BACKGROUND: A randomized, pilot, placebo-controlled clinical trial was conducted with the aim of evaluating the effectiveness of a cream based on Bach flower remedies (BFR) on symptoms and signs of carpal tunnel syndrome. METHODS:Forty-three patients with mild to moderate carpal tunnel syndrome during their "waiting" time for surgical option were randomized into 3 parallel groups: Placebo (n = 14), blinded BFR (n = 16), and nonblinded BFR (n = 13). These groups were treated during 21 days with topical placebo or a cream based on BFR. RESULTS: Significant improvements were observed on self-reported symptom severity and pain intensity favorable to BFR groups with large effect sizes (η2partial > 0.40). In addition, all signs observed during the clinical exam showed significant improvements among the groups as well as symptoms of pain, night pain, and tingling, also with large effect sizes (φ > 0.5). Finally, there were significant differences between the blinded and nonblinded BFR groups for signs and pain registered in clinical exam but not in self-reports. CONCLUSION: The proposed BFR cream could be an effective intervention in the management of mild and moderate carpal tunnel syndrome, reducing the severity symptoms and providing pain relief.
RCT Entities:
BACKGROUND: A randomized, pilot, placebo-controlled clinical trial was conducted with the aim of evaluating the effectiveness of a cream based on Bach flower remedies (BFR) on symptoms and signs of carpal tunnel syndrome. METHODS: Forty-three patients with mild to moderate carpal tunnel syndrome during their "waiting" time for surgical option were randomized into 3 parallel groups: Placebo (n = 14), blinded BFR (n = 16), and nonblinded BFR (n = 13). These groups were treated during 21 days with topical placebo or a cream based on BFR. RESULTS: Significant improvements were observed on self-reported symptom severity and pain intensity favorable to BFR groups with large effect sizes (η2partial > 0.40). In addition, all signs observed during the clinical exam showed significant improvements among the groups as well as symptoms of pain, night pain, and tingling, also with large effect sizes (φ > 0.5). Finally, there were significant differences between the blinded and nonblinded BFR groups for signs and pain registered in clinical exam but not in self-reports. CONCLUSION: The proposed BFR cream could be an effective intervention in the management of mild and moderate carpal tunnel syndrome, reducing the severity symptoms and providing pain relief.
Authors: Mohammad Setayesh; Amir Reza Sadeghifar; Nozar Nakhaee; Mohammad Kamalinejad; Hossein Rezaeizadeh Journal: J Evid Based Complementary Altern Med Date: 2016-12-01