| Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY OF 5 PARALLEL GROUPS OF OVERWEIGHT PATIENTS FROM GENERAL PRACTICES. 166 PATIENTS WITH BODY MASS INDEX(BMI) < 25 KG/M2 WERE INCLUDED CONSECUTIVELY BY 25 GENERAL PRACTITIONERS IN DENMARK AND
RANDOMIZED INTO 5 GROUPS:(1) HYPERTENSIVE PATIENTS TREATED WITH BETA-BLOCKERS AND E+C; (2) HYPERTENSIVE PATIENTS TREATED WITH ANTIHYPERTENSIVE AGENTS OTHER THAN BETA-BLOCKERS, AND E+C; (3) NORMOTENSIVE PATIENTS TREATED WITH E+C; (4) HYPERTENSIVE
PATIENTS UNDER ANY ANTIHYPERTENSIVE TREATMENT + PLACEBO; AND (5) NORMOTENSIVE PATIENTS + PLACEBO. ALL PATIENTS WERE INSTRUCTED IN A 1200 KCAL (=5040 KJ) DIET. OF A TOTAL OF 138 PATIENTS AGED 20-74, 112 COMPLETED THE STUDY PROTOCOL, FLUCTUATIONS
IN SYSTOLIC + DIASTOLIC BLOOD PRESSURE WERE SEEN IN ALL GROUPS. THE SYSTOLIC BLOOD PRESSURE WAS REDUCED SIGNIFICANTLY (5.5 MM HG) IN THE PATIENTS TREATED WITH ANTIHYPERTENSIVE AGENTS OTHER THAN BETA BLOCKERS, PLUS E+C. IN THE OTHER HYPERTENSIVE
GROUPS THE REDUCTION IN BLOOD PRESSURE WAS NOT SIGNIFICANT. IN NORMOTENSIVE PATIENTS TREATED WITH E+C, THE SYSTOLIC AND DIASTOLIC BLOOD PRESSURE DECLINED SIGNIFICANTLY (4.4/3.9 MM HG). AT THE END OF THE TREATMENT PERIOD HEART RATE HAD INCREASED
SIGNIFICANTLY (4.9 BEATS/MIN) IN THE GROUP OF NORMOTENSIVE PATIENTS TREATED WITH E+C. BLOOD PRESSURE AND HEART RATE MEASURED BY THE PATIENT AT HOME SHOWED SIMILAR FLUCTUATIONS FROM BASELINE PRIOR TO AND DURING TREATMENT WITH E+C OR PLACEBO.
A MEAN LOSS OF WEIGHT OF APPROXIMATELY 4 KG IN 6 WEEKS WAS SIGNIFICANT FOR ALL THE GROUPS. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS DURING THIS SHORT PERIOD OF TREATMENT. IN 56% OF THE PATIENTS TREATED WITH E+C COMPLAINTS/SIDE-
EFFECTS RELATED TO MEDICAL TREATMENT WERE FOUND AT QUESTIONING. CORRESPONDING COMPLAINTS OCCURRED IN 21% OF THE PLACEBO TREATED PATIENTS. IN THE E+C TREATED GROUP 7% DROPPED OUT DUE TO SIDE-EFFECTS. IN THE PLACEBO GROUP THERE WERE NO DROPOUTS.
CONCLUSIONS: THE STUDY DOES NOT SUPPORT THE ASSUMPTION THAT E+C SHOULD CAUSE A RISE IN BLOOD PRESSURE, ACUTELY OR DURING SHORT TERM TREATMENT IN EITHER NORMOTENSIVE OR HYPERTENSIVE OBESE PATIENTS. THE ANTIHYPERTENSIVE EFFECT OF THE BETA BLOCKERS
WAS NOT REVERSED BY E+C.
A COMMERCIAL PRODUCT, LETIGEN, WAS USED. |