Abstract
INTRODUCTION: the placebos' analgesic effect seems to depend on different factors such as socio-cultural, psychological and genetic aspects. The effects of gender on placebos' analgesic response have rarely been documented in clinical studies, even though there have been some reports in experimental studies.
OBJETIVE: study the analgesic effect of anticonvulsant and antidepressive drugs in adults suffering from painful diabetic neuropathy and its relationship with gender
MATERIAL AND METHODS: a search and systematic selection was made of all clinical trials for analgesic treatment of diabetic neuropathy with anticonvulsant and antidepressive drugs published between January 2000 and February 2011. Randomized, placebo-compared clinical trials were included which had studied the analgesic effect of anticonvulsant and antidepressive drugs in adults suffering from painful diabetic neuropathy, evaluated in such a way that improvement in pain could be objectively classified. The following information was obtained from each article: criteria for diagnosing diabetic neuropathy, medicaments received and improvement of pain in the group being treated and in the placebo group according to patient gender.
RESULTS: 12 studies fulfilling the inclusion criteria were found which analyzed latest generation anticonvulsant and antidepressive agents used in managing pain in diabetic neuropathy. Only one study included gender-discriminated results regarding controlling pain in the placebo group.
CONCLUSION: the foregoing easily justifies the need for and importance of studying the relationship between gender and placebo response. This association has not been suitably reported to date, except by very few studies.
References
SHAPIRO AK. Factors contributing to the placebo effect: their implications for psychotherapy. Am J Psy-chother. 1964; 18 Supl 1: 73-88.
OKEN BS. Placebo effects: clinical aspects and neurobiology. Brain. 2008; 131: 2812-23.
CHEING GLY, CHEUNG KSH. Placebo analgesia: clinical considerations. Physiotherapy. 2002; 88: 735-43.
WALL PD. The placebo and the placebo response. In: Wall PD, Melzack R (Eds). Textbook of pain. Edinburgh: Churchill, Livingstone; 1999:419-30.
FINNISS DG, BENEDETTI F. Mechanisms of the placebo response and their impact on clinical trials and clinical practice. Pain. 2005; 114: 3-6.
PRICE DD, FINNISS DG, BENEDETTI F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59: 565-90.
DIEDERICH NJ, GOETZ CG. The placebo treatments in neurosciences: new insights from clinical and neuroimaging studies. Neurology. 2008; 71: 677-84.
POLLO A, BENEDETTI F. Neural mechanisms of placebo-induced analgesia. In: Price DD, Bushnell MC (Eds). Psychological methods of pain control: Basic science and clinical perspectives. Seattle, WA: IASP Press; 2004: 171-86.
KLOSTERHALFEN S, ENCK P. Neurophysiology and psychobiology of the placebo response. Curr Opin Psychiatry. 2008; 21: 189-95.
ENCK P, BENEDETTI F, SCHEDLOWSKI M. New insights into the placebo and nocebo responses. Neuron. 2008; 59: 195-206.
EISENBERG E, LURIE Y, BRAKER C, DAOUD D, ISHAY A. Lamotrigine reduces painful diabetic neuropathy. Neurology. 2001; 57: 505-9.
KOCHAR DK, JAIN N, AGRAWAL RP, SRIVAS-TAVA T, AGARWAL P, GUPTA S. Sodium valproate in the management of painful neuropathy in type 2 diabetes: a randomized placebo controlled study. Acta Neurol Scand. 2002; 106: 248-52.
LESSER H, SHARMA U, LAMOREAUX L, POOLE RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004; 63: 2104-10.
OTTO M, BACH FW, JENSEN TS, SINDRUP SH. Valproic acid has no effect on pain in polyneu-ropathy: a randomized controlled trial. Neurology. 2004; 62: 285-8.
RASKIN P, DONOFRIO PD, ROSENTHAL NR, HEWITT DJ, JORDAN DM, XIANG J, ET AL. Topiramate vs placebo in painful diabetic neuropathy: analgesic and metabolic effects. Neurology. 2004; 63: 865-73.
ROSENSTOCK J, TUCHMAN M, LAMOREAUX L, SHARMA U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004; 110: 628-38.
DOGRA S, BEYDOUN S, MAZZOLA J, HOPWOOD M, WAN Y. Oxcarbazepine in painful diabetic neuropathy: a randomized, placebo-controlled study. Eur J Pain. 2005; 9: 543-54.
FREYNHAGEN R, STROJEK K, GRIESING T, WHALEN E, BALKENOHL M. Efficacy of pre-gabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain. 2005; 115: 254-63.
RASKIN J, PRITCHETT YL, WANG F, D'SOUZA DN, WANINGER AL, IYENGAR S, ET AL. A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med. 2005; 6: 346-56.
GOLDSTEIN DJ, LU Y, DETKE MJ, LEE TC, IYENGAR S. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain. 2005; 116: 109-18.
WERNICKE JF, PRITCHETT YL, D'SOUZA DN, WANINGER A, TRAN P, IYENGAR S, ET AL. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology. 2006; 67: 1411-20.
ZIEGLER D, PRITCHETT YL, WANG F, DESA-IAH D, ROBINSON MJ, HALL JA, ET AL. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007; 30: 664-9.
SNIDVONGS S, HOLDCROFT A. Gender differences in responses to medication and side effects of medication. Pain: Clinical Updates. 2008; vol XVI: 1-6.
CRAFT RM. Sex differences in opioide analgesia: "from mouse to man". Clin J Pain. 2003; 19: 175-86.
DAHAN A, KEST B, WAXMAN AR, SARTON E. Sex-especific responses to opiates: animal and human studies. Anesth Analg. 2008; 107: 83-95.
LOYD DR, WANG X, MURPHY AZ. Sex differences n µ-opioid receptor expression in the rat midbrain periaqueductal gray are essential for eliciting sex differences in morphine analgesia. J Neurosci. 2008; 28: 14007-17.
KEPLER KI, STANDIFER KM, PAUL D, KEST B, PASTERNAK GW, BODNAR RJ. Gender effects on central opioid analgesia. Pain. 1991; 45: 87-94.
OKAMOTO K, TASHIRO A, HIRATA H, BEREITER DA. Differential modulation of TMJ neurons in superficial laminae of trigeminal subnucleus cau-dalis-upper cervical cord junction region of male and cycling female rats by morphine. Pain. 2005; 114: 203-11.
JI Y, MURPHY AZ, TRAUB RJ. Estrogen modulation of morphine analgesia of visceral pain in female rats is supraspinally and peripherally mediated. J Pain. 2007; 8: 494-502.
UNRUH AM. Gender variations in clinical pain experience. Pain. 1996; 65: 123-67.
CEPEDA MS, CARR DB. Women experience more pain and require more morphine than men to achive a similar degree of analgesia. Anesth Analg. 2003; 97: 1464-8.
RICHARDSON J, HOLDCROFT A. Results of forty years Yellow Card reporting for commonly used perioperative analgesic drugs. Pharmacoepidemiol Drug Saj. 2007; 16: 687-94.
RADEMAKER M. Do women have more adverse drug reactions? Am J Clin Dermatol. 2001; 2: 349-51.
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