Treatment of osteoarthritis with Pycnogenol^®. The SVOS (San Valentino osteo‐arthrosis study). evaluation of signs, symptoms, physical performance and vascular aspects

Abstract

The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of 100 mg Pycnogenol daily (oral capsules) in a 3 month study in patients with osteoarthritis (OA). OA symptoms were evaluated by WOMAC scores, mobility by recording their walking performance (treadmill). Treatment (77 patients) and placebo group (79) were comparable for age, sex distribution, WOMAC scores, walking distances and use of antiinflammatory drugs. The global WOMAC score decreased by 56% (p < 0.05) in the treatment group versus 9.6% in the placebo group. Walking distance in the treadmill test was prolonged from 68 m at the start to 198 m after 3 months treatment (p < 0.05), under placebo, from 65 m to 88 m (NS). The use of drugs decreased by 58% in the treatment group (p < 0.05) versus 1% under placebo. Gastrointestinal complications decreased by 63% in the treatment group, but only 3% under placebo. Overall, treatment costs were reduced significantly compared with placebo. Foot edema was present in 76% of the patients of the treatment group at inclusion and in 79% of the controls. After 3 months edema decreased in 79% of Pycnogenol patients (p < 0.05) vs 1% in controls. In conclusion, Pycnogenol offers an option for reduction of treatment costs and side effects by sparing antiinflammatory drugs.

Pine Bark Extracts: Nutraceutical, Pharmacological, and Toxicological Evaluation

“…Downregulation of 5-lipoxygenase consequently decreases leukotriene levels in asthmatic patients (Canali et al, 2009), and the anti-inflammatory activity of PYC may be best used in combination with inhalation corticosteroids, enabling reduced dosage and frequency of inhalation corticosteroid administration and potentially reducing the need for other asthma medications . Anti-inflammatory properties include alleviating pain and stiffness in arthritis and osteoarthritis patients (Belcaro et al, 2008a), and PYC is a promising antiarthritic drug candidate.…”

Oral herbal therapies for treating osteoarthritis

“…Eighteen studies were of confirmatory design (Altman 2001; Appelboom 2001; Belcaro 2008; Biegert 2004; Blotman 1997; Chopra 2004; Chopra 2013; Jung 2001; Jung 2004; Kuptniratsaikul 2009; Kuptniratsaikul 2011; Leblan 2000; Lequesne 2002; Maheu 1998; Maheu 2013; Pavelka 2010; Sengupta 2008; Sengupta 2010), that is effect size was estimated a priori, statistical power and alpha level were set, and sample size recruitment undertaken according to these calculations. The remaining 32 studies were of exploratory design and were generally of poorer methodological quality.…”

“…A total of 45 new studies, including four studies published between 1988 and 1997 that had been overlooked in the previous review (Bernhardt 1991; Huber 1991; Schadler 1988; Schmelz 1997), were identified for inclusion in the updated review (Adegbehingbe 2008; Altman 2001; Appelboom 2001; Badria 2002; Belcaro 2008; Biegert 2004; Biller 2002; Bliddal 2000; Cao 2005; Cheras 2010; Chopra 2004; Chopra 2011; Chopra 2013; Cisar 2008; Farid 2007; Frerick 2001; Gupta 2011; Jung 2001; Jung 2004; Kimmatkar 2003; Kuptniratsaikul 2009; Kuptniratsaikul 2011; Leblan 2000; Lequesne 2002;Maheu 2013;Majima 2012;Medhi 2009; Mehta 2007; Oben 2009; Pavelka 2010; Piscoya 2001; Rein 2004a; Schmid 2000; Sengupta 2008; Sengupta 2010; Sontakke 2007; Teekachunhatean 2004; Vishal 2011; Warholm 2003;Wigler 2003;Winther 2005). These new studies were added to the four studies of oral herbal products included in the original review (Blotman 1997; Ferraz 1991; Maheu 1998; Mills 1996).…”

“…We attributed low risk of bias to 28 studies that fully described an appropriate process of generating a randomisation schedule (Adegbehingbe 2008; Altman 2001; Belcaro 2008; Bernhardt 1991; Biegert 2004; Bliddal 2000; Blotman 1997; Cheras 2010; Chopra 2004; Chopra 2013; Jung 2004; Kimmatkar 2003; Kuptniratsaikul 2011; Lequesne 2002; Maheu 1998; Maheu 2013; Mehta 2007; Oben 2009; Pavelka 2010; Rein 2004a; Schmid 2000; Sengupta 2008; Sengupta 2010; Sontakke 2007; Vishal 2011; Warholm 2003; Wigler 2003; Winther 2005). We also attributed low risk of bias to two studies that reported compliance with the ICH GCP guidelines but did not fully describe the randomisation processes because in these studies adequate randomisation processes could be inferred (see Other potential sources of bias) (Biller 2002; Frerick 2001).…”

“…Allocation concealment was assessed according to the Cochrane format, as described in the methods (Higgins 2011). We attributed low risk of bias to three studies (Adegbehingbe 2008;Maheu 1998; Maheu 2013) in which allocation concealment was explicitly reported, and the 20 studies in which it could reasonably be inferred from the description of methods (Altman 2001; Belcaro 2008; Bernhardt 1991; Biegert 2004; Biller 2002; Bliddal 2000; Cao 2005; Cheras 2010; Chopra 2004; Chopra 2013; Frerick 2001; Kimmatkar 2003; Lequesne 2002; Pavelka 2010; Rein 2004a; Schmid 2000; Sengupta 2010;Vishal 2011;Wigler 2003;Winther 2005). One study reported that allocation was not concealed, neither from participants nor the research assistant (Kuptniratsaikul 2011).…”