Abstract
Bromazepam was compared with placebo and with chlorprothixene in a randomized, double-blind group-comparative multicenter trial in general practice. Two hundred and forty-five patients with generalized anxiety disorder (DSM-III 1980) were treated for 2 weeks with two daily doses of bromazepam, 3 mg or chlorprothixene, 15 mg or placebo. Median reductions in Hamilton Anxiety rating were 12 (bromazepam), 10.3 (chlorprothixene) and 7.3 (placebo). The study revealed significant superiority of bromazepam over placebo (median differences 3.3, 95% confidence limits: 0.3 and 6.1) but not over chlorprothixene (median difference 1.4, 95% confidence limits −0.8 and +3.5). Significantly higher rates of tiredness, sedation and hypersomnia were found on bromazepam and chlorprothixene compared to placebo. Tolerance was rated as “at least good” in 85.6% on bromazepam, in 86% on chlorprothixene and in 87.8% on placebo. Neither previous psychopharmacological treatment nor presence of psychosocial stress were of perceptible influence. Bromazepam and chlorprothixene are both superior to placebo in generalized anxiety states treated in general practice, but spontaneous improvements/placebo effects are substantial.
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References
American Psychiatric Association (1980) Diagnostic and Statistical Manual of Mental Disorders. 3rd ed. Washington DC, American Psychiatric Association
Bech P, Kastrup M, Rafaelsen OJ (1986) Mini-compendium of rating scales for states of anxiety, depression, mania, schizophrenia with corresponding DSM-III syndromes. Acta Psychiatr Scand [Suppl 326] 73:19–22
Bjertnaes A, Block JM, Hafstad PE, Holte M, Ottemo I, Larsen T, Pinder RM, Steffensen K, Stulemeijer SM (1982) A multicentre placebo-controlled trial comparing the efficacy of mianserin and chlordiazepoxide in general practice patients with primary anxiety. Acta Psychiatr Scand 66:199–207
Catalan J, Gath DH (1985) Benzodiazepines in general practice: time for decision. Br Med J 290:1374–1376
Condren L, Devins J, Dillon J, Golden N, Henry PJ, Heraughty D, Jack H, Spellman R (1983) A double-blind randomized control trial of diazepam. J R Coll Gen Pract 33:635–636
Fynboe C, Christensen N, Halberg T, Hansen EA, Holm P, Knudsen JP, Lindhardt J, Maul B, Musaeus C, Nielsen MT, Schaumburg E (1981) Bromazepam (Lexotan) and Chlorprothixene (Taractan) in acute psychoneurotic anxiety states. A randomized, double-blind investigation from general practice concerning the effect, amount of medicine required, and risk of repeated treatment. Curr Ther Res 30:1014–1023
Goldberg D, Huxley P (1980) Mental illness in the community: The pathway to psychiatric care. Tavistock, London
Greenblatt DJ, Shader RJ (1974) Benzodiazepines in clinical practice. Raven Press, New York
Hamilton M (1959) The assessment of anxiety states by rating. Br J Med Psychol 32:50–55
Jellinek EM (1946) Clinical tests on comparative effectiveness of analgesic drugs. Biometrics 2:1587–1591
Lader MH, Bond AJ, James DC (1974) Clinical comparison of anxiolytic drug therapy. Psychol Med 4:381–387
Lingjærde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987) The UKU side effect rating scale. Acta Psychiatr Scand 76: Supp 334
Lofft JG, Demars JP (1974) A chemotherapeutic alternative to the antianxiety agents for the extended treatment of psychoneuroses. Dis Nerv Syst 35:409–415
McDonald CJ, Mazzuca SA (1983) How much of the placebo “effect” is really statistical regression? Stat Med 2:417–427
Montandon A, Skreta M, Riggenbach H, Ward J (1986) Comparison of controlled-release diazepam capsules and placebo in patients in general practice. Curr Med Res Opin 10:10
Skegg DCD, Doll R, Perry J (1977) Use of medicines in general practice. Br Med J 1:1561–1563
Solomon K, Hart R (1978) Pitfalls and prospects in clinical research on antianxiety drugs: benzodiazepines and placebo — a research review. J Clin Psychiatry 39:823–831
Tyrer P (1987) Benefits and risks of benzodiazepines. In: Freeman M, Rue Y (eds) International congress and symposium series No 114. The benzodiazepines in current practice. Royal Society of Medicine Services, London New York, pp 3–12
Wheatley D (1982) Buspirone: multicenter efficacy study. J Clin Psychiatry 43(12):92–94
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The following general practitioners are gratefully acknowledged for their excellent co-operation: K. Andreasen (Grenaa), T. Andreasen (Helsingoer), C. Bjerre-Christensen (Viby J), J. Brix (Aabenraa), N.B. Caning (Stokkemarke), N. Christensen (Odense), P. Dehn-Jensen (Lyngby), J. Eggert (Langebaek), H. Fuglsang-Damgaard (Havndal), I. Fraemohs (Allingaabro), J. Gylling (Nykoebing Sjaelland), E. Halkjaer-Soerensen (Roedding), B. Hansson (Frederiksvaerk), C. Hauge (Espergaerde), S. Hede (Aalborg), G. Jensen (Copenhagen S), T. Knudsen (Arden), P. Kofod (Vejle), K. Kraen (Varde), V. Lade (Hjoerring), S. Mehlsen (Auning), J. Meyer-Christensen (Hobro), R. Michael (Langebaek), J. Munch (Oersted), L. Moeller-Hansen (Alleroed), U. Moeller (Graasten), K. Nielsen (Malling), S. Kjaerem Nielsen (Copenhagen), P.V. Nielsen (Odense), J. Peulicke (Espergaerde), O. Ravn (Roedding), C.U. Rosenberg (Aarhus), J. Rude (Goerlev), S. Spangsberg (Holbaek), H. Soegaard (Oelgod), O. Tang (Hoersholm)
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Kragh-Sørensen, P., Holm, P., Fynboe, C. et al. Bromazepam in generalized anxiety. Psychopharmacology 100, 383–386 (1990). https://doi.org/10.1007/BF02244611
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DOI: https://doi.org/10.1007/BF02244611