Double-blinded placebo-controlled 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. 

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. 

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. 

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. 

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. 

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... 

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... 

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). 

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. 

Heresco-Levy U, Javitt DC, Ermilov M, Silipo G, Shimoni J. 1998. Double-blind, placebo-controlled, crossover trial of D-cycloserine adjuvant therapy for treatment-resistant schizophrenia. Int J Neuropsychopharmacol 1 131-136. 

Tiihonen J, Halonen P, Wahlbeck K, Repo-Tiihonen E, Hyvarinen S, et al. 2005. Topiramate add-on in treatment-resistant schizophrenia A randomized, double-blind, placebo-controlled, crossover trial. J Clin Psychiatry 66 (8) 1012-1015. 

In a randomized, double-blind, placebo-controlled, crossover trial the effect of the synthetic delta-9-tetrahy-drocannabinol dronabinol on central neuropathic pain was evaluated in 24 patients with multiple sclerosis (58). Oral dronabinol reduced central pain. Adverse events were reported by 96% of the patients compared with 46% during placebo treatment. They were more common during the first week of treatment. The most common adverse events during dronabinol treatment were dizziness (58%), tiredness (42%), headache (25%), myalgia (25%), and muscle weakness (13%). There was increased tolerance to the adverse effects over the course of treatment and with dosage adjustments. 

Svendsen KB, Jensen TS, Bach FW. Does the cannabinoid dronabinol reduce central pain in multiple sclerosis Randomised double blind placebo controlled crossover trial. BMJ 2004 329(7460) 253. 

Some antibiotics can reduce the efficacy of oral contraceptives. However, there is pharmacokinetic evidence that plasma concentrations of oral contraceptive steroids are unchanged by co-administration of ciprofloxacin (75). Furthermore, ciprofloxacin (500 mg bd) did not interfere with the ovarian suppression produced by the oral contraceptive Marvelon (30 micrograms of ethiny-lestradiol plus 150 micrograms of desogestrel) in 24 healthy women in a randomized, double-blind, placebo-controlled, crossover trial (76). 

In a randomized, double-blind, placebo-controlled, crossover trial, alosetron (2 mg bd) delayed left colonic transit in both patients with irritable bowel syndrome (n = 13) and healthy volunteers (n = 12) (28). In another double-blind, placebo-controlled trial in 25 non-constipated patients with irritable bowel syndrome, alosetron (1 and 4 mg bd) had no significant effect on gastrointestinal transit or rectal sensory and motor mechanisms (29). 

A single center, prospective, double-blind, placebo-controlled, crossover trial investigated the activity of Echinacea in humans for the treatment of recurrent genital herpes. The 1 -year study involved 50 patients who were each given the product Echinaforce for 6 months and placebo for 6 months. The study found no statistically significant benefit in using Echinaforce vs placebo for frequently recurrent genital herpes (15). 

DeWeerdt CJ, Bootsma HPR, Hendriks H. Herbal medicine in migraine prevention randomized, double-blind, placebo-controlled crossover trial of a feverfew preparation. Phytomedicine 1996 3 225-230. 

Naltrexone is an opiate receptor antagonist used in the management of addictive behaviours. In a double-blind placebo controlled crossover trial, naltrexone reduced binge/purge frequency in 18 out of 19 patients with BN (Marrazzi et al. 1995). 

To test the hypothesis that elevated endogenous opiate levels contribute to autism and/or to self-injurious behavior, 33 adult subjects with autism and/or self-injurious behavior were treated for 4 weeks with 50 or 150 mg/day naltrexone in a double-blind, placebo-controlled crossover trial. Naltrexone was not superior to placebo with respect to either frequency of self-injurious behavior or CGI and ABC measures of autistic symptoms (Zingarelli et al., 1992). 

Huycke MM, Naguib MT, Stroemmel MM, Blick K, Monti K, Martin-Munley S, Kaufman C. A double-blind placebo-controlled crossover trial of intravenous magnesium sulfate for foscarnet-induced ionized hypocalcemia and hypomagnesemia in patients with AIDS and cytomegaloviral infection. Antimicrob Agents Chemother 2000 44 2143-2148. 

Stears AJ, Woods SH, Watts MM, Burton TJ, Graggaber J, Mir FA, et al. A double-blind, placebo-controlled, crossover trial comparing the effects of amiloride and hydrochlorothiazide on glucose tolerance in patients with essential hypertension. Hypertension 2012 59(5) 934—42. 

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