A simple cold pressure technique for the evaluation of analgesic drugs in healthy subjects

Reddy, K. Sunil Kumar; Rani, P. Usha; Naidu, M. U. R.; Rao, T Ramesh Kumar

doi:10.4103/0253-7613.100375

Cited by 4 publications

(4 citation statements)

References 14 publications

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“…The cold pressor stress test model equipment used in the present study was designed and validated by the department of clinical pharmacology and Therapeutics, NIMS, Hyderabad. [ 10 ]…”

Section: Methodsmentioning

confidence: 99%

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Evaluation of Phyllanthus emblica extract on cold pressor induced cardiovascular changes in healthy human subjects

Fatima¹,

Pingali²,

Pilli³

2014

Phcog Res

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Background:Acute and chronic stress is a risk factor for the development and progression of coronary artery disease. Increased arterial stiffness is an independent marker for cardiovascular disease. Cold pressor test (CPT) is known to be associated with substantial activation of the autonomic nervous system.Objective:The aim of this study was to evaluate the effect of Phyllanthus emblica extract on cold pressor stress test induced changes on cardiovascular parameters and aortic wave reflections in healthy human subjects.Materials and Methods:This was a double-blind, placebo-controlled, crossover study. Participants were randomized to receive either two capsules of P. emblica extract 250 mg (containing aqueous extract of P. emblica, highly standardized by high-performance liquid chromatography to contain low molecular weight hydrolysable tannins emblicanin-A, emblicanin-B, pedunculagin and punigluconin) or two capsules of placebo twice daily for 14 days. Pharmacodynamic parameters such as heart rate, augmentation pressure, augmentation index (AIx), subendocardial viability ratio (SEVR), radial and aortic blood pressure (BP) were recorded before and after CPT at baseline and end of treatment. After washout period of 14 days, subjects crossed over to the other treatment and the same test procedure was repeated again. Safety assessments were done at baseline and at the end of treatment.Results:A total of 12volunteers completed the study. Compared with baseline and placebo, P. emblica extract produced a significant decrease of mean percent change in the indices of arterial stiffness (AIx, radial and aortic BP) and increase in SEVR, an index of myocardial perfusion with CPT. Both treatments were well-tolerated and no serious adverse events were reported.Conclusion:Proprietary P. emblica extract, showed a significant decrease in cold pressor stress test induced changes on aortic wave reflections.

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“…The cold pressor stress test model equipment used in the present study was designed and validated by the department of clinical pharmacology and Therapeutics, NIMS, Hyderabad. [ 10 ]…”

Section: Methodsmentioning

confidence: 99%

“…Then the subject was then asked to immerse his hand again in hot water bath maintained at 35°C for 1 min for normalization of temperature. [ 10 ]…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Phyllanthus emblica extract on cold pressor induced cardiovascular changes in healthy human subjects

Fatima¹,

Pingali²,

Pilli³

2014

Phcog Res

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“…Cold water stress test was performed as per the standard operating procedure prepared in accordance with previously published studies. [10][11][12][13] Before initiating cold stress test, procedure was well explained to the participants. Participants were checked for adequate sleep over previous night and had light breakfast 2 hours before performing the test in the morning.…”

Section: Cold Water Stress Test Proceduresmentioning

confidence: 99%

“…A commonly used experimental set up involves the use of cold-water stress test that induces acute pain for the evaluation of analgesic effect of drugs. 9,10 In this test, pain perception is evaluated by measuring parameters like pain threshold time and pain tolerance time. In clinical research, pain intensity is commonly assessed using visual analogue scale.…”

Section: Introductionmentioning

confidence: 99%

A comparative evaluation of placebo effect on pain perception parameters in open-label versus double-blind groups: a prospective randomized pilot study in healthy volunteers

Bhargava

Sarangi

Kumar

2023

Int J Basic Clin Pharmacol

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Background: Considerable placebo response rate is commonly observed in placebo-controlled trials involving analgesics. However, there is paucity of evidence with regard to comparison of effect of open-label placebo versus double-blind placebo on pain perception. Methods: In this study, cold water maintained at 4±1°C was used to induce experimental pain. Enrolled subjects were randomized to receive either 2% lignocaine gel as active drug or K-Y jelly as placebo as per the groups in open-label (two groups) and double-blind (two groups) study. Pain perception was evaluated using pain threshold time and pain tolerance time after immersion of subject’s hand in the cold water. Pain intensity was assessed using visual analogue scale (VAS). Results: Sixty-nine subjects were randomized into 4 study groups namely open-label lignocaine (OLL; N=17), open-label placebo (OLP; N=18), double-blind lignocaine (DBL; N=17) and double-blind placebo (DBP; N=17). OLP application increased pain intensity on VAS from 67 (47, 84) to 72 (39, 88) mm (p=0.018). OLL application reduced pain perception pain threshold time from 20.4 (4.0, 45.1) to 24.1 (6.3, 124.2) seconds (p=0.049) and pain tolerance time from 32.7 (6.8, 110.2) to 40.0 (7.7, 156.7) seconds (p=0.019). The change in pain parameters (before and after application of study intervention) was comparable without any significant difference among the four study groups (p=0.257 for pain threshold time, p=0.165 for pain tolerance time and p=0.563 for pain intensity score). Conclusions: Lignocaine and placebo gel application showed comparable change in pain perception irrespective of blinding.

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Topical high‐concentration menthol: Reproducibility of a human surrogate pain model

Mahn

Hüllemann

Wasner

et al. 2014

European Journal of Pain

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A simple cold pressure technique for the evaluation of analgesic drugs in healthy subjects

Cited by 4 publications

References 14 publications

Evaluation of Phyllanthus emblica extract on cold pressor induced cardiovascular changes in healthy human subjects

Evaluation of Phyllanthus emblica extract on cold pressor induced cardiovascular changes in healthy human subjects

A comparative evaluation of placebo effect on pain perception parameters in open-label versus double-blind groups: a prospective randomized pilot study in healthy volunteers

Topical high‐concentration menthol: Reproducibility of a human surrogate pain model

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