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Documentation of an instrument for assessment of subjective CNS-related symptoms during cardiovascular pharmacotherapy

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Summary

The aim of this work was to develop and initiate the documentation of an instrument for the assessment of subjective CNS-related symptoms occurring during cardiovascular pharmacotherapy. The selfapplied questionnaire developed for minor symptom evaluation (MSE profile) includes 24 items and uses a visual analogue scale to record symptoms.

Three different studies were performed using a total of 86 healthy volunteers. Based on a subjective grouping followed by principal component analysis to confirm the grouping, three dimensions-contentment (eight items), vitality (five items), and sleep (three items)—were formed. The Cronbach's alpha coefficient, used to evaluate the internal consistency of these dimensions, was found to be 0.90, 0.88, and 0.85 respectively.

To validate the MSE profile, the subjective symptoms of two classes of drugs with well-known symptom profiles, a nonselective, beta-blocker (propranolol) and a benzodiazepine (oxazepam), were compared in placebocontrolled randomized double-blind crossover studies. The obtained results indicate that the symptom profiles were different but were compatible with the previously reported effects of these compounds. It can be concluded that the MSE profile is practical, useful, and sensitive enough to also detect subtle drug-induced effects.

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References

  1. Andersson O, Berglund G, Hansson L, et al. Organization and efficacy of an out-patient hypertension clinic.Acta Med Scand 1978; 203:391–398.

    PubMed  Google Scholar 

  2. Weinstein C, Stason WB:Hypertension: A Policy of Perspective. Cambridge, MA: Harvard Univ. Press, 1976:60.

    Google Scholar 

  3. Soghikian F, Fallick Hunkler E, et al. Effect of high blood-pressure treatment and awareness on emotional well-being.Clin Invest Med 1981; 4:1191–1196.

    Google Scholar 

  4. Kottke TE, Tuomilehto J, Puska P, et al. The relationship of symptoms and blood pressure in a population sample.Int J Epidemiol 1979; 8:355–359.

    PubMed  Google Scholar 

  5. Veterans Administration Cooperative Study Group on Antihypertensive Agents. Effects of treatment on morbidity in hypertension. Results in patients with diastolic blood pressure averaging 115 through 129 mmHg.JAMA 1967; 213:1143–1152.

    Google Scholar 

  6. Veterans Administration Cooperative Study Group on Antihypertensive Agents. Results in patients with diastolic blood pressure averaging 90 through 114 mmHg.JAMA 1970; 213:1143–1152.

    Google Scholar 

  7. Wilhelmsen L, Berglund G, Elmfeldt D, et al. Beta-blockers versus diuretics in hypertensive men: Main result from the HAPPHY trial.J Hypertens 1987; 5:561–572.

    PubMed  Google Scholar 

  8. Curb JD, Borhani NO, Blaszkowski TP, et al. Long-term surveillance for adverse effects of antihypertensive drugs.JAMA 1985; 253 (22):3263–3268.

    PubMed  Google Scholar 

  9. Croog SH, Levine S, Testa MA, et al. The effects of antihypertensive therapy on the quality of life.N Engl J Med 1986; 314:1657–1664.

    PubMed  Google Scholar 

  10. Vandenburg MJ, Evans SJW, Kelly BJ, et al. Factors affecting the reporting of symptoms by hypertensive patients.Br J Clin Pharmacol 1984; 10:189–195.

    Google Scholar 

  11. Lewis RV, Jackson PR, Ramsay LE. Quantification of side-effects of β-adrenoceptor blockers using visual analogue scales.Br J Clin Pharmacol 1984; 18:325–330.

    PubMed  Google Scholar 

  12. Lewis RV, Jackson PR, Ramsay LE. Side-effects of β-adrenoceptor blocking drugs assessed by visual analogue scales.Br J Clin Pharmacol 1985; 19:255–257.

    PubMed  Google Scholar 

  13. Wikstrand J, Westergren G, Berglund G, et al. Antihypertensive treatment with metoprolol or hydrochlorothiazide in patients aged 60 to 75 years.JAMA 1986; 255: (10):1304–1310.

    PubMed  Google Scholar 

  14. Muiesan G, Agabiti-Rosei E, Carotti RA. Antihypertensive activity of once daily metoprolol alone and with chlorothalidone and comparison with twice daily regimen.Eur J Clin Pharmacol 1982; 23:209–213.

    PubMed  Google Scholar 

  15. Bulpitt CJ, Dollery CT, Carne S. A symptom questionnaire for hypertensive patients.J Chron Dis 1974; 27:309–323.

    PubMed  Google Scholar 

  16. Jachuck SJ, Brieley H, Jachuck S, et al. The effect of hypotensive drugs on the quality of life.J Roy Coll Gen Pract 1982; 32:103–105.

    Google Scholar 

  17. Hunt MS, McKenna SP, McEven J, et al. A quantitative approach to perceived health status: A validation study.J Epidemiol Community Health 1980; 34:281–286.

    PubMed  Google Scholar 

  18. Bergner M, Bobbit RA, Carter WB, et al. The sickness impact profile: Development and final revision of a health status measure.Med Care 1981; 19:787–805.

    PubMed  Google Scholar 

  19. Goldburg DP, Millier VF. A scaled version of the general health questionnaire.Psychol Med 1979; 9:139–145.

    PubMed  Google Scholar 

  20. Derogatis LR, Lipman RS, Rickels K, et al. The Hopkins symptom checklist (HSCL). A self-report symptom inventory.Behav Sci 1974; 19:1–15.

    PubMed  Google Scholar 

  21. Hamilton M. The assessment of anxiety states by rating.Br J Med Psychol 1959; 32:50–55.

    PubMed  Google Scholar 

  22. Adler L. New York V.A.M.C. Study Group. CNS effects of beta-blockade: A comparative study.Psychopharmacol Bull 1988; 24:232–237.

    PubMed  Google Scholar 

  23. Aitken RCB. Measurement of feelings using visual analogue scales.Proc Roy Soc Med 1969; 62:989–993.

    PubMed  Google Scholar 

  24. Koran LM. The reliability of clinical methods, data and judgement.N Engl J Med 1975; f 293:642–645; 695–701.

    PubMed  Google Scholar 

  25. Kellner R, Sheffield BF. A self-rating scale of distress.Psychol Med 1973; 3:88–100.

    PubMed  Google Scholar 

  26. Currie D, Lewis RV, McDevitt DG, et al. Central effects of β-adrenoceptor antagonists I—performance and subjective assessments of mood.Br J Clin Pharmacol 1988; 26:121–128.

    PubMed  Google Scholar 

  27. Nicholson AN, Wright NA, Zetlein MB, et al. Central effects of β-adrenoceptor antagonists. II—Electroencephalogram and body sway.Br J Clin Pharmacol 1988; 26:129–141.

    PubMed  Google Scholar 

  28. Fodor JG, Chockalingam A, Drover A, et al. A comparison of the side effects of atenolol and propranolol in the treatment of patients with hypertension.J Clin Pharmacol 1987; 27:892–901.

    PubMed  Google Scholar 

  29. Bond AJ, Lader MH. Comparative effects of diazepam and buspirone on subjective feelings, psychological tests and the EEG.Int Pharmacopsychiat 1981; 16:212–220.

    Google Scholar 

  30. Bond AJ, Lader MH. Correlations among measures of response to benzodiazepines in man.Pharmacol Biochem Behav 1983; 18:295–298.

    Google Scholar 

  31. Guyatt B, Bombardier C, Tugwell PX. Measuring disease — specific quality of life in clinical trials.Can Med Assoc J 1986; 134:889–895.

    Google Scholar 

  32. Cronbach LJ. Coefficient alpha and the internal structure tests.Psychometrika 1951; 16:297–334.

    Google Scholar 

  33. Fleiss JL.The Design and Analysis of Clinical Experiments. New York: John Wiley & Sons.

  34. New Mathematical Statistical Package User Manual. Lund, Sweden. 1985.

  35. Goldman L, Hashimoto B, Cook EF, et al. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: Advantages of a new specific activity scale.Circulation 1981; 64:1227–1234.

    PubMed  Google Scholar 

  36. Scott JP, Huskisson EC. Measurement of functional capacity with visual analogue scales.Rheumatol Rehabil 1977; 16:257–259.

    PubMed  Google Scholar 

  37. Price DD, McGrath PA, Rafii A, et al. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain.Pain 1983; 17:45–56.

    PubMed  Google Scholar 

  38. Bond A, Lader M. The use of analogue scales in rating subjective feelings.Br J Med Psychol 1974; 47:211–218.

    Google Scholar 

  39. Sjöberg L, Svensson E, Persson L-O. The measurement of mood.Scand J Psychol 1979; 20:1–18.

    PubMed  Google Scholar 

  40. Rosén RC, Kostis JB. Biobehavioral sequelle associated with adrenergic-inhibiting antihypertensive agents: A critical review.Health Psychol 1985; 4:579–604.

    PubMed  Google Scholar 

  41. Salem SA, McDevitt DG. Central effects of beta-adrenoceptor antagonists.Clin Pharmacol Ther 1983; 33:52–57.

    PubMed  Google Scholar 

  42. Gengo FM, Huntoon L, McHugh WB. Lipid-soluble and water-soluble β-blockers: Comparison of the central nervous system depressant effect.Arch Intern Med 1987; 147:39–43.

    PubMed  Google Scholar 

  43. Gengo FM, Fagan SC, de Padova A, et al. The effect of β-blockers on mental performance in older hypertensive patients.Arch Intern Med 1988; 148:779–784.

    PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Clinical Pharmacology, Sahlgrenska Hospital, S. 413 45, Gothenburg, Sweden

    C. Dahlöf

  2. Research Laboratories, AB Hässle, Mölndal, Sweden

    E. Dimenäs & B. Olofsson

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  1. C. Dahlöf
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  2. E. Dimenäs
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  3. B. Olofsson
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Dahlöf, C., Dimenäs, E. & Olofsson, B. Documentation of an instrument for assessment of subjective CNS-related symptoms during cardiovascular pharmacotherapy. Cardiovasc Drug Ther 3, 919–927 (1989). https://doi.org/10.1007/BF01869582

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