Is Patch It® better than placebo in alleviating swelling and ache in the lower legs and feet? A randomized, placebo-controlled, double blind, crossover, sequential trial
Aliya Shakeel1, Hoong Keong Hui2, Chetan S Patil3, Manojkumar V Chaudhari4, Yogesh D Kadam5, Shrikant V Pensalwar6, Suhas G Erande7, Rajesh M Kewalramani8
1Vedic Lifesciences Pvt Ltd, Mumbai, Maharashtra, India; 2Nutriworks Limited, Kowloon, Hong Kong; 3Muktai Hospital, Nasik, 4Bhagirathi Medical Foundation, 5Poona Diabetes Center, 6Balaji Clinic, Mumbai, 7Akshay Hospital, Pune, 8Shanti Niketan, Kandar Pada, Dahisar, Mumbai, Maharashtra, India
Background: Existing therapeutic measures for swelling, aching and discomfort in the lower limbs, which include compression stockings and leg elevation, are difficult to use and inconvenient. Patch It®, a proprietary herbomineral patch is an easy-to-use alternative therapy. This trial was conducted to compare it's efficacy against that of a placebo in swollen and aching lower legs and feet.
Methods: This randomized, placebo-controlled, double blind, crossover, sequential trial was conducted in the private clinics of physicians. A total of 100 patients (24 men and 76 women), aged 25 to 60 years, with recurring swelling in the feet and (optionally) up to two more related complaints, having an average visual analog score (VAS) of at least 60 (scale 0–100) for each complaint were recruited into the study. Patches (active or placebo) were applied to both soles overnight for 8 weeks: 4 consecutive weeks each with active or placebo in randomized sequence. Outcome measures included the average VAS score (baseline to week 4, and week 5 to week 8), preference for either patch (difference of >5 mm in average VAS score reduction), ankle figure-of-eight measures, investigator's global assessment (good, fair, poor), patient's willingness to continue using the patch after the trial (yes, no), and adverse events.
Results: Out of 100 patients, 86 completed the trial, while ten were excluded for noncompliance, three withdrew, and one was lost to follow-up. The active placebo boundary of the sequential chart was crossed when 82 patients completed the trial. Active patch was also superior to placebo patch by mean reductions in average VAS scores (13.14 versus 9.6, P = 0.02), mean reduction in figure-of-eight ankle measurements (1.21 cm versus 0.79 cm, P = 0.003), investigator's global assessment (P < 0.01), and by proportion of patients willing to continue using the patch after the trial (P < 0.01). Ten percent of patients experienced localized itching with each patch, but this did not require interruption of treatment.
Conclusion: Patch It had greater efficacy than the placebo in alleviating recurring swelling and aching in the legs and feet, and is well tolerated.
Keywords: ankle swelling, leg ache, dermal patch, reflexology, sequential analysis, figure-of-eight
This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php
Readers of this article also read:
Gerace D, Martiniello-Wilks R, Simpson AM
Published Date: 29 January 2015
Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Östlund O, Anzueto A
Published Date: 27 January 2015
Published Date: 24 February 2014
Retrospective cohort study of the efficacy of caprylic triglyceride in patients with mild-to-moderate Alzheimer's disease
Maynard SD, Gelblum J
Published Date: 23 October 2013
Cumulative clinical experience from over a decade of use of levofloxacin in community-acquired pneumonia: critical appraisal and role in therapy
Noreddin AM, Elkhatib WF, Cunnion KM, Zhanel GG
Published Date: 7 October 2011
Hypertension and other morbidities with Cushing’s syndrome associated with corticosteroids: a review
Melpomeni Peppa, Maria Krania, Sotirios A Raptis
Published Date: 3 March 2011
Fadi Kayali, Muhamad A Janjua, Damian A Laber, Donald Miller, Goetz H Kloecker
Published Date: 6 February 2011
Paul A Bourne, Chloe Morris, Christopher AD Charles, et al
Published Date: 26 May 2010
Eduardo Pimenta, Suzanne Oparil
Published Date: 19 May 2009
Local anesthetic failure associated with inflammation: verification of the acidosis mechanism and the hypothetic participation of inflammatory peroxynitrite
Takahiro Ueno, Hironori Tsuchiya, Maki Mizogami, Ko Takakura
Published Date: 13 November 2008