Ablin JN, Buskila D Emerging therapies for fibromyalgia: an update. Expert Opin Emerg Drugs. 2010 Sep;15(3):521-33. doi: 10.1517/14728214.2010.491509.
Amris K, Waehrens EE, Jespersen A, Bliddal H, Danneskiold-Samsoe B Observation-based assessment of functional ability in patients with chronic widespread pain: a cross-sectional study. Pain. 2011 Nov;152(11):2470-2476. doi: 10.1016/j.pain.2011.05.027. Epub 2011 Jun 28.
Bandak E, Amris K, Bliddal H, Danneskiold-Samsoe B, Henriksen M Muscle fatigue in fibromyalgia is in the brain, not in the muscles: a case-control study of perceived versus objective muscle fatigue. Ann Rheum Dis. 2013 Jun;72(6):963-6. doi: 10.1136/annrheumdis-2012-202340. Epub 2012 Dec 8.
Banerjee S, McCormack S Medical Cannabis for the Treatment of Chronic Pain: A Review of Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jul 24. Available from http://www.ncbi.nlm.nih.gov/books/NBK546424/
Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10. Erratum In: Arthritis Res Ther. 2009;11(5):415.
Bifulco M, Pisanti S Medicinal use of cannabis in Europe: the fact that more countries legalize the medicinal use of cannabis should not become an argument for unfettered and uncontrolled use. EMBO Rep. 2015 Feb;16(2):130-2. doi: 10.15252/embr.201439742. Epub 2015 Jan 9. No abstract available.
Bramness JG, Dom G, Gual A, Mann K, Wurst FM A Survey on the Medical Use of Cannabis in Europe: A Position Paper. Eur Addict Res. 2018;24(4):201-205. doi: 10.1159/000492757. Epub 2018 Aug 22.
Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
Drug Enforcement Administration, Department of Justice Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments. Fed Regist. 2017 Mar 23;82(55):14815-20.
EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Fisher, A G. (2010) Assessment of Motor and Process Skills: Development, Standardization, and Administration Manual. Fort Collins, Colorado: Three Star Press.
Fiz J, Duran M, Capella D, Carbonell J, Farre M Cannabis use in patients with fibromyalgia: effect on symptoms relief and health-related quality of life. PLoS One. 2011 Apr 21;6(4):e18440. doi: 10.1371/journal.pone.0018440.
Hauser W, Wolfe F, Tolle T, Uceyler N, Sommer C The role of antidepressants in the management of fibromyalgia syndrome: a systematic review and meta-analysis. CNS Drugs. 2012 Apr 1;26(4):297-307. doi: 10.2165/11598970-000000000-00000.
Henry JD, Crawford JR The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
Iffland K, Grotenhermen F An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies. Cannabis Cannabinoid Res. 2017 Jun 1;2(1):139-154. doi: 10.1089/can.2016.0034. eCollection 2017.
Jones GT, Atzeni F, Beasley M, Fluss E, Sarzi-Puttini P, Macfarlane GJ The prevalence of fibromyalgia in the general population: a comparison of the American College of Rheumatology 1990, 2010, and modified 2010 classification criteria. Arthritis Rheumatol. 2015 Feb;67(2):568-75. doi: 10.1002/art.38905.
Lynch ME, Campbell F Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x.
Millar SA, Stone NL, Yates AS, O'Sullivan SE A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans. Front Pharmacol. 2018 Nov 26;9:1365. doi: 10.3389/fphar.2018.01365. eCollection 2018.
Moore AR, Straube S, Paine J, Phillips CJ, Derry S, McQuay HJ Fibromyalgia: Moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain. Pain. 2010 May;149(2):360-364. doi: 10.1016/j.pain.2010.02.039. Epub 2010 Mar 26.
Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ Amitriptyline for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2012 Dec 12;12:CD008242. doi: 10.1002/14651858.CD008242.pub2.
Pertwee RG The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin. Br J Pharmacol. 2008 Jan;153(2):199-215. doi: 10.1038/sj.bjp.0707442. Epub 2007 Sep 10.
Pro medicin Information til sundhedsfaglige (2018) Sativex. https://pro.medicin.dk/Medicin/Praeparater/6456.
Rasmussen MU, Rydahl-Hansen S, Amris K, Samsoe BD, Mortensen EL The adaptation of a Danish version of the Pain Self-Efficacy Questionnaire: reliability and construct validity in a population of patients with fibromyalgia in Denmark. Scand J Caring Sci. 2016 Mar;30(1):202-10. doi: 10.1111/scs.12232. Epub 2015 Apr 29.
Sjogren P, Ekholm O, Peuckmann V, Gronbaek M Epidemiology of chronic pain in Denmark: an update. Eur J Pain. 2009 Mar;13(3):287-92. doi: 10.1016/j.ejpain.2008.04.007. Epub 2008 Jun 10.
Smith HS, Bracken D, Smith JM Pharmacotherapy for fibromyalgia. Front Pharmacol. 2011 Mar 31;2:17. doi: 10.3389/fphar.2011.00017. eCollection 2011.
Smith HS, Harris R, Clauw D Fibromyalgia: an afferent processing disorder leading to a complex pain generalized syndrome. Pain Physician. 2011 Mar-Apr;14(2):E217-45.
Ste-Marie PA, Fitzcharles MA, Gamsa A, Ware MA, Shir Y Association of herbal cannabis use with negative psychosocial parameters in patients with fibromyalgia. Arthritis Care Res (Hoboken). 2012 Aug;64(8):1202-8. doi: 10.1002/acr.21732.
Temple LM Medical marijuana and pain management. Dis Mon. 2016 Sep;62(9):346-52. doi: 10.1016/j.disamonth.2016.05.014. Epub 2016 Jun 27. No abstract available.
Uceyler N, Sommer C, Walitt B, Hauser W Anticonvulsants for fibromyalgia. Cochrane Database Syst Rev. 2013 Oct 16;(10):CD010782. doi: 10.1002/14651858.CD010782.
Waehrens EE, Bliddal H, Danneskiold-Samsoe B, Lund H, Fisher AG Differences between questionnaire- and interview-based measures of activities of daily living (ADL) ability and their association with observed ADL ability in women with rheumatoid arthritis, knee osteoarthritis, and fibromyalgia. Scand J Rheumatol. 2012 Mar;41(2):95-102. doi: 10.3109/03009742.2011.632380. Epub 2012 Jan 30.
Walitt B, Nahin RL, Katz RS, Bergman MJ, Wolfe F The Prevalence and Characteristics of Fibromyalgia in the 2012 National Health Interview Survey. PLoS One. 2015 Sep 17;10(9):e0138024. doi: 10.1371/journal.pone.0138024. eCollection 2015.
Wise J FDA approves its first cannabis based medicine. BMJ. 2018 Jun 27;361:k2827. doi: 10.1136/bmj.k2827. No abstract available.
Wolfe F, Brahler E, Hinz A, Hauser W Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care Res (Hoboken). 2013 May;65(5):777-85. doi: 10.1002/acr.21931.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.