Primary studies included in this systematic review

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Primary study

Unclassified

Journal Clinical Pharmacology & Therapeutics
Year 1999
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Cyclobenzapine (CYC) is aproved treatment of acute musculoskeletal spasm. This randomized, double-blindparalle group trial compared the efficacy and safety of the prescription doce of CYC (10 mg t.i.d) to a lower doce (5 mg t.i.d) and placebo (PBO) in 737 adults with acute back or neck pain and palpable paraspinal spasm. Compared to PBO, CYC 5 and 10 mg t.i.d for 7 days were significantly better (p<0.001) in all 3 primary patient-reported categorical scales (medication Helpful-ness, ReRelief from Starting Backache, Global Impression of Change) and a physician rating of muscle spam at primary time points (48-72 hours and 1 week).Dailypain relief ratings showed of dosing.median times to "A Lot¨or¨complete¨Relief were >2 days longer with PBO than CYC 10. The most com-mon adverse experiences were sedation and dry mouth; both were dose-related (incidence of sedation/dry mouth was 38%32& on CYC 10,32%/21& on CYC 5, and 11%/7&on PBO).Sedation was generally mild;5.2& discontinued CYC 10 with sedation versus 2.5% on CYC 5 and 0.8& on PBO CONCLUSIONS: CYC 5 mg and 10 mg t.i.d provided the back or neck. meaningful relief from painful muscle spasm of the back or neck. CYC 5 appeared to be less sedating than CYC 10

Primary study

Unclassified

Journal Osteopathic Annals
Year 1980
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Primary study

Unclassified

Authors Aiken, DW.
Book Clinical Evaluation of Flexeril (Cyclobenzaprine HCL/MSD). Minneapolis, Minn:Postgraduate Medicine Communications
Year 1978
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Primary study

Unclassified

Authors Basmajian JV
Journal Archives of physical medicine and rehabilitation
Year 1978
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A new drug, Cyclobenzaprine hydrochloride (Flexeril), was compared with diazepam (Valium) and placebo in double-blind trials for efficacy in treating spasms and pain in the neck and low back. Complex recording methods involving clinical evaluations (graded), patient self-ratings, goniometry, motion analysis by computer, electromyography of controlled motions and detailed statistical analysis were used. Clinical improvement over two weeks was statistically significant in all treatment groups with a statistically significant preference for Cyclobenzaprine hydrochloride. The most striking improvements recorded were in the electromyographic findings, which showed statistically significant changes for the Cyclobenzaprine group. Clinical muscle spasms are not accompanied by increased myoelectric activity; the reverse is true. With improvement, myoelectric activity in back muscles is augmented during prescribed stressful movements as measured by electromyography and computer analysis combined with complex electrogoniometry.

Primary study

Unclassified

Authors Aiken, DW.
Book In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCL/MSD). Minneapolis, Minn:Postgraduate Medicine Communications.
Year 1978
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Primary study

Unclassified

Authors Scheiner, JJ.
Book In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCL/MSD). Minneapolis, Minn: Post-graduate Medicine Communications
Year 1978
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Cyclobenzapine (CYC) is aproved treatment of acute musculoskeletal spasm. This randomized, double-blindparalle group trial compared the efficacy and safety of the prescription doce of CYC (10 mg t.i.d) to a lower doce (5 mg t.i.d) and placebo (PBO) in 737 adults with acute back or neck pain and palpable paraspinal spasm. Compared to PBO, CYC 5 and 10 mg t.i.d for 7 days were significantly better (p<0.001) in all 3 primary patient-reported categorical scales (medication Helpful-ness, ReRelief from Starting Backache, Global Impression of Change) and a physician rating of muscle spam at primary time points (48-72 hours and 1 week).Dailypain relief ratings showed of dosing.median times to "A Lot¨or¨complete¨Relief were >2 days longer with PBO than CYC 10. The most com-mon adverse experiences were sedation and dry mouth; both were dose-related (incidence of sedation/dry mouth was 38%32& on CYC 10,32%/21& on CYC 5, and 11%/7&on PBO).Sedation was generally mild;5.2& discontinued CYC 10 with sedation versus 2.5% on CYC 5 and 0.8& on PBO CONCLUSIONS: CYC 5 mg and 10 mg t.i.d provided the back or neck. meaningful relief from painful muscle spasm of the back or neck. CYC 5 appeared to be less sedating than CYC 10

Primary study

Unclassified

Authors Bianchi, M.
Book In: Clinical Evaluation of Flexeril (Cyclobenzaprine HCL/MSD). Minneapolis, Minn:Postgraduate Medicine Communications
Year 1978
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Primary study

Unclassified

Authors Brown BR , Womble J
Journal JAMA : the journal of the American Medical Association
Year 1978
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The effectiveness of cyclobenzaprine hydrochloride, a new tricyclic skeletal muscle relaxant, was shown in patients with long-term intractable pain of cervical and lumbar origin aggravated by skeletal muscle spasm and tenderness. The investigation was double-blind and randomized, comparing cyclobenzaprine hydrochloride (10 mg three times a day) with diazepam (5 mg three times a day) and with placebo. After two weeks of treatment, the 16 patients in the cyclobenzaprine group showed an overall improvement in pain variables as did the 16 patients in the diazepam group. No serious adverse reactions to cyclobenzaprine were observed in the study. However, dry mouth due to cyclobenzaprine's anticholinergic action and mild degrees of drowsiness were encountered more often than with diazepam or placebo.

Primary study

Unclassified

Authors Bercel, NA
Journal Current Therapeutic Research
Year 1977
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cyclobenzaprine was compared with placebo in a population with greater than a 30-day symptom duration over 14 days, again showingsuperiority of the treatment arm.