Open labelled evaluation of injection Manyana (a combination of diclofenac + pitofenone + fenpiverinium) in ureteric, biliary and intestinal spasm--a preliminary report.

To study the efficacy and safety of a parenteral formulation of 'Manyana' (a combination of diclofenac + pitofenone + fenpiverinium) in ureteric, biliary and intestinal colic, an open labelled study was conducted at two centres. A total of 206 patients were enrolled and evaluated for decrease in pain with time on a visual analogue scale. A statistically significant difference was observed in pain within 30 minutes of drug administration and the pain relief lasted for as long as 24 hours post dosing. The study shows definite synergism between the antispasmodics pitofenone and fenpiverinium with the NSAID-diclofenac, reducing the prostaglandin levels and also the spasm related to colic.

Double blind, randomised, parallel, prospective, comparative, clinical evaluation of a combination of antispasmodic analgesic Diclofenac + Pitofenone + Fenpiverinium (Manyana vs Analgin + Pitofenone + Fenpiverinium (Baralgan) in biliary, ureteric and intestinal colic.

In this double blind, prospective study, the relative efficacy of Diclofenac + Pitofenone + Fenpiverinium (Manyana) and Analgin + Pitofenone + Fenpiverinium (Baralgan) in 200 patients of biliary, ureteric and intestinal colic was evaluated. Patients were given these coded drugs thrice daily for five days starting from day 0 to day 5. The results of the present clinical evaluation demonstrated that Manyana appeared to be superior to Baralgan in biliary and ureteric colic while it was therapeutically equivalent to Baralgan in reducing the pain intensity in intestinal colic. Both the medications were tolerated well and there were no side-effects reported.

Effect of sublingual nitroglycerine on pain relief in renal and ureteral colic

The effect of sublingual nitroglycerine [TNG] on relieving pain in renal and ureteral colic was studied in a randomized, prospective, double blind and placebo controlled clinical trial. One hundred out-patients between 16-60 years of age from either sex who were admitted to the urology emergency center of Ayatollah Taleghani and Ashrafi Esfahani hospitals were chosen for this study. They were divided into two groups; fifty-one of them were treated with TNG [0.4 mg initially and two similar doses if necessary at 5 minute intervals] and the remaining received placebo. The scoring of pain was performed using Lee et al's method. Chi-square test was used for statistical analysis of data. Although the severity of pain was reduced one degree by TNG [p<0.07] in comparison with placebo, TNG was not effective in the treatment of colic pain [p<0.05]

Diclofenac sodium in renal and ureteral colic: a double-blind comparison with hyoscine N-butyl bromide

The analgesic effects of diclofenac 75 mg IM and hyoscine N- buty1 bromide 20 or 40 mg or IV were compared in a randomized double-blind study, in 422 patients reporting moderate to severe pain due to renal or ureteral colic. Patients evaluated their pain intensity and pain relief at 0 [baseline], 15, 30, 45 minutes and hourly for 3 hours. A significant difference [p < 0.05] was found between the two groups with respect to pain intensity difference [PID], mean pain relief and onset time of analgesia. Diclofenac sodium was significantly [p < 0.05] superior to hyoscine N buty1 bromide in pain relief. Significantly [p < 0.05] fewer patents required a second dose in diclofenac sodium treated group compared to the other spasmolytic group. The dose and the route of administration of hyoscine N buty1 bromide had no significant [p > 0.05] effect on the proportion of patients with complete relief. These results confirmed that diclofenac sodium can be safely used in the management of acute renal and ureteral colic as an alternative to hyoscine N buty1 bromide