Clinical Studies On Soma Carisoprodol
SOMA is a proven drug for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been recognized and because acute, painful musculoskeletal conditions are generally of short duration.
Clinical Studies
Several studies have been conducted to test the efficacy. Based on a study made on SOMA, the relief of acute, idiopathic mechanical low back pain was assessed in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). This study included 18 to 65 years old who had acute back pain (≤ 3 days of duration).
Patients who had chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); inflammatory back pain, or had evidence of a neurologic deficit were disqualified from participation. Simultaneous use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was forbidden.
Patients were randomized to one of three treatment groups (i.e., SOMA 250 mg, SOMA 350 mg, or placebo) in study 1. On the other hand, in study 2, patients were randomized to two treatment groups (i.e., SOMA 250 mg or placebo). Patients were administered study medication three times a day and at bedtime for seven days in each study.
The study resulted in relief from starting backache and the global impression of change, as reported by patients, on Study Day #3. The primary statistical comparison was between the SOMA 250 mg and placebo groups in both studies.
The percentage of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was equal in the treatment groups.
The average age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.
These two trials found no deaths or serious adverse reactions. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively. These patients were made to stop using due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively. These patients discontinued because of central nervous system adverse reactions.
The following table shows adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with SOMA in the two trials described above.
Table 1: Patients with Adverse Reactions in Controlled Studies
Adverse |
Placebo |
SOMA 250 mg |
SOMA 350 mg |
Drowsiness |
31 (6) |
73 (13) |
47 (17) |
Dizziness |
11 (2) |
43 (8) |
19 (7) |
Headache |
11 (2) |
26 (5) |
9 (3) |
From patients treated with placebo, 31 % suffered drowsiness, while patients treated with soma 250, it was 73%. Around 47% patients taking SOMA 350 mg reported drowsiness. Among those patients who reported headache, the number was 11%, 26% and 9% respectively.