- The gist of this article
The pharmaceutical industry uses a special statistic sleight of hand to inflate the marginal and negligible absolute benefits of certain medicines. Example: Aspirin® in cases of Cardiovascular problems. Instead of presenting the truth, results of clinical trials are grossly inflated by misrepresenting them in terms of “relative risk” or “relative benefit.” In light of the impressive absolute benefits produced by supplementing the diet with Masquelier’s OPCs, there is no need to use this statistical “technique” to inflate these results and present them in terms of OPCs’ relative benefits.
Table of contents
What is absolute risk or benefit ?
Suppose you wish to investigate the effect of a cardiovascular drug by measuring whether it reduces the mortality rate in a relevant group of patients. You design a clinical study among 1.000 people who are at risk of dying from heart disease. You randomly divide them in 2 groups of 500 subjects each. You give Group 1 the medicine you wish to investigate, the “verum” or “real thing,” while Group 2 gets an inert “placebo,” the “fake thing.” At the end of the trial, you count the number of deaths and find that in the medicine-Group 1 subject died, while in the placebo-Group 2 subjects died. Normal people will not be very impressed, because the “gain” is 1 person out of 499, the other person would have died anyway, as shown in the placebo group. In terms of absolute risk/benefit, the genuine efficacy of your medicine is 2 ‰ (2 promille), meaning that instead of 4 persons per 1.000 you now have 2 persons who died.
Next time, ask your doctor to explain
When you express the results of the theoretic study described in the previous paragraph in terms of relative risk, your efficacy soars from 2‰ (2 promille) to 50% (50 percent !!!), since you’ve saved the lives of 2 out of 4 people. Obviously, this is a gross and misleading misrepresentation of the facts, but the pharmaceutical industry loves it and the authorities tasked with regulating medicinal products and your health don’t seem to mind. If you’d fall into the category of cardiovascular risk, wouldn’t you want to slash your risk of dying by 50% !!! But, wouldn’t you be very disappointed to hear that your chances would not exceed the 2 promille (2‰) threshold. So, the next time your doctor prescribes you a medicine, ask him to explain its activity in terms of absolute benefits or absolute risk reduction.
Upscaling your study !
Now, let’s say that you would upscale your cardiovascular study to an impressive group of 10.000 people. That would make the group and the study “statistically relevant.” Suppose that now you’d find that instead of 30 people in the placebo Group, “only” 15 people died of a cardiovascular incident in the medicine Group. You’ve now saved the lives of 15 out of 10.000 patients, which is, in terms of absolute risk/benefit 1.5‰ (1.5 promille). Your product turns out to be 25% less effective when used by 10.000 people. However, in terms of relative risk, your product would still show an “efficacy” of 50% because you’ve saved the lives of 15 out of 30 people.
In an earlier article Aspirin®, Masquelier’s OPCs and Cardiovascular Health, I had already drawn the readers’ attention to the fact that long-term Aspirin® treatment yields an average 12% relative risk reduction in major cardiovascular events (i.e. myocardial infarction, stroke, or vascular death), but that this average relative risk reduction of 12% shrinks to 0.08% when calculated as absolute risk reduction. [i] Meaning that out of 10.000 people not 1.200 but no more than 8 people will experience benefits.
Example: Masquelier’s OPCs and venous insufficiency
Venous insufficiency in the legs, in some cases accompanied insufficiency of the valves in the veins, manifests itself essentially in the lower parts of the legs as: sensation of heaviness, tired legs, swelling sensations, itching, prickling and cramps. All these conditions are the result of capillary weakness. In 1985, French researchers studied the effects of daily intake of Masquelier’s OPCs during a period of 4 weeks by a group of 92 people suffering from various signs of venous insufficiency. [ii] They checked the following criteria: heaviness, pain, fatigue, swelling, tingling or creeping sensations, nocturnal cramps and swelling of the feet. Each criterion was rated for its intensity, according to a standard scale: 0: absent; 1: mild; 2: average; 3: severe or intense. The sum of the valuations could, therefore, vary between 0 and 12 points. The lower the score, the better the condition of the legs.
Benefits in 75% of the “OPCs” group
Without knowing what they were actually taking, the subjects supplemented their daily diets with either 300mg/day of Masquelier’s OPCs or an inert placebo. All in all, 32 people took Masquelier’s OPCs, while 39 people took the placebo. The principal outcome was presented as the difference between the two scores measured at Days 0 and 28. At the start of the trial the average score was 6.9 points in the “OPCs” group and 5.8 points in the placebo group. After 4-weeks of supplementation, the average result was 2.3 points in the “OPCs” group and 3.2 points in the placebo group, representing an improvement of 4.6 points versus 2.6 points respectively. A beneficial effect was observed in 24 of the 32 participants who supplemented their diet with Masquelier’s OPCs (75% of the cases), while this effect was observed in only 16 out of 39 subjects who took the placebo (41% of the cases).
Results in terms of absolute and relative benefits
Calculated as absolute and relative benefits, the absolute benefits occurred in 75% of the “OPCs” group, while the absolute benefit of the placebo occurred in 41% of the “placebo” group. In terms of relative benefits, the improvement shows a 183% increase of the beneficial results when those obtained in the “placebo” group are compared with those obtained in the “OPCs” group. Benefits went up from 41% to 75% by taking OPCs. Meaning that, strictly speaking, 34% of the participants would not have shown vascular benefits had they not taken Masquelier’s OPCs. Compare this to the cardiovascular benefits of Aspirin®, which scores a negligible 0.08% in absolute cardiovascular risk reduction, which corresponds to an inflated yet meager 12% relative risk reduction in major cardiovascular events (i.e. myocardial infarction, stroke, or vascular death).
What about the placebo effect ?
When people participate in clinical trials like the one performed with Masquelier’s OPCs, there is always a mysterious placebo effect. A “fake” compound that is inert still produces an effect. This magical effect occurs because participants somehow improve their condition for no other reason than that they participate in a clinical trial. Being actively involved in a study seems to somehow “boost” the healing powers of some people, even when after all they haven’t taken the active ingredient. This is the reason why benefits were observed in 41% of the participants in the placebo group of the aforementioned venous insufficiency study. However, we may safely assume that this placebo effect would not have spontaneously occurred had the placebo-takers not participated in the clinical trial. Still, when we deduct the placebo-effect from the OPCs-effect, the absolute benefits of Masquelier’s OPCs may safely be presented as occurring in 34% of all people suffering from venous insufficiency.
[i] Aspirin for primary prevention of vascular events in women: individualized prediction of treatment effects; Johannes A.N. Dorresteijn Frank L.J. Visseren Paul M Ridker Nina P. Paynter Annemarie M.J. Wassink Julie E. Buring Yolanda van der Graaf Nancy R. Cook; European Heart Journal, Volume 32, Issue 23, December 2011, Pages 2962–2969.
[ii] Étude de l'Endotelon® dans les manifestations fonctionelles de l'insuffisance veineuse périphérique. Résultats d'une en double aveugle portant sur 92 patients. J.F. Thebaut, P. Thebaut et F. Vin. Centre Alfred Kastler. Boulevard Alexis Carrel, Sarcelles. Gazette Medicale 1985; 92(12): 96-100.