturbance (p=0.032) in patients who received lettuce seed syrup.
Conclusions
Lettuce seed syrup may improve self-reported sleep quality in participants with breast cancer. Larger trials are indicated in diverse samples of participants with caner to learn if these finds are generalizable.
Funding source: Shiraz University of Medical Sciences
Award Identifier / Grant number: 1396-01-64-15514
Acknowledgments
The authors would like to thank the Traditional Medicine and Materia Medica Research Center, school of traditional medicine, Shahid Beheshti University of Medical Sciences, and the office of the Vice-chancellor for Research of Shiraz University of Medical Sciences.
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Research funding: Shiraz University of Medical Sciences was supporting this research project through grant No. 1396-01-64-15514.
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Author contributions: SHM, HRM and GH designed the research project; SHM, BM, RG, MMP, GH, and MP conducted the research project, including recruitment, intervention and biochemical analysis; MP and GH performed statistical analysis and together with MMP and RB., drafted the manuscript. All authors provided critical comments, read and approved the final version.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The protocol of this study was approved by The Ethics committee of Shiraz University of Medical Sciences (code: IR.SUMS.REC.1397.417) on July 29, 2018. Furthermore, this clinical trialwas registered at Iranian Registry of Clinical Trials (IRCT) website by IRCT20150825023753N13 code.
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