Abstract
Treatment of chronic pain in diabetic neuropathy or neuropathic pain of other origins is challenging. Compounded topical formulations have evolved as potential treatment options. The objective of this retrospective study was to evaluate the efficacy of a compounded topical cream (Transdermal Therapeutics). Two versions of TT-CTAC cream were evaluated. Both creams contain Ketamine (10%), Baclofen (2%), Gabapentin (6%), amitriptyline (4%), bupivacaine (2%), Clonidine (0.2%). Additionally, one cream (7B) contains nifedipine (2%). The primary efficacy outcome was the change in numeric pain intensity score from pre-treatment to post-treatment. Secondary outcomes were qualitative grading (excellent, good, poor, or no effect), reduction …show more content…
Sensorimotor polyneuropathy is the most common type, occurring in 30% of diabetic patients in hospital and 25% of those in the community (1). The underlying pathophysiologic mechanism of diabetic neuropathy is not well understood. Neuropathic pain is associated with problems of the somatosensory system, primarily the sensory small caliber unmyelinated C fibers and myelinated Aδ nerve fibers (1,2). Initially in diabetic neuropathy Aδ and C nerve-fiber function is intact and there is no pain. With damage to C fibers, there is sympathetic sensitization, and peripheral symptoms with pain. The death of C fibers leads to nociceptor sensitization. Aδ fibers conduct peripheral stimuli, such as touch, which can be interpreted as pain, and this condition is called allodynia (1). Over time, there is reorganization at the cord level in the second order pain pathway in the dorsal spinal cord. Eventually, neuropathic pain is caused by pathophysiologic processes resulting in activation of abnormal pathways of pain in the peripheral nerves and posterior roots (peripheral neuropathic pain) or at the level of spinal cord and brain (central pain) …show more content…
Approximately 90% of all patients with painful diabetic neuropathy, as well as patients suffering neuropathic pain caused by other factors never receive adequate analgesia (14,19,20). Anticonvulsants and antidepressants are the first choice treatments for the reduction of neuropathic pain (21,22). Amitriptyline is frequently the drug of choice for diabetic neuropathic pain (22). However, these oral agents have dose-limiting adverse effects, which considerably reduce patient compliance (14, 23). Using topical therapy for the treatment of neuropathic pain, either in combination with oral agent, or as topical therapy alone is a viable approach (14,15,16). The advantages of topical creams are that multiple medications can be combined into a single cream, allowing therapeutic drug concentration locally with low systemic bioavailability (14,15,16), which may avoid side effects due to the lack of significant blood levels of the locally applied drugs that cause toxicity. In this study, almost 85% of the patients had neuropathic pain either due to diabetic neuropathy or due to other causes and they responded very well with significant pain reduction. Furthermore, the topical creams had a minimal adverse event profile .
CONCLUSIONS
In this study, the analgesic activity of TT-CTAC cream, a compounded topical formulation of Transdermal Therapeutics, Inc., was evaluated in patients with diabetic neuropathy or other
Treatment of chronic pain in diabetic neuropathy or neuropathic pain of other origins is challenging. Compounded topical formulations have evolved as potential treatment options. The objective of this retrospective study was to evaluate the efficacy of a compounded topical cream (Transdermal Therapeutics). Two versions of TT-CTAC cream were evaluated. Both creams contain Ketamine (10%), Baclofen (2%), Gabapentin (6%), amitriptyline (4%), bupivacaine (2%), Clonidine (0.2%). Additionally, one cream (7B) contains nifedipine (2%). The primary efficacy outcome was the change in numeric pain intensity score from pre-treatment to post-treatment. Secondary outcomes were qualitative grading (excellent, good, poor, or no effect), reduction …show more content…
Sensorimotor polyneuropathy is the most common type, occurring in 30% of diabetic patients in hospital and 25% of those in the community (1). The underlying pathophysiologic mechanism of diabetic neuropathy is not well understood. Neuropathic pain is associated with problems of the somatosensory system, primarily the sensory small caliber unmyelinated C fibers and myelinated Aδ nerve fibers (1,2). Initially in diabetic neuropathy Aδ and C nerve-fiber function is intact and there is no pain. With damage to C fibers, there is sympathetic sensitization, and peripheral symptoms with pain. The death of C fibers leads to nociceptor sensitization. Aδ fibers conduct peripheral stimuli, such as touch, which can be interpreted as pain, and this condition is called allodynia (1). Over time, there is reorganization at the cord level in the second order pain pathway in the dorsal spinal cord. Eventually, neuropathic pain is caused by pathophysiologic processes resulting in activation of abnormal pathways of pain in the peripheral nerves and posterior roots (peripheral neuropathic pain) or at the level of spinal cord and brain (central pain) …show more content…
Approximately 90% of all patients with painful diabetic neuropathy, as well as patients suffering neuropathic pain caused by other factors never receive adequate analgesia (14,19,20). Anticonvulsants and antidepressants are the first choice treatments for the reduction of neuropathic pain (21,22). Amitriptyline is frequently the drug of choice for diabetic neuropathic pain (22). However, these oral agents have dose-limiting adverse effects, which considerably reduce patient compliance (14, 23). Using topical therapy for the treatment of neuropathic pain, either in combination with oral agent, or as topical therapy alone is a viable approach (14,15,16). The advantages of topical creams are that multiple medications can be combined into a single cream, allowing therapeutic drug concentration locally with low systemic bioavailability (14,15,16), which may avoid side effects due to the lack of significant blood levels of the locally applied drugs that cause toxicity. In this study, almost 85% of the patients had neuropathic pain either due to diabetic neuropathy or due to other causes and they responded very well with significant pain reduction. Furthermore, the topical creams had a minimal adverse event profile .
CONCLUSIONS
In this study, the analgesic activity of TT-CTAC cream, a compounded topical formulation of Transdermal Therapeutics, Inc., was evaluated in patients with diabetic neuropathy or other