Efficacy and safety of Wuling capsule, a single herbal formula, in Chinese subjects with insomnia: A multicenter, randomized, double-blind, placebo-controlled trial

Journal of Ethnopharmacology

Volumn 145, Issue 1, 2013, Pages 320-327

  Lin, Yan ^a   Wang, Xiao Yun ^b   Ye, Ren ^a   Hu, Wan Hua ^c   Sun, Shu Chen ^d   Jiao, Hong Juan ^e   Song, Xiu Hua ^f   Yuan, Zheng Zhong ^a   Zheng, Yuan Yuan ^a   Zheng, Guo Qing ^a   He, Jin Cai ^a  

^a WENZHOU MEDICAL UNIVERSITY   (China)

^b GUANGDONG PROVINCIAL HOSPITAL OF CHINESE MEDICINE   (China)

^c Wenzhou City Hospital   (China)

^d INSTITUTE OF CHINESE MATERIA MEDICA   (China)

^e HANGZHOU NORMAL UNIVERSITY   (China)

^f Jinhua City People's Hospital   (China)

Author keywords

Clinical trial; Insomnia; Multi center randomized trial; Wuling capsule

Indexed keywords

CHINESE DRUG; PLACEBO; UNCLASSIFIED DRUG; WULING;

ABDOMINAL DISTENSION; ADULT; ARTICLE; BLOATING; BLOOD ANALYSIS; BODY WEIGHT; CLINICAL EVALUATION; CLINICAL GLOBAL IMPRESSION SCALE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG CAPSULE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HAND PARESTHESIA; HEADACHE; HEART RATE; HUMAN; INSOMNIA; KIDNEY FUNCTION; LIVER FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARESTHESIA; PITTSBURGH SLEEP QUALITY INDEX; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SLEEP; SLEEP PARAMETERS; SLEEP QUALITY; SLEEP TIME; SOMNOLENCE; STOMACH PAIN; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; WORLD HEALTH ORGANIZATION ON QUALITY OF LIFE BRIEF SCALE; XEROSTOMIA;

ADOLESCENT; ADULT; CAPSULES; DOUBLE-BLIND METHOD; DRUGS, CHINESE HERBAL; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MIDDLE AGED; PHYTOTHERAPY; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; SLEEP INITIATION AND MAINTENANCE DISORDERS;

XYLARIA;

EID: 84871300945     PISSN: 03788741     EISSN: 18727573     Source Type: Journal    
DOI: 10.1016/j.jep.2012.11.009     Document Type: Article

References (30)

1. S. Bent, A. Padula, D. Moore, M. Patterson, and W. Mehling Valerian for sleep: a systematic review and meta-analysis American Journal of Medicine 119 2006 1005 1012
2. X.L. Chen, and X.F. Fan Clinical observation on Wuling capsule in treating 60 cases insomnia Zhejiang Journal of Integrated Traditional Chinese and Western Medicine 17 2007 442 443
3. Y. Chen, J. Lu, M. Zhu, and L. Luo Determination of multiple constituents in Wuling capsules by HPLC simultaneously China Journal of Chinese Materials Medica 37 2012 218 221
4. J. Charles, C. Harrison, and H. Britt Insomnia Australian Family Physician 38 2009 283
5. S.C. Chow, J. Shao, and H.S. Wang Sample Size Estimation in Clinical Research 2003 Marcel Dekker New York
6. Angelis C. De, J.M. Drazen, F.A. Frizelle, C. Haug, J. Hoey, R. Horton, S. Kotzin, C. Laine, A. Marusic, A.J. Overbeke, T.V. Schroeder, H.C. Sox, and M.B. Van Der Weyden International committee of medical journal editors. Clinical trial registration: a statement from the international committee of medical journal editors Lancet 364 2004 911 912
7. K. Doghramji The epidemiology and diagnosis of insomnia American Journal of Managed Care 12 8 Suppl 2006 S214 S220
8. J.D. Edinger, M.H. Bonnet, R.R. Bootzin, K. Doghramji, C.M. Dorsey, C.A. Espie, A.O. Jamieson, W.V. McCall, C.M. Morin, and E.J. Stepanski American Academy of Sleep Medicine Work Group. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group Sleep 27 2004 1567 1596
9. M.I. Fernández-San-Martín, R. Masa-Font, L. Palacios-Soler, P. Sancho-Gómez, C. Calbó-Caldentey, and G. Flores-Mateo Effectiveness of Valerian on insomnia: a meta-analysis of randomized placebo-controlled trials Sleep Medicine 11 2010 505 511
10. C. Gyllenhaal, S.L. Merritt, S.D. Peterson, K.I. Block, and T. Gochenour Efficacy and safety of herbal stimulants and sedatives in sleep disorders Sleep Medicine Reviews 4 2000 229 251
11. J. Han, and S.Q. Gao Clinical applications and adverse reactions of Wuling capsule (review) China Pharmacy 18 2007 1184 1186
12. X.R. He, and P. Liu Determination of 14 kinds of amino acids in Wuling capsule by HPLC-FLD Chinese Traditional Patent Medicine 32 2010 1358 1361
13. R.C. Kessler, W.T. Chiu, O. Demler, K.R. Merikangas, and E.E. Walters Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication Archives of General Psychiatry 62 2005 617 627
14. M. Lader Benzodiazepines revisited-will we ever learn? Addiction 106 2011 2086 2109
15. D.Q. Li, X.J. Li, J.F. Duan, and W. Cai Effects of Wuling capsule on hippocampal dependent cognitive changes in post-stroke depression rats International Journal of Pharmacology 7 2011 50 57
16. Y.R. Li, and Y.F. Pan Wuling capsule in treatment of insomnia of aged patients Chinese Journal of New Drugs and Clinical Remedies 25 2006 289 291
17. J.X. Lu, M. Zhu, Y. Chen, P. Zhang, and L. Fang HPLC specific chromatogram of chemical constituents of Wuling capsules Chinese Journal of Pharmaceutical Analysis 31 2011 764 767
18. H.B. Ma, L. Han, and J. Wang Wuling capsule in treatment of 42 cases insomnia due to disharmony between the heart and kidney Chinese Journal of Traditional Medical Science and Technology 10 2003 304
19. Z.Z. Ma, P.P. Zuo, W.R. Chen, L.J. Tang, Y. Shen, X.H. Sun, and Y. Shen Studies on the sedative and sleeping effects of Wuling mycelia and its pharmacological mechanism Chinese Pharmaceutical Journal 34 1999 374 377
20. K. Morgan, E. Kucharczyk, and P. Gregory Insomnia: evidence-based approaches to assessment and management Clinical Medicine 11 2011 278 281
21. No authors listed, 2005. National Institutes of Health State of the Science Conference Statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep 28, 1049-1057.
22. M.M. Ohayon, and M. Caulet Insomnia and psychotropic drug consumption. Progress in Neuro-psychopharmacology & Biological Psychiatry 19 1995 421 431
23. N.J. Pearson, L.L. Johnson, and R.L. Nahin Insomnia, trouble sleeping, and complementary and alternative medicine: analysis of the 2002 national health interview survey data Archives of Internal Medicine 166 2006 1775 1782
24. J. Sarris, and G.J. Byrne A systematic review of insomnia and complementary medicine Sleep Medicine Reviews 15 2011 99 106
25. J. Sarris, A. Panossian, I. Schweitzer, C. Stough, and A. Scholey Herbal medicine for depression, anxiety and insomnia: a review of psychopharmacology and clinical evidence European Neuropsychopharmacology 21 12 2011 841 860
26. D.M. Taibi, C.A. Landis, H. Petry, and M.V. Vitiello A systematic review of valerian as a sleep aid: safe but not effective Sleep Medicine Reviews 11 2007 209 230
27. J.L. Wang, R.J. Guo, and Y.L. Wang Review on pharmacological effects and clinical application of Wuling shen Global Traditional Chinese Medicine 13 2010 150 152
28. X.J. Wang, J. Li, Q.D. Zou, and L. Jin Wuling capsule for climacteric patients with depression and anxiety state: a randomized, positive parallel controlled trial Chinese Journal of Integrative Medicine 7 2009 1042 1046
29. C.H. Yeh, C.K. Arnold, Y.H. Chen, and J.N. Lai Suan zao ren tang as an original treatment for sleep difficulty in climacteric women: a prospective clinical observation Evidence Based Complementary and Alternative Medicine 2011 2011 673813
30. D.H. Yin, J. Zhang, and C.L. Liu Advance in clinical application of Wuling capsule Chinese Journal of New Drugs 20 2011 1530 1533