Good news from Canada
Although my knowledge of life in Canada is limited to the stereotypes of Mounties chasing bad guys and the people’s love of ice hockey, I did see that their Therapeutic Products Directorate (TPD) (the Canadian equivalent of the FDA) has given a nod of approval to expanding the use of the once-daily version of tramadol. To date, it has only been indicated for the treatment of moderate pain. Now the TPD has accepted new evidence of its appropriateness in the treatment of moderately severe pain.
So what is this new evidence? Biovail Corp which manufactures the once-daily version of tramadol in Canada, has held a series of four clinical trials. Each trial lasting for twelve weeks was properly conducted using randomization, a double-blind format and placebo control. A total of more than 3,000 people participated. In a fifth study, a separate trial was run over fifty-eight weeks. All the participants in the five trials were referred by physicians, diagnosed either with osteoarthritis of the knee or with hip or low back pain. In all cases, the condition caused persistent, moderate to severe pain.
The results demonstrated a significant reduction in the level of the intensity of the pain for those taking tramadol. The effects were apparent from the first day, with the degree of pain relief improving steadily over the first month as the concentration of tramadol increased in the blood stream. One of the more usual side effects of pain is difficulty in sleeping. Because the pain is constant, it makes it difficult to fall asleep or it wakes you during the night or early in the morning. This tendency to insomnia adds to the difficulty in pain management. As people grow more tired and depressed, the pain becomes more intrusive. Those taking tramadol reported a significant improvement in sleep patterns. However, the most interesting results come from the fifth study which produced more evidence that once-daily tramadol is both safe and effective over longer periods of time. There is always some concern if people take a strong painkiller for months. This study suggests that lower doses over time can be effective and not give rise to significant risks of dependence.
Tags: tramadol