| Disease | RANDOMIZED, PLACEBO CONTROLLED CLINICAL EVALUATION OF A COMBINATION OF GANODERMA LUCIDUM AND SAN MIAO SAN (SMS), A MIX OF MEDICIINAL HERBS (RHIZOMA ATRACTYLODIS, CORTEX PHELLODENDRI, AND RADIX ACHYRANTHES BIDENTATAE) WITH PURPORTED HEALTH BENEFITS INCLUDING TREATMENT OF RHEUMATOID ARTHRITIS (RA). 32 PATIENTS WITH ACTIVE RA WERE ASSIGNED TO INTERVENTION GROUP, AND 33 TO PLACEBO, IN ADDITION TO ANY CURRENTLY-PRESCRIBED MEDICATIONS, FOR 24 WEEKS. THE TREATMENT GROUP RECEIVED GANODERMA LUCIDUM (4 GM) AND SMS (2.4 GM) DAILY. THE PRIMARY OUTCOME WAS THE NUMBER OF PATIENTS ACHIEVING AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) 20% RESPONSE AND SECONDARY OUTCOMES INCLUDED CHANGES IN THE ACR COMPONENTS, PLASMA LEVELS, AND EX VIVO–INDUCED CYTOKINES AND CHEMOKINES AND OXIDATIVE STRESS MARKERS. ALL PATIENTS WERE EVALUATED AT BASELINE AND AT 4, 8, 16, AND 24 WEEKS. THE FOLLOWING CLINICAL AND LABORATORY VARIABLES WERE ASSESSED AT EACH VISIT: NUMBER OF TENDER JOINTS AND SWOLLEN JOINTS, PATIENT’S GLOBAL ASSESSMENT (USING A 0–10-CM VISUAL ANALOG SCALE [VAS]), PHYSICIAN’S GLOBAL ASSESSMENT (USING A 0–10-CM VAS), DURATION OF MORNING STIFFNESS, PLASMA C-REACTIVE PROTEIN (CRP) LEVEL, CONCENTRATION, AND ERYTHROCYTE SEDIMENTATION RATE (ESR). DESPITE CLAIMS THAT THE EXTRACTS ARE OF BENEFIT TO MANY CONDITIONS INCLUDING VARIOUS TYPES OF ARTHRITIS, OUR STUDY IS THE FIRST CLINICAL TRIAL TO EXAMINE THE EFFECTS OF A COMBINATION OF G LUCIDUM AND SMS IN PATIENTS WITH RA. OUR FINDINGS INDICATE THAT THESE COMPOUNDS MAY HAVE ANALGESIC EFFECTS BUT DO NOT APPEAR TO HAVE ANY ANTIOXIDANT OR ANTIINFLAMMATORY PROPERTIES. |