1.
A double-blind controlled trial of a single dose naproxen and an amino acid medical food theramine for the treatment of low back pain.
Shell, WE, Charuvastra, EH, DeWood, MA, May, LA, Bullias, DH, Silver, DS
American journal of therapeutics. 2012;(2):108-14
Abstract
To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was present for at least 6 weeks and was not mild. Patients were randomly assigned to receive medical food alone (n = 43), naproxen alone (250 mg/d, n = 42), or both medical food and naproxen (n = 44). All patients were assessed by using Roland-Morris Disability Questionnaire, Oswestry Low Back Pain Scale, Visual Analog Scale Evaluation and laboratory analysis performed at baseline and at 28 days for assessing the safety and impact on inflammatory markers, which included complete blood counts, C-Reactive protein (CRP), and liver function (alkaline phosphatase, aspartate transaminase, and alanine transaminase). At baseline, there were no statistically significant differences in low back pain when assessed by Roland-Morris function or Oswestry assessments nor were there differences in the blood indices of inflammation. At day 28, both the medical food group and combined therapy group (medical food with naproxen) were statistically significantly superior to the naproxen-alone group (P < 0.05). The medical food and naproxen group showed functional improvement when compared to the naproxen-alone group. The naproxen-alone group showed significant elevations in CRP, alanine transaminase, and aspartate transaminase when compared with the other groups. Medical food alone or with naproxen showed no significant change in liver function tests or CRP, with medical food potentially mitigating the effects seen with naproxen alone. The medical food (Theramine) appeared to be effective in relieving back pain without causing any significant side effects and may provide a safe alternative to presently available therapies.
2.
Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study.
Mibielli, MA, Geller, M, Cohen, JC, Goldberg, SG, Cohen, MT, Nunes, CP, Oliveira, LB, da Fonseca, AS
Current medical research and opinion. 2009;(11):2589-99
Abstract
OBJECTIVES To assess the influence of vitamins B1, B6 and B12 on the analgesia success achieved by diclofenac in subjects with acute lumbago. RESEARCH DESIGN AND METHODS A randomised, double blind controlled clinical study in parallel groups, in which subjects received twice-daily oral administration of either the combination therapy, Group DB (50 mg diclofenac plus 50 mg thiamine, 50 mg pyridoxine and 1 mg cyanocobalamin) or diclofenac monotherapy, Group D (50mg diclofenac). The study period lasted a maximum of 7 days. If sufficient pain reduction was achieved (defined as Visual Analogue Scale <20 mm and patient's satisfaction), subjects could withdraw from the treatment after 3 or 5 days. All subjects gave written informed consent to participate in the study. MAIN OUTCOME MEASURES The primary confirmatory study objective was to determine the number of patients with sufficient pain reduction after 3 days of treatment. RESULTS Three hundred and seventy-two subjects were allocated at random to either treatment group: Group DB - 187 subjects and Group D - 185 subjects. After 3 days of treatment, a statistically significant higher proportion of subjects in Group DB (n = 87; 46.5%) than in Group D (n = 55; 29%) terminated the study due to treatment success (chi(2): 12.06; p = 0.0005). Furthermore, the combination therapy yielded superior results in pain reduction, improvement of mobility and functionality. Drug safety monitoring profile throughout the trial was within the expected safety profile of diclofenac. CONCLUSIONS The combination of diclofenac with B vitamins was superior to diclofenac monotherapy in lumbago relief after 3 days of treatment. As a study drawback, daily VAS measurements were only recorded until subject withdrawal from treatment, whether after 3, 5, or 7 days. There were no differences in safety profile between the two study groups.
3.
A multicentre, randomised, double-blind study comparing the efficacy and tolerability of intramuscular dexketoprofen versus diclofenac in the symptomatic treatment of acute low back pain.
Zippel, H, Wagenitz, A
Clinical drug investigation. 2007;(8):533-43
Abstract
BACKGROUND Low back pain is an important medical problem in Western industrialised countries. NSAIDs are one of the main options for symptomatic pain relief in the early management of this painful condition. Dexketoprofen is an NSAID belonging to the arylpropionic acid group that has demonstrated good analgesic efficacy and a good safety profile in different acute and chronic painful conditions. METHODS A randomised, double-blind, parallel, active controlled, multicentre study that included 370 outpatients with acute low back pain was conducted to compare the analgesic efficacy of dexketoprofen 50mg twice daily versus diclofenac 75mg twice daily administered intramuscularly for 2 days. Efficacy outcomes were assessment of pain intensity (PI) measured on a visual analogue scale, total PI scores from baseline to 6 hours after the first-dose administration (primary efficacy endpoint; SAPID(0-6)), score on a physical disability scale using the Roland Disability Questionnaire (RDQ), and use of rescue medication. Tolerability and safety were also assessed as secondary variables. RESULTS The adjusted mean (SAPID(0-6)) scores were very similar, 117.3 mm/h with dexketoprofen and 114.7 mm/h with diclofenac. The adjusted ratio of means was 1.023 and the lower 95% confidence limit was 0.81, demonstrating non-inferiority of dexketoprofen (defined by a lower limit of the 95% CI >0.80) in comparison with diclofenac (per-protocol analysis). The median change in the RDQ was -6 points for both groups (p = 0.69), showing an overall improvement on the disability scale. No significant differences between groups were observed regarding the percentage of patients needing rescue medication or in the mean values of pain after repeated doses (SAPID(0-last)). Dexketoprofen was well tolerated, with a reported incidence of adverse events similar to that of diclofenac. No serious adverse events were reported in either treatment group. CONCLUSION From the results of this study it can be concluded that dexketoprofen 50mg administered twice daily intramuscularly provides a clinically relevant analgesic effect with good tolerability after single and repeated doses in patients with acute severe low back pain.
4.
[Dexketoprofen-trometamol and tramadol in acute lumbago].
Metscher, B, Kübler, U, Jahnel-Kracht, H
Fortschritte der Medizin. Originalien. 2001;(4):147-51
Abstract
UNLABELLED BACKGROUND, METHOD The analgesic efficacy and tolerability of dexketoprofen-trometamol (DKPT) was compared with tramadolhydrochloride (TRAM) in a multicentre, randomised, double-blind, clinical trial in 192 Patients with acute low back pain. The initial pain at rest and on movement should be at least 50 mm on a 100 mm visual analogue scale. The daily dose during the 7 days' treatment was 50 mg TRAM t.i.d. (n = 95) or 25 mg DKPT t.i.d. (n = 97). The patients were allowed to take additional Paracetamol up to 4 x 500 mg per day as rescue medication. RESULTS From the 4th day of treatment pain on movement decreased significantly (p = 0.044) in the DKPT-group in comparison with the TRAM-group. The nocturnal pain decreased during the treatments with a difference in therapies of 22.9% in favour of DKPT. Within the DKPT-group the patients required additional Paracetamol more often only during the 1st day of treatment whereas the patients of the TRAM-group required the additional rescue medication mainly during the first 3 days of treatment. This difference was statistically significant (p = 0.011). Under DKPT treatment patients experienced significantly less adverse events (with an at least "possible" causal relationship; p = 0.026). This can be explained by central nervous disturbances that occurred only in the TRAM group. The distribution of gastro-intestinal disorders was identical in both treatment groups. CONCLUSION With this results DKPT in comparison with TRAM also showed to be a strong analgesic drug with a better risk-benefit relation due to its better tolerability.
5.
[Therapy of acute lumbago. Non-steroidal anti-rheumatic analgesic promotes early mobility].
Metscher, B, Kübler, U, Jahnel-Kracht, H
MMW Fortschritte der Medizin. 2000;(46):52