The DOI matches its Crossref record; 41 of the 42 references it cites were found in a registry or an index; 6 of the 50 sources its claims cite were checked for support.
Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial
Abstract
BACKGROUND: Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis. The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide acetate (LA) for treating the pain associated with endometriosis. METHODS: Patients with confirmed endometriosis were randomized to treatment with dienogest (2 mg/day, orally) or LA (3.75 mg, depot i.m. injection, every 4 weeks) for 24 weeks. The primary efficacy variable was absolute change in pelvic pain from baseline to end of treatment, assessed by visual analogue scale (VAS). Safety variables included adverse event profile, laboratory parameters, bone mineral density (BMD), bone markers and bleeding patterns. RESULTS: A total of 252 women were randomized to treatment with dienogest (n = 124) or LA (n = 128); 87.9 and 93.8% of the respective groups completed the trial. Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA, demonstrating the equivalence of dienogest relative to LA. Hypoestrogenic effects (e.g. hot flushes) were reported less frequently in the dienogest group. As expected, bleeding episodes were suppressed less with dienogest than with LA. Changes in mean lumbar BMD between screening and final visit were +0.25% with dienogest and -4.04% with LA subgroups (P = 0.0003). Markers of bone resorption increased with LA but not dienogest. CONCLUSIONS: Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis, although offering advantages in safety and tolerability.
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Claims the paper makes
50 Own result · 23 Own method · 12 No full text of the sources · 9 Own interpretation · 5 Sources not found · 5 Not checked yet · 5 No basis given · 4 Partly supported · accuracy not yet measured
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“As is appropriate for noninferiority studies (Piaggio et al., 2006), the primary analysis was based on the per protocol set (PPS), which included all randomized patients except those with major protocol deviations that affected the primary efficacy variable.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Statistical analysis
What the sources say
- Partly supportedcites Piaggio et al., 2006 sourceExperimental — accuracy not yet measured
The Methodological Issues section (p. 2) says per-protocol or other non-ITT analyses might be desirable in noninferiority trials because ITT can increase the risk of falsely concluding noninferiority. It also warns that excluding nonadherent patients can bias results in either direction, so it does not unconditionally endorse a per-protocol primary analysis. The cited paper does not define the citing study’s specific PPS exclusions; those are the citing authors’ description of their own analysis. (LLM, conf=0.84)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“By Week 24, mean VAS scores had decreased to 12.7 (+20.3)mm in the dienogest group and to 11.9 (+16.9)mm in the LA group (PPS; Fig. 2).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Primary efficacy variable
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Seven serious adverse events were reported in six women during the study.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Adverse events
plainn = 6- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Headache was the most common treatment-related adverse event in both groups (12.5%, dienogest; 19.5%, LA; Table II).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Adverse events
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The proportions of women who experienced an improvement in VAS score by study end were similar in the dienogest and LA groups.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Secondary efficacy variables
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Both dienogest and LA were associated with substantial reductions in VAS score between baseline and Week 24.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Primary efficacy variable
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: The open-label design did not bias the assessment of pelvic pain by visual analogue scale.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Responder analyses showed similar proportions of responders in the two treatment groups for all response definitions that were investigated.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Secondary efficacy variables
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Comparison of bleeding patterns during the first 90-day reference period showed that infrequent bleeding was the predominant pattern (80.6%) in the LA group, while the highest incidences in the dienogest group were prolonged bleeding (45.1%) and irregular bleeding (44.2%).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Bleeding patterns
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In the PPS, 96.7% of women in the dienogest group and 95.8% of women in the LA group experienced an improvement in pelvic pain after 24 weeks in comparison with baseline (P for non-inferiority , 0.0001).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Secondary efficacy variables
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean (+SD) serum bone-specific alkaline phosphatase levels increased at 24 weeks relative to baseline by 0.2 (+2.5) mg/l in the dienogest group and by 3.2 (+3.0) mg/l in the LA group (FAS).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Markers of bone metabolism
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- It may state two separate claims as one. 36
- Probably not a substantial claim. 19
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Depot medroxyprogesterone acetate (MPA; 104 mg, subcutaneous injection, every 3 months) has demonstrated an efficacy equivalent to LA, but long-term use of depot MPA preparations is shown to impact adversely on bone mineral density (BMD), while the delay in resumption of ovulation that may follow discontinuation of this therapy is a contraindication to use in women wishing to conceive in the near”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Introduction
What the sources say
- Partly supportedcites Vercellini et al., 2003 sourceExperimental — accuracy not yet measured
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
- Not checked — no full text of the sourcecites Crosignani et al., 2006 source
- Partly supportedcites Schlaff et al., 2006 sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Progestins offer long-term efficacy in endometriosis, but a number of these agents are associated with weight gain and androgenic effects when administered at the high doses required for efficacy”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Introduction
What the sources say
- Not checked — no full text of the sourcecites Mahutte and Arici, 2003 source
- Partly supportedcites Vercellini et al., 2003 sourceExperimental — accuracy not yet measured
The Introduction and Conclusions say progestogens can be used long term and effectively control endometriosis pain. The Results report weight gain with some treatments and describe medroxyprogesterone acetate as having moderate androgenic activity. They do not establish that high doses are required for efficacy or link those adverse effects specifically to such doses. (LLM, conf=0.86)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Irregular uterine bleeding is a known adverse effect of treatment with progestins, including depot preparations of MPA, which have been compared in trials against LA (Vercellini et al., 2003;Crosignani et al., 2006;Schlaff et al., 2006).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
- Partly supportedcites Vercellini et al., 2003 sourceExperimental — accuracy not yet measured
The intramuscular-route section identifies DMPA as a depot formulation of MPA and says uterine breakthrough bleeding may be prolonged and repeated. The paper describes a DMPA trial against an oral contraceptive plus danazol, but the passages do not support the claim that depot MPA was compared against LA. (LLM, conf=0.86)
- Not checked — no full text of the sourcecites Crosignani et al., 2006 source
- Supportedcites Schlaff et al., 2006 source
The Safety and Tolerability section reports more intermenstrual bleeding and significantly more bleeding or spotting days with depot medroxyprogesterone acetate (DMPA-SC 104) than with leuprolide. The discussion (p. 323) identifies increased spotting and bleeding as the treatment’s most significant disadvantage and describes its side effects as typical of progestin-only contraception. (LLM, conf=0.94)
boostedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Partly supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean (+SD) body weight increased marginally and to a similar extent in the dienogest group (1.21 + 4.12 kg) and the LA group (1.15 + 3.46 kg; FAS).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Vital signs and weight
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean levels of serum estradiol remained stable in the dienogest subgroup (n ¼ 32; from 256.3 to 249.9 pmol/l) and showed a pronounced decrease in the LA subgroup (n ¼ 38; from 299.0 to 68.5 pmol/l; Fig. 4a).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Clinical laboratory parameters
plainn = 32- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Continued use of dienogest was also associated with shift in incidence toward amenorrhoea (from 1.8% in period 1 to 38.9% in period 2), with reductions in irregular and prolonged bleeding (16.7 and 7.4%, respectively, in period 2).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Bleeding patterns
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean (+SD) VAS score reductions were 40.2 (+32.0)mm in the dienogest group and 41.8 (+28.6)mm in the LA group, representing a treatment difference of 1.6 mm (95% CI, -6.42 to 9.58; P for non-inferiority ¼ 0.0004).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Primary efficacy variable
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The severity of the individual symptoms of pelvic pain, dysmenorrhoea and dyspareunia and the severity of the physical signs of pelvic tenderness and induration also decreased in both treatment groups between screening and final visit (data not shown).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Secondary efficacy variables
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The absolute reduction in VAS score was 47.5 (+28.8)mm with dienogest and 46.0 (+24.8)mm with LA, representing a treatment difference of 1.5 mm in favour of dienogest [95% confidence interval (CI), -9.26 to 6.25).”
- Also stated in: § Abstract · boosted
“Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA, demonstrating the equivalence of dienogest relative to LA.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Primary efficacy variable
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § Abstract · boosted
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean BMD of the lumbar spine (L1-L4) was 1.062 g/cm 2 in the dienogest subgroup (n ¼ 26) and 1.070 g/cm 2 in the LA subgroup (n ¼ 31) at screening, and was 1.036 g/cm 2 (n ¼ 23) and 1.014 g/cm 2 (n ¼ 30), respectively, at final visit (FAS).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Bone mineral density
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In women whose measurements were available at both screening and final visit, mean lumbar BMD increased by 0.0022 g/cm 2 in the dienogest subgroup (n ¼ 21) and decreased by 0.0415 g/cm 2 in the LA subgroup (n ¼ 29), representing mean (+SD) percentage changes of þ0.25 (+2.77) and -4.04 (+4.84) for dienogest and LA, respectively (P ¼ 0.0003 for superiority of dienogest; Fig. 4c).”
- Also stated in: § Abstract · plain
“Changes in mean lumbar BMD between screening and final visit were þ0.25% with dienogest and -4.04% with LA subgroups (P ¼ 0.0003).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Bone mineral density
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The bone mineral density subgroup is representative of the overall study population.
- Also stated in: § Abstract · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean (+SD) serum osteocalcin levels decreased by 0.4 (+1.5) nmol/l in the dienogest group and increased by 0.5 (+1.4) nmol/l in the LA group (FAS).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Markers of bone metabolism
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Quality of life, assessed by the SF-36 Health Survey, improved in both treatment groups, with an indication of more pronounced benefit in the dienogest than LA group.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Quality-of-life variables
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean (+SD) urinary Cross-Laps w levels increased by 7.6 (+261.8)mg/mmol creatinine in the dienogest group and by 189.4 (+231.0)mg/mmol creatinine in the LA group (FAS).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Markers of bone metabolism
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean (+SD) urine calcium levels decreased by 137.4 (+295.5)mmol/mol creatinine in the dienogest group and increased by 111.3 (+ 227.9) mmol/mol creatinine in the LA group during the study (FAS).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Markers of bone metabolism
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In general, the number of bleeding/spotting episodes and the number of bleeding/spotting days over time decreased in both groups, with a stronger trend in the LA group than in the dienogest group (Table III).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Bleeding patterns
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Whereas 12.2% of women in the dienogest group and 6.3% of women in the LA group had very severe symptoms at screening, none had this symptom grade at final visit.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Secondary efficacy variables
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mean lumbar BMD was unchanged over the study period in dienogest-treated women, but decreased by approximately 4% in the LA group, with statistically significant differences in mean BMD between the treatment groups.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Adverse events were of mild or moderate intensity in most women and overall rates of study discontinuation due to adverse events were low in both groups.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In addition, dienogest was associated with acceptable safety and tolerability, offering advantages when compared with LA including a substantially lower incidence of hot flushes and minimal change in BMD and bone metabolism.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study protocol was approved by the local independent ethics committees and all participants provided written, informed consent before study enrolment.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Patients were randomized in a 1:1 distribution to receive dienogest at a dose of 2 mg, given orally at the same time once daily, or LA at a standard dose of 3.75 mg as a depot i.m. injection every 4 weeks.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study was a 24-week, multicentre, randomized, open-label, parallel-group study of dienogest versus LA.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Compliance with dienogest treatment was monitored by diary records completed by patients.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The VAS score was selected as the primary efficacy variable in this study because the VAS is an appropriate and well-established tool for the measurement of pelvic pain associated with endometriosis”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Efficacy variables
What the sources say
- Not checked — no full text of the sourcecites Fauconnier et al., 2009 source
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Randomization was done using randomization blocks, with a randomization list generated by Corporate Biometry, Schering AG.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Assuming a withdrawal rate of 30%, a total of 252 patients was therefore required for enrolment.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Statistical analysis
plainn = 252- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis, although offering advantages in safety and tolerability.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Abstract
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The open-label design did not bias the assessment of pelvic pain by visual analogue scale.
- Rests on an assumption: The bone mineral density subgroup is representative of the overall study population.
- Rests on an assumption: The trial population is representative of women with endometriosis in general.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Dienogest is a selective progestin that combines the pharmacological properties of 19-norprogestins and progesterone derivatives, offering a pronounced progestogenic effect at the endometrium with an absence of androgenicity and moderate suppression of ovarian activity”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Introduction
What the sources say
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The FAS analysis included 248 patients (n ¼ 120, dienogest; n ¼ 128, LA), while the PPS analysis included 186 women (n ¼ 90, dienogest; n ¼ 96, LA).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Patient characteristics
plainn = 248- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Danazol is characterized by adverse changes in lipid metabolism and androgenic adverse effects, including weight gain, oedema, acne, hirsutism and oily skin, which lead to low compliance with therapy”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Introduction
What the sources say
- Not checked — no full text of the sourcecites Winkel and Scialli, 2001 source
- Not matchedcites Selak et al., 2007
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The number of patients whose BMD had to be measured was calculated under the assumption of a 4% point difference in BMD change between the treatments and a common SD of 4% points.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Statistical analysis
plainn = 22- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“A total of 88 evaluable patients were required in each treatment group to yield a power (1 -b) of 90% to demonstrate the non-inferiority of dienogest relative to LA.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Statistical analysis
plainn = 88- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“By this approach, 22 evaluable patients per group were needed to achieve the power (1-b) ¼ 90%.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Statistical analysis
plainn = 22- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In a phase II dose-finding study, dienogest 2 mg daily offered improvements in patient-reported symptoms and in second-look laparoscopic assessments of pathology after 24 weeks.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
- Not matchedcites Ko ¨hler et al., 2010
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Of 269 women screened, 252 were randomized to treatment with either dienogest (n ¼ 124) or LA (n ¼ 128; Fig. 1).”
- Also stated in: § Abstract · plain
“A total of 252 women were randomized to treatment with dienogest (n ¼ 124) or LA (n ¼ 128); 87.9 and 93.8% of the respective groups completed the trial.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Patient characteristics
plainn = 252- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Also stated in: § Abstract · plain
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“In clinical trials, including a dose-response study (Ko ¨hler et al., 2010), a placebo-controlled study (Seitz et al., 2008), an activecontrolled study versus triptorelin after laparoscopic surgery (Cosson et al., 2002) and a long-term safety study (Seitz et al., 2009), dienogest was shown to be an effective and well-tolerated treatment for endometriosis.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Introduction
What the sources say
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Combined oral contraceptives, whereas widely used to manage symptoms of endometriosis, are not approved for this indication in most countries and lack a solid body of supportive clinical trial evidence”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Introduction
What the sources say
- Not checked — no full text of the sourcecites Davis et al., 2007 source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“BMD was assessed in a subgroup of 57 women (n ¼ 26, dienogest; n ¼ 31, LA), and estradiol levels were measured in 70 women (n ¼ 32, dienogest; n ¼ 38, LA).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Patient characteristics
plainn = 57- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The sample size was calculated on the assumption of equal efficacy for dienogest and LA and a common standard deviation (SD) of 30 mm for the primary efficacy variable.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Statistical analysis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The efficacy and safety profile of dienogest characterized in this study suggests that dienogest may offer an effective and well-tolerated treatment in endometriosis.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“As VAS scoring for pain is a subjective measure, the process of obtaining patients' scores by investigators could have introduced bias.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“GnRH agonists such as LA are associated with hypoestrogenic effects and related adverse effects on BMD (Winkel and Scialli, 2001), which limits treatment to 6 months in the absence of add-back therapy.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
- Not checked — no full text of the sourcecites Winkel and Scialli, 2001 source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Although add-back therapy can reduce the hypoestrogenic effects of GnRH agonists, the optimal add-back regimen has not yet been established and this approach adds to the cost of therapy (Mounsey et al., 2006).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
- Not matchedcites Mounsey et al., 2006
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Not matched
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Dienogest, in contrast, appears to have no relevant effect on lipids (Ko ¨hler et al., 1989;Schindler et al., 2006;Seitz et al., 2008) and lacks androgenic side effects (Oettel et al., 1999;Schindler et al., 2003).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: Danazol is associated with adverse effects on lipid metabolism and androgenic adverse effects.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Despite these potential limitations, dienogest provided consistent improvements in a range of patient-and physician-assessed symptoms at 24 weeks similar to LA, indicating that these outcomes are robust and clinically relevant in the treatment of endometriosis.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“This may also indicate an advantage of dienogest compared with depot MPA, which has been associated with a significant loss of BMD resulting in a 'black box warning' by the US Food and Drug Administration (Physician Information, 2009).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
- Not matchedcites Physician Information, 2009
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“A further potential limitation of the study relates to a treatment duration that was restricted to 24 weeks, which was necessary because GnRH agonists are approved in the treatment of endometriosis for up to 6 months only, due to their deleterious effects on BMD.”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Other studies that examined bleeding patterns during dienogest treatment, including the 1-year extension study, also reported progressive reductions in bleeding irregularity over time (Cosson et al., 2002;Seitz et al., 2008Seitz et al., , 2009;;Ko ¨hler et al., 2010).”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Discussion
What the sources say
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper relies on this without support.
The open-label design did not bias the assessment of pelvic pain by visual analogue scale.
“The study was a 24-week, multicentre, randomized, open-label, parallel-group study of dienogest versus LA.”
“The primary efficacy variable was the absolute change in endometriosis-associated pelvic pain from baseline to the end of treatment, assessed by a visual analogue scale (VAS; 0 mm ¼ absence of pain, 100 mm ¼ unbearable pain).”
The paper relies on this without support.
The bone mineral density subgroup is representative of the overall study population.
“BMD was assessed in a subgroup of 57 women (n ¼ 26, dienogest; n ¼ 31, LA)”
“In women whose measurements were available at both screening and final visit, mean lumbar BMD increased by 0.0022 g/cm 2 in the dienogest subgroup (n ¼ 21) and decreased by 0.0415 g/cm 2 in the LA subgroup (n ¼ 29)”
The paper relies on this without support.
The trial population is representative of women with endometriosis in general.
“Women aged 18 -45 years were eligible for study enrolment if they experienced pain associated with histologically proven endometriosis in revised-American Fertility Society (r-AFS, 1985) stages I -IV.”
“Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis”
The paper relies on this without support.
Pelvic pain is one of the most important symptoms of endometriosis.
“as pelvic pain is one of the most important symptoms of endometriosis”
The paper relies on this without support.
Weight gain is a characteristic of a number of other progestins used in endometriosis.
“Weight gain, which is a characteristic of a number of other progestins used in endometriosis, was minimal in dienogesttreated women.”
The paper relies on this without support.
Danazol is associated with adverse effects on lipid metabolism and androgenic adverse effects.
“Danazol, although remaining a standard therapy for endometriosis in some countries, is associated with adverse effects on lipid metabolism and androgenic adverse effects.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Six months of GnRHa treatment improved women’s HRQoL even at one year after treatment, according to the SF-36 questionnaire [24-27,29], as well as work-related indexes [18,20].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [29]
Experimental — accuracy not yet measuredIn the citing paper
“Progestins can be used in women with metabolic or cardiovascular contraindications to estrogen–progestins and limit the risk of post-operative dysmenorrhea recurrence also when released locally via an intrauterine system (Strowitzki et al., 2010; Brown et al., 2012; Petraglia et al., 2012; Abou-Setta et al., 2013).”
From When more is not better: 10 ‘don’ts’ in endometriosis management. An ETIC* position statement (2019) · cites this paper as Strowitzki et al., 2010
In the citing paper
“Progestins can be used in women with metabolic or cardiovascular contraindications to estrogen–progestins and limit the risk of post-operative dysmenorrhea recurrence also when released locally via an intrauterine system (Strowitzki et al., 2010; Brown et al., 2012; Petraglia et al., 2012; Abou-Setta et al., 2013).”
From When more is not better: 10 ‘don’ts’ in endometriosis management. An ETIC* position statement (2019) · cites this paper as Strowitzki et al., 2010
In the citing paper
“The lack of changes in laboratory parameters supports previous trials that investigated the metabolic effects of dienogest [13, 14, 16, 23].”
From Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment (2012) · cites this paper as [14]
In the citing paper
“In addition, there were minimal changes in mean body weight, consistent with the previous dienogest experience [13, 14, 16].”
From Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment (2012) · cites this paper as [14]
In the citing paper
“Clinical trials of 12–24 weeks’ duration have shown that dienogest (at a dose of 2 mg/day) provides effective pain relief equivalent to GnRH agonists, a reduction of endometriotic lesions and a favorable safety and tolerability profile in endometriosis [12–14].”
From Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment (2012) · cites this paper as [14]
In the citing paper
“Moreover, DNG was particularly well tolerated by women with symptomatic endometriosis (43,44).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [43]
In the citing paper
“Dienogest, a semisynthetic 19-nortestosterone-derivative progestin, has been investigated and registered also for the treatment of endometriosis.Its effect on pain was demonstrated to be significantly superior to placebo and equivalent to a GnRH analogue (43,44).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [43]
In the citing paper
“Women were informed that DNG was indicated as step 3 instead of step 2 because DNG is much more expensive that NETA and may have an adverse impact on bone mineral density (43,45).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [43]
In the citing paper
“Women were informed that DNG was indicated as step 3 instead of step 2 because DNG is much more expensive that NETA and may have an adverse impact on bone mineral density (43,45).”
From A stepped-care approach to symptomatic endometriosis management: A participatory research initiative (2018) · cites this paper as [43]
In the citing paper
“Progestins were positively associated with HRQoL in women with endometriosis [20,21,23-25,27,29,30].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [29]
In the citing paper
“Moreover, six months of therapy with progestins seemed equivalent to that of GnRHa in improving HRQoL and reducing pain, according to six RCTs [20,23-25,27,29].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [29]
In the citing paper
“Similar results were reported for dienogest in women with symptomatic endometriosis [27,29].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [29]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
“Dienogest 2 mg (n 5 120) Leuprolide acetate 3.75 mg (n 5 128) n % n % Headache 15 12.5 25 19.5 Weight gain 8 6.7 5 3.9 Depression 6 5.0 11 8.6 Decreased libido 5 4.2 8 6.3 Acne 5 4.1 6 4.7”
§ Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial > Clinical laboratory parameters
Reported 4.1 · recomputed 4.166667
Cited works that were retracted
Works this paper cites that were later retracted, from the retraction notices publishers deposit. Major when the notice came out before this paper was published.
Rated major: it would touch a result — a value a result rests on, reported and recomputed p-values on opposite sides of the significance level, two passages that conflict with no sign which is right, or a cited work retracted before this paper was published.
Cited work 10.1002/14651858.cd000346 · retracted 1999-04-26 · notice 10.1002/14651858.cd000346.pub2 · this paper published 2010-01-19
Citations
Cites
1 retracted
Gonadotrophin-releasing hormone analogues for pain associated with endometriosis
Prentice, A., Deary, A., Goldbeck-Wood, S., Farquhar, C., & Smith, S. (1999) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000346 · Cited by 116
RetractedTHE JOURNAL OF REPRODUCTIVE MEDICINE
Reddy, D. M., & Wasserman, S. A. (1999) · AJN American Journal of Nursing · doi:10.1097/00000446-199901000-00024 · Cited by 2,483
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Endometriosis: pathogenesis and treatment
Vercellini, P., Viganò, P., Somigliana, E., & Fedele, L. (2014) · Nature Reviews Endocrinology · doi:10.1038/nrendo.2013.255 · Cited by 1,940
Endometriosis is a chronic systemic disease: Clinical challenges and novel innovations
Taylor, H. S., Kotlyar, A. M., & Flores, V. A. (2021) · The Lancet · doi:10.1016/s0140-6736(21)00389-5 · Cited by 1,425
Consensus on current management of endometriosis
Johnson, N. P., Hummelshoj, L., for the World Endometriosis Society Montpellier Consortium, Abrao, M. S., Adamson, G. D., Allaire, C., Amelung, V., Andersson, E., Becker, C., Birna Árdal, K. B., et al. (2013) · Human Reproduction · doi:10.1093/humrep/det050 · Cited by 558
“…(Vercellini et al., 2011; Brown et al., 2012) and dienogest (Cosson et al., 2002; Harada et al., 2009; Momoeda et al., 2009; Köhler et al., 2010; Strowitzki et al., 2010a, b, 2012; Petraglia et al., 2012) can also be considered as first-line treatments taking into consideration their different…”
BackgroundSelf-citationSystematic review of endometriosis pain assessment: how to choose a scale?
Bourdel, N., Alves, J., Pickering, G. P., Ramilo, I. D. T. M., Roman, H., & Canis, M. J. (2014) · Human Reproduction Update · doi:10.1093/humupd/dmu046 · Cited by 378
RETIRED: No. 345-Primary Dysmenorrhea Consensus Guideline
Burnett, M. A., & Lemyre, M. (2017) · Journal of Obstetrics and Gynaecology Canada · doi:10.1016/j.jogc.2016.12.023 · Cited by 365
Reevaluating response and failure of medical treatment of endometriosis: a systematic review
Becker, C. M., Gattrell, W. T., Gude, K., & Singh, S. S. (2017) · Fertility and Sterility · doi:10.1016/j.fertnstert.2017.05.004 · Cited by 302
“Among women receiving danazol, GnRH agonists, or progestins, the median proportions of individuals experiencing no improvement were 11% (one treatment arm) (9), 14% (range 0%–20%, three treatment arms) (16, 17), and 14% (range 3%–24%, four treatment arms) (34, 35, 51), respectively.”
BackgroundMethodProgestagens and anti-progestagens for pain associated with endometriosis
Brown, J., Kives, S., & Akhtar, M. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002122.pub2 · Cited by 250
Estrogen-progestins and progestins for the management of endometriosis
Vercellini, P., Buggio, L., Berlanda, N., Barbara, G., Somigliana, E., & Bosari, S. (2016) · Fertility and Sterility · doi:10.1016/j.fertnstert.2016.10.022 · Cited by 243
Strowitzki, T., Faustmann, T., Gerlinger, C., & Seitz, C. (2010) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2010.04.002 · Cited by 227
Self-citationNonsteroidal antiinflammatory drug resistance in dysmenorrhea: epidemiology, causes, and treatment
Oladosu, F. A., Tu, F. F., & Hellman, K. M. (2017) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2017.08.108 · Cited by 225
“APRIL 2018 Dienogest was also as effective in reducing menstrual pain when compared to the GnRH agonist leuprolide.(101) An open-label study found norethindrone acetate was as effective at reducing menstrual pain as OCPs.”
BackgroundTreatment of endometriosis: a review with comparison of 8 guidelines
Kalaitzopoulos, D. R., Samartzis, N., Kolovos, G. N., Mareti, Ε., Samartzis, E. P., Eberhard, M., Dinas, K., & Daniilidis, A. (2021) · BMC Women s Health · doi:10.1186/s12905-021-01545-5 · Cited by 231
“administration of dienogest showed comparable efficacy to GnRH-analogues with better tolerability [34, 35].”
BackgroundReduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment
Petraglia, F., Hornung, D., Seitz, C., Faustmann, T., Gerlinger, C., Luisi, S., Lazzeri, L., & Strowitzki, T. (2012) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-011-1941-7 · Cited by 200
“The lack of changes in laboratory parameters supports previous trials that investigated the metabolic eVects of dienogest [13, 14 , 16, 23].”
ResultInfluentialSelf-citationCasper, R. F. (2017) · Fertility and Sterility · doi:10.1016/j.fertnstert.2017.01.003 · Cited by 205
“In addition, there is evidence that progestin-only therapy may be as effective for pain relief as second-line therapies such as gonadotropin-releasing hormone agonists (40, 41).”
BackgroundMedical treatment of endometriosis-related pain
Vercellini, P., Buggio, L., Frattaruolo, M. P., Borghi, A., Dridi, D., & Somigliana, E. (2018) · Best Practice & Research Clinical Obstetrics & Gynaecology · doi:10.1016/j.bpobgyn.2018.01.015 · Cited by 188
“Waiting for Godot”: a commonsense approach to the medical treatment of endometriosis
Vercellini, P., Crosignani, P., Somigliana, E., Vigano, P., Frattaruolo, M. P., & Fedele, L. (2011) · Human Reproduction · doi:10.1093/humrep/deq302 · Cited by 180
“…GnRH agonists and aromatase inhibitors (Vercellini et al., 1993, 1996; Prentice et al., 2000, 2004; Cosson et al., 2002; Petta et al., 2005; Schlaff et al., 2006; Crosignani et al., 2006b; Davis et al., 2007; Selak et al., 2007; Harada et al., 2009; Ferrero et al., 2009b; Strowitzki et al., 2010a).”
BackgroundDienogest in the treatment of endometriosis: systematic review
Andres, M. P., Lopes, L. A., Baracat, E. C., & Podgaec, S. (2015) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-015-3681-6 · Cited by 166
Prevention of the recurrence of symptom and lesions after conservative surgery for endometriosis
Koga, K., Takamura, M., Fujii, T., & Osuga, Y. (2015) · Fertility and Sterility · doi:10.1016/j.fertnstert.2015.08.026 · Cited by 159
“relieving endometriosis-associated pain and was associated with a favorable safety profile and, therefore, can be considered an effective and well-tolerated treatment for endometriosis (36).”
BackgroundDienogest in long-term treatment of endometriosis
Schindler, A. E. (2011) · International Journal of Women s Health · doi:10.2147/ijwh.s5633 · Cited by 162
“57,58 An open-label pilot study of dienogest at the higher dose of 10 mg twice daily for 24 weeks provides additional information on the safety of this medication.”
BackgroundMenstruation pulls the trigger for inflammation and pain in endometriosis
Laux-Biehlmann, A., d’Hooghe, T., & Zollner, T. M. (2015) · Trends in Pharmacological Sciences · doi:10.1016/j.tips.2015.03.004 · Cited by 150
Current and emerging treatment options for endometriosis
Ferrero, S., Evangelisti, G., & Barra, F. (2018) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2018.1494154 · Cited by 152
“In these studies, the severity of women’s pain symptoms decreased significantly without inter-group differences [39,40].”
BackgroundBedaiwy, M. A., Allaire, C., & Alfaraj, S. (2017) · Fertility and Sterility · doi:10.1016/j.fertnstert.2016.12.024 · Cited by 126
“Lowest effective dose is 2 mg/d. Strowitzki et al. 2010 (18) Double-blind, placebocontrolled, multicenter RCT 198 [1] DNG, 2 mg/d (n ¼ 102) [2] Placebo (n ¼ 96) 12 wk Significantly superior to placebo in reduction of pelvic pain, dysmenorrhea, dyspareunia, and pelvic tenderness with remarkable…”
BackgroundSystematic review of quality of life measures in patients with endometriosis
Bourdel, N., Chauvet, P., Billone, V., Douridas, G., Fauconnier, A., Gerbaud, L., & Canis, M. J. (2019) · PLoS ONE · doi:10.1371/journal.pone.0208464 · Cited by 139
Gerlinger, C., Schumacher, U., Faustmann, T. A., Colligs, A., Schmitz, H., & Seitz, C. (2010) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-8-138 · Cited by 135
“, better tolerability and/or safety) even if it is not superior to existing treatments with regard to efficacy [19-21].”
BackgroundSelf-citationMcCormack, P. L. (2010) · Drugs · doi:10.2165/11206320-000000000-00000 · Cited by 126
“[23] The treatment difference for the absolute reduction in VAS score in favour of dienogest (1.5mm [95% CI -9.26, 6.25]) was within the prespecified noninferiority margin of 15mm (p 0.0001).”
InfluentialCurrent and Emerging Therapeutics for the Management of Endometriosis
Ferrero, S., Barra, F., & Maggiore, U. L. R. (2018) · Drugs · doi:10.1007/s40265-018-0928-0 · Cited by 135
Health-related quality of life in women with endometriosis: a systematic review
Jia, S.-Z., Leng, J.-H., Shi, J.-H., Sun, P.-R., & Lang, J.-H. (2012) · Journal of Ovarian Research · doi:10.1186/1757-2215-5-29 · Cited by 132
“Moreover, six months of therapy with progestins seemed equivalent to that of GnRHa in improving HRQoL and reducing pain, according to six RCTs [20,23-25,27,29].”
BackgroundMethodResultInfluentialVercellini, P., Bracco, B., Mosconi, P., Roberto, A., Alberico, D., Dhouha, D., & Somigliana, E. (2016) · Fertility and Sterility · doi:10.1016/j.fertnstert.2015.11.016 · Cited by 127
Treatment of pain associated with deep endometriosis: alternatives and evidence
Ferrero, S., Alessandri, F., Racca, A., & Maggiore, U. L. R. (2015) · Fertility and Sterility · doi:10.1016/j.fertnstert.2015.08.031 · Cited by 124
Use of dienogest in endometriosis: a narrative literature review and expert commentary
Murji, A., Biberoglu, K. O., Leng, J., Mueller, M. D., Römer, T., Vignali, M., & Yarmolinskaya, M. I. (2020) · Current Medical Research and Opinion · doi:10.1080/03007995.2020.1744120 · Cited by 123
Strowitzki, T., Faustmann, T., Gerlinger, C., Schumacher, U., Ahlers, C., & Seitz, C. (2015) · International Journal of Women's Health · doi:10.2147/ijwh.s77202 · Cited by 120
“Bone metabolism and BMD As previously reported, dienogest 2 mg was associated with minimal changes in bone turnover markers (bone alkaline phosphatase, osteocalcin, and urinary CrossLaps) and in lumbar spine BMD at 24 weeks.(12) LA-treated women showed increases in bone turnover markers and a clinically relevant reduc…”
InfluentialSelf-citationHayashi, A., Tanabe, A., Kawabe, S., Hayashi, M., Yuguchi, H., Yamashita, Y., Okuda, K., & Ohmichi, M. (2012) · Journal of Ovarian Research · doi:10.1186/1757-2215-5-31 · Cited by 116
“Dienogest (17a-cyanomethyl-17b-hydroxyestra-4,9-dien3-one) is an oral progestin that has been systematically investigated for the treatment of endometriosis in doseranging [25], placebo-controlled [26,27], active comparatorcontrolled [28,29] and long-term trials [30] conducted in Europe and Japan.”
BackgroundBone health in estrogen-free contraception
Hadji, P., Colli, E., & Regidor, P. (2019) · Osteoporosis International · doi:10.1007/s00198-019-05103-6 · Cited by 111
Ovarian hormones and chronic pain: A comprehensive review
Hassan, S. I., Muere, A., & Einstein, G. (2014) · Pain · doi:10.1016/j.pain.2014.08.027 · Cited by 115
“One investigated the efficacy of GnRH analogue with dienogest [103].”
Diagnosis and treatment of bladder endometriosis: state of the art
Maccagnano, C., Pellucchi, F., Rocchini, L., Ghezzi, M., Scattoni, V., Montorsi, F., Rigatti, P., & Colombo, R. (2012) · Urologia Internationalis · doi:10.1159/000339519 · Cited by 112
Barra, F., Scala, C., & Ferrero, S. (2018) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2018.1461840 · Cited by 100
“at lumbar spine, respectively) following a 6-month treatment with DNG [94,103].”
BackgroundMaccagnano, C., Pellucchi, F., Rocchini, L., Ghezzi, M., Scattoni, V., Montorsi, F., Rigatti, P., & Colombo, R. (2013) · Urologia Internationalis · doi:10.1159/000345140 · Cited by 100
Ruan, X., Seeger, H., & Mueck, A. O. (2012) · Maturitas · doi:10.1016/j.maturitas.2012.01.018 · Cited by 98
Yamanaka, K., Xu, B., Suganuma, I., Kusuki, I., Mita, S., Shimizu, Y., Mizuguchi, K., & Kitawaki, J. (2012) · Fertility and Sterility · doi:10.1016/j.fertnstert.2011.11.005 · Cited by 95
Endometriosis, an Ongoing Pain—Step-by-Step Treatment
Mechsner, S. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11020467 · Cited by 103
“under GnRha, aromatase inhibitor treatment (with or without progestin, COC or GnRH analog), significantly reduced pain compared with GnRH analog alone [17].”
An update on the pharmacological management of endometriosis
Streuli, I., de Ziegler, D., Santulli, P., Marcellin, L., Borghese, B., Batteux, F., & Chapron, C. (2013) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2013.767334 · Cited by 109
“for the treatment of endometriosis-related pain in a 24-week non-inferiority trial [57,58].”
BackgroundMethodEbert, A. D., Dong, L., Merz, M., Kirsch, B., Francuski, M., Böttcher, B., Roman, H., Suvitie, P., Hlavackova, O., Gude, K., et al. (2017) · Journal of Pediatric and Adolescent Gynecology · doi:10.1016/j.jpag.2017.01.014 · Cited by 97
Self-citationHormonal therapy for endometriosis: from molecular research to bedside
Tosti, C., Biscione, A., Morgante, G., Bifulco, G., Luisi, S., & Petraglia, F. (2017) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2016.05.032 · Cited by 96
“Quality-of-life analyses also demonstrated an improvement in both treatment groups, with a slightly greater benefit in the DNG group [48].”
Osuga, Y., Seki, Y., Tanimoto, M., Kusumoto, T., Kudou, K., & Terakawa, N. (2021) · Fertility and Sterility · doi:10.1016/j.fertnstert.2020.07.055 · Cited by 97
Morotti, M., Sozzi, F., Remorgida, V., Venturini, P. L., & Ferrero, S. (2014) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2014.10.036 · Cited by 84
Medical Treatments for Endometriosis-Associated Pelvic Pain
Zito, G., Luppi, S., Giolo, E., Martinelli, M., Venturin, I., Lorenzo, G. D., & Ricci, G. (2014) · BioMed Research International · doi:10.1155/2014/191967 · Cited by 94
“Regarding the optimal dose, in a European randomized controlled trial (RCT), the authors concluded that 2mg/day represents the optimal dosage, because it is well tolerated and less encumbered by side effects, in particular abnormal uterine bleeding, and it has little influence on bone mineral density (BMD) [33].”
BackgroundKlipping, C., Duijkers, I. J. M., Remmers, A., Faustmann, T. A., Zurth, C., Klein, S., & Schuett, B. (2011) · The Journal of Clinical Pharmacology · doi:10.1177/0091270011423664 · Cited by 84
“It is notable that dienogest 2 mg daily was associated with stable lum bar bone mineral density (BMD) in a recent 24week trial of women with endometriosis, whereas the com parator GnRH agonist (leuprolide acetate) induced a substantial decrease in BMD.(6) A 1year study of dienogest therapy in Japan reported no los…”
BackgroundMethodInfluentialSelf-citationStrowitzki, T., Marr, J., Gerlinger, C., Faustmann, T. A., & Seitz, C. (2012) · International Journal of Gynecology & Obstetrics · doi:10.1016/j.ijgo.2012.01.009 · Cited by 90
“Study methods for the comparative trial of DNG and LA have been described in detail previously [11].”
BackgroundMethodInfluentialSelf-citationMiyashita‐Ishiwata, M., Koga, K., Takamura, M., Izumi, G., Nagai, M., Harada, M., Hirata, T., Hirota, Y., Fujii, T., & Osuga, Y. (2014) · Gynecological Endocrinology · doi:10.3109/09513590.2014.911279 · Cited by 89
Römer, T. (2018) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-018-4864-8 · Cited by 82
The role of prostaglandin E 2 in endometriosis
Sacco, K. A., Portelli, M., Pollacco, J., Schembri-Wismayer, P., & Calleja‐Agius, J. (2011) · Gynecological Endocrinology · doi:10.3109/09513590.2011.588753 · Cited by 88
“Moreover, cases of depression were also reported [77,82].”
BackgroundTakaesu, Y., Nishi, H., Kojima, J., Sasaki, T., Nagamitsu, Y., Kato, R., & Isaka, K. (2016) · Journal of obstetrics and gynaecology research · doi:10.1111/jog.13023 · Cited by 79
Does dienogest influence the inflammatory response of endometriotic cells? A systematic review
Grandi, G., Mueller, M. D., Bersinger, N. A., Cagnacci, A., Volpe, A., & McKinnon, B. D. (2015) · Inflammation Research · doi:10.1007/s00011-015-0909-7 · Cited by 81
“production and serum concentrations [9–11].”
BackgroundSafety of medical treatments for endometriosis
Berlanda, N., Somigliana, E., Viganò, P., & Vercellini, P. (2016) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2016.1121991 · Cited by 78
Caruso, S., Iraci, M., Cianci, S., Casella, E., Fava, V., & Cianci, A. (2015) · Journal of Endocrinological Investigation · doi:10.1007/s40618-015-0383-7 · Cited by 76
National German Guideline (S2k): Guideline for the Diagnosis and Treatment of Endometriosis
Ulrich, U. A., Buchweitz, O., Greb, R. R., Keckstein, J., von Leffern, I., Oppelt, P., Renner, S. P., Sillem, M., Stummvoll, W., Wilde, R. L. D., et al. (2014) · Geburtshilfe und Frauenheilkunde · doi:10.1055/s-0034-1383187 · Cited by 75
Park, S. Y., Kim, S. H., Chae, H. D., Kim, C., & Kang, B. M. (2016) · Daehan saengsik uihak hoeji/Clinical and experimental reproductive medicine · doi:10.5653/cerm.2016.43.4.215 · Cited by 71
“216 showed that dienogest was as effective as leuprolide acetate (LA), which is considered to be one of the current standard therapies for endometriosis, in relieving the pain associated with endometriosis [7].”
BackgroundInfluentialValidation of the SF-36 in patients with endometriosis
Stull, D. E., Wasiak, R., Kreif, N., Raluy, M., Colligs, A., Seitz, C., & Gerlinger, C. (2013) · Quality of Life Research · doi:10.1007/s11136-013-0442-5 · Cited by 77
“…parallel-group, non-inferiority study investigating the efficacy and safety of daily oral administration of 2 mg dienogest versus intra-muscular administration of 3.75 mg leuprorelin acetate every 4 weeks for the treatment for symptomatic endo-metriosis in 248 subjects with endometriosis [40].”
InfluentialSelf-citationDienogest in the treatment of endometriosis
Bizzarri, N., Remorgida, V., Leone Roberti Maggiore, U., Scala, C., Tafi, E., Ghirardi, V., Salvatore, S., Candiani, M., Venturini, P. L., & Ferrero, S. (2014) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2014.943734 · Cited by 63
“A recent meta-analysis [52] included two studies [31,50] that compared the efficacy and safety profile of DNG and GnRH analogs, one performed in Europe and the other in a Japanese population.”
BackgroundMethodInfluentialA Lifelong Impact on Endometriosis: Pathophysiology and Pharmacological Treatment
Chen, L.-H., Lo, W.-C., Huang, H.-Y., & Wu, H. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24087503 · Cited by 94
Efficacy of dienogest in the treatment of symptomatic adenomyosis: a pilot study
Hirata, T., Izumi, G., Takamura, M., Saito, A., Nakazawa, A., Harada, M., Hirota, Y., Koga, K., Fujii, T., & Osuga, Y. (2014) · Gynecological Endocrinology · doi:10.3109/09513590.2014.926882 · Cited by 64
“The efficacy of dienogest for endometriosis-associated pelvic pain has been established [3–6,16] and has been shown to be comparable to that of GnRH agonists [3,4].”
BackgroundKatayama, H., Katayama, T., Uematsu, K., Hiratsuka, M., Kiyomura, M., Shimizu, Y., Sugita, A., & Ito, M. (2010) · Human Reproduction · doi:10.1093/humrep/deq241 · Cited by 68
“Because DNG exhibits antiovulatory activity (Moore, 1999), antiproliferative action on endometrial cells (Okada et al., 2001) and inhibits cytokine production by endometriotic cells (Horie et al., 2005), it is expected to have a therapeutic effect against endometriosis (Strowitzki et al., 2010).”
BackgroundA comprehensive review of hormonal and biological therapies for endometriosis: latest developments
Barra, F., Grandi, G., Tantari, M., Scala, C., Facchinetti, F., & Ferrero, S. (2019) · Expert Opinion on Biological Therapy · doi:10.1080/14712598.2019.1581761 · Cited by 69
“after 24 weeks in comparison with baseline [57].”
BackgroundResultLang, J., Yu, Q., Zhang, S., Li, H., Gude, K., Ludwig, C., Ren, X., & Dong, L. (2017) · Journal of Women s Health · doi:10.1089/jwh.2017.6399 · Cited by 64
“12,15,16 17–21 In clinical trials performed in Europe and Japan, dienogest has provided pain relief significantly superior to placebo 22,23 and equivalent to the GnRH agonists leuprolide acetate 24 and buserelin, 22 with tolerability advantages over these GnRH agonists.”
InfluentialWhen more is not better: 10 ‘don’ts’ in endometriosis management. An ETIC* position statement
Club, E. E. T. I., Alio, L., Angioni, S., Arena, S., Bartiromo, L., Bergamini, V, Berlanda, N., Bonin, C., Busacca, M., Candiani, M., et al. (2019) · Human Reproduction Open · doi:10.1093/hropen/hoz009 · Cited by 64
A stepped-care approach to symptomatic endometriosis management: A participatory research initiative
Vercellini, P., Donati, A., Ottolini, F., Frassineti, A., Fiorini, J., Nebuloni, V., Frattaruolo, M. P., Roberto, A., Mosconi, P., & Somigliana, E. (2018) · Fertility and Sterility · doi:10.1016/j.fertnstert.2018.01.037 · Cited by 64
Taha, L. E., Musa, A. A., Khalifeh, D., Khalil, A., Abbasi, S. A., & Nassif, J. (2021) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2021.10.029 · Cited by 62
Granese, R., Perino, A., Calagna, G., Saitta, S., FRANCISCIS, P. D., Colacurci, N., Triolo, O., & Cucinella, G. (2015) · Acta Obstetricia Et Gynecologica Scandinavica · doi:10.1111/aogs.12633 · Cited by 63
“In addition, there are advantages in safety and tolerability, including a reduced incidence of hypoestrogenic effects and minimal change in bone mineral density (5).”
BackgroundInfluentialSeo, J.-W., Lee, D., Yoon, B.-K., & Choi, D. (2017) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2017.03.011 · Cited by 63
Fawzy, M., & Mesbah, Y. (2015) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-015-3755-5 · Cited by 62
“The efficacy of dienogest for endometriosis-associated pelvic pain has been established [13].”
Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis
Becker, K., Heinemann, K., Imthurn, B., Marions, L., Moehner, S., Gerlinger, C., Serrani, M., & Faustmann, T. A. (2021) · Scientific Reports · doi:10.1038/s41598-021-99681-3 · Cited by 56
Self-citationCeccaroni, M., Clarizia, R., Liverani, S., Donati, A., Ceccarello, M., Manzone, M., Roviglione, G., & Ferrero, S. (2021) · Gynecological Endocrinology · doi:10.1080/09513590.2021.1929151 · Cited by 56
“Leuprolide Acetate about pelvic pain and life quality [20,21].”
BackgroundNew trends of progestins treatment of endometriosis
Angioni, S. L., Cofelice, V., Pontis, A., Tinelli, R., & Socolov, R. V. (2014) · Gynecological Endocrinology · doi:10.3109/09513590.2014.950646 · Cited by 60
“leuprolide acetate for relieving endometriosisassociated pain; compared with depot leuprolide acetate, DNG was associated with a favorable safety profile in this randomized trial; so, DNG may offer an effective and well tolerated treatment in endometriosis [32].”
MethodKitawaki, J., Kusuki, I., Yamanaka, K., & Suganuma, I. (2011) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2011.03.012 · Cited by 65
Use of dienogest over 53 weeks for the treatment of endometriosis
Sugimoto, K., Nagata, C., Hayashi, H., Yanagida, S., & Okamoto, A. (2015) · Journal of obstetrics and gynaecology research · doi:10.1111/jog.12811 · Cited by 60
“A number of studies conducted on the efficacy and tolerability of DNG show that its therapeutic effects on endometriosis are equivalent to those of GnRHa,with fewer hypo-estrogenic symptoms, such as hot flushes and decreased bone mineral density.(4,8,9) DNG is currently approved for the treatment of endometriosis in t…”
BackgroundOral and depot progestin therapy for endometriosis: towards a personalized medicine
Buggio, L., Somigliana, E., Barbara, G., Frattaruolo, M. P., & Vercellini, P. (2017) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2017.1381086 · Cited by 58
“[26] observedminimal changes in bone turnovermarkers and lumbar spine BMD after 6 months of DNG treatment.”
BackgroundGrandi, G., Mueller, M. D., Bersinger, N. A., Papadia, A., Nirgianakis, K., Cagnacci, A., & McKinnon, B. D. (2016) · American Journal of Reproductive Immunology · doi:10.1111/aji.12552 · Cited by 57
Dienogest reduces endometrioma volume and endometriosis-related pain symptoms
Uludağ, S. Z., Demirtaş, E., Şahin, Y., & Aygen, E. (2021) · Journal of Obstetrics and Gynaecology · doi:10.1080/01443615.2020.1867962 · Cited by 49
“Treatment of endometriosis with dienogest for 12weeks was more effective than the placebo in reducing endometriosis-associated pain with tolerable adverse events (Strowitzki et al. 2010a).”
BackgroundAdachi, K., Takahashi, K., Nakamura, K., Otake, A., Sasamoto, N., Miyoshi, Y., Shioji, M., Yamamoto, Y., Fujitani, M., Wakimoto, A., et al. (2016) · Gynecological Endocrinology · doi:10.3109/09513590.2016.1147547 · Cited by 53
“have reported that long-term dienogest is well tolerated and has a favorable safety profile, including a low incidence of hypoestrogenic effects and minimal change in bone mineral density [10].”
BackgroundImpact of Medical and Surgical Treatment of Endometriosis on the Cure of Endometriosis and Pain
Mettler, L., Ruprai, R., & Alkatout, İ. (2014) · BioMed Research International · doi:10.1155/2014/264653 · Cited by 54
“Up to now, this theory “The production of pseudopregnancy” has been regarded as the “gold standard,” but it is now supplemented by a simple progesterone (dienogest, 2mg per day) treatment or a GnRh analogue treatment with add-back therapy [2].”
MethodEvaluation and treatment of endometriosis.
Schrager, S., Falleroni, J., & Edgoose, J. Y. C. (2013) · PubMed · Cited by 54
Ezzati, M., & Carr, B. R. (2015) · Women s Health · doi:10.2217/whe.14.68 · Cited by 54
Endometriosis: Diagnosis and Management
Leyland, N. A., Casper, R. F., Laberge, P. Y., Singh, S. S., Allen, L. M., Arendas, K., Leyland, N. A., Allaire, C., Awadalla, A., Best, C., et al. (2010) · Journal of Endometriosis and Pelvic Pain Disorders · doi:10.1177/228402651000200303 · Cited by 52
Khalifa, E. M., Mohammad, H., Abdullah, A., Rasheed, M. A., Khairy, M., & Hosni, M. (2021) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-021-03736-2 · Cited by 43
Heinemann, K., Imthurn, B., Marions, L., Gerlinger, C., Becker, K., Moehner, S., & Faustmann, T. A. (2020) · Advances in Therapy · doi:10.1007/s12325-020-01331-z · Cited by 45
Self-citationMorelli, M., Sacchinelli, A., Venturella, R., Mocciaro, R., & Zullo, F. (2013) · Journal of Obstetrics and Gynaecology Research · doi:10.1111/jog.12030 · Cited by 52
Hassanin, A. I., Youssef, A. A., Yousef, A. M., & Ali, M. K. (2021) · International Journal of Gynecology & Obstetrics · doi:10.1002/ijgo.13600 · Cited by 46
Progestin Therapy in Endometriosis
Gezer, A., & Oral, E. (2015) · Women s Health · doi:10.2217/whe.15.42 · Cited by 50
Effectiveness of Dienogest for Treatment of Recurrent Endometriosis: Multicenter Data
Lee, J. H., Song, J. Y., Yi, K. W., Lee, S. R., Lee, D.-Y., Shin, J.-H., Cho, S., Seo, S. K., & Kim, S. H. (2018) · Reproductive Sciences · doi:10.1177/1933719118779733 · Cited by 44
“42 for the primary outcome.(13) A total of 6 evaluable patients were required to yield a power (1 b) of 90% to demonstrate the efficacy of DNG treatment.”
BackgroundResultInfluentialOn-label and off-label drug use in the treatment of endometriosis
Quaas, A. M., Weedin, E. A., & Hansen, K. R. (2015) · Fertility and Sterility · doi:10.1016/j.fertnstert.2015.01.006 · Cited by 45
Grandi, G., Xholli, A., Napolitano, A., Palma, F., & Cagnacci, A. (2014) · Reproductive Sciences · doi:10.1177/1933719114556488 · Cited by 46
Effects of Dienogest on Surgically Induced Endometriosis in Rats after Repeated Oral Administration
Fischer, O. M., Kaufmann-Reiche, U., Moeller, C., & Fuhrmann, U. (2011) · Gynecologic and Obstetric Investigation · doi:10.1159/000331642 · Cited by 36
Clinical Diagnosis and Early Medical Management for Endometriosis: Consensus from Asian Expert Group
Kim, M.-R., Chapron, C., Römer, T., Aguilar, A., Chalermchockcharoenkit, A., Chatterjee, S., Đào, L. T. A., Fong, Y. F., Hendarto, H., Hidayat, S. T., et al. (2022) · Healthcare · doi:10.3390/healthcare10122515 · Cited by 43
Dienogest. A possible conservative approach in bladder endometriosis. Results of a pilot study
Angioni, S., Nappi, L., Pontis, A., Sedda, F., Luisi, S., Mais, V., & Melis, G. B. (2015) · Gynecological Endocrinology · doi:10.3109/09513590.2015.1006617 · Cited by 45
Cho, B., Roh, J.-W., Park, J., Jeong, K., Kim, T.-H., Kim, Y. S., Kwon, Y.-S., Cho, C.-H., Park, S. H., & Kim, S. H. (2020) · Reproductive Sciences · doi:10.1007/s43032-019-00094-5 · Cited by 44
Samy, A., Taher, A. M., Sileem, S., Abdelhakim, A. M., Fathi, M. M., Haggag, H. M., Ashour, K., Ahmed, S. A., Shareef, M. A., AlAmodi, A. A., et al. (2020) · Journal of Gynecology Obstetrics and Human Reproduction · doi:10.1016/j.jogoh.2020.101798 · Cited by 44
Fukuda, S., Hirata, T., Neriishi, K., Nakazawa, A., Takamura, M., Izumi, G., Harada, M., Hirota, Y., Koga, K., Wada-Hiraike, O., et al. (2018) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2018.04.021 · Cited by 44
“However, OCs and dienogest are optimal for patients with mild symptoms as shown in this study because unlike GnRH agonists, they do not induce hypo-estrogenic effects even after long-term treatment [16,17].”
BackgroundMehdizadehkashi, A. (2017) · Pain Physician · doi:10.36076/ppj.2017.195 · Cited by 46
“Among these 23 studies, there were 7 (14-20) and 16 (21-36) studies with surgical and medical treatments, respectively.”
BackgroundDienogest, a new conservative strategy for extragenital endometriosis: a pilot study
Harada, M., Osuga, Y., Izumi, G., Takamura, M., Takemura, Y., Hirata, T., Yoshino, O., Koga, K., Yano, T., & Taketani, Y. (2011) · Gynecological Endocrinology · doi:10.3109/09513590.2010.533800 · Cited by 43
“Other studies showed that dienogest is as effective as buserelin acetate [12] or leuprolide acetate [13] and significantly more effective than placebo [14] in relieving the painful symptoms of endometriosis.”
BackgroundD’Alterio, M. N., Saponara, S., Agus, M., Laganà, A. S., Noventa, M., Loi, E. S., Féki, A., & Angioni, S. L. (2021) · Gynecological Surgery · doi:10.1186/s10397-021-01096-5 · Cited by 41
“WHOQOLBREF Strowitzki et al. 2010 [53] Randomized, double-blind, placebocontrolled study 188 n = 90 Placebo n = 98 Dienogest 18-45 Dienogest at a dose of 2 mg daily for 12 weeks Not specified Quality-of-life analyses indicated greater improvements in the dienogest group for two of eight SF-36…”
MethodInfluentialMita, S., Shimizu, Y., Sato, A., Notsu, T., Imada, K., & Kyo, S. (2013) · Fertility and Sterility · doi:10.1016/j.fertnstert.2013.10.038 · Cited by 43
Metadata
- Authors
- Strowitzki, T., Marr, J., Gerlinger, C., Faustmann, T., & Seitz, C.
- Affiliations
- Heidelberg University (DE)
- Bayer (Germany) (DE)
- Venue
- Human Reproduction
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-01-19
- Volume
- 25
- Issue
- 3
- Pages
- 633-641
- ISSN
- 0268-1161 (ISSN-L)
- 1460-2350
- OpenAlex
- W2101417341
- Cited by
- 381
- References
- 38
- Citations by year
- 2026: 15 · 2025: 17 · 2024: 23 · 2023: 26 · 2022: 13 · 2021: 27 · 2020: 19 · 2019: 16 · 2018: 29 · 2017: 31 · 2016: 17 · 2015: 42 · 2014: 26 · 2013: 24 · 2012: 22
- FWCI
- 30.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Human Reproduction (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Obstetrics and Gynecology › Ectopic Pregnancy Diagnosis and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
- Keywords
- dienogest, leuprolide, endometriosis, pelvic pain, GnRH agonist, non-inferiority, bone mineral density, bone resorption markers, bleeding patterns, safety and tolerability
- MeSH terms
- Adult, Endometriosis, Female, Humans, Nandrolone, Progestins, Quality of Life, Bone Density, Leuprolide, Pelvic Pain
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