Efficacy of lettuce seed syrup on insomnia in patients with breast cancer: a pilot double blind randomized placebo controlled clinical trial

Seyed Hamdollah Mosavat; Hamid Reza Mirzaei; Bahram Mofid; Reyhaneh Gharehgozlou; Mohammad Mahdi Parvizi; Ryan Bradley; Mehdi Pasalar; Ghazaleh Heydarirad

doi:10.1515/jcim-2021-0181

Article

Efficacy of lettuce seed syrup on insomnia in patients with breast cancer: a pilot double blind randomized placebo controlled clinical trial

Seyed Hamdollah Mosavat , Hamid Reza Mirzaei , Bahram Mofid , Reyhaneh Gharehgozlou , Mohammad Mahdi Parvizi , Ryan Bradley , Mehdi Pasalar and Ghazaleh Heydarirad

Published/Copyright: August 30, 2021

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From the journal Journal of Complementary and Integrative Medicine Volume 19 Issue 4

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.

Keywords: breast cancer; insomnia; lettuce; Persian medicine; sleep disorder

Corresponding author: Ghazaleh Heydarirad, MD, PhD, Traditional Medicine and Materia Medica Research Center, No.8 Shams Alley, Vali-e-Asr Street, 1516745811, Tehran, Iran, Phone/Fax: +98(21) 88776027, E-mail: ghazalrad@yahoo.com; and Mehdi Pasalar, MD, MPH, PhD, Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Faculty of Medicine, Zand St., 7134845794, Shiraz, Iran, Phone/Fax: +98(71)32338476, E-mail: pasalar@sums.ac.ir

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.

Research funding: Shiraz University of Medical Sciences was supporting this research project through grant No. 1396-01-64-15514.
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.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
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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Received: 2021-05-01

Accepted: 2021-08-19

Published Online: 2021-08-30

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Articles in the same Issue

https://doi.org/10.1515/jcim-2021-0181

Keywords for this article

breast cancer; insomnia; lettuce; Persian medicine; sleep disorder