Tammadon MR, Nobahar M, Hydarinia-Naieni Z, Ebrahimian A, Ghorbani R, Vafaei AA. The Effects of Valerian on Sleep Quality, Depression, and State Anxiety in Hemodialysis Patients: A Randomized, Double-blind, Crossover Clinical Trial.Oman Med J. 2021;36(2):e255. Published 2021 Mar 31. doi:10.5001/omj.2021.56

Publication Date: "2021"

Peer Reviewed: Yes

Study Design: "randomized, double-blind, placebo-controlled, crossover clinical trial"

Methodology: Patients were randomly assigned to two groups, received either valerian or placebo capsules one hour before sleep for one month, followed by a one-month washout period, then switched treatments. Sleep quality, state anxiety, and depression were measured using questionnaires before and after interventions.

Sample Size: "39 patients"

Controls Used: "placebo"

Dose Used: "530 mg dried root of Valeriana officinalis"

Statistical Significance Declared: Sleep quality reduction: "p< 0.001" Depression score reduction: "p =0.013" State anxiety score reduction: "p =0.003"

Adverse Events: "no side effects during and after the interventions were reported"

Conflict of Interest: "The authors declared no conflicts of interest."

Shinjyo N, Waddell G, Green J. Valerian Root in Treating Sleep Problems and Associated Disorders-A Systematic Review and Meta-Analysis.J Evid Based Integr Med. 2020;25:2515690X20967323. doi:10.1177/2515690X20967323

Publication Date: "Accepted for publication September 27, 2020."

Peer Reviewed: Yes

Study Design: "Systematic review and meta-analysis."

Methodology: PubMed, ScienceDirect, and Cochrane Library searched for studies on valerian's effectiveness in treating sleep problems and associated disorders. Sixty studies were reviewed, and meta-analyses performed.

Sample Size: "A total of 60 studies (n=6,894) were included in this review."

Controls Used: "Placebo-controlled."

Dose Used: "Repeated treatments with the whole root/rhizome consistently promoted sleep quality at 450-1410 mg per day for 4-8 weeks, whereas valerian extracts 300-600 mg per day for 5 days-4 weeks resulted in inconsistent outcomes."

Statistical Significance Declared: "Global self-assessment of change was better for valerian group (p=0.04)."

Adverse Events: "There were no severe adverse events associated with valerian intake in subjects aged between 7 and 80 years."

Conflict of Interest: "The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article."

Palmieri G, Contaldi P, Fogliame G. Evaluation of effectiveness and safety of a herbal compound in primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes.Nat Sci Sleep. 2017;9:163-169. Published 2017 May 26. doi:10.2147/NSS.S117770

Publication Date: "Annual 2017"

Peer Reviewed: Yes

Study Design: "randomized, single-blind, placebo-controlled study"

Methodology: One hundred and twenty subjects with sleep disturbances symptoms were randomized into two groups, receiving either the herbal compound or placebo at a dosage of two pills per day 30 minutes before bedtime. Sleep quality and daytime activity were assessed at baseline, after 10 days, and after 20 days.

Sample Size: "One hundred and twenty subjects"

Controls Used: "placebo-controlled"

Dose Used: "two pills per day 30 minutes before their scheduled bedtime"

Statistical Significance Declared: "p<0.001" for sleep onset, total slept time, night awakenings frequency, daily symptom improvement, tension and irritability, difficulty in concentration, and fatigue intensity.

Adverse Events: "None of the 60 subjects reported adverse reaction related to the herbal compound"

Conflict of Interest: "Professor Giancarlo Palmieri has a role of scientific consultant in Mediolanum Farmaceutici S.p.a.; Cristalfarma belongs to Mediolanum Pharmaceutical Group. The authors report no other conflicts of interest in this work."

Mirabi P, Mojab F. The effects of valerian root on hot flashes in menopausal women.Iran J Pharm Res. 2013;12(1):217-222.

Publication Date: "2013 Winter"

Peer Reviewed: Yes

Study Design: "double blind clinical trial"

Methodology: 68 menopausal women with hot flashes were randomly divided into drug and placebo groups, receiving either 255 mg Valerian capsules or placebo three times a day for 8 weeks. Severity and frequency of hot flashes were measured and recorded through questionnaires.

Sample Size: "68 menopausal women"

Controls Used: "placebo"

Dose Used: "255 mg Valerian capsules 3 times a day for 8 weeks"

Statistical Significance Declared: "p < 0.001" for severity and frequency of hot flashes after Valerian treatment

Adverse Events: "Some subjects were excluded from the study due to gastrointestinal disorders, dizziness and taking other medications affecting hot flashes."

Conflict of Interest: Not stated in the provided text

Jenabi E, Shobeiri F, Hazavehei SMM, Roshanaei G. The effect of Valerian on the severity and frequency of hot flashes: A triple-blind randomized clinical trial.Women Health. 2018;58(3):297-304. doi:10.1080/03630242.2017.1296058

Publication Date: "Accepted 18 January 2017"

Peer Reviewed: Yes

Study Design: "triple-blind, randomized, controlled clinical trial"

Methodology: 60 postmenopausal women aged 45-55 were randomly assigned to either placebo or Valerian group. An oral Valerian 530 mg capsule was given twice per day for two months. The severity and frequency of hot flashes were determined by the Kupperman index before the intervention, one month after, and two months after the intervention.

Sample Size: "a total sample size of 64"

Controls Used: "placebo"

Dose Used: "oral Valerian 530 mg capsule was given twice per day for two months"

Statistical Significance Declared: "p = .048" for severity of hot flashes at one month, "p = .020" for severity of hot flashes at two months, "p = .033" for frequency of hot flashes at two months

Adverse Events: "No participants in the present study had any side effects after using Valerian."

Conflict of Interest: "This article is part of a PhD by research thesis supported by Hamadan University of Medical Sciences."

Cuellar NG, Ratcliffe SJ. Does valerian improve sleepiness and symptom severity in people with restless legs syndrome?.Altern Ther Health Med. 2009;15(2):22-28.

Publication Date: "MAR/APR 2009"

Peer Reviewed: Yes

Study Design: "Prospective, triple-blinded, randomized, placebo-controlled, parallel design."

Methodology: Participants received 800 mg of valerian or placebo for 8 weeks. Data were collected at baseline and after 8 weeks using Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale for sleep disturbances and International RLS Symptom Severity Scale for RLS symptoms.

Sample Size: "Thirty-seven participants"

Controls Used: "Placebo tablet identical in smell and sight"

Dose Used: "800 mg of valerian"

Statistical Significance Declared: "Significant differences in sleepiness (P=.01) and RLS symptoms (P=.02)." "A strong positive association between changes in sleepiness and RLS symptom severity (P=.006)."

Adverse Events: "GI disturbances, fatigue/mental sluggishness, vivid dreams, agitation/restlessness, headache, dizziness, rash, and RLS symptoms worsening."

Conflict of Interest: None declared.

Jokar A, Kargosha A, Akarzadeh M, Asadi N, Setoudeh Z. Comparing the influence of relaxation training and consumption of valerian on insomnia of menopause women: A randomized clinical trial. Afr J Tradit Complement Altern Med. 2016;13(1):6. doi:10.4314/ajtcam.v13i1.6.

Publication Date: "published Jan 2016"

Peer Reviewed: Yes

Study Design: "randomized clinical trial"

Methodology: Randomized 129 menopausal women with insomnia into three groups (valerian, relaxation, control). Used demographic questionnaire and sleep quality Petersburg index. Data analyzed with SPSS20 at significance level 0.05.

Sample Size: "129 menopausal women"

Controls Used: "placebo capsule (containing 50.0 mg starch)"

Dose Used: "two capsules before going to bed for a period of one month"

Statistical Significance Declared: "Comparing average scores before and after treatment of sleep disorders were determined in valerian and relaxation group was significant difference (p <0.001) and in the control group no correlation was found (p >0.05)."

Adverse Events: "We did not observe any adverse side effects or events in our study group as a result of Valerian consumption or relaxation therapy."

Conflict of Interest: "Authors haven’t conflict of interest"

Nazem-Ekbatani N, Tavoni S, Haghani H, Gharayagh-Zandi S. Evaluation of Satisfaction from Valerain for Treatment of Menopause Sleep Disorder. J Arak Uni Med Sci. 2012;15(5):49-57.

Publication Date: " Accepted: 27 Dec 2011"

Peer Reviewed: Yes

Study Design: "clinical trial"

Methodology: Randomized clinical trial with 100 postmenopausal women. Used Pittsburgh Sleep Quality Scale and Visual Analogue Scale. Data collection immediately after intervention, one month, and six months post-intervention.

Sample Size: "100 postmenopausal eligible women"

Controls Used: "placebo capsule (containing 50 mg starch)"

Dose Used: "two capsules before going to bed for a period of one month"

Statistical Significance Declared: "The difference between intervention and control group in satisfaction and sleep scores was significant only immediately after taking Valerian (p=0.001)"

Adverse Events: "We did not observe any adverse side effects or events in our study group as a result of Valerian consumption or relaxation therapy."

Conflict of Interest: "Authors haven’t conflict of interest"

Fernández-San-Martín MI, Masa-Font R, Palacios-Soler L, Sancho-Gómez P, Calbó-Caldentey C, Flores-Mateo G. Effectiveness of Valerian on insomnia: A meta-analysis of randomized placebo-controlled trials. Sleep Medicine. 2010;11(6):505-511. doi:10.1016/j.sleep.2009.12.009

Publication Date: "Available online 26 March 2010."

Peer Reviewed: Yes

Study Design: "randomized clinical trials"

Methodology: Search for randomized clinical trials of Valerian preparations compared with a placebo. Outcomes: sleep-quality improvement, sleep-quality improvement quantified through visual analogical scales, and the latency time in minutes until getting to sleep. Three meta-analyses were carried out using inverse-variance weighted random effects models.

Sample Size: "Eighteen RCTs were selected; eight had a score of 5 on Jadad’s scale. The sample sizes oscillated between 5 patients and 434."

Controls Used: "placebo"

Dose Used: "The dosage of valerian root extract ranges from 300 to 600 mg/day."

Statistical Significance Declared: "The mean differences in LT between the Valerian and placebo treatment groups was 0.70 min (95% CI, −3.44 to 4.83); the standardized mean differences between the groups measured with SQS was −0.02 (95% CI, −0.35 to 0.31); treatment with Valerian showed a relative risk of SQ of 1.37 (95% CI, 1.05–1.78) compared with the placebo group."

Adverse Events: "The secondary effects reported are basically of two types: gastrointestinal effects, e.g., diarrhea, epigastralgia, nausea, and pyrosis, and central nervous system effects, e.g., headache, nervousness, and drowsiness. These effects are usually low intensity and no different from those seen with the placebo. The exception was diarrhea: it proved to be much more frequent in patients taking Valerian (18%) in comparison with ones taking a placebo (8%, P = 0.02)."

Conflict of Interest: "No conflicts of interest declared."

Andreatini R, Sartori VA, Seabra MLV, Leite JR. Effect of valepotriates (valerian extract) in generalized anxiety disorder: a randomized placebo-controlled pilot study. Phytother Res. 2002;16(7):650-654. doi:10.1002/ptr.1027

Publication Date: "Accepted 24 April 2001"

Peer Reviewed: Yes

Study Design: "a parallel, double-blind, flexible-dose, placebo-controlled design"

Methodology: 36 outpatients with generalized anxiety disorder randomized to valepotriates, diazepam, or placebo for 4 weeks after a 2-week washout period. Assessed with HAM-A and STAI. Data analyzed using Kruskall-Wallis ANOVA and Wilcoxon test.

Sample Size: "n = 12 per group"

Controls Used: "placebo"

Dose Used: "mean daily dose: 81.3 mg"

Statistical Significance Declared: "No significant difference was observed among the three groups at baseline or in the change from baseline on the Hamilton anxiety scale (HAM-A) or in the trait part of the state-trait anxiety inventory (STAI-trait)."

Adverse Events: "No complaint of moderate or serious adverse reactions was observed during the study and only two patients (one taking diazepam and the other placebo) abandoned the study due to an adverse effect."

Conflict of Interest: "The present study was partially supported by BYK Química e Farmacêutica Ltda (Brazil), who also supplied the drugs used."

Azizi H, Shojaii A, Hashem-Dabaghian F, et al. Effects ofValeriana officinalis(Valerian) on tension-type headache: A randomized, placebo-controlled, double-blind clinical trial.Avicenna J Phytomed. 2020;10(3):297-304.

Publication Date: "2020 May-Jun"

Peer Reviewed: Yes

Study Design: "double-blind randomized clinical trial"

Methodology: 88 participants with tension-type headache were randomly assigned to intervention (valerian) and control (placebo) groups. Valerian group received 530 mg of valerian root extraction, and placebo group received 500 mg of breadcrumbs, both as two capsules daily for a month. Headache impact on daily living, disability, and severity were measured using questionnaires at baseline and one month after intervention.

Sample Size: "88 participants"

Controls Used: "placebo"

Dose Used: "530 mg of valerian root extraction"

Statistical Significance Declared: "The impact of headache on daily livings performance, significantly reduced in intervention group (mean=51.2) versus the placebo (mean=57.0), (p<0.001)." "A significant reduction in disability in intervention group (mean=22.9) compared to the placebo (mean=27.4) (p<0.001)." "The severity score showed significant reductions in intervention group (mean=3.5) versus the placebo group (mean=5.1) (p<0.001)."

Adverse Events: "No drug complications were reported in the treatment and control groups during the study period. However, one participant in valerian group was diagnosed with dizziness at the beginning of the treatment."

Conflict of Interest: "The authors have declared that there is no conflict of interest."