Crossover trials

Brown SG, Wiese M, Blackman K, Heddle R Ant 47 venom immunotherapy a double blind, placebo-controlled crossover trial. Lancet 2003 361 1101-1106. 

Finally, trials can follow parallel or crossover study designs. In a parallel trial, patients are assigned to a therapy that they remain on, and they are compared with patients in alternate therapy groups. In a crossover trial, patients switch or change therapy assignments during the course of the trial. 

Benjamin, J., Levine, J., Fux, M. et al. Double-blind, placebo-controlled, crossover trial of inositol treatment for panic disorder. Am. ]. Psych. 152 1084-1086,1995. 

Palatnik, A., Frolov, K., Fux, M., Benjamin, J. Double-blind, controlled, crossover trial of inositol versus fluvoxamine for the treatment of panic disorder./. Clin. Psychopharmacol. 21 335-339, 2001. 

A randomised, placebo-controlled, crossover trial. Anaesthesia. 48(5) 393-5. 

In some instances it may be better to design the trial so that each patient provides his own control - by having various treatments in turn. This is known as a "crossover " trial By such means we may sometimes make... 

Senn SJ. Crossover Trials in Clinical Research London Wiley, 1983. 

Martini and Wood (2002) tested the bioavailability of 3 different sources of Ca in 12 healthy elderly subjects (9 women and 3 men of mean SEM age 70 3 and 76 6 years, respectively) in a 6-week crossover trial conducted in a Human Study Unit. Each Ca source supplied 1000 mg Ca/day and was ingested for 1 week with meals (as 500 mg Ca 2x/day), thus contributing to a high-Ca intake (1300 mg Ca/day). A low-Ca intake (300 mg Ca/day strictly from the basal diet) was adhered to for 1 week in-between each treatment. The Ca sources included skim milk, CCM-fortified OJ, and a dietary supplement of CaCOa. Assessment parameters were indirect measures predicted to reflect the relative bioavailability of Ca postprandially via an acute PTH suppression test (hourly for 4h). Longer-term responses to Ca supplementation were assessed via a number of urinary and serum hormone, mineral, and bone resorption biomarkers (i.e., vitamin D, Ca, phosphorus, and collagen t) e 1 N-telopeptide cross-links). 

Rossing K, Jacobsen P, Pietraszek L, Parving HH. Reno-protective effects of adding angiotensin II receptor blocker to maximal recommended doses of ACE inhibitor in diabetic nephropathy a randomized doubleblind crossover trial. Diabetes Care 2003 26 2268-74. 

I. 18-1.62), number-needed-to-treat (NNT) was 6 for complete control of nausea relative risk was 1.28 (Cl 1.08-1.51), NNT 8 for complete control of vomiting. Cannabinoids were not more effective in patients receiving very low or very high emetogenic chemotherapy. In crossover trials, patients preferred cannabinoids for future chemotherapy cycles relative risk 2.39 (2.05-2.78), NNT 3. Some potentially beneficial side effects occurred more often with cannabinoids high 10.6 (6.86-16.5), NNT 3 sedation or drowsiness 1.66 (1.46-1.89), NNT 5 euphoria 12.5 (3-52.1), NNT 7. Harmful side effects also occurred more often with cannabinoids dizziness 2.97 (2.31-3.83), NNT 3 dysphoria or depression 8.06 (3.38-19.2), NNT 8 hallucinations 6.10 (2.41-15.4), NNT 17 paranoia 8.58 (6.38-... 

Muller-Vahl, K. R., U. Schneider, A. Koblenz, et al.Treatment of Tourette s syndrome with Delta 9-tetrahydrocannabinol (THC) a randomized crossover trial. Pharmacopsychiatry 2002 35(2) 57-61. 

ZOl 15 Phillips, S., S. Hutchinson, and R. Ruggier. Zingiber officinale does not affect gastric emptying rate. A randomised, placebo-controlled, crossover trial. Anaesthesia 1993 48(5) 393-395. 

Peterson, B.S., Zhang, H., Bondi, C., Anderson, G.M., and Leckman, J.F. (1998b) A double-blind, placebo-controlled, crossover trial of an antiandrogen in the treatment of Tourette s syndrome. J Clin Psychopharmacol 18 324—331. 

George, M.S., Wasserman, E.M., Williams, W.E., Danielson, A.L., Greenberg, B.D., Hallett, M., and Post, R.M. (1997) Mood improvements following daily left prefrontal repetitive transcranial magnetic stimulation in patients with depression a placebo-controlled crossover trial. Am J Psychiatry 154 1752-1756. 

A randomized, double-blind, placebo-controlled crossover trial of botulinum toxin for the treatment of simple motor tics was conducted in 20 patients, ages 15-55, 18 of whom completed the study (Marras et al., 2001) (Table 40.2). As rated blindly on a 12-minute videotape sample, the proportional change in treated tics per minute was —39% during the botulinum toxin phase in contrast to an increase of +5.8% during the placebo phase. Half of the patients noted weakness of the injected muscles that was not functionally disabling. Two patients reported inner restlessness, accompanied by an increased urge to perform the treated tic. Two others felt that the decrease in the treated tic prompted a new replacement tic. Despite improvement in the treated tic, there was no significant evidence of overall improvement. 

Tourette s syndrome improvement with pergolide in a randomized, double-blind, crossover trial. Neurology 54 1310-1315. 

Singer, H.S., Wendlandt, J., Krieger, M., and Giuliano, J. (2001) Baclofen treatment in Tourette syndrome a double-blind, placebo-controlled, crossover trial. Neurology 56 599-604. 

Reid, A.D., Naylor, G.J., and Ka, D. (1981) A double-blind placebo controlled crossover trial of carbamazepine in overactive severely mentally handicapped patients. Psychol Med 11 109-113. 

Estruch, R., Sacanella, E., Badia, E., Antunez, E., Nicolas, J.M., Fernandez-Sola, J., Rotilio, D., De Gaetano, G., Rubin, E., and Urbano-Marquez, A., Different effects of red wine and gin consumption on inflammatory biomarkers of atherosclerosis a prospective randomized crossover trial effects of wine on inflammatory markers, Atherosclerosis, 175, 117, 2004. 

Benjamin J, Levine J, Fux M, et al Inositol treatment for panic disorder a double-blind placebo-controlled crossover trial. Am J Psychiatry 152 1084-1086, 1995... 

Sandford JJ, D Orlando KJ, Gammans RE, et al Pilot crossover trial of pagoclone and placebo in patients with DSM-IV panic disorder. Poster presented at the CINP Congress, Glasgow, Scotland, 1998... 

Broughton RJ, Fleming JA, George CF, et al Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of excessive daytime sleepiness in narcolepsy. Neurology 49 444-451, 1997... 

Figure 3.8 Effects of tf-amphetamine on the wake EEG Mean EEG spectral values for six healthy male subjects who took placebo. 5 mg and 10 mg of d-amphetamine on separate occasions in a balanced crossover trial are shown Whereas the EEG trace 2 h after placebo (upper third) shows a rapid decline in alpha waves and an increase in theta waves (see arrows pointing to the alpha decrease and the theta increaee), the corresponding changes occurred later after 5 mg (middle third) andlOmg (tower third) d-amphetamine The decay of alpha and increaee of theta activities occurred after 2 mm on placebo, but only after 7 min on 5 mg d-amphetanine and after 12 mn on 10 mg of d-amphetamine, thus reflecting a vigilance-stabilizing effect of tf-aiphetamine (Matejcek, 1979, with permission)...

Gabapentin has been approved in the United States since 1993 for adjunctive use in the management of treatment-refractory partial epilepsy. Early evidence in open-label trials indicated possible mood-stabilizing properties ( 227, 234). Recent data from a placebo-controlled crossover trial, however, found no difference between gabapentin and placebo for manic or depressed episodes (235). 

Finally, a small, double-blind, placebo-controlled, crossover trial of fluoxetine in 14 children and adolescents with OCD also showed a significant decrease in CY-BOCS total scores (151). 

Baskett JJ et al Does melatonin improve sleep in older people A randomised crossover trial. Age Ageing 2003 32 164. [PMID 12615559]... 

Goldenberg, D., Mayskiy, M., Mossey, C., Ruthazer, R., Schmid, C. A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia, Arthritis Rheum. 1996, 39, 1852-1859. 

Bruera, E., Ripamonti, C., Brennis, C., Macmillan, K., Hanson, J. A randomized double-blind crossover trial of intravenous lidocaine in the treatment of neuropathic cancer pain, J. Pain Symptom Manage. 1992, 7, 138-141. 

Zakrzewska, J. M, Chaudhry, Z., Nurmikko, T. J., Patton, D. W., Mullens, E. L. Lamotrigine (lamictal) in refractory trigeminal neuralgia results from a double-blind placebo controlled crossover trial, Pain 1997, 73, 223-230. 

Dextromethorphan for the treatment of neuropathic pain a double-blind randomised controlled crossover trial with integral n-of-1 design, Pain 1994, 59, 127-133. 

The suitability of medroxyprogesterone for women with sickle cell disease has been evaluated in a controlled crossover trial, which showed that both hematological and clinical parameters were improved (24). 

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