PMID- 27433837
OWN - NLM
STAT- MEDLINE
DCOM- 20180914
LR  - 20181025
IS  - 1078-6791 (Print)
IS  - 1078-6791 (Linking)
VI  - 22 Suppl 2
DP  - 2016 Jun
TI  - Effects of a Combined Therapy With D-002 (Beeswax Alcohols) Plus D-003 (Sugarcane 
      Wax Acids) on Osteoarthritis Symptoms.
PG  - 15-23
AB  - Context * Nonsteroidal, anti-inflammatory drugs effectively relieve 
      osteoarthritis (OA) symptoms but also induce adverse effects (AEs) that limit 
      their long-term use, which drives a search for safer treatments. D-002, a mixture 
      of beeswax alcohols, and D-003, a mixture of sugarcane wax acids, have been 
      effective in experimental and clinical studies for patients with OA. Objective * 
      The study intended to investigate the effects on OA symptoms of a combined 
      therapy using D-002 and D-003 (D-002/D-003), which were administered for 6 wk. 
      Design * The study was a randomized, double-blind, placebo-controlled trial. 
      Setting * The study was conducted at the Surgical Medical Research Center in 
      Havana, Cuba. Participants * Participants were patients with mild-to-moderate OA. 
      Intervention * Participants were randomly assigned to 1 of 4 groups-(1) a control 
      group, which received a placebo; (2) the D-002 group (intervention group), which 
      received 50 mg/d of D-002; (3) the D-003 group (intervention group), which 
      received 10 mg/d of D-003; or (4) the D-002/D-003 group (intervention group), 
      which received a combined therapy of 50 mg/d of D-002 plus 10 mg/d of D-003. The 
      control group received tablets that were indistinguishable in appearance from the 
      D-002 and D-003 tablets and had a similar composition, except that the active 
      ingredients were replaced by lactose. The groups took the medications once per 
      day for 6 wk. Outcome Measures * Symptoms were assessed using the Western Ontario 
      and McMaster Individual Osteoarthritis Index (WOMAC) and a visual analogue scale 
      (VAS). The primary outcome was the reduction in the total WOMAC score. The 
      subscale scores on the WOMAC for pain, stiffness, and physical function, the VAS 
      scores, and the use of rescue medications were secondary outcomes. Results * Of 
      the 120 enrolled participants, 116 completed the study. The treatments with 
      D-002, D-003, and D-002/D-003 reduced the mean total WOMAC scores significantly 
      from baseline to postintervention, by 75.1%, 72.8%, and 91.2%, respectively. 
      Compared with the placebo, the treatments decreased the mean WOMAC scores for 
      pain, joint stiffness, and physical function significantly. The VAS scores 
      significantly decreased, showing a 71.4%, a 66.9%, and an 84.7% reduction for the 
      D-002, D-003, and D-002/D-003 groups, respectively. All the reductions were 
      significant from the first week and were enhanced during the trial. The 
      D-002/D-003 treatment was more effective in improving all of the scores than 
      either monotherapy. With respect to rescue medications, 3/30, 2/30, and 2/30 used 
      the medications in the D-002, D-003, and D-002/D-003 groups, respectively, vs 
      17/30 in the control group. The treatments were well tolerated. Conclusions * 
      Administered for 6 wk, 50 mg/d of D-002 and 10 mg/d of D-003 ameliorated OA 
      symptoms, but the combined therapy, D-002/D-003, was more effective than either 
      monotherapy. All treatments were well tolerated.
FAU - Puente, Roberto Antonio
AU  - Puente RA
FAU - Illnait, Jose
AU  - Illnait J
FAU - Mas, Rosa Maria
AU  - Mas RM
FAU - Carbajal, Daisy Maria
AU  - Carbajal DM
FAU - Mendoza, Sarahi
AU  - Mendoza S
FAU - Ceballos, Alfredo
AU  - Ceballos A
FAU - Fernandez, Julio Cesar
AU  - Fernandez JC
FAU - Mesa, Meilis
AU  - Mesa M
FAU - Reyes, Pablo
AU  - Reyes P
FAU - Ruiz, Dalmer
AU  - Ruiz D
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Altern Ther Health Med
JT  - Alternative therapies in health and medicine
JID - 9502013
RN  - 0 (Alcohols)
RN  - 0 (D 002)
RN  - 0 (Fatty Alcohols)
RN  - 0 (Waxes)
RN  - 2ZA36H0S2V (beeswax)
SB  - IM
MH  - Alcohols
MH  - Double-Blind Method
MH  - Fatty Alcohols/*therapeutic use
MH  - Humans
MH  - Ontario
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Saccharum
MH  - Treatment Outcome
MH  - Waxes/*therapeutic use
EDAT- 2016/07/21 06:00
MHDA- 2018/09/15 06:00
CRDT- 2016/07/20 06:00
PHST- 2016/07/20 06:00 [entrez]
PHST- 2016/07/21 06:00 [pubmed]
PHST- 2018/09/15 06:00 [medline]
PST - ppublish
SO  - Altern Ther Health Med. 2016 Jun;22 Suppl 2:15-23.