Rubus idaeus extract improves symptoms in knee osteoarthrit…

Henrotin et al. BMC Musculoskeletal Disorders

(2022) 23:650

Page 9 of 11

rescue medication use. For those with data, 61.0% (Total N = 108; Placebo N = 33; Active product N = 75) took no rescue medication before baseline to the end of the study, and 22.0% (Total N = 39; Placebo N = 15; Active product N = 24) reduced their use of rescue medication, 13.6% (Total N = 24; Placebo N = 11; Active product N = 13) increased their use of rescue medication and 3.4% (Total N = 6; Placebo N = 3; Active product N = 3) used the rescue medication at the same frequency that at base- line and week 12. The active product group (either dose) attended to have a higher ratio (61.5%; N = 24) of reduc- ing their rescue medication use compared to the placebo (38.5%; N = 15). Discussion In this paper, we report the data of a clinical trial investigating the clinical efficacy of two doses of RIE, administered orally for 3 months in patients with symptomatic established knee OA. Compared to pla- cebo, RIE was not effective on the WOMAC pain which was the primary end-point. In contrast, RIE sig- nificantly and rapidly relieved pain evaluated by VAS in knee OA patients. At the daily dosage of 200 mg or 400 mg, the effect size calculated on the VAS pain score of the ITT population was 0.30 and 0.45 after 12 weeks, respectively. Compared to NSAIDs and par- acetamol, the effect size for the pain of RIE is compa- rable. Indeed, a meta-analysis has reported effect sizes for pain compared to oral placebo comprised between 0.38 and 0.52 for NSAIDs after 12 weeks of treatment [10]. Comparing to paracetamol (ES: 0.18 (0.04 to

were due to gastrointestinal issues reported by ten par- ticipants ( N = 1 Placebo; N = 5 RIE 200 mg group; N = 4 RIE 400 mg group) where three participants had to dis- continue the study due to diarrhea. One of these AEs (RIE 400 mg) was deemed severe for epigastric pain (RIE 400 mg) but this had resolved within one day with no reoccurrence. Two (8.3%) were due to skin rashes ( N = 2 RIE 400 mg group). The two remaining AEs were a severe AE for a swollen knee (RIE 400 mg) and an AE (Placebo) for Deep Vein Thrombosis which occurred after a flight abroad. In sum, there were no SAEs related to the product and there was a low proportion of related-to-product AEs in either active product group. In addition, the overall pat- tern of safety blood panel and vitals results from baseline to end of the intervention indicated no safety concerns. The product can be viewed as tolerable as only 2.2% ( N = 3) of the active product groups ( N = 135) had to dis- continue the product due to gastrointestinal AE. In total, 191 participants returned their product by end of the trial and the population had high study product compliance and adherence to protocol. Of the partici- pants who returned the product, 185 (96.9%) had a study product consumption compliance equal to or greater than 80%. The mean compliance was 95.96% (SD 7.12, Min 57.0%, max 110.0%). Rescue medication use was recorded in the daily e-diary app as an exploratory outcome. This analy- sis focused on the week before baseline and week 12 (Table 3). Due to missing data, 21 participants from the ITT population were not included in the analysis for

Table 3 Rescue Medication Use the week prior to baseline and end of intervention in the ITT population for participants with available data ( N = 177) N %

Placebo ( N = 62)

No medication use at either Week 0 or Week 12 Medication use reduces from Week 0 to Week 12 Medication use increases from Week 0 to Week 12 No change between Week 0 and Week 12 No medication used at either Week 0 or Week 12 Medication use reduces from Week 0 to Week 12 Medication use increases from Week 0 to Week 12 No change between Week 0 and Week 12 No medication used at either Week 0 or Week 12 Medication use reduces from Week 0 to Week 12 Medication use increases from Week 0 to Week 12 No change between Week 0 and Week 12 No medication used at either Week 0 or Week 12 Medication use reduces from Week 0 to Week 12 Medication use increases from Week 0 to Week 12 No change between Week 0 and Week 12

33 15 11

53.2% 24.2% 17.7%

3

4.8%

Treatment (200 dose) ( N = 59)

43 11

72.9% 18.6%

2 3

3.4% 5.1%

Treatment (400 dose) ( N = 56)

32 13 11

57.1% 23.2% 19.6%

0

0.0%

Treatment ( N = 115)

75 24 13

65.2% 20.9% 11.3%

3

2.6%

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