Sleep disorders are a substantial problem for cancer survivors, with prevalence estimates ranging from 23% to 61%. Although numerous prescription hypnotics are available, few are approved for long-term use or have demonstrated benefit in this circumstance. Hypnotics may have unwanted side effects and are costly, and cancer survivors often wish to avoid prescription drugs. New options with limited side effects are needed. The purpose of this trial was to evaluate the efficacy of a Valerian officinalis supplement for sleep in people with cancer who were undergoing cancer treatment. Participants were randomized to receive 450 mg of valerian-or placebo orally 1 hour before bedtime for 8 weeks. The primary end point was area under the curve (AUC) of the overall Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes included the Functional Outcomes of Sleep Questionnaire, the Brief Fatigue Inventory (BFI), and the Profile of Mood States (POMS). Toxicity was evaluated with both self-reported numeric analogue scale questions and the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Questionnaires were completed at baseline and at 4 and 8 weeks. A total of 227 patients were randomized into this study between March 19, 2004, and March 9, 2007, with 119 being evaluable for the primary end point. The AUC over the 8 weeks for valerian was 51.4 (SD = 16), while that for placebo was 49.7 (SD = 15), with a P value of 0.6957. A supplemental, exploratory analysis revealed that several fatigue end points, as measured by the BFI and POMS, were significantly better for those taking valerian over placebo. Participants also reported less trouble with sleep and less drowsiness on valerian than placebo. There were no significant differences in toxicities as measured by self-report or the CTCAE except for mild alkaline phosphatase increases, which were slightly more common in the placebo group. This study failed to provide data to support the hypothesis that valerian, 450 mg, at bedtime could improve sleep as measured by the PSQI. However, exploratory analyses revealed improvement in some secondary outcomes, such as fatigue. Further research with valerian exploring physiologic effects in oncology symptom management may be warranted.
A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia.Sleep Med. 2009 Mar;10(3):319-28. doi: 10.1016/j.sleep.2008.02.001. Epub 2008 May 14. Sleep Med. 2009. PMID: 18482867 Free PMC article. Clinical Trial.
An internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia.Medicine (Baltimore). 2005 Jul;84(4):197-207. doi: 10.1097/01.md.0000172299.72364.95. Medicine (Baltimore). 2005. PMID: 16010204 Clinical Trial.
Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial.Sleep. 2005 Nov;28(11):1465-71. doi: 10.1093/sleep/28.11.1465. Sleep. 2005. PMID: 16335333 Clinical Trial.
Treating primary insomnia - the efficacy of valerian and hops.Aust Fam Physician. 2010 Jun;39(6):433-7. Aust Fam Physician. 2010. PMID: 20628685 Review.
Valerian for sleep: a systematic review and meta-analysis.Am J Med. 2006 Dec;119(12):1005-12. doi: 10.1016/j.amjmed.2006.02.026. Am J Med. 2006. PMID: 17145239 Free PMC article. Review.
Cited by 8 articles
Plant Extracts for Sleep Disturbances: A Systematic Review.Evid Based Complement Alternat Med. 2020 Apr 21;2020:3792390. doi: 10.1155/2020/3792390. eCollection 2020. Evid Based Complement Alternat Med. 2020. PMID: 32382286 Free PMC article. Review.
Prognostic significance of baseline fatigue for overall survival: A patient-level meta-analysis of 43 oncology clinical trials with 3915 patients.Trends Cancer Res. 2017;12:97-110. Trends Cancer Res. 2017. PMID: 31213748 Free PMC article.
A Review of Herbal Therapy in Multiple Sclerosis.Adv Pharm Bull. 2018 Nov;8(4):575-590. doi: 10.15171/apb.2018.066. Epub 2018 Nov 29. Adv Pharm Bull. 2018. PMID: 30607330 Free PMC article. Review.
Pharmacologic interventions for fatigue in cancer and transplantation: a meta-analysis.Curr Oncol. 2018 Apr;25(2):e152-e167. doi: 10.3747/co.25.3883. Epub 2018 Apr 30. Curr Oncol. 2018. PMID: 29719440 Free PMC article.
Systematic review of sleep disorders in cancer patients: can the prevalence of sleep disorders be ascertained?Cancer Med. 2015 Feb;4(2):183-200. doi: 10.1002/cam4.356. Epub 2014 Nov 30. Cancer Med. 2015. PMID: 25449319 Free PMC article. Review.
- CA-107586/CA/NCI NIH HHS/United States
- CA-35133/CA/NCI NIH HHS/United States
- U10 CA035267/CA/NCI NIH HHS/United States
- CA-03011/CA/NCI NIH HHS/United States
- U10 CA052352/CA/NCI NIH HHS/United States
- N01 CA035431/CA/NCI NIH HHS/United States
- U10 CA035269/CA/NCI NIH HHS/United States
- CA-37404/CA/NCI NIH HHS/United States
- CA-95968/CA/NCI NIH HHS/United States
- K05 CA124477/CA/NCI NIH HHS/United States
- CA-52352/CA/NCI NIH HHS/United States
- CA-35195/CA/NCI NIH HHS/United States
- CA-67753/CA/NCI NIH HHS/United States
- U10 CA037404/CA/NCI NIH HHS/United States
- N01 CA035119/CA/NCI NIH HHS/United States
- U10 CA035448/CA/NCI NIH HHS/United States
- U10 CA063848/CA/NCI NIH HHS/United States
- U10 CA035195/CA/NCI NIH HHS/United States
- CA-35103/CA/NCI NIH HHS/United States
- U10 CA107586/CA/NCI NIH HHS/United States
- CA-25224/CA/NCI NIH HHS/United States
- CA-124477/CA/NCI NIH HHS/United States
- U10 CA035261/CA/NCI NIH HHS/United States
- U10 CA095968/CA/NCI NIH HHS/United States
- U10 CA035101/CA/NCI NIH HHS/United States
- CA-63848/CA/NCI NIH HHS/United States
- U10 CA035415/CA/NCI NIH HHS/United States
- U10 CA037404-26/CA/NCI NIH HHS/United States
- U10 CA063849/CA/NCI NIH HHS/United States
- U10 CA067575/CA/NCI NIH HHS/United States
- CA-35415/CA/NCI NIH HHS/United States
- U10 CA035431/CA/NCI NIH HHS/United States
- U10 CA035119/CA/NCI NIH HHS/United States
- CA-35261/CA/NCI NIH HHS/United States
- CA-35269/CA/NCI NIH HHS/United States
- CA-35448/CA/NCI NIH HHS/United States
- N01 CA067575/CA/NCI NIH HHS/United States
- CA-35101/CA/NCI NIH HHS/United States
- U10 CA025224/CA/NCI NIH HHS/United States
- U10 CA067753/CA/NCI NIH HHS/United States
- CA-35267/CA/NCI NIH HHS/United States
- CA-63849/CA/NCI NIH HHS/United States
- U10 CA035103/CA/NCI NIH HHS/United States