Research from JAMA — Analgesic Effect of the Synthetic Cannabinoid CT-3 on Chronic Neuropathic Pain — A Randomized Controlled Trial — Context1′,1′Dimethylheptyl-Δ8-tetrahydrocannabinol-11-oic acid (CT-3), a potent analog of THC-11-oic acid, produces marked antiallodynic and analgesic effects in animals without evoking the typical effects described in models of cannabinoids. Therefore, CT-3 may be an effective analgesic for poorly controlled resistant neuropathic pain.ObjectiveTo examine the analgesic efficacy and safety of CT-3 in chronic neuropathic pain in humans.Design and SettingRandomized, placebo-controlled, double-blind crossover trial conducted in Germany from May-September 2002.ParticipantsTwenty-one patients (8 women and 13 men) aged 29 to 65 years (mean, 51 years) who had a clinical presentation and examination consistent with chronic neuropathic pain (for at least 6 months) with hyperalgesia (n = 21) and allodynia (n = 7).InterventionsPatients were randomized to two 7-day treatment orders in a crossover design. Two daily doses of CT-3 (four 10-mg capsules per day) or identical placebo capsules were given during the first 4 days and 8 capsules per day were given in 2 daily doses in the following 3 days. After a washout and baseline period of 1 week each, patients crossed over to the second 7-day treatment period.Main Outcome MeasuresVisual analog scale (VAS) and verbal rating scale scores for pain; vital sign, hematologic and blood chemistry, and electrocardiogram measurements; scores on the Trail-Making Test and the Addiction Research Center Inventory–Marijuana scale; and adverse effects.ResultsThe mean differences over time for the VAS values in the CT-3–placebo sequence measured 3 hours after intake of study drug differed significantly from those in the placebo–CT-3 sequence (mean [SD], −11.54 [14.16] vs 9.86 [21.43]; P = .02). Eight hours after intake of the drug, the pain scale differences between groups were less marked. No dose response was observed. Adverse effects, mainly transient dry mouth and tiredness, were reported significantly more often during CT-3 treatment (mean [SD] difference, −0.67 [0.50] for CT-3–placebo sequence vs 0.10 [0.74] for placebo–CT-3 sequence; P = .02). There were no significant differences with respect to vital signs, blood tests, electrocardiogram, Trail-Making Test, and Addiction Research Center Inventory–Marijuana scale. No carryover or period effects were observed except on the Trail-Making Test.ConclusionsIn this preliminary study, CT-3 was effective in reducing chronic neuropathic pain compared with placebo. No major adverse effects were observed.
Auricular acupuncture can be an effective treatment for acute anxiety, but there is a lack of direct comparisons of acupuncture to proven standard drug treatments. In this study we compared the efficacy of auricular acupuncture with intranasal midazolam, placebo acupuncture, and no treatment for reducing dental anxiety. Patients having dental extractions (n = 67) were randomized to (i) auricular acupuncture, (ii) placebo acupuncture, and (iii) intranasal midazolam and compared with a no treatment group. Anxiety was assessed before the interventions, at 30 min, and after the dental extraction. Physiological variables were assessed continuously. With the no treatment group as control, the auricular acupuncture group, and the midazolam group were significantly less anxious at 30 min as compared with patients in the placebo acupuncture group (Spielberger Stait-Trait Anxiety Inventory X1, P = 0.012 and <0.001, respectively). In addition, patient compliance assessed by the dentist was significantly improved if auricular acupuncture or application of intranasal midazolam had been performed (P = 0.032 and 0.049, respectively). In conclusion, both, auricular acupuncture and intranasal midazolam were similarly effective for the treatment of dental anxiety.
In order to examine the role of muscular mechanisms in chronic tension-type headache a study with needle acupuncture was performed. Needle acupuncture could be of therapeutic value because it has shown some positive effects in myofascial pain syndromes. We performed a double-blind, placebo-controlled study with 39 patients (mean age 49.0 years, SD=14.8) fulfilling the International Headache Society criteria for chronic tension-type headaches. Participants were randomly assigned to verum or placebo condition. Six weeks after end of treatment no significant differences between placebo and verum could be observed with respect to visual analogue scale and frequency of headache attacks. Nevertheless, pressure pain thresholds significantly increased for the verum group. The findings of our study support the hypothesis that peripheral mechanisms - such as increased muscle tenderness - only play a minor role in the pathogenesis of chronic tension-type headache.