| Disease | RANDOMISED, PLACEBO-CONTROLLED AND DOUBLE-BLIND STUDY WAS PLANNED TO INVESTIGATE THE EFFECTS OF HARPAGOPHYTUM PROCUMBENS (DEVIL'S CLAW) ON SENSORY, MOTOR AND VASCULAR MECHANISMS OF MUSCLE PAIN. THE STUDY WAS PERFORMED IN PATIENTS WITH MILD TO
MODERATELY SEVERE MUSCLE TENSION OR MILD MUSCLE PAIN IN THE BACK, THE SHOULDER OR THE BACK OF THE NECK. THE ACTIVE TREATMENT GROUP-DOUBLE-BLIND AND RANDOMISED-RECEIVED ONE FILM COATED TABLET TWICE DAILY, I.E., TWO DOSES OF 480 MG/DAY
HARPAGOPHYTUM EXTRACT LI174 (RIVOLTAN) AT 8.00 AND 20.00 HOURS. THE DURATION OF TREATMENT WAS FOUR WEEKS. DATA WERE RECORDED AT 14 DAY INTERVALS BY MEANS OF A VISUAL ANALOGUE SCALE, A PRESSURE ALGESIMETRIC TEST. TESTING OF ANTINOCICEPTIVE
MUSCLE REFLEXES, THE MUSCLE RESISTANCE OR STIFFNESS TEST, EMG SURFACE ACTIVITY, THE MUSCLE ISCHAEMIA TEST, THE CLINICAL GLOBAL SCORE AND THE SUBJECTIVE IMPRESSIONS OF PATIENTS AND DOCTORS. IN ALL, THERE WERE 31 PATIENTS IN THE ACTIVE
TREATMENT GROUP AND 32 PATIENTS IN THE PLACEBO GROUP. AFTER FOUR WEEKS' TREATMENT THERE WAS EVIDENCE OF DEFINITE CLINICAL EFFICACY OF THE ACTIVE DRUG IN THE CLINICAL GLOBAL SCORE AND IN THE JUDGEMENTS OF PATIENTS AND DOCTORS. HIGHLY SIGNIFICANT
EFFECTS WERE APPARENT IN THE VISUAL ANALOGUE SCALE, IN THE PRESSURE ALGESIMETER TEST, IN MUSCLE STIFFNESS OR RESISTANCE TESTING AND IN THE MUSCLE ISCHAEMIA TEST. NO DIFFERENCE FROM PLACEBO WAS FOUND IN THE RECORDING OF ANTINOCICEPTIVE MUSCLE
REFLEXES OR IN EMG SURFACE ACTIVITY. THE PRODUCT WAS WELL TOLERATED, AND THERE WERE NO-SERIOUS ADVERSE DRUG REACTIONS. HIGHLY SIGNIFICANT CLINICAL EFFICACY WAS ACHIEVED BY MONOTHERAPY WITH HARPAGOPHYTUM DRY EXTRACT LI174 AFTER FOUR WEEKS'
TREATMENT IN DOSES OF 480 MG TWICE DAILY FOR THE TREATMENT OF MILD TO MODERATELY SEVERE MUSCLE PAINS. AS REGARDS STUDIES OF THE MECHANISMS OF ACTION, IT MAY BE CONCLUDED THAT TREATMENT WITH HARPAGOPHYTUM EXTRACT LI174 CAN PRODUCT SIGNIFICANT
EFFECTS ON SENSORY AND VASCULAR MUSCLE REACTIVITY TOGETHER WITH REDUCTION IN MUSCLE STIFFNESS OR RESISTANCE. THERE WAS NO EVIDENCE OF ANY CENTRAL NERVOUS EFFECTS. |